FOR IMMEDIATE RELEASE:
MONDAY - March 9, 2009
CALIFORNIA MAN PLEADS GUILTY IN HUMAN TISSUE IMPLANT CASE
RALEIGH - United States Attorney George E.B. Holding announced that in federal court here today PHILIP JOE GUYETT, JR., 42, of Moorpark, California, pleaded guilty today to three counts of mail fraud, committed in relation to his recovery and sale of human tissue for medical implantation.
The Criminal Information filed on February 5, 2009, lays out the details of GUYETT’s scheme. GUYETT, acting through the corporate identify “Donor Referral Services, Inc.,” recovered human tissue from deceased individuals at funeral homes in and around the Eastern District of North Carolina and sold such tissue to various tissue banks for subsequent sale to medical facilities for the eventual implantation in medical patients throughout the United States. Food and Drug Administration regulations require that certain medical information of the deceased tissue-donor be collected and analyzed by the tissue harvester, as certain medical conditions of the deceased would preclude their tissue from being used for implantation in medical patients.
As part of the scheme to defraud, and to ensure the sale and purchase of the human tissue he harvested, GUYETT knowingly falsified information on the medical history reports concerning the medical histories of the deceased donors from whom tissue was harvested. He would alter, omit, fabricate, and falsify material on the reports, including the deceased donors’ age at death, or their cause of death so that the tissue he was attempting to sell would not be rejected from purchase by various tissue banks because of the disqualifying medical conditions of the donors. He would also resubmit for sale tissue under a false donor name that had been previously rejected for purchase under the actual donor’s name, and submit false blood samples (i.e. blood samples from a different deceased donor) for tissue he knew would be otherwise rejected for purchase.
Commenting on this case, United States Attorney George E.B. Holding stated: “Mr. Guyett chose to tell lies in a matter as sensitive as the implantation of tissue into medical patients around the country, all to make a quick buck. This flagrant and selfish disregard for the health and safety of citizens of this country is reprehensible and simply will not be tolerated.”
David Bourne, Special Agent, FDA Office of Criminal Investigations, Miami Field Office, commented: “The FDA’s Office of Criminal Investigations aggressively pursues and supports the prosecution of those who endanger the public health through illicit misrepresentations and misleading sales practices of human tissue products to unsuspecting patients.”
The FDA and the CDC strongly recommend that health care providers inform their patients who received tissues initially recovered by DRS that they may have received tissues from donors whose eligibility may not have been adequately performed. Further, the FDA and the CDC recommend that health care providers offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Further recommendations for testing are posted on the CDC website at: http://www.cdc.gov. Health care providers who still have concerns or questions about the source of their patients' tissue implants should contact the health care facilities where the procedures were performed. The FDA will continue its investigation into this matter and will issue further public health updates, as needed.
Patients and health care providers should report any adverse reaction which may possibly be related to a tissue transplant to the appropriate processing and/or distributing firms. The FDA requires tissue establishments to investigate any adverse reaction involving a communicable disease for which there is a reasonable possibility that the transplanted HCT/P, distributed by them, caused the reaction, and to report fatalities and/or serious injuries to FDA. Information on reporting of such reactions may be found on the web at: http://www.fda.gov.
Health care providers are also encouraged to report all adverse reactions related to HCT/Ps directly to the FDA. You can report any adverse reaction to MedWatch, FDA's voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov. Consumers can also report any adverse reaction directly to MedWatch.
To getting more information: Additional questions may be directed to the FDA's Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at firstname.lastname@example.org.
Investigation of the case was conducted by the Office of Criminal Investigations of the United States Food and Drug Administration. Assistant United States Attorney Jason Cowley served as prosecutor for the government.