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US Supreme Court rules in pharma's favour

The US Supreme Court has ruled 6-2 in favour of Pfizer's Wyeth unit upholding a previous ruling preventing civil suits against manufacturers of vaccines

The US Supreme Court has ruled 6-2 in favour of Pfizer's Wyeth unit upholding a previous ruling by the US Court of Appeals for the Third Circuit preventing civil suits against manufacturers of FDA-approved childhood vaccines under the terms of the National Childhood Vaccine Injury Act.

The lawsuit in question relates to a claim made by the parents of Hannah Bruesewitz from Pennsylvania, who suffered seizures as an infant after her third dose of a diphtheria-tetanus-pertussis (DTP) vaccine in 1992, that Wyeth could have produced a safer vaccine but chose not to.

Justice Antonin Scalia, speaking on behalf of the court said: "[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Programme 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 US, 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. We are pleased that the US Supreme Court affirmed the ruling of the Third Circuit."

The US vaccine compensation programme, run by the federal government, sets aside funds for those who suffer rare injuries from vaccines. Under the Vaccine Act, compensation may be awarded without showing any fault or defect in the administered vaccine.

Following the Supreme Court ruling, individuals allegedly harmed by childhood vaccines will still have the right to sue in state or federal court based on the alleged improper manufacture or inadequate labelling of a vaccine.

In its amicus brief, the American Academy of Paediatrics and 21 other physician and public health organisations noted that a Court ruling against Wyeth 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 unimmunised children, and, perhaps, a resurgence of preventable diseases.'"

23rd February 2011

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