Justices Reduce U.S. Protection From Lawsuits

The Supreme Court, trimming back the federal government’s protection against lawsuits, ruled Monday that the government may be held liable for the paralysis suffered by a child who contracted polio from a federally approved vaccine.

In a unanimous opinion, the justices said that the federal government can be forced to pay damages if officials fail to follow their own rules and approve a dangerous product.

Doors Open to Suits

The ruling opens the door to suits by persons who contend that they were injured in part because federal regulators were lax and ignored “relevant safety standards.” The Reagan Administration had contended that the government is immune from liability for its regulatory actions.

The court decision may also renew the debate over the merits of the Sabin vaccine for polio, which has largely replaced the weaker but safer Salk vaccine in this nation’s immunization program.

Thanks to the two vaccines, introduced in the 1950s, polio has become extremely rare in this country. However, between six and nine new cases of polio are reported annually, most in young children who have just been given an oral dose of the Sabin vaccine, which carries a live virus.

“The only new cases of polio in this country arise from the vaccine itself,” said Dorothy Raizman, a Pittsburgh attorney who brought the suit on behalf of Kevan Berkovitz, who was paralyzed in all four limbs soon after taking the Sabin vaccine in 1979, when he was 2 months old.

The lawsuit could not attack the government directly for licensing an unduly risky vaccine. The Federal Tort Claims Act, which allows persons to sue the government for negligent acts, includes an exception for “discretionary” actions by officials. This exception has resulted in the dismissal of most suits challenging a flawed government decision.

Last year, for example, the high court dismissed a suit filed by the victims of atomic bomb tests in Utah because, the judges said, the government had both the discretion to test the bomb and the discretion not to warn residents of its danger.

But the lawyers for the young polio victim found evidence that the Food and Drug Administration had allowed distribution of some Sabin vaccine that did not meet established safety standards. Congress has required that federal officials issue licenses for new drugs and vaccines “only upon a showing that they meet such (safety) standards.”

To test a new lot of a vaccine, FDA officials administer doses to monkeys, which are then observed for 30 days. The vaccine lot is not supposed to be approved if it causes undue damage to the test monkeys.

Until Monday’s decision, however, it had not been clear that anyone could force the government to pay for the mistake even if the FDA had ignored the test standards.

Government attorneys have argued that the federal regulators are “overseers” for private industry but that they may not be held responsible for the mistakes of private companies. Last year, a federal appeals court in Philadelphia accepted that argument and threw out the suit brought by the parents of Berkovitz, now 9 years old.

But, on Monday, the Supreme Court reversed course somewhat and reinstated the suit.

The government may be sued if an agency fails “to perform its clear duty under federal law,” Justice Thurgood Marshall wrote for the court in the case (Berkovitz vs. U.S., 87-498). Although agencies are immune from liability for “policy judgments” made by their officials, they are not immune when they “fail to act in accord with a specific mandatory directive.”

“I think this is an important ruling because it preserves the right to sue the government,” said Paul Friedman, a Washington lawyer who worked on the case. “There has been a move in the Reagan Administration to gut the Federal Tort Claims Act entirely and give the government absolute immunity. This is a step in the other direction,” he said.

Friedman and other lawyers said that they were not sure how broadly the ruling could be applied to the multitude of products and services regulated by the federal government. The language of the court opinion makes clear that it applies only in instances in which the government itself has issued clear regulations.

The Berkovitz case now returns for a trial in Pittsburgh to determine whether the government negligently violated its regulations in approving a strain of the vaccine.

In other actions, the high court:

--Agreed to decide whether the new federal sentencing rules are constitutional. The rules, which were put together by a seven-member U.S. Sentencing Commission, have been struck down by scores of federal judges around the nation. Others have upheld them. In acting on an emergency appeal from the Justice Department, the justices agreed to consider the issue in the fall and issue a ruling sometime next year (U.S. vs. Mistretta, 87-1904).

--Ruled 6 to 3 that states may not bar lawyers from sending truthful and nondeceptive mailings to potential clients. In 1977, the high court rejected total bans on advertising by lawyers. Since then, most states have permitted generalized ads but not direct appeals to specific clients. The American Bar Assn. believes that such direct appeals to victims can result in fraud and deception. But the high court struck down Kentucky’s ban on “targeted solicitation letters” as a violation of the First Amendment (Shapero vs. Kentucky Bar Assn., 87-16).