A proposed class action lawsuit has been filed against Johnson & Johnson Consumer Inc. and Janssen Pharmaceuticals Inc., in a Pennsylvania federal court. The companies are accused of fraudulently misrepresenting and selling a class of antibiotics that allegedly causes irreversible nerve damage. It’s alleged in the suit that Johnson & Johnson and subsidiary Janssen intentionally concealed the risk associated with taking a class of antibiotics known as fluoroquinolones, which is sold as Levaquin.
Michelin Rowell, a resident of North Carolina, who is the named Plaintiff, alleges she developed irreversible nerve damage – technically called peripheral neuropathy – after taking Levaquin. She is seeking class designation on behalf of herself and other persons who developed the condition after using Levaquin. She also contends in the complaint that any statute of limitations should be tolled because of the fraudulent concealment of the drug’s risks. Janssen manufactures, tests, advertises and sells Levaquin to treat sinus, skin and urinary tract infections caused by bacteria.
The suit alleges that between 2004 and 2013, Levaquin’s label misled patients and physicians by saying patients develop nerve damage after taking the antibiotic on “rare” occasions and patients can avoid nerve damage by stopping treatment. At the time, it’s alleged that scientific evidence had established a clear association between the drug and developing peripheral neuropathy that is at its worst irreversible.
The U.S. Food & Drug Administration (FDA) notified the drug makers in 2002 and 2003 that “numerous reports” had been submitted to the agency alleging peripheral neuropathy continued long after patients stopped taking the antibiotic. In 2013, the FDA determined the drug labels were inadequate, and, as a result, Janssen removed phrasing indicating that nerve damage only occurred in “rare” cases. In July, the FDA signed off on safety labeling changes for fluoroquinolones warnings about a link with potentially permanent side effects.
Concerns about Levaquin’s impact on the nervous system first arose in the scientific community in 1992 when a doctor submitted a letter to The Lancet, a peer-reviewed medical journal, describing a 37-year-old patient who developed nerve damage after she took fluoroquinolones, according to the suit. Four years later, another study was published that linked the antibiotic to nerve damage based on 37 separate reports, and in 2001 an American doctor published a report with similar results that studied 45 patients.
Between 1997 and 2012, according to the complaint, there were 539 reports of nerve damage out of about 46,000 adverse incidents associated with the drug. A 2014 study that compared a group of 48- to 80-year-old men taking the antibiotic with a control group showed that the men were at higher risk of developing nerve damage.
Since 1992, five drugs made of fluoroquinolones have been removed from the U.S. market because of their adverse health effects, but Levaquin is still on the market. In 2006, Levaquin was the top prescribed antibiotic in the world, generating $1.6 billion in revenue and representing 6.5 percent the company’s total revenue. The FDA approved Levaquin in December 1996, and in 2003 it became the top prescribed antibiotic in the U.S.
The suit is making several claims against Johnson & Johnson and Janssen. The drugmakers are accused of failing to warn, negligence, breach of warranty, negligent misrepresentation, fraud and fraudulent concealment. The Plaintiff seeks medical expenses, attorneys’ fees, punitive and compensatory damages, and refunds for money spent on purchasing Levaquin on behalf of herself and other class members.
Ms. Rowell is represented by Russell Budd and Sindhu S. Daniel of Baron & Budd PC. The case is Rowell v. Johnson & Johnson et al. in the U.S. District Court for the Eastern District of Pennsylvania.
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