Dermatron Devices Seized

FDA Consumer 28(8):36, 1994

SUBJECT: Denial of use of Dermatron and interference with desired medical treatment, Reno, Dist. Nev.; Civil No. N-91-041-HDM.

PETITIONED 1-28-91 by Century Clinic, Reno, Nev., Yiwen Y. Tang, M.D., H.M.D., clinic medical director, Katrina C. Tang, H.M.D., clinic staff member, six named patients of the clinic, and an association of clinic patients, against HHS Secretary Louis W. Sullivan and FDA Commissioner David A. Kessler in a complaint for declaratory judgment and injunction: That the Dermatron was a galvanic skin response measurement device employed by thousands of physicians and that the Dermatron had been in commercial distribution prior to the enactment of the Medical Device Amendments on May 28, 1976, and accordingly had a "grandfather" status; that the Century Clinic and the other plaintiffs had their property seized with attendant threatened criminal prosecution and violations of their civil rights, and the patients had been unlawfully denied access to the Dermatron and other modalities.

The asserted unlawful course of action of the defendants included, among other actions, the following: On Sept. 9, 1990, FDA agents, purportedly acting pursuant to a search warrant, seized medical records of 49 patients as well as medications, Dermatrons, and other medical equipment, private files, and other items; and on Oct. 25, 1990, FDA agents, purportedly acting pursuant to a search warrant, seized the medical records of 22 or more active clinic patients, as well as medications, Dermatrons, and other medical equipment, private files, and other items.

In addition, the plaintiffs asserted that no statute authorized the defendants to interfere with free choice as to the Dermatron, and that, by virtue of the above actions, the patient plaintiffs had been denied lawful access to the Dermatron. The plaintiffs accordingly prayed for a declaratory judgment that the Dermatron was a lawful and proper medical device, and for a declaratory judgment that the defendants' actions were null and void. The plaintiffs also prayed for a preliminary and permanent injunction against such actions.

DISPOSITION: The government generally denied the charges, except for admitting the execution of search warrants and the seizure of Dermatrons, other medical devices, and other objects. The government moved for a stay of the proceedings pending completion of a criminal investigation and potential criminal proceedings. The plaintiffs moved for a preliminary injunction to enjoin the government from harassing and interfering with the doctor-patient relationship between the patients of Dr. Tang and seeking to destroy the homeopathic medical practice of the plaintiffs Tang.

The court denied the plaintiffs' motion for a preliminary injunction and granted a stay of the proceedings pending outcome of criminal proceedings. Ultimately, pursuant to a consent decree of permanent injunction against Century Clinic, Inc., and Katrina Tang, this action was dismissed. (Misc. 941; S.J. No. 23)

This article was posted on May 11, 2010.

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