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CINCINNATI — (Mealey’s) A split Sixth Circuit U.S. Court of Appeals on Jan. 21 reversed dismissal of a fentanyl patch overdose lawsuit, saying the trial court needs to determine whether the patch is a combination product that is not preempted by Michigan’s drug preemption law (Beth Ann Miller, et al. v. Mylan Inc., et al., No. 12-2502, 6th Cir.).
(Opinion available. Document #28-140123-011Z.)
Beth Ann Kelly died after receiving an overdose of the narcotic pain drug fentanyl from a transdermal pain patch made by Mylan Inc. Beth Ann Miller sued Mylan in Michigan state court on behalf of Kelly, alleging strict products liability, negligence, negligent misrepresentation, fraud, warranty and violation of the Michigan Consumer Protection Act.
Mylan removed the case to the U.S. District Court for the Eastern District of Michigan and moved to dismiss, arguing that Miller’s claim is barred by Michigan Compiled Law Section 600.2946(5), which provides that drugs approved by the Food and Drug Administration are immune from product liability lawsuits. The District Court rejected Miller’s argument that the patch was a device, ruling that it is a drug and that the lawsuit is thus preempted.
Miller appealed to the Sixth Circuit.
Not Convinced Of Patch’s Classification
The Sixth Circuit majority said “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 applied to certain inactive ingredients such as ‘coatings, binders, and capsules.’”
“We are not entirely convinced that it applies to a product, like the patch, that appears to have a mechanical (rather than a chemical) effect on the human body,” the majority said.
More importantly, the majority said the District Court “failed to take full account of the statutory scheme governing federal drug regulation.” The majority said the lower court assumed that an item is either a drug or a medical device.
New ‘Combination’ Category
The majority said that in 1990, Congress amended the Food, Drug and Cosmetic Act to add a third category: combination products. Under the amended law, the majority said the FDA determines a product’s primary mode of action and regulates a product accordingly.
In amending the law, the majority said Congress deleted language stating that drugs do not include devices or their components, parts or accessories.
Mylan argued that the FDA regulated the fentanyl patch as a drug, not a device or combination product. However, the majority said Michigan’s drug shield law provides immunity only if the product is a drug.
“It follows 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 majority said.
State Law ‘Ambiguous’
“At best, Michigan law is ambiguous as to whether the manufacturer of a combination device should be immune from suit,” the majority said. “Accepted canons of statutory construction require this ambiguity to work against immunity for manufacturers of combination products.”
“In light of the Michigan legislature’s failure to clearly immunize manufacturers of ‘combination products,’ the statute should not be construed to exempt those manufacturers from suit,” the majority said.
The majority said that it is unprepared to answer whether the fentanyl patch is a combination product and that remand is appropriate. “In light of the now tripartite division of products into drugs, devices and combination products, the district court shall determine whether the fentanyl patch should be designated only as a ‘drug’ for purposes of the Michigan statute.”
The majority opinion was written by Circuit Judge Gilbert S. Merritt.
Concurrence: Improper Reliance
Circuit Judge Julia Smith concurred separately. He agreed that the case should be remanded for a determination on whether the patch is a combination product, but said the District Court also improperly focused on document submitted Mylan to support the order to dismiss.
Judge Smith said that Miller did not submit any documents. Mylan, she said, submitted documents that it did not authenticate.
In addition, Judge Smith said there is no indication that the labeling or medication guide Mylan submitted was provided to the FDA or to Kelly. She said “it is inappropriate to use the documents submitted by Mylan as if they were a part of plaintiff’s pleadings.”
The documents, she continued, should have triggered conversion of the motion to dismiss to a motion for summary judgment, which would have required Mylan to provide evidentiary basis for admission of the documents and would have required the District Court to admit all evidence pertinent to the motion.
Dissent: It’s A Drug
Circuit Judge David W. McKeague dissented, concluding that the Mylan fentanyl patch does not include a device and does not fit the definition of a device. In addition, he said there is no indication that the FDA approved the patch as anything but a drug.
Fentanyl transdermal patches became the subject of products liability litigation after some of them leaked fentanyl gel, resulting in an overdose by patients using them. Some plaintiffs have also argued that the porous surface that allows the gel to seep onto the skin allowed too much gel to be released, resulting in overdoses.
Miller is represented by S. Jay Ahmad of Ishbia & Gagleard in Birmingham, Mich. Mylan is represented by Clem C. Trischler of Pietragallo Gordon Alfano in Pittsburgh.
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