Torts - Cases, Principles, and Institutions Fifth Edition, 2016a

Witt & Tani, TCPI 9. Liability without Fault?
no-fault compensation program “designed to work faster and with greater ease than
the civil tort system.” . . .
Fast, informal adjudication is made possible by the Act’s Vaccine Injury Table,
which lists the vaccines covered under the Act; describes each vaccine’s
compensable, adverse side effects; and indicates how soon after vaccination those
side effects should first manifest themselves. Claimants who show that a listed
injury first manifested itself at the appropriate time are prima facie entitled to
compensation. No showing of causation is necessary; the Secretary bears the
burden of disproving causation. . . . Unlike in tort suits, claimants under the Act are
not required to show that the administered vaccine was defectively manufactured,
labeled, or designed. . . . These awards are paid out of a fund created by an excise
tax on each vaccine dose.
The quid pro quo for this, designed to stabilize the vaccine market, was the provision
of significant tort-liability protections for vaccine manufacturers. The Act requires
claimants to seek relief through the compensation program before filing suit for
more than $1,000. Manufacturers are generally immunized from liability for failure
to warn if they have complied with all regulatory requirements (including but not
limited to warning requirements) and have given the warning either to the claimant
or the claimant’s physician. They are immunized from liability for punitive
damages absent failure to comply with regulatory requirements, “fraud,”
“intentional and wrongful withholding of information,” or other “criminal or illegal
activity.” And most relevant to the present case, the Act expressly eliminates
liability for a vaccine’s unavoidable, adverse side effects[.]
In Breusewitz, the Court held that the National Childhood Vaccine Injury Act preempted state tort
claims alleging that a vaccine was defectively designed. This statutory scheme has a mechanism
for deterrence (compliance with federal regulation) and a mechanism for compensation (a no-fault
compensation scheme funding through an excise tax). But unlike state tort law, the Vaccine
Injury Act does not link the two functions together.
3. Medical device preemption. Medical devices, despite being similar to prescription drugs
in many ways, face a different preemption structure from the one at issue in Wyeth v. Levine. For
devices, the text of the relevant statute provides that “no State or political subdivision of a State
may establish or continue in effect with respect to a device intended for human use any
requirement (1) which is different from, or in addition to, any requirement applicable under this
chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under this chapter.” 21 U.S.C. §
360k(a). The U.S. Supreme Court has interpreted this statute broadly to preempt state tort claims
concerning devices that have gone through the full FDA premarket approval process. See Riegel
v. Medtronic, Inc., 555 U.S. 312 (2008). However, devices that were already on the market before
the creation of the medical devices regulatory regime were “grandfathered” and exempted from
the premarket approval process, as were devices that were substantially similar to grandfathered
devices. The Court ruled that such devices were not subject to “requirements” under the statute,
and therefore that state tort claims were generally not preempted. Medtronic, Inc. v. Lohr, 518
U.S. 470 (1996).
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