In Aredia®/Zometa® litigation, Florida federal court limits plainitff's duty-to-warn case.



M.D. Fla. -- United States District Court for the Middle District of Florida

Complex Litigation


In a July 1, 2014 order, Middle District of Florida Judge Steven D. Merryday limited plaintiffs’ failure-to-warn case against Novartis Pharmaceuticals Corporation ("NPC") by holding in limine that NPC’s duty to warn of the risk of osteonecrosis of the jaw (“ONJ”) was only to the physicians who prescribed its drugs Aredia® and Zometa®, and did not extend to other treaters such as oral surgeons.  Arnold v. Novartis Pharm. Corp., 8:06-cv-1709-T-23MAP (M.D. Fla. July 1, 2014)

This case arose out of the Aredia®/Zometa® multidistrict litigation (“MDL”), which was remanded to the Middle District of Florida.  Plaintiff claims NPC did not adequately warn that Aredia® and Zometa® were associated with ONJ, and that Cathy Arnold developed the condition as a result of the purportedly deficient warning.  Notably, plaintiff claims that Ms. Arnold’s dental providers should have been warned of that risk in addition to her prescribing physician.  Judge Merryday ruled that the Florida learned intermediary doctrine limits the duty to warn to the prescribing physician alone, observing that “no authority is cited by Arnold (and none is available) to establish that ‘other healthcare providers’ are part of Florida’s present rule governing a pharmaceutical manufacturer’s duty to warn.”  Arnold Order at 4.  Further, Judge Merryday also ruled that any evidence “that [plaintiff] would not have taken Aredia®/pamidronate or Zometa® if she had been warned about any risk of ONJ” is irrelevant.  Id. at 3.  Judge Merryday also prohibited any evidence pertaining to punitive damages, in line with its recent ruling that punitive damages were not appropriate in Aredia®/Zometa® cases.  Id

These favorable rulings continue Novartis’s string of recent successes in the Aredia®/Zometa® litigation in Florida.  Earlier this summer, a Florida federal jury found that Novartis provided an adequate warning to plaintiff’s prescribing oncologist regarding the risk of ONJ.  Dopson-Trout v. Novartis Pharm. Corp., No. 8:06-cv-1708-T-24-EAJ (M.D. Fla. April 9, 2014).  The court had previously excluded punitive damages in that case, a ruling that has since been reaffirmed in another Aredia®/Zometa® case in Florida.  Dopson-Troutt v. Novartis Pharm. Corp., No. 8:06-cv-1708-T-24-EAJ (M.D. Fla. July 22, 2013); Kirchman v. Novartis Pharm. Corp., 8:06-cv-1787-T-24-TBM (M.D. Fla. June 16, 2014).

Novartis is represented in this matter by Firm partners Donald W. Fowler and Gregory S. Chernack.