September 9, 2008

Judge Rules Product Liability Suit Pre-empted by Federal Vaccine Act


Judge Rules Product Liability Suit Pre-empted by Federal Vaccine Act

Amaris Elliott-Engel
The Legal Intelligencer
September 9, 2008

A Philadelphia judge has ruled that a federal law governing the liability of pharmaceutical companies for drug vaccines pre-empts state tort claims of design defect and failure to warn in the products liability case of an 11-year-old boy who has autism.

In an apparent case of first impression, Philadelphia Common Pleas Judge Arnold L. New wrote an Aug. 27 opinion required under Pennsylvania Rule of Appellate Procedure 1925 to affirm his decision to grant summary judgment in favor of pharmaceutical defendants Aventis Pasteur Inc., Merck & Co. Inc. and Wyeth in Wright v. Aventis Pasteur.

New said both the plaintiffs' design defect and failure to warn claims were expressly pre-empted by the federal National Childhood Vaccine Injury Act. New also found that the failure to warn claim failed to raise any genuine issues of material fact that can overcome the protection the Vaccine Act provides to pharmaceutical manufacturers.

New said in his opinion that it appears no Pennsylvania state court has addressed whether §22(b) of the Vaccine Act expressly pre-empts claims of design defects against vaccine manufacturers, or whether each case has to be examined individually to determine "whether a vaccine is unavoidably safe before they gain the protection of Section 22(b)."

"Congress clearly intended when it enacted the Vaccine Act to exercise its constitutionally delegated authority to preempt all state design defect claims without case-by-case determination that the side effects are unavoidable," New wrote.

The 1986 Vaccine Act was created to provide recovery of damages to injured vaccine recipients without the requirement that the recipients prove the manufacturer was negligent and that a vaccine was defective, New said. The Vaccine Act was also aimed at preventing the undermining of national vaccine supply by expensive litigation, New said.

New noted that other courts' decisions -- including the U.S. District Court for the Eastern District of Pennsylvania's 2006 ruling in Sykes v. Glaxo-SmithKline and its 2007 ruling in Bruesewitz v. Wyeth -- have been similar.

"This court was guided by their opinions and concluded Section 22(b)(1) preempts, without there first being a case-by-case determination as to whether a vaccine is unavoidably unsafe, all state law claims that an FDA-approved vaccine was defectively designed, " New wrote.

The only contrary ruling was a 2007 Georgia state court ruling in Ferrari v. American Home Products Corp., New said.

In Wright, Jared Wright, 11, of Texas, was administered five vaccines in the first year-and-a-half of his life that contained thimerosal, a mercury-based preservative once used in vaccines to deter bacterial growth, as well as one other vaccine, New wrote. Jared's parents, Howard and Jacqueline Wright, claimed that the mercury in those six vaccines manufactured by the pharmaceutical defendants caused Jared's autism.

Plaintiffs' attorney Marc P. Weingarten of Locks Law Firm said the case is "an extremely important issue to be heard by the courts of Pennsylvania" because of the federal pre-emption issues arising in pharmaceutical and medical device litigation in both state and federal jurisdictions.

The plaintiffs argued that the defendants were negligent because the public and the medical profession were not warned about the alleged hazards of mercury in the vaccines, New said. The plaintiffs also argued that the pharmaceutical defendants failed to use ordinary cases in designing the vaccines containing thimerosal because of the risks the plaintiffs say toxic mercury poses to infants and children.

The plaintiffs said the Vaccine Act didn't automatically pre-empt the design defect claim because the vaccine defendants have the burden of proof to show on a case-by-case basis that the use of thimerosal is "‘unavoidably safe,'" New said.

Courts can interpret the Vaccine Act two ways, the plaintiffs argued, and should only interpret the Vaccine Act to pre-empt design defect claims "only if first the side effects are determined to be unavoidable on a case-by-case basis," New said.

New said Congress intended the Vaccine Act to pre-empt all state design defect claims without a case-by-case assessment if the vaccines' side effects were unavoidable because Congress didn't want instability in the vaccine market to be caused by numerous torts over vaccine injuries. That's why Congress set up its National Vaccine Injury Compensation Program, the judge said.

If the plaintiffs' argument is given credence, New said, then the protection provided by the Vaccine Act will no longer extend to vaccine manufacturers and, in turn, to the stability of the supply of child vaccines.

Manufacturers can obtain a presumption of proper warning under the Vaccine Act by providing evidence showing compliance with federal Food and Drug Administration vaccine regulations, New said. Plaintiffs can only overcome this presumption, New said, by showing the vaccine manufacturer engaged in fraud or wrongful withholding of information from the FDA regarding the vaccine prior to approval; wrongfully withheld information related to the vaccine's safety after its approval; or failed to exercise due care even though the manufacturer complied with federal laws and regulations.

Every major public health organization -- as well as the Food and Drug Administration -- that has examined the alleged link between the use of thimerosal in vaccines and neurological injury has not found a causal link, New said.

Merck defense attorney Madeline M. Sherry of Gibbons, Aventis Pasteur defense attorney Jonathan Dryer of Wilson Elser Moskowitz Edelman & Dicker and Wyeth defense attorney Reetu Dandora of Reed Smith could not be reached for comment.

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