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Immunization Rules docket 0900-30570
Wednesday, July 17, 2013 4:25:47 PM
Draft #14 4 oclock before Anne..docx
Dear Court:
The attached are addition comment for Immunization Rules docket 0900-30570
Thank you so much.
Diane Miller
www.nationalhealthfreedom.org
Phone: 507-663-9018
Fax: 507-663-9013
OAH Docket No. 8-0900-30570
(Revisor No. RD4101)
BEFORE
MINNESOTA ADMINISTRATIVE LAW JUDGE ERIC LIPPMAN
FOLLOW-UP ADDITIONAL COMMENTS AFTER
PUBLIC HEARING ON RULEMAKING HELD ON JUNE 17, 2013
MINNESOTA DEPARTMENT OF HEALTH
ADDITIONAL COMMENTS OF
NATIONAL HEALTH FREEDOM ACTION
ON THE MDH PROPOSED AMENDMENTS TO RULES GOVERNING CHILD CARE
AND SCHOOL IMMUNIZATIONS
Entitled:
“Proposed Permanent Rules Relating to Immunization of School Age Children and Children
in Child Care and School-Based Early Childhood Programs”
Comments Submitted July 17, 2013
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
In 1967 Minnesota passed its first vaccine reporting mandates for parents regarding whether or not their
child had been vaccinated against a dangerous contagious disease before enrolling in school. The parents
were asked to report whether or not their child had been vaccinated against measles. 1 The law included
a medical and religious exemption in the event parents did not wish to vaccinate their child. 2
There has been a profound and expansive evolution since that time in the understanding of health and
health care systems on a state, national, and international basis including changes in the way that
governments interface with the health care systems and are used to impact health. The cultural context of
the 1967 epidemic prevention reporting law and the role of the state and federal governments in health
care policy has changed and are important considerations for the forthcoming legal discussion of whether
the proposed rule recommendations for the addition to the Minnesota School Immunization Schedule are
reasonable and necessary, whether the current MN 121A.15 is constitutional, and whether the broad
delegation of rulemaking power to the Minnesota Department of Health regarding School Immunization
Reporting Schedules is an impermissible delegation of power. We hereby offer this analysis for
consideration:
I. Are the proposed Amendment to Rules Governing Child Care and School Immunizations,
Minnesota Rues Part 4604.0100-4604.1020 (hereinafter proposed rules), including but not limited to
the addition of hepatitis B and meningococcal vaccines to the School Immunization Schedule
unreasonable and unnecessary because they are agency actions without consideration and in
disregard of the facts and circumstances before it and unsupported by the evidence?
II. Are the current MN 121A.15 and proposed Amendment to Rules Governing Child Care and
School Immunizations unconstitutional, because:
A. MN Stat 121A.15 and the proposed regulations go beyond the state police power
parameters described in Jacobson for compulsory vaccination of citizens supporting
necessary state action to be taken when citizens are endangered by dangerous contagious
epidemic diseases prevalent and increasing; and
B. MN Stat 121A.15 and the current proposed rules (implementing a disease prevention
program) require a strict or intermediate scrutiny analysis of constitutionality rather than
a rational basis review to address the fundamental rights and liberties of the targeted
population for injection of vaccines; and
1
2
MN Stat. 123.05 1967
Id.
2
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
C. MN Stat 121A.15 provides for an overly broad and impermissible delegation of
rulemaking power to the Minnesota Department of Health to modify the Reporting
Schedule of Immunization for School Children exclusively allowing only federally
recommended protocols and prohibiting the state from acting when it needs to on behalf of
its citizens?
Unreasonable and Unnecessary
I. The proposed rules, including but not limited to the addition of hepatitis B and meningococcal
vaccines to the School Immunization Schedule are unreasonable and unnecessary because they are
agency actions without consideration and in disregard of the facts and circumstances before it and
unsupported by the evidence.
Epidemic Urgency as Compared to Prevention:
The Minnesota Department of Health (hereinafter Department), begins their promotion of the proposed
rules by claiming that “In 1967, the Minnesota Legislature enacted the Minnesota School Immunization
law (Minnesota Statutes, section 121A.15) to ensure that school children are protected against vaccinepreventable diseases (bold added) in an appropriate and timely manner and to prevent epidemics of
vaccine-preventable diseases in the community.” 3 However it does not sight where they find the term
“vaccine-preventable disease” in the law or literature. We contend that the 1967 law was not passed to
protect against “vaccine-preventable diseases” but rather was passed more in line with Jacobson v.
Massachusetts 4 in that it was being put forth for an emergency to protect against a dangerous epidemic
that was “prevalent and increasing” 5
In 1967 we contend that the measles was seen by the Minnesota legislature, as the next smallpox, and
most likely feared as the next dangerous contagious disease that could potentially cause a perilous
epidemic. It was most certainly not mandated simply because it was a vaccine-preventable disease, but
rather because it rested under the shadow of the smallpox history. The term “vaccine-preventable
diseases” is introduced to us and presented by the Department as if it were a legally binding term. But
our understanding of this term is that it is a vaccine policy and industry term to assist in the promotion of
the use of vaccines and the adoption of vaccine mandates and recommendations for disease prevention.
The term and the proposed rules to add additional vaccines to the already heavy burden carried by
Minnesota children under the Minnesota School Immunization Schedule goes far beyond the spirit and
vision of Jacobson where vaccines were considered a balancing of liberty interests necessity for times of
dire emergency to protect against a dangerous epidemic to a population, a danger that was prevalent and
increasing. The 1967 law, (which was at the time cited as MN Stat. 123.70) does not mention any intent
3
Sonar Pg. 1
Jacobson v. Massachusetts, 25 S. Ct. 358, 197 U.S. 11, 49 L.Ed. 643, 1905
5
Jacobson v. Massachusetts Id. At Pg. 27 and 28.
4
3
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
to ensure that school children are protected against “vaccine-preventable diseases” and today the term
“vaccine-preventable diseases” is nowhere to be found in Minnesota current law. The 1967 law read:
123.70 HEALTH STANDARDS; NEWLY ENROLLED STUDENTS. Subdivision
1. Prior to his initial enrollment in any school in this state every child shall
submit to the principal or other person having general control and supervision of
the school, one of the following statements: (1) a statement signed by a physician
that he has received immunization against measles by such means as is approved
by the state board of health and that such immunization is currently effective; or
(2) a statement signed by a physician that the physical condition of the child is
such that immunization would seriously endanger his life or health; or (3) a statement
signed by his parent or guardian that he has not been immunized as prescribed
in clause (1) because he is being reared as an adherent of a religious denomination
whose teachings are opposed to such immunization; or (4) a request
signed by his parent or guardian that the local health officer administer the prescribed
immunization.
Subd. 2. The local school administrator shall, without delay, notify the local
board of health, which shall provide, without delay, the immunization requested by
this section to those children under subdivision 1, clause (4), at public expense.
U967 c 858 s 1,21 6
Minnesota, like many states in 1967, was experiencing relief of the eradication of smallpox, a dangerous
contagious disease that had been of epidemic proportion. The last Minnesota case of smallpox was in
1947, and smallpox was well on its way to complete eradication in 1977. 7 In 1967 Minnesota had laws
on how the state board of health could successfully exercise its police power regarding smallpox and
other dangerous contagious diseases that could potentially cause a similar epidemic. For example
regarding the state’s role in suppression of epidemics: “All local health boards of each county shall
cooperate so far as practicable and the state board by written order may require any two or more local
boards to act together for the prevention or suppression of epidemic diseases. 8 and “The state board of
health shall exercise general supervision overall health officers and boards, take cognizance of the
interests of health and life among the people, investigate sanitary conditions, learn the cause and source
of diseases and epidemics, observe the effect upon human health of localities and employments, and
gather and diffuse proper information upon all subjects to which its duties relate. .. 9 and for example the
state’s role in Tuberculosis, another dangerous contagious disease that could potential cause an epidemic
“The employees of all school districts, as defined in section 120.02, shall prior to employment and
annually thereafter show freedom from tuberculosis by a report of a tuberculin test or chest x-ray
examination…” 10.
6
MN Stat. 123.70, 1967
MDH: Overview of Smallpox 2002, accessed power point online July 12, 2013 @
www.health.state.mn.us/divs/idepc/diseases/smallpox/...
8
MN Stat 145.01, 1967
9
MN Stat 144.05, 1967
10
MN Stat 123.69, 1967
7
4
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
By 1983, the Department of Health had effective rules in place for prevention of communicable diseases
in general, and the MN Rules included many preventive measures such as quarantines, physician
reporting of disease, disinfection of premises, exclusion of children from school when experiencing
communicable diseases such as “(tonsillitis, mumps, conjunctivitis, impetigo contagiosa, itch, ringworm,
etc.) or a parasitic infection (lice or other vermin)…” 11
The nature of the communicable disease laws has changed over the years as the state of Minnesota has
begun to recommend vaccines for children before they enroll in school. Due to the number of vaccine
recommendations, the state has actually developed a schedule. . In 1988 the legislature passed
exemptions for parents who did not want their children to receive the vaccines. 12 Over the years the
legislature and the Department added more vaccines to the recommended schedule but there has been a
gradual trend to add vaccines that are not imminently dangerous threatening the annihilation of the
population, i.e. chickenpox vaccine. 13 Minnesota now promotes multiple vaccines including dozens of
doses of foreign antigens and including additives and adjuvants to be injected into young children.
It is NHFA’s contention that the current MN121A.15 and the proposed rules are not reflective of the facts
in Jacobson v. Massachusetts and are not focused on protecting the public from dangerous population
epidemics present and imminent, but rather have evolved into general disease prevention laws and are
now being used to promote one form of treatment, namely the use of federally promoted vaccines, over
other options to support immunity. The statute and rules are promoting the injection of federally
recommended foreign antigens into the bodies of children, for the purpose of disease prevention without
consideration of the proper limits on police power to do so.
Reasonable and Necessary:
NHFA believes the Department improperly determined that its recommended modifications for
Hepatitis B and Meningococcal vaccines are reasonable and necessary because the explanation
for creating the modifications is unsupported by the evidence, is unreasonable, and fails to
consider important angles of the matter. NHFA will demonstrate how the Department’s
consideration of the criteria, required to be considered by the Department in proposing
modifications, is inadequate for the hepatitis B and meningococcal vaccines in turn, below.
The Department’s power to make modifications to the immunization schedule is not absolute.
An example of a limitation on the power to modify is that a proposal must be one that appears in
11
MN Rule 4605.1300, 1983
MN Stat 121A.15 Subd. 3.
13
In the Matter of the Proposed Rules Relating to Child Care and School Immunizations, MN Rules, Chapter 4604,
Report of the Administrative Law Judge, 2003
12
5
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
the current immunization recommendations of Federal and Occupational organizations. 14
Additionally, in proposing a modification, the department must consider six criteria listed in the
statute. 15 Further constraints on the Department’s power to modify the immunization schedule
are found in the requirements in chapter 14. 16
Under Minn. Stat.§ 14.14 subd.2 and Minn. Rule 1400.2100, a determination must be made in a
rulemaking proceeding as to whether the agency has established the need for and reasonableness
of the proposed rule by an affirmative presentation of facts. 17 The question of whether a rule has
been shown to be reasonable focuses on whether it has been shown to have a rational basis, or
whether it is arbitrary, based upon the rulemaking record. 18 A rule is generally considered
reasonable if it rationally related to the end sought to be achieved by the governing statute. 19
Arbitrary or unreasonable agency action is action without consideration and in disregard of the
facts and circumstances of the case. 20 Although the Agency has broad leeway regarding the facts
on which it may rely in support of a proposed rule 21 and the agency is entitled to make choices
between possible approached as long as the choice made is rational 22, in order to determine if the
agency acted arbitrarily and capriciously the court must make a "searching and careful" inquiry
of the record to ensure that the agency action has a rational basis. 23 The Agency’s burden in
adopting rules requires the agency to “explain on what evidence it is relying and how the
evidence connects rationally with the agency’s choice of action to be taken.” 24 Simply saying
that a particular rule is reasonable does not make it so. 25 Requiring an agency to explain its
methodology or reasoning when support for its conclusions is not readily discernible on the
evidentiary record, as when the agency must make a judgment call, is not some idle exercise in
judicial officiousness. 26 The purpose of "articulated standards and reflective findings" is to
14
Minn. Stat. subd. 12(a)(Federal and Occupational organizations include: the United States Public Health Service's
Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American
Academy of Pediatrics).
15
Minn. Stat. 121.A15 subd.12(a)(2). Criteria to be considered include: the epidemiology of the disease, the
morbidity and mortality rates for the disease, the safety and efficacy of the vaccine, the cost of a vaccination
program, the cost of enforcing vaccination requirements, and a cost-benefit analysis of the vaccination. Id.
16
Id. at subd. 12(c).
17
Minn. Stat.§ 14.14 subd.2; Minn. Rule 1400.2100
18
19
Mammenga v DHS, 442 N.W.2d 786 (Minn. 1989); Broen Memorial Home v. Dept. of Human Services, 364
N.W.2d 436 (Minn. Ct. App. 1985).
20
Greenhill v. Bailey, 519 F.2d 5 (8th Cir. 07/21/1975)
21
Mammenga v DHS, 442 N.W.2d 786 (Minn. 1989); Manufactured Housing Institute v. Pettersen, 347 N.W.2d
238, 244 (Minn. 1984).
22
FSA v Quaker Oats Co, 318 U.S. 218 (U.S. 03/01/1943)
23
Manufactured Housing Institute v. Pettersen, 347 N.W.2d 238, 244 (Minn. 1984).
24
Manufactured Housing Institute v. Pettersen, 347 N.W.2d 238, 244 (Minn. 1984).
25
Id.
26
Id.
6
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
ensure "furtherance of even-handed application of law, rather than impermissible whim,
improper influence, or misplaced zeal." 27
Analysis of Proposed Rules by Topic
(a)
Part 4604.0810 Hepatitis B Vaccination - The Department’s conclusion that
the proposed Hepatitis B vaccination requirement is a reasonable and
necessary change is unreasonable (would be held to be arbitrary and
capricious upon judicial review) because the explanation for creating the
modification is unsupported by the evidence and the department fail to
consider an important angle of a matter.
The Department is proposing to add Hepatitis B vaccination to the list for all children over 2
months old enrolling or enrolled in child care or a school-based early education program. 28
Currently, no hepatitis B immunization requirement exists for children in child care; only
children in kindergarten and seventh grade must show documentation of receipt of this vaccine
or a legal exemption. 29 The department concludes that this change is reasonable and necessary
to ensure that all children are protected against this disease. 30 Another stated motivation for its
strategy is “the chance of eliminating or greatly reducing the incidence of this disease in the
United States in one or two generations.” 31
At the Hearing the Department primarily relied upon the SONAR as its affirmative statement of
need and reasonableness for the proposed amendments. In making its determination of need and
reasonableness for the new Hepatitis B requirement, the Department documented consideration
of and findings on the relevant statutory factors of criteria for proposing a modification to the
immunization schedule. Although the department considered each of the six factors, the
departments findings on several of the factors are not supported by, and are counter to, evidence
in the record and do not reflect consideration of important aspects of the matter. In light of the
record as a whole, the decision is so implausible that it cannot be ascribed to a difference in view
or the product of agency expertise. The decision appears to be based on an overreaction to the
nature of the disease and a desire to align with federal recommendations rather than a reasoned
determination of the matter based on the record.
Epidemiology and Morbidity/Mortality Rates of the Disease
27
Id.
MDH, Summary of Proposed School and Child Care Immunization Law Changes (last updated April 25, 2013);
MDH SONAR p22-30.
29
Id.
30
SONAR p23.
31
Id.
28
7
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
In consideration of factors one and two, Epidemiology and Morbidity/Mortality Rates of the
Disease, the Department took notice of the Clinical Manifestations, Epidemiology, Childhood
Risk, and Transmission of Hepatitis B. 32 The findings were correct with regard to the
description of the various health problems potentially associated with acute and chronic
infections of Hepatitis B and in acknowledging that the majority of people with the disease show
no symptoms of infection. 33 The Department also correctly observed that an 82% reduction in
rates of Hepatitis B disease has occurred since 1991 and highlighted that this reduction has been
most dramatic among children. 34
Additional findings in this section, however, are based on the department’s erroneous attribution
of the dramatic decrease in rates of US cases of Hepatitis B since 1991 to the implementation of
routine Hepatitis B vaccination in 1991. The evidence before the Department clearly reveals that
the decline observed from 1991 onward was in fact a continuation of a decline that began several
years earlier for other reasons. The department fails to mention that the decline began before
1991. Since it is not mentioned, the department also failed to provide any explanation as to the
cause for the reduction in incidence of disease that occurred between 1988 and 1991 and why
that cause could not equally be attributed with the dramatic reduction or why the observed
reduction achieved could not have been reached without the 1991 implementation of routine
vaccination for Hepatitis B. There are clear peaks in the graph provided on page 25 of the
SONAR revealing that a pre-1991 reduction in the incidence of the disease was occurring, but
the Department makes no effort at explaining why it’s charts point to a reduction starting date of
2 years earlier than the year the Department credits for reduction. Why is the Department not
giving consideration to changes in vaccine policy occurring at the graph’s indicated reduction
starting date, which is closer to 1988?
If the Department had thoroughly examined causes for the reduction and acknowledged the
discrepancy between its conclusion that 1991 policy changes were responsible for the decline
and the evidence that the decline began before 1991, the Department would have discussed in
depth the screening program of pregnant women for hepatitis B which began in 1988. The
Department makes cursory mention of this program only twice: once in the introductory
comments preceding the factors analysis and again in the section responding to opposition to the
new Hepatitis B requirement.
In the first instance, the screening program is noted as a part of the evolution of the vaccination
strategy for Hepatitis B but there is no discussion of the breadth of the program, let alone any
discussion of its effectiveness. The failure to elucidate the program and its effective
contributions to the reduction in the incidence of disease is additionally troubling in light of the
32
Id. at 23-26.
P 24, clinical manifestations
34
Id., Epidemiology
33
8
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
Department misrepresentation of the causes for the evolving strategy. The Department claims
that the ACIP 1991 recommendation resulted because “the incidence of Hepatitis B in the US
remained unchanged 10 years after the vaccine was introduced (1981-1991).” This is
problematic for the reasons articulated above (reduction occurred prior to 1991) and because it
analyzes the evolution of the strategy without a full discussion of the policies at work.
