Federal Government Moves for Seizure and Forfeiture of Unapproved Medical Devices
News Desk
The following is a press release issued by the US. Attorney's Office
for the District of Connecticut on June 12, 2006.
U.S. Department of Justice
United States Attorney -- District of Connecticut
Connecticut Financial Center
157 Church Street
New Haven, Connecticut 06510
FOR IMMEDIATE RELEASE
June 12, 2006
Further Inquiries:
Tom Carson
Public Information Office
(203) 821-3722
(203) 996-1393 (cell)
Federal Government Moves for Seizure and Forfeiture of Unapproved
Medical Devices
Kevin J. O'Connor, United States Attorney for the District of
Connecticut, and Dr. Andrew C. von Eschenbach, Acting Commissioner of
FDA, today announced that the United States has filed a Complaint in
the U.S. District Court in New Haven that seeks the seizure and
ultimate forfeiture of numerous medical devices and their component
parts and accessories that were stored in a distribution warehouse in
Meriden, Connecticut. The Complaint, filed on Wednesday, June 7,
alleges that the medical devices, which were muscle stimulators being
sold as "Dr. Ho's Double Massage" and "Dr. Ho's Muscle Massage," are in
violation of a series of Food and Drug Administration (FDA) statues in
that the devices are both adulterated and misbranded.
The seized devices are owned by Universal Academy, Inc., an importer
located in Markham, Ontario, Canada. Universal Academy, Inc. is
associated with a Dr. Ho from China, who has sold various products and
has marketed these devices touting miracle cures.
On Thursday, June 8, the United States Marshals Service, accompanied by
FDA officials and State of Connecticut Department of Consumer
Protection Drug Control Agents, executed a warrant to seize the items,
which have an estimated retail value of more than $1 million, from
Fosdick Fulfillment Corporation in Meriden.
U.S. Attorney O'Connor noted that Fosdick has cooperated fully in the
investigation.
The devices, components, and accessories, are adulterated under the
Federal Food, Drug, and Cosmetic Act because they are unapproved class
III medical devices and they do not meet mandatory performance
standards. In addition, the devices are labeled for use to treat
serious medical conditions, including diabetic neuropathy,
fibromyalgia, arthritis, and migraine headaches. Since these devices
have not been approved by FDA, the safety parameters associated with
their use and the efficacy of the devices for use to treat diseases
have not been determined. These devices are misbranded because their
labeling lacks adequate directions for intended use, they are not
labeled prescription use only, and they are not being used by consumers
by order of a licensed practitioner. They are further misbranded
because they were manufactured at an unregistered facility.
U.S. Attorney O'Connor noted that the U.S. Attorney for the Western
District of New York also has filed a civil complaint and has seized
approximately $2.7 million worth of Dr. Ho medical devices.
Protecting the public against products illegally marketed without FDA
approval is an important part of the mission of our agency," stated FDA
Acting Commissioner von Eschenbach. "The unapproved claims on products
such as these often lead patients to forego proven therapies, which can
cause serious health consequences."
The case has been assigned to Senior United States District Judge
Alfred V. Covello in Hartford.
This case is being investigated by the FDA under the direction of Gail
T. Costello, New England District Director. The case is being
prosecuted by Assistant United States Attorney William M. Brown, Jr.,
and Jennifer Caruso, a trial attorney from the FDA Office of Chief
Counsel.
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