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.‎‎