The woman, Jacqueline Whiters, is a resident of Philadelphia who was diagnosed with peripheral neuropathy after taking Avelox (moxifloxacin) in 2012 and 2013. She accuses Bayer and Merck & Co. of inadequately warning about this side effect.
Between 2004 and August 2013, the label on Avelox stated that peripheral neuropathy was a “rare” side effect and did not mention the possibility of irreversible nerve damage. According to the lawsuit (PDF):
“Though this injury can be significant and debilitating, the language regarding the “rare” risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions that were included on the Avelox label.”
She alleges that doctors first established the link between Avelox and nerve damage in 1992, and the FDA put drug-makers on notice in 2002. The label was updated with fine-print warnings about the side effect, but those warnings were “in no way highlighted” for the benefit of doctors and patients.
In August 2013, the FDA issued a Drug Safety Communication to announce that drug-makers would be required to strengthen warnings about the risk of peripheral neuropathy from all antibiotics in the fluoroquinolone class, including Avelox.
The case was filed in the Philadelphia Court of Common Pleas (Case No. 150502686) on May 22, 2015.