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A Pre-Market Approval System For Driverless Vehicles?
Law360, New York (October 3, 2016, 4:06 PM EDT) -The advent of driverless and automated vehicle technologies offers
enormous opportunities to improve the safety and mobility of Americans on the
road. To accelerate the development of self-driving cars, the Department of
Transportation (DOT) and the National Highway Traffic Safety Administration
(NHTSA) released a highly anticipated guidance document that includes ideas about
an entirely new regulatory structure for highly automated vehicles (HAV).[1] This
116-page document is divided into four parts: 1) Vehicle Performance Guidance; 2)
Model State Policy; 3) Current Regulatory Tools; and 4) Modern Regulatory
Tools that NHTSA may implement in the future to facilitate the “expeditious
development of HAVs.”[2]
Geoffrey M. Drake
In the latter section, the guidance discusses specific new regulatory tools and
authorities that federal policymakers have identified as having the potential to aid
the safe and efficient introduction of HAVs.[3] In particular, the guidance
contemplates implementing a pre-market approval system for new driverless and
automated technologies whereby the federal government would assess vehicle
prototypes to determine if the vehicle meets all applicable safety and performance
standards prior to entry to market.[4] If such a system is ever employed, it will
have implications in product liability litigation involving manufacturers of HAVs,
automated technologies and components.
Under current law, the National Traffic and Motor Vehicle Safety Act (the
“Vehicle Safety Act”) relies on a self-certification system premised on the concept
that before a vehicle reaches the consumer, the particular automotive design has
been evaluated by the manufacturer and found by the manufacturer to comply
with a number of defined, objective protocols articulated by NHTSA. Should a
manufacturer later determine that one of its models is not in compliance with these
federal laws and regulations, the manufacturer must follow the
regulatory requirements for correcting the issue, including, but not limited to, a
vehicle recall. As new automated vehicle technologies enter the marketplace,
regulators have questioned whether this self-certification system will continue to
be adequate to protect public safety.[5]
Susan M. Clare
Alexandra Royal
To keep pace with this transformative technology, federal policymakers have
been contemplating changes to the existing regulatory structure to provide safety assurances
to consumers of HAVs. For now, as Secretary of Transportation Anthony Foxx has explained, DOT has
decided to table the introduction of a formal pre-market approval process for HAVs.[6] Instead, NHTSA
intends to implement the guidance’s 15-point safety assessment in the coming year and work to set
clear expectations for manufacturers developing and deploying automated technologies.
Regardless, should policies continue to evolve annually as the agency has promised, future federal
regulations could include a pre-market approval system.[7] Such novel responsibilities for NHTSA would
certainly alter the traditional framework of automobile manufacturer certification, and, in turn, impact
product liability litigation.
This type of regulatory development in response to increased automation would not be unique to the
automobile industry. For example, in the face of increased automation across the aircraft industry,
the Federal Aviation Administration adopted a product certification process to regulate the safety of
complex, software-driven products such as autopilot systems. The FAA and Industry Guide to Product
Certification includes a component called the “Partnership for Safety Plan.”[8]
In the context of an original product certification, the Partnership for Safety Plan requires both FAA and
industry representatives to engage in interactive planning sessions at different stages in the
development cycle to establish general expectations or operating norms, define expected performance
measures, and create a series of milestones that can be used as a project management tool moving
forward.[9] According to FAA, the program’s intent is to ensure early, value-added joint involvement
with the expectation that the parties will work together to identify and service critical areas early in the
product development life cycle.[10]
In the past, and in this most recent policy guidance, DOT and NHTSA have carefully deconstructed FAA
processes that have proven successful in the commercial airline area and considered how they may
apply to the roadways. In the context of addressing new technological innovations, the concept of a
joint product development structure may be appealing to NHTSA as it seeks to adapt the current
regulatory framework to facilitate the introduction of original products.
If federal regulators are not included in the early creation stages of these automated vehicles and their
underlying technologies, they run the risk of becoming obsolete in the eyes of the industry and stalling
future progress in the field. Overall, while FAA’s pre-approval program is not a perfect model for NHTSA,
it does include enough of an automation module to inform NHTSA on how it might move forward to
define a regulatory structure that applies to HAVs.
