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From Products Liability Law Daily, September 19, 2013

Patient could pursue claim of inadequate warning of risk that bisphosphonate drug could cause ONJ

By John W. Scanlan, J.D.

A patient’s claim that she received an inadequate warning of the risk of using a bisphosphonate drug to treat the spread of her cancer was permitted to proceed to trial, but her claim that the drug was defectively designed or formulated was dismissed on summary judgment by a U.S. District Court for the Southern District of Ohio (Sheffer v. Novartis Pharmaceuticals Corp., September 18, 2013, Rice, W.). The court allowed the patient to pursue her claim of nonperformance with manufacturer’s representations because the manufacturer completely failed to address the factual allegations made in her amended complaint.

Background. In May 2005, Shirley Sheffer was prescribed Zometa, an intravenous nitrogenous bisphosphonate, after being diagnosed by Stage IV breast cancer that had metastasized to her bones. Zometa is commonly used to prevent bone pain, fractures, and skeletal complications in cancer patients. In 2006, she experienced tooth problems and had two teeth extracted on different occasions. A biopsy after the first extraction revealed necrotic tissue consistent with osteonecrosis of the jaw (ONJ). The site of each extraction later became infected, and in 2008 her jaw was broken near where the second tooth was extracted.

Sheffer brought various common law claims in the U.S. District Court for the District of Columbia against Novartis Pharmaceuticals, the manufacturer of Zometa, alleging that her use of Zometa caused her to develop ONJ. The case was consolidated for pretrial purposes as part of multi-district litigation involving Zometa, after which it was remanded to the DC district court, and then was transferred to the Southern District of Ohio. Novartis moved to exclude testimony from Sheffer’s expert witnesses on specific causation and also moved for summary judgment on her claims. The court ordered Sheffer to file an amended complaint reasserting her claims under the Ohio Products Liability Act (OPLA) because her common law claims were abrogated by OPLA. Her amended complaint contained claims for, inter alia, strict liability—design defect, negligence—inadequate warning, and nonconformance with manufacturer’s specifications.

Expert testimony—specific causation. Testimony by the patient’s treating physicians on whether Zometa caused her ONJ was excluded because none was an expert in diagnosing ONJ and none expressed an opinion about the cause of her ONJ based on a reliable methodology. Her oncologist, her general dentist, and an infectious diseases specialist could testify regarding her course of treatment, but each of them had admitted to having no expertise in ONJ and its causes. Her treating oral and maxillofacial surgeon, who diagnosed her with ONJ in 2006 and has treated her for it since then, stated that he was not an expert in causes of ONJ and was not sure what caused it in her case. Although his pathology report ruled out metastatic disease, he ruled out no other possible causes, and this differential etiology was not reliable enough for him to testify as to the cause of her ONJ, although he could testify about his diagnosis and treatment of her ONJ.

However, a board-certified oral pathologist and oral maxillofacial surgeon retained by the patient as an expert witness could testify as to his opinion that, to a reasonable degree of medical certainty, her use of the Zometa caused her ONJ. Although he admitted that the causal relationship between Zometa and ONJ as not yet been scientifically proven through controlled studies, he testified that there was a strong association between bisphosphonate drugs and ONJ, and the MDL court had found a genuine issue of material fact concerning general causation. The expert specifically ruled out many other possible causes, and the fact that he had not ruled out the patient’s use of Avastin or that she had metastasis to her jaw did not make his methodology unreliable.

Statute of limitations. The patient’s claims were not barred by Ohio’s two-year statute of limitations, even though she filed her claim more than two years after she learned that her ONJ was likely caused by the Zometa, because she filed her claim in the District of Columbia, which has a three-year statute of limitations. The manufacturer argued that the District Columbia had no connection to the suit and that the patient had engaged in forum shopping in that she filed there only because the statute of limitations had expired in Ohio. However, the order granting the manufacturer’s motion to transfer the case from the District of Columbia to the Southern District of Ohio specifically stated that Ohio’s statute of limitations applied to the suit due to the District of Columbia’s choice of law rules.

Defective design or formulation. The patient did not present evidence from which a reasonable jury could find that the foreseeable risks of Zometa’s design or formulation exceeded their benefits and did not present any evidence of the existence of a safer design that was equally effective. The patient’s own expert said that the benefits of bisphosphonate drugs outweighed the risks because “runaway cancer” was worse than ONJ, and her treating oncologist continued to prescribe Zometa to other patients because risks of not taking the drugs were significantly higher than the risks of taking them.

Inadequate warning. There were genuine issues of fact on the negligence—inadequate warning claim that precluded summary judgment. On the issue of breach of duty, the patient contended that although warnings of the risk of ONJ caused by the use of bisphosphonate drugs were given, the manufacturer did not adequately warn of the magnitude of the risk. Because the MDL court already found that there were genuine issues of material fact regarding the adequacy of the warnings in the first wave of the multidistrict litigation, and the court in this case determined that the inadequate warning issues in that wave were similar to those in this case, the court concluded that there was no reason to reach a different result here.

There also was a genuine issue of material fact as to whether an adequate warning proximately caused her injury. Her oncologist testified that if the patient had come to him in the same condition as she did in 2005, he would still recommend the use of Zometa. However, he also testified that it was his usual practice to discuss with his patients all of the most serious risks that can happen with the use of drugs, and based on his testimony, the court inferred that the higher the known risk of a particular side effect, the more likely he would have discussed it with the patient. The patient testified that he did not warn her of the risks of ONJ, and that if he had, she would have refused to take the drug. A reasonable jury could find that a stronger warning from the manufacturer would have resulted in his disclosure of the risk of ONJ to the patient and possibly in her refusal to take it. The court noted that the patient had refused the oncologist’s recommendation to undergo radiation treatment because of the risk of liver damage, showing that she had no qualms about rejecting her doctor’s recommendation after being informed of the risks.

Furthermore, there was a genuine issue of fact as to whether a different warning would have altered the course of her dental treatment. The manufacturer argued that the treating oral surgeon extracted the teeth despite the risks involved related to her taking of Zometa and, thus, the patient could not show that the lack of an adequate warning was the proximate cause of her injury. However, according to her expert pathologist/oral surgeon, the onset of her ONJ was not triggered by the removal of the teeth; therefore, regardless of whether different warnings would have resulted in different dental treatment, there was still an issue of fact regarding whether lack of an adequate warning contributed to her use of Zometa and whether her use of Zometa proximately caused her ONJ.

The case number is 3:12-cv-238.

Attorneys: Charles Franklin Shane (Bieser, Greer & Landis) for Shirley E. Sheffer. Gregory S Chernack and Katharine R. Latimer (Hollingsworth LLP) and Rex A. Littrell (Ulmer & Berne) for Novartis Pharmaceuticals Corporation.

Companies: Novartis Pharmaceuticals Corporation

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