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A group of 48 plaintiffs have filed a joint lawsuit indicating that they have been left with peripheral neuropathy from Levaquin, Avelox and Cipro antibiotic treatments, suffering painful and debilitating nerve damage.
The complaint (PDF) was filed late last month in the U.S. District Court for the Western District of Oklahoma, naming Bayer Healthcare, Merck & Co., Johnson & Johnson and its Janssen subsidiary as defendants.
Each of the plaintiffs indicate they developed a form of nerve damage known as peripheral neuropathy, with some of the plaintiffs experiencing fatal injuries.
Peripheral neuropathy involves damage to the nerves that may impair sensation, movement and other aspects of health. This typically leaves 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 case joins hundreds of other Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits filed on behalf of individuals nationwide, each raising similar allegations that the drug makers failed to provide adequate warnings for users and the medical community about the risk of permanent peripheral neuropathy from the antibiotics, which may continue long after the medication is no longer used.
Prior warnings provided with the medications, which are part of a class of drugs known as fluoroquinolones, suggested that reports of nerve damage were rare and typically resolved after the drug was no longer used. However, the FDA required the manufacturers to update the warning label in August 2013, indicating that in many cases that peripheral neuropathy from Avelox, Levaquin and Cipro is permanent.
“[R]ather than warning patients and physicians that the use of Fluoroquinolones may result in permanent nerve damage, Defendants instead adopted a warning that misleadingly indicated such damage was rare and in any event could be avoided by simply discontinuing the drug upon the onset of certain symptoms,” the joint lawsuit filed last month on behalf of nearly 50 people states. “Defendants’ failure to adequately warn physicians resulted in (1) patients receiving Fluoroquinolones instead of another acceptable and adequate non-fluoroquinolone antibiotic, sufficient to treat the illness for which Plaintiffs presented to the provider; (2) and physicians failing to warn and instruct consumers about the risk of peripheral nervous system injuries associated with Fluoroquinolones.”
Given the risk of nerve damage and other injuries associated with the antibiotics, the FDA issued a new drug safety communication in May 2016, urging doctors not to prescribe Avelox, Levaquin, Cipro or other fluoroquinolones for many common infections that are uncomplicated and have other available treatment options, indicating that the risks associated with the antibiotics outweigh the benefits. The federal regulatory agency considered available information on the risk of peripheral neuropathy, tendon ruptures, retinal detachments and other health concerns linked to the drugs at that time.
Antibiotic Peripheral Neuropathy Lawsuits
This recent complaint will be consolidated with about 600 other claims pending in the federal court system, which are centralized for pretrial proceedings before U.S. District Judge John R. Tunheim in the District of Minnesota, as part of an MDL, or Multidistrict Litigation.
Given similar questions of fact and law raised in the lawsuits over peripheral neuropathy from the antibiotics, the cases are being coordinated during discovery, bellwether trials and other pretrial litigation.
Judge Tunheim will hold a “Science Day” in the peripheral neuropathy litigation in January 2017, at which time the parties will present scientific information in a non-adversarial manner designed to educate the court about issues that will come up in the litigation.
It is expected that a small group of cases in the MDL will ultimately be selected for a series of “bellwether” trials, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of claims. While the outcomes of these early trial dates are not binding on other claims, they may help facilitate potential peripheral neuropathy settlements for individuals who have been left with the severe and debilitating nerve damage from Avelox, Levaquin or Cipro.
As the peripheral neuropathy cases move forward, the drug makers also face an increasing number of aortic aneurysm lawsuits and aortic dissection lawsuits that are being investigated by individuals nationwide, as recent studies have suggested that medications may cause collagen degradation issues throughout the body, impacting the aorta.
Plaintiffs in those cases point out that users and doctors have never been provided any warning about the risk of an aortic aneurysm or dissection from Avelox, Levaquin or Cipro.