US Supreme Court decides for vaccine makers in Pfizer/Wyeth case

24 February 2011

In a six to two vote, the USA’s Supreme Court affirmed the ruling of the US Court of Appeals for the Third Circuit in favor of Wyeth versus Bruesewitz. The Third Circuit had determined that the National Childhood Vaccine Injury Act prevents civil suits against manufacturers of FDA-approved childhood vaccines based on a claim that a particular vaccine should have been designed differently. In so doing, it rejected plaintiffs' arguments that they should be able to sue global drug’s behemoth Pfizer's (NYSE: PFE) Wyeth unit over allegations that the company could have marketed a safer vaccine but decided not to.

The opinion of the Court, written by Justice Antonin Scalia, stated that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA [Food and Drug Administration] and the National Vaccine Program rather than juries."

“Vaccines are one of modern medicine's greatest success stories,” said Pfizer executive vice president and general counsel Amy Schulman. “Their nearly universal administration to children is responsible for the elimination of polio and smallpox in the United States, and the near-elimination and containment of other childhood diseases. The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems,” she added.

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