Human Parts 'Harvested' from New York Funeral Homes Being Recalled

Cox News Service

WASHINGTON - Human tissues that may not have been screened for diseases like HIV/AIDS and hepatitis are being voluntarily recalled in Georgia, Texas and Florida, the Food and Drug Administration said Thursday.

However, some of the suspect bone, skin, tendons and other tissues may have been implanted in patients as long ago as early 2004, the agency said.

The body parts appear to have gotten into the national tissue supply through a New Jersey company that reportedly is the focus of an investigation by the Brooklyn, N.Y., district attorney's office.

The New York Daily News, which made the Brooklyn probe public three weeks ago, said investigators are looking into reports that medical records were changed after parts were "harvested" from some corpses without authorization.

The newspaper said that in one case, medical records were altered to indicate a woman in her 20s, whose tissues were taken, had died of heart failure when in fact her death was caused by habitual intravenous drug use.

The FDA said in a statement posted on its Web site that it was recommending that physicians who already have implanted the suspect tissues notify their patients and offer to have them tested for disease.

In addition to HIV-1 and -2 and hepatitis B and C, syphilis is a disease for which the tissues should have been screened, FDA said.

The agency said it and the Centers for Disease Control and Prevention believe the overall risk of infection in any person who has received the tissues is "likely low."

The agency said the New Jersey firm being investigated, Biomedical Tissue Services Ltd. (BTS) of Ft. Lee, shipped tissues to the following tissue processors:

- Lost Mountain Tissue Bank of Kennesaw, Ga.

- Blood and Tissue Center of Central Texas in Austin, Texas.

- Tutogen Medical, Inc., of Alachua, Fla.

- Regeneration Technologies, Inc., of Alachua, Fla.

- LifeCell Corp. of Branchburg, N.J.

David Wade, who identified himself as the director of Lost Mountain Tissue Bank, refused to answer questions about the matter.

"We have no comment of any kind," he said.

It was not clear Thursday how or when the FDA learned of possible fraudulent records attached to body parts distributed by BTS.

Marshall Cothran, chief executive officer of the nonprofit Blood and Tissue Center of Central Texas, said his organization became aware of a problem when it received a subpoena from the Brooklyn prosecutor in late September. He said the subpoena requested records of tissues it received from BTS.

Cothran said he notified FDA of a possible problem with BTS tissues and records a few days later after receiving a tip from a tissue industry source.

FDA records show that Lost Mountain Tissue Bank informed the agency on Oct. 10 that it was notifying "consignees" to whom it shipped tissue it received from BTS.

"Lost Mountain Tissue Bank was informed of some discrepant and possibly fraudulent information in donor documentation," the records state.

It also was not clear Thursday how long the New York police investigators have known of possible health record alterations affecting tissues that were being shipped and transplanted into human beings, or whether the investigators ever notified FDA.

"It's a practice of our office that we don't comment on ongoing investigations," a spokesman for the Brooklyn prosecutor said Thursday. The spokesman confirmed that an investigation of the matter was under way.

The Daily News reported that records of more than 1,000 corpses from at least six funeral homes were being studied in the investigation. It said relatives were not informed when bodies were dissected for parts.

FDA records show that Lost Mountain Tissue Bank received an official warning in 2003 that it was failing to "prepare, validate, and follow written procedures for prevention of infectious disease contamination or cross-contamination by tissue during processing."

The agency also said the Kennesaw facility "routinely reworks tissue products in order to extend the expiration date without validated written procedures for the reworking of human tissue products."

The records indicate the company corrected the problems to the agency's satisfaction.

Jeff Nesmith's e-mail address is jeffn@coxnews.com