Overwhelming Evidence Pharmaceutical Company Knew Drugs Caused ONJ Made Failure to Warn Claim Evidentiary Errors Harmless; Punitive Damages Upheld

A woman suffered from breast cancer, which metastasized to her bones. She began receiving infusions of Aredia. Aredia is a prescription drug manufactured by Novartis Pharmaceuticals Corporation that falls within a class of drugs known as bisphosphonates, which are commonly used to prevent the loss of bone mass. Five months later her doctor switched her to Zometa, another bisphosphonate marketed by Novartis. About 16 months after she started on Zometa, the woman developed osteonecrosis of the jaw (ONJ), a condition characterized by areas of dead jaw bone that become exposed to the oral cavity. The woman remained on Zometa for approximately three and a half years.


The woman sued Novartis alleging that Aredia and Zometa caused her ONJ and that Novartis failed to warn adequately either the woman or her prescribing physician of the ONJ risk associated with the drugs. The woman died. Her husband maintained the suit as the representative of her estate and individually.


After coordinated Multidistrict Litigation proceedings in the Middle District of Tennessee, the Judicial Panel on Multidistrict Litigation remanded this case to the Middle District of North Carolina for trial. Following a trial, a jury awarded compensatory damages and $12,600,000 in punitive damages to the husband as representative of the estate and damages for loss of consortium individually. Per North Carolina General Statute § 1D–25, the district court reduced the punitive damages award to $861,000. The total award, including pre-judgment interest, was $1,258,083.19.


Novartis filed a motion for judgment as a matter of law on punitive damages and a motion for a new trial. The United States District Court for the Middle District of North Carolina denied both motions.


The Fourth Circuit United States Court of Appeals affirmed holding, first, that the district court did not err in denying Novartis a new trial based on its admission of certain e-mails. The court reasoned that to the extent that the jury concluded that Novartis knew of the ONJ risks associated with bisphosphonates and that it failed to warn of those risks or intentionally concealed those risks, the e-mails at issue were not the sole cause. This conclusion was also supported by the trial testimony of another member of the expert panel that convened to discuss identification of risk factors for ONJ; to develop clinical guidelines for prevention, early diagnosis, management, and multidisciplinary treatment of ONJ in cancer patients; and to develop recommendations to reduce ONJ in cancer patients receiving bisphosphonates.


Similarly, the court held that the district court did not err in denying Novartis a new trial based on its limiting the testimony of Vice President of Regulatory Affairs at Novartis because any such error was harmless. Novartis's regulatory expert provided the testimony that Novartis maintained the Vice President of Regulatory Affairs could have provided.


The court held that the district court did not err in denying Novartis a new trial based on its refusal to admit deposition testimony that a member of the expert panel had provided in another Aredia and Zometa case to undermine the plaintiff’s claims. The deposition would have simply contradicted an argument that the plaintiff never pressed, that the member of the expert panel reported cases of ONJ to Novartis in April 2002. Similarly, the member of the expert panel’s testimony that he did not know Novartis attempted to prevent publication of his case series would have failed to contradict effectively the plaintiff's evidence that Novartis had indeed engaged in such conduct. One would not expect that Novartis would notify the member of the expert panel of its own suppression attempts. It is unsurprising that he was unaware of Novartis's actions, and evidence supporting this fact would not have advanced Novartis's defense.


The court held that the district court did not err in denying Novartis a new trial based on its admitting evidence of the Zometa’s 2007 label revision. Evidence of the revision was relevant to Novartis's awareness of the dangers of Zometa and to whether Zometa caused the woman's ONJ. Given that the plaintiff presented extensive evidence apart from the 2007 label change that supported both of these claims, the Fourth Circuit could not conclude that admission of the label change substantially swayed the jury's verdict.


The court held that the district court did not abuse its discretion in declining to give the punitive damages jury instructions Novartis requested. Due process does allow reference to and consideration of nonparty injuries as evidence of reprehensibility. Thus the Novartis-requested jury charge not to consider any harm inflicted on any nonparty or any conduct that occurred outside of North Carolina was improper. When the court admonished the jury to consider only evidence connected to reprehensibility and evidence of “actual damages suffered by the woman,” it sufficiently dealt with the risk that the Novartis-requested jury charge presumably sought to guard against, that the jury would award damages for harm suffered by strangers to the litigation.


The court affirmed the district court's denial of Novartis's post-trial motion for judgment as a matter of law on punitive damages. The court reasoned that the plaintiff presented evidence showing that Novartis's high-ranking officials knew about the drugs' side effects and subverted medical inquiries into such effects, which provided a sufficient foundation for the jury to determine that Novartis's actions were willful, not simply negligent.


With regard to causation, the court held that the plaintiff presented evidence sufficient to support a determination that Novartis's acts proximately caused her ONJ. The woman's deposition testimony, taken before her death and presented at trial, indicated that she would not have taken Aredia and Zometa if she had known the drugs' risks. Evidence presented at trial indicated that the woman stopped taking the drugs once she knew their hazards. Although the prescribing physician testified that she would have continued the woman's treatments even if she had known that ONJ was a possibility, the jury could have determined from other evidence that the prescribing physician would have modified various aspects of the woman's treatment had she been adequately warned of the drugs' perils.


The court also affirmed the district court's denial of Novartis's motion for judgment as a matter of law on a preemption theory. The Federal Food, Drug, and Cosmetic Act (FDCA) does not preempt state law claims against a drug company whose drug label complies with FDA regulations. Had Congress intended to preempt punitive damages recovery, it could have clearly indicated as much—just as it did when it addressed medical devices.


See: Fussman v. Novartis Pharmaceuticals Corp., 2013 WL 474330 (C.A.4 (N.C.), February 8, 2013) (not selected for publication in the Federal Reporter).