An Illinois woman will be able to pursue fraudulent concealment claims against the manufacturers of Levaquin, after a federal judge in Chicago found that Johnson & Johnson and Janssen Pharmaceuticals had a duty to provide her with important safety information.
Lisa Ringelestein and her husband are seeking compensation from the drug makers for serious side effects that allegedly resulted from treatment with Levaquin, including multiple tendon ruptures, chronic pain and “mitochondrial impairment/fluoroquinolone toxicity.” Her lawsuit, which is currently pending in the U.S. District Court, Northern District of Illinois, claims that Johnson & Johnson and Janssen were aware of these risks, but concealed that information from the public. Defendants were seeking to dismiss the complaint’s claims of fraud and fraudulent concealment.
In an order dated May 31, Judge Gary Feinerman declined to dismiss the fraudulent concealment claims, finding that “common sense” dictates the drug makers had a duty to provide safety information to Ringelestein and her husband. While Judge Feinerman did dismiss the Levaquin lawsuit’s fraud claims after finding they were not pled with required particularity, he did so without prejudice. Plaintiffs have been given until June 21st to file an amended fraud claim.
Levaquin belongs to a class of drugs called fluoroquinolone antibiotics, which are indicated to treat pneumonia and other serious bacterial infections. Other name-brand medications in this class include Cipro and Avelox.
While fluoroquinolones are widely-used, the drugs have been the subject of several regulatory warnings due to their potentially serious side effects. Last May, for example, the U.S. Food & Drug Administration (FDA) warned against their use for most cases of sinusitis, bronchitis and uncomplicated UTIs, as their risks generally outweigh their benefits when other treatment options are available. The warning followed an agency review that suggested fluoroquinolones could cause multiple and permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
In August 2014, the agency ordered the drugs’ manufacturers to modify label information regarding their potential to cause a serious nerve disorder called peripheral neuropathy. While mention of the condition had been added to the prescribing information in 2004, the FDA determined that the labels did not reflect the possible rapid onset of the condition, or the potential for permanence.
In 2008, a Boxed Warning detailing a potential for serious tendon injuries, including ruptures of the Achilles tendon, was added to the labeling of Levaquin and other fluoroquinolone antibiotics.
The manufacturers of Levaquin, Cipro and Avelox have been named defendants in more than 740 peripheral neuropathy lawsuits, all of which are currently undergoing coordinated pretrial proceeding in the U.S. District Court, District of Minnesota. Plaintiffs pursuing these claims allege that the association between fluoroquinolones and peripheral neuropathy was recognized as early as the 1990s. They further assert that the current peripheral neuropathy warnings contained on the drugs’ labels remain “inadequate and confusing.”