A federal court jury in Minneapolis has decided the health care giant failed to properly warn about the risk of tendon damage linked to its Levaquin antibiotic and awarded damages of $1.8 million in compensatory and punitive damages to 82-year-old John Schedin. However, the jury rejected his claim that J&J violated state consumer-fraud law by misrepresenting or concealing information.
The retired salesman ruptured both Achilles tendons after taking the antibiotic and subsequently charged J&J and its Ortho-McNeil-Janssen Pharmaceuticals with failing to warn about tendon damage. He filed suit in 2008. During the trial, he testified his quality of life has declined - he can't vacation with his family and when he goes to bed, he must "crawl" up the stairs on his hands and knees (here is his lawsuit).
Two years ago, you may recall, the FDA required J&J and others that make the class of antibiotics known as fluoroquinolones to add warnings about the risk of tendonitis and tendon ruptures (back story). The risks are greatest in those over 60 years old; kidney, heart, and lung transplant recipients, and when used in conjunction with steroids, according to the FDA.
Schedin's lawyers charged that Ortho-McNeil failed to send doctors letters about Levaquin’s risks before the 2008 label change and that his doctor would have otherwise prescribed a different antibiotic. Although as Bloomberg News notes, the jury assigned 75 percent of the liability to J&J, 10 percent to Schedin and 15 percent to his doctor, reducing the judgment against Ortho to $630,000. There are approximately 2,600 Levaquin lawsuits in federal and state courts.