Fluoroquinolone Lawsuit Centralization Opposed by Antibiotic Makers

Although a mounting number of Levaquin lawsuits, Cipro lawsuits and Avelox lawsuits continue to be filed throughout the federal court system, alleging that the popular antibiotics caused users to suffer peripheral neuropathy, the drug manufacturers are opposing calls to centralize pretrial proceedings in the litigation.

Last month, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Mutldistrict Litigation (JPML) calling for the consolidation of all peripheral neuropathy lawsuits filed against makers of fluoroquinolone-based antibiotics, which all involve similar allegations that users and the medical community were provided with inadequate warnings about the risk of permanent nerve damage.

There are currently at least 24 cases filed against the makers of Levaquin, Cipro and Avelox, which are pending in 16 different U.S. District Courts throughout the country. As additional cases are filed by individuals who experienced permanent and long term peripheral neuropathy problems from the antibiotics, it is ultimately expected that hundreds, if not thousands, of complaints will be filed throughout the federal court system.

On June 10, Bayer filed a response (PDF) in opposition to the consolidation of cases involving Cipro and Avelox, and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, filed a separate response (PDF) opposing the centralization of cases involving their antibiotic Levaquin as well.

The drug makers argue that there are too many different antibiotics and too few individual cases currently filed to justify centralizing the cases before one judge for coordinated discovery and pretrial proceedings.

Plaintiffs argue that consolidating the cases as part of an MDL, or Multidistrict Litigation, is necessary to avoid conflicting rulings from different judges, reduce duplicative discovery into common issues that will arise in the case and to serve the convenience of the parties, witnesses and the courts.

In their opposition briefs, both Bayer and Janssen attorneys argue that there are crucial differences in the three drugs and in the conditions they are meant to treat, as well as the extent of their label warnings. They also argue that case-specific details will dominate the lawsuits, making consolidation inefficient.

The U.S. JPML has scheduled oral arguments on the motion to be heard during an upcoming hearing session on July 30, in San Francisco, California.

Fluoroquinolone Peripheral Neuropathy Risk

Levaquin, Avelox and Cipro are among the most widely used antibiotics in the United States, which are all part of the same class of drugs, known as fluoroquinolones.

All of the fluoroquinolone lawsuits over peripheral neuropathy have been filed since a warning update required by the FDA in August 2013, at which time the federal drug regulatory agency required the manufacturers to provide stronger warnings about the risk of users developing nerve problems that may last for months, or even years, after they stop taking the drugs.

Lawsuits allege that prior warnings provided with Levaquin, Avelox, Cipro and other similar drugs misleadingly suggested that reports of peripheral neuropathy among users were rare and that the nerve problems resolve when the medications are no longer used. The new label warnings indicated that the problems could be permanent and urge doctors to consider switching patients to a different class of antibiotics if they experience symptoms of peripheral neuropathy.

Peripheral neuropathy involves damage to the nerves that may impair sensation, movement and other aspects of health. This may leave users with persistent pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs, as well as other problems that cause a major disruption to daily activities.

The first indication of a possible link between long-term peripheral neuropathy and fluoroquinolone antibiotics came in a study published in 2001, which highlighted reports of 45 patients who suffered persistent peripheral nervous system damage. Plaintiffs maintain that if adequate warnings had been provided about the risk of permanent neuropathy problems, they may have avoided painful and debilitating injuries.

Plaintiffs argue that if the drug makers had provided adequate warnings they may have avoided the debilitating nerve problems by choosing not to use a fluoroquinolone or by closely monitoring for symptoms of peripheral neuropathy while using the antibiotics.