Life Science Compliance Update

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March 03, 2011

Supreme Court Rules in Favor of Protecting Vaccine Makers from State Lawsuits

The United States Supreme Court reached a decision recently, concluding that federal law protects vaccine makers from product-liability lawsuits that are filed in state courts and seek damages for injuries or death attributed to a vaccine.

In the 57-page opinion written by Justice Antonin Scalia, the Supreme Court explained that the National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects.

The Court’s 6-2 decision reasoned that “a vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the [NCVIA] thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design.

This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act’s failure to mention design-defect liability is “by deliberate choice, not inadvertence.”

The opinion further explained that “design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process.” As a result, the Court concluded that this “lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability.”

Justice Scalia’s opinion further reflected the belief that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.” 

The family that brought the lawsuit against Wyeth (now Pfizer) argued that their daughter suffered seizures as an infant after her third dose of a diphtheria-tetanus-pertussis, or DTP vaccine in 1992. They also stated that she had serious developmental delay caused by the DTP vaccine, and that a safer alternative had been available but not made available. Eventually, the vaccine was taken off the market in 1998 and replaced.

Pfizer argued that a Supreme Court ruling in favor of the family would have sparked countless lawsuits, including some claiming links to autism, and threatened the supply of childhood vaccines.

One of the rationales for the Supreme Court’s decision came from the fact that “vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries. In exchange, they avoid costly tort litigation and the occasional disproportionate jury verdict.”

According to an article from Reuters, the vaccine court has awarded more than $1.8 billion for vaccine injury claims in nearly 2,500 cases since 1989.

After the ruling, American Academy of Pediatrics (AAP) president O. Marion Burton applauded the Supreme Court’s decision in a statement. He noted that the “decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country.”

The AAP, along with 21 other physician and public health organizations submitted amicus brief's supporting Wyeth, and noted that a ruling against the manufacturer could “precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: ‘the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.”

Ultimately, this decision could have significant impacts on similar vaccine suits associated with diseases such as autism.

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