Gaps in system let ghoulish tale unfoldMay 21, 2006 | www.democratandchronicle.com
His career ravaged by narcotics addiction and a felony drug arrest, Dr. Michael Mastromarino, a New Jersey oral surgeon, agreed in 2002 to a suspension of his license to practice dentistry in New York state.
But just 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.
Mastromarino's company, Biomedical Tissue Services, closed down in October. He and three colleagues face 122 charges, including operating a criminal enterprise, forgery, grand larceny, body stealing and unlawful dissection of a human being. The charges stem from Biomedical's harvesting of tissue from 10 cadavers without getting consent from survivors and without screening for communicable diseases.
Biomedical operated unimpeded for more than two years before that criminal probe even began in November 2004, showing gaps in the systems that oversee the expanding human tissue industry, according to a Democrat and Chronicle investigation.
Over its first three years, Biomedical harvested tissue from about 1,075 cadavers and earned $4.6 million before the allegations came to light, prompting a recall of the human body parts it had distributed. That ongoing recall 15,672 tissues so far is far larger than any of the 343 other U.S. tissue recalls in the past decade.
The Biomedical recall came too late for thousands of patients in the United States, Canada, South Korea, Australia and other countries who were implanted with bones, skin, tendons or other tissue collected by the company before it ceased operations in October. More than a dozen people have claimed to have contracted communicable diseases from implantation of Biomedical-supplied tissue.
Biomedical's activities, including tissue recovery done in Rochester, remain under criminal investigation.
Here is what interviews and a review of public records show:
- 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 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.
In Rochester, the scandal has resonated with particular strength. Not only did at least 60 area residents receive implants collected by Biomedical, but some collecting was done locally.
The company opened its sole branch office in Brighton in November 2004, and harvested tissue from as many as 65 cadavers in local funeral homes.
"I feel my dad's remains were what's the right word? defiled, I guess, or desecrated," said Don Ulp, a Greece resident who has been told by authorities that tissue was removed from his 84-year-old father's body without permission at a Hilton funeral home last year.
Ed VandeWater, a Williamson, Wayne County, resident, experienced similar feelings of violation after he learned in February that he had received a Biomedical bone implant in his neck.
"It makes you sick to see what this company was doing," he said. "How did nobody ever catch this?"
Mastromarino, who had been an oral surgeon in New York and New Jersey since 1993, was arrested in July 2000 in New Jersey for drug possession and being under the influence of a controlled substance. His arrest followed a number of incidents, later documented in court filings, that were attributed to his illegal use of drugs. Mastromarino, 43, was stripped of his dentistry licenses in both states. But he quickly hit upon another way to earn a living: running a tissue bank.
He had used bone implants extensively in his oral surgery and had done research on the topic, said his lawyer, Mario Gallucci of Staten Island.
And the booming industry was in constant need of new sources of raw material: Between 1994 and 2003, the number of bones grafts distributed for implanation grew sixfold, to 1.3 million, said P. Robert Rigney, Jr., chief executive of the American Association of Tissue Banks.
By March 2002, Mastromarino and a partner had formed a tissue bank company, BioTissue Technologies Ltd., and were preparing to go into business.
Over the next few months, the company would be licensed by New York and registered with the FDA with regulators never showing awareness of Mastromarino's licensing woes, drug problems or arrest record.
To register with the FDA, a tissue bank operator need only fill out a one-page form, which asks for name and address, nothing more.
"FDA does not do background checks on owners or operators of tissue banks," said FDA spokeswoman Julie Zawisza. FDA rules also don't set minimum qualifications or standards for tissue bank operators but do say that employees must have the "necessary education, experience and training to ensure competent performance of their assigned functions."
The FDA reserves the right to check employees' background and training during inspections. But there is no mandatory inspection of a company when it begins operation, and there is no set interval at which inspections must be done.
FDA regulations do not require that tissue harvesters have the consent of survivors. McNeill said it is left to the states to create and enforcedonor-consent rules.
New York, one of the few states that regulates tissue banks, has a detailed license application that requires applicants to provide information about background. The application also asks about arrests and professional misconduct, and requires the Health Department to consider "character and competence.
In his application, a copy of which the Democrat and Chronicle obtained under the Freedom of Information Law, Mastromarino did not reveal anything about his drug arrest or the loss of his dental licenses.
