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Levaquin Litigation Moving Ahead

Jul 6, 2009 | Parker Waichman LLP

Because of the many lawsuits involved over Johnson & Johnson’s antibiotic Levaquin, the cases have been deemed a mass tort and assigned to an Atlantic County, New Jersey, judge, reports Levaquin is prescribed for bacterial infections of the lungs, urinary tract, and skin. Levaquin is made by Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical Inc., and received U.S Food and Drug Administration (FDA) approval in 1996 noted

The lawsuits, which we recently reported as having begun to circulate through the courts, allege that Levaquin has caused Achilles' tendon ruptures and other damage. Just over a year ago, federal regulators ordered that Levaquin and similar antibiotics bear Black Box warnings about their association with serious tendon injuries.

In May we wrote that most litigation specialists expected thousands of people to file lawsuits against the makers of Levaquin and similar drugs. Last June, federal Levaquin lawsuits were consolidated in Multi-District Litigation before U.S. District Judge John R. Tunheim in the District of Minnesota.

Recently, attorneys representing Levaquin victims in New Jersey state court requested that those lawsuits be centralized before one judge, as well. Now, according to, that mass-tort status is expected to encompass thousands of cases against the same defendants arguing similar “complex issues of law and fact,” with patients alleging similar damages and injuries, said

When the FDA required that the labeling of Levaquin and other fluoroquinolone antibiotics be revised to include a Black Box warning about tendon injuries in 2008, the FDA database showed 262 reported cases of tendon ruptures, 259 cases of tendonitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures—61 percent—were tied to Levaquin.

At the time, the FDA warned that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other areas can happen in patients taking Levaquin. The agency said such injuries were more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. The most common tendon injury associated with Levaquin involves the Achilles tendon.

In some cases, Levaquin tendon ruptures have required surgical repair, and victims have needed to undergo extensive rehab. Tendon rupture can occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported.

New York law firm, Parker, Waichman & is among the firms that have filed Levaquin lawsuits in New Jersey.

According to a prior Wall Street Journal report, one of the latest Levaquin lawsuits filed in a New Jersey state court on behalf of three plaintiffs from around the U.S. charged that Johnson & Johnson and Ortho-McNeil represented Levaquin as a safe antibiotic despite its known association with tendon damage. The attorney representing the three Levaquin plaintiffs also pointed out that the drug is far more expensive than generic alternatives that have better safety profiles, the Journal said.

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