Former FDA commissioner Margaret Hamburg, and her husband, investment banker Peter Brown, have been named in a federal-level anti-racketeering lawsuit alleging that the two conspired with executives from Johnson & Johnson and Ortho-McNeil-Jansen Pharmaceuticals to supress data about side-effects associated with Levaquin.
The suit, filed on April 11, in the US District Court for the District of Columbia, charges that during her tenure as head of the FDA, Dr. Hamburg colluded with her husband--who runs a hedge fund called Renaissance Technologies, LLC, to "reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin."
Levaquin, aka levofloxacin, is a broad-spectrum antibiotic approved by the FDA in 1996 and marketed by the J & J-owned Ortho McNeil company. Though most mainstream clinicians consider it to be a fairly safe drug, Levaquin has in recent years come under scrutiny for its potential adverse effects. The drug has been the subject of roughly 3,400 individual state and federal lawsuits, as well as a class-action suit filed by people who claimed exposure to the drug caused severe tendon damage. J & J has opted to settle in all but 363 of these cases.
The new suit was brought by Larry Klayman, a former federal prosecutor, on behalf of five individuals who claim they were severely injured by taking Levaquin.
Citing the federal Racketeer Influenced and Corrupt Organizations (RICO) law, Klayman claims that while serving as FDA Commissioner, "acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly."
Klayman, who served as a Justice Department prosecuter during the Reagan Administration, is considered a thought leader in right-wing Tea Party circles, and he has been an outspoken critic of President Obama, and both Clintons.
Dr. Hamburg resigned from her FDA post in March 2015, after a tenure of nearly 6 years. Shortly after leaving FDA, she was appointed as the Foreign Secretary for the Insitute of Medicine, under the National Academy of Science.
In his Levaquin filing, Klayman contends that Hamburg had access to a 2013 FDA report entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that directly links Levaquin to mitochondrial toxicity and, possibly, neurodegenerative diseases like ALS, Parkinson's and Alzheimers, but that she deliberately failed to take action to disclose and disseminate this information because she had a personal financial stake in the success of Ortho-McNeil and J & J.
The suit states that Hamburg, and her husband "reaped and continues to reap huge financial gain as a result of Renaissance Technology's holdings of Johnson & Johnson stock."
It also claims that Hamburg basically turned a blind-eye to data from the Federal Adverse Events Reporting System (FAERS) documenting a link between Levaquin exposure and a host of multi-system disabilities--a constellation of side-effects that an FDA advisory committee terms "Fluoroquinolone-Associated Disability." The drug's manufacturer does not include this on it's warning labels.
During Hamburg's tenure at FDA, J & J was involved in a number of questionable actions, including a program of illegally bribing Omnicare--a large pharmaceutical distributor in the nursing home industry--to increase the sales of Levaquin.
In addition to these charges, the suit also alleges that Hamburg and her husband were engaged in quid pro quo political donations to President Obama's campaigns; that Hamburg's appointment as FDA head in 2009 was a result of her donations to the Clinton Foundation in exchange for endorsements by Secretary of State Hillary Clinton; and that during the congressional deliberations prior to her confirmation, Hamburg failed to disclose the large pharmaceutical holdings by her husband's investment firm--a red flag for what Klayman sees as a "clear-cut conflict of interest."
The plaintiffs in this suit are seeking $120 million in compensatory damages, as well as up to $750 million in punitive damages from the drug makers. Since racketeering and conspiracy are criminal acts, the defendants could also face prison sentences if found guilty.
So far, none of the defendants has issued a formal statement specifically addressing the suit or the allegations therein.