Surgeries using cadaver tissue pose risks

Don't worry, the doctor told Brian Lykins' parents, as he prepared to use cartilage from a cadaver to fix their son's knee. A million people a year have operations that use tissue from donated dead bodies. The nation's largest tissue bank had supplied this cartilage. It was disinfected and perfectly safe, he assured them. But it wasn't.

Four days after this routine, elective surgery, Lykins — a healthy, 23-year-old student from Minnesota — died of a raging infection.

He died because the cartilage came from a corpse that had sat unrefrigerated for 19 hours — a corpse that had been rejected by two other tissue banks. The cartilage hadn't been adequately treated to kill bacteria.

And it could happen again today — likely is still happening today — because of shoddy practices by some in the billion-dollar body parts business and the lack of government regulation.

The industry is in the news because a New Jersey company is accused of scavenging corpses without families' permission and then selling those parts to tissue processors. But apart from this scandal, thousands more Americans each day are put at risk in more insidious ways by legitimate tissue suppliers.

A three-month investigation by The Associated Press found problems ranging from inadequate testing for potentially deadly germs to lack of a unified system for tracking tissues as they travel from donor to recipient.

At every step — from funeral homes, where the journey often begins, to hospitals and doctors' offices, where it ends with patients receiving the eyes, bones, skin and other parts of the dead — poor oversight invites abuse and creates danger.

Most tissue transplants involve reputable companies and do a lot of good. Olympic skiers, people who have lost eyesight and children born with bad hearts are among the millions who have benefited. But when things go wrong, the consequences are horrific.

Ken Alesescu died May 14 in his San Luis Obispo, Calif., home, victim of a fungus-infested heart valve.

Alan Minvielle, of Santa Cruz, Calif., lost a job and almost lost a leg to gangrene from a bad tendon.

Bonny Gonyer in Chippewa Falls, Wis., has pain and walks with a limp because of tainted tissue.

"It angers me when I read these stories," Pam Alesescu, the heart valve recipient's widow, said in an interview shortly before he died. "My kids are losing their dad, and I am losing my husband."

The federal agency responsible for tissue safety, the Food and Drug Administration, is well aware of the problems. Yet, many experts believe the rules the FDA enacted last year as a long-promised overhaul fall short of providing the level of oversight needed.

Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services — the now-notorious New Jersey company — wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS (incident) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."

_A trade group, the American Association of Tissue Banks, requires accredited members to follow high standards, but without the FDA doing the same, hospitals and doctors can buy from unaccredited suppliers that offer tissue quicker or cheaper.

_The FDA sets no limits on age or health of donors, or how long after death tissue can be taken.

_Funeral homes don't have to report deaths to organ procurement groups, leaving them outside a regulatory system and able to cut side deals to supply body parts.

_Doctors often know little about the origins of tissue they use. Some hospitals buy it like surgical gloves and other supplies — based on price and availability. Patients are not always told they are receiving tissue from a cadaver or offered alternative treatments.

_Hospitals and doctors do not have to report tissue infections to health officials, and evidence suggests that many are missed.

The number of tissues distributed for transplants rose from 350,000 in 1990 to 650,000 in 1999 and 1.3 million in 2003. Tissue companies are awash in cash — even the nonprofits. The biggest is the Musculoskeletal Transplant Foundation Inc. of New Jersey. In 2004, it had $243 million in revenues and paid its chief executive $542,212.

The FDA, on the other hand, lacks staff and money. It spends $5.4 million a year on tissue regulation — less than two days' revenue for the industry. Inspections of tissue businesses peaked at 285 in 2004, but the number of companies rose from 1,325 two years ago to 2,030 now.

However, many gaps in oversight have nothing to do with resources, and stem instead from an FDA and Bush administration philosophy of not wanting to burden industry.

The FDA rules often state broad goals and let industry decide how to meet them. They say tissue should be tested for germs but do not specify the type or level of testing. Ditto for how tissue is disinfected. Some tissue, in fact, is not disinfected at all.

An FDA quality and compliance official, Mary Malarkey, said she believes tissue is safe and that she would have no qualms about receiving it.

"I do actually have family members and friends who have," Malarkey said. "I take that very seriously."

The trade association's president, James Forsell, said that most big companies are association members and that consumers are protected by his group's accreditation process.

When Lykins and others got contaminated tissue a few years ago from the Georgia-based bank, CryoLife Inc., that company was not accredited. Now it is, and company officials say they have several new testing and treatment procedures to prevent such problems.

If a non-member like BTS wants to falsify records or ignore proper procedures, "there is precious little that can be done," Forsell said.

Even doctors don't understand the risk of tissue they are using. "It comes in a nice package, it looks sterile," said Dr. Matthew Kuehnert, a tissue safety expert at the federal Centers for Disease Control and Prevention.

