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, as explained by Katie Thomas in The Times on Wednesday. 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.
The Supreme Court’s disparate rulings hinge on the ability of the drug makers to change a warning label if they detect new evidence of dangers. In 2008, the court found that brand-name manufacturers had the unilateral power to change warnings through various mechanisms even before asking the Food and Drug Administration for a formal change.
Then, in 2011, the court found that, under the F.D.A.’s interpretation of a 1984 law, known as the Hatch-Waxman amendments to the Food, Drug and Cosmetic Act, the generic versions must carry warning labels identical to those of the brand-name drug. The goal was to minimize confusion and dispel any doubt that a generic was therapeutically equivalent to the brand-name drug. Generic makers can’t change the warnings but can propose a change to the F.D.A., which can then bring about a revision of the brand-name label to trigger a corresponding change in the generic label. The court ruled that because the generic makers do not control the labeling, they cannot be sued under state law for inadequate warnings.
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.
Generic drugs have rapidly expanded their reach, and, by one estimate, from one-third to one-half of all generic drugs no longer have a brand-name competitor. The regulatory system needs to hold generic companies, many of them large multinationals, accountable for labels on the products they sell.
http://www.nytimes.com/2012/03/24/opinion/a-bizarre-outcome-on-generic-drugs.html?sq=drug%20damage%20suits%20hinge&st=cse&scp=1&pagewanted=print