Tulane Endoscopy Litigation

Between October 7, 2010, and December 1, 2010, 366 patients presented to Tulane Medical Center and underwent endoscopy procedures. Endoscopy procedures, such as colonoscopies, sigmoidoscopies, and upper endoscopies of the stomach [EGD procedures], require utilization of a medical device known as an endoscope, which is a tubular instrument used to examine the interior of the hollow viscera. Because endoscopes enter body cavities and are constantly re-used in the hospital setting, the United States Center for Disease Control [CDC] mandates that endoscopes be subjected to "high-level disinfection" utilizing chemical disinfectants. "High-level disinfection" is defined as "the complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores."

Tulane Medical Center utilizes two Medivator DSD-201D AERs, manufactured by Minntech, which the hospital purchased in June 2009 and installed in August 2009. A third party contractor, General Electric Company-GE Healthcare Division ["GE"], was retained to perform servicing, maintenance, and repair of the endoscopes, and pursuant to that contract, GE serviced the device throughout the fall of 2010.

During the time period in question, Tulane had in effect an "Endoscopy Policies and Procedures Manual," which specifically included a policy concerning the "reprocessing," or sterilization, of the hospital's AERs. Initially, Tulane programmed its AERs to operate with a high-level disinfectant called "Cidex OPA." Pursuant to Minntech's instruction manual, high-level disinfection for the AER, when utilizing Cidex OPA, is achieved upon 5 minutes of contact at 25 degrees Celsius. Moreover, the hospital's own policies and procedures require that the disinfectant temperature be "at least 3 degrees Celsius higher than the disinfectant manufacturer's recommendations."

On October 7, 2010, a GE employee performed repairs to one of Tulane's AERs and was asked by a hospital employee to switch the high level disinfectant from Cidex OPA to "Rapicide." Subsequently, on October 26, 2010, the GE employee conducted repairs to Tulane's other AER and again, switched the high-level disinfectant from Cidex OPA to Rapicide.

Critically, high level disinfection utilizing Rapicide, pursuant to the manufacturer's explicit instructions, occurs upon "5 minutes contact at 35 degrees Celsius"-which is 7 degrees higher than the temperature required for Cidex OPA. In addition, pursuant to Tulane's own policies and procedures, the AERs should have been set to reprocess the endoscope three degrees higher than the manufacturer's recommendations, or at 38 degrees Celsius.

When changing the disinfection fluid from Cidex to Rapicide, Tulane failed to comply both with the manufacturer's recommendations, as well as its own policies and procedures. The error was discovered by an interim manager of Tulane's endoscopy department on December 1, 2010, and subsequently, both AERs were adjusted to sterilize at the appropriate temperature.

On or about January 3, 2011, the hospital mailed 366 identical certified letters to all affected patients stating:

Tulane Medical Center routinely follows a five-step procedure in processing endoscopes for use. Recently, during a routine maintenance inspection, we found that one of several steps used in disinfecting endoscopes for procedures conducted between October 7 and December 1, 2010 at our downtown facility was not being performed at the appropriate temperature as recommended by the manufacturer . . .

The letter additionally recommended that the affected patients present for screening for HIV, Hepatitis B, and Hepatitis C. Tulane offered to provide the testing free of charge and also offered to provide "counseling."

If you or a loved one underwent an endoscopy procedure between October 7th and December 1st, 2010, you may have a claim for injury and damages. The court has ruled that the litigation cannot proceed as a class action and so, you should retain counsel and file your claim quickly to be eligible. Based on the court-issued notice, which was published in both New Orleans newspapers, if you do not file a claim before October 12, 2015 you will forever lose your legal rights.