Regulatory Actions against Katrina Tang

Stephen Barrett, M.D.

During 1990, FDA agents twice raided the Century Clinic, of Reno, Nevada (now called the Century Wellness Canter) and seized Dermatron devices and the medical records of 71 patients [1] The case was settled in 1993 with a consent agreement under which the clinic and its director, Katrina C. Tang, were prohibited from using EAV devices without either FDA approval or under an approved application for an investigational device exemption (INE) that would permit legitimate experimental use. The agreement also proivded for a $200,000 penalty for violation of the consent decree.

After the agreement was signed, Biosource, which was not a party to it, obtained an investigational device exemption (IDE) by claiming that its Listen System devices would be used experimentally to see whether they could detect diabetes. According to court documents filed by the U.S. Justice Department, Tang and the clinic then used two of these devices to diagnose other serious diseases and did not collect the data necessary for the Biosource study. In 1998, a magistrate judge recommended that a $400,000 fine be imposed on Tang and the clinic [2]. A petition to overturn this ruling was denied by two federal courts and the U.S. Supreme Court [3].

In 2002, Tang signed a stipulated agreement with the Nevada Board of Homeopathic Examiners indicating that she was retiring and agreeing not to accept any new nonemergency patients [4]. The stipulation noted that between December 27, 2001, and February 4, 2002, 18 complaints had been made against her that had not been investigated by the board.

References

  1. Denial of use of Dermatron and interference with desired medical treatment. FDA Consumer 28(8):36, 1994.
  2. United States v. Century Clinic, Inc., et al. (D. Nev.) GC Litigation Summaries, Feb 11, 1998.
  3. Century Clinic, Inc., and Katrina Tang, Petitioners, v. United States of America. Brief for the United States in opposition to petition for a writ of certeriori, Feb 2000. [PDF]
  4. Stipulated settlement agreement and order. In re Katrina Tang, H.M.D. Nevada Board of Homeopathic Examiners, Dec 14, 2002.

This article was posted on May 11, 2010.

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