Johnson & Johnson faces a new product liability lawsuit that alleges side effects of Levaquin caused peripheral neuropathy for a Maryland woman, leaving her with the severe and often permanent form of nerve damage after using the popular antibiotic.
The complaint (PDF) was filed last month by Karyn Grossman in the U.S. District Court for the Northern District of California, naming Johnson & Johnson, it’s Ortho-McNeil-Janssen Pharmaceuticals subsidiary and the drug distributor, McKesson Corp. as defendants.
The Levaquin peripheral neuropathy lawsuit comes one year after the FDA required new warnings about the risk of nerve damage associated with the entire class of antibiotics known as fluoroquinolones, which also include Cipro, Avelox and others.
In August 2013, the FDA issued a drug safety communication warning that peripheral neuropathy may arise at any time during treatment with the popular antibiotics and may continue for months or even years after use of the medications is stopped.
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.
According to allegations raised by Grossman in the complaint, Johnson & Johnson ignored information about the link between Levaquin and peripheral neuropathy for years, failing to adequately warn consumers and the medical community about the risk of permanent and long-lasting nerve damage.
“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 was ‘rare’ and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms,” the complaint states. “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.”
The lawsuit notes that the warnings about rare cases of nerve damage from Levaquin were buried deep within the drug safety guides and prescribing information. Grossman alleges that if adequate warnings had been provided to her and her physician, complications from peripheral neuropathy may have been avoided by choosing to use a different antibiotic.
Grossman presents claims for strict liability, failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation, and fraudulent concealment, seeking both punitive and compensatory damages. – Click here for full article