Generic Drug Lawsuit and the Safety Debate

Washington, DCThe US Supreme Court is currently debating whether generic drug manufacturers should be held liable for failing to warn users about the safety risks posed by their products, just as brand-name drug makers are.

In November 2010, the generic Reglan manufacturer filed an appeal to the Supreme Court. The company contested the court’s ruling that the manufacturer was liable for damages because it could have appealed to the FDA for a label change to warn of the health risk, and could have also taken other measures to warn the public and health care professionals of potential side effects.

Two women recently sued generic drug companies Mylan Inc. and Teva Pharmaceutical Industries Ltd. after they contracted a severe neurological disorder as a result of long-term use of metoclopramide to treat stomach conditions.They are asking the Supreme Court to allow their separate lawsuits against the drug makers to proceed.

Two years ago, the Court ruled that federal warning requirements by the FDA did not preempt (block) state court claims against brand-name prescription drug makers. If the women's cases go forward, generic drug manufacturers can be held to the same liability as brand-name pharmaceutical companies. According to the Associated Press, Louis Bograd, attorney for the victims, said, "This case is about the duty that the company owes to my clients and their doctors to provide them with adequate warnings.”

Bograd told the nine justices (who are split into almost equal camps) that a ruling favoring the companies would leave many injured patients with little recourse. He pointed out that generic drugs are used to fill 70 percent of US prescriptions, and a third of them no longer have brand-name competition.

If consumers can only sue brand-named products, it wouldn’t make sense to use generic, regardless of cost. On the other hand, the generic companies argue that it is unlawful for suits to be filed against them because they infringe upon the jurisdiction of the FDA and the FDA should act as enforcers.

The generic drug debate should prove interesting. According to AP, Justice Antonin Scalia said, "I don't see how you can hold [generic companies] liable, so long as they continued to give the warnings that they had to give," while Justice Sonia Sotomayor does not believe the law makes generic drugs immune from being held responsible.

Should generic drug makers be required to update their labels accordingly? Should all drug makers be treated equally? The Supreme Court is set to answer these questions at the end of this summer.