Novartis Wins Again
September 6, 2013
Three weeks before a scheduled trial, the U.S. District Court for the Eastern District of Tennessee granted summary judgment for Novartis Pharmaceuticals in Payne v. Novartis Pharm. Corp., No. 1:12-CV-77 (E.D. Tenn. Sept. 6, 2013). Senior Judge Curtis L. Collier found that the evidence shows that the prescribing physician “would have prescribed these drugs to Mrs. Payne regardless of Novartis’s warnings,” order at 19, and held that plaintiffs had failed to prove that any allegedly inadequate warning was the proximate cause of plaintiffs’ alleged injuries.
Plaintiffs Charlotte and Brent Payne alleged that Mrs. Payne developed osteonecrosis of the jaw (“ONJ”) as a result of her use of the bisphosphonate medications, Aredia and Zometa, which “have been quite successful at preventing or minimizing bone condition caused by metastasized cancer and reducing the risk of bone fracture.” Order at 2. Mrs. Payne was prescribed Aredia in 1999 and Zometa in 2002, and continued to take Zometa until her oncologist suspended her treatment in October 2005 for a dental evaluation.
Ruling on a long-pending summary judgment motion, the court held that “Plaintiffs fail[ed] to establish proximate causation between Novartis’s insufficient warnings and Mrs. Payne’s injury,” order at 20, finding that Mrs. Payne’s oncologist would have prescribed Aredia and Zometa to Mrs. Payne even if warned of ONJ. The court rejected plaintiffs’ argument that Mrs. Payne would not have taken Aredia and Zometa if warned about ONJ because the relevant question under Tennessee law is whether the prescribing physician’s decision would have changed. The court “need not speculate whether” Mrs. Payne’s oncologist would have prescribed Aredia and Zometa to Mrs. Payne even if warned of ONJ because he continues to prescribe bisphosphonates to this day and he continued Mrs. Payne’s treatment after learning of the possible association with ONJ. Order at 14.
Although plaintiffs argued that Mrs. Payne’s oncologist now informs his patients about the risk of ONJ and advises them to get a pre-treatment dental examination, the court found that “plaintiffs offered no evidence to demonstrate that a pretreatment dental exam would have prevented the onset of ONJ.” Order at 16. Plaintiffs could not overcome the testimony of their own expert, Dr. Richard Kraut, who opined that Mrs. Payne’s injury was spontaneous, meaning that it was not associated with dental trauma. Even if plaintiffs could show that the extractions did precipitate her injury, the court found that a dental exam prior to treatment would not have prevented her injury because “no evidence suggests these teeth would have been removed” prior to her prescription. Order at 17. Further, Mrs. Payne’s 2005 extractions were undertaken with knowledge of the risk of ONJ. The court concluded this case was indistinguishable from previous cases granting summary judgment to Novartis where “plaintiffs could not demonstrate the prescribing doctor’s new procedures would have prevented their ONJ.” Order at 19.