Johnson & Johnson faces a new wave of lawsuits in federal court in New Jersey alleging its antibiotic Levaquin caused nerve damage.
From August 1 to 11, 13 Levaquin suits with 18 plaintiffs were filed against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, New Jersey Law Journal reports.
An attorney involved in the filings hopes to see the cases moved to the District of Minnesota as part of a multidistrict litigation established in August 2015 for suits claiming the fluoroquinolone antibiotics Levaquin (levofloxacin), Cipro (ciprofloxacin), and Avelox (moxifloxacin) caused peripheral neuropathy in users. Symptoms of peripheral neuropathy include weakness, numbness and pain, usually in the hands and feet, but peripheral neuropathy can also affect other areas of the body, according to the Mayo Clinic.
The New Jersey Law Journal reports that the new lawsuits linking Levaquin to neuropathy are the second wave of Levaquin litigation, following hundreds of suits linking Levaquin to tendonitis and injured tendons. A multidistrict litigation (MDL) for that tendon damage suits was created in Minnesota in 2008. Litigation of tendonitis cases is still happening.
In May 2016, the Food and Drug Administration (FDA) issued a warning that “disabling” side effects of Levaquin and drugs in the fluoroquinolone family “generally outweigh the benefits” for patients with sinus infections, bronchitis and urinary tract infections who have other treatment options.
Documents in the new group of lawsuits indicate that Levaquin is the most-prescribed antibiotic in the world. In 2007, Levaquin generated $1.6 billion in revenue, accounting for 6.5 percent of Johnson & Johnson’s total revenue, the New Jersey Law Journal reports. The lawsuits allege that J&J and Janssen failed to adequately warn users and their physicians about the risks of neuropathy associated with use of the drug. From 2004 to 2013, Levaquin was sold with a label saying neuropathy was “rare” among users of the drug and could be avoided by discontinuing Levaquin if certain symptoms occurred. But the onset of neuropathy is often rapid and discontinuing Levaquin will not ensure it can be reversed, the lawsuits allege. Peripheral neuropathy can occur at any time during treatment with a fluoroquinolone and can last for months to years after the drug is stopped or it can be permanent, according to the FDA.
The lawsuits cite studies going back to 1990 that indicate a connection between fluoroquinolone drugs and neuropathy. In 2002 and 2003, numerous reports to the FDA’s Adverse Event Reporting System identified fluoroquinolone users who suffered neuropathy that persisted even after they stopped taking the drug.
According to the New Jersey Law Journal, many of the lawsuits in the 2008 MDL have been settled. In 2012, Johnson & Johnson disclosed that it reached settlements with about 845 plaintiffs in the tendonitis MDL who alleged that the drug maker did not properly warn of the risks of tendon damage from Levaquin. The amounts of the settlements were not revealed. In 2013, the Levaquin label was updated to include the risk of rapid-onset neuropathy, but the attorney in the new lawsuits says the label remains “inadequate and confusing.” The attorney said that one of the new plaintiffs cannot walk and must use a wheelchair.