Levaquin Trial Denies Wrongdoing by Manufacturer

Paul Gaffney, 67, and Robert Beare, 72, both of New Jersey, claim to have suffered Levaquin achilles tendon tears injuries because of Levaquin. Both men, who took Levaquin to treat sinus infections, were left them unable to walk and required surgery. The jury, in the end, found for the defendant leading to 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.

In July 2008, the FDA announced that they will require the makers of fluoroquinolone antibiotics to place a prominent “Black Box” warning about the risk of Levaquin tendon rupture and tendonitis. They are also requiring a Medication Guide to be given to users when the prescription is filled. This requires the manufacturers to adequately describe the risk and urges users to contact their doctor if they develop signs of a tendon rupture, such as pain, swelling or inflammation.In August 2006, the consumer advocacy group Public Citizen filed a Levaquin lawsuit with the FDA requesting that these stronger warnings be provided, but the drug makers and FDA failed to take steps at that time to warn users.
In January 2008, a Levaquin lawsuit was filed against the FDA alleging that their petition had been ignored.

There are currently more than 2,500 lawsuits that have been filed on behalf of individuals throughout the United States who suffered a tendon rupture on Levaquin. Of those cases, more than 1512 are pending in New Jersey state court and about 1000 are pending in federal court, where the litigation has been centralized for pretrial preceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of Minnesota before U.S. District Judge John Tunheim.  All suits claim that Ortho-McNeil, a subsidiary of Johnson & Johnson which manufactures the antibiotic, has failed to provide adequate warnings about Levaquin side effects, including an increased risk of: tendon rupture, tendon damage and tendonitis.