The U.S. Sixth Circuit Court of Appeals has ruled that lawsuits against manufacturers of the fentanyl pain patch are not necessarily pre-empted under a state law which bars lawsuits against “drug” manufacturers. According to the appeals court ruling, these lawsuits may be allowed to go forward depending on whether the fentanyl pain patch is defined as a “combination” product, rather than a “drug.”
The court’s ruling involved a lawsuit filed by the estate of Beth Ann Kelly, a Michigan woman who died after she allegedly received an excessive amount of fentanyl from the pain patch. Mylan, the manufacturer of the patch, moved to dismiss Kelly’s claim on the grounds that manufacturers of “drugs” are immune from lawsuits under Michigan state law.
After Kelly’s lawsuit against Mylan was dismissed by a district court, her attorneys filed an appeal with the Sixth Circuit. The court reversed the district court ruling, finding that because the fentanyl patch that Kelly used could be considered a “combination” product, the claim filed by her estate was not necessarily pre-empted under Michigan law.
Although the court of appeals reversed the district court’s ruling, it did not rule on the question of whether the fentanyl patch is a “combination product” or a “drug,” leaving this question to be decided by the district court. However, based on the court of appeals ruling, Kelly’s case was remanded to the lower court for further proceedings.