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