Ken Paxton

Monday, December 1, 2003

Attorney General Abbott Sues ' Colonic Hydrotherapy ' Providers For Abuse Of Medical Devices; One Death Reported

AUSTIN - Texas Attorney General Greg Abbott has filed six lawsuits against clinics, manufacturers and one training association that have engaged in the promotion, sale or unauthorized use of prescription devices for "colonic hydrotherapy" treatments without physician involvement. The suits - five filed in Dallas and one in Austin - seek temporary and permanent injunctions to protect the public from further deaths and serious injuries.

The lawsuits - and prior investigations by the Texas Department of Health - allege the defendants advertised, promoted, sold or used these devices without physician involvement, a serious public health threat. At least one death was involved.

The treatments involve the thorough cleansing of the colon using prescription systems and nozzles. The purchase, possession and use of this equipment require physician approval and supervision, according to state and federal laws. The treatments are approved by the U.S. Food and Drug Administration for patients only when medically indicated, such as prior to undergoing radiologic or endoscopic examinations.

"We believe the routine use of these devices without a physician's approval or knowledge is like a ticking time bomb, and the patients may not be aware of the serious health risks involved," said Attorney General Abbott. "Doctors should decide when and if to approve the use of these devices in medically necessary situations."

One death and four serious injuries involving patients with perforated colons occurred this year following the treatments. The TDH referred the cases to the Attorney General for legal action.

Named in the lawsuits are:

At no point along the chain of trade in these devices - from manufacturers, to the consulting association, to the unlicensed practitioners and their clinics - did anyone seek or obtain a physician's order to purchase or use these devices or offer the treatments to the public, according to the lawsuits.

And while the suits allege the defendants had no physician involvement, a violation of the Texas Health and Safety Code, the suits also establish several violations of the Texas Deceptive Trade Practices Act.

For example, advertising that colonic cleansing is a legally available treatment for "general well-being" and for "re-energizing life" is fraudulent, the suits maintain. Such uses are not approved by the FDA. Likewise, claiming this method of treatment, as well as "ozone steam spas," can be used to treat and cure cancers, immune system problems and other maladies have not been proven by scientific study and are not authorized by the FDA.

The state's lawsuit seeks civil penalties of up to $25,000 per day, per violation of the Health and Safety Code, up to $20,000 per violation of the Deceptive Trade Practices Act, investigative costs and attorneys' fees.