By focusing on the policy directed toward vaccination only of those thought to be at increased
risk, to the exclusion of the 1988 screening program, the department was able to say that the
strategy was changed because it “did not address prevention of chronic hepatitis B in which
children play a major role.” This conceals reality; the strategy prior to 1991 did address the role
children play in prevention of chronic hepatitis. It is inappropriate to provide an explanation for
the 1991 change in strategy by pointing to failures associated with one part of the evolution but
not discussing the existence and effectiveness of other parts of the strategy also in place prior to
the 1991 change.
In the second instance, the Department dismisses the relevancy of the role of the screening
program as relevant to the department’s goal because “the proposed change addresses all
children in child care and early childhood programs, not just infants.” It justifies its dismissal of
the importance of the program with a statement that “about 16% of cases have no identified risk
factor for infection and not all disease is passed from mother to child at birth.” 35 While that may
be true, the fact that 16% of the cases have no identified risk factor, this statistic speaks to the
cases in the population at large. It says nothing about the % of cases among children in child
care and early childhood programs that have no identified risk factor and therefore it is not a
persuasive rebuttal to the opposition. While it is also true that “not all disease is passed from
mother to child at birth”, given that the major route for infants to be infected is perinatal
infection, 36 or transmission from an infected mother to her baby at childbirth, the Department’s
hasty dismissal of the program’s role seems unfounded.
If it had thoroughly discussed the evolution of the strategy, the Department would have
acknowledged that the program of screening women in pregnancy has been extremely
successful. Under the program, virtually all women receiving medical care in pregnancy are
now checked for hepatitis B. If a woman is found to be positive (infected) then the infant when
born is treated with immunoglobulin, and also receives three doses of hepatitis B vaccine. Most
of the treated children are later found to be negative for hepatitis B. For example, this paragraph
from the MDH Infection Control Newsletter describes the program and the results for 2009:
In addition to the 39 hepatitis B cases, 4 perinatal infections were identified in infants
who tested positive for HBsAg during post-vaccination screening performed between 9
35
36
Id. at 29, Opposition to New Hepatitis B Requirement.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3290915/
9
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
and 15 months of age. The infants were born in 2008. The perinatal infections were
identified through a public health program that works to ensure appropriate prophylactic
treatment of infants born to HBV-infected mothers. All four infants were born in the
United States and had received hepatitis B immune globulin and 3 doses of hepatitis B
vaccine in accordance with the recommended schedule and were therefore considered
treatment failures. Despite these treatment failures, the success of the public health
prevention program is demonstrated by the fact that an additional 321 infants born
to HBV-infected women during 2008 had post-serologic testing demonstrating no
infection.37
Additionally, when a positive finding for hepatitis B results, all of the woman’s family members
and contacts can be tested and treated.
In discussing Childhood Risk, the Department refers to infection data for children younger than
10 years from the early 1990s. In its very brief childhood risk discussion under criteria one, the
department relies on 1990s estimates of childhood infection and then provides a series of
percentages of the likelihood of developing chronic infection across various age groups to
essentially make confusing, the relatively obvious maxim that the longer one is infected with the
disease, the more likely it will become a chronic infection. That’s it. The department doesn’t
provide estimates for how many children are estimated to be infected with the disease since the
decrease began in 88 or in 91, depending on your chosen reference point. Although the
Department has data from which it could conceivably calculate a more recent incidence of
infection among children, since it provided a table on page 24 revealing the overall disease
burden for Hepatitis B from 2005-2010, this figure is noticeably absent.
The safety and efficacy of the hepatitis B vaccine:
Safety – The Department properly notes that there are two manufacturers of the Hepatitis B
vaccine and their vaccines were licensed in mid-late 1980s. Also it notes that the FDA reviewed
the safety and efficacy information of the vaccines prior to their licensure and that ACIP also
review safety and efficacy data from the clinical trials and any peer-reviewed literature. Also it
properly notes that on-going safety monitoring occurs after the vaccine is licensed. Noticeably
absent however is any detail on the depth of the pre-licensure clinical studies provided to the
FDA and, consequently, any explanation of why the Department is satisfied with their review.
The Department has given complete deference with no comment of their own to the FDA and the
ACIP review, as it applies to Minnesota children. Notably other Minnesota commentators at the
hearing pointed out the they were concerned that by the package insert of RECOMBIVAX HB®,
37
Jerri’s resource; see also Smith, Carrol, Et. Al, The National Perinatal Hepatitis B Prevention Program, 1994–
2008 (Pediatrics) PEDIATRICS Vol. 129 No. 4 April 1, 2012, pp. 609 -616
http://pediatrics.aappublications.org/content/129/4/609.abstract
10
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
hepatitis B vaccine, that in clinical trials, the persons receiving the vaccines were only monitored
for 5 days 38. That leaves the VAERS program for monitoring adverse events, with the function
of providing long term studies at the risk to the population.
The most glaring lack of consideration of an important angle of the matter is found in the
Department’s discussion of the safety of the vaccine as it applies to adverse events. In this
section the department downplays the documented adverse events and side effects and
undermines the VAERS data without any mention of the cases compensated under the NVIC.
The Department repeatedly states that “few serious side effects have been noted” and that “major
complications are rare” while emphasizing the mildness of the most common side effects. Then
the Department goes on to say that critics of immunization39 are not adept at the “complex task”
of analyzing VAERS reports and that they don’t “fully understand its limitations” and, as a
result, they misinterpret the VAERS results. Even if this was a proper generalization to make of
the complexity of the analysis of the data, it shouldn’t properly stand without any mention of the
post-surveillance results from which a person, and even a “critic of immunization”, is less likely
to misinterpret: the actual cases of successful compensations under the NVIC. In the entire
SONAR report the department is silent on the cases in which Hepatitis B vaccination was
associated with compensation.
Efficacy
The Department states that the hepatitis B vaccine has been shown to be very effective in
children because over 95% of infants, children, and adolescents develop protective antibody
responses after receipt of 3 doses of the vaccine. 40 But, the Department does not provide data on
the effectiveness of the vaccine in just infants – the subject of this rulemaking proposal. Nor
does the Department discuss the effectiveness of one does or two does of the vaccine – in just
infants nor in infants, children, and adolescents combined. Also, because MN modified the
requirement for hepatitis B in 2003 so that a hepatitis B vaccine licensed for an alternative
dosing schedule (2 doses instead of 3) is valid for purposes of the hepatitis B vaccination
requirement, the absence of a any mention of the efficacy of the 2 dose schedule is troubling.
38
Testimony of Jerri Johnson, Exhibit ap, at 11;available at
http://www.health.state.mn.us/divs/idepc/immunize/immrule/exhibits/exhibitap.pdf
39
On a side note, NHFA takes issue with the mischaracterization by the Department that vaccine-safety advocates
are “critics of immunization.” This is an unfair description that pro-vaccine advocates perpetuate to their
advantage. NHFA believe these types of statements are used to dismiss the genuine concerns about the safety of
FDA-regulated products by claiming that the people voicing concerns would be critical of vaccines no matter how
safe; this is not true. “Americans are rightfully concerned. There are no safe vaccines but only difficult choices to
weigh and make. Americans want and deserve a more accurate, measured, and responsible national dialogue
concerning vaccination. To dismiss as “anti-vaccine” those who advocate for choice, safety, transparency, and
restraint harms us all.” Louis Kuo Habakus, MA & Mary Holland, JD, Vaccine Epidemic, Introduction, the case for
vaccination choice, Loc 288
40
Sonar p 27
11
National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
This would make one to conclude that possibly the Department might intend to allow only the 3
doses series to be administered to infants but without any guidance from the Department on this
subject, the questions remain to be answered.
The Department then cites to a study of Alaskan natives as support of the efficacy of the hepatitis
B vaccine. The study examined the effects of a hepatitis B immunization program that included
routine vaccination of all infants and screening of all pregnant women. The dual nature of the
Alaska program makes this citing unpersuasive in a discussion about adding routine vaccination only
when a screening program has already been implemented. While the results of the Alaska study are
impressive and the public health benefits to the Yup’ik community involved cannot be denied, it
would be inappropriate to expect similar results in the MN population from the addition of the
proposed hepatitis B vaccination requirement for infants beginning at 2 months of age. This is
because the Alaska study began in 1984, 4 years before the ACIP recommendation to screen all
pregnant women was made in 1988. 41 For the same reasons mentioned above, regarding the
Department’s error in crediting the reduction of hepatitis B prevalence in the U.S. with the 1991
ACIP recommendation for universal infant vaccination and making no mention of the 1988
screening program’s contribution to this reduction, any conclusions drawn from this study cannot
accurately be attributed to one component of the program (routine vaccination) over the other
(the screening program).
Cost-Effectiveness of Hepatitis B Vaccine
The Department’s discussion of the cost-effectiveness of the hepatitis B vaccine cites a study
finding that the vaccine is not cost-effective from a medical cost perspective. The same study
found that from a societal perspective cost-savings do result in medical and work-loss costs. The
study attributes this societal cost-savings to the fact that HBV-related morbidity and mortality
are greater than for most-vaccine preventable diseases. But, this study says nothing about the
societal savings that result from adding an infant vaccination requirement to a schedule that
already includes a childhood and adolescent requirement for hepatitis B vaccination, which is the
subject of this rulemaking proposal.
The Department then states that the public’s health is implicated by the absence of the proposed
requirement for infants because “the adequacy of the nation’s blood supply” suffers since
“persons with HBV infection cannot donate blood.” This statement seems out of context in a
cost-effectiveness analysis for a number of reasons but it is specifically troubling because: it is
devoid of any monetary values, it makes no effort to quantify the number of would-be donors
who are currently prevented from donating due to HBV infection transmitted to them by an
infant and explain how those numbers would contribute to cost-savings if in fact that data could
41
Harpaz, R., et al. Elimination of new chronic hepatitis B virus infections: results of the Alaska immunization
program. J Infect Dis. 2000;181:413-80, available at http://jid.oxfordjournals.org/content/181/2/413.long#ref-16
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ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
be properly extrapolated into a monetary value, and it is not reflective of the long-standing policy
of the Center for Biologics and Research and of the American National Red Cross. 42
Finally, and most important to NHFA and others who are opposed to the proposed rule, is that
this Cost-Effectiveness section is completely devoid of any assessment of the costs associated
with injuries from vaccines. Given that the Department does not acknowledge anywhere in the
SONAR that serious injury from vaccines is a real possibility, it should not be surprising that
these costs are not part of its cost-effectiveness assessment but that does not excuse the absence
of this cost consideration. There is adequate evidence that adverse side effects of vaccines, both
mild and severe, result in measurable medical, special education, and work-loss costs. ..The
Department ignores this. There are documented cases of government compensation being
provided that are associated with the hepatitis B vaccine but the Department makes no attempt to
weigh those into its assessment. The failure to include the costs of vaccine injuries into its
assessment of the cost-effectiveness of the hepatitis B vaccine reveals that this is not an accurate
summary of the real costs involved.
Cost of Enforcing Hepatitis B Vaccination Requirement
The Department appropriately acknowledges that the costs of implementation are likely to be
negligible because the vaccines are essentially “free.” The only concern that NHFA has with this
section is that this is the only place where attention is given to the public health benefits to be
expected to result from the passage of the ACA. The passage of that Act is a major
development for preventive disease policy and one deserves great consideration in policy
assessments concerning the eradication of disease in the population at large. This is because, as
the Department mentions, the ACA requires full coverage of all ACIP-recommended vaccines.
The current vaccination coverage rates for hepatitis B as high as they are without the vaccines
being “free” to everyone. This begs the question, what would rates look like once ACA is fully
implemented and once all of the grandfathered plans are eliminated? Wouldn’t it be reasonable
to assume that coverage rates will increase when the vaccines are free to everyone, and not just
to those who are insured or are enrollees of the VFC or the MHCP aid programs? NHFA
believes it would be extremely judicious to wait and see what the new ACA access and coverage
means for hepatitis B vaccination coverage in the population at large before we require infants to
be injected with another dangerous vaccine. There is evidence that suggests states anticipate an
increase in coverage rates will result under ACA. For example, numerous state legislative
efforts have passed that will expand the list of vaccines pharmacists may administer, decrease the
age restriction on whom various immunization providers may administer to, and increase the list
of qualified immunization providers in the state. 43 The impact of these new laws on vaccine
42
See Exhibit AO, available at:
http://www.health.state.mn.us/divs/idepc/immunize/immrule/exhibits/exhibitao.pdf
43
See e.g., Indiana Public Law _____ (Pharmacists were already authorized to provide all adolescent and adult
immunizations recommended by the Centers for Disease Control and Prevention with a prescription. Under the new
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
access and coverage rates are already appearing as demonstrated in the actions of clinic and
retailers such as Walgreens which significantly expanded vaccine availability at all of its
locations across impacted states.
Cost-Benefit Analysis is Entirely Absent.
The Department’s assessment of the new hepatitis B vaccine requirement is glaringly
incomplete because it completely fails to address one of the required statutory factors of
consideration. Minn. Stat. 215A.15, Subd.12(2) clearly states that one of the factors that the
Department must consider: “[…] a cost-benefit analysis of the vaccination.” The
Department’s Rule by Rule analysis for the hepatitis B vaccine requirement does not discuss
this Risk/Benefit factor in isolation as it did for each of the other statutory factors but the
statute requires them to do otherwise. The Department indicates that it is aware of this
requirement because it says “These factors are discussed under Section IV of the Regulatory
Analysis and each relevant part in Section VI, the Rule by Rule Analysis”. Are we to
conclude that this absence is due to an assumption by the Department that the factor is
undeserving of individual consideration; or that the Department think Cost Benefit is
synonymous with the Cost-Effectiveness (see e.g., Meningococcal Rule by Rule analysis,
p50); or that the Department just forgot to include this part? Its NHFA’s understanding that
the Cost-Benefit analysis is a separate and unique factor for the Department to consider with
respect to each proposed change to the immunization schedule and so it is very troubling that
this section is entirely absent from the SONAR report. The importance of a cost/benefit
analysis is critical to the decision as to whether are not to add a vaccine to the schedule
because it takes the analysis beyond cost and compares the cost to the actual benefits of the
program in general.
(b)
Part 4604.1020 Meningococcal Vaccination - The Department’s conclusion
that the proposed Meningococcal vaccination requirement is a reasonable and
necessary change is unreasonable because the explanation for the need for the
modification is unsupported by the evidence and it fails to consider an
important angle of a matter.
In making its determination of need and reasonableness for the new Meningococcal requirement,
the Department documented consideration of and findings on the relevant statutory factors of
criteria for proposing a modification to the immunization schedule. Although the department
considered each of the six factors, the department’s findings on several of the factors are not
supported by, and are counter to, the evidence in the record and do not reflect consideration of
law, five of those vaccines are available without a prescription and with no appointment necessary. patients age 11
and older do not require a prescription for influenza, tetanus, diphtheria, pertussis (Tdap), Human papillomavirus
(HPV) or meningococcal vaccines. In addition, patients age 65 and older will no longer need a prescription for
pneumococcal vaccine) (signed by Indiana Gov. Mike Pence April 2013).
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
important aspects of the matter. In light of the record as a whole, the decision is so implausible
that it cannot be ascribed to a difference in view or the product of agency expertise.
The Department is seeking to require a child enrolling in a secondary school to have a
meningococcal vaccination beginning in 7th grade and to require students in grades 8 through 12
to be able to show, upon request, either proof of vaccination consistent with medically acceptable
standards against meningococcal disease, or documentation of a legal exemption. 44 This is a
new vaccination requirement for all children in seventh through twelfth grades. 45 Currently, the
department recommends meningococcal vaccine (MCV4) for all children at 11-12 years and
recommends booster doses beginning at 16 years of age. 46
Epidemiology and Morbidity/Mortality Rates of the Disease
In consideration of factors one and two, Epidemiology and Morbidity/Mortality Rates of the
Disease, the Department took notice of the Clinical Manifestations, Epidemiology, Minnesota
Information [on Childhood Risk], and Transmission of meningococcal disease. 47 The findings
were correct with regard to the description of the various health problems potentially associated
with meningococcal disease and in acknowledging the rapid rate at which the disease can
become serious and result in permanent disability or death. 48 The Department also correctly
observed that between 1996 and 2011, the overall incidence of meningococcal disease in
Minnesota declined and that there are no immunizations to prevent viral or fungal meningitis. 49
Noticeably absent from the Department’s discussion under this factor, is any explanation of why
the incidence of the disease was observed to have decreased in the years between 1996 to 2011.
The Department states in its introductory comments to the new meningococcal requirement, that
the Meningococcal vaccine was not licensed in 2003, when the department last revised the
School Immunization law. 50 Without speculating as to why the department is including this
statement in its report, the inclusion of this fact in the introduction without any mention of what
the department did recommend in 2003, and in years prior, to reduce the incidence of
meningococcal disease in the state is misleading. In fact, stating that the meningococcal vaccine
wasn’t added in the last revisions because it wasn’t yet licensed seems to be a potentially
misleading way to say that the state didn’t do anything to control the incidence of the disease.
This is far from accurate.
44
MDH, Summary of Proposed School and Child Care Immunization Law Changes (last updated April 25, 2013)
SONAR at 44.
46
Id.
47
Id. at 46-48.
48
P 46, clinical manifestations
49
Id. at46, Epidemiology and Minnesota Information.
50
Id. at 45.
45
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
A more accurate description of the state’s efforts to control the incidence of the disease up until
this time would have been to discuss what was done by the state in 2003 and 1992. In 2003 the
department took efforts to control the incidence of the disease by adding a requirement that postsecondary educational institutions provide information on the risk of meningococcal disease and
the availability of an effective vaccine to first-time enrollees residing in on-campus housing.
The Department fails to mention that in 2003 the Department also added a new Pneumococcal
vaccine requirement to the schedule of immunizations, in part, to protect against meningitis. 51
Pneumococcal disease is an infection due to the bacteria Streptococcus pneumonia, is a common
bacterial infection in infants and children in the U.S., and is the leading cause of bacterial
meningitis. 52 In fact, as far back as 1992, the Department revised the immunization
requirements to reduce the incidence of meningococcal disease in MN. In the 1992 revisions,
the department added Hib for children in child care and ECSE. Hib (Haemophilus influenza type
b) was cited as being “a major cause of meningitis in young children.”
