A New Jersey state court jury ruled today that Johnson & Johnson was not responsible for the tendon damage suffered by two men who took its Levaquin antibiotic. The decision was the second consecutive verdict that the health care giant has won in the sprawling Levaquin litigation, although J&J lost the first trial, which took place in a federal court in Minneapolis earlier this year.
In the latest case, lawyers for Paul Gaffney, 67, and Robert Beare, 72, argued that J&J knew Levaquin posed the highest risk of tendon damage of all the antibiotics in its class, which are known as fluroroquinolones, but the drugmaker failed to include the info on the warning label. The men claimed their Achilles tendon snapped after they took Levaquin to treat respiratory infections.
Three years ago, the FDA required all drugmakers that produce fluoroquinolones to add Black Box warnings about tendon ruptures. At the time, the agency noted that the risks are greatest in those over 60 years old; kidney, heart, and lung transplant recipients, and when used in conjunction with steroids (back story and FDA statement).
“We’re obviously disappointed with the verdict,” Andy Alonso, a lawyer for Gaffney and Beare, tells Bloomberg News. “We felt the evidence was clear that the warnings were flawed." A J&J spokesman writes the news service that "the evidence showed Ortho-McNeil-Janssen Pharmaceuticals properly informed of the benefits and risks associated with the use of Levaquin and that the company acted responsibly by providing appropriate and timely information about” the antibiotic.
Meanwhile, a growing number of lawsuits have been filed against J&J over the side effect and warning issues. Some 2,600 lawsuits are now populating state and federal courts, some of which were brought by people who also claim the antibiotic has caused central nervous system damage. And the issue has generated substantial publicity, such as this PBS segment (look here).
In June, a federal court jury in Minneapolis decided J&J 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 (read here). In January, a jury in the same court decided that JNJ 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 (see this).
gavel thx to walknboston on flickr