Pennsylvania federal court grants complete summary judgment in one Aredia®/Zometa® case and partial summary judgment in two others.



W.D. Pa. -- United States District Court for the Western District of Pennsylvania

Pharmaceutical Products


On July 28, 2014, Judge Mark R. Hornak of the U.S. District Court for the Western District of Pennsylvania granted summary judgment in favor of Novartis Pharmaceuticals Corporation (“Novartis”) in three cases alleging that plaintiffs’ treatment with Novartis’s drug Zometa® caused osteonecrosis of the jaw (“ONJ”).  Rowland v. Novartis Pharm. Corp., No. 2:12-cv-01474, slip op. (July 28, 2014) (granting complete summary judgment in Machen and partial summary judgment in Orr and Rowland).  The order disposes of the non-negligence claims in all three cases, and dismisses the Machen case in its entirety for lack of proximate causation.

Machen, Orr, and Rowland are three of a number of cases that were remanded out of the multidistrict litigation captioned In re Aredia and Zometa Pharmaceutical Products Liability Litigation that is currently pending before the U.S. District Court for the Middle District of Tennessee.  In all three cases, the plaintiffs were treated with Novartis’s drug Zometa® to prevent the serious and possibly life-threatening complications of their metastatic cancer.  All three plaintiffs claimed that Novartis did not adequately warn that Zometa® was associated with osteonecrosis of the jaw (“ONJ”), and that they developed the condition as a result of the purportedly deficient warning.  Novartis has obtained dismissals of over 297 cases in the Aredia®/Zometa® federal and state consolidated litigation, including 66 wins on summary judgment.

Judge Hornak’s order disposed of all the non-negligence claims (sounding in strict liability and warranty) in all three cases.  Judge Hornak held that “products liability claims may not be brought against a pharmaceutical drug company in strict liability” under Pennsylvania law, Order at 15, citing Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996), and that “[c]ourts have interpreted Hahn broadly to bar all non-negligence claims asserted against a manufacturer of prescription drugs,” id. at 16.

Judge Hornak’s order also disposed of the Machen case in its entirety, holding that “Pennsylvania case law requires a plaintiff to show that with a different warning, the prescribing doctor would have changed his prescribing practices, and the plaintiff’s injury would have been avoided.”  Order at 29 (emphasis added).  Judge Hornak found that Mr. Machen failed to demonstrate how he would have avoided injury if his prescribing physician had discussed the risk of ONJ with him, or asked him to undergo a pre-treatment dental examination.  Id

Notably, Judge Hornak analyzed the adequacy of the Zometa® warnings in the context of plaintiffs’ prescribing physicians only, holding there was “no basis for the Court to conclude that Pennsylvania law, in its current state, extends a manufacturer’s duty to warn beyond the doctor who prescribed the drug to the plaintiff.”  Order at 19.  The court also rejected the application of a heeding presumption to these cases under Pennsylvania law.  Id. at n. 10.

The Machen, Orr, and Rowland decisions are just the latest of hundreds of resolutions favorable to the Company related to plaintiffs’ claims regarding osteonecrosis of the jaw (ONJ) after treatment with Zometa® (zoledronic acid) injection and/or Aredia® (pamidronate disodium), which include more than 300 dismissals, summary judgments, and trial wins in the Company’s favor – most recently the jury’s complete defense verdicts in trials in May and April in Earp v. Novartis (Raleigh, E.D.N.C.) and Dopson-Troutt v. Novartis (Tampa M.D.Fla.).  The Company remains committed to defending the litigation on the merits.

Novartis is represented in these matters by Firm partner Neil S. Bromberg.