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From Health Law Daily, May 8, 2018

Failure to warn, design defect claims against generic drug risperidone preempted

By Rebecca Mayo, J.D.

State law claims against generic prescription drug manufacturers based on failure to warn and design defect are preempted by the provisions of federal law that require the labeling and composition of generic drugs to be identical to those of their name-brand counterparts. A district court dismissed state law products liability claims against the manufacturers of the generic prescription drug risperidone, finding that the claims were preempted (Coleson v. Qualitest Pharmaceutical Manufacture, May 4, 2018, Koeltl, J.).

Claim. After a diagnosis of schizophrenia mania and bipolar disorder, a patient was prescribed risperidone. Risperidone is a generic version of Risperdal, which is an antipsychotic prescription drug used to treat schizophrenia and bipolar mania in adult patients. Both drugs include a warning that mentions gynecomastia as a potential side effect. The patient continued taking risperidone for over three years. The patient was then prescribed Seroquel, and at that time the patient complained to his doctors about chest pain, the development of a lopsided chest, and discharge from his chest. The doctor examined the patient and determined that he did not have gynecomastia. However, a year later the patient was diagnosed with gynecomastia and underwent a bilateral mastectomy.

According to the patient, the surgery left him with scars from his armpits to the center of his chest and caused significant pain and suffering. The patient alleged that he suffered these injuries because the manufacturers failed to properly warn on the drug label of risperidone’s side effects on male patients and because the drug suffered from a design defect.

Previous litigation. The patient originally sued the manufacturers of the brand name Risperdal. The case was dismissed when the court determined that the manufacturer of a brand name drug is not liable for any failure to warn or design defects associated with the drug’s generic equivalents and because the patient could not show that he ever took Risperdal. The patient then filed suit against the manufacturers of the generic drug risperidone.

Preemption. The manufacturers moved to dismiss the claims because of preemption. A generic drug’s approval by the FDA is conditioned on the generic drug being identical to the already-approved brand name drug in several key respects, including the labeling. This duty of "sameness" extends beyond the approval process. A generic drug must always be the same as its brand name equivalent.

The court held that the manufacturers could not have altered risperidone‘s label to strengthen its warnings about gynecomastia, nor fiddle with its composition to mitigate that possible side effect, without violating federal law. The patient’s claims would have required the manufacturers to do just that. Therefore, the patient’s failure to warn and design defect claims were preempted.

The case is No. 17-cv-5381 (JGK).

Attorneys: Samuel Coleson, Jr., pro se. Matthew Sinon Mulqueen (Baker, Donelson, Bearman, Caldwell & Berkowitz P.C.) for Qualitest Pharmaceutical Manufacture and Endo Pharmaceutical. Lewis Avery Bartell (L'Abbate, Balkan, Colavita & Contini, LLP) and Jennifer Snyder Heis (Ulmer & Berne LLP) for Teva Pharmaceutical USA.

Companies: Qualitest Pharmaceutical Manufacture; Endo Pharmaceutical; Teva Pharmaceutical USA

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews GenericDrugNews PreemptionNews PrescriptionDrugNews PLDrugNews SafetyNews NewYorkNews

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