The dangers of the antibiotic Levaquin are well known by now, thanks to media reports and a growing number of Levaquin injury lawsuits filed by pharmaceutical liability attorneys like me. So I was interested to see a decision from the Eighth U.S. Circuit Court of Appeals on a Levaquin lawsuit that ended in a victory for the patient. In Schedin v. Ortho-McNeil-Janssen Pharmaceuticals Inc., John Schedin sued Levaquin’s manufacturer for failing to adequately warn patients of the risk of tendon rupture for patients who, like Schedin, are older and are also taking corticosteroids. After a jury found for Schedin, OMJP appealed the denial of its motion for judgment as a matter of law that would have overturned the verdict. The Eighth Circuit left the verdict in place but found the punitive damages unsupported.
Levaquin (levofloxacin) is a quinolone antibiotic suitable for people with penicillin allergies or drug-resistant infections. Schedin was prescribed both Levaquin and a corticosteroid in 2005, when he was 76. He later ruptured his left Achilles tendon and partially tore his right Achilles tendon, disabling injuries that are now known to be likely when those drugs are taken together. At the time, the package insert for Levaquin warned patients of the risk, but hid the warning in 15 pages of small print. No letter was sent to warn the prescribing doctor, Dr. Beecher, and he testified that he would not have prescribed it if he’d known the risk. The FDA later required a black box warning about the tendon rupture risk because tendon ruptures continued. Schedin’s lawsuit alleged that the warning to doctors was inadequate and that its warning to everyone failed to mention that Levaquin carried more tendon risks than other quinolones. He was awarded $630,000 in compensatory damages and punitive damages of $1.115 million.
OMJP appealed the verdict as well as the punitive damages award, but the Eighth Circuit upheld only the verdict. Judgment as a matter of law is granted when the verdict is against the great weight of the evidence. After reviewing the case, the appeals court found that the verdict in this case was adequately supported by evidence. The warning at issue added one sentence to the last paragraph of the 10-paragraph warnings section of the package insert, among more than 15 pages of small print. Furthermore, the FDA continued receiving reports of tendon ruptures from combining Levaquin and corticosteroids in the elderly until 2008. Both would allow a reasonable jury to conclude that doctors were unaware of the warning. However, the court found that the punitive damages award was not supported by clear and convincing evidence that OMJP disregarded others’ safety. The trial court found that OMJP attempted to cloud academic study of the tendon risks, but the Eighth found this to be mere speculation.
I am pleased to see this decision in favor of the injured patient who brought the Levaquin lawsuit. The decision turned in part on whether warnings are adequate under state law just by being included in the package. Different states have different rules on this issue, but in my experience as a dangerous drug lawyer, package warnings are often inadequate for exactly the reason the Eighth Circuit cited. When a warning is buried deep in small text and not highlighted, it’s hard to believe it’s a very important safety issue—even when it is. Indeed, as the dissent in the case noted, doctors tend to rely on direct communications from drug companies for important safety information, but no such communication was sent out about Levaquin. That’s why, as a defective drug attorney, I would have liked to see the punitive damages upheld as well.
If you believe a prescription or over-the-counter drug injured or sickened you, and you’d like to talk to an experienced attorney about your rights and your options, call Carey, Danis & Lowe today. You can call us at 1-877-678-3400 for a free consultation, or send us a message online.
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