Avelox Lawsuit Filed Over Peripheral Neuropathy Risk

According to claims raised in a recently filed product liability lawsuit against Bayer and Merck, consumers and the medical community were provided inadequate warnings about the link between Avelox and peripheral neuropathy for years, which allegedly left a Tennessee woman with irreversible and permanent nerve damage.

The complaint (PDF) was filed last month by Sherri Kellerman, in the U.S. District Court for the Northern District of California.

Kellerman indicates that she developed peripheral neuropathy from side effects of Avelox (moxifloxacin), which is a popular antibiotic that is part of a class of medications known as fluoroquinolones. Other medications in the same class include the blockbuster antibiotics Levaquin and Cipro.

Fluoroquinolone Antibiotic Failure to Warn

The case joins a growing number of antibiotic peripheral neuropathy lawsuits being pursued nationwide, which all involve similar allegations that makers of fluoroquinolones provided false and misleading information about the risk of permanent nerve damage that may result from use of the medications.

Peripheral neuropathy 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.

Until last year, the peripheral neuropathy warnings provided with Avelox suggested that the problems were “rare” and failed to adequately disclose that users may be left with irreversible nerve damage, according to allegations raised by Kellerman.

In August 2013, the FDA required new, more stringent warnings about the peripheral neuropathy risk with Avelox, Levaquin, Cipro and other fluoroquinolone antibiotics, indicating problems may last for months or years after an individual stops taking the drug.

The new label announced by the FDA required the drug makers to warn patients that if they experience symptoms of peripheral neuropathy, they should contact their doctors and be switched to another antibiotic from a different class of drugs.

Avelox Risks Withheld

Fluoroquinolones are among the most widely used antibiotics in the United States, with about 23.1 million patients receiving prescriptions for an oral version of the antibiotics in 2011. Since it was introduced in 1999, Avelox has increased in popularity within the class, approaching blockbuster drug status.

Kellerman alleges that Bayer and Merck knew or should have known about the Avelox peripheral neuropathy risk for years, indicating that studies have linked fluoroquinolones to a risk of permanent nerve damage for years before the medication was even introduced.

A study published last month in the medical journal Neuorology suggested that users of oral fluoroquinolones may face double the risk of developing peripheral neuropathy. Researchers found that current users of Avelox and other similar antibiotics faced an 83% increased risk of suffering nerve damage, and new users faced more than double the risk of peripheral neuropathy compared to those not taking the drugs.

“Defendants failed to appropriately and adequately inform and warn Plaintiff and Plaintiff’s prescribing physicians of the serious and dangerous risks associated with the use of Avelox concerning peripheral neuropathy, as well as other severe and personal injuries, which are permanent and/or long-lasting in nature, cause significant physical pain and mental anguish, diminished enjoyment of life, and the need for medical treatment, monitoring and/or medications,” according to Kellerman’s complaint.

The Avelox lawsuit pursues claims for strict liability, failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation and fraudulent concealment. It comes amid a growing number of similar Levaquin lawsuits and Cipro lawsuits being pursued on behalf of former users of those related antibiotics, which have also been linked to a risk of peripheral neuropathy.