29 December 2004 – LAWFUEL – Best for law news – Marcos Daniel Jiménez, United States Attorney for the Southern District of Florida;
David W. Bourne, Special Agent in Charge, Miami Field Office, United States Food
and Drug Administration (FDA) Office of Criminal Investigations, announced today
that during the afternoon of December 23, 2004, the United States moved for and
obtained in the Southern District of Florida entry of an Ex Parte Emergency
Temporary Restraining Order prohibiting defendants, Dr. Chad Livdahl, N.D., Dr.
Zarah Karim, N.D., Toxin Research International, Inc., Powderz, Inc., The Cosmetic
Pharmacy, Inc., and Z Spa, Inc., from committing violations of the Federal Food and
Drug Cosmetic Act, Title 21, United States Code, Section 332, and from committing
fraud on the United States Government, in violation of Title 18, United States
Code, Section 1345. The Emergency Temporary Restraining Order prohibits the
defendants from the use, sale, marketing, and promotion of a toxic substance for
treatment of wrinkles in human beings, as the defendants do not have the approval
of the FDA to conduct such activities. The Emergency Temporary Restraining Order
was entered in Ft. Lauderdale, Florida, by United States District Court Judge James
L. Cohn, after the United States filed its Ex Parte Complaint for Emergency
Temporary Restraining Order and Preliminary and Permanent Injunction (Complaint),Ex Parte Motion for Emergency and Temporary Restraining Order and Preliminary and
Permanent Injunction (Motion for TRO), and supporting papers. The case is styled
as United States v. Dr. Chad Livdahl, N.D, et al., Case No. 04-61717-CIV-COHN.
Based on the allegations in the Complaint and the Motion for TRO, the individual
defendants, Doctors Livdahl and Karim, through their principal company Toxin
Research International, Inc., (TRI), offered for sale a dangerous toxin, Botulinum
Toxin Type A. Doctors Livdahl and Karim, through their other companies, Powderz,
Inc., The Cosmetic Pharmacy, Inc., and Z Spa, Inc., marketed this Botulinum Toxin
Type A for use in humans, with full knowledge that in
order to do so, they were required to have FDA approval, which they did not.
The Complaint further alleges that the defendants purposefully and knowingly tried
to avoid FDA regulations by labeling their product “For Research Purposes Only. Non
Human Use Only.” However, as alleged in the Complaint, the defendants sold their
products for use on humans. Sales were made to plastic surgeons, dermatologists,
and other physicians in the Southern District of Florida and throughout the
country. Further, Doctors Livdahl and Karim conducted seminars, through Powderz,
Inc., and The Cosmetic Pharmacy, Inc., instructing attendees how to inject this
unapproved toxin into human beings, and conducted live demonstrations to this
effect. Notably, seminar attendees were strictly warned that photography or
videotaping of any kind was strictly prohibited, and violators would be subject to
expulsion. As reflected in the Government’s flings, Dr. Bach McComb was one of
the presenters at a seminar in July 2003 held by Powderz, Inc. Dr. McComb is an
osteopathic doctor, whose license to practice medicine was suspended by the State
of Florida in April 2003. He and three (3) other victims are currently
hospitalized with symptoms of botulism, as a result of injecting non FDA approved
Botulinum Toxin Type A obtained from a source other than the defendants.
The Complaint further alleges that the defendants committed a fraud on the United
States. In October 2004, FDA Inspectors conducted an inspection of TRI. Doctors
Livdahl and Karim represented to inspectors that they only sold the Botulinum Toxin
Type A for research purposes, and claimed no specific knowledge of the uses their
customers might have for their product. However, the Complaint alleges that
subsequent to this FDA inspection, the defendants sold their product to
non-research physicians, and physicians who worked at “Skin Clinics.” Also, as
reflected in the government’s filings, a person or person(s) attempted to delete
computer records reflecting sales of the Botulinum Toxin by TRI.
Additionally, on December 1, 2004, Doctor Livdahl finalized an architectural
contract to open up Z Spa, Inc., a company which advertises itself as having, “the
most advanced anti-aging skin care treatments available.” Z Spa’s website
publicizes an “Open House,” scheduled for January 15 and 16, 2005, were patrons can
expect “Free Education on the latest cosmetic treatments.” As the Complaint
alleges, given the great potential for harm when this non FDA approved Botulinum
Toxin is used on human beings, the United States sought the Temporary Restraining
Order to cease the defendants’ illegal and dangerous activities.
Mr. Jiménez commended the investigative efforts of the United States Food and Drug
Administration. This case is being prosecuted by Assistant United States Attorneys
Russell Koonin, George Karavetsos, and Robin Rosenbaum.
A copy of this press release may be found on the website of the United States
Attorney’s Office for the Southern District of Florida at www.usdoj.gov/usao/fls
. A copy of the Complaint, Motion for TRO, the
Government’s memorandum in support of the TRO, the TRO, and the two affidavits (one
with exhibits) in PDF format are attached below. Related court documents and
information may be found on the website of the District Court for the Southern
District of Florida at www.flsd.uscourts.gov or on
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