The New Jersey Supreme Court has designated mounting litigation over the Johnson & Johnson antibiotic Levaquin as a mass tort and has assigned it to an Atlantic County, N.J., judge. The suits charge 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 plaintiffs law firm that sought mass-tort status, Douglas & London of New York, maintains that the litigation will likely involve thousands of cases with the same defendants, similar complex issues of law and fact, and plaintiffs with a high degree of commonality in their injuries and damages.
The firm, which has filed six Levaquin suits in New Jersey, also said Atlantic County is appropriate because its docket is less crowded than those in Bergen or Middlesex counties, the other venues hearing mass-tort cases.
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, and injuries are most frequent in users over age 60, people taking steroids, or persons who have had a kidney, heart or lung transplant, the plaintiffs allege.
Johnson & Johnson had supported mass-tort designation but asked for venue in Middlesex County, N.J., where its headquarters is located, rather than Atlantic County.
But London, in his petition, said geographical location of the parties and attorneys and proximity to airports and highways favored Atlantic County as the venue. He also cited the experience of Atlantic County Superior Court Judge Carol Higbee and her staff in handling high-volume product-liability cases.
London also noted that five mass torts are centralized in Atlantic County, including Vioxx and Bextra/Celebrex, which have been settled and will require only "housekeeping" from the court. Meanwhile, Middlesex County has seven mass torts and Bergen County has five, but London described four of the Bergen cases -- Depo-Provera, the Mahwah toxic dump site, Zelnorm and NuvaRing -- as new cases.
London said two other firms, Lanier Law Firm of Houston and New York's Parker, Waichman & Alonso, have filed Levaquin suits in New Jersey. In addition, London's firm has spoken with other national firms that expect to file Levaquin suits in New Jersey, according to his petition.
Ortho-McNeil Pharmaceutical is represented by Susan Sharko of Drinker Biddle & Reath in Florham Park, N.J. She was on vacation and could not be reached.
Higbee has scheduled a case management conference for July 16 to discuss selection of liaison counsel, preparation of a master complaint, the filing of answers and initial discovery issues.
Public Citizen of Washington, D.C., 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 Dec. 31, 2005, that were associated with Fluoroquinolone antibiotics. Sixty-one percent of the ruptures were associated with Levaquin.