Lawsuit Alleges Avelox Side Effects Caused Peripheral Neuropathy
Bayer Healthcare Pharmaceuticals faces a new product liability lawsuit, which alleges that side effects of Avelox caused an Illinois woman to suffer severe and long-lasting nerve damage, known as peripheral neuropathy, after using the popular antibiotic.
The complaint (PDF) was filed last week by Jeanne Bullard, in the U.S. District Court for the Southern District of Illinois.
According to allegations raised in the lawsuit, Bullard was prescribed a 10-day treatment of the antibiotic Avelox in January 2013, after which she suffered began to develop peripheral neuropathy, which now appears to be permanent.
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The case joins a growing number of peripheral neuropathy lawsuits filed nationwide, against Bayer and the makers of other antibiotics that are part of a class of drugs known as fluoroquinolones, which also includes Levaquin, Cipro and others. All of the complaints raise similar allegations that false and misleading warnings were provided about the risk of antibiotic nerve problems.
Peripheral neuropathy is a medical condition that involves damage to the nerves, which may impair sensation, movement and other aspects of health. Symptoms may include pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs.
While warnings provided with Avelox, Levaquin, Cipro and other fluoroquinolones have indicated that users may face a risk of peripheral neuropathy, for years the drug makers indicated that the problems were rare and failed to adequately disclose that users may be left with irreversible nerve damage, according to Bullard’s complaint.
In August 2013, the FDA required drug makers to provide stronger warnings about the peripheral neuropathy risk with fluoroquinolones, indicating problems may last for months or years after an individual stops taking the drug. The new label now warns patients to contact their doctors and consider switching to a different class of antibiotics if they experience symptoms of peripheral neuropathy.
Similar Levaquin lawsuits and Cipro lawsuits are also being pursued throughout the U.S. by users of those other popular fluoroquinolones, raising nearly identical allegations that indicate the drug makers placed their desire for profits before consumer safety by withholding adequate warnings about the risk of peripheral neuropathy for years.
Bullard’s lawsuit claims that the manufacturers knew or should have known about the risk of permanent nerve damage since at least 2003.
“A scientific review by the FDA of the adverse events in the FDA Adverse Event database in 2003 concerning Avelox and other fluoroquinolones revealed numerous reports of long-term peripheral neuropathy,” the lawsuit states. However, the label warning called such cases rare and did not mention long-term risks. “Thus, rather than warning patients and physician that the use of Avelox may result in permanent nerve damage, Defendants instead adopted a warning that misleadingly indicated such damage was rare and failed to make any mention of the risk of permanent nerve damage.”
Bullard presents claims for strict liability, failure to warn, breach of warranty, negligence, fraud, negligent misrepresentation, fraudulent concealment, and negligent infliction of emotional distress, seeking both compensatory and punitive damages.
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