The New Jersey Supreme Court has designated litigation over Levaquin, the Johnson & Johnson antibiotic, as a mass tort and has assigned the case to Judge Carol Higbee. The suits allege that the drug, which is prescribed for bacterial infections of the lungs, urinary tract and skin, has caused Achilles’ tendon ruptures and other damage. The litigation could likely involve thousands of cases with the same Defendants, similar complex issues of law and fact, and pPaintiffs with a high degree of commonality in their injuries and damages.

Levaquin, made by J&J subsidiary Ortho-McNeil Pharmaceutical Inc., was approved by the Food and Drug Administration in 1996. But in July 2008, the FDA warned that Levaquin, and other drugs in the fluoroquinolone class of antibiotics, put users at heightened risk of developing tendonitis and tendon ruptures. The FDA ordered Ortho-McNeil to include on Levaquin’s label a warning about the incidence of those injuries.

The most common injury associated with Levaquin, a ruptured Achilles’ tendon, may require surgery to repair and frequently entails two months of immobility, then surgery and a rehabilitation period of six months or more, says Michael London of Douglas & London. Other reported injuries are ruptures of the rotator cuff, hand, biceps and thumb. Most ailments occur during or soon after a course of Levaquin, although cases occurring several months after completion have been reported. Injuries are most frequent in users over age 60, people taking steroids, or persons who have had a kidney, heart or lung transplant.

Interestingly, in this case, Johnson & Johnson actually supported mass-tort designation, but asked for the case to be in Middlesex County, New Jersey, where its corporate headquarters is located. But geographical location of the parties and lawyers, as well as proximity to airports and highways, were said to favor Atlantic County as the proper venue. The experience of Atlantic County Superior Court Judge Carol Higbee and her staff in handling high-volume product-liability cases was also a definite factor.

It should be noted that Public Citizen, which originally urged the FDA to issue its labeling order and has reviewed the agency’s database, has turned up 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 other tendon disorders between November 1997 and December 31, 2005, that were associated with Fluoroquinolone antibiotics. Sixty-one percent of the ruptures were associated with Levaquin.


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