Fentanyl patch may be ‘combination product’ rather than ‘drug,’ not immune from Michigan lawsuits

by Jim Orr

Beth Ann Kelly died after receiving a fatal dose of fentanyl. Her estate subsequently brought a lawsuit alleging that the defendant’s fentanyl patch caused Kelly’s death. The defendant pleaded immunity under a Michigan statute that immunizes manufacturers of “drugs” from suit. The district court determined that the fentanyl patch was a “drug” and consequently granted the defendant’s motion to dismiss the complaint.

In Miller v. Mylan Inc., 2014 WL 211217 (6th Cir. January 21, 2014), the Sixth Circuit Court of Appeals has now reversed the dismissal. The court of appeals held that a factual question remains as to whether the fentanyl patch was a “combination product,” which does not enjoy immunity under Michigan law. The court of appeals therefore reversed the judgment of the district court and remanded for further proceedings.

Mylan is the manufacturer of a fentanyl patch that is the generic version of Duragesic. The product is intended to treat pain. It essentially has two parts: fentanyl (its active ingredient) and a “transdermal system” (i.e., the patch that delivers the drug). The patch is affixed to the patient’s skin and is designed to deliver a regulated dose of fentanyl to the patient for a prolonged period. The lawsuit filed by the Kelly estate alleged that a Mylan patch caused Kelly’s death by delivering an excessive amount of fentanyl.

Kelly’s estate brought suit alleging counts based on common law and statutory torts, i.e., strict products liability, negligence, negligent misrepresentation, fraud, warranty, and the Michigan Consumer Protection Act. Mylan moved to dismiss the complaint for failure to state a claim upon which relief can be granted. Mylan based its motion on Mich. Comp. Laws § 600.2946(5), which provides that manufacturers of “drugs” are immune from suit. The district court concluded that the fentanyl patch is a “drug” and dismissed the complaint in its entirety. In pertinent part, the statute reads:

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.

A manufacturer is immune under the statute only if the product at issue is a “drug.” Michigan defines “drug” as the term is defined in federal law: “ ‘Drug’ means that term as defined in section 201 of the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 321.” Mich. Comp. Laws § 600.2945(b). In turn, the federal Act defines “drug” to mean:

(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).

21 U.S.C. § 321(g)(1). Michigan’s definition of “drug” also provides that a “drug” is not a “medical appliance or device,” though the statute neither defines “medical appliance or device” nor refers to the federal definition of “device.” FN2 Mich. Comp. Laws § 600.2945(b).

The plaintiff argued that the patch is not a drug even if fentanyl, the product’s active ingredient, is. The district court disagreed, holding that “there is no factual or legal basis to disassociate the pharmacologically active and inactive components of the [fentanyl patch],” and that the fentanyl patch, “including all its system components, is an FDA-approved drug.” The court determined that the patch was akin to a time-release capsule in a pill and that it qualified as an “article intended for use as a component of any article specified in clause (A), (B), or (C).”

The Sixth Circuit found the district court’s conclusion to be problematic for two reasons. First, it is unclear that the patch is an “article intended for use as a component” of fentanyl, as that phrase is most naturally understood. The phrase applies to certain inactive ingredients such as “coatings, binders, and capsules.” See United States v. Generix Drug Corp., 460 U.S. 453, 454, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). The court of appeals was not entirely convinced that it applies to a product, like the patch, that appears to have a mechanical (rather than chemical) effect on the human body.

Second, and more importantly according to the court of appeals, the district court failed to take full account of the statutory scheme governing federal drug regulation. The district court improperly assumed a binary scheme whereby a particular item is defined as either a “drug” or “device” and is regulated accordingly. In 1990, Congress amended the federal Act to add a third category of products known as “combination products.” Pub.L. No. 101–629, § 16, 104 Stat. 4511, 4526 (1990) (codified as amended at 21 U.S.C. § 353(g)). The apparent purpose of this law was to determine whether ambiguous products would be regulated as drugs or as devices. (The approval process is different for each.) The law gives the Secretary authority to determine a combination product’s “primary mode of action” and to regulate the product accordingly. Simultaneously, Congress deleted language in the definition of “drug” stating that drugs do not “include devices or their components, parts, or accessories.” The deletion reflected the replacement of the binary scheme with a tripartite scheme.

The effect of the 1990 amendment was to create a distinction between how a product is defined and how that product will be regulated. In many cases, it will be obvious that a product should be defined as a statutory “drug” or a statutory “device” and will be regulated as such. In other cases, a product is neither a statutory “drug” nor “device” but rather is a “combination product.” Whether a combination product is regulated as a drug or a device is left to the Secretary’s discretion.

Mylan argued that it is irrelevant whether the fentanyl patch is labeled a “combination product” or a “drug” because the FDA actually regulated the patch as a drug. The court of appeals disagreed, concluding that Mylan’s argument ignores the plain language of the Michigan immunity statute. Under the statute, a manufacturer is only immune if the suit regards a “product that is a drug” (i.e., if it is defined as a drug) and “if the drug was approved for safety and efficacy by the United States Food and Drug Administration” (i.e., if it is regulated as a drug). Mich. Comp. Laws § 600.2946(5). In turn, a product is a “product that is a drug” only if it falls within the federal definition of “drug.” Mich. Comp. Laws § 600.2945(b). Thus, the Sixth Circuit held that if a product is better defined as a “combination product” than a “drug” under federal law, then its manufacturer is not immune from suit in Michigan.

The court of appeals did not decide whether the fentanyl patch is indeed a “combination product” rather than a “drug.” Whether the fentanyl patch meets the definition of “combination product” or should be designated as only a “drug” for purposes of the Michigan statute is a question of fact to be determined in the first instance by the district court. Accordingly, the judgment of the district court was reversed and the case remanded for further proceedings.

Fentanyl Patch Litigation at Heygood, Orr & Pearson

Heygood, Orr & Pearson has successfully prosecuted more cases involving deaths due to fentanyl products than all the other firms in the country combined. We have spent years studying fentanyl, its uses and its misuses. We have deposed hundreds of doctors, scientists and experts on the subject of fentanyl products.

In the very first jury trial by the lawyers of Heygood, Orr & Pearson against makers of a fentanyl transdermal pain patch, a Florida jury awarded a $5.5 million verdict to the family of a man who died while wearing a Duragesic pain patch. More recently, Heygood, Orr & Pearson obtained a $16 million verdict for the family of a Cicero, Illinois woman who died while wearing a Duragesic pain patch. That verdict was upheld on appeal, resulting in a payment of more than $21 million.

Fatal mistakes that our firm has seen doctors commit in prescribing fentanyl patches include:

  • Overestimating the initial dose of fentanyl patches
  • Prescribing them for acute or post operative pain
  • Prescribing fentanyl patches to opioid naïve patients
  • Prescribing fentanyl patches to patients with significant pulmonary problems
  • Prescribing fentanyl patches at the same time as other CNS depressants

If you or a loved one has experienced the tragedy of losing a family member as a result of fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.

To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form.