It's a state court ruling. It directly affects only one drugmaker. But the Alabama Supreme Court's decision to allow a patient to sue Pfizer ($PFE) for damages could ripple through the industry--and not in a good way for branded drugmakers.
The case involves Alabama plaintiff Danny Weeks, who claims he developed the serious movement disorder tardive dyskinesia after taking generic versions of the stomach drug Reglan. Weeks sued Actavis and Teva, which had made the versions he used, and Wyeth, which developed the branded version.
Now, Pfizer is familiar with patient claims related to Reglan; it inherited all of them when it bought Wyeth in 2009. As The New York Times notes, hundreds of patients have sued, alleging that Wyeth didn't do enough to warn about Reglan's potential links with tardive dyskinesia. The FDA required warnings about the risks to be added to official labeling on Reglan and its generics in 2009.
But what of patients who used generic versions? In 2011, the Supreme Court ruled that generic drugmakers can't be sued for failing to warn about a drug's risks. Generic drugs are required to use the same FDA-approved labeling as the branded versions, so copycat drugmakers don't control whether warnings and risk data are included. So, if patients who use generic drugs can't sue their manufacturers, then can they file their claims against the branded drugmaker responsible for that official labeling?
That's the question the Alabama Supreme Court addressed. And the court ruled that "an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product," the NYT reports.
Other courts have ruled differently. A Pfizer lawyer told the NYT that more than 70 decisions had gone the other way. The Alabama suit apparently exploits a particular feature of Alabama state law allowing third parties to be held liable for injury in certain cases. But plaintiff's lawyers may flock to Alabama with their drug-liability suits, legal advocates warn. And at least one plaintiff's attorney said the decision would change his practices immediately.
"I suspect that now, like most folks, if a client comes into my office, I'd be suing both the generic they took and the brand who's responsible for the label," Dallas lawyer Bill Curtis told the NYT.
Coming up later this year are arguments in another Supreme Court case involving generics makers' liability. In Mutual Pharmaceutical Co. v. Bartlett, the Court will decide whether patients can sue generics makers in state court for damages--or whether following federal rules is enough to shield them from those legal complaints.
- get the story from the Times