Mastromarino answered no to a question about sustained or pending charges "of administrative violations of local, state or federal laws, rules and regulations concerning the provision of health care services or reimbursement for such services."
Asked whether Mastromarino should have discussed his dentistry problems in the application, Health Department spokesman Robert Kenny said he could not elaborate because it would be "subject to legal interpretation."
The Health Department would not speculate about whether Mastromarino's background would have disqualified him from operating a tissue bank, although spokeswoman Claire Pospisil said "a criminal conviction or sustained administrative charge related to operation of a health-care services site or funeral home is grounds for denial of a license."
A check with dentistry licensing officials in either state would have shown that Mastromarino had surrendered his license and the reason behind it but the Health Department did not make those checks, Kenny said.
"We didn't take action at that time. We had no reason to believe from his application that we would have to (check)."
Through his lawyer, Mastromarino declined to comment.
Mastromarino's tissue bank application was dated June 17, 2002.
On July 8, in a different setting in Albany, he admitted to the state dentistry board that he had practiced dentistry without a license in New York. A second charge, that of insurance fraud, was dropped. His license, which he had surrendered two years earlier, was formally suspended for four more years.
Four days after that, the Health Department issued him a provisional one-year tissue bank license.
The opportunity for additional oversight went by the wayside as BioTissue opened.
State regulations require an inspection at the time a tissue bank opens.
But in the case of Mastromarino's company, that inspection was deferred because he moved the base of operations from Brooklyn to Fort Lee, N.J., shortly after the company began recovering tissue. He also transferred his licenses and registration from BioTissue to Biomedical Tissue Services.
Unlike most tissue recovery companies which are nonprofit and do their work in hospitals Biomedical was set up for-profit, and it harvested at funeral homes, which is not barred in New York state.
Biomedical's first inspection came a year after the company opened and had removed human bones, tendons and other tissue from roughly 200 cadavers and sold them for use in medical procedures.
Records indicate that on July 21, 2003, state Health Department inspector Tem Gonzalez, visited Biomedical's office in Fort Lee, N.J., looked around and spoke to Mastromarino. He directed Gonzalez to Daniel George and Son, a Brooklyn funeral home owned by his one-time partner in the tissue business, Joseph Nicelli.
Two days later, Gonzalez visited the funeral home, according to a written summary of his inspection obtained by the Democrat and Chronicle. He spoke with Nicelli, who told Gonzalez he offered families the option of tissue donation; Biomedical was summoned when a family consented.
Gonzalez also wrote that Nicelli told him the tissue collection was done in a second-floor room otherwise used for autopsies and body washing rituals.
"The room looks clean but not equipped with air filtration system or environmental control system," Gonzalez reported.
Sixteen months later, a New York City police detective, looking into financial irregularities at Daniel George, would discover the small room sparking an inquiry into Biomedical's tissue harvesting practices. That inquiry ultimately led to Biomedical's closure last fall, and to the indictment of Mastromarino, Nicelli and two other men Feb. 23 on charges they plundered human remains at Daniel George without consent.
The state Health Department was not aware in 2003 of any accusations of improprieties at Biomedical, said department spokesman Kenny, and had no reason to suspect any link between the second-floor room and the allegations that would surface later.
"Based on what we knew at the time, everything appeared to be legitimate," he said.
The inspector did cite the company for seven violations, including lack of involvement by Biomedical's medical advisory committee and its medical director, Dr. Mary Basco, a Virginia physician.
In retrospect, another citation for failure to keep a log of blood samples taken from donor cadavers is noteworthy. The samples are tested for evidence of certain infectious diseases as a way to ensure the tissue is safe for implantation.
Since the investigation of Biomedical has gone public, accusations have surfaced that the company submitted blood samples that came not from the cadavers, but from some other source.
Perhaps the most serious offense, though, was that Biomedical was overstepping its license, which permitted it to recover only musculoskeletal tissue bones and tendons, primarily.
Gonzalez had found that Biomedical also was taking skin and cardiovascular tissue heart valves, veins and the like from cadavers. The Health Department requires separate authorizations for each type of tissue recovery because the regulatory requirements differ between tissue types.
Biomedical submitted a corrective plan, which the Health Department accepted; no fines were assessed. Instead, regulators forwarded Biomedical an application for recovering cardiovascular tissue, to make lawful what it had been doing already.
