Arizona Federal Court Determines Novartis Warnings Adequate and Grants Summary Judgment

July 2, 2013

The U.S. District Court for the District of Arizona granted Novartis Pharmaceuticals Corporation’s (“NPC”) motion for summary judgment based on adequacy of warnings and lack of proximate (or “warnings”) causation in D’Agnese v. Novartis Pharm. Corp.,952 F. Supp.2d 880 (D. Ariz. 2013), and dismissed all of plaintiffs’ claims against NPC.

Plaintiff John D’Agnese alleged that he developed osteonecrosis of the jaw (“ONJ”) as a result of his use of the bisphosphonate medications, Aredia and Zometa, which his oncologists had prescribed to prevent the debilitating bone destruction and pain caused by his multiple myeloma.  Mr. D’Agnese began receiving Aredia in 1996 because of “the known incidence of increased bone events in patients who are not taking Aredia® with multiple myeloma.”  Order at 9.  He was switched to Zometa in June 2002 and continued to use the medication until November 2005.  In 2005, Mr. D’Agnese’s oncologist informed him of the risk of ONJ, advised him to see his dentist, and presented him with a written informed consent form disclosing that ONJ was a potential risk of continuing Zometa therapy.  Mr. D’Agnese signed the form and later “made it clear that he wanted to continue receiving Zometa® therapy despite being informed of the risk of ONJ multiple times over the preceding months.”  Order at 11.  Even after Mr. D’Agnese was diagnosed with alleged ONJ, his oncologist, in 2010, “encouraged Mr. D’Agnese to restart Zometa® at the same dosage and frequency that he was on previously” due to his recurrent bone pain and mobility impairments after his spine had again started collapsing on itself.  Order at 12.

NPC argued that the plaintiffs failed to prove that the warnings for Aredia and Zometa were inadequate at any time and that, even if the warnings were inadequate, any such inadequacy was not the proximate cause of Mr. D’Agnese’s alleged ONJ.  The court granted NPC’s motion, holding that plaintiffs failed to establish that the warnings accompanying Aredia were inadequate when Mr. D’Agnese first received the medication in 1996.  The court rejected plaintiff’s contentions that a 1983 study in which rats exposed to a different bisphosphonate medication developed devitalized bone protruding in the oral cavity should have put NPC on notice of the risk of ONJ.  The court also rejected plaintiffs’ argument that NPC’s retrospective identification of six possible cases of ONJ in clinical trials should have likewise notified NPC of the risk of ONJ.  The court concluded that ONJ was not a “knowable risk of using Aredia® in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution” prior to NPC adding an ONJ warning to its label in 2003.  Order at 16-17 (reasoning that it is “clear that claims based on inadequate warnings cannot be based on the information now available regarding connections between ONJ and bisphosphonates, but rather must be based on what was knowable at the time a warning should have allegedly been given”).

The court then turned to plaintiff’s failure to prove that a different or more “adequate” warning would have prevented Mr. D’Agnese from receiving the drugs or developing ONJ.  The court held that “Plaintiffs’ claims also fail because Plaintiffs have offered no evidence that warnings to [Mr. D’Agnese’s oncologist at the time] would have changed his decision to prescribe Aredia® to Mr. D’Agnese in 1996.”  Order at 17.  The court rejected application of Arizona’s heeding presumption because NPC had presented sufficient evidence to overcome the presumption given (1) Mr. D’Agnese’s history of requesting Zometa after being warned of the potential risk of ONJ, (2) his oncologist’s recommendation to restart Zometa after Mr. D’Agnese had been diagnosed with alleged ONJ, and (3) his oncologist’s decision to continue prescribing Zometa long after Mr. D’Agnese’s alleged ONJ diagnosis. This is the first summary judgment victory on warnings causation against plaintiffs’ counsel John Vecchione who, until now, has been arguing that he personally never loses summary judgment on proximate cause in courts throughout the country.

Finally, the court also rejected plaintiffs’ counsel’s usual tactic of trying to “incorporate by reference” multiple documents filed in the MDL and other courts that were never even part of the record in this case in an attempt to give the impression of some mountain of non-existent “evidence” that might have saved his case.  Order at 5 (“This is completely unacceptable and has served no other purpose than to needlessly complicate the Court’s ability to rule on the motions pending before it.”).