A Rock and a Hard Place: Court Rejects Drug Manufacturer’s Defense that Changes to the Label Required FDA Approval and Were Preempted

This week, a Florida federal court denied a drug manufacturer’s motion in limine to preclude a plaintiff’s alternative warning theory on the basis that any changes to the label required FDA approval and were preempted. Dopson-Trout v. Novartis Pharma. Corp., 2013 U.S. Dist. LEXIS 135834 (M.D.Fla. Sept. 23, 2013). During her treatment for breast cancer that had metastasized to her bones, the plaintiff was infused with Aredia and then Zometa. She then had her tooth extracted, after which she began experiencing jaw pain caused by osteonecrosis of the jaw (“ONJ”). In 2006, the plaintiff and her husband brought this action against Novartis, alleging that its manufacturing, labeling, marketing, selling, advertising, and distributing of Aredia and Zometa caused her injuries and that Novartis failed to adequately warn of the risk of ONJ.

Novartis moved in limine to preclude evidence or argument that it should have recommended a different dosage than the one approved by the FDA, or suggested stopping Zometa after a certain number of doses. Novartis argued that any changes to the FDA-approved dosing recommendations on the labels required prior FDA approval and are therefore preempted. The plaintiff argued that the FDA does not prohibit including safety information about dosing and cited to the changes-being-effected (“CBE”) regulation 21 CFR 314.70(c)(2)(iii) which allows a manufacturer to change the label “to add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.” The Court rejected Novartis’ argument that any change to the FDA-approved dosage language would constitute “major changes” requiring prior FDA approval under the rationale that the regulation defining “major changes” expressly excludes changes described in the CBE regulation.

The Court also rejected Novartis’s argument that the label changes regarding dosing would render Aredia and Zometa a new drug, requiring a new drug application and new clinical studies. While the newness of any drug may arise, among other reasons, from a newness of a dosage, the Court found that Novartis had failed to provide any evidence how the subject changes would be considered “newness of dosage”, as opposed to changes that strengthen an instruction about dosage, which do not require FDA-approval. In denying Novartis’ motion, the Court also reasoned that the manufacturer had failed to address the Supreme Court’s finding that manufacturers are presumptively able to make label changes about dosage without FDA approval under the CBE process absent clear evidence that the FDA would not have approved a change.

Drug manufacturers have had some cover since their labeling was approved by the FDA. Now, decisions such as this one enable plaintiffs to assert claims for failure to properly warn based on minor changes to labeling that may not require FDA approval. Should manufacturers now be seeking FDA approval of lesser changes to ensure preemption of these claims? How is the manufacturer supposed to make that judgment call? What is also not addressed in this decision is whether these claimed label changes, from a human factors perspective, really render the labeling inadequate. Also, the plaintiffs will ultimately have the burden to show that changes in the labels would have made a difference in this particular case. While Novartis may have lost the preemption battle at this point, it still has solid warnings defenses.

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