Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

A United States District Court Judge, sitting in the Middle District of Florida, has rejected arguments by Novartis Pharmaceutical Corporation (“Novartis”) that federal law would prohibit claims that the company should have added “Black Box” warnings regarding potential side effects of Zometa, including potential bone loss.  As a result, plaintiffs will be allowed to proceed with their claims notwithstanding the company’s arguments (1) that all of the failure-to-warn claims were controlled by the Supreme Court’s 2009 decision in Wyeth vs. Levine; and (2) that the claims were also preempted based upon the more recent decisions in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) and Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  If sustained, this ruling may represent a significant exception to recent decisions which significantly curtailed failure-to-warn claims in our federal courts.  A copy of the opinion can be found here.

Plaintiff, Nancy Guenther, was diagnosed with breast cancer in February 1999.  In October 2001, her physician found that the cancer had metastasized to her bones.  In May 2002, Guenther’s oncologist prescribed Zometa in an effort to reduce the incidence of pathological fractures and other problems occurring in the bones of patients with certain types of cancer.  After taking Zometa, Guenther began to experience a series of dental problems including osteonecrosis of the jaw (“ONJ”), a condition in which a portion of the jaw bone essentially fails or dies.  In her lawsuit, Guenther claimed that use of Zometa caused her to suffer ONJ and that Novartis failed to provide an appropriate warning of this risk.  In its defense, Novartis claimed that the package insert for Zometa had been revised in 2003 to include information about ONJ.  Plaintiffs responded that Novartis knew or should have known about the connection between Zometa and ONJ prior to May 2002, when Guenther began taking the drug.

In the federal litigation, Novartis filed a motion in limine to preclude plaintiffs from arguing that it should have issued a “black box” warning to Zometa; that is, a bold letter statement appearing in a black box at the outset of the drug label with the heading or title “WARNING”.  Novartis argued that it was prohibited by law from doing so without prior approval of the United States Food and Drug Administration (FDA).  Plaintiffs argued, however, that the failure-to-warn claims were controlled by Wyeth vs. Levine, in which the United States Supreme Court granted certiorari to decide the issue of whether FDA labeling judgments preempted state law product liability claims based upon a theory that different labeling judgments were necessary in order to make drugs reasonably safe for use.  In Levine, the Supreme Court ultimately permitted state law “failure to warn” claims to proceed against brand-name manufacturers, and on this basis the Guenther decision rejected efforts by Novartis to preclude similar claims regarding Zometa.

Novartis, however, also contended that many of the arguments plaintiffs would present in Guenther were preempted because they would conflict with the FDA’s regulatory authority over the marketing of prescription drugs.  According to Judge Presnell’s decision in Guenther,  Novartis based its argument here on the Supreme Court’s recent decisions in Bartlett and PLIVA, Inc.  These rulings were distinguished, however, on the basis that they involved challenges to manufacturers of generic drugs, who did not have the ability to modify drug labels (prior to FDA approval) which had been extended to brand name manufacturers.

Judge Presnell’s decision was not a complete endorsement of the plaintiffs’ case, however.  Novartis contended that FDA regulations prevented a manufacturer from adding a “black box” warning without preapproval.  The plaintiffs in Guenther did not challenge this claim, and for that reason the District Court ruled that they would not be permitted to argue at trial that Novartis should have done so.  At the same time, Judge Presnell recognized that evidence bearing on the issue of potential black box warnings could be relevant to issues such as the types of warnings Novartis could have added without preapproval, and accordingly evidence regarding the same would not be deemed inadmissible per se.

The Guenther decision clearly reflects the areas of contested discovery, and potential state law liability, which remain viable notwithstanding the recent Supreme Court decisions in this field.  There can be little doubt that state and federal courts will continue to focus on similar theories as plaintiffs’ counsel continue their efforts to litigate beyond the limitations of the decisions in Levine, Bartlett and Pliva.

For pharmaceutical manufacturers, the past 5 years have seen major decisions from the Supreme Court and an emerging body of case law as our state and federal trial courts apply these rulings to an expanding field of litigation.  While it is probably too soon to identify emerging decision patterns, the decisions thus far clearly underscore the need for continuing “due diligence” by the manufacturers of both generic and brand name drugs in identifying potential side effects.  Moreover, despite the FDA’s prior statements regarding the risk of overwarning of theoretical hazards and diluting necessary warnings, this decision may force manufacturers to reexamine the scope of its warnings.

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