First Settlements of Levaquin Trials Find Fault With Warnings

An antibiotic sold since 1997 is the subject of a proposed class action that argues the drug causes a higher incidence of tendon injuries. Levaquin, a broad spectrum fluoroquinolone antibiotic, is marketed as a first-line therapy for common bronchitis and sinusitis infections. It is also approved for the use in treatment of various upper respiratory infections, urinary tract infections, prostatitis and other bacterial infections. Many injured parties continue to seek legal council in order to file a Levaquin lawsuit throughout the United States against Johnson & Johnson and Ortho-McNeil Pharmaceuticals over problems with Levaquin tendon ruptures. According to court documents, there are currently over 1500 Levaquin injury lawsuits pending in federal court, with hundreds more expected to be filed in the coming months.

In July 2008, the FDA required that a “black box” warning be added about the Levaquin side effects and those of other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for 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.  Based on information available to the drug makers, this warning should have been added years earlier, which would have prevented thousands of people from suffering severe and debilitating injuries, including Achilles tendon ruptures and ruptures of other tendons in the shoulder, hands and other parts of the body.

The two cases are part of a group of six proposed bellwether trials that have been scheduled in the federal Levaquin litigation. The early trials are designed to help the parties gauge the relative strengths and weakness of their cases. The outcome of these trials may help lead to a possible Levaquin settlement agreement between the parties to avoid taking each case before a jury. In December, another jury ruled that the drug makers failed to adequately warn of Levaquin tendon ruptures, and awarded the plaintiff in that case, John Schedin, $1.8 million in damages.