Health Law Daily Challenge to infertility drug’s labeling halted because FDA already said no
Thursday, March 17, 2016

Challenge to infertility drug’s labeling halted because FDA already said no

Challenge to infertility drug’s labeling halted because FDA already said no

By Bryant Storm, J.D.

Federal law preempted a patient’s claims that Aventis, Inc. inadequately labeled its infertility drug Clomid® by failing to warn about birth defect risks. A district court held the patient’s claims that the labeling did not adequately address Clomid’s risks to pregnant women and a fetus, if taken prior to pregnancy, were preempted by the federal Food, Drug, and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.) because they sought to impose labeling changes the FDA would not have approved. The court explained that the FDA’s denial of a Citizen Petition requesting the same labeling change, 15 years after the patient took Clomid, constituted “clear evidence” that the agency would not have authorized the additional warnings prior to when the patient took the drug (Cerveny v. Aventis, Inc., March 15, 2016, Benson, D.).

Labeling. Aventis manufactures Clomid, a selective-estrogen-receptor modulator used to induce ovulation in women who are unable to ovulate. Since the drug’s approval in 1967, its manufacturers have warned that Clomid should not be taken while pregnant. Beginning in 1994, the drug’s label included Category X labeling—a special label denoting positive evidence of fetal risk if taken while pregnant. The current label specifies that patients should be carefully observed while taking Clomid to ensure that the drug is not ingested while a patient is pregnant.

Risks prior to pregnancy. Despite the warnings about the risks of taking Clomid while pregnant, the FDA has never required that the drug’s label warn that the drug can cause birth defects if ingested prior to pregnancy. A 2007 Citizen Petition, based upon scientific research that Clomid has a long half-life and remains biologically active into the second month of pregnancy, asked the FDA to revise the drug’s label to reflect the associated risks. The FDA denied the petition and made its own scientific findings, which were dismissive of the alleged risks. The FDA also denied a reconsideration of the petition.

Birth defects. In 1992, a patient was prescribed Clomid and she took it as directed in the package insert. After her second round of the drug, she discovered she was pregnant. Her son was born with without his first and fifth digits on his left hand and with “a congenital dislocation of the left radial head” on his left elbow. Relying on scientific information from the Citizen Petition, the patient contended that the birth defects were a result of Clomid remaining in the patient’s system during conception and the pregnancy. The patient filed a products liability action challenging the drug’s labeling with a failure to warn theory. Specifically, the patient alleged that Aventis falsely represented that there was a lack of causal evidence regarding the negative effects of Clomid therapy on a human fetus. She alleged that the manufacturer had a duty to warn her about the birth defect risks and, if the manufacturer had done so, she would not have used Clomid prior to her pregnancy.

Clear evidence. The court noted that the injury predated the FDA’s denial of the Citizen Petition by almost 15 years. As a result, the court held that the FDA’s denial of the patient’s theories, as they were embodied in the 2007 Citizen Petition, constituted “clear evidence” that the agency would not have permitted Aventis to change its label prior to 1992. The court was also persuaded by the fact that the FDA-approved changes to Clomid’s labeling consistently rejected the theories the patient relied upon with respect to the birth defect risks. The court determined that the FDA’s inaction with respect to changing the Clomid labeling, coupled with the denial of the 2007 Citizen Petition, was sufficiently persuasive to allow a conclusion that the patient’s claims were preempted by federal law because they sought to impose labeling requirements that the FDA would not have approved.

The case is No. 2:14-CV-00545.

Attorneys: Christopher L. Schnieders (Wagstaff & Cartmell, LLP) for Victoria Cerveny. Eric A. Swan (Shook, Hardy & Bacon LLP) and Gary T. Wight (Kipp & Christian PC) for Aventis, Inc.

Companies: Aventis, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews LabelingNews PrescriptionDrugNews PLDrugNews SafetyNews UtahNews

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