A US jury has decreed that Johnson & Johnson is not responsible for tendon damage suffered by two men who took the healthcare giant's former blockbuster antibiotic Levaquin.
A jury in Atlantic City, New Jersey, cleared J&J’s Ortho-McNeil-Janssen Pharmaceutical unit of liability for the injuries suffered by the two men (aged 67 and 72) who claimed that their Achilles tendons snapped after taking Levaquin (levofloxacin) to treat respiratory infections. It agreed that the company had properly warned of the risks involved in taking the drug, which is a fluroroquinolone.
The plaintiffs had claimed that the drugmaker failed to include sufficient warnings on the label but J&J stressed that it has included information about tendon problems since Levaquin was first approved by the US Food and Drug Administration in 1996. The jury agreed with the company (by 8-1) and the verdict follows a similar victory in a Minneapolis court in July this year, although J&J lost a case in the same court in December 2010; then, a jury awarded $1.8 million to a man who had ruptured both Achilles tendons.
In July 2008, the FDA notified the manufacturers of fluoroquinolone drugs such as Levaquin and Bayer's Cipro (ciprofloxacin) that a black box warning about the risk of tendon ruptures and tendonitis were required. The warning particularly highlights the possible problem in people aged 60 who are taking corticosteroids, and in those with kidney, heart, or lung transplants.
A statement from a lawyer for the company noted that "we are pleased with the jury verdict, which recognises that Ortho-McNeil-Janssen Pharmaceuticals properly disclosed the risks associated with this medicine that has been used to treat millions of patients over 15 years”. However, the coast is not clear yet, and about 2,600 Levaquin lawsuits are still pending.
Second-quarter sales of Levaquin sank 47.0% to $159 million, and that figure is going to fall even further now that a number of generics are available in the USA.