Dozens of suits against drug companies have been dismissed in federal and state courts because of a decision by the Supreme Court last year that makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers. This outrageous denial of a patient’s right to recover fair damages makes it imperative that Congress or the Food and Drug Administration fashion a remedy.
This situation is particularly bizarre because patients using the brand-name drug can sue when those using the generic form of the drug cannot…In 2008, the Supreme Court ruled that a Vermont woman who had her hand and forearm amputated because of gangrene after being injected with a brand name antinausea drug could sue the manufacturer for inadequate warning of the risks; she won $6.8 million from Wyeth.
In 2011, the court ruled that similar failure-to-warn suits could not be brought against makers of generic drugs. As a result, an Indiana woman who was also forced to have her hand amputated because of gangrene after being injected with a generic version of the same antinausea drug had her case dismissed.
Same drug. Same devastating health consequences. Opposite results. This injustice will affect more people as generics, which already dominate the market, expand even more under the pressure to control health care costs…You buy what you can afford.
Justice Clarence Thomas, writing for the majority in 2011, acknowledged that the distinction “makes little sense” in the eyes of consumers, and Justice Sonia Sotomayor, writing the dissent, predicted “absurd consequences” depending on the “happenstance” of whether a prescription was filled with a brand-name or generic drug.
Congress should fix the disparity by amending the law to make it clear — as Representative Henry Waxman, a co-author of the statute contends — that the act did not intend to pre-empt all failure-to-warn claims. Alternatively, the F.D.A. should fix the liability problem by amending its regulations to allow generic manufacturers to change the warning labels.
And the Supreme Court should fix their priorities by learning to pass down sensible decisions affecting the lives of we ordinary mortals who get screwed-over enough by corporate sleaze.
Leaving people’s lives in jeopardy, in the way of physical harm and poverty because of a disagreement over labeling regulations which either do or don’t require FDA approval – is the saddest excuse for an incompetent court I ever heard.