Macabre body part case remains undead in court

South Florida Business Journal - March 24, 2006 by John T. Fakler

A body part scandal that turned even hardened New Yorkers queasy last year may have infected the Sunshine State - and South Florida in particular.

The Ferraro Law Firm, a claimant's litigation firm in Miami, said it filed a lawsuit on behalf of transplant patient Ralph Steadman of Los Angeles, who allegedly received illegally harvested body parts.

The civil negligence lawsuit, filed March 14 in Alachua County Circuit Court, where co-defendant Tutogen Medical is based, alleges that tissue was illegally harvested from corpses and untested for disease.

Steadman, according to Ferraro, allegedly received illegally harvested and untested tissue as part of routine dental surgery in Eugene, Ore. Defendants in the case include Allograft Tissue Systems, which graphs human tissue in Bonita Springs; distributor Tutogen Medical; and the now-defunct Biomedical Tissue Services (BTS), along with two of its founders.

Those founders, Michael Mastromarino and Joseph Nicelli, were recently charged in State Supreme Court in Brooklyn, N.Y., for operating a corrupt $4.6 million enterprise to harvest human tissue from funeral homes and sell it for use in transplants and research.

Steadman underwent dental surgery June 14, at which time he received a Tutogen tissue implant in his mouth.

In December, less than 6 months later, he received a letter from his doctor, informing him that the tissue used in his surgery was processed and packaged by Tutogen.

Tutogen also informed Steadman the parts were part of a recent recall by the company because they were potentially tainted with numerous diseases.

"Ralph will have to be tested every three months for the most serious diseases known to mankind," said James L. Ferraro, founding partner of the Ferraro Law Firm.

"Could you imagine living every day knowing any day you could become positive for HIV, syphilis or hepatitis because of a routine dental procedure?"

Paid to deliver
Mastromarino was an oral surgeon who went into the tissue business after losing his dentist license, press reports said last month. Co-founder and co-defendant Nicelli was paid up to $1,000 per body to deliver corpses to a secret operating room at his funeral parlor, where Mastromarino would remove body parts.

By selling the tissue, prosecutors allege Mastromarino made up to $7,000 a body before corpses were returned to unsuspecting funeral directors for burial.

Hospitals nationwide have reported receipt of the illegally harvested and potentially dangerous tissue, according to Ferraro, who said his firm believes that, due to poor industry regulations, the problem may extend far beyond what has been included in the recent BTS case.

And that includes South Florida, he said.

"It's in the millions of dollars," Ferraro said of the damages he will be seeking. "There's no question there will be cases in South Florida. The amount of tainted tissue is much more than at first glance. From our research, Florida was one of the most affected states."

The Ferraro Law Firm, which is also representing family members of those whose bodies were unlawfully stolen and harvested, is representing implant cases in Florida with the assistance of the Motley Rice law firm in Mount Pleasant, S.C.

Attorney Alice Hector, who represented Allograft, a Delaware company formally known as Anthrex Tissue Systems as the plaintiff in a separate suit brought by Allograft in 2005, did not return calls. A phone number given for Allograft by directory assistance was a fax number.

Mario Gallucci, Mastromarino's Staten Island attorney, could not be reached. Two calls to Dee Mayor, who handles public relations for Tutogen Medical, were not returned.

But an FAQ regarding Tutogen's medical tissue recall posted on its Web site said Tutogen sent, with the approval of the FDA, two recall letters after the company was unable to verify donor consent for certain tissues provided by one of its recovery agencies, BTS of Fort Lee, N.J. Customer shipment information was assembled before the recall letters were sent to "affected customers," the company said.

"We immediately identified all biomedical tissue, from raw material stock through finished goods and field distribution, and quarantined all material within our control."

Only 2 percent of tissue processed by Tutogen came from BTS, the FAQ said.

The FDA on March 2 issued an update to its public health notification on BTS. On Jan. 31, the agency issued an order to cease manufacturing and to retain human cells, tissues and cellular and tissue-based products to BTS and Mastromarino, its CEO and executive director of operations. The order was issued after FDA's inspection of BTS uncovered serious violations of the regulations governing donor screening and record keeping practices.

The FDA did not return calls seeking comment on the case.

Ferraro said the case was so new that opposing counsel had not been assigned yet. A March 21 public records search confirmed defense attorneys had yet to be named.

Tutogen, according to Newsday, estimates the worldwide market for its products to be about $1 billion.

Several entities, including BTS and Tutogen, are currently suing each other, according to federal court records.

"They are all trying to turn state's evidence against each other," Ferraro said.

E-mail Senior Reporter John T. Fakler at jfakler@bizjournals.com.