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From Health Law Daily, September 3, 2013

Court limits patient’s evidence in failure to warn case against drug manufacturer

By Sheila Lynch-Afryl, JD, MA

A patient who alleged the manufacturer of Zometa® failed to warn of the risk of suffering osteonecrosis (ONJ) of the jaw was permitted to introduce evidence that the manufacturer knew about a connection between Zometa and ONJ before she began taking the drug (Guenther v Novartis Pharmaceutical Corp., August 29, 2013, Presnell, G). After the patient filed her complaint, the manufacturer filed a motion in limine seeking to limit the evidence presented and arguments made by the patient at trial. The court denied the manufacturer’s motion in part but also granted it in part, as the patient failed to dispute certain arguments.

Background. Nancy Guenther was diagnosed with breast cancer in February 1999, and in October 2001, she discovered that the cancer had metastasized to her bones. In May 2002, she was prescribed Zometa, which is produced and marketed by Novartis Pharmaceutical Corp. (Novartis), to reduce the incidence of pathological fractures and other problems occurring in the bones of patients with certain types of cancer. After she began taking Zometa, Guenther began suffering from a number of dental problems, including ONJ of the jaw. In March 2008, she filed suit against Novartis alleging that Zometa caused her to suffer ONJ and that the company failed to provide proper warning of that risk. She asserted claims based on strict liability, negligent manufacturing, failure to warn, breach of express warranty, and breach of implied warranty, and her husband filed a claim for loss of consortium. Novartis filed a motion in limine on several evidentiary issues.

Notice. According to Novartis, the Zometa package insert was revised in September 2003 to include information about ONJ. Novartis sought to exclude a study and information about conditions known as “phossy jaw” and osteopetrosis, which suggested that Novartis knew or should have know about a connection between Zometa and ONJ before May 2002, when she began taking the drug. The court rejected Novartis’s argument, finding that the company offered nothing more than its own assertion about the relevance of the evidence.

FDA issues. Novartis anticipated that Guenther would argue that it should have added a “black box” warning; Novartis argued, however, that it was prohibited from doing so without FDA approval. It further argued that a number of Guenther’s expected arguments are preempted because they conflict with the FDA’s authority over the marketing of prescription drugs. The court concluded that the authority Novartis relied on in support of its preemption argument was inapposite, as it involved manufacturers of generic drugs. The court also rejected Novartis’s argument that Guenther should be barred from challenging the formatting of the Zometa label, since federal regulations impose no limitations on the format of such warnings. The court nevertheless prohibited Guenther from making the following arguments because she failed to dispute Novartis’s contentions: (1) that Novartis should have added a black box warning; and (2) that Novartis violated FDA regulations by withholding information from the agency.

Expanded scope. The court, adopting the position espoused by the Restatement (Third) of Torts, found that Guenther was permitted at trial to argue that the learned intermediary doctrine obligated Novartis to provide warnings to medical professionals other than prescribing physicians. However, it saw “no basis” for admitting evidence of promotional material that was not seen by the oncologist who initially prescribed the drug to Guenther.

The case number is 6:08-cv-456-Orl-31DAB.

Attorneys: Donald W. Fowler (Hollingsworth, LLP) for Novartis Pharmaceutical Corporation

Companies: Novartis Pharmaceutical Corp.

MainStory: TopStory CaseDecisions PLDrugNews DrugBiologicalNews LabelingNews PreemptionNews FloridaNews

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