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Mass-Tort Treatment Sought for Suits Over Ortho-McNeil Antibiotic Levaquin
FDA says Levaquin users are at heightened risk of tendonitis and tendon rupture in the shoulder, biceps, hand and thumb
New Jersey Law Journal
May 13, 2009
Users of Levaquin, an antibiotic linked to muscle ailments, are asking the New Jersey Supreme Court to accord mass-tort treatment to their suits against the manufacturer, Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical Inc.
Acting Administrative Director of the Courts Glenn Grant made the application public in a notice to the Bar that solicits comments on or before June 5.
There will likely be thousands of suits involving the same defendants, similar complex issues of law and fact and plaintiffs with a high degree of commonality in their injuries and damages, making the litigation ideally suited for central management, says plaintiffs lawyer Michael London.
In requesting mass-tort treatment last month, London also asked that the litigation be centralized with Superior Court Judge Carol Higbee in Atlantic County, where he has already filed six suits. London says his firm, Douglas & London in New York, represents more than 200 plaintiffs from 38 states and expects to file many additional suits.
Levaquin, a fluoroquinolone, is prescribed for bacterial infections of the respiratory system, urinary tract and skin. Its users are at heightened risk of tendonitis and tendon rupture in the shoulder, biceps, hand and thumb, according to the Food and Drug Administration.
The risk is greater in older patients, those taking corticosteroids, such as prednisone, and those with kidney, heart and lung transplants, the FDA said.
In July 2008, the FDA ordered manufacturer Ortho-McNeil, of Raritan, N.J., to include on Levaquin's label a warning about the incidence of ruptured tendons and other tendon injuries.
The FDA labeling order was issued at the urging of Public Citizen of Washington, D.C. The organization's review of the FDA's adverse-event database shows 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of 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, which has accounted for 45 percent of all fluoroquinolone prescriptions in the past four years, Public Citizen said.
Since then, the suits have been mounting. In the federal courts, Levaquin litigation was consolidated in the District of Minnesota by the Judicial Panel on Multidistrict Litigation last June.
London said Atlantic County is an ideal venue because of its comparatively small case load among counties handling mass torts. It has only three: Accutane and Fosamax drug litigation and suits over a contaminated Bristol-Myers Squibb plant in New Brunswick.
Middlesex County, by contrast, has seven mass torts: asbestos, Ciba-Geigy environmental contamination, Gadolinium contrast agents, hormone replacement therapy, Ortho Evra, Risperdal/Seroquel/Zyprexa and Zometa/Aredia. Bergen County has four, over Depo-Provera, Digitek, NuvaRing and a toxic dump site in Mahwah.
London also said Judge Higbee has significant experience handling complex mass tort and product liability actions and a staff equipped to handle thousands of cases. Higbee was in charge of New Jersey Vioxx mass-tort litigation, presiding over 16,400 cases -- 61 percent of the national total -- before Merck & Co. announced a $4.85 billion global settlement of Vioxx cases in late 2007.
Susan Sharko of Drinker Biddle in Florham Park, N.J., who represents Johnson & Johnson and Ortho-McNeil in the Levaquin suits, did not return a reporter's call.
