WEST VIRGINIA RECORD

CHARLESTON - Two lawsuits have been filed recently after recipients of bone or tissue grafts were informed the body parts used were illegally harvested and improperly screened.

Terrance Reedy, of Ironton, Ohio, filed a suit March 12 in Cabell Circuit Court, while Rosemary Huffman filed the suit April 2 in Kanawha Circuit Court. Both seek compensatory and punitive damages for their injuries.

The suits were filed against Biomedical Tissue Services, Regeneration Technologies Inc., Medtronic, Sofamore, Danek and SpinalGraft Technologies.

Reedy and Huffman both underwent surgeries in West Virginia hospitals.

Reedy underwent a complete radical interior cervical diskectomy at St. Mary's Medical Center in Huntington on Dec. 9, 2004. The surgical procedure was performed without complication and Reedy believed it to be successful, the suit says.

In October 2005, RTI issued a voluntary recall of all tissue it received from BTS, "as a result of information regarding the accuracy of donor screening documentation," the suit says.

Reedy then learned the bone implanted during his surgery was illegally obtained and contained the Hepatitis C virus antibody. On June 12, 2006, Reedy was diagnosed with Hepatitis C due to the infected bone, which was obtained by BTS.

According to the suit, Huffman underwent surgery Oct. 21, 2005, and claims she received bone and tissue grafts at Charleston Area Medical Center that were harvested, distributed and sold by BTS, Regeneration Technologies and MedTronic.

On April 3, 2006, Huffman received a notice from Dr. John H. Schmidt III advising her that the donor bone tissue she received had not been properly screened or tested.

According to the suit, Huffman has suffered severe emotional distress since she learned the bone and tissue she was implanted with could have an infectious disease.

According to the suit, BTS provided tissue, bone and organs to RTI and Medtronic. However, BTS obtained the tissue and bones from human bodies they improperly obtained from various funeral homes and city morgues, when the bodies were unclaimed or unidentified, the suit says.

Michael Mastromarino and Joseph Nicelli, a master embalmer, opened BTS in 2000, allegedly for the purpose of obtaining parts of human corpses for resale.

Mastromarino was indicted Feb. 22, 2006, in a 22-count indictment issued by the Supreme Court of King County (Brooklyn), New York, for activities related to illegal body harvesting.

Mastromarino faces 18-54 years in prison and will forfeit $4.68 million.

According to the suit, employees of BTS, including Mastromarino, secretly dissected the bodies, removed the materials and prepared the bodies for burial without notifying family members of the removal.

Also, agents of BTS altered the medical records, death certificates, and identities of the corpses to conceal the lifestyle, medical or disease histories, as well as age, or the corpses, the suit says. According to the suit, the tissue or bone harvested and sold for implantation came from people who potentially suffered from chronic diseases such as syphilis, HIV, AIDS, or hepatitis.

According to the suit, RTI specifically promotes and markets its products on its Web site, and states all tissue must meet strict criteria before it is released for implantation.

"Despite the statements set out on its Web site, RTI accepted stolen and improperly screened donor bone and tissue from BTS," the suit says.

In February 2006, the Food and Drug Administration ordered BTS to close its operations because its deviations from FDA standards were so serious in nature that it constituted a danger to the public health.

Attorneys Paul Farrell, Anthony Majestro and Harry G. Deitzler are representing the plaintiffs.