A federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.
The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.
The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.
The plaintiff died in October 2008, and her personal representative filed the lawsuit on her behalf against Novartis Pharmaceuticals, which manufactures Aredia and Zometa. Her claims included strict liability, negligent manufacturing, and negligent failure to warn. The case was consolidated with other similar cases by the Judicial Panel on Multidistrict Litigation for pretrial matters, then returned to the Oregon court in late 2012.
The defendant moved for summary judgment on all of the plaintiff’s claims. The court’s decision primarily involved the question of proximate cause and alleged deficiencies in the warnings provided with the two drugs. The plaintiff must prove that the physician would not have prescribed the drug had the warnings been adequate, but the doctor’s testimony appeared to say otherwise. The plaintiff argued that the court should presume that a consumer would have heeded a manufacturer’s warning had it been adequate. This is sometimes known as a “heeding exemption.” The court did not find this persuasive, noting that the plaintiff had only cited an unpublished Ninth Circuit opinion applying Alaska law. It granted the defendant’s motion and dismissed the lawsuit.
The Maryland attorneys at Lebowitz & Mzhen can assist victims of pharmacy errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, contact us today online or at (800) 654-1949.
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Fosamax Plaintiff Receives $285,000 Verdict After Jury Trial, Pharmacy Error Injury Lawyer Blog, February 12, 2013
Pharmaceutical Company Allegedly Knew of Harmful Fosamax Side Effects as Far Back as 2004, According to Review of Internal Documents: In Re: Fosamax Products Liability Litigation, Pharmacy Error Injury Lawyer Blog, December 5, 2012
Fosamax Lawsuit in New York May Proceed, but With Limitations, Pharmacy Error Injury Lawyer Blog, September 8, 2011