Thanks to the U.S. Court of Appeals for the Sixth Circuit, Michigan residents now enjoy greater protection from dangerous drugs and defective devices.
The court issued an opinion in Miller v. Mylan Inc., a case in which Beth Ann Kelly was prescribed a medicated patch for her pain, but suffered a fatal overdose of fentanyl – the active drug in the device. Her estate brought a wrongful death lawsuit against Mylan, Inc., the patch’s manufacturer.
In its defense, Mylan successfully raised Michigan’s drug immunity statute as a complete bar to the case. The trial court found that the fentanyl patch was covered by Michigan’s drug immunity law and dismissed plaintiff’s case On appeal, the Sixth Circuit disagreed, holding that the trial court’s analysis was wrong and incomplete, and sent the case back to the trial court for further proceedings.
The case is important to Michigan residents because it calls attention to the fact that modern healthcare treatment is not limited to just drugs or just devices. In reality, there are combination products – medical devices that use drugs in their mode of operation. Congress recognized this fact as far back as 1990 when it amended the Food, Drug & Cosmetic act and Food and Drug Administration (FDA) regulations to include “combination products.” The Sixth Circuit acknowledged this distinction with its holding that Michigan’s immunity does not cover combination products.