FDA Liable for Polio Vaccine

In the landmark case, In Re Sabin Oral Polio Vaccine Products Liability Litigation, Kreindler of Counsel attorney Marc Moller was successful in holding the United States government liable for allowing the distribution of a polio virus vaccine that failed to meet complex federal safety standards. This allowed the recovery of substantial damages for people who contracted polio from the Sabin live oral polio vaccine. The trial and appellate court victory in In re Sabin established the liability of the U.S. government for mandatory regulatory violations and has become one of the most frequently cited cases defining the scope of the discretionary function exception to the U.S. Government’s tort liability. The 4^th U.S. Circuit Court of Appeals affirmed judgments entered against the federal government because an agency violated its own regulations in approving two batches of Sabin oral polio vaccine manufactured by Lederle Laboratories under the trade name, Orimune.

The awards were entered under the Federal Tort Claims Act which allows economic recovery if a government agency fails to follow its own rules. The FTCA bars recovery if the claim involves a discretionary action of a federal agency, even if the agency abuses that discretion.

The awards went to two men who had contracted polio after their children had taken the Sabin live oral polio vaccine. Lederle earlier had settled other claims filed against it. The amount of the judgments were characterized as “substantial,” but could not be named because of confidentiality. Attorney Moller added that evidence at trial showed that the Sabin vaccine is the only source of polio in the U.S. with about 10 cases of vaccine-associated disease reported each year.

A Discretionary Act?

The government had defended the case by contending that agency approval of the vaccines was a discretionary act by the former Department of Health, Education and Welfare, acing through the Food and Drug Administration and its Division of Biological Standards.

The U.S. Supreme Court undermined much of that argument in Berkovitz v. United States, 486 U.S. 531 (1988), a case in which the court held that “the discretionary function exception will not apply when a federal statute regulation, or policy specifically prescribes a course of action for an employee to follow.” The high court’s ruling reinstated an FTCA action filed on behalf of an infant who had contracted polio.

The Berkovitz case held only that the plaintiffs might prevail if they could show that the federal agencies had no discretion in following the regulations governing their approval of specific batches of the Salk vaccine; that they had violated the regulations; and that the violation breached a duty of care to the plaintiffs and proximately caused the polio.

Judge Motz ruled in favor of the plaintiffs in a series of three opinions adopted by the 4^th Circuit in a brief, published per curiam opinion Jan. 21. In Re: Sabin Oral Polio Vaccine Products Liability Litigation, 91-2398.

Although Judge Motz rejected several theories advanced by the plaintiffs, he found that the agencies had approved batches of the vaccine that did not meet safety standards prescribed for the vaccine before it could be released to the public.

“In making these findings, the district court acknowledged that the officers of [the Division of Biological Standards] and their consultants were motivated by what they perceived to be the public interest,” the 4^th Circuit noted. “Confronted by the prospects of delay in the [oral polio vaccine] program and concerned about the public’s possible adverse reaction to the program if DBS undertook to amend the regulations, they elected to take other actions which they deemed to be safe, rather than seek amendments to the regulations.”

The 4^th Circuit added: “The district court found that although the vaccine DBS released was ‘state of the art,’ it was not vaccine that conformed to the safety provisions of the regulations. In agreement with the district court, we conclude that DBS’s concerns cannot justify the violation of the regulations.” The plaintiffs proved that the government was the proximate cause of their injuries because the batches of vaccine would not have been released to the public if the agencies had followed the regulations, the 4^th Circuit held.

Mr. Moller said that the deviation from the regulations lasted from 1961 through at least 1989.