High court rules on bad vaccines. Government is responsible when vaccinations fail

In a key decision regarding government liability, the United States Supreme Court ruled unanimously on Monday that a federal agency may be sued when it licenses a vaccine that causes the disease it was supposed to prevent. This finding overturned a lower court decision exonerating the federal government from legal responsibility in this case.

The Justice Department argued unsuccessfully that if the government can be sued in such matters, it could be forced to insure vaccines or may even refuse to license them.

Some believe that this ruling could put the brakes on the national immunization policy and affect the licensing of many pharmaceutical products.

Also this decision raises questions regarding manufacturers' reliance on government guidelines in bringing products to the market.

The justices' action in this case, Berkovitz v. US, revived the suit of a polio victim who at two months of age in 1979 was orally given a dose of a suspect batch of Orimune and was stricken with the disease within 30 days.

The US Communicable Disease Center traced the child's resulting paralysis directly to the vaccine.

The parents of the Pennsylvania youngster sued the federal government for permitting the release of a batch of vaccine which did not meet government regulations. They claimed that the negligence of a government worker caused their child's polio.

And they denied that acceptable policymaking discretion was involved in approving the defective batch of vaccine.

In earlier high court cases, the justices had said that employees of the federal government were not liable for injuries brought about when performing discretionary duties.

The Food and Drug Administration (FDA) is responsible for licensing and testing biological products, such as vaccines, used in health care.

In this instance, however, the FDA failed to perform the necessary tests, yet issued a license to release the batch anyway.

A district court refused to dismiss the parents' complaint on the basis that the government was immune from such a lawsuit. But the Third US Circuit Court of Appeals based in Philadelphia held that the actions of the FDA were ``discretionary'' and thus shielded from a liability claim.

The Supreme Court saw the case differently.

Associate Justice Thurgood Marshall wrote that governmental immunity from lawsuit applies only to situations where an official exercises discretion or judgment.

``The discretionary function exception, however, does not apply if the acts complained of do not involve the permissible exercise of policy discretion,'' Justice Marshall explained.

Marshall added that if a federal policy ``leaves no room for an official to exercise policy judgment in performing a given act, or if the act simply does not involve the exercise of such judgment'' the government may be sued for causing personal injury.