Miller v. Mylan, Inc.

Mylan manufactures generic Duragesic, a drug to treat pain. It consists of fentanyl (active ingredient) and a “transdermal system” (patch that delivers the drug). Kelly’s estate claimed that the patch caused Kelly’s death by delivering an excessive amount of fentanyl, alleging strict products liability, negligence, misrepresentation, fraud, warranty, and violation of the Michigan Consumer Protection Act. The district court dismissed, based on Mich. Comp. Laws 600.2946(5), which provides that “drug” manufacturers are immune from suit. The Sixth Circuit reversed and remanded. Michigan defines “drug” using the federal definition, 21 U.S.C. 321: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). Michigan’s definition provides that a “drug” is not a “medical appliance or device.” Immunity might not apply to a product, like the patch, that has mechanical (rather than chemical) effect on the body. Under the federal definition a product might be neither “drug” nor “device” but a “combination product.” Whether a combination product is regulated as a drug or a device is left to the Secretary’s discretion. View "Miller v. Mylan, Inc." on Justia Law