Monday, May 22, 2006

Contaminated Bone and Tissue Update

From New York, to Austin, Texas, to Atlanta, GA the scandal continues.

A key figure in this scandal is Dr. Michael Mastromarino, who was a New Jersey oral surgeon who agreed in 2002 to the suspension of his license to practice dentistry in New York state. Four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.

Here is what we have learned form the FDA records and state records, open to all:

*The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.

* New York State requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.

* Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.

The FDA also issued findings in late January that indicated:

*Eight cases where company records included false statements about a donor's age or cause of death;

*There cases in which the records misstated where tissue recovery was done;

*Six cases where BTS did not disclose that a donor had been hospitalized;and

*Two cases that listed a fictitious spouse on a consent form;