Novartis’ PLIVA-Bartlett Argument Rejected on the Eve of ZometaTrial

In a clever move, Novartis sought to use the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc. v Bartlett, to exclude evidence that it could have strengthened the labeling of its bone-cancer drug, Zometa, in a products liability suit slated to start on Monday in a Florida federal court.  The court rejected Novartis’ motion in limine, ruling that those Supreme Court decisions provided a preemption defense to generic manufacturers only.


The 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 and in May, 2002, she was prescribed Zometa by her oncologist.  Zometa was approved for reducing the incidence of pathological fractures and associated problems occurring in the bones of patients with certain types of cancer.  After she began taking Zometa, the plaintiff began to suffer a number of dental problems, including osteonecrosis of the jaw (“ONJ”), a condition in which a portion of the jaw essentially dies.  On March 28, 2008, the plaintiff filed suit against Novartis, alleging that Zometa had caused her to suffer ONJ, and that Novartis failed, inter alia, to provide a proper warning of that risk.

Anticipating that the plaintiff would argue that it should have added a “black box” warning to Zometa’s label, Novartis argued in its motion that it was prohibited by law from doing so without prior FDA approval, and that the plaintiff had no evidence that the FDA would have granted Novartis’ request for a black box warning even if it had made one.  In support of its position, Novartis quoted the FDA, stating that “to ensure the significance of boxed warnings in drug labeling, they are permitted only when specifically required by the FDA.” 44 Fed. Reg. 37434, 37448 (June 26, 1979).  In response, the plaintiff argued that the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009) was controlling and that preemption did not apply in this case.

In agreeing with the plaintiff, the court noted that in Levine the Supreme Court found that the FDA’s “changes in being effected” (“CBE”) regulation permitted manufacturers to make pre-approval changes to “add or strengthen a contraindication, warning, precaution or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.”  Levine, at 568.  The court further noted that drug manufacturers, rather than the FDA, remain primarily responsible for drug labels and that absent clear evidence that the FDA would not have approved a labeling change, it would not be impossible for a manufacturer to comply with both federal and state law, thereby defeating a preemption defense.  In rejecting Novartis’ argument that the Supreme Court’s post-Levine decisions in PLIVA and Bartlett have effectively displaced Levine, the court ruled that those decisions were “inapposite” because they involved generic manufacturers, which do not possess the ability to alter drug labels through the CBE regulation or otherwise: “the Court notes that Novartis is unable to point to any authority  — case law, treatise, or otherwise — suggesting that Bartlett altered the legal landscape in regard to failure-to-warn claims against manufacturers of name-brand prescription drugs.”


Although a reader might conclude that Novartis’ motion in limine  and argument that it could avail itself of the PLIVA-Bartlett rationale was a dead letter, given the seemingly unmistakable clarity that PLIVA-Bartlett offered a preemption defense to generic manufacturers only, in an ironic twist, the Florida district court effectively granted the motion because the plaintiff never directly disputed Novartis’s contention that the FDA regulations precluded a manufacturer from adding a black box warning without preapproval.  In our July post, Fallout From Mensing/Bartlett: FDA Proposes Leveling the Labeling Playing Field Between Brandeds and Generics, we reported that “the FDA plans to issue a rule this September that would allow generic drug makers to change their labeling based on new information. If approved and implemented, the new rule would effectively overrule the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, enabling the plaintiffs’ mass tort bar to go after generic drug manufacturers for personal injuries caused by their products.”  If the the FDA follows through sometime soon on issuing such a rule, it may be that the last litigant to ever argue the PLIVA-Bartlett preemption defense (somewhat successfully) in a products liability suit will be a brand manufacturer.  Now, that is what you call real irony.


About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

Speak Your Mind