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Bone transplant recipients in Atlantic County, N.J., are pretty rattled of late. In suits filed this month, plaintiffs charge that bone pieces implanted in them during surgery at Shore Memorial Hospital are of unknown origin – that they were pilfered from cadavers and sold without the consent of the deceaseds’ families or the protective screening required by law, leaving recipients exposed to risk of infection with HIV, hepatitis and syphilis. The suits, Augustin v. Medtronic Sofamor Danek and Pieper v. Medtronic Sofamor Danek, come in the wake of recalls of bone and tissue products and investigations by the Food and Drug Administration and the Brooklyn, N.Y., District Attorney’s Office, which has reportedly been exhuming bodies in Brooklyn and Queens graveyards. Suits have also been filed in Brooklyn by people who claim that the bodies of their relatives were carved up and sold without their knowledge or permission. More litigation is on the way. Patrick D’Arcy, whose Galloway law firm is handling the Atlantic County cases, was planning to file more suits this week on behalf of bone and tissue recipients. One will likely feature a plaintiff who claims she tested positive for hepatitis C only a week or so after the surgery. The allegations center around Joseph Nicelli, an embalmer, and Michael Mastromarino, an oral surgeon who operated Biomedical Tissue Services, a company that supplied bone and tissue from cadavers for medical uses. Nicelli, Mastromarino and Biomedical are defendants in the suits, along with Daniel George & Son Funeral Home in Brooklyn. Nicelli’s lawyer, New York solo Richard Medina, acknowledged that his client briefly owned the funeral home two or three years ago but said he does not know whether it was during the time of the alleged harvesting. The defendants allegedly worked together to remove bone, tissue and body parts without permission or the proper protocols or papers. Also named as defendants are Regeneration Technologies Inc. of Alachua, Fla., and Medtronic Sofamor Danek Inc. of Memphis, who were allegedly parts of the distribution chain by which suspect bone matter made its way from Biomedical to the hospital and into the spines of Gary Pieper and Heather Augustin. Those companies were at least negligent, and whether they knew what was going on will be determined by the litigation, D’Arcy said. The complaints allege, among other things, negligence, strict liability, racketeering, misrepresentation, breach of warranty and infliction of emotional distress. Violations of the New Jersey Consumer Fraud Act and a federal statute, 42 U.S.C. 274(e), that outlaws trafficking in human organs are also alleged. Documentation Discrepancy The situation came to light in September when LifeCell Corp., a human tissue supplier in Branchburg, N.J., learned of discrepancies in documentation from Biomedical. On Sept. 30, LifeCell voluntarily recalled products that had originated with Biomedical and contacted the FDA. Four other suppliers, including Regeneration Technologies, also recalled Biomedical’s products. On Oct. 28, the FDA announced it was investigating whether bone, skin and tendons supplied by Biomedical came from human donors “who may not have met FDA eligibility requirements and who may not have been properly screened for certain infectious diseases.” In addition to testing for specific diseases, suppliers are supposed to take medical histories and assess donors to guard against transmitting infections through transplanted tissue. The FDA recommended that all doctors who implanted Biomedical materials notify their patients of the risk of illness and offer to test them for it. D’Arcy says he has spoken with nearly 70 people who learned from doctors or hospitals that they received questionable bone or tissue. Their common refrain is “get this out of me,” he said. Most of them, including Pieper and Augustin, had bone implanted during surgery for herniated disks that involved fusing the bone, making removal harmful, if not impossible. And given the incubation times for some diseases, negative test results do not ease their minds. D’Arcy said Pieper is worried that he does not know whether old bone was placed in his back. Pieper, a construction worker, was told he needed young bone for the three-level fusion or his back might collapse, said D’Arcy. The cases present D’Arcy and his brother Andrew, who is also working on them, with such uniquely challenging problems as tracing the origin of the bones along a trail of allegedly false documentation and, where a client does fall ill, proving a link with the transplant. Pre-admission testing that shows a now ailing client was healthy before the surgery should help, especially absent lifestyle or other risk factors, said D’Arcy. “I’d be comfortable proving that case.” At least one other New Jersey lawyer is considering filing similar suits but is not sure. Richard Bagolie, of Jersey City’s Bagolie Friedman, has spoken with about a dozen potential plaintiffs around the country, mainly bone recipients, none of whom has tested positive for the screened diseases. “I’m still not convinced at the end of the day we’re going to be able to do anything with them,” he said, noting that the suits would essentially be over emotional distress and medical monitoring. ‘Harvesting’ Alleged At the supply end of the chain are the two New York suits, filed in Kings County Supreme Court, Bruno v. English Brothers Funeral Home and Kogut v. English Brothers Funeral Home. They were filed about two months ago on behalf of families who claim they never agreed to donate pieces of their loved ones. The complaints accuse Mastromarino and Nicelli of “harvesting” corpses at English Brothers Funeral Home in Brooklyn. Sanford Rubenstein, of Brooklyn’s Rubenstein & Rynecki, who represents both families, said they found out when police contacted them in the course of an investigation into forged consent forms that also misrepresented what killed the men. They both died of cancer. Mastromarino’s lawyer, Mario Gallucci, said he had not been served with any complaints but “these lawsuits will be routinely tossed out of court.” His client “owns a procurement company that followed FDA regulations and was audited every single year by the FDA as well as every single processing company that received tissue” and was not responsible for obtaining consent, he asserted. Mastromarino is doing consulting work but expects to eventually return to “the business of selling tissue,” said Gallucci, of Helbock Nappa & Gallucci. Medina, Nicelli’s lawyer, said he had also not been served with anything nor had any law enforcement official subpoenaed him or tried to interview him. He called the lawsuits “an interesting shot in the dark.” Medtronic Sofamor spokesman Bert Kelly said the company had not been served but is recalling tissue from Regeneration Technologies, for which it is a distributor. Regeneration Technologies’ manager of corporate communications, Wendy Crites, responded to a reporter’s request for comment by referring to an Oct. 14 press release about the recall and the steps routinely taken by the company to ensure tissue safety. The Daniel George Funeral Home has no telephone listing. A call to the English Brothers Funeral Homes was not returned. The Brooklyn District Attorney’s Office declines comment on what it terms an ongoing investigation, while the New York Daily News and other papers report that investigators are digging up coffins in area graveyards to determine, among other things, if the corpses are intact. This article originally appeared in the New Jersey Law Journal , a publication of ALM.

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