Were NHTSA to develop such a full or partial pre-approval system, the system would undoubtedly
impact the landscape for product liability cases involving personal injuries from alleged automotive
defects. For starters, there has been much discussion in recent months about the extent to which the
federal government should advance new guidelines, regulations and legislation that would result in
federal law preempting state law with respect to liability for injuries arising from alleged HAV defects,
whether that liability arises from a design defect or a failure to provide an adequate warning.
Presently, preemption under the Vehicle Safety Act is limited. While the Vehicle Safety Act contains an
express preemption provision prohibiting states from adopting rules that are not identical to the federal
standards, it also contains a savings clause making clear that compliance with the federal standards does
not exempt manufacturers from civil liability.[11]
Accordingly, far-reaching preemption for HAVs would likely require legislation at the federal level. That
said, a pre-market approval system, like that seen with respect to prescription medications, could
bolster automobile manufacturers’ preemption arguments. Under a pre-approval system,
manufacturers could argue that NHTSA reviewed and evaluated the proposed vehicle or technology
design at issue and approved that vehicle/technology for marketing and sale in the United States.
As such, the defendant would argue that there is no valid claim that the design is defective. On top of
this notion that the government has already approved the vehicle/technology at issue, thereby deeming
it to be nondefective, the manufacturer may be able to point to specific record evidence that the
agency evaluated regarding the particular risk involved in a given accident and determined it
was adequately dealt with in the design or warnings.
As with prescription medications, however, it is somewhat unlikely that pre-market approval, on its
own, would be sufficient to absolve an HAV manufacturer of all liability under state tort law. As the U.S.
Supreme Court explained in Wyeth v. Levine, “in establishing minimum standards for drug labels,
[Congress] did not intend [for the FDA] to preclude the states from imposing additional labeling
requirements.”[12] But even if a pre-market approval system does not result in total immunity for HAV
manufacturers from state law claims, increased regulatory oversight prior to market introduction and
compliance with more rigorous federal regulations may make it more difficult for plaintiffs to prevail on
product liability claims premised on theories of design defect or failure to warn.
For instance, in a typical design defect claim, if the product at issue has been vetted rigorously by a
government agency during its well-established pre-market approval process (as opposed to a
manufacturer self-certification), it may be more difficult for a plaintiff to convince a jury that the preapproved design was defective. In other words, with DOT and/or NHTSA, neutral arbiters, having
reviewed the same design plans that the plaintiff now asserts were defective, the manufacturer may be
in a better position to defend against a claim of design defect.
This argument may also carry over to a claim for failure to warn in which the plaintiff asserts that the
manufacturer failed to provide adequate warnings of a risk about which the plaintiff now complains. If
the warning material that accompanied the vehicle was considered and approved by the regulator
before the product reached the market, a plaintiff will have a more difficult time arguing that the label
was inadequate.
Examples of how pre-market approval may impact product liability litigation involving HAVs, even in the
absence of express preemption, abound in the context of prescription medications. While FDA approval
of a prescription drug does not by itself preempt state law product liability claims, such approval does
impact litigation involving such products.
In most product liability cases involving prescription drugs, the manufacturer relies on the
extensive information FDA reviewed (both pre- and post-market) concerning the risks about which
the plaintiff complains. And in some instances where FDA has actually reviewed the data on the risk at
issue but determined that an enhanced warning was unnecessary, courts will even find preemption.[13]
A NHTSA pre-approval system would also be beneficial to HAV manufacturers in documenting their
product’s “safety story,” a critical component of defending against product liability claims. Assuming
that DOT and/or NHTSA retains an approach focused on performance criteria, rather than specified
design standards, in order to allow for competitive differentiation, a pre-market approval process would
likely include a series of development and testing protocols configured to verify the product’s safety
rating. As a product moves through the program, companies will memorialize each step of the product’s
life cycle, thereby creating supporting documentation that can be useful in defending claims regarding
the reasonableness of the design and the due care taken by the company in developing the technology.
In particular, communications with federal regulators regarding government approval of the vehicle
or underlying technology can be used as evidence of compliance with applicable regulations, and thus
lack of liability. Although regulatory compliance is currently only one factor in the liability analysis under
most states’ laws,[14] federal pre-approval standards and requirements, if implemented, would likely
impact the liability regime surrounding the automotive and transportation industries and result in
compliance becoming a more significant consideration.
