Levaquin Intravenous Use Resulted in Peripharel Neuropathy, Lawsuit Alleges

Johnson & Johnson and its subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, face another product liability lawsuit over Levaquin, with a recent complaint alleging that a Kentucky woman was left with peripheral neuropathy following intravenous use of the antibiotic. 

A case filed by Geraldine Beverly in the U.S. District Court for the Northern District of California on November 26 alleges that the drug makers failed to adequately warn users and the medical community about the risk of permanent nerve damage from Levaquin.

According to allegations raised in the complaint (PDF), Beverly was given Levaquin intravenously at Pineville Community Hospital in Kentucky, and subsequently developed symptoms of peripheral neuropathy, which involves debilitating pain, weakness, burning, tingling or numbness in the hands or feet, as well as limitations on sensitivity, feeling and range of motion.

Beverly raises allegations similar to those in a growing number of Levaquin peripheral neuropathy lawsuits filed throughout the U.S. in recent months, which all indicate that the drug makers have known about the risk of long-term nerve damage for years, yet failed to provide adequate label warnings until forced to do so by the FDA in August 2013.

“The warning label for Levaquin during the period from September 2004 through August 2013 misled Plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Levaquin were ‘rare’ and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms,” the complaint filed by Beverly indicates. “The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible.”

Risk of Peripheral Neuropathy from Levaquin, Other Antibiotics

Levaquin is part of a popular class of antibiotics known as fluoroquinolones, which also include Cipro, Avelox and other medications. However, Levaquin has been the best-selling member of this class in recent years, generating over $1.3 billion in annual sales before generic versions became available in 2011.

Last year, the FDA issued a drug safety communication to announce that it is requiring the manufacturers of Levaquin and other fluoroquinolones to change their warning labels about the risk of peripheral neuropathy problems, providing warnings for the first time that symptoms may continue for months or even years after an individual stops taking the drug.

While prior warnings suggested that reports of Levaquin neuropathy problems were rare and often resolve once the medication is no longer used, Levaquin, Avelox, Cipro and other similar antibioitics have been linked to permanent and disabling nerve damage that may last the rest of a user’s life.

Earlier this year, a study published in the medical journal Neurology added further support for these warnings, indicating that side effects of Levaquin and other fluoroquinolones may double the risk of peripheral neuropathy.

Researchers recommendeded that doctors more carefully weigh the risks and benefits of Levaquin and other fluoroquinolones when prescribing them to patients for less severe infections or conditions, suggesting that many former users may have been able to avoid Levaquin neuropathy if stronger warnings had been provided in the past.

Given the widespread use of the medication, many peripheral neuropathy lawsuits are being reviewed by lawyers, with many expecting that several thousand cases will be filed over the coming months and years.

Beverly seeks both punitive and compensatory damages, and accuses the manufacturers of strict liability, failure to warn, negligence, breach of warranty, fraud, negligent representation, and fraudulent concealment.