Biomedical Tissue Services
Encyclopedia
Biomedical Tissue Services (BTS) was a Fort Lee
, New Jersey
-based human tissue recovery firm that was shut down by the U.S. Food and Drug Administration (FDA) on October 8, 2005 after its president, Dr Michael Mastromarino, and two other employees were convicted of illegally harvesting human bones, organs, tissue and other cadaver parts from individuals awaiting cremation, for forging numerous consent forms, and for selling the illegally obtained body parts to medical companies without consent of their families.
investigated Michael Mastromarino and his company BTS for allegedly selling stolen human body parts. The probe was first reported by the New York Daily News in October 2005, and led to a number of exhumations, including one of a Queens
, New York
woman who had had many of her bones removed and replaced with PVC
piping. According to government witnesses, BTS sought business relationships with a number of funeral home
s in New York
and Pennsylvania
solely to obtain access to recently deceased people, often paying the funeral homes $1,000 or more per corpse. In nearly every case, BTS employees obtained human allograft tissue, bones, ligaments and other cadaver material by forging family consent and other donor forms without actual authorized consent, and often against the written wishes of families. BTS employees engaged in highly irregular and unsafe practices, such as allowing cadavers to deteriorate before collecting tissue and parts, not testing donor material for diseases such as HIV/AIDS, and even accepting cancerous and other diseased cadavers for harvesting and selling. Under federal regulatory guidelines for the proper care and management of donated human tissue, firms are required to "screen and test donors for relevant communicable disease agents and diseases and to ensure that HCT/Ps are processed in a way that prevents communicable disease contamination and cross-contamination."
To conceal their practices, BTS employees forged a variety of the necessary certificates and even, as in the case of an exhumed Queens woman, replaced bone with piping to fool family members of the deceased. Of the numerous companies who purchased the illegally obtained body parts, or tissue, none had ever contacted the family member listed on the deceased consent forms to verify the consent, or even that the consenting person listed actually existed. The BTS scandal became international news after it was determined that the deceased Alistair Cooke
, a famed British
broadcaster, was among the remains that were violated and sold in New York.
In February 2006, Michael Mastromarino, then a 42-year-old former New Jersey
-based oral surgeon and CEO and executive director
of operations of BTS, was convicted along with three employees of wrongdoing and sentenced to prison terms. Mastromarino and Lee Cruceta, one of the convicted employees, agreed to a deal that resulted in their imprisonment. Mastromarino was sentenced on June 27, 2008 in the Supreme Court in Brooklyn
, New York
to between 18 to 54 years in prison
.
On September 4, 2008, defense attorneys for human graft tissue distributors asked U.S. District Judge William J. Martini
to dismiss hundreds of charges, asserting that the companies "never knew the body parts were illegally obtained, and they say there is no evidence the transplanted tissue made anyone ill."
According to the FDA, all tissue products collected and distributed by BTS were recalled and will be monitored for a complete accounting of all graft material. BTS sold its products to five companies; two of the companies were Life Cell Corporation, of New Jersey, and Regeneration Technologies, of Florida
. Overall, about 10,000 patients in the U.S. and Canada
received graft tissue from BTS.
BTS was not an accredited member, nor did the company ever apply to be a member, of the American Association of Tissue Banks
. Robert Rigney, who heads the association, said he doubts anyone who received tissue donations originating from the company is in any kind of health danger, because the processors the company dealt with would have subjected the tissues to their own screening processes.
However, transplant patient Betty Pfaff was one person who suffered severe infection, septic shock, underwent dialysis and ultimately paralysis due to having received an implant made from infected cadaver tissue from Mastromarino's company. Although a recent judicial ruling has increased the difficulty of patients in proving pain and suffering from receiving bad donor tissue in cases like these, Pfaff’s lawsuit is still pending.
Other patients who received BTS-derived tissue and body parts include a Colorado woman who had to repeat her ACL replacement surgery after her first BTS tendon failed, an Ohio woman who developed syphilis after receiving a bone from BTS, and an Ohio man who developed both HIV and hepatitis C after receiving BTS bone implants in surgery.
On January 8, 2010, Michael Mastromarino's now ex-wife Barbra Mastromarino appeared on The Oprah Winfrey Show
in a segment "Husbands' Secret Lives" and discussed the effect of the actions on her life and their sons'. After confronting his father about the reasons for his crimes while Dr Mastromarino was incarcerated at Rikers Island
, their older son now refuses to speak to his father. During the broadcast, Barbra Mastromarino also listened to and apologized to the daughter of a victim of her husband's crimes, while mentioning she had no knowledge of her husband's illegal acts. Mrs Mastromarino acknowledged ignoring warning signs about the character of her ex-husband early in their relationship.
Fort Lee, New Jersey
Fort Lee is a borough in Bergen County, New Jersey, United States. As of the 2010 United States Census, the borough population was 35,345. Located atop the Hudson Palisades, the borough is the western terminus of the George Washington Bridge...
, New Jersey
New Jersey
New Jersey is a state in the Northeastern and Middle Atlantic regions of the United States. , its population was 8,791,894. It is bordered on the north and east by the state of New York, on the southeast and south by the Atlantic Ocean, on the west by Pennsylvania and on the southwest by Delaware...
-based human tissue recovery firm that was shut down by the U.S. Food and Drug Administration (FDA) on October 8, 2005 after its president, Dr Michael Mastromarino, and two other employees were convicted of illegally harvesting human bones, organs, tissue and other cadaver parts from individuals awaiting cremation, for forging numerous consent forms, and for selling the illegally obtained body parts to medical companies without consent of their families.
History
In late 2005, the New York City Police DepartmentNew York City Police Department
The New York City Police Department , established in 1845, is currently the largest municipal police force in the United States, with primary responsibilities in law enforcement and investigation within the five boroughs of New York City...
investigated Michael Mastromarino and his company BTS for allegedly selling stolen human body parts. The probe was first reported by the New York Daily News in October 2005, and led to a number of exhumations, including one of a Queens
Queens
Queens is the easternmost of the five boroughs of New York City. The largest borough in area and the second-largest in population, it is coextensive with Queens County, an administrative division of New York state, in the United States....
, New York
New York
New York is a state in the Northeastern region of the United States. It is the nation's third most populous state. New York is bordered by New Jersey and Pennsylvania to the south, and by Connecticut, Massachusetts and Vermont to the east...
woman who had had many of her bones removed and replaced with PVC
PVC
Polyvinyl chloride is a plastic.PVC may also refer to:*Param Vir Chakra, India's highest military honor*Peripheral venous catheter, a small, flexible tube placed into a peripheral vein in order to administer medication or fluids...
piping. According to government witnesses, BTS sought business relationships with a number of funeral home
Funeral home
A funeral home, funeral parlor or mortuary, is a business that provides burial and funeral services for the deceased and their families. These services may include aprepared wake and funeral, and the provision of a chapel for the funeral....
s in New York
New York
New York is a state in the Northeastern region of the United States. It is the nation's third most populous state. New York is bordered by New Jersey and Pennsylvania to the south, and by Connecticut, Massachusetts and Vermont to the east...
and Pennsylvania
Pennsylvania
The Commonwealth of Pennsylvania is a U.S. state that is located in the Northeastern and Mid-Atlantic regions of the United States. The state borders Delaware and Maryland to the south, West Virginia to the southwest, Ohio to the west, New York and Ontario, Canada, to the north, and New Jersey to...
solely to obtain access to recently deceased people, often paying the funeral homes $1,000 or more per corpse. In nearly every case, BTS employees obtained human allograft tissue, bones, ligaments and other cadaver material by forging family consent and other donor forms without actual authorized consent, and often against the written wishes of families. BTS employees engaged in highly irregular and unsafe practices, such as allowing cadavers to deteriorate before collecting tissue and parts, not testing donor material for diseases such as HIV/AIDS, and even accepting cancerous and other diseased cadavers for harvesting and selling. Under federal regulatory guidelines for the proper care and management of donated human tissue, firms are required to "screen and test donors for relevant communicable disease agents and diseases and to ensure that HCT/Ps are processed in a way that prevents communicable disease contamination and cross-contamination."
To conceal their practices, BTS employees forged a variety of the necessary certificates and even, as in the case of an exhumed Queens woman, replaced bone with piping to fool family members of the deceased. Of the numerous companies who purchased the illegally obtained body parts, or tissue, none had ever contacted the family member listed on the deceased consent forms to verify the consent, or even that the consenting person listed actually existed. The BTS scandal became international news after it was determined that the deceased Alistair Cooke
Alistair Cooke
Alfred Alistair Cooke KBE was a British/American journalist, television personality and broadcaster. Outside his journalistic output, which included Letter from America and Alistair Cooke's America, he was well known in the United States as the host of PBS Masterpiece Theater from 1971 to 1992...
, a famed British
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
broadcaster, was among the remains that were violated and sold in New York.
In February 2006, Michael Mastromarino, then a 42-year-old former New Jersey
New Jersey
New Jersey is a state in the Northeastern and Middle Atlantic regions of the United States. , its population was 8,791,894. It is bordered on the north and east by the state of New York, on the southeast and south by the Atlantic Ocean, on the west by Pennsylvania and on the southwest by Delaware...
-based oral surgeon and CEO and executive director
Executive director
Executive director is a term sometimes applied to the chief executive officer or managing director of an organization, company, or corporation. It is widely used in North American non-profit organizations, though in recent decades many U.S. nonprofits have adopted the title "President/CEO"...
of operations of BTS, was convicted along with three employees of wrongdoing and sentenced to prison terms. Mastromarino and Lee Cruceta, one of the convicted employees, agreed to a deal that resulted in their imprisonment. Mastromarino was sentenced on June 27, 2008 in the Supreme Court in Brooklyn
Brooklyn
Brooklyn is the most populous of New York City's five boroughs, with nearly 2.6 million residents, and the second-largest in area. Since 1896, Brooklyn has had the same boundaries as Kings County, which is now the most populous county in New York State and the second-most densely populated...
, New York
New York
New York is a state in the Northeastern region of the United States. It is the nation's third most populous state. New York is bordered by New Jersey and Pennsylvania to the south, and by Connecticut, Massachusetts and Vermont to the east...
to between 18 to 54 years in prison
Prison
A prison is a place in which people are physically confined and, usually, deprived of a range of personal freedoms. Imprisonment or incarceration is a legal penalty that may be imposed by the state for the commission of a crime...
.
On September 4, 2008, defense attorneys for human graft tissue distributors asked U.S. District Judge William J. Martini
William J. Martini
William J. "Bill" Martini is a United States district court judge for the District of New Jersey, having served in this position since November 19, 2002...
to dismiss hundreds of charges, asserting that the companies "never knew the body parts were illegally obtained, and they say there is no evidence the transplanted tissue made anyone ill."
According to the FDA, all tissue products collected and distributed by BTS were recalled and will be monitored for a complete accounting of all graft material. BTS sold its products to five companies; two of the companies were Life Cell Corporation, of New Jersey, and Regeneration Technologies, of Florida
Florida
Florida is a state in the southeastern United States, located on the nation's Atlantic and Gulf coasts. It is bordered to the west by the Gulf of Mexico, to the north by Alabama and Georgia and to the east by the Atlantic Ocean. With a population of 18,801,310 as measured by the 2010 census, it...
. Overall, about 10,000 patients in the U.S. and Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
received graft tissue from BTS.
BTS was not an accredited member, nor did the company ever apply to be a member, of the American Association of Tissue Banks
American Association of Tissue Banks
The American Association of Tissue Banks ; a transplant trade organization that is dedicated to ensuring that human tissues intended for transplantation are safe and free of infectious disease, of uniform high quality, and available in quantities sufficient to meet national needs.The AATB provides...
. Robert Rigney, who heads the association, said he doubts anyone who received tissue donations originating from the company is in any kind of health danger, because the processors the company dealt with would have subjected the tissues to their own screening processes.
However, transplant patient Betty Pfaff was one person who suffered severe infection, septic shock, underwent dialysis and ultimately paralysis due to having received an implant made from infected cadaver tissue from Mastromarino's company. Although a recent judicial ruling has increased the difficulty of patients in proving pain and suffering from receiving bad donor tissue in cases like these, Pfaff’s lawsuit is still pending.
Other patients who received BTS-derived tissue and body parts include a Colorado woman who had to repeat her ACL replacement surgery after her first BTS tendon failed, an Ohio woman who developed syphilis after receiving a bone from BTS, and an Ohio man who developed both HIV and hepatitis C after receiving BTS bone implants in surgery.
On January 8, 2010, Michael Mastromarino's now ex-wife Barbra Mastromarino appeared on The Oprah Winfrey Show
The Oprah Winfrey Show
The Oprah Winfrey Show is an American syndicated talk show hosted and produced by its namesake Oprah Winfrey. It ran nationally for 25 seasons beginning in 1986, before concluding in 2011. It is the highest-rated talk show in American television history....
in a segment "Husbands' Secret Lives" and discussed the effect of the actions on her life and their sons'. After confronting his father about the reasons for his crimes while Dr Mastromarino was incarcerated at Rikers Island
Rikers Island
Rikers Island is New York City's main jail complex, as well as the name of the island on which it sits, in the East River between Queens and the mainland Bronx, adjacent to the runways of LaGuardia Airport. The island itself is part of the borough of the Bronx, though it is included as part of...
, their older son now refuses to speak to his father. During the broadcast, Barbra Mastromarino also listened to and apologized to the daughter of a victim of her husband's crimes, while mentioning she had no knowledge of her husband's illegal acts. Mrs Mastromarino acknowledged ignoring warning signs about the character of her ex-husband early in their relationship.