“Parents Lose High Court Appeal in Vaccine Case”

WASHINGTON--(BUSINESS WIRE)--Feb. 22, 2011-- Today, in a 6-2 decision, the U.S. Supreme Court affirmed the ruling of the U.S. Court of Appeals for the Third Circuit in favor of Pfizer’s subsidiary Wyeth, in Bruesewitz v. Wyeth. The Third Circuit 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.

“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. We are pleased that the U.S. Supreme Court affirmed the ruling of the Third Circuit.”

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Source: Pfizer Inc.

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“Court Eases Way to Sue U.S. For Safety Policy Violations”

One perennial nightmare of all parents is the possibility that a defective vaccine might injure a child. The drug companies have always been liable for damages in those cases. But these vaccines are produced under stringent federal regulation, and now the Supreme Court says the government can be sued if it fails to carry out its own safety rules.

No responsible parent would allow a child to remain unprotected against polio or any of several other deadly diseases, and this kind of pharmaceutical disaster is rare. But it happens. The FDA says that there are currently four other polio vaccine cases pending in lower courts.

In the case that went to the Supreme Court, an infant two months old had been given a dose of Orimune, an oral vaccine that resulted in a full-blown case of polio and severe paralysis. The manufacturer, Lederle Laboratories, settled out of Court. Then the child’s parents sued the government charging that the FDA had allowed the vaccine to be distributed in violation of its own standards. The Government lawyers argued that Congress has specifically given regulators discretion, and granted them immunity from lawsuits when they exercise it.

Not so fast, said the Supreme Court. Justice Marshall, writing for a unanimous court, agreed that Congress has given administrators discretion to make rules. But once the rules are set, administrators don’t have the discretion to evade or bend them. Congress, he said, never intended to protect regulatory corner-cutting.

The injured child’s parents charge that some of the FDA’s employees allowed the vaccine to be shipped with the knowledge that it was not quite up to standard. The court’s decision now gives the parents an opportunity to prove that accusation in a trial and, if they succeed, to collect damages from the Government itself.

This decision reaches far beyond vaccines to every kind of health, safety and environmental regulation. For all of the endless talk in the Reagan administration about the revolt against the regulators, those are three areas in which the principles laid down in the 1970s remain undiminished. There has been plenty of deregulation over the years, but it has been elsewhere – in finance, transportation and communications. The federal laws to protect your life and your health have not been rolled back.

Now the Supreme Court has created a powerful sanction to force tighter enforcement of those laws and the administrative regulations that carry them out. No one who has ever watched a child be vaccinated will doubt that, in its impact on the regulators, the effects of this decision can only be healthy.”

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“Viewed in light of these principles, petitioners' claim regarding the release of the vaccine lot from which Kevan Berkovitz received his dose survives the Government's motion to dismiss. Petitioners allege that, under the authority granted by the regulations, the Bureau of Biologics has adopted a policy of testing all vaccine lots for compliance with safety standards and preventing the distribution to the public of any lots that fail to comply. Petitioners further allege that notwithstanding this policy, which allegedly leaves no room for implementing officials to exercise independent policy judgment, employees of the Bureau knowingly approved the release of a lot that did not comply with safety standards. See App. 13; Brief for Petitioners 20-21; Reply Brief for Petitioners 15-17. Thus, petitioners' complaint is directed at a governmental action that allegedly involved no policy discretion. Petitioners, of course, have not proved their factual allegations, but they are not required to do so on a motion to dismiss. If those allegations are correct - that is, if the Bureau's policy did not allow the official who took the challenged action to release a noncomplying lot on the basis of policy considerations - the discretionary function exception does not bar the claim. 13 Because petitioners may yet show, [486 U.S. 531, 548]   on the basis of materials obtained in discovery or otherwise, that the conduct challenged here did not involve the permissible exercise of policy discretion, the invocation of the discretionary function exception to dismiss petitioners' lot release claim was improper.

IV

For the foregoing reasons, the Court of Appeals erred in holding that the discretionary function exception required the dismissal of petitioners' claims respecting the licensing of Orimune and the release of a particular vaccine lot. The judgment of the Court of Appeals is accordingly reversed, and the case is remanded for further proceedings consistent with this opinion.

It is so ordered.

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