Indianapolis News and Headlines


Alleged antibiotic victims sue ex-FDA head

Posted at 10:36 AM, Feb 05, 2016
and last updated 2016-02-05 11:02:40-05

Alleged victims of an antibiotic are suing the former head of the Food and Drug Administration.   

They say the company and others hid information about debilitating side effects of the antibiotic Levaquin, and that they did so for their own financial gain.

The lawsuit says while Johnson & Johnson made the drug, former Food And Drug Administration commissioner Margaret Hamburg's husband made money off Johnson & Johnson stock.

MORE | Read the full lawsuit here

Call 6 Investigates Kara Kenney raised questions about the powerful drug last year.

PREVIOUS | CALL 6 Investigates: Patients raise concerns about powerful antibiotics

Levaquin is part of a family of antibiotics collectively known as fluoroquinolones and are marketed under brand names including Levaquin, Cipro and the generic form Levofloxacin.

Neal Travis of Bloomington took fluoroquinolones from 2009 to 2013 while in the hospital for pulmonary problems.

“It hurts to breathe, my skin burns like I’ve been in a fire and taken back out,” Travis said in 2015. “It’s difficult to lay down, sit up. It’s getting continually more difficult to walk.”

The new lawsuit is unusual because the plaintiffs are alleging that the company engaged in racketeering and violated the Federal RICO act -- a law normally used to prosecute organized crime.

Attorney Larry Klayman out of Washington, D.C. is arguing that Johnson & Johnson and other defendants worked together to mislabel and misbrand Levaquin, despite being aware of serious harmful side effects of the drug.

Levaquin and other fluoroquinolone drugs were discussed at an FDA hearing in November. Two FDA committees overwhelmingly voted that the existing labels do not fully explain the risks of taking the drugs.

In a statement, Jennifer Norton, a spokeswoman for Janssen Pharmaceuticals under Johnson & Johnson wrote, in part:

"We continually monitor the safety and efficacy of all our medicines and, in cooperation with the US FDA and other health authorities, we update our product labels with new information so doctors and patients can make informed decisions. While we haven't been served the complaint you reference, we stand behind Levaquin and believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients."

The suit also names Dr. Margaret Hamburg, former FDA commissioner, and her husband as defendants. The plaintiffs are seeking close to a billion dollars in damages.

Hamburg's attorney emailed this statement:

"Mr. Klayman's allegations against Dr. Hamburg are patently false. There is no factual or legal basis for his lawsuit, and we are confident the court will dismiss his claims in their entirety.

Fluoroquinolones are used to combat serious infections such as pneumonia and kidney infections and are so powerful they are used in the treatment of anthrax cases.

RTV6 obtained a 2013 FDA report that raises new concerns about possible "mitochondrial toxicity."

Since 2008, the FDA has provided its highest level warning - known as a black box warning - alerting doctors that side effects can include ruptured tendons and nerve damage.

In addition, our investigation obtained an FDA database of adverse effects and found 3,000 deaths and 200,000 complaints of serious effects associated with Levaquin and similar drugs.


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