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3rd Circuit: Kids Hurt by Vaccines Can't Pursue Design Defect ClaimsRuling could prompt U.S. Supreme Court to take up significant pre-emption case involving drug product liability
The 3rd Circuit has ruled that children allegedly injured by vaccines are barred from pursuing any design defect claims because Congress expressly prohibited such suits in an effort to guarantee immunity to manufacturers. By rejecting the analysis of a recent ruling from the Georgia Supreme Court, the 3rd Circuit ruling creates a direct split between the federal courts and a state's highest court on the question of how broadly courts should read the pre-emption clause in the National Childhood Vaccine Injury Act.
The Legal Intelligencer2009-04-02 12:00:00 AM
Pre-emption is the buzz word at the U.S. Supreme Court this year, and the 3rd U.S. Circuit Court of Appeals may just have done its part to pump up the volume of that buzz.
In a ruling that could prompt the justices to take up yet another significant pre-emption case in the area of drug products liability, the 3rd Circuit ruled that children allegedly injured by vaccines are barred from pursuing any design defect claims because Congress expressly prohibited such suits in an effort to guarantee immunity to manufacturers.
By rejecting the analysis of a recent ruling from the Georgia Supreme Court, the 3rd Circuit's Friday ruling in Bruesewitz v. Wyeth Inc. creates a direct split between the federal courts and a state's highest court on the question of how broadly courts should read the pre-emption clause in the National Childhood Vaccine Injury Act.
In its October 2008 decision in American Home Products Corp. v. Ferrari, the Georgia justices held that alleged victims of vaccine side effects have a right to court review of whether those side effects were truly "unavoidable."
But the 3rd Circuit has now held that allowing such court battles would defeat the purpose of the Vaccine Act's pre-emption clause.
The U.S. Supreme Court already has a pending petition for certiorari in the Georgia case, and the 3rd Circuit's ruling, by creating a split in authority, could prompt the justices to take a closer look.
In Ferrari, the Georgia Supreme Court held that the Vaccine Act "clearly does not pre-empt all design defect claims against vaccine manufacturers, but rather provides that such a manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that a particular vaccine was unavoidably unsafe."
Before Ferrari, vaccine manufacturers had prevailed in a string of rulings in both state and federal courts. Every court to address the issue of vaccine design defect pre-emption -- including federal judges in Pennsylvania and Texas and state court judges in New York -- found the Vaccine Act provides blanket pre-emption of any state law defective design claims.
Now, in the first ruling to respond to Ferrari, the 3rd Circuit has declared that the Georgia justices got it wrong.
"We do not consider the Ferrari court's reading to be compelling," 3rd Circuit Judge D. Brooks Smith wrote.
"If we interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court," Smith wrote in an opinion joined by Judges Theodore A. McKee and Joseph F. Weis.
In a footnote, Smith said the pre-emption question at issue in the vaccine cases is very different from the issue decided by the U.S. Supreme Court March 4 in Wyeth v. Levine, which examined whether federal law pre-empted state tort claims alleging that a drug manufacturer failed to adequately warn of the dangers associated with a drug.
"Though we recognize that the Supreme Court concluded that state tort law claims were not pre-empted in that case, Levine is readily distinguishable on several grounds," Smith wrote.
Most notably, Smith said, the Levine case was a question of whether there was implied pre-emption, while in the Vaccine Act, the question is the scope of an express pre-emption clause.
"In this case," Smith wrote, "Congress included an express pre-emption provision that was prompted ... by the prevalence of state tort litigation."
The Levine court also noted that drug manufacturers have the power to strengthen warnings on an FDA-approved drug label, Smith said. But by contrast, he said, in a design defect case, there is no analogous power to defy or ignore the Food and Drug Administration's "far-more extensive control and oversight of the approval of a drug's design and alteration."
Under the Vaccine Act's pre-emption clause, manufacturers cannot be held liable for an injury or death that resulted from "side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." Smith found that the phrase "hinges on the word 'unavoidable,' yet the term is not defined in the Vaccine Act."
In Ferrari, Smith said, the Georgia justices noted that the language of the pre-emption clause is conditional and implies that some vaccine-related injuries and deaths may be avoided.
From that inference, Smith said, the Ferrari court reasoned that a reading of the pre-emption provision that excluded all design defect claims would render the clause superfluous, and that, if Congress intended to pre-empt all design defect claims, it could have achieved that result by omitting the "unavoidable" clause so that the provision would prevent liability "if the vaccine was properly prepared and was accompanied by proper directions and warnings."
Smith disagreed, saying, "While we recognize that the language is conditional, such a reading does not foreclose the pre-emption of some claims."
Instead, Smith said, "it is always possible to construct through hindsight an alternate structure for a statute with alternative wording that would render it more clear."
The Ferrari court's reading of the law would also "create an awkward dichotomy" in the caselaw of many states, Smith noted, as trial judges would be required to engage in case-by-case analysis of all strict liability and negligent design defect claims brought under the Vaccine Act, while barring strict liability design defect claims against prescription drug manufacturers.
"Congress could not have intended such a result," Smith wrote.
The 3rd Circuit's decision upholds a ruling by U.S. District Judge Michael M. Baylson that dismissed all claims against Wyeth in a suit brought by the parents of a 17-year-old girl who allegedly suffered serious side effects as a result of receiving the third of five shots in a DPT (diphtheria-pertussis-tetanus) vaccine.
Hannah Bruesewitz was born in October 1991 and was given doses of the DPT vaccine at 2 months, 4 months and 6 months.
After the third DPT shot, she suffered a series of seizures and doctors later diagnosed her as having residual seizure disorder and developmental delay.
In the suit, Bruesewitz's parents claim that, before their daughter received the vaccine, the reporting system created by Congress had uncovered two child deaths and 66 serious injuries associated with the same vaccine lot administered to Hannah.
But the suit alleges that Wyeth never warned either Hannah's parents or her doctor about the serious problems with the vaccine.
In dismissing the suit, Baylson concluded that Congress explicitly intended to prohibit any suits against vaccine manufacturers for design defect claims. In passing the Vaccine Act, Baylson said, Congress intended to apply the immunity for unavoidably unsafe products outlined in comment k of the Restatement (Second) of Torts Section 402A across the board to bar all design defect claims, whether sounding in negligence or strict liability, against vaccines covered by the law.
"An FDA-approved vaccine design includes the side-effects of that vaccine, and is therefore, by statutory definition, the unavoidably unsafe product subject to comment k immunity," Baylson wrote.
As a result, Baylson said, the Vaccine Act "represents part of a comprehensive statutory scheme which pre-empts all design defect claims brought under state tort law."
Baylson concluded that Congress "did not intend to allow a case-by-case determination as to whether a vaccine is unavoidably unsafe."
Doing otherwise, Baylson said, "would allow state common law to impose additional requirements on vaccine manufacturers wishing to avoid liability, rather than merely providing additional remedies for violating federal law."
The Bruesewitzes were represented in the appeal by attorney Collyn A. Peddie of Williams Kherkher Hart & Boundas in Houston.
Wyeth was represented by attorneys Richard W. Mark and Daniel J. Thomasch of Orrick Herrington & Sutcliffe in New York.