It is very surprising that the Department failed to discuss the success in decreasing the incidence
of this disease in Minnesota. It failed to make any mention of the fact that, in the department’s
own words, it has already been vaccinating against “the leading cause bacterial meningitis” since
2003 and against a major cause of meningitis since 1992. Especially alarming alongside of the
observed decrease in the incidence of the disease since the mid-1990s to 2011.
If the Department is now proceeding with the recommendation for the meningococcal vaccine in
spite of the fact that it already requires the Hib and the Pneumococcal vaccine, then the public
deserves, and the state requires, an explanation of why the Department believes the addition of
the Hib and Pneumococcal vaccine requirements to the schedule have not been sufficient to
protect against the disease so far and won’t be in the future.
The Department might argue that the new vaccines are necessary to capture those strains not
caused by Hib and Pneumococcal, but it would not be able to explain that adding the
requirement will fill the need to protect adolescents especially when the new vaccine does not
contain the strain that is the most common cause of Neisseria meningitides in infants and may
cause some cases in adolescents. In fact, the Department acknowledges the possibility that
someone receiving the new vaccine could still get meningitis from a meningococcal strain not in
the vaccine or from a non-meningococcal infection precisely because the vaccine does not
protect against all strains of meningitis.
In discussing the transmission of the disease, the department correctly noted that the
meningococcal bacteria cannot live for more than a few minutes outside the body and that close
51
Report of Administrative Law Judge, In the Matter of the Proposed Rules Relating to Child Care and School
Immunizations, Minnesota Rules, Chapter 4604 (3-0900-15220-1) at Findings of Fact, Nature of the Proposed
Rules, paragraph 60, p. 20 (2003).
52
Id.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
contact and secretion exchange are the key elements of transmission. 53 Further correct in
pointing out that outbreaks are uncommon. It is important to note, however, that the Department
begins this section by stating that: “At any given time, about 10-15 percent of all people are
believed to carry Neisseria meningitides bacteria in their throats and nasal passages. This means
the bacteria is always present in the community, and given the right circumstances, it can cause
disease.” This statement appears without further explanation of its significance. Placing this
statement in its proper context would require the state to acknowledge that just vaccinating
adolescents with the new vaccine will not create herd protection for the community. 54 The
Department should have contrasted the new vaccine’s lack of community protection with the
community protection provided by the previously added vaccine requirements in 1992 and 2003
for Hib and pneumococcal vaccines. 55
The safety and efficacy of the vaccine
Safety – The Department properly notes that there are two manufacturers of the Meningococcal
vaccine and that their vaccines are approved for use in persons within the ages to be vaccinated
under the proposed rule. Also correctly noted that prior to the licensure of the two vaccines, the
FDA reviewed the safety and efficacy information of the vaccines and that ACIP also reviewed
safety and efficacy data from the clinical trials and any peer-reviewed literature before adding
the vaccine to the childhood schedule. Also properly notes that on-going safety monitoring
occurs after the vaccine is licensed. Noticeably absent however is any detail on the depth of the
pre-licensure clinical studies provided to the FDA and, consequently, any explanation of why the
Department is satisfied with this level of review.
Although the Department says it can point to studies showing the vaccine is safe, the record
shows that as many as 50% of the people who get the vaccine have mild side effects and that
systemic reactions within 7 days of vaccination are reported in up to 60% of recipients. Despite
these high percentages of adverse side effects reported, the Department minimizes those risks by
immediately making the broad claim that severe reactions are extremely rare and by devoting the
rest of the section to study results showing no increased incidence of Guillain-Barré Syndrome
(GBS) among the vaccinated compared to what would be expected in the general population
53
Id at 48, Transmission.
Dr Offit, Vaccine Education Center, Children's Hospital of Philadelphia, [and] Division of Infectious Disease at
Children's [Hospital of Philadelphia] (explaining that “some evidence for herd immunity was expected, as had been
seen for the conjugate Haemophilus influenzae type-B vaccine and the conjugate pneumococcal vaccine, but that
didn't appear to be happening. It appears that the vaccine is protecting only those who are vaccinated and not
extending beyond that group.” http://www.medscape.com/viewarticle/732947; ACIP, Meningococcal,
Recommendations and Reports / Vol. 62 / No. 2, at p 7 (2013)(reporting that the “[i]ncidence did not decline in
other age groups, suggesting an impact of [meningococcal] vaccination on adolescent disease, but no evidence of
herd protection.” http://www.cdc.gov/mmwr/PDF/rr/rr6202.pdf
55
Id.
54
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
without vaccination. Focus on these studies appears to be an attempt to demonstrate that
concerns about the risks associated with the vaccine are unfounded.
Efficacy:
A glaring incidence of the Department’s decision being against the weight of the evidence exists
in the discussion of the efficacy of the meningococcal vaccine. In this section the department
properly acknowledges that the new vaccine does not contain the B strain, which is the most
common cause of Neisseria meningitides in infants and may cause some cases in adolescents,
and, therefore, persons may still become infected with the disease even if they receive the
vaccine being recommended. The rest of the Department’s discussion goes to great lengths to
downplay the documented lack of evidence of protection afforded by the vaccine.
It goes on to cite efficacy rates as high as 98% were observed in pre-licensure studies but this
achievement is tempered by the Department’s reference to later studies in which the vaccine was
found to be less effective. Without revealing how much less effective the vaccine was found to
be, the Department admits that “a decline in antibodies three to five years after vaccination” will
result. This is not overtly problematic in and of itself but when considered alongside of the
Department’s next comments - that booster doses are available and that a decline in antibodies
has not been associated with a rise in observed disease, a significant analytical problem is
revealed.
At the same time that the decline in antibodies is noted as the reason why ACIP now
recommends booster shots before the age of 16 the Department tells the reader that the booster
recommendation is based on serological studies, not disease rates. This disclaimer has the effect
of encouraging the reader to believe that the recommended boosters should not raise suspicions
regarding efficacy; that the basis of the ACIP recommendation in this case, to administer booster
doses, is insignificant and is not worthy of in depth treatment. Because the department is not
recommending booster doses in this proposed rule, it makes sense that the Department would try
to explain why the basis for boosters is not compelling. What doesn’t make sense is why the
remainder of the Department’s discussion is about efficacy rates achieved using boosters. For
example, the department’s remaining evidence is that the “duration of the protective
concentrations of antibody after a booster dose is not known” and that the recommended booster
doses are “expected to result in the protective antibody concentrations through the age of 21, if
not longer, in health individuals.” (emphasis added). The Department should have been
forthright about the evidence in its possession in the first instance: that vaccine effectiveness has
been shown to be 75% - 85%, much lower than initially observed. 56
56
“With respect to meningococcal conjugate vaccine effectiveness, last June a simulation model was presented to
ACIP that modeled breakthrough disease to give a vaccine effectiveness for meningococcal conjugate vaccine.
These data suggest the vaccine effectiveness of MenACWY to be 75% to 85%.”
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
And if the Department’s presentation about efficacy data when booster doses are administered
despite boosters not being part of its recommendation wasn’t misleading enough, the Department
completely avoids honest discussion of the efficacy of the dose it is recommending. This
avoidance is notable in the context of the SONAR as a whole because the Department elsewhere
acknowledges that data on long-term persistence of protection is limited for a vaccine that has
“only been available since 1995 and 1996.” 57 If the Department is of the opinion that over 20
years of use is an insufficient amount of time from which an understanding of efficacy can be
made, then why is the Department not forthright about this lack of knowledge for a vaccine that
has been licensed for less than 10 years?
Cost-Effectiveness of Meningococcal Vaccine
Before proceeding, it’s important to note that the Department labeled its discussion of the
following information “Cost-Effectiveness/ Cost-Benefit of Meningococcal Vaccine”. Without
explanation, the Department chose to combine the Cost-Effectiveness factor analysis with the
Cost-Benefit factor analysis. And even though it combined the factors in the title, it did not in
fact do a cost-benefit analysis in this section as required by Minn. Stat. 215A.15, Subd.12(2). NHFA
does not believe that a sufficient cost-benefit analysis by the Department exists when, as demonstrated
below, there is no independent judgment by the Department about the factors under its consideration.
Apart from this unexplained merged factor analysis, the Department’s discussion is devoid of
any evidence that would contribute to a decision that the vaccine is necessary and reasonable.
The Department cites to two studies on the cost-effectiveness of the vaccine: the first,
determined that the routine vaccination of MCV4 is not cost-effective and, the second revealed
that routine vaccination plus catch-up doses actually yields net economic costs. The Department
then quotes each of the studies in an attempt to downplay their respective findings in the context
of the larger picture of the disease. The Department cautions, by citing to the first study, that
“the impact of meningococcal disease cannot be wholly accounted for by any single analysis,
and cost effectiveness is only one of the measures that should be used to inform a policy decision
on the routine use of conjugate meningococcal vaccines in the United States”. Likewise the
department says that despite the net economic costs of the program in the second study, such a
program holds the “greatest promise” for substantial and quick reductions in overall
meningococcal disease in the United States”.
[PDF] Advisory Committee o Immunization Practices (ACIP) DEPARTMENT OF HEALTH AND HUMAN
SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION Advisory Committee on Immunization
Practices (ACIP)Summary Report June 23-24, 2010 P 66 Advisory Committee o Immunization Practices (ACIP)
http://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-jun10.pdf
57
SONAR p37 (discussing hepatitis A vaccine).
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
It’s important to note that the Department quotes a study indicating that cost-effectiveness is just
one factor that is to be weighed against other factors used to inform policy decisions in the same
instance that it avoids its duty to weigh MN statutory factors against one another.
The Department’s consideration of cost-effectiveness finishes by stating that: “Because of the
severe nature of the disease and the high incidence of life-long disabilities, in 2005, the ACIP
determined that the benefit of meningococcal vaccination was worth the cost and recommended
MCV4 in adolescents.” The entire discussion of this factor comes from the judgments and the
analysis conducted by others, not the Department itself. If the Department wants to rely on the
judgments of others in fulfilling its statutory duties of analysis, then it at least has an obligation
to explain why those judgments deserve adoption as it applies to Minnesota.
Finally, this Cost-Effectiveness section is completely unsatisfactory because it is devoid of any
assessment of the costs associated with injuries from vaccines. As discussed above for the costeffectiveness section of the hepatitis B vaccine, the failure to include these real and reasonably
measurable costs in its consideration causes the cost-effectiveness analysis to be completely
unacceptable and a marginalization of the pain and suffering of Minnesota families. .
Cost of Enforcing Meningococcal Vaccination Requirement
We reiterate the concern about the minimal discussion of the impact of the ACA on vaccination
coverage that we highlighted in the hepatitis B vaccination analysis.
Weaknesses shared by Agency consideration in both
Neither analysis of both HepB and meningococcal vaccine additional adoptions has proper costbenefit analysis that assesses strength or weight of one factor of the analysis against the others.
Without that type of balancing, how can it be said that a “reasoned determination of why” its
proposals were selected.
Neither considers whether the addition of the particular vaccine is reasonable and necessary in
the context of the schedule of immunizations as a whole. It is our understanding that this can’t
be done since studies are admittedly lacking thus there should be an immediate hold on any more
additions to the vaccination schedule
Because these deficiencies in the record are shared by each of the proposed modifications and
because we believe they are essential to a finding of reasonableness, we oppose any type of
addition to the immunization schedule unless there is a pandemic and/or until SCOTUS
reexamines the issue so that the modern day realities of immunization statutes can be given
proper attention.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
Conclusion of Reasonable and Necessary / RBR analysis:
This court should find that the new requirements to include Hepatitis B vaccine and the
Meningococcal vaccine to the schedule are not reasonable and necessary to protect the public
health and that the Department’s conclusion to the contrary was arbitrary and capricious and in
violation of substantive due process. In so holding, the court does not have to substitute its
judgment for that of the Department of Health, or evaluate the merits of the conflicting scientific
evidence, or supply its own "legislative facts" to arrive at an appropriate public health policy.
Rather, it only has to conclude that having made a "careful and close" scrutiny of the
Department's explanation for its proposed action that it finds that there is no explanation of how
the conflicts and ambiguities in the evidence are resolved, no explanation of any assumptions
made or the suppositions underlying such assumptions, and no articulation of the policy
judgments. 58 The court does not need to say that the proposed modifications are wrong; it need
only say it cannot tell if they are within the bounds of what is right. 59
Even if the Court finds that the Department’s proposed rules are reasonable, the Court should still
hold that the rules are invalid because the Minnesota School Immunization law is unconstitutional
as shown below.
Constitutionality
II. MN Stat 121A.15 and the proposed regulations are unconstitutional because they go beyond the
state police power parameters described in Jacobson for compulsory vaccination of citizens
supporting necessary state action to be taken when citizens are endangered by dangerous
contagious epidemic diseases prevalent and increasing; they require a strict or intermediate
scrutiny analysis of constitutionality rather than a rational basis review to address the fundamental
rights and liberties of the targeted population for injection of vaccines for the purpose of disease
prevention; they provide for an impermissible delegation of rulemaking power to the Minnesota
Department of Health to give complete deference to the federal government when modifying the
Reporting Schedule of Immunization for School Children and prohibiting the state from acting
when it needs to on behalf of its citizens; and they breach the right of patients to have effective
recourse for harm, informed consent, and proper patient/physician relationships .
II.A Minnesota Stat 121A.15 and the proposed rules are unconstitutional because the proposed
regulations go beyond the state police power balancing parameters described in Jacobson for
compulsory vaccination of citizens and necessary state action to be taken when citizens are
endangered by dangerous contagious epidemic diseases prevalent and increasing.
58
59
Mnfctr Housing Inst. At Paragraph 47, citing Borman Transportation, Inc., 419 U.S. at 285-86.
Mnfctr Housing Inst. At Paragraph 47
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
In 1905, In Jacobson, the Supreme Court considered a constitutional challenge to a general
compulsory vaccination requirement of the smallpox vaccine. 60 Although Minnesota’s current
school vaccination requirement law could be considered by some to not be compulsory for the
receipt of the vaccine because the law contains an exemption provision for those who wish to
decline the vaccine based upon conscientiously held beliefs, the law is in fact compulsory for the
participation in the childhood vaccination program overall, because it mandates reporting
confidential identifiable health care information to the government as to whether or not an
individual has received a particular preventive vaccine. Mandating that families disclose whether
they have received federally recommended disease-preventable vaccines is an important privacy
and liberty interest that should not be ignored. And taking into consideration the dominance of
industry influence and the coercive nature of vaccine campaigns throughout the country that ride
on promoting fear in the population, the liberty interests of families in America are in jeopardy.
In the Matter of the Proposed Rules Relating to Child Care and School Immunizations,
Minnesota Rules, Chapter 4604, Report of the Administrative Law Judge, the court indicated that
“Even absent such a broad exemption provision, it was settle long ago that it is well within the
police power of a state to provide for compulsory vaccination. 61 However, NHFA points out
that since Jacobson, the Supreme Court has decided several cases about medical intervention,
bodily integrity, and sexual autonomy, further articulating what constitutes valid individual
liberty interests and the level of scrutiny a court must apply to laws restricting them. These
personal autonomy cases contrast starkly with Jacobson’s legacy. While none of the cases
addressing personal autonomy touch on vaccination, they are relevant to how the Supreme Court
would view a challenge under the Fourteenth Amendment to a compulsory vaccination mandate
today. 62
NHFA asks the court today to consider and scrutinize the following constitutional arguments as a
whole given the vast history of the manufacturing and distribution of vaccines in our country
since Jacobson and the impact of that history, including the impact of the federal government
programs on the lives of citizens of the individual states. NHFA contends that a final
determination as to whether MN121A.15 and the propose rules are constitutional under the 14th
amendment to the constitution would result in their unconstitutionality because they put
Minnesota citizens in constant jeopardy and deprive Minnesotans of life, liberty, and property,
without due process of law; and deprive Minnesotans of the equal protection of the laws” for the
purpose of disease prevention rather than for the purpose of avoiding a dangerous and imminent
epidemic.
60
Jacobson Id.
In the Matter of the Proposed Rules Relating to Child Care and School Immunizations, MN Rules, Chapter 4604,
Report of the Administrative Law Judge, 2003
62
Yale Journal of health Policy, Law, and Ethis, XII:1 (2012), Compulsory Vaccination, the Constitution, and the
Hepatitis B Mandate for Infants and Young Children, Holland 2012, Page 21.
61
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
Jacobson
In 1905 Massachusetts enacted a law at the turn of the twentieth century empowering the
municipal board of health to require vaccination of inhabitants if necessary for the public health
or safety. The Cambridge Board of Health, under authority of the statute, adopted the following
regulation: “whereas, smallpox has been prevalent … in the city of Cambridge and still continues
to increase; and whereas it is necessary of the speedy extermination of the disease …; be it
ordered, that all inhabitants of the city be vaccinated.” The mandate was applicable to all adults
and failure to comply with the mandate resulted in the imposition of a penalty of a five-dollar
fine (the equivalent of about $110 today). 63 Jacobson refused the vaccination, was convicted in
the trial court, and was sentenced to pay the fine. The Massachusetts Supreme Court upheld the
conviction and the case was appealed to the US Supreme Court in 1905. 64
Jacobson argued that “a compulsory vaccination law is unreasonable, arbitrary and oppressive,
and therefore, hostile to the inherent right of every freeman to care for his own body and health
in such way as to him seems best.” 65 His claim was grounded in constitutional liberty interests
under the Fifth and Fourteenth Amendments. 66 He argued that the state mandate threatened his
life, liberty, and property, and deprived him of the due process and equal protection of the law.
In essence, he argued that his right to bodily integrity and personal liberty trumped the state’s
right to impose vaccination in the name of public health.
In rejecting Jacobson’s appeal and upholding the Cambridge regulation, the Supreme Court
adopted a narrower view of individual liberty while emphasizing a more community-oriented
philosophy in which citizens have duties to one another and to society as a whole. 67 The court
reasoned that constitutional protection of individuals is not unlimited and that states retain police
powers to ensure public health and safety. States retain the right to issue reasonable regulations,
it argued, and, in the context of a potential smallpox epidemic, Cambridge’s ordinance was not
“unreasonable, arbitrary and oppressive.” 68
Although the police powers authorize an array of governmental action in the interest of the
public health, the Court also recognized that there are limits to these broad powers. The
regulation being challenged by Jacobson was justified as reasonable upon specific recognition
that it imposed “one vaccine, on the entire adult population, in the context of a contagious,
63
Id. Jacobson
Id. Jacobson
65
Id. Jacobson at 26
66
Id. Jacobson at 24
67
Id. Jacobson at 26
68
Id. Jacobson at 31
64
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Submitted July 17, 2013
deadly epidemic, with a relatively small fine for non-compliance.” 69 Utilizing state police
powers in support of vaccination requirements is constitutionally permissible only if the powers
are exercised in conformity with the following principles: (1) public health necessity, (2)
reasonable means, (3) proportionality, (4) harm avoidance, and (5) fairness. 70
Public Health Necessity – still a factor from Jacobson
Justin Harlan, writing for the Court in Jacobson insisted that the police powers must be based on
the “necessity of the case” and could not be exercised in “an arbitrary, unreasonable manner” or
go “beyond what was reasonably required for the safety of the public.” 71 The holding of the case
can therefore be understood to mean that a mandate is permissible in “an emergency” where
there was “imminent danger”, when “an epidemic of a disease … threatens the safety of society’s
members, when there was pressure of great dangers” and for an “epidemic that imperiled the
entire population.” 72
In the case at hand, this court would need to first decide whether there is a sufficient public
health necessity for the state to impose the new requirements to its vaccination program
mandates. Although this court will be highly deferential, it’s not proper to grant the Department
a blank check. Because the Court’s language in Jacobson suggests that a grave risk of disease to
the population must exist, this court would have to find that each of the Department’s proposed
modifications including the mandatory reporting of use of vaccines, was in response to the
existence of a grave risk.
Therefore the department would need to show that there is a grave risk of Hepatitis B and of
Meningococcal disease in MN. Based on the state’s evidence that the incidence of each disease
is low and has generally been on a decline in the state for the past several years, it is unlikely that
the test of public health necessity would be satisfied in the case at hand.
Reasonable Means
The Jacobson Court introduced a means–ends test that required a reasonable relationship
between the public health intervention and the achievement of a legitimate public health
objective. This test requires the court look beyond the stated objective and focus on the
connection between the objective and the means chosen. Even though the objective of the
69
Holland at p 46.
Compare Gostin (finding 5 factors, as listed in text) with ________(listing 4 factors only; did not include (5)
fairness)
70
71
72
Id.
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legislature may be valid and beneficent, the methods adopted must have a “real or substantial
relation” to protection of the public health, and cannot be “a plain, palpable invasion of rights.” 73
The court would therefore have to ask whether a vaccination mandate for infants beginning at
2months of age is a reasonable means of addressing the threat of the prevalence of Hepatitis B
disease in the individual and in the broader society. In the case of the Department’s hepatitis B
recommendation, consideration should be given by the court to the evidence showing that the
vaccine’s efficacy wore off before puberty and that infants would require booster shots by age 12
to maintain protection of the disease. In the case of Meningitis vaccine, MDH acknowledges
that its long-term efficacy is not yet known.
Minnesota already has Hepatitis B mandate for kindergartners, coverage rates of ~80% already
achieved 74 and MDH admits it has reason to believe its data showing 80% compliance
underestimates rates of coverage 75, so state would have to show that adding it for infants would
-Scholarly writings suggest that the absence of linkage of disease to school activities should
weigh heavily against a vaccination requirement. 76
In case of Hepatitis B – government’s burden is high b/c (1) infants are not likely to be engaged
in high risk transmission activities, such as sexual contact or needle sharing, on or off school
property; and (2) risks of medical harm from vaccination are documented and would weigh
against a finding of necessity.
Proportionality – This test assesses whether vaccination mandate is proportionate to the risk of
disease. MDH would have to argue that the risks of disease to these children outweigh the risks
73
74
See MDH, Childhood Immunization Coverage in Minnesota (September 2012) at Table labeled Vaccination
coverage among children age 19-35 months, NIS (reporting MN has coverage rate for HepB of 94.1% +/- 3.6 and
for HepB Birth a coverage rate of 56.8 +/- 8.0), available at:
http://www.health.state.mn.us/divs/idepc/immunize/stats/coverdata.html; See Id at Table labeled Vaccination
coverage among children age 24-35 months, MIIC (reporting MN coverage rate for HepB to be 84.5&)
75
MDH, About Childhood Immunization Rates from NIS and MIIC (updated Sept. 2012) (explaining the validity of
the NIS and MIIC childhood immunization rates and stating that “MIIC data may underestimate the actual percent
of children receiving vaccines because: Health care provider participation in MIIC is voluntary, MIIC may include
children who have moved, and Cross border-state immunization data exchange is limited to Wisconsin. Although
approximately 85-90% of Minnesota health care providers routinely submit immunization data to MIIC, not all
those who do report every dose of vaccine administered or historical immunization reported by the patient. Also,
when a child moves out of Minnesota his or her MIIC record may not be updated and the child would still be
included in the denominator used to calculate the proportion of children receiving immunization. Finally, data
exchange with border state immunization information systems is currently limited to Wisconsin. Vaccinations
received in Wisconsin by Minnesota residents are in MIIC but there is no similar data exchange with North Dakota,
South Dakota, or Iowa at this time.”), available at:
http://www.health.state.mn.us/divs/idepc/immunize/stats/coverdatacomp.html#valid
76
Jacobs, Hamline Law Review Article….(2010)
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Submitted July 17, 2013
of the vaccine. Very difficult to prove b/c incidence of the disease in preschool population is
exceedingly low yet risks of adverse events from the vaccine are well documented. Additionally
hard because the public health rationale for the mandate isn’t to reduce disease solely in this age
group; it was to prevent risks to the entire population. Benefits to preschoolers not likely to be as
proportionate to risks. Especially when being added to an already high and ever-increasing
number of infant vaccinations.
Harm avoidance – This demonstrates that it offers a fair process for allowing medical
exemptions to those who are at risk of injury or death from the vaccine. While it is true that MN
provides a medical exemption, there is reason to believe that a medical exemption would not
necessarily satisfy the harm avoidance requirement in the context of vaccination requirements for
newborn babies and infants. A policy recommending vaccination of persons with little to no
health history from which an assessment of “at risk”-ness could be made via a successful
screening and follow-up process, such as is the case with newborns and infants, makes it
arguably impossible to construe as satisfying the harm avoidance.
So if harm avoidance is an essential element to the state’s right to compel vaccination and if
administering a vaccine may prevent any meaningful opportunity for harm avoidance, then the
only way that this criteria could be met is by avoiding infant medical interventions other than
screening altogether.
Non-discrimination: Since the recommendations would be imposed on all children in same way
the state would say non-discriminatory. But that right is limited. Where it is imposed without
(1) a rational relation to an educational purpose and (2) is based on population wide necessity, its
application may be arbitrary. If imposed solely on young children and not older children, not
primarily for their benefit, its non-discrimination is questionable.
Fairness - The vaccination mandate that the Supreme Court upheld in 1905 is markedly different
than MDH’s suggested Hepatitis B mandate for infants. The Jacobson decision upheld a
mandate for the entire population, in the context of an airborne epidemic emergency, with a
relatively small monetary fine for non-compliance. MDH’s Hepatitis B mandate is imposed
exclusively on children, for preventative purposes, although children are at minimal risk of
contracting the disease – a disease that is transmitted through intimate contact – on penalty of
limiting the right to an education.
Jacobson’s holding, that the state may impose reasonable regulations to ensure the public health
and safety even if such regulations infringe individuals’
Jacobson Factors of Analysis weigh against adoption of rule revisions
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Docket No. 8-0900-30570
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Submitted July 17, 2013
NHFA believes the rule revisions epitomize the situation which Harlan cautioned against: where
the vaccination mandates “might be exercised in such an arbitrary, unreasonable manner, or
might go so far beyond what reasonably required for the safety of the public, as to authorize or
compel the courts to interfere…” Because of the cautionary language used by Justice Harlan in
Jacobson and because the Courts holding made it clear that it applied specifically “to the
necessities of the case”, NHFA argues that MN121A.15 as it authorizes and applies to the
proposed rules and the current proposed MDH rules are too unreasonable and unnecessary to
pass constitutional muster.
II B. MN Stat 121A.15 and proposed regulations require a strict or intermediate scrutiny analysis
rather than a rational basis review to address the fundamental rights and liberties of recipients of
vaccines when the state is using its power and the power of the federal government to direct or
coerce a group of citizens into utilizing vaccines for disease prevention;
Liberty Interests in Due Process
The Supreme Court decided Jacobson before it adopted explicit standards for review of government
authority. Jacobson decision makes no mention of substantive due process because that doctrine
was not articulated until the Lochner decision, which was decided by the Court after issuing its
Jacobson decision. It is from this pre-Lochner era decision that all modern day childhood vaccination
are derived.
Since Jacobson, the Supreme Court has decided several cases about medical intervention, bodily
integrity, and sexual autonomy, further articulating what constitutes valid individual liberty
interests and the level of scrutiny a court must apply to laws restricting them. 77
The due process provision of the United States Constitution is found in the 14th Amendment,
which provides that no State shall "deprive any person of life, liberty, or property, without due
process of law." 78
Careful review of the Supreme Court's recent Cruzan decision reveals that eight of the nine Justices found
a federal Due Process liberty interest in refusing unwanted medical treatment. Cruzan, 497 U.S. at 278; at
287 (O'Connor, J., Concurring); at 302 (Brennan, Marshall and Blackmun, JJ., Dissenting); at 331
(Stevens, J., Dissenting). See also Mack v. Mack, 329 Md. 188, 618 A.2d 744, 755-56 (1993) (noting
Supreme Court Justices' apparent acceptance of liberty interest in rejecting treatment). 79
Fundamental Right
77
78
79
Holland at 21
Unites States Constitution, Fourteenth Amendment to the Constitution, ratified July 9, 1868.
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Submitted July 17, 2013
Cruzan citing Zablocki v. Redhail, 434 U.S. 374, 388 (1978), “ if a requirement imposed by a State
"significantly interferes with the exercise of a fundamental right, it cannot be upheld unless it is supported
by sufficiently important state interests and is closely tailored to effectuate only those interests." The
Constitution imposes on this Court the obligation to "examine carefully . . . the extent to which [the
legitimate government interests advanced] are served by the challenged regulation." Moore v. East
Cleveland, 431 U.S. 494, 499 (1977). See also Carey v. Population Services International, 431 U.S. 678,
690 (1977) (invalidating a requirement that bore "no relation to the State's interest"). An evidentiary rule,
just as a substantive prohibition, must meet these standards if it significantly burdens a fundamental
liberty interest. Fundamental rights "are protected not only against heavy-handed frontal attack, but also
from being stifled by more subtle governmental interference." Bates v. Little Rock, 361 U.S. 516, 523
(1960). 80
And parents have a fundamental liberty interest in caring for their children. The parent-child
relationship is among the fundamental rights protected by the constitutional guarantees of due
process. B.J.B., 747 N.W.2d at 608 81
There is a recognized substantive due process right to freedom from governmental interference
in childrearing decisions. See, e.g., Moore v. City of East Cleveland, 431 U.S. 494, 97 S. Ct.
1932 (1977) (striking down zoning ordinance prohibiting grandmother from raising two
grandsons of different parentage); Wisconsin v. Yoder, 406 U.S. 205, 92 S. Ct. 1526 (1972)
(allowing Amish to withdraw children from public school after completing eighth grade); Meyer
v. Nebraska, 262 U.S. 390, 43 S.áCt. 625 (1923) (striking down law prohibiting teaching foreign
languages to schoolchildren). Parents have a fundamental interest in childrearing and in
childbearing decisions. LaChapelle v. Mitten, 607 N.W.2d 151, 163 (Minn. App. 2000), review
denied (Minn. May 16, 2000), cert. denied sub nom. Mitten v. LaChapelle, 531 U.S. 1011, 121
S. Ct. 565 (2000). Parents have a fundamental right to the custody and companionship of their
children. In Welfare of H.G.B., 306 N.W.2d 821, 825 (Minn. 1981). In general, deprivation of
this fundamental right, like most other fundamental rights, is subject to strict judicial scrutiny,
meaning that the state bears the burden of proving that such deprivation is narrowly tailored to a
compelling state interest. State ex rel. Morrow v LaFleur, 590 N.W.2d 787, 796 (Minn. 1999),
cert. denied sub nom. Morrow v. Hvass, 528 U.S. 1013, 120 S. Ct. 517 (1999). 82
And "[P]ursuant to the substantive due process component of the Fourteenth Amendment,
parents have a fundamental liberty interest in making decisions concerning the care, custody, and
control of their children." Conlogue v. Conlogue, 2006 ME 12, ¶ 12, 890 A.2d 691. A court
80
Cruzan v. Missouri Department of Health, 110 S. Ct. 2841, 497 U.S. 261, 111 L.Ed. 2d 224 1990
752 N.W.2d 88, 2008.MN July 8, 2008 IN THE MATTER OF THE WELFARE OF THE CHILDREN OF: D.F. AND D.F.,
PARENTS.
81
82
657 N.W.2d 577, 2003.MN.March 04, 2003 IN THE MATTER OF THE CHILD OF: P.T. AND A.T., PARENTS.
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Submitted July 17, 2013
order that assigns even temporary rights to a non-parent interferes with the parent's fundamental
liberty interest. Cf. Rideout, 2000 ME 198., 83
Compelling State Interest
Since the right to refuse medical treatments and the right to parent are fundamental, the strict
scrutiny test must be applied. 84 This calls for a heightened review of the addition of childhood
vaccines to the school schedule in light of these liberty interests.
The first question upon review is: Does the state have a compelling state interest to add vaccine
dosages for children to the vaccine schedule? NHFA contends that Minnesota does not have a
compelling state interest because it has not met the reasonable and necessary standards for their
proposed rules as outlined above and thus there is no compelling state interest to modify the
current vaccine schedule. And in addition, because the vaccine policy and intention has been
changed from imminent epidemic concerns to a program for promoting vaccine-preventable
disease protection, for both vaccinated and unvaccinated children, the state does not have a
compelling state interest to attempt to convince parents to participate in a state wide disease
prevention program recommended by the federal government, that is not reasonable and
necessary, and forcing children and their parents to either go to a health care provider and get
recommended vaccines, or fill out and submit to the government reports disclosing their private
and personal identifiable health care and medical information. 85 Parents have the right and
ability to make medical decisions for their children and do not have a duty to follow the
recommendations of the Department or the federal government recommendations when it comes
to preventive medicine. And families have a right to protect their personal privacy and medical
records regarding their medical choices. 86
Narrowly Tailored, Least Restrictive
Even if the proposed rules have a compelling state interest, the state bears the burden of proving
that such deprivation is narrowly tailored 87 In regards to the proposed rules, the proposed rules
are not narrowly tailored to protect liberty interests, in fact they go to the broadest form of liberty
infringement including either having to receive a vaccine, having to notarize and disclose your
identifiable private medical information to the government, or not being able to enroll in and
attend school. And the reason why childhood school enrollment is being used as a tool to
mandate compliance for preventive medicine ordered by the government has not been disclosed.
83
Sparks v. Sparks, Maine Supreme Judicial Court, 2013.ME No. Docket: Cum-12-73 (Me. 04/04/2013)
Strict scrutiny
85
Behar v. Pennsylvania Department of Transportation, U.S. District Court for the Middel District of Pennsylvania,
2011.MPA No 1:09-CV-2453
86
Medical records privacy
87
MN 657 N.W.2d 577, 2003.MN.March 04, 2003 IN THE MATTER OF THE CHILD OF: P.T. AND A.T., PARENTS
84
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Submitted July 17, 2013
The Department downplayed options that would not have these infringements on liberty. They
downplayed the power of an educational effort that would encourage parents to voluntarily
utilize the additionally recommended vaccines. They indicated a need for the use of the state
police power to get parents to use vaccines because education does not work alone. NHFA finds
it questionable to use the state’s police power to command compliance with injecting dangerous
drugs into the bodies of small innocent children, vaccines that have documented side effect, and
with limited options for legal recourse, when the reasonableness and necessity has not been met
for a compelling state interest and when documentation of the adequacy or inadequacy of
resources for educational plans has not been disclosed. The Department also downplayed the
power of screening programs, such as the maternal Hepatitis B program which produced great
success. 88 They also did not disclose any alternative methods of promoting immunity in the
community presented to them independently at the Department offices, or disclose any local,
national, or international research on ways to encourage stronger immunity in the community.
They did not disclose that there were no studies on the maximum number of antigens that a child
can withstand and still keep a healthy immune system or put forth guidance to parents as to what
the optimum number of vaccines should be for their children so that parents could plan over the
lifetime of their children what would be best to recommend. In fact, it was noted by
commentators that they discounted in their SONAR the opinions of Doctors of Chiropractic,
when the Doctors of Chiropractic raised the concern of multiple vaccines damaging the overall
immune system and that the term doctor was not used by the Department when referring to the
chiropractors. However, Minnesota is a leader in holistic medicine, and the schools and the
Doctors of Chiropractic, Acupuncture, and the Doctors of Naturopathic Medicine have much to
contribute to Minnesota and options for increasing community immune care.
Privacy Interests of the Fourteenth Amendment to the United States Constitution
There is no longer any question that the United States Constitution provides protection for an
Individual’s right of privacy. At least two distinct types of privacy interests have been
recognized. "One is the individual interest in avoiding disclosure of personal matters, and
another is the interest in independence in making certain kinds of important decisions." 89
At common law, even the touching of one person by another without consent and without legal
justification was a battery. See W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and
Keeton on Law of Torts � 9, pp. 39-42 (5th ed. 1984). Before the turn of the century, this Court
observed that "[n]o right is held more sacred, or is more carefully guarded, by the common law,
than the right of every individual to the possession and control of his own person, free from all
restraint or interference of others, unless by clear and unquestionable authority of law." Union
Pacific R. Co. v. Botsford, 141 U.S. 250, 251 (1891). This notion of bodily integrity has been
88
89
SONAR downplay of screening.
Fiori v, Pennsylvania, Superior Court of Pennsylvania, 1995.PA.22040
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Submitted July 17, 2013
embodied in the requirement that informed consent is generally required for medical treatment.
