Please Turn The Learned Intermediary Ruling Off Before Leaving West Virginia

With little fanfare last month, Mylan Pharmaceuticals let the learned intermediary genie out of the bottle in West Virginia and is now trying to finesse it back inside.

As I reported in the April 1 issue of Mealey's Emerging Drugs & Devices, Mylan was being sued in the Northern District of West Virginia by the parents of a son who lost 90 percent of his epidermis in an apparent reaction to phenytoin, the generic version of Dilantin made by Mylan.  Mylan sought summary judgment on some pretty standard defenses:  the claims are not allowed by the applicable state law and they're preempted.

Judge Irene M. Keeley responded with some pretty standard rulings:  yes, some claims are barred by the state statute, no, some aren't, and no, the claims aren't preempted.  Then the ruling went from surgical to systemic:  Judge Keely ruled that the West Virginia Supreme Court of Appeals would not recognize the learned intermediary doctrine.  And just like that, there was case law that the learned intermediary wasn't a defense in West Virginia.

Three weeks later, Mylan told the judge that the case had settled, and oh, would you mind vacating your "advisory" opinion?  The state Supreme Court will take it up some other time, it said.

As of March 31, Judge Keeley hadn't ruled on Mylan's motion.