A New York woman is bringing an antibiotic peripheral neuropathy lawsuit against Johnson & Johnson, alleging the company failed to warn her or her physician about the risk of peripheral neuropathy associated with Levaquin.

Plaintiff Joanne P. is suing Johnson & Johnson and its subsidiaries Janssen Pharmaceuticals and Janssen Research and Development, the makers of the antibiotic Levaquin.

Joanne alleges she developed peripheral neuropathy after taking Levaquin.

She now argues that Levaquin is “defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce,” and she says the warnings accompanying the medication were inadequate to give her a fair warning of the risk of peripheral neuropathy associated with the drug.

Joanne says she was prescribed Levaquin in 2001 and used it according to the instructions. She began to have symptoms of peripheral neuropathy shortly after that, she says. She claims she was soon diagnosed with peripheral neuropathy, and she says she continues to suffer from that condition today.

Antibiotic Peripheral Neuropathy Lawsuit Says Warnings Were Inadequate

According to this antibiotic peripheral neuropathy lawsuit, Levaquin (also known by its generic name levofloxacin) entered the U.S. market after it was first approved for sale by the FDA in 1996. By 2006, Levaquin had become the most frequently prescribed antibiotic in the world.

The next year, sales of Levaquin generated $1.6 billion in revenue for J&J, accounting for 6.5 percent of the company’s total revenue for that year, Joanne reports.

Levaquin is one of a class of antibiotics known as fluoroquinolones.

Fluoroquinolone antibiotics emerged in the early 1980s as the second generation of quinolone antibiotics, Joanne says. These antibiotics were broader and more potent compared to the ones that came before them.

However, fluoroquinolones have known associations with serious side effects, the antibiotic peripheral neuropathy lawsuit says.

Joanne lists several different fluoroquinolone antibiotics that have been removed from the market due to side effects like kidney failure, liver toxicity, abnormal heart rhythm and abnormalities of blood sugar.

In the case of Levaquin, Joanne claims, “scientific evidence has established a clear association between Levaquin and an increased risk of long-term and sometimes irreversible peripheral neuropathy.”

She cited several studies, some from as early as 1992, that suggested an association between peripheral neuropathy and fluoroquinolone antibiotics including Levaquin.

Joanne argues that J&J and the Janssen companies knew or should have known about the link between Levaquin and peripheral neuropathy, and that they failed to adequately warn her and her physicians about that risk.

Specifically, Joanne claims that from 2004 to 2013, the warning label for Levaquin stated that peripheral neuropathy linked to Levaquin was “rare” and that it could be avoided by discontinuing the drug.

Joanne says both these statements are false. She claims that peripheral neuropathy has an onset so quick that discontinuing the drug may not ensure that any resulting neuropathy will be reversible.

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

She seeks a damage award to include punitive damages, refund of her purchase costs of Levaquin, and reimbursement of her attorneys’ fees and costs of litigation.

The Levaquin Antibiotic Peripheral Neuropathy Lawsuit is Case No. 1:16-cv-04867 in the U.S. District Court for the District of New jersey, Civil Division.