Sixth Circuit reinstates product liability case against Fentanyl patch
The Estate of Beth Ann Kelly sued Mylan Pharmaceuticals, claiming that Kelly died because the drug delivery mechanism in her Fentanyl patch delivered an inappropriate amount of medication. The Defendants cited Michigan's law granting immunity to the manufacturer of any drug approved by the FDA (a little special interest favor for the Kalamazoo pharmaceutical industry that no other state has approved) and sought summary disposition.
The trial judge concluded that since the patch contains a drug, the Defendants should be granted immunity and dismissed the action. The family appealed, pointing out that the patch is essentially a "combination product" as to which the FDA approval warranty does not apply. The majority of the Sixth Circuit agreed with the family and reinstated the case, pointing out that the mechanical delivery system of the patch was more akin to a delivery device and that the patch met the definition of the third product category created by the FDA to categorize medications and devices.