Charolette Payne v. Novartis Pharm. Corp., 767 F.3d 526

Charolette Payne received Novartis’s bisphosphonate drugs Aredia (1999) and Zometa (2001) for metastatic breast cancer; she later developed osteonecrosis of the jaw (ONJ) and underwent partial jaw resection in 2009.
Payne sued Novartis for failure to warn that Aredia/Zometa could cause ONJ; consolidated in MDL and remanded to district court, which granted summary judgment for Novartis on proximate-cause grounds.
Dr. Darrell Johnson (Payne’s oncologist) testified he was unaware of the ONJ risk when prescribing but now warns patients of ONJ and recommends pre-treatment dental exams.
Payne submitted an affidavit stating she would not have taken the drugs if she had been warned of ONJ.
The district court characterized Payne’s affidavit as speculative and concluded Novartis’s failure to warn was not a proximate cause under Tennessee’s learned intermediary doctrine.
The Sixth Circuit reversed, holding that Payne’s and her doctor’s testimony create genuine issues of fact for a jury on causation.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Novartis’s failure to warn was a proximate cause of Payne’s ONJ	Novant(is) would have warned Dr. Johnson; Dr. Johnson would have warned Payne; Payne would have refused the drugs and avoided ONJ	District court: Payne’s affidavit that she would have refused is speculative; no causal link proven	Reversed — jury question: combined affidavit and doctor testimony can establish causal link under Tennessee law
Proper application of the learned intermediary doctrine in causation analysis	Plaintiff: doctrine does not bar patient testimony that she would have refused treatment upon adequate warning	Novartis: doctrine shifts causation inquiry to physician actions; plaintiff’s counterfactual choice is insufficient	Court: Tennessee allows patient testimony on what she would have done; doctrine does not foreclose submission to jury

Haynes v. Hamilton Cnty., 883 S.W.2d 606 (Tenn. 1994) (causation is ordinarily a jury question unless facts make outcome clear)
Hale v. Ostrow, 166 S.W.3d 713 (Tenn. 2005) (plaintiff must show defendant’s omission was a substantial factor in causing harm)
Pittman v. Upjohn Co., 890 S.W.2d 425 (Tenn. 1994) (drug manufacturers’ duty to warn; context for learned intermediary doctrine)
Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119 (Tenn. 1999) (patient’s testimony about what she would have done upon full disclosure is admissible on causation)
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (U.S. 1986) (summary judgment standard; credibility and inference issues for jury)
Celotex Corp. v. Catrett, 477 U.S. 317 (U.S. 1986) (movant’s burden on summary judgment)