Thursday, July 30, 2015

Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims

Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims

By Steven Trader
Law360, New York (June 29, 2015, 10:02 PM ET) -- Drugmaker Janssen Pharmaceuticals and parent company Johnson & Johnson were hit with a lawsuit Monday in Pennsylvania federal court alleging the drugmaker mislabeled and continued to market an antibiotic drug despite a growing body of research indicating that it led to permanent nerve damage.

Gordon Olsommer, who was prescribed Janssen’s blockbuster fluoroquinolone antibiotic Levaquin in 2010 for a case of bronchitis and a sinus infection, contends that the drugmaker incorrectly advised consumers between 2004 and 2013 that the peripheral neuropathy side effects associated with the drug were rare and that symptoms would disappear once the drug was discontinued.

Further, Olsommer says that even after the FDA determined the warning label was inadequate in 2013, consumers of Levaquin, whose chemical name is levofloxacin, were still advised that stopping the drug immediately upon the onset of symptoms would prevent permanent nerve damage, which contradicted the later warning that the symptoms may be irreversible in any case, according to the lawsuit.

Olsommer says that shortly after he was prescribed Levaquin in June and July 2010, he began suffering the symptoms familiar to peripheral neuropathy, including weakness, numbness and pain in his hands and feet, and he was diagnosed with peripheral nerve damage shortly afterward.

“As a direct and proximate result of defendants’ carelessness and negligence, plaintiff suffered severe and permanent physical and emotional injuries including, but not limited to, irreversible peripheral neuropathy,” the complaint says. “Plaintiff has endured pain and suffering, has suffered economic loss, including incurring significant expenses for medical care and treatment, and will continue to incur such expenses in the future.”

The FDA approved Levaquin in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections such as bronchitis or pneumonia.

The complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy, and a 2001 paper published after Levaquin hit the market reported neurological side effects in 45 patients, half of them lasting more than a year.

However, in 2004 the drugmakers altered the label of Levaquin only to state that peripheral neuropathy symptoms were rare, even after they were advised that patients were still suffering symptoms of neurological damage despite having discontinued the drug, according to the complaint.

It wasn’t until 2013 that Levaquin’s label was updated with a phrase stating peripheral neuropathy may be irreversible, and the plaintiff points to a 2014 study of more than 6,000 cases of peripheral neuropathy published in the journal Neurology which found that “those on fluoroquinolones were at a statistically significant higher risk of developing peripheral neuropathy.”

The plaintiff is seeking an unspecified amount of money for actual and punitive damages on claims that Johnson & Johnson and Janssen were negligent of the research and fraudulently concealed the danger of their product and are therefore liable for the resulting neurological effects.

Representatives for the parties did not respond Monday to requests for comment.

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