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Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary face a product liability lawsuit alleging a California woman has been left with peripheral neuropathy from Levaquin, resulting in permanent nerve damage that causes severe pain, burning and tingling.
The complaint (PDF) was filed by Zelda Ellis in the U.S. District Court for the Eastern District of Pennsylvania on December 22, alleging that the drug makers failed to adequately warn consumers and medical community about the risk of irreversible neuropathy linked to the antibiotic.
Ellis indicates that she was prescribed Levaquin by her doctor, but after she took the drug, she developed symptoms of pain, burning, tingling, numbness, weakness, and alterations of sensation, which never went away. The lawsuit claims that Ellis would have taken a different antibiotic if she or her physicians had known about the Levaquin neuropathy risks.
Levaquin is part of a widely used class of antibiotics, known as fluoroquinolones (FLQs), which also includes Avelox and Cipro. While the medications have been prescribed for a variety of different infections in recent years, use of the antibiotics has been curtailed over the past year as more information has become available about the risk of peripheral neuropathy and other health problems linked to the drugs.
“Despite the fact that Defendants knew or should have known that their FLQ drugs caused serious injuries, they failed to exercise reasonable care to warn of the dangerous side effect of developing irreversible peripheral neuropathy from their use, even though this side effect was known or reasonably scientifically knowable at the time of their initial marketing and distribution,” the lawsuit states. “Defendants willfully and deliberately failed to avoid the consequences associated with their failure to warn, and in doing so, Defendants acted with a conscious disregard for the safety of Plaintiff.”
In August 2013, the FDA required the makers of Levaquin and other fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk with the antibiotics, adding information to the label for the first time that suggested problems may last for months or years after an individual stops taking the drug. The new label now warns patients to contact their doctors and consider switching to a different class of antibiotics if they experience symptoms of peripheral neuropathy. The FDA also no longer allows the drug manufacturers to claim that the condition is rare on the warning labels.
The case filed by Ellis joins more than 700 similar Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits filed throughout the federal court system over peripheral neuropathy problems allegedly caused by the antibiotics.
Given the side effects linked to the antibiotics, the FDA issued a new drug safety communication in May 2016, urging doctors not to prescribe fluoroquinolones for many common infections that are uncomplicated and have other available treatment options, indicating that the potential risks outweigh the benefits. The federal regulatory agency considered available information on the risk of peripheral neuropathy, tendon ruptures, retinal detachments and other health concerns linked to the drugs at that time.
More recently, research has also suggested that fluoroquinolones may cause severe collagen degradation issues that impact the aorta. As a result, a growing number of aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued by former users of Levaquin and Avelox, alleging that the painful and potentially life-threatening complication may have been avoided if proper warnings had been provided to users of the antibiotics.