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The side effects of Avelox have left a Texas man suffering from severe nerve damage for nearly a decade, according to allegations raised in a recently filed lawsuit.
Brian Kueker, and his wife, Joyce, filed a complaint (PDF) against Bayer Healthcare and Merck & Co. in the U.S. District Court for the Eastern District of Pennsylvania on December 12, indicating that the drug makers failed to adequately warn consumers or doctors that peripheral neuropathy caused by the antibiotic Avelox may be permanent.
Kueker was diagnosed with peripheral neuropathy in 2007, but was not aware of the possible connection between his prior use of Avelox and nerve damage until he saw internet advertisements warning about the risks in December 2015.
Avelox is part of a controversial class of antibiotics, known as fluoroquinolones (FLQs). Although the drug has been widely used to treat a wide variety of infections, it has been linked to a number of serious side effects in recent years, including a risk of permanent peripheral neuropathy.
Due to the risks associated with Avelox and other fluoroquinolones, the FDA to warned earlier this year that the antibiotics should no longer be used to treat uncomplicated infections.
Peripheral neuropathy from Avelox 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.
Although the drug makers have indicated a potential risk of nerve damage from the antibiotics, plaintiffs allege that the warnings were misleading by suggesting that reports were rare and resolve when the drug is no longer used.
In August 2013, the FDA required updated the peripheral neuropathy warnings, which now indicate that users may be left with nerve damage problems that continue long after the medication is no longer used.
Kueker’s lawsuit indicates that patients and doctors were unaware of the risks for years because of deceptive practices by the manufacturers.
“The lack of awareness concerning the causal relationship between FLQs and irreversible peripheral neuropathy was not the result of silence or passive concealment,” the lawsuit states. “Defendants, through their marketing statements and labeling, made affirmative representations and engaged in deliberate omissions to the medical community and patients, both of which suggested, both expressly and impliedly, that symptoms of neuropathy were reversible, thereby excluding suspicion of any drug-induced relationship or cause and preventing subsequent discovery.”
Antibiotic Peripheral Neuropathy Lawsuits
This recent complaint will be consolidated with about 700 other Avelox, Levaquin and Cipro claims involving failure to warn about the risk of peripheral neuropathy, which are centralized for pretrial proceedings in the federal court system before U.S. District Judge John R. Tunheim in the District of Minnesota.
Given similar questions of fact and law raised in the lawsuits over peripheral neuropathy from the antibiotics, the cases are being coordinated as part of a federal multidistrict litigation (MDL) 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.