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New development in fluoroquinolone antibiotics cases

There has been a procedural development in lawsuits filed against the makers of fluoroquinolone drugs, which are linked to serious nerve damage. A group of judges known as the U.S. Judicial Panel on Multidistrict Litigation centralized all of the federal litigation of this nature before a single judge Aug. 17. The judge is based at a federal trial court in Minnesota.

What does this mean for the alleged victim of fluoroquinolones? The panel transfers cases that have common questions of fact so that the pretrial process can be more efficient. And efficiency is important. Cases coordinated before a single judge ideally "to avoid duplication of discovery, to prevent inconsistent pretrial rulings, and to conserve the resources of the parties, their counsel and the judiciary," according to the panel.

The panel transferred 20 fluoroquinolone lawsuits pending in 15 federal districts two weeks ago. There are 58 more fluoroquinolone lawsuits pending in 23 additional federal districts, possibly poised to be transferred.

"The actions allege that fluoroquinolone antibiotics - principally, Levaquin, Avelox, and Cipro - cause or substantially contribute to the development of irreversible peripheral neuropathy and that defendants' warnings concerning the alleged risks were inadequate," the judges wrote. "The involved manufacturers and distributors are Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor)."

Factive, Floxin and Noroxin are also fluoroquinolones.

Peripheral neuropathy can be hard to deal with, particularly when it is irreversible.

"Peripheral neuropathy," the U.S. Food and Drug Administration wrote in 2013, "is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent. Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away. FDA will continue to evaluate the safety of drugs in the fluoroquinolone class and will communicate with the public again if additional information becomes available."

One reason the facts of so many fluoroquinolone lawsuits are similar is the sweeping FDA warning label update of all the drugs in question. The judges took that into account when it issued its transfer order. And the warning does not apply to drugs applied by ear or eye.

As the judges reasoned, "On August 15, 2013, the U.S. Food and Drug Administration announced that it had required a revised label for the entire class of oral and injectable fluoroquinolone antibacterial drugs concerning the risk of irreversible peripheral neuropathy. The warning labels of Levaquin, Avelox, and Cipro allegedly were revised to contain virtually identical warnings with respect to that risk. Plaintiffs' actions followed the FDA announcement, relying on the same regulatory history and scientific background to support the allegation that fluoroquinolone antibiotics, as a class, are causally linked to the development of irreversible peripheral neuropathy."

Panelists concluded, "... while we typically are hesitant to centralize litigation on an industry-wide basis, here all fluoroquinolone actions, regardless of the manufacturer, will share factual questions regarding general causation (in particular, the biological mechanism of the alleged injury), the background science, and common regulatory issues."

The complications can get worse. Who would have thought that was possible? In addition to peripheral neuropathy, side effects from the use of fluoroquinolones may also include tendinitis, tendon rupture, seizure, convulsions and psychosis.

Anyone who used a fluoroquinolone antibiotic and suffered from doctor-diagnosed peripheral neuropathy may want to contact an attorney to determine whether there is an entitlement to compensation for medical expenses, lost wages, and other losses.

Members of the Pharmaceutical Injury Litigation Team at Reich & Binstock specialize in handling these types of actions and have considerable experience in taking on big pharmaceutical corporations in order to protect their clients' rights.

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