"Most physicians don't even know the questions to ask," said Dr. Ty Endean, a Tucson, Ariz., orthopedic surgeon. "They order tissue and they leave it up to the surgical center at their hospital. And those people are just going on price."

Often, the people who order tissue for operations don't know how it was treated or even all the companies that handled it. When the BTS scandal broke, some hospitals did not even realize their tissue had come from an unaccredited supplier.

Kuehnert wants a uniform system to trace tissue instantly from donor through processors to recipients.

It's doable if people want it, says Steve Lykins, father of the Minnesota student who died.

"What the tissue companies did when Brian died was legal. The problem was, there were no laws out there to break," he said. "Any one of us could have opened a tissue bank in our garage. We could have hired the neighborhood kids who were interested in science to work for us."

Lykins and his wife, Leslie, have made many trips to Washington, lobbying for change.

"We didn't want to be sitting around watching TV and hear of another case where someone had lost a son like we lost Brian and know that we didn't do anything about it," he said. "We worked very hard for quite a while to encourage the FDA to start regulating this industry."

Scandal rocks human tissue industry
By TOM HAYS, Associated Press Writer
Sun Jun 11, 12:27 PM ET

Dr. James Forsell, senior vice president of Tissue Banks International, discusses the details of tissue processing at his companys San Rafael, Calif., processing facility in this May 12, 2006, file photo. (AP Photo/Noah Berger, File)

NEW YORK - As a seasoned "cutter," Lee Cruceta thought he knew when it was safe to harvest human tissue from the dead for transplants to the living — and when it wasn't.

This time, it wasn't.

The man's body stretched out in front of Cruceta in the back room of a Manhattan funeral home after hours one day last summer had yellowish skin. His vacant eyes had the same sickly cast — a sign of jaundice. Cruceta telephoned his boss, Michael Mastromarino, to tell him the bad news: The body had failed inspection.

"We always went by the rule that if you come across a body and you say to yourself, 'I don't want any part of that person in my body,' you rule the case out," Cruceta said.

But Mastromarino, by Cruceta's account, surprised him. Stay put, he said.

The boss came down, checked out the body himself and declared that "everything looked fine."

"I was overruled," Cruceta said.

Out came the surgical tools. The extraction of flesh and bone began.

This is, again, Cruceta's account. He, like Mastromarino, faces criminal charges in a scandal so grotesque that it reads like a real-life sequel to "Frankenstein."

It was Mastromarino who built a business that took from the dead and gave to the living. There are many legitimate businesses that do this, but authorities say Mastromarino's company was not one of them.

Authorities say Biomedical Tissue Services secretly carved up hundreds of cadavers — among them, that of the British-born host of "Masterpiece Theatre," Alistair Cooke — without the families of the deceased knowing about it. They then peddled the pieces on the lucrative non-organ body parts market.

Even scarier: They say BTS doctored paperwork to hide the inconvenient fact that some of the dead were too old and diseased to be donors. As a result, they say, the market was flooded with potentially tainted tissue, and an untold number of patients across the country may have received infections along with their dental implants and hip replacements.

___

To all the world, Michael Mastromarino appeared to be a man of character and accomplishment: College athlete. Oral surgeon. Family man. Author. Multimillionaire.

There were rumors. Cruceta, a 33-year-old nurse who worked closely with Mastromarino for three years, recalled asking his boss if it was true that he'd had run-ins with the authorities.

"He told me it was all lies," he said.

There were several malpractice lawsuits — an occupational hazard for a doctor tackling tough cases, his lawyer says. But dental board records reveal other troubles.

Mastromarino was arrested in July 2000 for being under the influence of drugs and in possession of a hypodermic needle and Demerol, according to the documents. His lawyer, Mario Gallucci, said he became addicted to painkillers while being treated for a back problem.

The criminal charge was eventually dropped, but because his urine tested positive for controlled substances — cocaine and another painkiller, Meperidine — he agreed to surrender his dentistry license for six months and enter rehab. He was later caught practicing without a license — a second offense resulting in a four-year suspension from the profession.

But by then, he had begun another career.

Using his contacts with companies that produce material for dental implants, Mastromarino opened BTS in Fort Lee, N.J., in 2001.

In 2002, Mastromarino sought licensing to do business in New York. As the company's chief officer, he was asked on an application to the state Department of Health whether he "had charges sustained of administrative violations of local, state or federal laws, rules and regulations ... concerning the provisions of health care."

"No," he answered.

The license was granted.

___

Femurs. Tendons. Heart valves. Swatches of skin from the thighs, stomach and back.

The body parts, though no longer of any value to their owners, became big business for Mastromarino. His lawyer said he was among the first in the industry to figure out that one way to meet the high demand for donated human tissue — traditionally procured in the controlled environment of hospitals — was to turn to funeral homes.

