A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.

The drug is one of the controversial group of antibiotics, including Levaquin, Cipro, Avelox and other fluoroquinolones. Public Citizen petitioned the FDA in 1996 and again in 2006, to issue Black Box warnings for tendon rupture and tendinitis. Had warnings been issued, the death toll from Levaquin– reputedly more than 5,000 — and the tens of thousands who were debilitated with life-threatening diseases would likely have been averted. (Read risks at RxList)

The suit, filed by Larry Klayman, a former federal prosecutor, charges Dr. Hamburg, her husband, Peter Brown, an executive in the hedge-fund Renaissance Technologies, with collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.

“While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

This lawsuit is unusual; it shines a light on blatant political corruption — the purchase of powerful executive posts.

In 2009, President Barak Obama nominated Dr. Margaret Hamburg for Commissioner of the FDA as a political appointee. The suit alleges that Dr. Hamburg and her husband had made large donations to Hillary Clinton’s campaigns, and to the Clinton Foundation. And that they “gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.”

“Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.”

The suit further charges that “During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest –specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.”

“Once confirmed as FDA commissioner, Dr. Margaret A. Hamburg 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.”

Hamburg also came under fire when she approved the highly addictive painkiller drug, Zogenix

In December 2012, an FDA advisory panel of experts voted 11 to 2 against approval of the painkiller, Zohydro ER. The panel cited concerns over that drug’s potential for overdose. Indeed, 28 law enforcement agencies and addiction experts had voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses and deaths. Zogenix, could be used by people addicted to other opioids, including oxycodone.

Fifteen anti-addiction groups wrote a letter of complaint to the Secretary of Health and Human Services. Despite the safety concerns by the medical and law enforcement community, and despite the expert panel’s overwhelming rejection of the drug, Dr. Hamburg approved it.

The lawsuit provides documentation showing that from 2011 to May 2015, Dr. Hamburg’s husband’s hedge fund, Renaissance Technologies, “not coincidentally, held stock in Alkermes, the manufacturer of Zohydro amounting to tens of millions of dollars. Does anyone not recognize corruption?

The conflict of interest doesn’t end there. Adding even more insult to injury, Alkermes also manufactures a drug to TREAT addiction. So, both Alkermes and Renaissance Tech were given the FDA green light to rake in profits from both the sale of a highly addictive drug, then cashing in on the sale of a treatment for that drug-induced addiction!!

Klayman, the lawyer for several of the victims told KCTV5:

“The alleged criminal corruption we are seeking to remedy in this case is typical of Hillary Clinton and the rest of the sleazy politicians of both political parties that infest Washington, D.C. It helps explain why the political establishment and their lobbyist friends at companies like Johnson & Johnson are being shown the door by the voters during this year’s election. By asking for $120,000,000 over in damages and $750,000,000 in punitive damages, if the victims are successful, they will put a chink in the sides of these alleged criminals and send a loud message that this misconduct will no longer be tolerated.”

The suit charges:

“From May of 2009 to March of 2015, Defendant Hamburg was employed as the FDA Commissioner. During the time Defendant Hamburg was FDA Commissioner, she was married to Defendant Brown, who at all material times was an executive or co-CEO of the hedge fund, Renaissance Technologies, during and throughout Defendant Hamburg’s tenure as FDA Commissioner. Defendant Hamburg was a political appointee of President Barack Obama. On information and belief, Defendant Hamburg was recommended to and promoted to President Obama to fill the role of FDA Commissioner by Hillary Clinton, to whom Defendant Hamburg and Defendant Brown had provided, and continue to provide, significant political contributions and other gratuities. ($2 million contribution to Hillary Clinton election campaign, according to OpenSecrets.org) For example, in 1993, Defendant Hamburg was President Bill Clinton’s first choice for the newly created federal AIDS coordinator. In 1997 President Bill Clinton selected in to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services. Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama. In addition, in 2014 Defendant Hamburg spoke at an open town hall meeting on behalf of The Clinton Foundation. Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner. Defendant Brown, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2000 and 2007 in order for Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama as FDA Commissioner. “While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.” As part of Defendant Hamburg’s pattern and practice of acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval. In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro’s approval. On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with the other Defendants to fraudulently withhold it.” Read the brief:

In 2014, Forbes listed Dr. Hamburg as the 51st most powerful woman in the world. Her husband is identified in Wikipedia as an “artificial intelligence researcher” rather than as a hedge-fund executive.

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