It is Pfizer ($PFE) that will get another chance to knock down an Alabama Supreme Court ruling on the safety of generic drugs, but it stands in for the entire drug development industry that wants to see the the ruling reversed. It's one of several cases that is trying to pinpoint who is responsible when there is patient harm from a copy of a branded drug.
According to Pharmalot, the Alabama Supreme Court has granted the drug giant a rehearing on its finding that generics patients can sue branded drugmakers if they believe they are harmed by the copies. The February ruling came in the case of a patient who sued Pfizer but had only used generic versions of its stomach drug Reglan. Pfizer immediately appealed, saying the ruling was inconsistent with other rulings throughout the country.
Pfizer was not alone on this one. A number of business groups filed briefs in support of its position, warning the court that its ruling could have wide unintended consequences. Backers not only included the drug-company association PhRMA but also the U.S. Chamber of Commerce and the Business Council of Alabama. "The only thing predictable about this court's opinion is that it will lead to more lawsuits, and this necessarily leads to less investment, less innovation, and fewer new jobs in Alabama," the chamber stated in its brief.
The question of who is responsible if health problems arise from a generic actually cuts both ways. The U.S. Supreme Court in March heard arguments in a case that turns on whether generic makers can be held accountable for design flaws in the drugs they copy. In that case, a New Hampshire woman sued Takeda's Mutual Pharmaceutical over severe vision loss and burns she suffered after using its anti-inflammatory drug sulindac, a generic of Clinoril. She argued the label on the generic should have warned her of a known danger. Mutual argued that its label has to be the same as the one the FDA approves for the branded drug.
- here's the Pharmalot story