Sixth Circuit Finds That Manufacturer of Medical Patch Not Immune to Lawsuit in Miller v. Mylan, Inc.

February 14, 2014

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.

pills-2-1160486-m.jpgThe 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.

The Sixth Circuit looked at the Michigan legal definition of a drug, which included "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and that such a drug was not a "medical appliance or device." The district court had determined that there was no way to separate the fentanyl-providing portion of the patch from the non-fentanyl portion, making the entire patch a drug approved by the FDA.

The Sixth Circuit, on the other hand, was unconvinced that the patch was an "article for use as a component" of fentanyl, noting that that phrase was originally applied to inactive ingredients like capsules and coatings. The patch, on the other hand, had a mechanical rather than a chemical effect on the body. Instead, the Court thought that a more appropriate category for the patch would be one created by Congress in 1990: the combination product. The law gave the federal government authority to determine the product's "primary mode of action" and to regulate it as such.

Because the patch did not meet the federal definition of drug, as required by Michigan law, but instead appeared to be a combination product, that meant that Mylan the manufacturer was not immune from lawsuits in Michigan. The Sixth Circuit was not prepared to make a definitive judgment, and therefore remanded the case back to determine whether in fact the patch was a combination product.

The Court's actions are positive for anyone harmed by medications that they were prescribed or that they purchased over the counter. It shows that manufacturers of these products are not necessarily safe from being scrutinized.

Miller & Falkner is an Indiana and Kentucky plaintiffs law firm serving residents of Kentucky and Indiana. Located in Louisville, Kentucky, the firm provides representation in the areas of personal injury and employment law. If you need a Kentucky product liability attorney, contact us today for a free consultation.

Related Posts:

Court to Decide if Generic Drug Makers can be Held Liable for Dangerous Drug Injuries

Health Inspections Find Numerous Issues at Most Massachusetts Compounding Facilities

Indiana Residents Still at Risk for Meningitis Infection from Tainted Steroid Shots