There have recently been a growing number of product liability lawsuits filed against drug manufacturers for culpability in the injury and death of persons who were given transdermal fentanyl patches.
It is alleged in these cases that the drug, when administered in this manner, has the potential to deliver an injurious or even fatal dose - something patients are never warned about prior to placing the patch on their skin.
In one such case out of Michigan, Miller v. Mylan Inc., the patch had to be defined under the state's product liability law as it pertains to drug manufacturers. The Sixth Circuit Court of Appeals recently wrestled with the issue of whether the patch should be considered a drug, a device or a combination product. The distinction will determine whether the case will be allowed to move forward.