Levaquin Damages Reduced on Appeal, As Settlements Reached in Cases

A federal appeals court has upheld a compensatory damages award in the first Levaquin bellwether trial, but has thrown out $1.1 million punitive damages awarded as a result of the manufacturer’s failure to warn about the risk of tendon ruptures from side effects of Levaquin. 

In December 2010, a Minnesota jury awarded John Schedin $1.8 million following the first Levaquin trial held in the United States, finding that Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals (OMJP) subsidiary failed to provide the 82 year old plaintiff or the medical community with adequate warnings about the increased risk of tendon ruptures, particularly involving the Achilles tendon.

The jury awarded punitive damages of $1.1 million after finding that the drug makers had acted with reckless disregard for the potential health risks of Levaquin.

A three-judge panel for the U.S. Court of Appeals for the Eight Circuit ruled on Friday (PDF), in a split decision, that there was not enough evidence to show that Johnson & Johnson deliberately hid or downplayed data linking the popular antibiotic to an increased risk of tendon damage. However, the compensatory damages of $630,000 awarded to Schedin was allowed to stand.

Judge Kermit Bye disagreed with the other two judges on the panel, indicating that there was enough evidence for the jury to conclude that Ortho-McNeil-Janssen purposefully deceived the public.

“I believe…there was sufficient evidence from which a reasonable jury could conclude OMJP deliberately disregarded the risk of tendon injuries in elderly patients who were prescribed Levaquin in association with corticosteroids,” Judge Bye wrote in the dissenting opinion. “I therefore respectfully dissent from the decision to reverse the denial of OMJP’s motion for judgment as a matter of law on punitive damages.”

Settlements Reached in Other Levaquin

In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for Levaquin tendon rupture warnings to be added at least two years earlier, with Public Citizen filing a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.

Johnson & Johnson faces more than 3,500 Levaquin lawsuits over similar tendon injuries, with the federal litigation centralized before U.S. District Judge John R. Tunheim in the District of Minnesota and state court litigation in New Jersey centralized in Atlantic County.

Schedin’s case was one of four lawsuits scheduled for early trial dates, with the other three juries returing defense verdicts for the drug maker. However, in one of those cases the jury did find that the drug makers failed to adequately warn about the risk of tendon damage, but found that the plaintiff failed to establish that his specific injury was caused by the antibiotic.

These early trial dates, known as bellwether trials, are often useful in complex litigation involving a large number of similar claims, allowing parties to gauge how juries are likely to respond to evidence that will be offered throughout a number of cases.

While the Schedin case was pending on appeal, Levaquin settlements have been reached in hundreds of other cases. During a status conference before Judge Tunheim on October 30, it was disclosed that agreements had been reached to resolve cases brought by about 845 plaintiffs and settlements were close in about 190 additional cases.

Following the series of trials for the bellwether Levaquin cases and settlement negotiations between the attorneys involved in the litigation, any unresolved lawsuits may be remanded back to the courts where they were originally filed for individuals trials.