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Tissue recall took months

Despite inquiry, body parts continued to be harvested, used

Jun 28, 2006 | www.democratandchronicle.com

For nearly a full year, a human tissue company continued to harvest and ship potentially contaminated body parts while New York City police and prosecutors investigated.

Meanwhile, federal and New York state public health officials took no discernible action to halt the flow of suspect body parts destined for surgical implantation.

Only after one of the company's business partners detected and reported a problem to health officials in September — about 11 months after the criminal investigation began did federal officials step in to challenge Biomedical Tissue Service's practices and order it closed. Ultimately, officials oversaw the largest-ever recall of human tissue, and recommended that thousands of people implanted with tissue gathered by Biomedical be tested for communicable diseases.

Biomedical now is accused by the Kings County (Brooklyn) District Attorney's Office of forging documents to gain access to cadavers and failing to ensure the tissue they harvested was free of communicable disease. Four company officials were indicted in February on 122 counts.

During that 11-month interval, Biomedical continued to recover tissue from human cadavers in the Rochester area, New York City and other locales, and continued to sell tissue for use in medical procedures.

In at least some cases, prosecutors say, tissue was gathered without proper consent from donors or their families.

Hundreds, if not thousands, of surgery patients during that time were implanted with tissue that came from the New Jersey company. In the Rochester area, most of the 60 patients known to have received Biomedical specimens had their implants after the criminal probe began.

Today, some of those patients are asking why authorities didn't act sooner to stop Biomedical.

"It could have been prevented if they'd notified the medical profession sooner. Now I blame the police for that," said Allis Sue Jones, an Albion, Orleans County, woman who received a Biomedical implant in June 2005, seven months after the New York Police Department and the Brooklyn district attorney began investigating the company.

Who knew what, when and whether any of the agencies involved could have shut down Biomedical sooner remain pressing questions, not only in the context of this case but also in other cases where criminal investigations and regulatory oversight converge.

"We simply cannot have a situation where the left hand doesn't know what the right hand is doing, and that's what happened here when an investigation is under way but the right folks aren't notified," said Sen. Charles Schumer, D-N.Y., who has introduced legislation to tighten federal oversight of tissue banks.

Neither the U.S. Food and Drug Administration nor the Kings County (Brooklyn) District Attorney's Office would discuss the chronology of their involvement in any detail. The state Department of Health, which licensed Biomedical, says it was notified of the criminal investigation in May 2005, about six months before Biomedical was closed. But its officials say they did not learn of the public health implications until after the tissue recall had begun in October.

Like thousands of other patients who received implants of bone, tendons, skin and other tissue from Biomedical, Jones has had to be tested to be sure she contracted no infections.

To date, her tests have been negative, though more than a dozen other recipients nationwide claim to have tested positive for hepatitis, syphilis or the virus that causes AIDS.

Suspect tissue not halted

Biomedical Tissue, which went into business in 2002, first came under suspicion by police in mid-November 2004, according to the Kings County District Attorney's Office. The investigation began when a man who had purchased a Brooklyn funeral home went to police with concerns about operations there, according to prosecutors. A police investigator went to the Daniel George and Son funeral home and learned that tissue was being recovered from bodies in a second-floor autopsy room by Biomedical.

How the police investigation unfolded from there is not clear; a spokesman for District Attorney Charles Hynes declined to provide details.

Whether the District Attorney's Office or the police informed the FDA of their probe also is not clear. An FDA spokeswoman, Julie Zawisza, declined to answer that question and many others, citing the FDA's own on-going investigation of Biomedical.

But on May 9, 2005, about six months into the probe, the New York state Health Department was first informed of the investigation by "appropriate law enforcement," according to department spokesman Robert Kenny.

Kenny would not say what the agency was told by the unnamed agency, or what, if anything, it did in response. "We have no comment, other than to say that when we're made aware of a criminal investigation, we certainly cooperate with the appropriate authorities," he said.

Within another month or so, in June 2005, Biomedical and the Daniel George funeral home learned they were under investigation, according to Mario Gallucci, a Staten Island lawyer representing Biomedical's owner, Dr. Michael Mastromarino.

"That's when all the original subpoenas went out," Gallucci said.

Despite that formal notification that Biomedical was a target of the investigation, neither law enforcement authorities nor health officials took any apparent action to halt shipment of tissue from the New Jersey firm.

Harvesting continued here

Still unclear is how many people nationwide received implants of Biomedical tissue while the investigation was ongoing.

Locally, at least 60 people received implants of tissue originating with the company. And about 85 percent of those patients underwent their surgeries after the investigation had begun, according to data supplied by area hospitals.