Deals were cut with funeral directors in New York City, Rochester, N.Y., Philadelphia and New Jersey: BTS would pay a $1,000 "facility fee" to harvest body parts on their premises.

Three-man teams were dispatched to mortuaries. Two workers would extract the parts. A third would bag them and put them on ice until they could be stored in a freezer at BTS headquarters.

Internal documents from BTS suggest the company had, at least on paper, a strict set of rules for obtaining signed consent for the procedures. A script instructed interviewers to tell family members, "We are about to proceed with the medical social history questionnaire. I have about 40 questions and this interview should take about 20 minutes."

Sample question: "Did the deceased have a tattoo, ear or other body piercing or acupuncture in the past 12 months in which shared instruments are known to have been used?"

Unfortunately, it seems that no questions were asked in hundreds of cases.

Family members have told investigators no one sought permission for body-part donations. The signatures at the bottom of the questionnaires, they said, were forged.

Mastromarino, through his lawyer, has blamed funeral home directors, insisting it was their job to get consent. The directors say it was the other way around.

As early as September 2003, the FDA detected trouble at BTS.

In a routine inspection, an investigator found evidence the company had failed to properly sterilize its equipment, and had no records of how it had disposed of tissue that failed screening for HIV, hepatitis and syphilis.

But nothing came of it. The FDA backed off after Mastromarino insisted he had voluntarily cleaned up his operation. In a letter, he told officials he would "look forward to your agency revisiting our facility."

___

In November 2004, New York City Police Department Detective Patricia O'Brien responded to a complaint from a funeral director in Brooklyn. The director claimed the parlor's previous owner had stolen down payments for funerals.

But once inside the funeral parlor, she sensed something far more sinister.

The detective was surprised to find an embalming room that looked more like an operating room, with a steel table and bright overhead lights. When she reviewed old files, she found the names of biomedical companies. She later Googled the names and learned each was involved in tissue transplants.

O'Brien had gone into the investigation thinking she was dealing strictly with "a financial situation," she said. "I had no idea. I was shocked."

The NYPD's Major Case Squad widened the investigation, interviewing the relatives of 1,077 dead people whose bodies were harvested for body parts. Only one said permission was given.

Meanwhile, the director of a Denver blood center, Dr. Michael Bauer, had been hired by several tissue banks to review medical charts of donors to make sure tissue was safe.

On the evening of Sept. 28, 2005, while flipping through charts at his desk, he spotted a notation on a woman's chart saying she had chronic bronchitis. As a precaution, he picked up the phone and dialed the number listed for her doctor.

"All I wanted to know was whether the doctor thought that might be an acute infection," meaning something present when she died, Bauer recalled. If so, the germ might still be in her tissue and make it unsuitable for transplantation.

A business answered, one "so unrelated to medicine that it didn't feel right to me."

So he picked up another chart and called another doctor.

Then another. And another.

Each time, no doctor answered. In each case, it appeared the charts were falsified.

"I got through the first 10 and that's when all the hair on the back of my neck stood up," Bauer said.

___

The case, said the prosecutor, is like a "cheap horror movie."

Authorities released photos of exhumed corpses that were boned below the waist like a freshly caught fish. The defendants, they alleged, had made a crude attempt to cover their tracks by sewing PVC pipe back into the bodies in time for open-casket wakes.

Lawsuits filed by implant patients accuse BTS of exposing plaintiffs to hepatitis and other infectious diseases. Families of the dead have sued, too.

Earlier this year, the Food and Drug Administration shut down BTS amid its own investigation. The agency said it had uncovered evidence the firm failed to screen for contaminated tissue. Parts were recovered from people who had diseases which may have been "exclusionary," an FDA report said.

Death certificates in the company's files, the FDA said, were at odds with those on file with the state: The company's version made people younger than they actually were, and altered the cause and time of the deaths.

Those responsible "were just some irresponsible crooks who were doing this and slipped through the cracks," said Dr. Stuart Youngner, a Case Western Reserve University medical ethicist and head of the ethics committee at Musculoskeletal Transplant Foundation, a large nonprofit tissue bank. "The good tissue banks ... don't do that."

Cruceta is free on $500,000 bond. His name is on papers indicating that he was the one who conducted interviews with family members of the deceased — interviews that authorities say never took place. He insists he signed only because he was instructed to do so; prosecutors don't believe him.

Mastromarino, 42, remains free on $1.5 million bail after pleading not guilty to body stealing, forgery, grand larceny and other counts. Through his lawyer, he refused requests for interviews by The Associated Press.

If convicted, he faces as much as 25 years in prison.

___

Associated Press Writer Adam Goldman and AP Medical Writer Marilynn Marchione contributed to this report.

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