Justice Cardozo, while on the Court of Appeals of New York, aptly described this doctrine:
"Every human being of adult years and sound mind has a right to determine what shall be done
with his own body; and a surgeon who performs an operation without his patient's consent
commits an assault, for which he is liable in damages." Schloendorff v. Society of New York
Hospital, 211 N. Y. 125, 129-130, 105 N. E. 92, 93 (1914). The informed consent doctrine has
become firmly entrenched in American tort law. See Keeton, Dobbs, Keeton, & Owen, supra, �
32, pp. 189-192; F. Rozovsky, Consent to Treatment, A Practical Guide 1-98 (2d ed. 1990). The
logical corollary of the doctrine of informed consent is that the patient generally possesses the
right not to consent, that is, to refuse treatment. 90
“The right of a person to control his own body is a basic societal concept…" In re Conroy, 98 N.J. 321,
346, 486 A.2d 1209 (1985). The doctrine of informed consent was developed to protect the right of selfdetermination in matters of medical treatment. Id. at 346-348, 486 A.2d 1209. Self-determination
encompasses the right to refuse medical treatment and is a right protected by common law as well as by
the federal and state constitutional right to privacy. Cruzan v. Director, Missouri Dep't of Health, 497
U.S. 261, 281-82, 110 S. Ct. 2841, 2852-53, 111 L. Ed. 2d 224, 244-45 (1990); In re Quinlan, 70 N.J. 10,
38-42, 355 A.2d 647, cert. den. sub nom., Garger v. New Jersey, 429 U.S. 922, 97 S. Ct. 319, 50 L. Ed.
2d 289 (1976); Conroy, supra, 98 N.J. at 348, 486 A.2d 1209. 91
While it is clear that a competent patient has the right to refuse life-sustaining medical treatment, she must
also have a clear understanding of the nature of the illness and prognosis; the risks and benefits of the
proposed treatment, and the capacity to analyze that information in order to exercise this right. In re
Farrell, supra, 108 N.J. at 354 n. 7, 529 A.2d 404. 92
The proposed rules unconstitutionally invade parents and children’s privacy because the rule
infringes on both the fundamental rights of parents to care for their children, the fundamental
right of parents to refuse unwanted medical treatments, or for those parents who do not get the
vaccines, the fundamental right of privacy of their personal identifiable medical records and
information, and is not narrowly tailored to avoid these infringements.
NHFA contends that the constitutional right of privacy for Minnesotans would be compromised by the
adoption of the proposed rules because in order to carry out their own self-determination in making
medical choices, parents need adequate information upon which to base a decision. The proposed rules
are being presented as part of an extensive industry and government system, often devoid of intimate and
detailed information exchanges between care provider and patient, that is implemented in a way where
parents do not receive enough information to obtain a clear understanding of the nature of the risks and
90
91
92
Cruzan v. Missouri Department of Health, 110 S. Ct. 2841, 497 U.S. 261, 111 L.Ed. 2d 224 1990
Id. Cruzan
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Submitted July 17, 2013
benefits of the proposed vaccines. Thus their right of self-determination is compromised. Parents and
children alike have a fundamental right of privacy in their choice of medical treatments. Parents have a
fundamental right to care for their children involving hundreds of choices for their well-being and safety
on a hour by hour, and daily basis. Parents need to have accurate information regarding the choices they
make for their children, and the information provided must honor the serious nature of their responsibility
for their child’s welfare as the primary care-taker of this precious life.
Although one might think that the state is innocent in infringing on the privacy rights of parents by
implementing the proposed rules, the mere fact that there is a system in place involving manufacturers,
hospital and facilities, clinics, and then doctors and nurses, provides a challenge and a need for
heightened scrutiny to discern whether liberty interests are being protected. The breadth and complexity
of the vaccine distribution chain is no excuse for blocking the ability of a person to make an informed and
important choice in their health care decisions.
We offer this example: The real time life of a new mother agreeing to a recommended or
required vaccine can look like this: First time Mom comes into the hospital in labor a few days
before her due date. She has not discussed vaccines with her doctor thinking that it is a subject
she can address when her child is older and she has more information. The birth is a flurry of
profound physical exertion, life transformation, and new experience and confusion. Support
relationships and staff are important in every regard. Within hours after the birth a nurse peaks
into her room and says she will be giving the HepB shot to the infant. There is a quick exchange
with mother, and the nurse says the doctor has recommended the shot. The federal Vaccine
Information sheet is in the new admittance folder that the mother received upon admission but the
Mom has not read the packet and the nurse does not find it and hand it to the mother. Even if she
read the form it is sparse in its information on side effect of vaccines. The nurse whisks the baby
away and returns the baby after the shot. The mother is focused on learning how to breast feed
and may not compute that the high pitched screams of the baby have anything to do with the
vaccine. It is not until the second dose months later after baby checkup that the mother becomes
concerned when she hears that familiar high pitched scream that she heard from her baby after the
first shot. The mother calls the clinic and describes the symptoms and the clinic reassures the
mom that this is a normal reaction to the vaccine. It is not until the third dose that the child
begins to experience neurological regression. This scenario does not include any in depth
conversation regarding vaccines until the mother begins to understand the seriousness and
potential side effects of vaccines on the third dose. And then her journey has begun. A parent
might try and find out the type of vaccine that her children got and try and find the package insert
from the manufacturer which she would not have gotten from the doctor or clinic. Whether on
the first vaccine or whether on the 10th vaccine, parents often learn from their own experience the
real dangers of vaccines rather than from a detailed conversation with health care providers.
Even if a parent is well informed, the state cannot step in and replace the parent’s decision for medical
choices in treatments. The state must show a compelling state interest to remove the authority of a parent
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to make medical decisions for themselves or for their child. And if there is a compelling reason, then the
states actions must also be tailored to a narrow solution. 93 In the case of the state designing a vaccine
program to be administered to address vaccine-preventable diseases, the state’s interest is not compelling.
In this case the state may not use the police power and children and parents to implement a disease
prevention program of their own. In the proposed rules the HepB and the Meningococcal vaccines did
not meet the necessary and reasonable tests. The proposed rules do not rise to the level of being a
compelling state interest that would allow the state to step in and replace a parent’s choice with the state’s
choice. The state has enough evidence to show that the proposed rule would infringe on a parent’s
fundamental right of privacy in the making of medical decisions.
Equal Protection:
All equal protection challenges are broken down into three questions: What is the classification?
What level of scrutiny should be applied? Does the particular government action meet the level
of scrutiny?
To answer the first question we need to look at the government’s classification and discern how
it is drawing a distinction among people. There are two ways to establish a classification. One is
where the classification exists on the face of the law such that the law’s terms draws a distinction
among people based on a particular characteristic. The other is where the law is facially neutral
but there is a discriminatory impact to the law or discriminatory effects from its administration. 94
To determine which level of scrutiny applies, the second question in the analysis, the type of
discrimination must be considered. The court has made it clear that discrimination based on race
or national origin will be subject to strict scrutiny. Under strict scrutiny, a law is upheld if it is
proved necessary to achieve a compelling government purpose. Generally this requires the state
to prove that it has a truly significant reason for discriminating and it must show that it cannot
achieve its objective through any less discriminatory alternative. The state’s burden then is to
prove the law is necessary to achieve a compelling purpose.
Intermediate scrutiny is used for discrimination based on gender and for discrimination against
non-marital children. Under intermediate review, a law will be upheld if it is substantially
related to an important government interest. 95 At this level of review the court doesn’t need to
find the government’s purpose is compelling, but it must characterize the objective as important.
The means used need not be necessary but they must have a “substantial relationship” to the end
being sought. The burden of proof is on the government. 96
93
IN THE MATTER OF THE CHILD OF: P.T. AND A.T., PARENTS, 657 N.W.2d 577, 2003.MN
The Supreme court has made it clear that discriminatory impact is not enough to prove a racial or gender
classification. If a law is facially neutral, demonstrating a racial or gender classification requires proof that there is a
discriminatory purpose behind the law. See e.g. Personnel Administrator of Mass. V. Feeny, 442 US 256 (1979).
95
Craig v Boren, 429 US 190, 197 (1976).
96
See US v. Va., 518 US 515, 533 (1996).
94
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Submitted July 17, 2013
Rational basis is the third test and it is the minimal level of scrutiny that all laws challenged
under equal protection must meet. Laws not subject to the other two tests are evaluated under
rational basis. Under a rational basis review, the law will be upheld if it is rational related to a
legitimate government purpose. The challenger has the burden of proof.
Under the third question, whether the government action meets the level of scrutiny, the level of
scrutiny is the rule of law applied to the government action being challenged as denying equal
protection. To answer this, the Court needs to evaluate both the law’s ends and its means. For
strict scrutiny the end must be deemed compelling; for intermediate scrutiny the end has to be
regarded as important; and for the rational basis test there just has to be a legitimate purpose.
In evaluating the relationship of the means of the law being challenged to the end, the Court has
focused on the degree to which the law is underinclusive and/or overinclusive. A law is
underinclusive if it does not apply to individual who are similar to those to whom the law
applies. A law is overinclusive if it applies to those who do not need to be included in order for
the government to achieve its purpose. These distinctions however are not mutually exclusive,
meaning a law can be both underinclusive and overinclusive, and their existence does not
necessarily means the law is going to be invalidated. Rather, they are distinctions that the court
uses to evaluate the fit between the governments means and its end. If strict scrutiny is applied, a
relatively close fit is required; the government will have to show that the means is necessary, or
is the least restrictive alternative, to achieve the goal. Under intermediate scrutiny, a closer fit
(i.e., less underinclusiveness or overinclusiveness) will be required than under the rational basis
test.
Equal protection analysis however is not limited to review of government classifications among
people based on specific characteristics. Sometimes equal protection is used if the government
discriminates among people as to the exercise of a fundamental right. 97 When a fundamental
right is at issue, the court applies strict scrutiny under the equal protection clause to analyze the
government’s discrimination as to the exercise of that right. The effect is the same whether a
right is deemed fundamental under the equal protection clause or under the due process clause:
government infringements are subject to strict scrutiny. If a right is not fundamental, then only
rational basis review is required under both equal protection and due process.
Minnesota Equal Protection Analysis
Minnesota case law equal protection reveals that the state does not strictly adhere to these three
tiers of review. When Minnesota applies rational basis review under art. I, § 2 of the Minnesota
97
Skinner v. Oklahoma, 316 US 535 (1942)(declaring law requiring sterilization for individuals convicted three of
more times for crimes of “moral turpitude” to be unconstitutional as violating equal protection because it
discriminate among people in their ability to exercise a fundamental liberty: the right to procreate).
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Docket No. 8-0900-30570
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Submitted July 17, 2013
Constitution, it sometimes uses a "higher standard." 98 This higher standard--often characterized
as the Minnesota rational basis test 99, requires that:
(1) The distinctions which separate those included within the
classification from those excluded must not be manifestly arbitrary
or fanciful but must be genuine and substantial, thereby providing
a natural and reasonable basis to justify legislation adapted to
peculiar conditions and needs; (2) the classification must be
genuine or relevant to the purpose of the law; that is there must be
an evident connection between the distinctive needs peculiar to the
class and the prescribed remedy; and (3) the purpose of the statute
must be one that the state can legitimately attempt to achieve. 100
"The key distinction between the federal and Minnesota tests is that under the Minnesota test 'we
have been unwilling to hypothesize a rational basis to justify a classification, as the more
deferential federal standard requires.'" 101
Under an equal protection claim based on suspect classifications, NHFA would argue that the
government’s classification in the proposed rules exists on the face of the regulation because its
terms draw a distinction among people based on a particular characteristic: age. The Minnesota
childhood immunization law draws a distinction among the people of Minnesota based on their
age. This classification clearly exists on the face of the law because the rules apply to a person
with a particular characteristic: a young age. While it’s true that numerous age distinctions can
be found throughout the various recommendations for the different required vaccinations, the
rules are applicable to persons of an age young enough for enrollment in childhood education
and child care programs and they do not apply to adults.
With this classification in mind, we suggest that Minnesota courts would apply intermediate
scrutiny to discrimination based on age despite the traditional level of review applied to age is
rational basis. 102 To determine which level of scrutiny applies, the type of discrimination must
98
See Kahn v. Griffin, 701 N.W.2d 815, 831 (Minn. 2005); see also Mitchell v. Steffen, 504 N.W.2d 198, 210
(Minn. 1993) (Tomljanovich, J., dissenting) (likening Minnesota's approach to rational basis review to "mid-level"
scrutiny).
99
See Scott, 615 N.W.2d at 74
100
State v. Russell, 477 N.W.2d 886, 888 (Minn. 1991) (quoting Wegan v. Vill. of Lexington, 309 N.W.2d 273, 280
(Minn. 1981).
101
State v. Garcia, 683 N.W.2d 294, 299 (Minn. 2004) (quoting Russell, 477 N.W.2d at 889).
102
Disclosure: At the time NHFA provided public testimony at the hearing on June 27, it had reason to believe that
MN courts had ruled that age can be a suspect classification under equal protection analysis. NHFA’s basis for that
belief stemmed from a 2003 Administrative Report stating that “MN courts provide that differing treatment of
individuals cannot be based on impermissible factors such as race, sex, age or marital status.” (emphasis added).
See Report of Administrative Law Judge, In the Matter of the Proposed Rules Relating to Child Care and School
Immunizations, Minnesota Rules, Chapter 4604 (3-0900-15220-1) at Objections Relating to MDH Authority, ¶24, p
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
be considered. The court has made it clear that discrimination based on race or national origin
will be subject to strict scrutiny. Several criteria are applied in determining the level of scrutiny
to give to a particular classification. For example, immutable characteristics are said to warrant
heightened scrutiny because of the concept that it is unfair to penalize a person for characteristics
that the person did not choose and that the individual cannot change. 103 The Court has also
considered the ability of the group to protect itself through the political process; if the political
process cannot be trusted to represent the interests of the group, this weighs in favor of a higher
level of review. Additionally, the history of discrimination against the group is relevant to the
determination of the level of review.
Although courts have ruled that age is not a classification that merits strict scrutiny review 104,
many of the factors that justify heightened scrutiny for race and national origin also exist with
regard to age. For example, a person’s age is immutable in the sense that a person cannot
voluntarily change it. Age is also a characteristic that is visible. Further, the history upon which
the creation of Minnesota’s childhood immunization law rests and the subsequent erosion of tort
law as an avenue of redress for injuries sustained under compliance with the requirements, is
uniquely rife with evidence that the ability of the children to protect itself through the political
process has been scant. However, if the court determined that age was not deserving of strict
scurinty, then intermediate scrutiny or the heightened rational basis review would apply to the
MN proposed amendments.
Since the level of scrutiny is the rule of law applied to the government action being challenged as
denying equal protection, the Court evaluates both the laws ends and its means. Under
intermediate review, a law will be upheld if it is substantially related to an important government
interest. 105 At this level of review the court doesn’t need to find the government’s purpose is
compelling, but it must characterize the objective as important. The means used need not be
necessary but they must have a “substantial relationship” to the end being sought. The burden of
proof is on the government. 106
In evaluating the relationship of the means of the law being challenged to the end, the Court has
focused on the degree to which the law is underinclusive and/or overinclusive. A law is
underinclusive if it does not apply to individual who are similar to those to whom the law
8 (dismissing allegation of discrimination by the agency for its different treatment of unvaccinated and vaccinated
children regarding its notarization requirement for exemptions but not for proof of immunization because the
different treatment was not based on “impermissible factors” and so the agency only needed to have a rational basis
for the different treatment which it was held to have). Prior to testifying, NHFA did not examine the legal authority
for support of this statement and we now acknowledge that this statement is against the equal protection
jurisprudence in this state. We apologize for advancing that argument at that time and for any confusion that we
caused. Now, however, based on a thorough review of caselaw, NHFA does feel confident that it has sufficient
grounds to make the argument that the age classification in the MN law should be subject to a level of review …
103
See e.g., Fullilove v. Klutznick, 457 US 55 (1982).
104
In re Estate of Turner, 391 N.W.2d 767, 769 (Minn.1986).
105
Craig v Boren, 429 US 190, 197 (1976).
106
See US v. Va., 518 US 515, 533 (1996).
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National Health Freedom Action (NHFA)
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ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
applies. A law is overinclusive if it applies to those who do not need to be included in order for
the government to achieve its purpose. These distinctions however are not mutually exclusive,
meaning a law can be both underinclusive and overinclusive, and their existence does not
necessarily mean the law is going to be invalidated. Rather, they are distinctions that the court
uses to evaluate the fit between the governments means and its end.
Because there are constitutional limits to what a legislative majority may impose on any minority
while leaving itself free of such constraints, NHFA argues that imposing a mandate for hepatitis
B vaccination exclusively on young children, when none is imposed on the adult population,
raises equal protection issues when state objective is eradication of the hepatitis B virus from
population at large. A child subject to the mandate could argue that the adult population, which
is at a far greater risk of contracting the disease, is exempted from mandate in violation of equal
protection. The Department’s proposed revisions could be seen to subject children to
discrimination where they are selectively vaccinated for a disease from which they are at
negligible risk. So even though a justice could find that the Department’s rule revisions meet
either the rational basis or the intermediate scrutiny test for assessing due process concerns, a
finding that the mandate fails the equal protection test could still result. 107
In light of the recent Supreme Court decisions striking down the Defense of Marriage Act, we
offer the following language from Lawrence v. Texas for additional insight to the way the Court
would rule on an equal protection challenge to the proposed rules depite the legacy of the
Jacobson decision:
In Lawrence v Texas, the question before the Court was the validity of a Texas statute making it
a crime for two persons of the same sex to engage in certain intimate sexual conduct. 108 The
questions before the court were:
"1. Whether Petitioners' criminal convictions under the Texas "Homosexual Conduct" law –
which criminalizes sexual intimacy by same-sex couples, but not identical behavior by differentsex couples -- violate the Fourteenth Amendment guarantee of equal protection of laws?
2. Whether Petitioners' criminal convictions for adult consensual sexual intimacy in the home
violate their vital interests in liberty and privacy protected by the Due Process Clause of the
Fourteenth Amendment?”
3. Whether Bowers v. Hardwick, 478 U. S. 186 (1986), should be overruled?
The Court of Appeals for the Texas Fourteenth District considered the petitioners' arguments
and, in a divided opinion, rejected the constitutional arguments and affirmed the convictions. 109
107
See e.g. Justice O’Connor’s rationale in Lawrence v Texas, 539 U.S. 558, at 579-80.
