Novartis Failed to Warn About Aredia, Zometa's ONJ Risks: 8th Cir.

By Aditi Mukherji, JD on January 10, 2014 | Last updated on March 21, 2019

There are few pains in life that top dental procedures. Seeking refuge in a cocktail of prescription pills feels like the only way to cope with the unrelenting agony radiating from your face, to keep from silently sobbing in some dark corner.

Plaintiff Ruth Baldwin wished she had known a little bit more about those pills she was popping -- and more importantly, the dangers that come with their use -- before ingesting two bone drugs, Aredia and Zometa, after her dental procedures.

Osteonecrosis of the Jaw

Baldwin developed osteonecrosis of the jaw (ONJ) -- commonly called "jaw death" -- after two of her teeth were extracted. ONJ occurs when the jaw bone is exposed and begins to starve from a lack of blood; it develops from the use of biphosphonates and occurs most often after dental extractions. Feeling phantom pangs of pain, eh?

Baldwin sued Novartis Pharmaceuticals Corporation, alleging the manufacturer negligently failed to provide adequate warnings about the risk of ONJ from taking Aredia and Zometa. After a jury trial, Baldwin, by her executor, received $225,000 in compensatory damages, plus certain costs.

Novartis appealed. Among its claims, Novartis argued that the district court improperly found that inadequate warnings proximately caused Baldwin's injuries.

Jury's Finding of Negligence was Reasonable

A three-member panel of the Eighth Circuit determined that the evidence was sufficient to support the jury's verdict that Baldwin's injuries were the "natural and probable consequence" of Novartis' negligent failure to provide adequate warnings for Aredia and Zometa.

The decision is interesting as Baldwin's doctor openly testified that he does not read drug warnings. According to the panel, that doesn't really matter. Relying on In re Levaquin Prods. Liab. Litig., the panel explained that failure to read a warning does not necessarily bar recovery; instead, greater attention must be paid to the manufacturer's efforts to warn medical professionals and their patients.

Attention also turned to the doctor's actions. Once Baldwin's doctor learned of the ONJ risks associated with these drugs, he stopped prescribing them. That change in prescribing patterns also carries evidentiary weight; citing Levaquin, a reasonable jury could conclude that Baldwin's doctor would not have prescribed her Aredia and Zometa if he had been adequately warned by Novartis of the ONJ, the panel ruled.

Deposition Costs Were Unreasonable

The only area where the appeals panel sided with Novartis was the lower court's award of deposition costs. On appeal, Novartis claimed the lower court abused its discretion in awarding litigation-wide costs to individual plaintiffs for depositions conducted as part of multi-district litigation.

The appeals panel agreed and determined that where litigation costs are incurred in connection with more than one proceeding, the court should allocate the costs. As a result, the lower court abused its discretion in awarding the entire amount of these costs in Baldwin's case.

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