Court Finds Failure to Warn and Design Defect Claims Preempted in Lawsuit Against Generic Antibiotic Manufacturer

CotrimoxazoleTablet-480mg-20120214.pngA federal court dismissed most of the causes of action in a lawsuit alleging that a generic antibiotic caused a dangerous, potentially-fatal reaction. Wilson v. Amneal Pharmaceuticals, LLC, No. 1:13-cv-00333, order (D. Id., Dec. 31, 2013). The lawsuit asserted claims under Idaho state law, but the decision is similar to federal court decisions in other states involving generic drug manufacturers. Federal laws and regulations make recovery of damages difficult for injuries caused by generic drugs.

The plaintiff’s doctor prescribed Bactrim, a generic antibiotic manufactured by the defendant, Amneal Pharmaceuticals. After taking the medication for one week, the plaintiff reportedly developed Stevens-Johnson syndrome, a reaction to a medication or infection that causes painful rashes and blisters. It can be very difficult to treat, and in severe cases, can cause permanent injury or death. The plaintiff sued Amneal in state court, asserting seven causes of action including defective design, negligent manufacture, and failure to warn. Amneal removed the case to federal district court based on diversity jurisdiction. It attached various FDA documents to its answer, including formal approvals of changes to the drug label.

Amneal moved the court to take judicial notice of the documents it produced with its answer, and to dismiss the plaintiff’s complaint for failure to state a claim on which the court could grant relief. The plaintiff opposed the motion for judicial notice and moved the court to allow discovery to proceed. The court denied the plaintiff’s motion and granted the motion to take judicial notice. Judicial notice is proper, it held, when the evidence in question is widely available or a matter of public record. It found that all of the documents in question were easily obtainable online, and that no one disputed their authenticity. The court proceeded to decide the motion to dismiss without the introduction of any further evidence besides the pleadings.

The court found that most of the plaintiff’s claims essentially amounted to claims for failure to warn and design defect. It found that federal law preempted those claims, citing the U.S. Supreme Court decisions in Mut. Pharm. Co. v. Bartlett, 133 S.Ct. 2466 (2013) and Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011). These cases held that federal law preempts state law when a private party cannot comply with state law without violating federal law.

Federal law requires generic drugs to have the same active ingredient or ingredients, and to be chemically equivalent and “bioequivalent” to its brand-name counterpart. 21 U.S.C. § 355(j)(2)(A). Once the FDA approves a generic drug, the manufacturer cannot make changes to its formula or its label. The FDA requires generic drug labels to match the corresponding brand-name labels. The court held that the plaintiff’s failure to warn and design defect claims, under state products liability law, would require Amneal to modify its label in a way that violates federal law. It dismissed those claims, but gave the plaintiff leave to amend his negligent manufacture claim to plead and prove causation.

The pharmacy error attorneys at Lebowitz & Mzhen can assist Maryland individuals who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, contact us today online or at (800) 654-1949.

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Biotech Company Pleads Guilty to Illegal Marketing of Anemia Drug, Pharmacy Error Injury Lawyer Blog, January 10, 2013
Photo credit: By Tomchiukc (Own work) [CC-BY-SA-3.0], via Wikimedia Commons.

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