August 15, 2016 — A class action lawsuit has been filed by a woman who developed nerve damage after taking the antibiotic Levaquin.
The lead plaintiff, Michelin Rowell, is a resident of North Carolina who was diagnosed with peripheral neuropathy after taking Levaquin.
She accuses Janssen Pharmaceuticals of failing to warn about the risk. She is seeking class action status on behalf of herself and everyone else who had nerve damage after taking Levaquin.
The lawsuit (PDF) was filed on August 11 in the U.S. District Court for the Eastern District of Pennsylvania — Rowell v. Johnson & Johnson et al., Case No. 2:16-CV-04369.
Peripheral neuropathy often causes weakness, numbness, and pain, usually in the hands and feet. Warnings have been on the label for Levaquin since 2004, but assured patients it was a “rare” side effect that could be avoided by discontinuing the drug when symptoms appeared.
Lawyers say those warning labels were inaccurate because peripheral neuropathy often develops rapidly and discontinuing Levaquin will not ensure that it goes away.
Furthermore, the warnings were at the bottom of a long list of side effects and in no way highlighted to warn prescribing physicians or patients.
In August 2013, the FDA ordered drug-makers to strengthen warnings to emphasize the rapid onset and permanent complications. It also removed the statement that nerve damage was a “rare” side effect.
In May 2016, the FDA warned that the risk of “disabling” side effects of Levaquin may “generally outweigh the benefits” for patients with relatively minor infections, such as sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs).
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