• 25
  • February
    2011

Earlier this week, the Supreme Court ruled that vaccine manufacturers cannot be sued in state court for defective design of drugs.

As a result of the decision, it will now be more difficult to bring cases against vaccine manufacturers for vaccines that many parents feel cause their children to develop autism.

The case at issue was brought by a couple who claimed their daughter was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she got as an infant back in 1992. The vaccine was manufactured by Lederle Laboratories, which is currently owned by Pfizer's Wyeth unit. They say the defective design of the vaccine was responsible for their daughter's disabilities and that the company is liable for negligent design under Pennsylvania law.

There is a bit of background to this case. A law passed back in 1986 allowed patients injured by "unavoidable" side effects of taking a vaccine to collect compensation from the federal government. The purpose of the law was to make it easier for children injured by vaccines to collect damages by giving the Department of Health and Human Services authority to hear the cases and handle compensation, which is funded by a tax on pharmaceutical companies making the vaccines. Since it was established, the vaccine fund has paid out over $2.5 billion.

Well when the couple in this case was denied compensation in the federal vaccine court back in 1995, they decided to sue all the way to the Supreme Court.

A lower court ruling would have allowed suits against vaccine manufacturers for "design defects." The ruling could have opened up the pharmaceutical industry to thousands of suits alleging that the defective vaccine designs were responsible for the development of autism in children.

The Supreme Court, however, overruled the lower court, saying the federal law in question only holds manufacturers liable for improper manufacturing and labeling, but not for improper design of the drug itself. If manufacture and warnings were proper, the court, said, side effects are deemed unavoidable, and state law tort claims are preempted by the federal law, meaning that manufacturers are off the hook.

The pharmaceutical industry, of course, views the ruling as a victory. According to General Counsel for Pfizer, "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."

Those opposed to the decision, however, say that decision thwarts the tort system's role of holding pharmaceutical companies accountable for defective vaccine design.

Source: National Journal, "Supreme Court Rules in Favor of Vaccine Manufacturers," Meghan McCarthy, 22 Feb 2011.