D'Agnese v. Novartis Pharmaceuticals Corp., 952 F. Supp. 2d 880

Plaintiff John D’Agnese, treated for multiple myeloma, received Aredia® (1996–2002) and Zometa® (2002–2005) and was diagnosed with bisphosphonate‑related osteonecrosis of the jaw (ONJ) in 2005.
Plaintiffs allege Novartis failed to warn that Aredia®/Zometa® cause ONJ and assert strict liability, negligence (manufacture and failure‑to‑warn), breach of express and implied warranty, and loss of consortium.
Novartis added ONJ language to labeling beginning in September 2003 and issued a Dear Doctor letter in September 2004; Zometa® labeling was further revised in February and September 2004 advising dental precautions and avoiding invasive dental procedures when possible.
Mr. D’Agnese’s treating oncologist, Dr. Olshan, documented discussing ONJ with Mr. D’Agnese and obtained a written informed‑consent form in March 2005 disclosing ONJ; Mr. D’Agnese signed and elected to continue therapy.
Novartis moved for summary judgment on inadequate‑warning and related claims; the court declined to consider Plaintiffs’ attempt to incorporate voluminous out‑of‑record MDL materials by reference.
The court granted Novartis summary judgment on Counts I–V and VI (strict liability, negligent manufacture, negligent failure‑to‑warn, breach of express and implied warranty, and loss of consortium), and denied as moot two other motions.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Were Novartis’s warnings inadequate (strict liability and negligence failure‑to‑warn)?	Novartis knew or should have known ONJ risk earlier (e.g., animal study, alleged trial cases) so warnings were inadequate.	Warnings were first added in 2003 when association became known; earlier knowledge was not established and labeling reasonably tracked science.	Court: No genuine dispute; warnings not inadequate as a matter of law based on record.
Did inadequate warnings proximately cause D’Agnese’s ONJ?	Heeding presumption: adequate warnings would have prevented injury (or altered prescribing).	Learned‑intermediary and evidence rebut heeding presumption: treating physicians were aware of risk and continued prescribing; patient signed informed consent and accepted risk.	Court: Novartis rebutted heeding presumption; Plaintiffs failed to show stronger warnings would have changed physician’s or patient’s conduct—no proximate cause.
Breach of express warranty claim (Count IV)	Plaintiffs allege warranties from Novartis.	No evidence Novartis made any express affirmation to D’Agnese or that any representation formed the basis of the bargain.	Court: Summary judgment for Novartis—Plaintiffs produced no evidence of express warranty.
Loss of consortium (Count VI)	Derivative of underlying torts.	Underlying tort claims fail.	Court: Derivative claim fails; summary judgment for Novartis.

Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden allocation)
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (nonmovant must present specific facts to create genuine issue)
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (standard for genuine dispute at summary judgment)
Motus v. Pfizer, Inc., 358 F.3d 659 (learned intermediary; insufficient warnings survive summary judgment only if physician’s conduct would change)
Golonka v. General Motors Corp., 204 Ariz. 575, 65 P.3d 956 (heeding presumption in strict liability information‑defect cases)
Powers v. Taser Int’l, Inc., 217 Ariz. 398, 174 P.3d 777 (difference between negligence and strict‑liability failure‑to‑warn standards)
Gebhardt v. Mentor Corp., 191 F.R.D. 180 (Arizona products‑liability elements and learned intermediary application)
Piper v. Bear Med. Sys., Inc., 180 Ariz. 170, 883 P.2d 407 (learned intermediary doctrine)