• 30
  • June
    2011

In our last post, we wrote about a recent Supreme Court decision which prevents plaintiffs from brining state law product liability claims against generic drug manufacturers alleging inadequacy of warning labels. The rationale behind that decision was that, since federal law already requires generics to abide by FDA approved standards.

The cases underlying last Thursday's decision reportedly involved two women who had suffered severe side effects as a result of using generic versions of the brand-name drug Reglan. As a result of the decision, consumers will not be able to hold generic drug manufacturers liable under state law for using federally-approved warning labels.

The court's ruling-a victory for generic manufacturers-is expected to have a dramatic effect on pharmaceutical product liability cases. While generics feel that the decision is also a victory for consumers-who ultimately bear the costs of product liability litigation-the plaintiffs' attorney said the decision cannot be seen as a victory for consumers, 75 percent of whose drug prescriptions involve generics. The only way to change the results of the decision, according to the latter, is to change the Hatch-Waxman Act.

The attorney who represented the generics in the case, according to sources, will now

The High Court's decision was based, in large part, on the Hatch-Waxman Act, which was designed to get low-cost generics on the market quickly. Rather than requiring generics to go through expensive safety testing, the law allowed them to show that their products are equivalent to the more expensive, brand-name versions.

Source: Westlaw News and Insight, "For generics' lawyers, landmark ruling was years in the making," Alison Frankel, 23 June 2011.