Similarly, Biomedical continued harvesting of tissue from human remains at funeral homes, including in the Rochester area, during the investigation.

In fact, all of Biomedical's tissue collection in Rochester likely occurred after the probe began.

Biomedical's only branch office, in an office building off Brighton-Henrietta Town Line Road, opened in November 2004, the same month the investigation began. Tissue recovery work at Rochester-area funeral homes did not begin until a few months later, said Kevin Vickers, a former Biomedical recovery specialist who lives in Honeoye, Ontario County.

As many as 65 cadavers were harvested for bone and other tissue in local funeral homes, and in at least some of those cases, decedents' families say they never gave consent for the donation.

Members of eight local families have joined lawsuits filed in Rochester courts asserting that their loved ones' bodies were desecrated after Biomedical recovered tissue without permission. The harvesting in those six cases took place between February and August 2005, after the criminal probe began.

Van Henri White, the Rochester lawyer who brought the lawsuit, said he has deliberated whether to name law enforcement or health agencies as defendants in the suit because of their failure to warn the public sooner about Biomedical's practices.

But he has dismissed the idea because the evidence is insufficient to support such a charge. He said that could change as more background on the investigation emerges in the pre-trial stages of his lawsuit.

White, a former prosecutor in Monroe County, said he assumed Brooklyn law enforcement officials didn't notify the public sooner because they thought a thorough investigation was needed to make sure any illegal conduct was stopped for good.

In terms of his clients people who say their loved ones' bodies were harvested for tissue without consent — White also wondered whether law enforcement was willing to let that activity continue because the victims were already dead.

"They might have thought and I'm speculating that this was a victimless crime," he said. "But that doesn't explain how they allowed these tissues to go into the bodies of other people. I really don't know how to explain comprehensively why they allowed this to go forward."

Industry spurs FDA recall

The public record does not show any action taken by the FDA or the state Health Department in the spring or summer of 2005. In fact, apparently nobody did anything to halt the flow of Biomedical tissue until September.

In that month, several of the companies that acquired tissue from Biomedical received subpoenas from a Brooklyn grand jury, according to public statements by those companies.

Toward the end of September, Dr. Michael Bauer, a Colorado physician working for one of those companies, LifeCell Corp., detected some inaccuracies with medical-screening information supplied by Biomedical and reported them to LifeCell. In turn, LifeCell notified the FDA of its concerns and began a voluntary recall of all tissue from Biomedical on Sept. 29, according to FDA reports.

According to the FDA's recall notice and statements by Mastromarino's lawyer, Mastromarino himself called in the FDA on Oct. 3.

"He contacted them and said, 'I have a problem with some of my tissue.' He put in effect the recall and had (FDA inspectors) come out," said the lawyer. The FDA began an inspection of the company the following day.

None of this became public until Oct. 7, when the New York Daily News published a lengthy story on the criminal investigation into Biomedical. Later that day, LifeCell issued a news release and stated that the company had begun its recall "when internal quality processes raised questions about the donor documentation" from Biomedical.

The FDA issued its first public statement on the case on Oct. 26, more than 11 months after investigators first began looking into the company. The agency noted there was no assurance that Biomedical had tested tissue properly, and it recommended that tissue recipients undergo medical testing.

Though she would not say when the FDA learned of the accusations against Biomedical, FDA spokeswoman Zawisza said the agency would have approached the matter deliberately.

"It takes time to collect and analyze all of the information and talk with the appropriate people and, finally, to determine the appropriate course of action," Zawisza said. "Throughout this process, (the) FDA continually considers the impact on public health and patient safety and the need for public notification, and strives to balance such concerns with the need to preserve the confidentiality of the investigation."

State health officials declined to say how they reacted when they learned of the Biomedical probe in May 2005. But they said they had no information at that time that the public was at risk.

Kenny said they did not realize that Biomedical was shipping tissue without ensuring it was safe until October, when the formal recall began.

"When it came to our attention that there could be an issue impacting public health, we didn't wait for the criminal investigation to be completed," he said. After gathering information about the recall, state health officials sent their own letter to New York physicians in December. They also began an independent assessment of the recall in March, amid complaints that the recall had progressed slowly.

Kenny said he had no information indicating that the Health Department should have been informed sooner of the facts behind the case.

Officials at the Kings County District Attorney's Office also declined to discuss any contacts the office had with health regulators.

Asked if the agency ever asked regulators to back off in deference to the criminal investigation, Jerry Schmetterer, the district attorney's information director, said: "We would never do anything to put anybody's health or life in jeopardy."


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