As manufacturers of automated vehicles and technologies seek to gain a better understanding of their
potential future product liability exposure, one possibility that may ultimately reduce such exposure is
the implementation of a new federal framework for pre-market approval. Although such a system would
undoubtedly increase the costs and burdens associated with bringing HAVs to market, such a process
may provide real benefits to manufacturers facing product liability litigation arising from accidents
involving those vehicles.
—By Geoffrey M. Drake, Susan M. Clare and Alexandra Royal, King & Spalding LLP
Geoffrey Drake and Susan Clare are partners, and Alexandra Royal is an associate, in King & Spalding’s
tort litigation and environmental group in Atlanta.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its
clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general
information purposes and is not intended to be and should not be taken as legal advice.
[1] U.S. DEPARTMENT OF TRANSPORTATION & NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION,
FEDERAL AUTOMATED VEHICLE POLICY (2016).
[2] Id. at 68.
[3] Id. at 70.
[4] Id. at 71-75.
[5] Jack Nicas & Mike Spector, U.S. Considers Expanding Automated-Driving Technology Oversight, WALL
ST. J. (July 19, 2016, 3:58PM), http://www.wsj.com/articles/u-s-considers-expanding-automated-drivingtechnologyoversight (Secretary of Transportation Anthony Foxx recently reported to a group of industry
members that “there is no express prohibition of autonomous vehicles in … federal motor vehicle safety
standards.”).
[6] National Highway Traffic Safety Administration, U.S. DOT Issues Federal Policy for Safe Testing
and Deployment of Automated Vehicles, available at http://www.nhtsa.gov.
[7] Russ Mitchell, Autonomous Cars Will Get New Federal Guidelines: ‘We Want People Who Start a Trip
to Finish It,” LA TIMES (July 19, 2016, 11:50AM), http://www.latimes.com/business/autos/ (at an
industry conference Foxx hinted at the need for pre-market approval steps to ensure that industry takes
“the safety aspects of [AVs] very seriously”).
[8] FEDERAL AVIATION ADMINISTRATION, THE FAA AND INDUSTRY GUIDE TO PRODUCT CERTIFICATION
(2004).
[9] Id. at 3-5.
[10] Id. at 1-2.
[11] See 49 U.S.C. § 30103(b) and (e); see also Williamson v. Mazda Motor of America Inc., 562 U.S. 323
(2011) (holding the Vehicle Safety Act does not preempt tort claims for the failure to install rear center
lap-shoulder belts where NHTSA had considered, but decided against, mandating such belts and
NHTSA’s reasoning was based on a cost/benefit analysis rather than the pursuit of an overarching
federal policy); Geier v. American Honda Motor Co., 529 U.S. 1236 (2000) (finding preemption where
allowing a tort claim for the failure to install air bags in particular vehicles during the phase-in period
conflicted with the federal purpose set forth in NHTSA’s regulation).
[12] Wyeth v. Levine, 555 U.S. 555, 578 (2009).
[13] See, e.g., Cerveny v. Aventis Inc., 155 F. Supp. 3d 1203 (D. Utah 2016) (determining that the FDA’s
denial of certain citizen petitions that included the same theory and substance on which plaintiffs’
claims rely is clear evidence that the FDA would not have permitted defendant to strengthen the
product’s labeling); In re Incretin-Based Therapies Prods. Liab. Litig., 142 F. Supp. 3d 1108 (S.D. Cal.
2015) (finding clear evidence that the FDA considered and would have rejected a new warning about the
risk of pancreatic cancer to be dispositive of plaintiffs’ failure to warn claims); In re Fosamax Pros. Liab.
Litig., 2014 U.S. Dist. LEXIS 42253 (D.N.J. Mar. 26, 2014) (dismissing plaintiffs’ claims on preemption
grounds due to clear evidence that the FDA would not have approved a stronger warning).
[14] See, e.g., Estep v. Mike Ferrell Ford Lincoln-Mercury Inc., 223 W. Va. 209, 220 (W. Va. 2008) (“[A]
jury may consider the federal safety standards, but that compliance with standards is not conclusive
proof that the design of the product was reasonable.”).
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