Federal lawsuit filed against former FDA Commissioner

FDA logo

RICHMOND, Va. (WRIC) — A federal lawsuit has been filed alleging the former FDA Commissioner who was well aware of problems with a popular antibiotic, but remained silent so she could profit.

8News has reported extensively about patients who say the drug Levaquin, which is often prescribed for everything from sinus infections to urinary tract infections, has been nothing but a prescription for pain. Now, attorney Larry Klayman, known for being a Washington watchdog, filed the suit on behalf of six patients who took the antibiotic Levaquin. It alleges that the former FDA Commissioner, Dr. Margaret Hamburg, defrauded consumers and conspired with Johnson and Johnson, the makers of the drug, to suppress information about the harmful effects of Levaquin for financial gain.

“Tens of thousands of people throughout this Country have been seriously injured and some died as a result of this dangerous drug,” said Klayman.

The suit claims while Dr. Hamburg was serving as FDA Commissioner her husband Peter Brown was co-CEO of the hedge fund Renaissance Technologies LLC. Renaissance Technologies held stock in Johnson and Johnson. So, the suit alleges if Johnson and Johnson did well, Dr. Hamburg’s husband profited enormously.

The suit claims brown took in millions and millions of dollars while his wife was the FDA Commissioner.

“Tens of thousands of people throughout this Country have been seriously injured and some died as a result of this dangerous drug.” — Larry Klayman

“Dr. Hamburg had a very big conflict of interest when she was FDA Commissioner,” says Klayman.

Past 8News investigations have exposed thousands of complaints about the drug Levaquin and others like it, part of a class of drugs known as fluoroquinolones. Complaints, this lawsuit claims, Dr. Hamburg was well aware back in 2010 but instead of ordering label changes for Levaquin, it accuses her of maintaining the “status quo”.

Attorneys for the former FDA Commissioner call Klayman’s allegations “patently false, reckless and offensive.” In a statement to 8News they say:

“There is no factual or legal basis for his lawsuit, and we are confident the court will dismiss his claims in their entirety.“

We also reached out to Johnson and Johnson they gave us the same statement they have given us in the past:

“We stand behind Levaquin and believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients.”

Meanwhile, the fight to warn others about the potential dangers from Levaquin and similar drugs Cipro and Avelox is moving to Capitol Hill. Rachel Brummert and Jonathan Furman, who are not part of the lawsuit but have shared their painful stories with 8News in the past, just met with Virginia Representative Dave Brat and Sen. Mark Warner.

“It seemed to be very productive, a lot of good information was shared,” says Furman.

As lawmakers now consider the 21st Century Cures Act, which aims to get cures from research into medical practice faster, Furman and Brummert (both part of theQuinolone Vigilance Foundation) want to make sure it includes provisions for patient safety and post market surveillance.

“In the last 10 years I have had ten tendon ruptures, I have neuro-degenerative disorder and I have heart problems as a result and I was never warned of it,” said Brummert.

Read the complaint

Comments are closed.