The other day I wrote about drugmakers putting profits before safety when they engage in off-label marketing and how drugmakers and their labeling strategies are coming under the scrutiny of the law. Interestingly, yesterday, the Supreme Court said state juries can award damages for harm done from unsafe drugs, even if their labels satisfied the FDA. This ruling is important because drugmakers can no longer protect themselves from lawsuits merely because their labels are in compliance with the FDA’s requirements. The underlying case, Wyeth Pharmaceuticals v. Levin, started in 2000 when Diana Levine went to a clinic to seek relief for a migraine and was injected with Wyeth’s drug Phenegran to help her with symptoms of nausea. Days later gangrene set in and her harm had to be amputated. She was awarded 6.7million in damages.
The fallout from this case? It is unknown how this decision will affect pharmaceutical companies, but it is likely that they will start strengthening and lengthening the language on labels. It was only until recently, under the Bush administration, that federal agencies were given the final word on drug product safety, and the FDA would claim that state law interfered with their business. This court ruling has turned the FDA’s fears upside down, along with our former administration’s effort to protect drugmakers from lawsuits. And now that these types personal injury claims are no longer pre-empted, more plaintiffs will feel less pressure to settle and be given the opportunity to be heard by a jury and receive compensation. Here at the Brod Law Firm we are prepared to take on product liability suits against drugmakers, now more than ever, due to the outcome of this case.