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Verdict upheld against Novartis for inadequate warnings about drugs

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A federal appeals court has upheld a $225,000 jury verdict against Novartis Pharmaceuticals Corp. in a case in which it was accused of inadequately warning about the dangers of two of its cancer-fighting drugs.

Separately, the New York attorney general accused East Hanover N.J.-based Novartis Pharmaceuticals Corp. of paying kickbacks to a New York-based pharmacy company to boost sales of iron-reduction drug Exjade.

Ruth Baldwin, who is now deceased, developed osteonecrosis of the jaw after two of her teeth were extracted, according to Thursday's ruling by the 8th U.S. Circuit Court of Appeals Christine Winter v. Novartis Pharmaceuticals Corp.. Ms. Winter was the executor of Ms. Baldwin's estate, as well as her daughter

Osteonecrosis is the death of bone cells due to decreased blood flow. It can lead to pain and the collapse of areas of bone, according to the Atlanta-based American College of Rheumatology.

Ms. Baldwin sued in U.S. District Court in Jefferson City, Mo., accusing Novartis of failing to provide adequate warnings for two Novartis drugs that she took, Acedia and Zometa. The drugs are prescribed to cancer patients, according to the U.S. Food and Drug Administration.

She alleged she developed osteonecrosis after two of her teeth were extracted because she had taken the drugs.

A Jefferson City, Mo., federal jury awarded her $225,000 in compensatory damages in 2012, plus certain costs, according to the ruling.

The woman's physician, Dr. James N. Hueser, first prescribed Aredia in July 2003 and Zometa in September that year. In upholding the jury verdict, a three-judge appeals court panel ruled unanimously Thursday that “Novartis knew the risk of (osteonecrosis) as early as 2002, but instructed its sales force not to mention the disease when making calls to physicians.”

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“The sales representative assigned to Dr. Hueser testified that he did not discuss the disease with Dr. Hueser until late September 2004. By then, Baldwin had been taking the drugs for 13 months, and (osteonecrosis) had been triggered by the extraction of two of her teeth,” according to the ruling.

In addition, a warning letter about osteonecrosis was not sent to Dr. Hueser until September 2004, after the condition had been triggered, the court said. “By that time, Baldwin's expert testified that (osteonecrosis) had become a 'growing epidemic.' On these facts, a reasonable jury could find that Novartis prevented warnings about (osteonecrosis) from reaching Dr. Hueser.”

The panel also held the District Court did not err in applying Missouri law to Ms. Baldwin's punitive damages claim and disagreed with Novartis that heresay evidence had tainted the jury.

It did rule, however, that the District Court abused its discretion in awarding litigationwide costs to an individual plaintiff, and remanded the case on that issue.

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