PENNY BROWN ROBERTS (The Advocate, 03/04/2006)

Hundreds of Louisianians may have body parts transplanted inside them that were looted from corpses - some riddled with cancer or infected with syphilis or hepatitis.

A class-action lawsuit made public Friday in Baton Rouge federal court alleges that a New York medical supply company sold illegal - and unscreened - tissue and bone to Our Lady of the Lake Regional Medical Center and other unnamed hospitals in the state.

Darrel Bourque of Gonzales says surgeons notified him in January that tissue transplanted in his neck during spinal surgery a year ago came from that supply company - Biomedical Tissue Services.

They urged the petrochemical industry supervisor to undergo blood testing to see if the transplanted tissue was infected with syphilis, HIV or hepatitis.

Although the tests haven't shown anything, Bourque said in an interview Friday that he's worried that, "There's still the possibility something could have been there."

"I have a lot of depression and a lot of anger. I don't really know what the future holds," Bourque said. "I'm worried about whether or not I'll still be able to get insurance coverage for further illnesses that may come about."

The lawsuit estimates the defective tissue has been implanted in hundreds of Louisiana patients since 2002. In addition to damages, it seeks to establish a comprehensive medical monitoring program and treatment of any future disease or complication related to the implants.

In an advisory issued Friday, the U.S. Food and Drug Administration "strongly" recommends health-care providers inform patients who received tissue implants from Biomedical Tissue Services that they "may be at increased risk for communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low . the actual infectious risk is unknown."

Baton Rouge lawyer Philip Bohrer said Friday the class-action lawsuit is intended to protect Louisiana victims from the potential "long-term consequences of what's happened to them."

Several patients outside the state who got transplants of the tissue in question already have tested positive for hepatitis and syphilis, according to news reports.

"I believe unfortunately that many people in our community may be victims of this practice," Bohrer said. "The people who received this contaminated tissue are at risk for the rest of their lives, and initial blood test or screening cannot rule out future diseases, such as cancer, leukemia or other diseases with long latency periods that may have been in the tissue they received."

Biomedical Tissue Services owners Michael Mastromarino and Joseph Nicelli and others are accused of secretly carving up bodies from funeral parlors and city morgues in three states and forging death certificates and organ-donor consent forms to make it appear as if the bones, skin, tendons, heart valves and other tissues were removed legally.

Some of the corpses were those of people who had not given consent; others didn't meet federal donor eligibility requirements because they were infected with syphilis, AIDS or hepatitis or had cancer or heart disease.

Among the cadavers they allegedly raided for parts was that of former PBS "Masterpiece Theatre" host Alistair Cook, who died of cancer in 2004 at the age of 95.

Last month, the FDA shut down Biomedical Tissue Services. Those involved have pleaded innocent to charges of enterprise corruption, body stealing and opening graves, unlawful dissection, forgery and other counts.

Staten Island lawyer, Mario Gallucci - who is representing Mastromarino and Biomedical Tissue Services - said Friday he was not aware of the Louisiana lawsuit.

Mastromarino "finds it unfortunate but does sympathize with all of these people who received the tissue," Gallucci said. "He is just as taken aback as all these people are that he was misled. Hopefully, the distribution companies have done what they were supposed to do in sterilization, processing and release of this tissue. Dr. Mastromarino is traumatized by the prospect that his life's work may have been tainted by the processing of this tissue."

According to prosecutors, Mastromarino is a former dentist and oral surgeon who went into the tissue harvesting business after losing his license. He was sued for malpractice by several patients - one of whom claimed he deserted them in the middle of surgery.

Also named as defendants in the Louisiana lawsuit are Florida-based Regeneration Technologies and Memphis-based Medtronic Sofamor Danek USA, which allegedly distributed the millions of dollars worth of tissue, bone and organs. The lawsuit alleges the companies violated industry standards, their own internal safety and testing procedures, and possibly state and federal laws.

The lawsuit does not blame Our Lady of the Lake Regional Medical Center, other hospitals or any local surgeons, saying none of them was aware that the body parts "consisted of the stolen human tissue obtained by BTS, or that RTI failed to follow its own safety protocols."

Our Lady of the Lake Regional Medical Center spokeswoman Catherine Harrell said Friday that 27 of its patients are known to have gotten such transplants. She said the hospital bought the tissue in question from Tennessee-based SpinalGraft Technologies.

Harrell said that once the hospital was notified of a nationwide recall of the tissue, it "immediately" returned its remaining supply to the manufacturer.

The hospital also notified surgeons of the situation "so that the physicians could communicate with their patients about the situation and really answer any questions the patients had."

She said the doctors should have notified all their patients by now.

The American Association of Tissue Banks estimates there are more than 1 million tissue transplants annually in the United States.

The FDA began regulating the billion-dollar industry in 1993 and now has strict regulations requiring examination of the cadaver, testing for disease-causing agents, interviews with the donor family and reviews of medical records, lab test results, coroner and autopsy reports and other relevant records.

In 2005, the agency added screening for diseases such as syphilis, West Nile, SARS and the neurological condition Creutzfeldt-Jakob to tests already required for HIV and hepatitis.

The Louisiana case has been assigned to U.S. District Judge Frank Polozola.

No hearing dates have been set.