Lawrence v. Texas, 539 U.S. 558 (2003)
109
41 S. W. 3d 349 (Tex. App. 2001).
108
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
The Supreme court reversed and held that the statute violated the Due Process Clause. Primary
to the court’s decision of the case was reconsideration of the Bowers holding which failed to
appreciate the extent of the liberty interest at stake. 110
The Court began its substantive discussion in Bowers by discussing the “broad statements of the
substantive reach of liberty under the Due Process Clause in earlier cases” including Pierce v.
Society of Sisters, 268 U. S. 510 (1925), and Meyer v. Nebraska, 262 U. S. 390 (1923); most
pertinent was the decision in Griswold v. Connecticut, 381 U. S. 479 (1965).
"The issue presented is whether the Federal Constitution confers a fundamental
right upon homosexuals to engage in sodomy and hence invalidates the laws of
the many States that still make such conduct illegal and have done so for a very
long time." Id., at 190. That statement, we now conclude, discloses the Court's
own failure to appreciate the extent of the liberty at stake. To say that the issue in
Bowers was simply the right to engage in certain sexual conduct demeans the
claim the individual put forward, just as it would demean a married couple were it
to be said marriage is simply about the right to have sexual intercourse. The laws
involved in Bowers and here are, to be sure, statutes that purport to do no more
than prohibit a particular sexual act. Their penalties and purposes, though, have
more far-reaching consequences, touching upon the most private human conduct,
sexual behavior, and in the most private of places, the home. The statutes do seek
to control a personal relationship that, whether or not entitled to formal
recognition in the law, is within the liberty of persons to choose without being
punished as criminals.
Because the Court mis-characterized the interest in Bowers, the inquiry that resulted in a finding
that proscriptions of sodomy have ancient roots in our history necessarily deserved
reconsideration by the court. Recharacterization of the interest revealed that “the historical
grounds relied upon in Bowers are more complex than the” holding indicated and that their
“historical premises are not without doubt and, at the very least, are overstated.”
The Court found additional evidence that the Bowers decision was deficient upon examining the
legislative and judicial developments following its holding. Since state laws prohibiting the
conduct at issue in Bowers had since been repealed in numerous states and because due process
clause decisions confirmed protections of personal deisions relating to marriage, procreation,
contraception, family relationships, child rearing, and education. 111 the integrity of the Bowers
decision was even more in doubt.
110
111
Id (citing Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833 (1992) and Romer v. Evans, 517 U.S.
620 (1996).
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
Equality of treatment and the due process right to demand respect for conduct protected by the
substantive guarantee of liberty are linked in important respects, and a decision on the latter point
advances both interests. 112
The foundations of Bowers have sustained serious erosion from our recent decisions in Casey
and Romer. When our precedent has been thus weakened, criticism from other sources is of
greater significance. In the United States criticism of Bowers has been substantial and
continuing, disapproving of its reasoning in all respects, not just as to its historical
assumptions. 113
To the extent Bowers relied on values we share with a wider civilization, it should be noted that
the reasoning and holding in Bowers have been rejected elsewhere. Court looked to laws of
other countries and found many to be consistent with affirmation of a protected right of
homosexual adults to engage in intimate, consensual conduct.
The right the petitioners seek in this case has been accepted as an integral part of human freedom
in many other countries. There has been no showing that in this country the governmental
interest in circumscribing personal choice is somehow more legitimate or urgent
The doctrine of stare decisis is essential to the respect accorded to the judgments of the Court and to
the stability of the law. It is not, however, an inexorable command. Payne v. Tennessee, 501 U. S.
808, 828 (1991) ("Stare decisis is not an inexorable command; rather, it `is a principle of policy and
not a mechanical formula of adherence to the latest decision' ") (quoting Helvering v. Hallock, 309
U. S. 106, 119 (1940))). In Casey we noted that when a Court is asked to overrule a precedent
recognizing a constitutional liberty interest, individual or societal reliance on the existence of that
liberty cautions with particular strength against reversing course. 505 U. S., at 855-856; see also id.,
at 844 ("Liberty finds no refuge in a jurisprudence of doubt").
The Lawrence Court acknowledged that the historical grounds on which the Bowers Court relied
evidenced a centuries old practice of condemning homosexual conduct as immoral and that the
condemnation was shaped by religious beliefs, conceptions of right and acceptable behavior,
and respect for the traditional family. For many persons these are not trivial concerns but profound
and deep convictions accepted as ethical and moral principles to which they aspire and which thus
determine the course of their lives. These considerations do not answer the question before us,
however. The issue is whether the majority may use the power of the State to enforce these views on
the whole society through operation of the criminal law. "Our obligation is to define the liberty of all, not
to mandate our own moral code." Planned Parenthood of Southeastern Pa. v. Casey, 505 U.
112
113
Id. at ¶ 68.
Id. at ¶ 70.
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National Health Freedom Action (NHFA)
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Submitted July 17, 2013
S. 833, 850 (1992).
Justice O’Connor’s concurrence relied on the Equal Protection Caluse, instead of on the substantive due
process component, of the 14th amendment. Applying a “heightened” rational basis review to the
legislation because the challenged relationship inhibits personal relationships, Justice O’Connor
concluded that Texas’ moral disapproval is an interest that is insufficient to satisfy rational basis review
under the EPC. She further stated that “the equal protection clause prevents a state from creating a
classification of persons undertaken for its own sake.”
"The framers of the Constitution knew, and we should not forget today, that there is no more
effective practical guaranty against arbitrary and unreasonable government than to require that the
principles of law which officials would impose upon a minority be imposed generally. Conversely,
nothing opens the door to arbitrary action so effectively as to allow those officials to pick and choose only
a few to whom they will apply legislation and thus to escape the political retribution that might
be visited upon them if larger numbers were affected." Railway Express Agency, Inc. v. New York,
336 U. S. 106, 112-113 (1949) (concurring opinion). 114
Justice Scalia’s dissent provides very interesting points. He takes issue with the majority’s
approach to stare decisis that identified three factors upon which the court could overrule an
erroneously decided precedent. Most interesting is his commentary regarding the third ground:
"[T]here has been," the Court says, "no individual or societal reliance on Bowers of the sort that
could counsel against overturning its holding ... ." Ante, at 16. It seems to me that the "societal
reliance" on the principles confirmed in Bowers and discarded today has been overwhelming.
countless judicial decisions and legislative enactments have relied on the ancient proposition that
a governing majority's belief that certain sexual behavior is "immoral and unacceptable"
constitutes a rational basis for regulation. See, e.g., Williams v. Pryor, 240 F. 3d 944, 949 (CA11
2001) (citing Bowers in upholding Alabama's prohibition on the sale of sex toys on the ground
that "[t]he crafting and safeguarding of public morality ... indisputably is a legitimate
government interest under rational basis scrutiny")[…]We ourselves relied extensively on Bowers
when we concluded, in Barnes v. Glen Theatre, Inc., 501 U. S. 560, 569 (1991), that Indiana's public
indecency statute furthered "a substantial government interest in protecting order and morality," ibid.,
(plurality opinion); see also id., at 575 (Scalia, J., concurring in judgment). State laws against bigamy,
same-sex marriage, adult incest, prostitution, masturbation, adultery, fornication, bestiality,
and obscenity are likewise sustainable only in light of Bowers' validation of laws based on moral
choices. Every single one of these laws is called into question by today's decision; the Court makes
no effort to cabin the scope of its decision to exclude them from its holding. See ante, at 11 (noting
"an emerging awareness that liberty gives substantial protection to adult persons in deciding how to
conduct their private lives in matters pertaining to sex" (emphasis added)). The impossibility of
114
Id. at 97. (O’Connor, J., concurring).
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
distinguishing homosexuality from other traditional "morals" offenses is precisely why Bowers
rejected the rational-basis challenge. "The law," it said, "is constantly based on notions of morality,
and if all laws representing essentially moral choices are to be invalidated under the Due Process
Clause, the courts will be very busy indeed." 478 U. S., at 196.*fn2
What a massive disruption of the current social order, therefore, the overruling of Bowers entails.
Not so the overruling of Roe, which would simply have restored the regime that existed for centuries
before 1973, in which the permissibility of and restrictions upon abortion were determined
legislatively State-by-State. Casey, however, chose to base its stare decisis determination on a
different "sort" of reliance. "[P]eople," it said, "have organized intimate relationships and made
choices that define their views of themselves and their places in society, in reliance on the
availability of abortion in the event that contraception should fail." 505 U. S., at 856. This falsely
assumes that the consequence of overruling Roe would have been to make abortion unlawful. It
would not; it would merely have permitted the States to do so. Many States would unquestionably
have declined to prohibit abortion, and others would not have prohibited it within six months (after
which the most significant reliance interests would have expired). Even for persons in States other
than these, the choice would not have been between abortion and childbirth, but between abortion
nearby and abortion in a neighboring State.
In any event, an "emerging awareness" is by definition not "deeply rooted in this Nation's history and
tradition[s]," as we have said "fundamental right" status requires. Constitutional entitlements do not
spring into existence because some States choose to lessen or eliminate criminal sanctions on certain
behavior. Much less do they spring into existence, as the Court seems to believe, because foreign
nations decriminalize conduct. The Bowers majority opinion never relied on "values we share with a
wider civilization," ante, at 16, but rather rejected the claimed right to sodomy on the ground that
such a right was not " `deeply rooted in this Nation's history and tradition,' " 478 U. S., at 193-194
(emphasis added). Bowers' rational-basis holding is likewise devoid of any reliance on the views of a
"wider civilization," see id., at 196. The Court's discussion of these foreign views (ignoring, of
course, the many countries that have retained criminal prohibitions on sodomy) is therefore
meaningless dicta. Dangerous dicta, however, since "this Court ... should not impose foreign moods,
fads, or fashions on Americans." Foster v. Florida, 537 U. S. 990, n. (2002) (Thomas, J., concurring
in denial of certiorari). 115
One of the most revealing statements in today's opinion is the Court's grim warning that the
criminalization of homosexual conduct is "an invitation to subject homosexual persons to
discrimination both in the public and in the private spheres." Ante, at 14. It is clear from this that the
Court has taken sides in the culture war, departing from its role of assuring, as neutral observer, that
the democratic rules of engagement are observed. Many Americans do not want persons who openly
engage in homosexual conduct as partners in their business, as scoutmasters for their children, as
115
Id. at ¶131.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
teachers in their children's schools, or as boarders in their home. They view this as protecting
themselves and their families from a lifestyle that they believe to be immoral and destructive. The Court
views it as "discrimination" which it is the function of our judgments to deter. So imbued is
the Court with the law profession's anti-anti-homosexual culture, that it is seemingly unaware that
the attitudes of that culture are not obviously "mainstream"; that in most States what the Court calls
"discrimination" against those who engage in homosexual acts is perfectly legal; that proposals to
ban such "discrimination" under Title VII have repeatedly been rejected by Congress, see
Employment Non-Discrimination Act of 1994, S. 2238, 103d Cong., 2d Sess. (1994); Civil Rights
Amendments, H. R. 5452, 94th Cong., 1st Sess. (1975); that in some cases such "discrimination" is
mandated by federal statute, see 10 U. S. C. �654(b)(1) (mandating discharge from the armed forces
of any service member who engages in or intends to engage in homosexual acts); and that in some
cases such "discrimination" is a constitutional right, see Boy Scouts of America v. Dale, 530 U. S.
640 (2000).
Let me be clear that I have nothing against homosexuals, or any other group, promoting their agenda
through normal democratic means. Social perceptions of sexual and other morality change over time,
and every group has the right to persuade its fellow citizens that its view of such matters is the best.
That homosexuals have achieved some success in that enterprise is attested to by the fact that Texas
is one of the few remaining States that criminalize private, consensual homosexual acts. But
persuading one's fellow citizens is one thing, and imposing one's views in absence of democratic
majority will is something else. I would no more require a State to criminalize homosexual acts -- or,
for that matter, display any moral disapprobation of them -- than I would forbid it to do so. What
Texas has chosen to do is well within the range of traditional democratic action, and its hand should
not be stayed through the invention of a brand-new "constitutional right" by a Court that is impatient
of democratic change. It is indeed true that "later generations can see that laws once thought
necessary and proper in fact serve only to oppress," ante, at 18; and when that happens, later
generations can repeal those laws. But it is the premise of our system that those judgments are to be
made by the people, and not imposed by a governing caste that knows best.
Today's opinion dismantles the structure of constitutional law that has permitted a distinction to be
made between heterosexual and homosexual unions, insofar as formal recognition in marriage is
concerned. If moral disapprobation of homosexual conduct is "no legitimate state interest" for
purposes of proscribing that conduct, ante, at 18; and if, as the Court coos (casting aside all pretense
of neutrality), "[w]hen sexuality finds overt expression in intimate conduct with another person, the
conduct can be but one element in a personal bond that is more enduring," ante, at 6; what
justification could there possibly be for denying the benefits of marriage to homosexual couples
exercising "[t]he liberty protected by the Constitution," ibid.? Surely not the encouragement of
procreation, since the sterile and the elderly are allowed to marry. This case "does not involve" the
issue of homosexual marriage only if one entertains the belief that principle and logic have nothing
to do with the decisions of this Court. Many will hope that, as the Court comfortingly assures us, this
is so.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
II C. MN Stat 121A.15 is unconstitutional because:
a. It provides for an overly broad and impermissible delegation of rulemaking power to the
Minnesota Department of Health to further modify the Reporting Schedule of
Immunization for School Children giving complete deference to the federal government and
inhibiting the right of the state of Minnesota to determine what products, protocols, and
procedures Minnesota wishes to use to protect its citizens from dangerous contagious
diseases that could potentially lead to an epidemic;
b. Undermines and infringes on the role of the primary care Physician as medical provider
abiding by his/her acceptable and prevailing standards of care;
c. Undermines and marginalizes the Minnesota’s true doctrine of informed consent;
d. Limits citizen options in obtaining immunization in state government programs; and
e. Infringes on the broad state police power and the role of the state to establish contagious
disease epidemic vaccine policy of their choice by establishing the federal government and
its programs to be the exclusive source and authority over contagious epidemic disease
health policy for the citizens of Minnesota.
II.C. a. MN 121A.15 is unconstitutional and is an impermissible delegation of rulemaking power
and inhibits the right of the state of Minnesota to determine what products, protocols, and
procedures Minnesota wishes to use to protect its citizens from dangerous contagious diseases that
could potentially lead to an epidemic, limits its ability to protect the public health and safety,
MN 121A.15 is not a local quarantine law impacting the location of a person. It is not a MN inspection
law impacting entrance into property. It is law that ultimately impacts what will potentially be injected
into the physical bodies of Minnesota children. And it calls upon the police power of the state to enforce
its reporting requirements. We acknowledge that Minnesotan law provides an exemption for those who
choose to decline vaccines based on medical reasons or upon conscientiously held beliefs.116 However
we contend that MN121A.15 does not protect Minnesotans, including both those who wish to participate
in an immunization program and those who decline, and does not protect Minnesota’s authority to design
its own contagious epidemic disease vaccine policy, or protect its citizens from obtaining immunization
options that are not federally recommended. It is not a law limited merely to saying Minnesota would be
wise to recommend only the federally recommended vaccine schedule. Rather it states that “A proposed
modification made under this subdivision must be part of the current immunization recommendations of
each of the following organizations: the United States Public Health Service's Advisory Committee on
116
MN121A.15 Subd. 3(d) 2013
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National Health Freedom Action (NHFA)
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Submitted July 17, 2013
Immunization Practices, the American Academy of Family Physicians, and the American Academy of
Pediatrics”. 117 This exclusive reliance has far reaching ramifications.
The United States Public Health Service's Advisory Committee on Immunization Practices, (ACIP) is a
federal entity. The ACIP has become the only federal entity to make vaccination recommendations to the
states for public health and for children in particular. 118 States today rely on ACIP’s recommendations for
school vaccination mandates. The federal government subsidizes vaccines on the ACIP-recommended
list for indigent children, and manufacturers receive liability protection for ACIP-recommended vaccines
by statute. 119
From a state’s police power perspective, this could undermine the state’s ability to act independently on
behalf of its citizens. This says to all Minnesotans: ‘Here is the schedule, these are the vaccinations
recommended by (and supplied and funded by) the federal government to be injected into your child, you
cannot sue for damages if your child is hurt but you can get $250,000 death benefit if your child dies if a
special vaccine court agrees your case is eligible for compensation, and the state of Minnesota has no
intention and the Department of Health has no authority to recommend an immunization schedule that is
not recommended by the federal government , no matter if Minnesota, on its own merit and authority,
determines that another approach, dosage, or schedules will protect Minnesotan’s, or if Minnesota
determines that it would be beneficial to use other FDA approved products for the immunization schedule
that are not recommended by federal programs for use, even if it finds that they are more likely to protect
the public health and safety of Minnesotans. Minnesota’s hands are tied and we will only do what the
federal government recommends.’
This comprehensive reliance of the state on federal recommendations is of a serious nature and impacts
the health care and lives of all state citizens. It is understandable that the federal government has
jurisdiction over the vaccine products themselves and the safety of the commerce involved therein. But
having the federal government be the entity recommending the treatment protocols for prevention rather
than primary care physicians, and also having the federal government provide the vaccines, the vaccine
evaluations, the adverse event programs, and the special court for limited compensation , infringes upon
the health care relationships citizens have with their primary physicians, as well as their relationship with
the state and the state’s police power to protect the health and safety of its citizens. Understandably, the
relationship between state, the federal government, and the relationship that a person has with their
personal physician all come together in vaccine law and is complex. The question is who or what entity is
really looking out for the best interest and health of each person? We contend that handing over complete
deference to the federal government regarding modifications to the School Immunization Schedule
infringes on the police power of Minnesota and takes away the right of Minnesota to determine what
products, protocols, and procedures Minnesota wishes to use to protect its citizens from dangerous
117
MN121A.15 subd. (12) 2013
Mary Holland law review Pg 54
119
May Holland Pg 54
118
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Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
contagious diseases that could potentially lead to an epidemic and limits its ability to protect the public
health and safety,
II. C. b. MN121A.15 is unconstitutional and infringes on the role of the primary Physician as
medical provider with a medical standard of care.
