Health Law Daily Chemically the same but legally different, patient preempted by taking a generic
Friday, January 8, 2016

Chemically the same but legally different, patient preempted by taking a generic

By Bryant Storm, J.D.

A district court granted Breckinridge Pharmaceutical, Inc.’s motion for judgment on the pleadings and Novo Nordisk, Inc.’s motion to dismiss in a products liability action brought by a woman who allegedly developed breast cancer as a result of her use of Hormone Replacement Therapy (HRT) drugs. The court granted the motion of Breckinridge Pharmaceutical, the manufacturer of the generic version of the drug, estradiol/norethindrone acetate (1.0mg/0.5mg), because the patient’s claims sought to impose requirements on the generic manufacturer that were preempted by federal law. The court also dismissed the patient’s claims against Novo Nordisk the brand name manufacturer of the HRT drug Activella® because the patient never took a drug manufactured or sold by Novo Nordisk (Tsavaris v. Pfizer, Inc., January 7, 2016, Moore, K.).

HRTs. While going through menopause, the patient suffered hot flashes and night sweats. To alleviate her symptoms, the patient’s physician prescribed a combination of HRT drugs. The patient first took the HRT drug, Prempro®, manufactured by Wyeth, Inc. After a period of time without taking any HRT drugs, she was prescribed Activella. However, she never took the brand name version of the drug because her pharmacy provided her with the generic version manufactured by Breckinridge Pharmaceutical. When the physician prescribed the second round of HRTs, the patient was advised by the physician “that the studies showing breast cancer risks included a different group of women and that the risks of breast cancer were very remote and insignificant.”

Cancer. On May 15, 2013, the patient developed breast cancer and was advised by the diagnosing radiologist to immediately cease taking any HRT drugs. Pathology tests revealed that she had “hormone receptor positive breast cancer.” Additionally, the tests reports showed negative for HER2 (a gene mutation that is not inherited) and negative for BRCA1 and BRCA2 (genes that are inherited). Hormone receptor breast cancer requires hormones to fuel the growth of the cancer. Because she was hormone deficient prior to taking the HRT drugs, the patient asserted that she did not have the endogenous hormones necessary to fuel the growth of the cancer prior to taking Prempro and Activella. Thus, she concluded, that had she not ingested the HRT drugs she would not have had the necessary hormone levels to develop the hormone receptor positive breast cancer.

Lawsuit. The patient filed an action against Breckinridge, Novo Nordisk, and Wyeth claiming that the HRT drugs caused her cancer and that the manufacturers knew or should have known the breast cancer risks of the HRT drugs. Breckinridge sought judgment on the pleadings, asserting that the patient’s claims against it were preempted by federal law because, as a generic manufacturer, Breckinridge was prohibited by federal law from making changes to either the chemical composition of the generic version of Activella or its labeling. The patient disagreed asserting that her claims were not preempted because they were not failure to warn claims, but, instead, identified specific actions Breckinridge could have taken to design a safer drug.

Preemption. The court agreed with Breckinridge, holding that the patient’s claims against the generic manufacturer for strict products liability, negligence, and negligent misrepresentation were preempted because they were premised upon failure to warn and defective design claims. Because, as a generic manufacturer, Breckinridge was prohibited by the federal Food, Drug, and Cosmetics Act (FDC Act) (21 U.S.C. § 301 et seq.) from making changes to either the design or the labeling of its generic version of Activella, the court held that any requirements imposed by the patient’s claims would be additional to or different from the FDA’s requirements. In other words the court reasoned that the patient could not successfully pursue products liability claims against a generic manufacturer for things that manufacturer “could have or should have done” with respect to the design or labeling of the generic drug.

Novo Nordisk. The brand manufacturer of Activella moved to dismiss the patient’s claims on the grounds that she never took a HRT drug manufactured or sold by Novo Nordisk. The court agreed with the manufacturer’s position and held, under Florida Law, an injured consumer does not have a cause of action against the brand name manufacturer of a drug if the consumer has only ingested the generic form of the drug. Thus, the court acknowledged that although Novo Nordisk was responsible for the design and labeling of the drug, because it was not the manufacturer of the specific drug ingested by the patient, the brand name manufacturer was not liable.

The case is No. 1:15-cv-21826-KMM.

Attorneys: Alexander Angueira (Alexander Angueira, PLLC) for Maggie Tsavaris. Jennise W. Stubbs (Shook, Hardy & Bacon, LLP) for Pfizer Inc., Wyeth, Inc., and Wyeth LLC.

Companies: Pfizer Inc.; Wyeth, Inc.; Wyeth LLC; Novo Nordisk A/S; Breckinridge Pharmaceutical, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews GenericDrugNews LabelingNews PreemptionNews PrescriptionDrugNews PLDrugNews SafetyNews FloridaNews

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