Levaquin Warnings About Tendon Problems Were Sufficient: NJ State Jury

A New Jersey jury has returned a defense verdict in the third trial out of several thousand Levaquin lawsuits that have been filed throughout the United States, finding that Johnson & Johnson provided adequate warning on the drug’s label about the risk of tendon problems with the antibiotic. 

The Levaquin trial involved a complaint brought by Paul Gaffney and Robert Beare, who alleged that they each suffered a ruptured tendon after taking the medication.

An estimated 2,500 people have filed a similar Levaquin tendon rupture lawsuit against Johnson & Johnson and their Ortho-McNeil-Janssen Pharmaceuticals subsidiary, raising nearly identical allegations that the injuries could have been avoided if the drug makers had placed a stronger warning on the medication instead of downplaying the risks.

Levaquin is the best selling antibiotic in the U.S., pulling in about $1.5 billion last year. It is now also available as a generic from other drug makers.

Although there has been information about the potential risk of tendon damage on the drug’s label since it was first approved by the FDA in 1996, plaintiffs alleged that those warnings were insufficient and that the drug maker actively attempted to downplay the risk for years.

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.

Following a five week trial, the New Jersey state court jury found that these plaintiffs failed to establish that Johnson & Johnson provided inadequate warnings, returning a defense verdict.

The decision is the second victory for Johnson & Johnson out of the three Levaquin cases that have made it to trial. In December 2010, the first trial ended in a $1.8 million award for the plaintiff, including punitive damages to punish the drug maker for their conduct. However, the drug maker successfully defended the second trial, which ended in June 2011.

The first two trials were held in federal court, where the Levaquin litigation has been consolidated in the U.S. District Court for the District of Minnesota as part of an MDL, or multidistrict litigation. This latest trial was held in New Jersey state court, where about 1,900 of the cases are currently pending.

These early trials, typically referred to as “bellwether” cases, are not binding on other lawsuits, but they are often useful in providing the parties with a gauge for how juries may respond to similar evidence that will be presented throughout other cases in the litigation. The parties often use the outcome of these bellwether trials to help facilitate potential Levaquin settlement agreements in other cases.