A woman who used the antibiotic Levaquin and developed permanent nerve damage has filed a class action lawsuit accusing Janssen Pharmaceuticals of failing to adequately warn patients and doctors about the risk of severe nerve damage from Levaquin.
The lawsuit (PDF) was filed on August 11 by Michelin Rowell, a woman from North Carolina who was diagnosed with peripheral neuropathy. She is seeking class action status on behalf of everyone who was injured.
The case is Rowell v. Johnson & Johnson et al, Case No. 2:16-CV-04369 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiff argues that the running of any statute of limitations has been tolled by reason of Defendants’ fraudulent concealment of risks associated with
State and federal litigation
Nearly 400 peripheral neuropathy lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue are pending in Levaquin Litigation MDL 1943 in U.S. District Court in Minnesota.
Additional claims with similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.
The defendants include Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).
Indications are that Judge John R. Tunheim, who is overseeing those cases, would be interested in coordinating with the multidistrict litigation. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)
Peripheral neuropathy was added to the label in 2004, but Janssen said nerve damage was a “rare” side effect that would go away when Levaquin was discontinued. The problem is that studies dating back to 2001 concluded that symptoms usually developed within a week, and in most cases problems persisted for at least one year.
In August 2013, the FDA ordered Janssen to update the label with stronger warnings about peripheral neuropathy. The word “rare” was removed and the new warnings emphasize the rapid onset of symptoms and potentially permanent complications, even if Levaquin is discontinued.
In May 2016, the FDA issued another warning about “disabling” side effects that “generally outweigh the benefits” when Levaquin is prescribed for common infections like sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs).