Texan suing over Transplanted Tissue

Posted on Sep 25, 2007
North Texan files suit over transplanted tissue By JAN JARVIS Star-Telegram Staff Writer A stolen bone fragment was implanted in Jim Livingston's neck during a surgery to relieve the pain of a ruptured disk. X-RAY COURTESY OF JIM LIVINGSTON A stolen bone fragment was implanted in Jim Livingston's neck during a surgery to relieve the pain of a ruptured disk. JIM LIVINGSTON Jim Livingston never gave much thought to the bone transplanted in his neck until that Sunday afternoon when his doctor called to tell him about the recall. "Do they want it back?" he asked, half-jokingly. Quickly it became clear that this was no laughing matter. Bone allegedly stolen from a corpse had been used in Livingston's neck to relieve the pain of a ruptured disk. With that bit of news, the 44-year-old Weatherford father joined hundreds of others nationwide who are living with the knowledge that they carry bones and tissue taken illegally from cadavers in what has become a bizarre tale of selling body parts for profit. The experience has left Livingston, an insurance inspector, yearning for answers. Fed up with wondering what will happen to his wife and three children if he became seriously ill, he filed a lawsuit last month in New York claiming fraud and negligence against the parties involved in the scandal. He is not seeking a specific amount. "How can you sell parts out of a body, just like parts from a stolen car?" he said. New York authorities investigating the case believe Biomedical Tissue Services owner Michael Mastromarino started by striking deals with funeral directors to remove body parts from corpses without notifying their families or screening for disease. Then, in a secret room in a Brooklyn funeral home, he removed bones, tendons and heart valves, according to a spokesman for the Kings County district attorney's office in New York. The charges include a Class B felony punishable by up to 25 years in prison. Mastromarino is accused of doctoring death certificates and forging consent forms, according to the Kings County district attorney's office. Then, investigators believe, he replaced the bones with PVC pipe and sewed the incision so it would not be noticed at the funeral. From there, the body parts were shipped to processing firms across the country. Once sterilized, they were implanted in patients from early 2004 to September 2005. Fear of disease Just how many patients received stolen tissue or bone, no one seems to know. Tissue from a single human body can be used for more than 100 tissue transplants. A body can bring more than $250,000 for harvesting, according to a spokesman for the Kings County district attorney's office. Although it is illegal to sell body parts, the law allows tissue banks to recover transportation and processing costs. Livingston's lawyer, John David Hart of Fort Worth, said he knows of no other related lawsuits in Dallas-Fort Worth, though there have been others around the country. After New York investigators started to unravel the case involving Mastromarino, five tissue processors that received human parts from Biomedical Tissue Services in Brooklyn issued voluntarily recalls. Medtronic, a Minneapolis distributor that received the parts, also issued a voluntary recall. When Baylor All Saints Medical Center at Fort Worth -- the hospital where Livingston had surgery -- learned of the recall, it immediately pulled the tissue from its stock. Physicians who had implanted the suspect material contacted their patients, said Wendy Walker, a spokeswoman for Baylor Health Care System. Five Baylor patients were notified, she said. When Livingston found out that the bone used in his Sept. 1, 2005, surgery was from Biomedical Tissue Services, he panicked. Then he got a blood test. Although there is no evidence of disease, Livingston worries that future tests will bring bad news. It's that fear and the lack of proof that he's not a risk that gnaws at him most. "Nobody can medically tell you that you don't have anything to worry about," he said. "For all I know, this guy died of bone cancer and I've got his bones." Medtronic, which is named in Livingston's lawsuit, has said he has nothing to worry about. The company has voluntarily recalled about 16,000 bones nationwide, said Medtronic spokesman Bert Kelly. "As of this date we have tested 12,000 to 13,000 people, and none have shown up with an infectious disease that is traceable to the recalled tissue," Kelly said. "A few patients have shown up with infectious diseases of some sort, but none have been linked to the tissue in their surgery." Once someone tests negative for an infectious disease "they should be cleared from here to eternity," Kelly said. An infectious disease cannot survive the sterilization process, he said. But Livingston, a one-time professional roper on the rodeo circuit who now works for State Farm's Premiere Service Program, said there's no guarantee that he won't get sick years from now. "It's a situation where I put it on the back burner, but it has just kept eating away at me," he said. "I want to believe that I got nothing to worry about, but it is the kind of thing you think about in the middle of the night and wonder, 'What if?'" More meaningful oversight of tissue harvesting is needed to protect people such as Livingston, Hart said. "There has to be some sort of process in place so these companies that obtain donor tissue and bone make sure that the product is safe," he said. "Patient safety is being compromised by an industry's greed and the failure of the government to provide adequate oversight." Sterilized parts About 1.5 million pieces of tissue are used in transplants each year, according to the American Association of Tissue Banks. The transplants are used to replace tissue or bones damaged by trauma, tumors and other conditions. Regulations require consent of the donor's family before the tissue can be removed. After the tissue is removed, it is disinfected using anti-microbial chemicals, irradiation or both. The process eliminates HIV, hepatitis, bacteria, mold, fungi and spores and removes 99.9 percent of blood, lipids and marrow, according to Regeneration Technologies, a Florida-based processing company that is also named in the lawsuit. By the time the tissue fragments reach a distributor such as Medtronic, they are hardly recognizable. Bone is crafted into different shapes, some as small as dice. Over time, the transplant fuses with natural bone to form a solid piece. Knowing that the bone he received went through a sterilization process is of little comfort to Livingston. He tried to trace the donor but was blocked by privacy laws. Now he worries about getting HIV, hepatitis, even mad cow disease. "My biggest concern is, nobody really knows," he said. "And there's a part of me that really does want to give that bone back." Medtronic After recalling the bone used in orthopedic procedures, the company set up a hot line to respond to patients' concerns. Call the toll-free hot line at 866-825-6158 A nurse is available to answer questions from 7 a.m. to 7 p.m. Mondays through Thursdays. For more information go to www.medtronicspinal.com Timeline 1993 -- FDA begins regulating human tissue for transplantation. 2000 -- Former oral surgeon Michael Mastromarino and embalmer Joseph Nicelli enter into an agreement to open Biomedical Tissue Services. Early 2004 to September 2005 -- Questionable tissue implanted in thousands of patients nationwide. October 2005 -- The Centers for Disease Control and Prevention and the FDA recommend that recipients of tissue recovered by Biomedical Tissue Services be tested for HIV, hepatitis B, hepatitis C and syphilis. Five processors issue a voluntary recall, including the Austin-based Blood and Tissue Center of Central Texas. January 2006 -- FDA orders Biomedical Tissue Services to cease manufacturing and retain existing inventory of human cells, tissue and products. February 2006 -- Mastromarino, Nicelli and two others are charged in a 122-count criminal indictment. They are accused of orchestrating a large-scale enterprise in which tissue was harvested from dead people and sold for use in surgery. Charges including corruption, a Class B felony punishable by up to 25 years in prison. Mastromarino is free on $150,000 bail. October 2006 -- Indictment is expanded to include criminal operations in Rochester, the Bronx and Manhattan. It charges that three additional funeral homes provided corpses. Seven licensed funeral home directors have pleaded guilty and have agreed to cooperate in the ongoing investigation. Source: Kings County district attorney's office Safe tissue transplants There have been more than 10 million tissue transplants in the past two decades. The last reported case of disease transmission in a tissue recipient was in 2002. There have been no transmissions of Chagas' disease, rabies or West Nile virus from tissue transplants. The only reported cases of tuberculosis and hepatitis B in tissue recipients occurred more than 50 years ago. The only reported transmission of HIV occurred 20 years ago, before more sensitive testing was required. A few hepatitis C cases were transmitted in the early 1990s. Source: American Association of Tissue Banks Alistair Cooke Alistair Cooke, the dignified British broadcaster who hosted the PBS series Masterpiece Theater for 22 seasons, wanted to be cremated. Most of him was. Cooke's body -- along with hundreds of others taken from funeral homes -- was cut up and his bones illegally harvested. The stolen tissue and bones were then sold to processors for a profit and eventually ended up in patients throughout the country, according to the district attorney's office in Kings County, New York. Cooke's face is perhaps the most famous in this body-snatching story, but many families have learned that their loved ones' body parts were sold. Others have been on the other side of this story and learned that they received those illegally harvested parts. Susan Cooke Kittredge -- who wrote about the loss in a New York Times editorial -- learned what happened to her father's bones 10 days before Christmas in 2005. His family had never agreed to donate his bones. Cooke died from lung cancer that had spread to his bones; he was frail and 95 years old. Using cancerous bone for transplantation is a Food and Drug Administration violation, as is using bone from the elderly. But New York investigators told Kittredge that the people who stole her father's bones changed his age to 85 and the cause of death to a heart attack in their paperwork. Source: The Associated Press