FDA Shuts Down Human Tissue Broker

The Food and Drug Administration ordered a New Jersey-based broker of human tissue closed this week in the midst of accusations that the company took body parts from cadavers without family permission and did not always screen these body parts for diseases.

The agency said an investigation showed that the company, Biomedical Tissue Services of Fort Lee, had improper documentation of the cause of death of some tissue donors.

Typically, the FDA takes several steps, varying in degree, prior to requiring a manufacturer or distributor actually shut its doors. These steps can include warning letters, formal hearings, and in some cases, a voluntary recall. A review of the FDA’s website reveals that a voluntary recall was issued on October 13, 2005. Apparently feeling that stricter measures were necessary, the FDA has ordered this facility to shut its doors.

In an article which can be found in the New York Times, the chief executive of Biomedical Tissue Services, Michael Mastromarino, stated he has complied with the order but is appealing it, said Mario Gallucci, a lawyer for the company. “We are litigating every piece of this,” Mr. Gallucci said.

The FDA investigation allegedly found death certificates on file that were inconsistent in age and manner of death with certificates filed with the state. In one case, tissue documented as coming from a 63-year-old man who died of a heart attack came from a body the state had listed as a 69-year-old who died of multiorgan failure due to liver dysfunction.

Mr. Gallucci said the company was not responsible for the death certificates, having simply received paperwork from funeral parlors and other body processors. “All we were was a middleman here, and we seem to be getting the short end of the stick.”

A spokesman for the Brooklyn district attorney’s office, which has been looking into funeral homes involved in tissue harvesting, said an investigation was ongoing.