By Jeffrey H. Brochin, J.D.
Where patient asserts that a generic drug manufacturer failed to update labels to match FDA-approved labels for brand-name manufacturers, and the claim is limited to the inadequacies of the non-updated label and is based on state law, that claim is not preempted by the FDC Act.
A federal district court in Minnesota has dismissed an MDL complaint—but with leave to amend—after Bayer Health Care Pharmaceuticals, Inc. filed a motion for judgment on the pleadings. The patient’s "failure to update generic label" theory which was recited in her initial complaint would have been lost if the court had disregarded that complaint in favor of the requisite MDL Short-Form Complaint attached to the MDL Master Complaint which did not include her failure to update label claims. After examining her initial complaint, the court found that her theory of liability was not preempted by federal law, but because she failed to plead sufficient allegations or explanations of the source of her claims under D.C. law, the court dismissed the complaint with leave to amend (Akman v. Bayer Health Care Pharmaceuticals, Inc., November 4, 2020, Tunheim, J.).
Change in label warnings. In November 2013, the patient was prescribed Cipro or its generic equivalent, ciprofloxacin, but she stopped taking it after 24 hours because she developed a severe adverse reaction. She has alleged that she continues to suffer nerve damage and other injuries from the medication. She filed her state law complaint in November 2016 alleging that on August 15, 2013, the FDA issued an updated warning about the risk of peripheral neuropathy from use of Cipro and ciprofloxacin, but that generic manufacturers had not updated their labels and other product information in compliance with the August 2013 mandate at the time she was prescribed ciprofloxacin.
State-law claim in MDL complaint. Her case was removed to the U.S. District Court for the District of Columbia on January 17, 2017, and then transferred to the District of Minnesota on January 27, 2017 to be consolidated for pretrial proceedings as part of In re: Fluoroquinolone Products Liability Litigation, Multi-District Litigation No. 2642 (the "Fluoroquinolone MDL"). On February 27, 2017, she filed an Amended Complaint by completing the Fluoroquinolone MDL Short Form Complaint (which incorporated the allegations of the MDL Master Complaint) in which she alleged that she was injured by generic ciprofloxacin and that D.C. law supported her generics-related claims. Bayer moved for judgment on the pleadings contending that her claims were preempted by federal law.
Brand name-generic requirement of ‘sameness’. The Supreme Court has issued two pivotal decisions about federal preemption of state law claims against generic drug manufacturers based on impossibility preemption, which exists where it is impossible for a private party to comply with both state and federal requirements. The Supreme Court has found that state law claims for failure to warn based on the inadequacy of a generic drug’s labeling are preempted by federal law because the warning labels of a brand-name drug and its generic copy must always be the same, and generic drug manufacturers therefore have an ongoing federal duty of "sameness." Claims asserting that generics should have stronger warnings, when their labels were the same as the brand-name counterpart, are preempted by impossibility because federal law prohibits a generic drug manufacturer from unilaterally strengthening the warnings on its product’s labeling.
Where the patient’s claim differs. The court noted that in the instant case, the patient’s failure to update scenario differed from the claims in the referenced Supreme Court cases, because she asserted that at the time she received the ciprofloxacin, the generic manufacturer’s product information was not the same as the brand-name equivalent. Rather, they failed to update their labels to match the brand-name labeling after FDA approval of a new warning. Unlike the Supreme Court cases where the plaintiffs argued that state law required generic manufacturers to provide more warnings or implement a safer design for their generic drug than the brand-name drug, the patient argued that state law merely required the generic manufacturer to match their labels to the FDA-approved brand-name version. Accordingly, the court held that her failure to update claims would escape preemption due to the generic manufacturer’s compliance with federal and state duties not only being possible, but mandatory.
D.C. Law not sufficiently pleaded. Although the court ruled that the failure to update claims were not necessarily preempted by federal law, their examination of the sufficiency of her pleadings determined that her Initial Complaint failed to state a claim based on her theory. She needed to allege that she was injured by the generic manufacturer’s failure to update their labels to match the August 2013 FDA-approved version. And, her complaint did not tie the alleged liability for failure to update to D.C. law. Therefore, the court granted her leave to amend her complaint.
The case is No. 0:17-cv-00260-JRT.
Attorneys: Christopher Nidel (Nidel Law PLLC) for Jennifer Akman. Michael J. Suffern (Ulmer & Berne LLP) and Kimberly Lewis Beck (Hilliard Martinez Gonzales LLP) for Bayer Health Care Pharmaceuticals, Inc., Cobalt Laboratories, Inc. a/k/a Cobalt Laboratories LLC and Actavis Pharma Co.
Companies: Bayer Health Care Pharmaceuticals, Inc.; Cobalt Laboratories, Inc. a/k/a Cobalt Laboratories LLC; Actavis Pharma Co.
MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews LabelingNews PreemptionNews PrescriptionDrugNews SafetyNews MinnesotaNews
Interested in submitting an article?
Submit your information to us today!Learn More
Health Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.