The Supreme Court will hear oral arguments Tuesday morning in the case of Mutual Pharmaceuticals v. Bartlett. Besides involving what until last year was a Philadelphia-based company, the case is about when and whether federal law trumps state law and, specifically, whether a generic drug company can be sued in state courts over alleged design flaws in a drug.
Besides its own litigation trail, the case has a cousin, of sorts. For pharma legal eagles and Supreme Court watchers (you know who you are), Pliva v. Mensing offered a glimpse of what might occur in Mutual Pharmaceutical v. Bartlett.
A link to Tuesday's Inquirer story on Mutual Pharmaceutical v. Bartlett is here.
Mutual was a subsidiary of URL Pharma, which was founded in Philadelphia in 1947. The company still has two plants in Northeast Philadelphia. But in June of 2012 URL Pharma was bought by Takeda Pharmaceuticals. Takeda then sold all of the company, except for one high-priced drug, to Sun Pharmaceutical Industries of India.
Karen Barlett suffered a terrible reaction to sulindac, a Mutual generic painkiller she took in 2004. Her skin sloughed off and she is mostly blind. She sued in state court in New Hampshire, alleging Mutual failed to warn and that the drug was designed badly.
The failure-to-warn part of the suit was dismissed. The design part of her suit gets a hearing Tuesday. Mutual contends the FDA rules and a previous Supreme Court ruling should protect it from the $21 million penalty awarded by the jury.
FDA rules say generic drugs are supposed to follow the approved label and formulation.
That previous ruling was Pliva v. Mensing, in which a very divided Supreme Court decided in 2011 that generic companies can't be sued in state courts over failure-to-warn allegations.
But it was a 5-4 decision. And though Justice Anthony Kennedy voted with conservatives Samuel A. Alito, Clarence Thomas, Antonin Scalia and Chief Justice John G. Roberts, Kennedy did not agree with part of Thomas' majority opinion. Ruth Bader Ginsburg, Sonia Sotomayor, Stephen G. Breyer and Elena Kagan voted the other way.
A link to the opinions in Pliva v. Mensing is here.