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Former FDA Commissioner Charged with Concealing Drug's Deadly Side-Effects

Dr. Margaret Hamburg, the former Commissioner of the Food and Drug Administration (FDA), is facing charges under the federal Racketeer Influenced and Corrupt Organizations (RICO) law. Hamburg is one of several defendants charged with conspiracy, racketeering, and colluding to conceal the deadly side-effects associated with the antibiotic Levaquin. Johnson & Johnson, the manufacturer of the drug, is also named in the suit.

As reported by AHRP.org, the eight plaintiffs bringing the RICO suit claim to have suffered serious harm after taking Levaquin, a fluoroquinolone antibacterial drug. They further allege that the drug’s potentially fatal side effects were concealed for financial gain. With regard to Hamburg, the suit maintains that the former FDA Commissioner used her position to boost the profits of her husband’s hedge fund, which invested heavily in Johnson & Johnson.

“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,” the complaint alleges.

“Had this information been disclosed to plaintiffs and the public at large, her and her husband’s financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg’s husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.’s holdings of Johnson & Johnson stock,” according to the complaint.

The suit also alleges that Hamburg ignored the calls from medical experts to include black box warnings on Levaquin and other fluoroquinolones in order to protect her own financial interests. As further evidence of the conflicts of interest, the complaint cites another controversial drug approved by Hamburg over the recommendations of doctors. Hamburg’s husband’s hedge fund, Renaissance Technologies, again held stock in the manufacturer.

In May, the FDA issued a drug safety communication advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with uncomplicated infections, such as acute sinusitis, acute bronchitis, and urinary tract infections. The FDA further warned that the antibiotics are associated with disabling and potentially permanent serious side effects involving the tendons, muscles, joints, nerves, and central nervous system. The agency is now requiring drug makers to update their labels accordingly.

If you or someone you care about has suffered serious harm due to a dangerous or defective drug, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation.