Thursday, July 30, 2015

Janssen Hit With Another Levaquin Nerve Damage Suit

Janssen Hit With Another Levaquin Nerve Damage Suit

By Steven Trader
Law360, New York (July 29, 2015, 1:49 PM ET) -- Drugmaker Janssen Pharmaceuticals and distributor McKesson Corp. were slapped with a suit Tuesday in Pennsylvania federal court by a Texas woman who says the companies failed to warn her of the known dangers of an antibiotic drug that ultimately gave her permanent nerve damage.

Catherine Farmer, who was administered the Johnson & Johnson unit's blockbuster fluoroquinolone antibiotic Levaquin both during and after heart surgery in 2006, contends in her complaint that rather than warning patients and physicians directly that the drug may result in permanent nerve damage, the drugmakers relied on a confusing label that between 2004 and 2013 advised consumers the side effect was rare and symptoms would disappear by discontinuing use.

Farmer's is the second suit in about a month claiming Janssen ignored the risk of nerve damage related to Levaquin, which in 2007 was ranked as one of the top prescribed and highest-selling drugs in the world, generating $1.6 billion in revenue for Johnson & Johnson.

Farmer says within weeks of receiving a Levaquin IV and pill prescription following her surgery she began to experience pain and numbness in her arms and legs, according to the complaint. By 2008 she was on disability and unable to work. To this day Farmer experiences burning in her arms and legs and tingling in her scalp, “as if it is on fire,” despite taking medication to help her live with her peripheral neuropathy symptoms, according to the complaint.

Farmer's attorney Ahmed Diab of Gomez Trial Attorneys said one of the cruxes of the complaint, as in some others, is that not only were the patients not adequately warned but the physicians weren't either. Diab said patients like Farmer would call their doctors complaining of pain, only to be told to finish the course of medication then see if the pain goes away.

"Even the doctor's weren't adequately warned, so they couldn't even advise patients in a proper manner," Diab told Law360. "Ms. Farmer just never had a shot at knowing this was a potential risk."

The U.S. Food and Drug Administration approved Levaquin — whose chemical name is levofloxacin — 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.

In 2013, the FDA warned that severe nerve damage can result from the drugs included in J&J’s Levaquin and required label updates, finding that earlier cautions about the risk of peripheral neuropathy failed to fully inform doctors and patients of the risks.

"There are a lot of cases like this being filed," said Diab. "I think we've hit a critical mass."

In her suit Farmer alleges Janssen, Johnson & Johnson and McKesson negligently developed the drug, failed to warn users of its dangerous effects and knowingly placed it into the stream of commerce despite its defect, then fraudulently concealed information about it from its users. She seeks an unspecified amount of compensatory and punitive damages.

Representatives Janssen and McKesson on Wednesday didn’t immediately return a request for comment. Counsel information for the defendants wasn’t immediately available.

Farmer is represented by Joseph G. Sauder and Matthew D. Schelkopf of Chimicles & Tikellis LLP, and John H. Gomez, John P. Fiske and Ahmed S. Diab of Gomez Trial Attorneys.

The case is Catherine and Timothy Farmer v. Johnson & Johnson, Janssen Pharmaceuticals Inc., and McKesson Corp., case number 3:02-at-06000, in the U.S. District Court for the Middle District of Pennsylvania.

--Editing by Jeremy Barker. 

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