The federal government has adopted the term “medically acceptable standards” as the term used to
establish their basis for the recommended vaccines 120, and now the Minnesota Department of Health is
asking Minnesota to adopt a definition in its proposed rule adopting that term. 121 We ask that this term
not be adopted into Minnesota law. Adopting this term could infringe on the authority of Physicians to
act on their patients behalf and cause more confusion regarding the privileges and duties of the primary
care Physician bestowed upon them by state law to be able to evaluate the “acceptable and prevailing
standards of care” in the treatment of their patients. We ask that Minnesota not adopt this definition
because it would suggest that the federal government, being the exclusive source and recommender of
vaccines, dictates what a standard of care is for vaccination for a Minnesota Physician.
Another example of a case where Minnesota was asked to consider allowing the federal government to
infringe on the practice standards of Minnesota Physicians is when, in 2003, the Minnesota Department of
Health initiated a legislative bill regarding bioterrorism and health emergencies that suggested that in the
case of a health emergency that any Physician not abiding by the federal government’s health care
mandates would be criminally charged. 122 Citizens and doctors in Minnesota fought hard to resist this
language in order to protect the Physician/Patient relationship and the Physicians right to do what they
deem appropriate for the patient. The language was struck from the bill. 123 However this type of
language was introduced and passed in other states.
II. C. c. MN Stat 121A.15 and the proposed rules giving deference to federal recommendations for
mass distribution of a federally approved and supplied product is unconstitutional under the 14th
Amendment and undermines and marginalizes the true doctrine of informed consent.
Informed Consent:
The foundational and constitutional concept of informed consent for health care treatments is one of the
most important and cherished protections of personal liberty interests. And the informed consent
doctrine has become firmly entrenched in American tort law.124 Justice O’Connor’s concurrence in
Cruzan eloquently articulated the importance of our ability to discern our path with our bodies; “notions
120
Sonar Pg. 1
Proposed rules regarding definition of medically acceptable standards
122
CHAPTER 402-H.F.No. 3031 An act relating to public health; establishing the
Minnesota Emergency Health Powers Act, 2002.
123
Health Emergencies act introduced version with doctor criminal charges in it HF 3031, introduced Feb 2002.
124
Id. Cruzan
121
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Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
of liberty are inextricably entwined with our idea of physical freedom and self-determination” and “the
Court has often deemed state incursions into the body repugnant to the interests protected by the Due
Process Clause.”
Most courts have based a right to refuse treatment either solely on the common-law right to informed
consent or on both the common-law right and a constitutional privacy right. See L. Tribe, American
Constitutional Law � 15-11, p. 1365 (2d ed. 1988). 125 NHFA contends that the information that
Minnesota parents receive, if any, before their child receives a vaccination, is not adequate for them to
make an informed decision and their safety is not ensured when receiving vaccines recommended in the
Minnesota School Immunization Schedule, and their right to informed consent and their right of privacy
under the 14th amendment are thus compromised.
For Minnesota children who are receiving injections of foreign antigens and toxic additives into their
bodies to prepare to enroll in school, the protections of self-determination and discernment afforded in
Minnesota’s principles of informed consent have been severely marginalized by a complex web of health
policy players and invested interest groups and their work to promote, administer, and mandate citizen
reporting of the use of vaccines nationwide. This powerful web of vaccine resources and authority has
jeopardized the very basic rights of parents to make truly informed choices for their children.
Minnesota generally requires physicians to disclose information to patients, even including risks that “a
doctor is aware that a patient attaches a particular significance to risks not generally considered serious
enough to require discussion” 126. In Minnesota,
“A cause of action for negligent nondisclosure "focuses on a doctor's duty to inform patients of
the risks attendant upon certain medical procedures." K.A.C. v. Benson, 527 N.W.2d 553, 561
(Minn. 1995). To make out a prima facie case, then, a plaintiff must demonstrate, among other
things, that the physician had a duty to disclose a particular risk of treatment. Id.; see also
Reinhardt, 337 N.W.2d at 93. In establishing that a physician had a duty to disclose a risk, a
plaintiff must offer evidence that the doctor "knows or should know" that the risk exists. Kinikin
v. Heupel, 305 N.W.2d 589, 594 (Minn. 1981); see also Cornfeldt, 262 N.W.2d at 699. Even
then, a duty to disclose arises for only certain types of risks, which the Minnesota Supreme Court
has described as falling into three distinct categories: those that are of a type "which a skilled
practitioner of good standing in the community would reveal"; those that present a "significant
probability" of "death or serious bodily harm"; and "to the extent that a doctor is aware that a
patient attaches a particular significance to risks not generally considered serious enough to
125
Cruzan at 19
Enid Stowell v. Paul Huddleston, M.D.; Mayo Clinic-Rochester, A Non-Profit, 643 F.3d 631 (8th Cir. 07/07/2011)
UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT
643 F.3d 631, 2011
126
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Submitted July 17, 2013
require discussion," those risks as well. Benson, 527 N.W.2d at 561; see also Kinikin, 305
N.W.2d at 595.” 127
The special relationship that patients have with their doctor is a trusted relationship, and parents expect
their doctors to let them know of any dangers that might come to their precious child. Similar to Benson
and Kinikin, doctors know that parents attach a particular significance to the possibility of the death of
their child, even if that risk might be considered small in the eyes of a researcher, manufacturer, or the
doctor his or herself. However, the liberty interests of Minnesotans has been dangerously infringed upon
and manipulated because the duty to inform by both physicians and manufacturers has been intentionally
watered down by federal and state promoters of vaccines to the point that the information that parents
receive, if any, before their child receives a dangerous vaccination, is not adequate to inform their
decision.
Federal law regarding prescription drugs, including vaccines and other health care products is
comprehensive in its stringent drug labeling laws with the mandatory information requirements being
carefully spelled out in package inserts and promotional materials. 128 However the manufacturer’s duty
to warn has been decreased by the intermediary doctrine described below.
A recent article in the Yale Journal of Health Policy, Law, and And Ethics regarding informed consent
sheds light on this and describes the reason for this phenomenon succinctly:
“With respect to vaccines, however, these norms are substantially relaxed. The NCVIA does not require doctors or
vaccine manufacturers to give complete warnings directly to the person or guardian of the child being vaccinated. It
requires that doctors give government-produced information and requires that manufacturers provide proper warnings
to doctors only, who are considered to be “learned intermediaries.”281 Both industry and the medical community
lobbied for this lowered standard.282
The NCVIA initially required more information than what parents receive today. It specified ten items for CDC-drafted
Vaccine Information Materials (VIMs).283 The initial versions were twelve pages long and required parental signature.
But pediatricians found the brochures were scaring parents and took too much time.284 The American Academy of
Pediatrics submitted legislation to shorten the VIMs and Congress enacted the proposed changes in 1993. Instead of ten
information items, statements for parents now contained four: the benefits of
280. See, e.g., 61 AM. JUR. 2D Physicians, Surgeons, Etc. § 175 (2010) (“The doctrine of
127
Enid Stowell v. Paul Huddleston, M.D.; Mayo Clinic-Rochester, A Non-Profit, 643 F.3d 631 (8th Cir. 07/07/2011)
UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT
643 F.3d 631, 2011
128
The Center for Biologics Evaluation and Research (CBER) reviews final and draft professional and direct-toconsumer (DTC) advertising and promotional labeling materials submitted for licensed biological products,
including vaccines, allergenic extracts, blood products, gene therapy products, and certain medical devices and test
kits regulated by CBER. Accessed online July 15, 2013 @
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMater
ials/ucm118171.htm
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Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
informed consent imposes on a physician the duty to explain the procedure to the patient and to warn him of
any material risks or dangers inherent in all collateral therapy, so as to enable the patient to make an
intelligent and informed choice about whether or not to undergo the treatment.”).
281. See, e.g., 28 C.J.S. Drugs and Narcotics § 128 (2010) (“Under the learned-intermediary
doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn
the patient, consumer or general public of the dangers involved with the product, but instead has a
duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the
manufacturer.”).
282. See COLGROVE, supra note 106, at 208-17.
283. 42 U.S.C. § 300aa-26(c) (2006).
284. Kristine M. Severyn, Jacobson v. Massachusetts: Impact on Informed Consent and
Vaccine Policy, 5 J. PHARMACY & L. 249, 270-71 (1996).
the vaccine, the risks, one sentence about the VICP, and a reference to the CDC for further information. Parents’
signatures were also eliminated. In an advisory to doctors, the CDC wrote that the new VIMs “provide enough
information that anyone reading the materials should be adequately informed.”285 The current statements largely
reassure parents that immunizations are safe and effective.
The current Hepatitis B Vaccine Information Statement provides the following information about possible adverse
events, claiming, “Hepatitis B is a very safe vaccine. . . . Severe problems are extremely rare. Severe allergic reactions
are believed to occur about once in 1.1 million doses. A vaccine, like any medicine, could cause a serious reaction. But
the risk of a vaccine causing serious harm, or death, is extremely small.”286
By contrast, the hepatitis B vaccine package inserts provide long lists of adverse events reported since the vaccine
entered the market. A partial list of adverse events reported for Engerix-B and Recombivax HB include anaphylaxis,
encephalitis, encephalopathy, paralysis, optic neuritis, multiple sclerosis, and vasculitis.287
Under the vaccine laws before 1986, these Vaccine Information Statements would not have met minimum requirements
for duty to warn. Some parents and caregivers today also find the statements insufficient for rational decision-making
and informed consent. In Oregon, for instance, a bill has been introduced in the state legislature to require physicians to
give parents the hepatitis B vaccine package insert and to have them consent in writing so that they can better
appreciate the risks.288 The citizen who took this initiative is the grandmother of an infant who suffered a severe stroke
after hepatitis B vaccination.
285. Id. at 272.
286. Hepatitis B Vaccine:What You Need To Know, CENTERS FOR DISEASE CONTROL &
PREVENTION (July 18, 2007), http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-b.pdf.
287. Merck & Co., supra note 226; GlaxoSmithKline, supra note 226.
288. H.R. 2635, 76th Leg. Assemb., 2011 Reg. Sess. (Ore. 2011), available at http://gov.
oregonlive.com/bill/2011/HB2635.
Holland’s research explains the reason for the current and blatant violation of liberty interests protected
under the 14th amendment and the many stories of parents who in addition to grieving for the loss of life
or health of a vaccine damaged child, are also experiencing a deep betrayal because of the inadequacy of
their informed consent. Many parents do not fully grasp the extent of the potential risks and seriousness
of the risks of a vaccine including the death of their child or the potential of their child to be permanently
and completely disabled for life from a vaccine because they have not had a thorough and vetted
conversation about this topic with their primary care Physician.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
In America, parent might generally understand that there are risks to their child for taking a prescription
drug. But also in America, because we are America, parents generally would understand and count on the
fact that those risks are very very small because they trust that they have the option of redress, and that
there is the potential for doctors and manufacturers to be sued and that fact keeps the market place safe
from pernicious products and people.
But in the case of vaccines parents are not told of the changes to the protections of the liberty interests in
informed consent as it applies to vaccines. They are not told that in the unique case of childhood
vaccines, the law eliminates manufacturer liability for a vaccine's unavoidable adverse side effects, now
most recently to include no liability for design defect claims. 129 They are not told that their right to sue in
a common court of law has been modified by the establishment of a special federal court for vaccine
injury claims. They have not been told that their doctor’s duty to inform has been decreased by the
existence of the federal Vaccine Information Sheet claiming to be adequate regarding risks and benefits
regarding their rights, they are simply given notice of an easy way to file a complaint with a general
federal disclosure form available. 130 Most parents would think that a notice to be able to file a complaint
is a kind and helpful gesture from an agency, hospital, or provider, and would consider it just the starting
place for any of their concerns. However they have no idea that the notice has another hidden aspect in
that it may be their only recourse, and that even to file a claim for damages in the offered location of the
United States Court of Federal Claims under the Vaccine Injury Compensation Program, the effects of
their child’s injury would have to have lasted for more than 6 months after the vaccine was given; or
resulted in a hospital stay and surgery; or resulted in death 131 And in the event their child dies, the
maximum amount of death benefit of compensation would be $250,000. 132
Informed consent embodies and reflects the protection of special relationships and sacred trusts that we
experience with our health care providers. The combination of the fact that more and more dangerous
vaccines are now being used for disease prevention rather than to stop a pending and imminent
dangerous epidemic, and the fact that the information parents receive about the vaccine is less than what
they would receive for taking any other prescription drug, and is in a special unprotected legal
environment for recourse in the event of harm even including the death of their child, calls for a stop to
the denial of life and liberty interests protected under the 14th amendment and a reclaiming and reinstating of the effective doctrine of informed consent in Minnesota on behalf of children and parents who
wish to participate in a School Immunization Program.
The federal government is not the only entity proliferating the number of un-informed parents. In
addition to the national watering down of informed consent, the local state efforts to inform parents of the
dangers of vaccine are marginalized by promotional campaigns.
129
Bruesewitz v. Wyeth 131 S.Ct. 1068, Feb. 22, 2011
Federal Vaccine Information Statements accessed online July 16, 2013 @
http://www.vaccines.gov/more_info/vis/index.html
131
Vaccine Compensation Program general information http://www.hrsa.gov/vaccinecompensation/eligibility.html
132
National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-1 etseq. (2000) (the "Vaccine Act").
130
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
A small but telling example of this dynamic is the local politics of the phrase “No shots, No school”.
Parents often depend on their health care providers, teachers, and support communities, for notices and
information on school preparation. And many Minnesota parents have not been aware of the
conscientiously held belief exemption because historically Minnesota has promoted vaccines in
campaigns claiming “No Shots, No School” even though there was in existence a legal right to exempt
out under the reporting statutes. However in 2002 parents of vaccine damaged children and other
concerned citizens gathered at the Minnesota legislature to initiate and support legislation that made the
option of exemptions more known and available to parents. 133 A law was designed and passed that stated
requirements to be complied with for any written information about immunization requirements for
enrollment in a school or child care facility. The new law even commented on the font size and page and
stated: “…The information on exemptions from immunizations provided according to this paragraph
must be in a font size at least equal to the font size of the immunization requirements, in the same font
style as the immunization requirements, and on the same page of the written document as the
immunization requirements.” 134 In addition citizens initiated and passed further language requiring that
before immunizing a person, an immunization provider must provide in writing:
(1) a list of the immunizations required for enrollment in a school or child care facility;
(2) a description of the exemptions from immunizations permitted under subdivision 3,
paragraphs (c) and (d);
(3) a list of additional immunizations currently recommended by the commissioner; and
(4) in accordance with federal law, a copy of the vaccine information sheet from the federal
Department of Health and Human Services that lists possible adverse reactions to the
immunization to be provided. 135
After the legislation passed the Minnesota Department of Health developed a “Pupil Immunization
Record” form including on the front of it in the proper font size the conscientiously held belief exemption
options:
Conscientious exemption: No student is required to have an immunization which is contrary to the conscientiously
held beliefs of his/her parent or guardian. To receive this exemption, a parent or legal guardian must complete and sign
the following statement and have it notarized:
I certify by notarization that immunization for my child is contrary to my conscientiously held beliefs. Indicate
vaccine(s):
133
Senate File 4, Introduced Dec 2002, Omnibus Health Bill accessed @
https://www.revisor.mn.gov/bills/text.php?session=ls82&number=SF0004&session_number=1&session_year=200
1&version=list
134
135
MN 121A.15 subd. 3a
Id.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
But in 2011 the Department redesigned their form without notice to the advocates of the prior legislation,
and moved the majority of the verbiage of the exemption notice to the back of the page, claiming in a
responsive email from Department attorney that it was still on the same page “Everything is still on the
same page, there is just a front and back side.” To add fuel to the fire, the new form notice on the back of
the page added additional language of the Department’s own addition, warning against the dangers of not
getting the vaccine which stated: “However, not following vaccine recommendations may endanger the
health or life of the student or others they come in contact with. In a disease outbreak schools may
exclude children who are not vaccinated in order to protect them and others.”
B. Conscientious exemption:
No student is required to have an immunization that is contrary to the conscientiously held beliefs of his/her parent or
guardian. However, not following vaccine recommendations may endanger the health or life of the student or others
they come in contact with. In a disease outbreak schools may exclude children who are not vaccinated in order to
protect them and others. (italics and underlining added) To receive an exemption to vaccination, a parent or legal
guardian must complete and sign the following statement and have it notarized:
I certify by notarization that it is contrary to my conscientiously held beliefs for my child to receive the following
vaccine(s):
136
These small but important changes in this form, distributed to millions of Minnesotans, displays the ease
of which a powerful agency can impact information and policy among populations. The old forms, vetted
by parties that had worked on the disclosure legislation, was neutral simply showing options in reporting
and not making value statements regarding the benefits of vaccines or the dangers of vaccines. However
the new form warns against the dangers of NOT getting vaccines and does not disclose any information
about the dangers of getting vaccines.
Another example of this minimization policy is the current rulemaking documents. Minnesota
Department of Health minimized the risk of death and harm from vaccines in their SONAR report.
Although phrases indicating the risk of death from disease was repeated over and over again throughout
the report, there were no phrases, no mention of risk of death from vaccines, except to twice mention that
the concern for risk of death from a vaccine was unfounded by review of the VAERS data:
“For this reason, it is incorrect and misleading to cite VAERS data to show that a vaccine causes
a specific number of adverse events or deaths. (For more information on VAERS see
Attachment H, Understanding the Vaccine Adverse Events Reporting System.)” 137
136
137
New form
Sonar Pg 27
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Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
“For this reason, it is incorrect and misleading to cite VAERS data to show that a vaccine causes
a specific number of adverse events or deaths. For more information on VAERS see discussion
on page 24 and Attachment H, Understanding the Vaccine Adverse Events Reporting” 138
There is an urgent need for a statewide discussion regarding the inadequacy of informed consent and the
pain of parents who have lost their child or who are living with and caring for a vaccine damaged child.
We believe that adding more vaccines to an already burdened schedule of vaccines, when the informed
consent doctrine is not in full force for parents making these decisions, is irresponsible and should be
avoided. We hereby call for the re-instatement of the doctrine of informed consent regarding the use of
vaccines in Minnesota.
