Levaquin Damages Reduced on Appeal

Johnson & Johnson has won a partial court victory in its long-running battle over the antibiotic Levaquin. The drugmaker has faced thousands of lawsuits claiming Levaquin caused tendon injuries–and that J&J didn’t do enough to warn patients and doctors of the risk.

Just last month, J&J settled at least 845 of the more than 3,400 Levaquin cases, and at last count it was negotiating to settle 190 more. Four of the Levaquin lawsuits have gone to trial, and J&J won three. In the fourth–in which the plaintiff, John Schedin, claimed Levaquin caused both of his Achilles tendons to rupture–a jury awarded more than $2 million in damages.

Now, however, the U.S. Court of Appeals in St. Louis has tossed out $1.1 million in punitive damages, leaving $630,000 in compensation for Schedin’s injuries. The appeals court upheld the jury’s determination that J&J didn’t properly warn about Levaquin’s tendon injury risk.

A three-judge panel for the U.S. Court of Appeals for the Eight Circuit ruled, 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.

“The evidence is neither clear nor convincing, as a matter of law, that OMJP deliberately disregarded the safety of the users of Levaquin,” U.S. Circuit Judge William Jay Riley said today. Proving deliberate disregard is “required for punitive damages under Minnesota law,” Riley said.

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.”

Schedin, 84, who said he ruptured both Achilles tendons after taking Levaquin, claimed the companies failed to warn doctors and patients of the drug’s association with tendon damage.

Levaquin’s official label includes a “black box” warning of the risk of tendon ruptures–a warning the FDA added in 2008 on all antibiotics in Levaquin’s class. Lawyers have argued that Levaquin was risker than the others in that class, but J&J points out that Levaquin’s label covered the potential for tendon-related side effects as far back as 1996.



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