Seventh Circuit Upholds Dismissal of Generic Drug Lawsuit on Preemption Grounds

intradermal-influenza-virus-vaccine-to-a-male-clinic-patient-using-the-patients-right-shoulder-725x483This month, a panel of federal appellate judges upheld the dismissal of a plaintiff’s action against the manufacturer of the generic drug allopurinol, based on preemption. In Houston v. United States, the plaintiff alleged that in 2011 he was diagnosed with gout, which is a type of arthritis, and prescribed allopurinol. This drug is a generic version of the brand name drug Zyloprim. Roughly 30 days later, the plaintiff indicated that he developed a rash on his face and pain in his eye. He was eventually diagnosed with Stevens-Johnson syndrome (SJS), a life-threatening skin condition, which his treating physicians attributed to a reaction to the allopurinol.

The plaintiff initiated an action in 2014 against the drug maker, Qualitest, the medical facility, and his health care provider, alleging that the drug maker failed to provide an adequate warning about the risk of developing SJS after taking the drug. The plaintiff also alleged a design defect claim. The health care facility and physicians were funded by the federal government, so the United States removed the action to federal court. All three defendants then filed a motion to dismiss, which the district court granted.

The plaintiff filed an appeal with the Seventh Circuit Court of Appeals, arguing that the district court erred when it failed to remand the claims against the drug maker to state court for lack of federal jurisdiction. The appellate court rejected this argument, finding that the claims against the drug maker involved the “same case or controversy” as the causes of action against the facility and physicians.

When it comes to generic drugs, the FDA requires manufacturers to design generic drugs that have the same strength, stability, purity, and quality as a brand-name equivalent. Also, the generic drug must bear a label that mirrors the brand-name label. This is known as the “duty of sameness.”

The Seventh Circuit also upheld the lower court’s finding that the plaintiff’s failure to warn and design defect claims were preempted under federal law. According to the court, state-based claims 0f this nature are preempted when they “would require the manufacturer to redesign its drug, change its labeling, or exit the market in order to avoid liability.” In his complaint, the plaintiff specifically alleged that the drug maker should have used a different label design or an alternative design of the drug and that this would contravene the drug maker’s obligations under the duty of sameness.

According to the panel, the only alternative for the drug maker in this situation would be to exit the market. Makers of generic drugs provide a benefit to consumers in the market by bringing drugs that have already been approved to the market, reasoned the panel. The court indicated that requiring the drug maker to exit the market would penalize consumers.

If you or someone you love has suffered injuries due to a dangerous drug, you may be entitled to compensation. At Moll Law Group, our skilled and aggressive team of product liability lawyers is ready to help you seek the compensation you deserve for your injuries. We represent clients across the country, including in Florida, New York, California, and Illinois. Call us to schedule your free consultation at 312-462-1700 or contact us online.

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