Court Reduces Fine Over Inadequate Label Alerts

(CN) - A 76-year-old man whose Achilles tendons ruptured or tore while he was taking the antibiotic Levaquin did not deserve punitive damages, the 8th Circuit ruled.

After taking Levaquin and a corticosteroid in 2005, John Schedin suffered a rupture of his left Achilles tendon and a partial tear of the right Achilles tendon.

Ortho-McNeil-Janssen Pharmaceuticals (OMJP) had appealed to the St. Louis, Mo.-based federal appeals court after a federal jury in Minneapolis found that it had failed to provide adequate warnings about the risks associated with Levaquin.

The jury awarded Schedin more than $1.7 million, but the 8th Circuit shaved off the punitive damages Friday, leaving him with just $630,000 in compensatory damages.

"As a matter of law, the record evidence failed to establish OMJP deliberately disregarded the risk of tendon injuries in elderly patients taking corticosteroids, as required for punitive damages under Minnesota law," according to the opinion authored by Chief Judge William Riley. "By warning of that risk in its package insert, OMJP 'actively sought ways to prevent the dangers associated with its product.'"

Judge Kermit Bye defended the award of punitive damages in a partial dissent, saying "the evidence was more than sufficient to allow a reasonable jury to infer that OMJP deliberately acted with indifference to a high degree of probability of injury."

OMJP knew of the potential for higher tendon toxicity when prescribing Levaquin to elderly patients in conjunction with corticosteroids, yet it deliberately ensured that "physicians would not be adequately apprised of the increased risk," Bye wrote.

"By reversing the punitive damages award we encourage other pharmaceutical companies to make the same devious choices OMJP made, instead of affirming the jury's decision to deter such conduct," he wrote.

The panel was unanimous in rejecting Ortho-McNeil-Janssen's bid for a new trial.

"The District Court did not abuse its discretion in deciding it was not against the preponderance of the evidence or a miscarriage of justice under Minnesota law for the jury to find OMJP had reason to know it needed to do more to inform physicians of the 2001 warning, such as sending 'Dear Doctor' letters or directing sales representatives to warn physicians directly," Riley wrote.

OMJP had claimed that its warning label was sufficient enough to alert physicians to the risk of tendon rupture, but the panel noted that "the Levaquin package insert consisted of over fifteen pages of small print information about the drug, including its proper use and possible side effects. The tendon warning appears in the last of the ten paragraphs in the 'Warnings' section."

Noting that the Food and Drug Administration had said in 2008 that it found a high number of tendon injuries among Levaquin users, the court said jurors "could infer that at least some of the reports were made between 2001 and Schedin's 2005 prescription and injury."

"OMJP had access to these adverse event reports," Riley wrote. "From this evidence, a reasonable jury could find OMJP should have realized the adverse event reports indicated physicians were unaware of the 2001 warning."

The drugmaker said Schedin failed to prove causation because his doctor spent little to no time with sales representatives, but the panel disagreed.

Schedin's physician, Dr. John Beecher, testified that "he relies on sales representatives 'only minimally' and tries 'very hard to be objective,'" the court noted.

"This reasonably can be interpreted as meaning Dr. Beecher did not rely heavily on sales representatives' promotional efforts - not that he would have ignored a warning - especially because Dr. Beecher said he would have appreciated having more knowledge about this particular side effect," Riley wrote.

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