Sixth Circuit Finds That Manufacturer of Medical Patch Not Immune to Lawsuit in Miller v. Mylan, Inc.
A recent product liability case involving Michigan may have significance for the other states in the Sixth Circuit, including Kentucky. In Miller v. Mylan, Inc., the Sixth Circuit Court of Appeals found that a medical patch could be a "combination product" rather than a drug, making its manufacturer (and similar manufacturers) vulnerable to lawsuit.
The case concerned a fentanyl patch, manufactured by Mylan, Inc., which is a generic version of Duragesic and intended to lessen pain. The patch had two parts: fentanyl, which was its active ingredient, and a "transdermal system," the patch that delivered the drug. The patch was placed on the patient's skin to provide doses of fentanyl to patients at regular intervals over a prolonged period. In the case of Beth Ann Kelly, however, the patch was blamed for giving her an excessive dose of fentanyl, causing her death.
Kelly's estate brought a lawsuit against Mylan in state court for negligence, negligent misrepresentation, product liability, warranty, fraud, and the Michigan Consumer Protection Act. Mylan had the case removed to federal district court and claimed that it was immune from lawsuit under a Michigan statute that gave immunity to the manufacturer of drugs. The court sided with Mylan in finding that the patch was a drug. Kelly's estate then appealed to the Sixth Circuit, arguing that the patch was not a drug as referenced in the statute.