A Supreme Court ruling last year has made it impossible for plaintiffs who experience bad reactions to generic drugs to obtain legal remedies.
On June 23, 2011, the high court decided 5-4 in Pliva v. Mensing that generic drug-makers are not liable for failing to warn patients about adverse side effects their drugs can cause. The majority reasoned that the Hatch-Waxman Act of 1984 prohibits generic manufacturers from changing their drugs’ labels to differ from their Food and Drug Administration (FDA)-approved brand-name equivalents’ labels at any point in time. Nonetheless, Justice Clarence Thomas, who wrote for the court, admitted that the ruling made “little sense” in light of the Supreme Court’s 2009 ruling in Wyeth v. Levine, in which the court found that plaintiffs can sue brand-name manufacturers for inadequate label warnings.
It is this conflict that has led various advocacy groups to petition the FDA to give generic-drug makers more control over their labels so they can be held equally liable for failure-to-warn claims, particularly because nearly 80 percent of prescriptions in the U.S. are filled with generics. Rep. Henry Waxman, D-Calif., co-writer of the Hatch-Waxman Act, said last week in a statement that he was exploring legislative and rule-change options to address the problem.
The New York Times reports that since Pliva v. Mensing, more than 40 judges have dismissed dozens of cases against generic-drug manufacturers. For instance, Debbie Schork sued a generic company after an emergency-room nurse injected her with a generic anti-nausea drug that caused gangrene in her hand, which then had to be amputated. A court threw out her case last fall. By contrast, Diana Levine of Wyeth v. Levine won $6.8 million when she sued Wyeth after the brand-name version of the same drug Schork took also caused gangrene and resulted in her losing her forearm and hand.
Read the New York Times for more about courts throwing out cases against generic-drug makers.