Payne v. Novartis Pharm. Corp. – Failure-to-Warn Claim Will Proceed

The U.S. Court of Appeals for the Sixth Circuit ruled recently that a woman asserting a claim for failure to warn against a drug manufacturer may proceed with her lawsuit, finding a reasonable jury could conclude she would not have taken the drugs had she known the severity of the risks.

In Payne v. Novartis Pharm. Corp., the plaintiff was diagnosed with osteonecrosis, or jaw death, after years of taking the defendant’s drugs, Aredia and Zometa. Both drugs, given intravenously, are effective in preventing certain types of fractures and bone pain. Unfortunately, they also can cause serious damage to the jaw bone, a problem that came to light within the medical community in the early 2000s.

Our product liability attorneys know that in order to prevail on a failure to warn claim, a plaintiff must prove the defendant knew more than it told consumers, or failed to convey adequate information or instructions for the plaintiff to effectively weigh the risks of a dangerous product. Courts have stressed it is the plaintiff’s burden to show exactly how and why the product is defective.

In this case, the appellate court noted that other jurisdictions have reached the conclusion that the drug manufacturer, Novartis, knew of the risks that its drugs Aredia and Zometa posed to jawbones before the knowledge became widespread in the medical community. In some cases, evidence was presented showing high-ranking executives knew about the issue but specifically instructed the sales teams not to mention it when calling on physicians.

The plaintiff was diagnosed with breast cancer in 1999, and the disease had spread to her bones. This prompted her doctor to prescribe her Aredia. He did not know about the risk of the drug. In 2001, he switched her to Zometa. Again, the doctor did not know about the possible risks associated with the drug.

It wasn’t until 2005, when the doctor noted a problem with the plaintiff’s jaw, that he instructed her to see a dentist. He also stopped writing her prescriptions for Zometa, noting new data was emerging about the risk of osteonecrosis.

Plaintiff had to undergo extraction of several teeth but noted displeasure with the oral surgeon’s work and continued to feel pain in the area where the teeth were removed. The surgeon diagnosed her with osteonecrosis. As her condition progressed, a portion of her jaw had to be taken out in 2009.

The patient testified had she known the risk, she never would have agreed to take the drugs.

Her doctor said he still sometimes prescribes the drugs but warns patients of potential risks and insists they receive a dental exam before proceeding.

Plaintiff sued the manufacturer, asserting failure to provide adequate warning about the link between the medication and the jaw disease.

Once the case was transferred to a multi-district litigation court, summary judgment was granted to the defense on the sole basis that the company’s failure to warn was not the proximate cause of the patient’s condition. The primary question was whether knowledge of the risk would have prompted either the doctor or patient to act differently. The court dismissed the plaintiff’s assertion that she would have acted differently as “entirely speculative.”

The court of appeals reversed. The court noted that although the record is relatively sparse in this case, the issue of causation is one for a jury unless the facts make it so clear that all reasonable persons must agree on the outcome.

The Ferraro Law Firm handles medical malpractice claims as a result of defective medical products or dangerous pharmaceuticals. Call (888) 554-2030 for a free and confidential consultation. Offices in Miami and Washington, D.C.

Frequently Asked Questions: Mesothelioma & Asbestos