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According to allegations raised in a lawsuit filed against Bayer Healthcare and Merck, side effects of Avelox have left a Florida man with a diagnosis of peripheral neuropathy, indicating that the drug makers failed warn about the risk of permanent nerve damage from their popular antibiotic.
The complaint (PDF) was filed late last week by Jason Parker in the U.S. District Court for the Eastern District of Pennsylvania, indicating that the widely used antibiotic Avelox is defective, dangerous to human health, and unfit to be sold in commerce.
Parker indicates that he was prescribed Avelox, which is part of a controversial class of antibiotics, known as fluoroquinolones. Although the drug has been widely used, it has been linked to a number of serious side effects in recent years, including a risk of permanent peripheral neuropathy, leading the FDA to warn earlier this year that Avelox and other fluoroquinolone-based antibiotics should not be used to treat uncomplicated infections since the risks outweigh the benefits.
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 Avelox lawsuits filed by individuals nationwide, which allege that the drug makers knew or should have known that the antibiotic may leave users with permanent nerve damage, yet provided false and misleading warnings for consumers and the medical community. Similar allegations have also been raised in Levaquin lawsuits and Cipro lawsuits, involving use of these competing antibiotics that are part of the same class of drugs.
Parker indicates that there was evidence as early as 1992 that fluoroquinolones could cause peripheral neuropathy, and numerous studies and research papers since then have indicated that the effects could be long-lasting or permanent. However, Avelox was introduced without warning about the risk of permanent peripheral neuropathy.
It was not until August 2013 that the FDA required the drug makers to update the peripheral neuropathy warnings to indicate that users may be left with nerve damage problems that continue long after the medication is no longer used. Prior warnings for Avelox, Levaquin and other fluoroquinolones suggested that reports of nerve damage were rare and typically resolved after the drug was no longer used. However, that is not the case.
Antibiotic Peripheral Neuropathy Lawsuits
This recent complaint will be consolidated with about 600 other Avelox, Levaquin and Cipro 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.
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.