Lawsuit Over Levaquin Nerve Damage. A Texas woman who alleges that she was not warned of the known danger of permanent nerve damage from the antibiotic Levaquin has filed a lawsuit against Janssen Pharmaceuticals and the drug distributor McKeeson Corp. The case was filed in the U.S. District Court for the Middle District of Pennsylvania.
The woman received Levaquin both during and after heart surgery in 2006, and her complaint alleges that the drug maker did not warn either physicians or patients that using the drug could result in permanent nerve damage.
Law360 reports that from 2004 until 2013, the drug carried a confusing label that advised consumers this side effect was rare and symptoms would disappear when the drug was discontinued.
According to Law360, this suit is the second suit in about a month that claims Janssen
According to Law360, this suit is the second suit in about a month that claims Janssen, which is a unit of Johnson & Johnson, ignored the risk of nerve damage related to Levaquin. The Texas woman received Levaquin intravenously and in pill form, and said within weeks she began to experience pain and numbness in her arms and legs.
She went on disability in 2008 because she was unable to work and, despite medication, she continues to experience burning in her arms and legs and tingling in her scalp, “as if it is on fire.”
The woman’s attorney said that in his client’s case, as well as in other cases involving nerve damage blamed on Levaquin, neither the patient nor the doctor was adequately informed of the risk.
The attorney said that some patients taking Levaquin who complained to their doctors of pain were advised to finish the course of treatment then see if the pain went away.
Levaquin (levofloxacin) received Food and Drug Administration approval 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 lawsuit alleges that there was scientific evidence
The lawsuit alleges that there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy as early as 1990. A paper published in 2001 reported neurological side effects in 45 patients; for half of them, the effects lasted more than a year.
In 2004 the drug maker changed the Levaquin label to state 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.
In 2013 the FDA warned that severe damage can result from fluoroquinolones and the agency ordered a label update. The FDA found that earlier warnings 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, and then fraudulently concealed information from users. The woman seeks both compensatory and punitive damages.