By January 2004, the state Department of Health had awarded Biomedical a pair of full, four-year tissue bank licenses — one for tissue intended for implantation, the other for tissue to be used for research. Biomedical never harvested for research, records show.
Biomedical's business was booming. It had recovered tissue from 61 cadavers in 2002 and 240 cadavers in 2003, according to reports it filed with the Health Department.
By 2004, Biomedical was averaging more than one body a day. Its total that year 383 cadavers surpassed those reported by established nonprofit tissue agencies in Buffalo, Rochester, Syracuse and Albany.
Meanwhile, the FDA inspected Biomedical's facilities at least twice, according to Kevin Vickers of Honeoye, Ontario County, who worked as a tissue recovery specialist for Biomedical in New Jersey and later Rochester.
The agency's spokeswoman, Zawisca would not disclose whether the FDA ever inspected the company. But Vickers remembers being at the Fort Lee office in late 2004 when FDA inspectors undertook a four-day inspection of the company.
Vickers said the inspection, which he considered routine, resulted in Biomedical receiving "a clean bill of health." Gallucci said much the same. The FDA's Web site has no sanctions or warning letters to indicate otherwise.
One reason that repeated inspections did not uncover anything untoward may be that Biomedical, according to prosecutors and others, was engaged in rampant fraud forging signatures on donor consent forms, altering medical histories so that donors conformed with suitability rules, faking blood tests.
Records appeared to be in order when inspectors called; only afterward was the alleged fraud uncovered.
"That's part of our problem here," Rigney said. "This (tissue banks) organization has been in existence for 30 years, and we know of no such situation prior to this, where you have allegations that people forged donor consent forms and falsified medical information."
Tissue industry screening initially failed to halt troubling practices by Biomedical.
At least some of the five companies that purchased tissue specimens from Biomedical did their own audits of the company and tested its tissue, Rigney said.
Some processors ruled out some Biomedical tissue, he said. "It could have been bacteria, or quality of the bone."
But no one sounded the alarm on Biomedical until late September 2005, when New Jersey processor LifeCell Corp. reported it had found discrepancies in Biomedical's records.
That company and others quickly began a recall of all material that had come from Biomedical.
This time, the FDA acted quickly. After learning of the record discrepancies, it appeared at Biomedical's New Jersey office in early October for another inspection.
FDA inspectors spent more than three weeks at the task, which also included a review of records and visits to several funeral homes involved with Biomedical.
The company's New York licenses were "inactivated" on Oct. 14 after the scandal went public and a recall began of all tissue from Biomedical.
More than three months later, when the FDA summarized its findings, it ordered Biomedical to cease operations, and reported that it had uncovered "significant violations," most of which were attributed to inaccurate records.
Among the findings the agency cited on Jan. 31:
- eight instances in which company records included false statements about a donor's age or cause of death.
- three cases in which the records misstated where tissue recovery was done.
- six instances in which it failed to disclose that a donor had been hospitalized.
- two instances where records listed a fictitious spouse on a consent form.
- two occasions in which records misstated the time between death and tissue recovery.
- two cases in which records failed to indicate that autopsies had been done.
- one instance in which Biomedical failed to ensure a funeral home had proper ventilation and refrigeration.
"These deficiencies, including your failure to create and maintain accurate records, are so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health," the FDA stated.
Mastromarino intends to fight the closure order, said Gallucci, his lawyer, and also expects to prevail in Brooklyn criminal court.
An investigation into other dealings by Biomedical and its business associates in funeral homes including in Rochester is continuing. The Monroe County District Attorney's office also is looking into activities here.
FDA has said it is continuing its own inquiry into Biomedical's activities. The state Health Department is preparing new regulations to bar recovery of tissue in funeral homes, said Pospisil on Thursday. And bills have have been introduced in Congress and the state Senate to change the way tissue recovery is regulated.
For the everyday people who have been dragged into the macabre case, closure and reform can't come soon enough.
"I don't know who's responsible for the fact that it did go on for so long but there needs to be some sort of safeguard in terms of who's authorizing this (harvesting)," said Donald Ulp.
Ulp has been told by authorities that the body of his father, George Ulp, who died in February 2005 of Alzheimer's disease and colon cancer, was harvested for tissue without consent at the Burger Funeral Home in Hilton.
"Obviously, some series of checks and balances need to be put in place so that this doesn't happen again."