Tuesday, September 25, 2012

Vaccine Act Preemption - Post-Bruesewitz

Breaking news here.  The Ninth Circuit has upheld a preemption-based dismissal of a Vaccine Act case. See Holmes v. Merck & Co., No. 08-16557, slip op. (9th Cir. Sept. 25, 2012).  As the docket number indicates, the Holmes appeal has been pending for over about 4 years.  It was resubmitted in 2011 after Bruesewitz v. Wyeth, 562 U.S. ___, 131 S. Ct. 1068 (2011).

Holmes involved MMR vaccine administered to a one-year-old baby.  Plaintiffs claimed that the vaccine caused seizures, brain damage and ultimately death.  Slip op. at 11794.  Plaintiffs sought compensation on the child's behalf through the federal system and received $250,000.  Id.  Not satisfied with that, they sought to ring the tort bell as well, on their own behalf, filing a wrongful death action in Clark County (Las Vegas) Nevada court.  Fortunately, there was diversity of citizenship.

The defendant received summary judgment on the basis of Vaccine Act preemption, and plaintiffs appealed.  The main issue was whether the parent's could dodge preemption by filing an action in their own behalf while simultaneously taking advantage of the Act's compensation system on behalf of their minor child.

Plaintiffs hinged their arguments mostly on the fact that the Vaccine Act only provides compensation and requires exhaustion of administrative remedies to those allegedly (we say allegedly because the Act does not require that causation be proven - as long as the vaccine and injury are on the Act's administrative list) physically injured by vaccines, not to next of kin.  Plaintiffs claimed that, by filing a separate wrongful death action on their own behalf, they could in effect double dip, receiving both federal and common-law compensation.  Slip op. at 11800.

In Holmes, the Ninth Circuit said no:
The exhaustion requirement in Section 11 is only a subsection of Congress’s larger statutory scheme to ensure that vaccine manufacturers have an affordable and predictable way of handling injured parties’ compensation claims.  Though parents are not bound by Section 11’s exhaustion requirement, they are not free from the Act’s tort liability limitations.  Regardless of whether a plaintiff is the vaccine-recipient or the parent of one, Section 22 expressly preempts design-defect claims seeking compensation for injury or death caused by a accine’s unavoidable side effects.  §300aa-22(b). Section 22 expressly preempts tort suits based “solely” on the manufacturer’s failure to provide direct warnings to the injured party.  §300aa-22(c).

Slip op. at 11800.

The Act's triple-barrelled elimination of design claims, imposition of a warning compliance defense and mandating of the learned intermediary rule "indicates that Congress expressly intended to prohibit states from regulating large aspects of tort suits against vaccine manufacturers."  Id. at 11802.  Thus, technicalities of state law (whether the plaintiff was the injured person or somebody bringing a wrongful death action) did not affect the Act's preemption of substantive claims - the design and warning claims were the same no matter who the plaintiff was:
Given the structure and broad purpose of the Act as a whole, it is most reasonable to apply Section 22 to all design defect and failure to warn claims arising out of a vaccine-related injury or death, not just those that could have first been brought in the Vaccine Court.

Slip op. at 11805.  Instead, the Act's preemption clauses apply to "any civil action for damages arising from a vaccine-related injury" without limiting the identity of the plaintiff.  Id. at 11806 (quotation marks omitted).  Moreover, to allow different claims for different categories of plaintiff would "create[] a convoluted trial and liability scenario," since where the vaccine recipient was not dead, both sets of claims would otherwise be tried together.  Id.  There was no basis for believing that "Congress gave greater rights" to family members than to the injured persons themselves.  Id.

 To allow parents to bring claims that were otherwise barred by the Vaccine Act also was at war with the broader purposes of the Vaccine Act:

[I]f we were to conclude that the parents of those suffering a vaccine-related injury could bring design defect and failure to warn claims outside of [preemptive] limitations, we would be acting contrary to the statute’s central purpose of managing vaccine manufacturers’ liability because our construction would do little to protect the vaccine manufacturers from suit.

 
Slip op. at 11807.  Protection from liability, after all was why Congress acted in the first place.

No comments: