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From Products Liability Law Daily, January 10, 2014

Drug maker failed to warn of ONJ risk; punitive damage law application ok’d

By Melissa Skinner, J.D.

A drug company’s failure to provide adequate warnings about its product’s tendency to cause osteonecrosis of the jaw (ONJ) was the proximate cause of a patient’s injury, namely the development of ONJ, the Eighth Circuit ruled, confirming a decision by a federal district court in Missouri. The court also confirmed that the lower court correctly applied Missouri law, which allowed for the showing of a punitive damages claim at the trial level. The appeal, filed by the patient’s estate, was only granted to the extent costs were incorrectly awarded (Winter v. Novartis Pharmaceuticals Corp., January 9, 2014, Benton, D).

Background. Ruth Baldwin had two teeth extracted while taking Aredia and Zometa, and developed ONJ allegedly as a result of taking the drugs. Baldwin’s executor sued Novartis Pharmaceutical Corporation (Novartis) alleging it failed to warn about the dangerous effects of its drugs, Aredia and Zometa. Following a jury trial, Baldwin’s executor was awarded $225,000 in compensatory damages. Novartis appealed claiming the lower court (1) incorrectly found that the failure to warn was a proximate cause of Baldwin’s injuries; (2) improperly applied Missouri law to establish a punitive damages claim; (3) erred in admitting hearsay evidence; and (4) improperly awarded costs to Baldwin’s estate for depositions conducted as a part of multi-district litigation.

Proximate cause. Novartis argued that based on the fact that Baldwin’s doctor testified that he did not read the package inserts when he prescribed one of the drugs to Baldwin in July of 2003, the inadequate warning could not have proximately caused Baldwin’s injuries. However, the Eighth Circuit did not believe that this fact severed the existence of proximate cause ties between the failure of Novartis to provide those package insert warnings until September 2003 and Baldwin’s ONJ. Moreover, in confirming the district court’s judgment, the court relied on Novartis’ failure to warn the physician in other manners, through the sales representative or letters, when Novartis first learned of the potential dangers in 2002. The court also determined that due to the doctor’s later termination of the prescription of those drugs after he was made aware of its effects with regard to ONJ, Novartis’ argument that Baldwin’s doctor would have proceeded with the prescription even with knowledge of the ONJ connection fails.

Punitive damages. Novartis also claimed that the district court inappropriately applied Missouri law, which provides for a claim of punitive damages in this matter. Although the judgment against Novartis did not include punitive damages, Novartis argued that the inclusion of the punitive count improperly tainted the compensatory award by the jury. The court confirmed the district court’s finding that Missouri law was properly applied because Missouri was the place the injury occurred and was where the sales representative who failed to warn the prescribing doctor was located.

Other issues. While the decision by the Eighth Circuit acknowledged the trial court’s error in admitting hearsay evidence, it nonetheless confirmed the trial verdict because the error did not prejudice the jury’s decision insofar that it warranted a new trial. However, the Eighth Circuit granted the drug company’s appeal to the extent the trial court awarded litigation-wide costs to an individual plaintiff in case that was a part of multi-district litigation. Specifically, the court found that the award to Baldwin’s executor of $88,930.25 for 18 depositions that were used throughout the multi-district litigation, which was a result of the consolidation of over 650, was incorrect and that the district court was obligated to allocate costs in such situations.

The case number is 12-3121.

Attorneys: John Joseph Beins (Beins & Goldberg) and Roger G. Brown (Roger G. Brown & Associates) for Christine Winter. Gregory S. Chernack (Hollingsworth LLP) and Deirdre C. Gallagher (Foley & Mansfield) for Novartis Pharmaceuticals Corp.

Companies: Novartis Pharmaceuticals Corp.

MainStory: TopStory CourtDecisions WarningsNews DamagesNews ExpertEvidenceNews EvidentiaryNews DrugsNews ArkansasNews IowaNews MinnesotaNews MissouriNews NebraskaNews

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