Trial has begun in New Jersey state court for two lawsuits that alleges Johnson & Johnson failed to adequately warn doctors and patients about the risk of tendon damage from side effects of Levaquin, a popular antibiotic that has been the subject of more than 2,600 similar lawsuits filed throughout the United States.
A jury in Atlantic City will hear the combined trial involving Levaquin lawsuits filed by Paul Gaffney and Robert Beare, who allege they each suffered tendon ruptures after taking the antibiotic. Plaintiffs are expected to argue that their injuries could have been avoided if Johnson & Johnson had placed a stronger warning on the label before they used Levaquin, instead of downplaying the risks.
Johnson & Johnson contends that are not liable for the men’s injuries because there were warnings on Levaquin labels about the risk of tendon damage since the antibiotic was first approved by the FDA in 1996. The company’s attorneys also contend that Gaffney, 67, and Beare, 72, had other symptoms that could have cause their tendon ruptures and claims the men did not follow their doctors’ advice, which may have prevented the ruptures.
In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for stronger Levaquin tendon rupture warnings to be added at least two years earlier, with Public Citizen filing a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.
Although this is the first Levaquin trial to begin in New Jersey state court, where about 1,900 of the cases are currently pending, it is the third trial over Levaquin tendon damage to reach a jury in the U.S. Two prior bellwether trials have been held in federal court, where the Levaquin litigation has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of Minnesota.
In December, a federal jury ruled that the drug makers failed to adequately warn about the risk of Levaquin tendon ruptures, and awarded the plaintiff in that case, John Schedin, $1.8 million in damages. However, in June a different jury sided with Johnson & Johnson, saying that the label warnings were adequate enough to reject 84-year-old Calvin Christensen’s Levaquin tendon rupture claim.
Although these early Levaquin trials are not binding on any other cases, they are closely watched by parties involved, as they provide a good gauge for how juries may respond to similar evidence that will be presented throughout other cases in the litigation. The outcome of the early trials may help facilitate a potential Levaquin settlement agreement for other cases that are pending.