Man unsure of the safety of his medicine

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From Products Liability Law Daily, September 9, 2013

Patient lacked evidence establishing that insufficient warnings on drug labels proximately caused her ONJ injuries

By Anthony H. Nguyen, J.D.

An individual with osteonecrosis of the jaw (ONJ) was unable to provide evidence that her injury was proximately caused by inadequate warnings on drug labels and her claims were dismissed on summary judgment (Payne v Novartis Pharmaceuticals Corp., September 6, 2013, Collier, C). The individual alleged that if the drugs in question had adequate warnings, it would have altered her physician’s prescription course or directed the physician to recommend a dental examination earlier. The district court found instead that her physician would have prescribed the drug, regardless of knowledge of the warning, and, thus, could not support a finding of proximate causation.

Background. Charlotte Payne (Payne) alleged that the prescription drugs Aredia and Zometa, manufactured by Novartis Pharmaceuticals Corp. (Novartis) caused her to develop ONJ. Payne was diagnosed with breast cancer and underwent both surgical and radiation therapy procedures. Her cancer metastasized to her bones and to reduce the risk of fracturing her bones, Payne’s physician eventually prescribed Aredia and Zometa. The physician did not provide any warnings and he was unaware at the time that ONJ was linked to the drugs. Although her physician did not remember receiving a “Dear Doctor” letter from Novartis, he became aware of the connection by reading journals and medical literature. After numerous oral surgeries, Payne still suffered jaw problems and sued Novartis on strict products liability, based on various theories of fraud and misrepresentation, failure to warn, and merchantability. Novartis argued that Payne failed to demonstrate proximate causation between any alleged inadequate warning and her injury and that all her claims should be dismissed on those grounds.

Proximate cause. The Tennessee Products Liability Act (TLPA) controlled Payne’s products liability claims. Under the TPLA, a manufacturer or seller is liable if an injury to a person or property is caused by a product which is determined to have been in a defective or unreasonably dangerous condition at the time it left the control of the manufacturer or seller. Payne alleged that Novartis’ failure to issue warnings regarding the risk of ONJ supported both her strict liability claim and her explicit failure to warn claim.

The court noted that Tennessee had established a stiff standard in failure to warn cases, namely that Payne bore the burden of establishing that the drugs in question were in a defective condition or otherwise unreasonably dangerous by reason of Novartis’ failure to provide an adequate warning. Additionally, even if an inadequate warning was found to render Aredia and Zometa defective or unreasonably dangerous, Payne still needed to establish proximate causation between the failure to warn and her injury by demonstrating that an adequate warning would have altered her physician’s conduct. The same Tennessee law would permit Novartis to escape liability if it could show that additional warnings would not have changed the prescribing doctor’s actions.

In granting Novartis’ summary judgment motion, the court found that Payne’s physician would have prescribed the drugs in question regardless of Novartis’ warnings. Payne’s physician testified that he still prescribed Aredia and Zometa to his patients in spite of his knowledge of the risk of ONJ. Payne’s physician kept her on the drug until her bone scan demonstrated an uptake in her jaw; only then did the physician decide to discontinue treatment with Zometa. Thus, the court held that had Novartis warned Payne’s physician of the risk of ONJ prior to prescribing either drug, the evidence demonstrated he would have still prescribed the drugs.

Payne also argued that she would not have taken the drugs if she had been warned of the risk of ONJ. Payne alluded to her physician’s testimony that he now explained the relationship between the drugs in question and ONJ and recommended that patients receive a dental exam before taking the drugs to determine whether dental work was needed. However, the record did not indicate that a dental examination would have prevented her ONJ, nor did Payne obtain any evidence in the form of expert testimony suggesting that a dental examination would have made a difference in her outcome.

Therefore, the court held that Payne did not establish proximate causation between Novartis’ insufficient warnings and her injury.

Other claims. Payne alleged, as she did in her products liability claim, Novartis inadequately labeled its products. However, the court noted that the claim also required proof the inadequate labeling proximately caused Payne’s injury. Moreover, Payne’s allegations of fraud, misrepresentation, and suppression committed by Novartis when it was alleged to have concealed information about ONJ and its drugs, too, ignored proximate causation, which was required under Tennessee law. Therefore, based on its earlier rationale, the court held that because proximate causation had not been established and Novartis’ motion for summary judgment dismissing all of Payne’s other claims was granted.

The case number is 1:12-CV-77.

Attorneys: Annesley H DeGaris (Cory, Watson, Crowder and DeGaris), Clinton L Kelly (The Kelly Firm), Megan England (Berke, Berke & Berke), and Robert G Germany (Pittman, Germany, Roberts & Welsh, LLP) for Charlotte Payne. Buffy J. Mims (Hollingsworth LLP), Dwight E Tarwater (Paine, Tarwater, Bickers, LLP), and Edward S Sledge, III (McDowell, Knight, Roedder & Sledge LLC) for Novartis Pharmaceuticals Corp.

Companies: Novartis Pharmaceuticals Corp.

MainStory: TopStory WarningsNews DesignManufacturingNews DrugsNews TennesseeNews

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