A federal court jury in Minneapolis decided late last week that Johnson & Johnson was not responsible for a tendon injury suffered by an 84-year-old man and that the health care giant properly warned of the risks posed by its Levaquin antibiotic. The decision comes six months after J&J lost the first trial over the same issues.
In the latest case, Calvin Christensen charged that his Achilles tendon in his right foot ruptured after he was given the drug while hospitalized for pneumonia, and that J&J's Ortho-McNeil Pharmaceutical unit downplayed the risks. J&J denied failing to warn and contended Christensen needed Levaquin to treat the pneumonia. He filed his lawsuit in 2007 (read the lawsuit here).
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.
Christensen claimed the warning should have been issued earlier and that J&J targeted the elderly for drug sales. His lawyers pointed out that regulators in France, Italy and Belgium sent out so-called Dear Doctor letters of the risk of tendon injury among the elderly in 2002, Bloomberg News notes.
Although the Ortho-McNeil unit upgraded the warning in the US in 2002, adding the increased risk to patients taking steroids, particularly elderly patients, Christensen charged this was insufficient because a 'Dear Doctor' was not sent in the US about the change and “muted” the additional warning, his lawsuit charged. His doctor testified he would have used a different drug.
For its part, J&J took comfort in the verdict. "The jury took a good, hard look at all the evidence and correctly concluded that Ortho-McNeil-Janssen Pharmaceuticals, Inc. acted responsibly and properly in disclosing the risks associated with this effective and life-saving medicine,” James Irwin of Irwin Fritchie Urquhart & Moore, a law firm representing J&J, says in a statement sent to us.
More than 2,500 lawsuits are pending over Levaquin risks and J&J warnings. In the first trial, which ended last December, a jury awarded $1.8 million to an 82-year-old man who ruptured both Achilles tendson (back story).