Janssen Pharmaceuticals and drug distributor McKeeson Corp. were hit with a lawsuit last week in Pennsylvania federal court by a Texas woman who says the companies failed to warn of known dangers of the antibiotic Levaquin, which she alleges caused her permanent nerve damage.
The woman was administered Levaquin both during and after heart surgery in 2006, and in her complaint she contends that the drug maker did not warn either physicians or patients that using the drug could result in permanent nerve damage. The suit said that from 2004 until 2013, the drug carried a confusing label that advised consumers the side effect was rare and symptoms would disappear when the drug was discontinued, Law360 reports.This is the second suit in about a month that claims Janssen, a unit of Johnson & Johnson, ignored the risk of nerve damage related to Levaquin. The Texas woman’s legal complaint says that within weeks of receiving intravenous Levaquin and then Levaquin in pill form, she began to experience numbness and pain in her arms and legs. By 2008 she was unable to work and went on disability. She still experiences burning in her arms and legs and tingling in her scalp, “as if it is on fire,” despite medication to help with symptoms of peripheral neuropathy, according to Law360.
The woman’s attorney said that in her case, as in others involving Levaquin, the patient was not adequately informed of the risk, nor was her doctor. The attorney said that even when some patients taking Levaquin called their doctors to report pain, they were advised to finish the course of the antibiotic then see if the pain went away.
The Food and Drug Administration (FDA) approved Levaquin (levofloxacin) in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections like bronchitis or pneumonia. The Texas woman’s complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy. A paper published in 2001 reported neurological side effects in 45 patients, half of them lasting more than a year. In 2004 the drug maker altered the Levaquin label to warn that peripheral neuropathy symptoms were rare, although the company had been advised that some patients still suffered symptoms of neurological damage despite having discontinued the drug, Law360 reports. The FDA warned in 2013 that severe damage can result from fluoroquinolones and the agency required a label update. The FDA found that earlier cautions did not fully inform doctors and patients of the risks.
The lawsuit alleges that Janssen, Johnson & Johnson, and McKesson negligently developed the drug, failed to warn users of its dangerous effects, knowingly marketed it despite knowing its defect, then fraudulently concealed information from users. The woman seeks both compensatory and punitive damages.
The case was filed in the U.S. District Court for the Middle District of Pennsylvania.