A Wisconsin woman is suing Bayer and Merck over an alleged case of Avelox peripheral neuropathy.

Plaintiff Jill E. says she started taking Avelox, a fluoroquinolone antibiotic now allegedly manufactured by Bayer, around February 2006.

She was later diagnosed with peripheral neuropathy, a condition in which damage to the peripheral nerves can result in impaired motor control or abnormal sensations like pain, tingling or numbness.

Jill says because of her Avelox peripheral neuropathy, she has had to live with “physical pain and mental anguish, including diminished enjoyment of life, physical impairment, expenses for hospitalization and medical treatment, and loss of earnings, among other damages.”

Jill’s Avelox lawsuit names as defendants Bayer Healthcare Pharmaceuticals Inc. and its related companies. Jill says the Bayer defendants developed Avelox and are now responsible for the manufacture and marketing of the drug.

Jill also names Merck & Co. Inc. as a defendant. Merck has allegedly promoted Avelox in the United States since its November 2009 acquisition of Schering-Plough Corp.

Avelox is the brand name associated with the drug known generically as moxifloxacin. It was originally approved for U.S. sales by the FDA in December 1999.

Avelox is one of a class of antibiotics called fluoroquinolones. Jill says that Bayer developed Avelox so that it could continue to be competitive in the market for third- and fourth-generation fluoroquinolone antibiotics. Cipro, an older fluoroquinolone, had yielded impressive revenues for Bayer, but its patent exclusivity was set to expire in 2003.

Avelox ended up drawing in considerable sales of its own. In 2007, international sales exceeded $697 million dollars, Jill says.

Jill alleges fluoroquinolones have been associated with severe side effects for a long time. Many other fluoroquinolones have been taken off the U.S. market because of unacceptable risks of adverse events, Jill claims.

Jill claims that, contrary to Bayer’s assertions that Avelox is safe and effective, scientific evidence shows a “clear association between Avelox and an increased risk of long-term and sometimes irreversible peripheral neuropathy.” She says that as early as 1988, the defendants were aware of at least one case study that suggested an association between fluoroquinolones and “peripheral paraesthesia.”

She cites several other studies published over the years showing an association between fluoroquinolones and peripheral neuropathy. One study published in 1990 found an “indisputable” relationship between one patient’s peripheral neuropathy and her earlier use of a fluoroquinolone.

Another study published in 1996 reported various neurological symptoms in many of 37 patients treated with fluoroquinolones. Patients variously reported numbness, pain, and muscle weakness, and 81 percent of the patients reported paresthesia.

Plaintiff: Avelox Peripheral Neuropathy Warning Was Inadequate

Jill accuses the defendants of failing to warn both her and her physicians of the risk of Avelox peripheral neuropathy.

She says that from September 2004 through July 2012, the warning label for Avelox stated that instances of peripheral neuropathy associated with Avelox treatment were “rare” – an assertion Jill says was false.

During the same time, she says, the label offered no warning that Avelox peripheral neuropathy could be irreversible.

Jill’s Avelox lawsuit raises claims for strict liability, failure to warn, negligence, breach of express and implied warranties, fraud, negligent misrepresentation, and fraudulent concealment.

The Avelox Peripheral Neuropathy Lawsuit is Case No. 2:16-cv-03797-LDD in the U.S. District Court for the Eastern District of Pennsylvania.