The Timing of the Elimination of Manufacturer Liability for Vaccine Side Effects as it
Relates to Minnesotans
The delegation of the rulemaking power to modify the immunization schedule occurred before
the Minnesota legislature understood the full impact of the National Childhood Vaccine Injury
Compensation Act of 1986 (Vaccine Act) on tort remedies for the citizens of Minnesota. The
delegation of authority to the Department occurred in 2001 in the flurry of the last six days 139 of
the first Special Session which had only lasted 18 days. 140
Since the federal Vaccine Act went into effect in 1986, courts have held that the Act preempts
state law in actions involving design defect claims, claims of failure to warn the public, claims to
recover medical expenses , and medical malpractice claims. However, with the variety of
holdings conflicting across the jurisdictions, the authority of those decisions remained in
question until 2011 when the Supreme Court decided Bruskwitz v. Wyeth. Prior to Bruesewitz
v. Wyeth LLC courts were split on whether the National Childhood Vaccine Injury
Compensation Act of 1986 preempted design defect claims. In Bruesewitz v. Wyeth LLC, the
Supreme Court held that the National Childhood Vaccine Injury Act (NCVIA) preempts all
design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation
for injury or death caused by vaccine side effects.
138
Sonar Pg 36
42 U.S.C.A. §§ 300aa-1 et seq, enacted November 14, 1986, as a new title to the Public Health Service Act of
November 14, 1986.
140
History of SF 4, Omnibus health and human services and corrections appropriations bill, available at:
https://www.revisor.mn.gov/bills/bill.php?b=House&f=SF4&y=2001&ssn=1; See also History of HF 3,
https://www.revisor.mn.gov/bills/bill.php?view=chrono&f=HF3&y=2001&ssn=1&b=house#actions; See also,
Governor veto of SF 2361 (May 15, 2001) (vetoing the bill as passed by both chambers and returning it to the
legislature).
139
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Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
This case was the last final blow to the citizens of Minnesota. This would be yet another fact
that parents might not be aware of as they make a decision to use a vaccine that is manufactured
in an environment where liability is not the norm for manufacturers.
What Parents Should Know: The 1986 Vaccine Act: Background, summary, and comment.
The National Childhood Vaccine Injury Compensation Act of 1986 or "Vaccine Act," created "a
new system for compensating individuals who have been injured by vaccines routinely
administered to children." 141 The new system, the National Vaccine Injury Compensation
Program (NVICP), was intended to be a streamlined, "no-fault" compensation scheme in which
injured vaccine recipients may recover damages without having to prove causation, negligence,
or defect. 142 Congress intended that this faster and easier scheme would provide a more
desirable alternative to litigation because of its speed, low transaction costs, no-fault nature, and
the relative certainty and generosity of its rewards. 143
At the same time, by creating incentives away from litigation, the program would save vaccine
manufacturers from the litigation and insurance costs related to lengthy, complex tort procedures
and large tort awards that could force manufacturers to leave the essential childhood vaccineproducing market. Compensation awards are paid from the Vaccine Injury Compensation Trust
Fund, which is funded by a manufacturers' excise tax on certain vaccines. 144 The Act became
completely effective, allowing suits to be brought thereunder, on October 1, 1988, when this
excise tax was enacted.
The system's special procedure begins with the filing of a petition in the United States Court of
Federal Claims, naming the Secretary of Health and Human Services as respondent. 145 An
Office of Special Masters within the Claims Court (generally called the "Vaccine Court") decides
petitions, provides for review by the Court of Federal Claims, and allows appeal of that court's
ruling to the Federal Circuit Court of Appeals. 146 To be eligible for compensation, a claimant
must show that he or she or the child he or she represents: (1) received a vaccine covered by the
Act; (2) suffered injuries associated with that vaccine and incurred unreimbursable expenses
greater than $1,000; and (3) it cannot be shown by a preponderance of the evidence that the
injuries were not caused by the vaccine. 147
141
42 U.S.C.A. §§ 300aa-1 et seq, enacted November 14, 1986, as a new title to the Public Health Service Act of
November 14, 1986.
142
Id
143
Cite to legislative history.
144
42 U.S.C.A. §§ 300aa-15(i)(2).
145
146
147
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
The Vaccine Act does not completely abandon or preclude a plaintiff's pursuit of traditional tort
rights. As was stated in the congressional discussions, "It is not the Committee's intention to
preclude court actions under applicable law. The Committee's intent at the time of considering
the Act and in these amendments was and is to leave otherwise applicable law unaffected, except
as expressly altered by the Act and the amendments." 148 Thus the Act explicitly provides that,
with certain exceptions, "State law shall apply to a civil action brought for damages for a
vaccine-related injury or death." 149
Therefore the contours of the Federal preemption embodied in the Act must be considered.
Preemption by federal law of state law occurs under the Supremacy Clause of the U.S.
Constitution, Art. VI, Cl. 2, in three instances: Express preemption occurs when Congress passes
a statute that by its express terms preempts state law; 150 or preemption may be implied either
where Congress leaves no room for supplementary state involvement because of a pervasive
scheme occupying an entire field of regulation, or where state law conflicts with federal law or
its purposes.
While recourse to state tort remedies is still very much a possibility, the Vaccine Act modifies
state law in certain but important respects. The most prominent preemption accomplished by the
Vaccine Act is its requirement, in 42 U.S.C.A. § 300aa-11, that petitioners who were injured
after October 1, 1988, must pursue the remedies under the Act and wait for the expedited time
period allotted for the Vaccine Court's determination before a civil action may be filed. The Act
specifically directs courts to dismiss causes of action that are not first filed with the Vaccine
Court. Once proceedings in the Vaccine Court have run their course, a petitioner/plaintiff may
opt to instead initiate or resume a civil action.
After the Vaccine Court has entered judgment, 151 a petitioner must elect either to accept the
award and formally abandon his or her tort rights, or to reject the award and proceed with a civil
action. If a decision is not rendered by the Vaccine Court within the statutorily allotted time, a
petitioner also may seek relief in state court. 152
Another way in which the Act alters the nature of a civil action and limits tort remedies is that a
vaccine manufacturer may not be held liable for "unavoidable" side effects of a properly
manufactured vaccine that was accompanied by proper directions and warnings. 153 This
provision mirrors Comment k of Restatement Second, Torts § 402A, which gives the example of
148
149
150
42 U.S.C.A. §§ 300aa-22(a)
151
42 U.S.C.A. § 300aa-11(a)(2)(A)(i)
42 U.S.C.A. §§ 300aa-21(b); however if a plaintiff seeks $1,000 or less in damages, he or she need not first
petition the Vaccine Court.
153
42 U.S.C.A. § 300aa-22(b)(1)
152
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National Health Freedom Action (NHFA)
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Submitted July 17, 2013
the rabies vaccine, which may lead to very serious and damaging consequences but without
which a patient would die of the disease. 154 The Restatement, upon which the Congress modeled
this provision, states that such a vaccine cannot be considered defective or unreasonably
dangerous.
An additional area of preemption is that of limitations; the filing of a petition under the Act stays
the running of state statutes of limitations. 155 Another modification of state tort law is that the
Act, in 42 U.S.C.A. § 300aa-22(c), frees manufacturers from liability for not providing direct
warnings to injured persons or their representatives. The Act in 42 U.S.C.A. § 300aa-22(b)(2)
also imposes a presumption that compliance with Food and Drug Administration requirements
means that a manufacturer provided proper directions and warnings.
Since the Act went into effect, courts have held that the Act does preempt state law in actions
involving design defect claims, claims of failure to warn the public, claims to recover medical
expenses, and medical malpractice claims. However, with the variety of holdings conflicting
across the jurisdictions, the authority of those decisions remained in question until the Supreme
Court decided Bruskwitz v. Wyeth in 2011.
The erosion of tort protections culminated in Bruesewitz v. Wyeth. Prior to Bruesewitz v. Wyeth
LLC courts were split on whether the National Childhood Vaccine Injury Compensation Act of
1986 preempted design defect claims. 156 In Bruesewitz v. Wyeth LLC, the Supreme Court held
that the National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims
against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death
caused by vaccine side effects. 157
In summary in to put this all in perspective, in Jacobson, the vesting of power by the legislature
into another body was deemed permissible in light of fact that that is was a body comprised of
members of the locality. However this is no longer the case and the decision makers, comprised
of government and industry parties, and state agency officials, do not answer to the local voters
of Minnesota. Parents of vaccinated children are left with few avenues of redress, especially in
light of the delegation of rulemaking power to the Department with complete deference to
154
155
42 U.S.C.A. § 300aa-16(c)
Eg, compare Wright v. Aventis Pasteur, Inc., 2011 PA Super 9, 14 A.3d 850, Prod. Liab. Rep. (CCH) P 18560
(2011) (National Childhood Vaccine Injury Act does not preempt any design defect claim based on state law, but
rather requires courts to conduct a case-by-case inquiry in order to determine whether a particular vaccine's side
effects are unavoidable. National Childhood Vaccine Injury Act of 1986, § 311(a), 42 U.S.C.A. § 300aa–22(b)(1).)
with Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007)(holding that strict liability defective design and
negligent design claims brought under state law against a vaccine manufacturer were expressly preempted by the
Vaccine Act.).
157
Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068, 1075 (2011).
156
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
federal recommendations, and the case law evolution of the 1986 Vaccine Act, and erosion of
tort protections in Bruesewitz v. Wyeth
II. C. d. MN Stat. 121A.15 and the exclusive deference to federal recommendations for mass
distribution of a federally approved product is unconstitutional and infringes on the broader state
police power and the role of the state to establish contagious disease epidemic vaccine policy of their
choice and establishes the federal government and its programs to be the exclusive source and
authority over contagious epidemic disease health policy for the citizens of Minnesota.
The federal government dominates the state in vaccine policy and the state is then in jeopardy of merely
being used because of its police power to implement the federal agenda. In as much, the state becomes a
puppet of the federal government. Of course states are vulnerable financially in these situations. And the
fact that there is no cost impact to the immunization schedule, because the federal government is covering
the cost and supplying the vaccines, impacts whether laws and rules are implemented. The subjects
flowing from “who is in charge” arises in a heated manner at the legislature. The state wants to listen to
the concerns of its citizens. However they are tied to the recommendations by financial concerns and
political concerns.
For example, in hearings regarding attempts by citizens to pass legislation demanding that recommended
vaccines not have any mercury content in them, the discussions that went forward ranged from parent
access to preferred vaccines, funding of vaccines, the health risks of disease, the side effects of vaccines,
the toxic substances potentially harmful to children that vaccines contain, what will be the long term
medical costs of a population of disabled children, and the limited liability of vaccine manufacturers for
vaccine damage. In listening to the original rationales for the Minnesota Department of Health to
maintain mercury in vaccines, citizens were struck by the fact that the resistance to mercury in vaccines
and the knowledge of the dangers neurologically of mercury in vaccines originally came from the public
and were resisted by the state agency. Many thought that the state should have been providing the cutting
edge research and should have acted promptly under the guidance of the precautionary principle to protect
all children from mercury damage to their brains. Now that there is more movement from citizens around
the world on this issue, some states are having success at removal of mercury in recommended
vaccines. 158
This same scenario of citizens being the first and only initiators of proper safe options could still unfold in
Minnesota on other vaccine issues due to the state’s blind deference to federal recommendations, such as
the issue of the current lack of research on how many vaccines over a child’s lifetime will damage a
child’s overall health. There has been no research completed on this subject although there have been
calls for such studies. It is thought that the federal vaccine industry does not have the incentive to
discuss the “maximum” number of vaccines a child could take because this would be against the
industry’s hope that children take an endless amount of vaccines. Thus citizens are addressing this issue
158
Iowa Law
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
themselves and an example of a citizen initiative is the German internet survey of 15,000 vaccinated and
unvaccinated children. Another survey by Generation Rescue is now showing that the health of
unvaccinated children far surpasses that of a vaccinated child. 159 Of course this research will not be
dispositive to a state setting a vaccine schedule, but it should be a warning to proceed with intense caution
and a call for immediate research and an approach embodying the precautionary principle before adding
any more vaccines to the already heavily burdened schedule for a child’s immune system, given the
inherent risks of vaccines in general.
II. C. e. MN Stat 121A.15 and the deference to federal recommendations for mass distribution of a
federally approved and supplied product is unconstitutional and limits citizen options in obtaining
immunization in state government programs.
There are many valid and helpful ways to address communicable diseases and that wisdom is
marginalized by the current police power statutes. Thousands of parents that have lost their children due
to federally approved vaccines or who have experienced parenting a neurologically challenged child are
asking questions and looking for other options in immunization. They are experiencing in their circles of
friends the growing number of stories of damage to children including adverse events surrounding
vaccines. They have become aware that vaccines can cause harm, but have found out after the fact. They
are learning about other options.
They are supporting each other in their confusion and pain. They have extensive information resources at
their fingertips. They are searching for options to protect their children and future children, not from an
imminent epidemic such as smallpox, but from unnecessary harm caused by a prescription drug
recommended for prevention by the federal government, not recommended by their doctor for a disease.
They are starting to understand that they could have been alerted to the risks in a more thorough manner
before consenting to vaccines. They are learning that there are alternatives to getting federally
recommended vaccines.160 They wish to comply with medical recommendations but the
recommendations appear to be limited to the vaccine recommendations of the federal government. So
some of their questions become: “Why didn’t the person giving the vaccine tell me that my child might
be harmed?” “I told them what happened in that first week and month to my child, how they changed,
but the clinic said that it is probably just coincidental.” “I can’t find any medical studies, what is the
greatest number of vaccines my child should have over a life time? Why can’t I find the studies?” “Why
are there so many vaccines, I’d rather have my child get chickenpox.” “Can all the vaccines I choose to
give my child be free from mercury? I have done research and found that even if a vaccine label says no
mercury, it still contains trace amounts and will accumulate with each vaccine.” “Are the homeopathic
159
Generation Rescue Oregon and California survey accessed summary online July 16, 2013 @
http://www.medicalnewstoday.com/releases/75333.php
160
Book: Vaccine Free - Prevention and Treatment of Infectious Contagious Diseases with Homeopathy
A Manual for Practitioners and Consumers, by Kate Birch.
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
vaccines available at my Dr.’s clinic because I do not want my children to have injection of antigens and
additives but would rather have them immunized homeopathically? “
The citizens of Minnesota deserve and have a right to more supported and state endorsed options for the
immune safety of their children. Presentations have been made to the Department on options for
immunization such as the homeopathic immunization protocols that avoid injecting foreign antigens into
children but have documented successes and are used internationally. 161 Presentations have been made by
medical experts to the Department on the use of homeopathic remedies in the case of a flu pandemics, and
remedy resources have been offered. 162 International efforts by prestigious Pastuer awardee medical
scientists have been used to provide non-harmful oral vaccination programs for disease prevention, for
example one million people were orally vaccinated with immune colostrum to prevent hepatic cancer.
These are just some examples of how the world is evolving and the injection of antigens and additives
into our children causing them serious adverse side effects and immune system failures is fast
approaching the end of its time.
The federal government and in the case of the Minnesota proposed rules, adding more vaccines to the
recommended schedule, minimizes these increasing cultural and more pervasive concerns. However the
Minnesota Department of Health is bound to implementing what the federal government is
recommending. And they have no authority to pose any schedule not recommended by the ACIP. In fact
the Minnesota Department of Health has not indicated and may not have evaluated other types of
immunization options that are not federally recommended because it has no authority to propose such
immunization options. And in the case of vaccines already on the schedule, as pointed out the court in its
2003 opinion, the Department of Health would be prohibited from removal of a vaccine that is already on
the Minnesota Immunization School Schedule, even if the Minnesota Department of Health thinks it
should be removed 163.
We contend that MN121A.15 is unconstitutional and contravenes the authority of the state of Minnesota’s
police power to protect its citizens. To hold otherwise would be to ignore one of the leading objects
which the Constitution of the United States was designed to secure.
Conclusion
There may be situations where the federal government may attempt to monopolize policy and dictate the
actions of a state in matters of vaccines and health such as in the case of national security or health
emergency when there is an active epidemic threatening the imminent safety of all citizens, such as a
pandemic, but Minnesota, even in that national security situation, protects the option of its citizens to
choose the option of quarantine over a federally recommended vaccine.
161
Id.
Jacob Mirman presentation
163
In the Matter of the Proposed Rules Relating to Child Care and School Immunizations, MN Rules, Chapter 4604,
Report of the Administrative Law Judge, 2003
162
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National Health Freedom Action (NHFA)
Docket No. 8-0900-30570
ADDITIONAL Comments on the MDH Immunization Rule Revisions
Submitted July 17, 2013
12.39 INDIVIDUAL TREATMENT; NOTICE, REFUSAL, CONSEQUENCE.
Subdivision 1.Refusal of treatment.
Notwithstanding laws, rules, or orders made or promulgated in response to a national security emergency or
peacetime emergency, individuals have a fundamental right to refuse medical treatment, testing, physical or
mental examination, vaccination, participation in experimental procedures and protocols, collection of
specimens, and preventive treatment programs. An individual who has been directed by the commissioner of
health to submit to medical procedures and protocols because the individual is infected with or reasonably
believed by the commissioner of health to be infected with or exposed to a toxic agent that can be transferred
to another individual or a communicable disease, and the agent or communicable disease is the basis for
which the national security emergency or peacetime emergency was declared, and who refuses to submit to
them may be ordered by the commissioner to be placed in isolation or quarantine according to parameters set
forth in sections 144.419 and 144.4195.
Subd. 2.Information given.
Before performing examinations, testing, treatment, or vaccination of an individual under subdivision 1, a
health care provider shall notify the individual of the right to refuse the examination, testing, treatment, or
vaccination, and the consequences, including isolation or quarantine, upon refusal.
For the reasons stated above we think that MN 121A.15 and it’s delegation of rulemaking power to the
Minnesota Department of health, is unconstitutional because it inhibits the right of the state of Minnesota
to determine what products, protocols, and procedures Minnesota wishes to use to protect its citizens
from dangerous contagious diseases that could potentially lead to an epidemic; undermines and infringes
on the role of the primary care Physician as medical provider abiding by his/her acceptable and prevailing
standards of care; undermines and marginalizes the true doctrine of informed consent, and in the case of
the federal vaccine disclosures, takes away the effectiveness of the information exchange between doctor
and patient where a wide range of options are often discussed; limits citizen options in obtaining
immunization in state government programs; and infringes on the broad state police power and the role of
the state to establish contagious disease epidemic vaccine policy of their choice by establishing the
federal government and its programs to be the exclusive source and authority over contagious epidemic
disease health policy for the citizens of Minnesota.
.
59