Julie deMahy sued generic drug maker Pliva over Reglan, alleging that the company didn’t properly warn her about the risks of her developing tardive dyskinesia on the label. Her case wound up all the way at the Supreme Court before it got a ruling on Thursday. The decision was a landmark one that was very divided — but in the end, the high court ruled 5-4 against her.
According to the Supreme Court, the makers of generic drugs can’t be held liable for alerting the public of the dangers of their drugs on the labels if the brand name version doesn’t actually list the warnings on their versions of them. DeMahy’s case, which also included another plaintiff, Gladys Mensing, has a lot of people speaking out while the generic drug makers claim that federal government regulations force them to put only the same information and warnings that are on the brand name versions of their drugs, in this case Reglan. Since Reglan didn’t have a warning about tardive dyskinesia, Pliva didn’t have to put one on the label, either.
The Supreme Court said federal laws trumped the victims’ complaints. deMahy’s lawyer, Brian Glorioso, said, “It’s a great disappointment, not only for our client, but for clients across the country who are victims of generic drugs. In the major opinion, they say that the decision makes little sense. If you took the generic you don’t have a case, but if you took the name brand you do.”
With more and more Americans buying generic drugs these days (75 percent of drugs dispensed in the U.S.), this decision has set a terrible precedent. Judge Sonia Sotomayor put this in perspective when she stated, “As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The court gets one thing right: This outcome makes little sense.”
Defendant Pliva asserts that it is not the company’s legal responsibility to ask for label changes and that the lawsuits that are filed in state courts are infringing on the FDA’s enforcement. While generic drug companies are not legally responsible to ask for the label changes, many people feel that they should be. Otherwise, the generic drug companies are just saying that if they can get away with it, they will keep excluding the dangers of their drugs from the public no matter what the cost to the consumer… including their lives.
