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Court Refuses to Block Vaccine Lawsuit in Virginia Case

October 17, 1988

WASHINGTON (AP) _ The Supreme Court today refused to block a $10 million lawsuit against the manufacturer of a government-approved whooping cough vaccine that allegedly caused brain damage in an infant who was inoculated.

The justices, without comment, let stand a ruling in a Virginia case that federal law does not foreclose such suits under state regulations that protect consumers against defectively designed products.

Tracy Abbot was five months old in August 1983 when she was inoculated with a vaccine called Tri-Immunol manufactured by Lederle Laboratories, a division of American Cyanamid Co.

Her mother filed a lawsuit in 1986, seeking $10 million in damages on grounds the vaccine caused brain damage in Tracy.

Tri-Immunol is a vaccine against diphtheria, tetanus and whooping cough - or pertussis - and is administered to millions of children without serious side effects. But it has caused serious injury in a small number of children.

The vaccine is approved by the federal Food and Drug Administration and other government health agencies.

Whooping cough claimed thousands of lives before the vaccine was developed. The most serious U.S. epidemic was in 1934 when there were 265,000 reported cases and 7,500 deaths.

The Abbot suit said Lederle failed to develop a safer whooping cough vaccine, even though other forms of the vaccine have been used outside the United States. The suit said Tri-Immunol is ″unreasonably dangerous.″

Only one other company in the United States is licensed to produce a whooping cough vaccine.

A federal judge threw out the Abbot suit. But the 4th U.S. Circuit Court of Appeals reinstated it last April.

The appeals court rejected arguments that the federal government’s interest in promoting use of the vaccine is frustrated by permitting suits alleging violation of state regulations. Federal law does not pre-empt such suits, the appeals court said.

In a somewhat related issue, the Supreme Court ruled last June that the government may be forced to pay damages when a vaccine it licenses causes the disease it was intended to prevent. That case reinstated a suit in behalf of a boy who contracted polio after receiving a dose of federally approved vaccine.

The Reagan administration has not announced a position on the Abbot suit. But the Justice Department has pointed out that alternative vaccines to the type Lederle produces have not been proven safe and effective.

Congress has passed a law which took full effect Oct. 1 creating a fund to help compensate children injured by vaccines. The new law places a tax on some vaccines to provide funds for injuries that occur from vaccinations after 1986.

The case is American Cyanamid vs. Abbot, 88-330.

10-17-88 1053EDT

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