May 16, 2007 — More than 450 people nationwide now claim they received illegally obtained and possibly diseased body parts from a New Jersey-based scheme, according to court documents.
The FDA has said it's concerned that the bone and tissue could be infected with the AIDS virus, syphilis and hepatitis, but the risk of infection is small.
The FDA, which did not return requests for comment, has not said whether any patients have ailments linked to the tissue, nor has it revealed how many people received it.
However, a document filed in a South Dakota lawsuit states that 13 plaintiffs nationwide claim they have contracted a disease.
The South Dakota case was brought by Charles Geigle of Oliver County, N.D., who claims he received transplanted bone tissue that might be infected.
He had back surgery April 30, 2004, at Sioux Valley Hospital in Sioux Falls, according to his complaint filed in U.S. District Court.
Defendants in the lawsuit, which seeks class-action status, have asked for a delay so they can argue that it should be transferred to the Judicial Panel on Multidistrict Litigation, which coordinates identical federal civil lawsuits into one jurisdiction.
Of the 451 cases filed so far, 189 are in federal courts and 134 of them have been transferred to the panel, court documents state. Two other South Dakota cases are among those that have been transferred.
"The need for coordination of this national litigation is compelling. The multiple proposed classes, as well as the individual actions, are overlapping. The complaints contain virtually identical allegations in many cases," according to one document in Geigle's case.
He received a letter in December 2005 from a doctor telling him the bone tissue he received might have been illegally acquired and that he could be at risk of getting a disease.
The supplier was Biomedical Tissue Services, a now-defunct Fort Lee, N.J., company owned by former dentist Michael Mastromarino, who made millions of dollars from the scheme, prosecutors have said.
He and three other men are accused of secretly removing skin, bone and other parts from up to 1,000 bodies from funeral homes without the families' permission.
"When a funeral was scheduled to be 'open casket,' harvested bone taken from the deceased was replaced with PVC pipe and other objects so the bodies would still appear normal during the funeral proceedings," court documents state.
The men also changed the names of the donors, medical records, death certificates and other information "in order to conceal the lifestyle and medical history of the donors," the documents said.
BTS supplied bone, skin and tendons to various processors that in turn provided the body parts to distributors for common procedures such as dental implants and hip replacements. Some of the tissue came from bodies that were not eligible to be donors because of age, disease or illness, according to Geigle's lawsuit.
Because of that, Geigle said he and perhaps thousands of others now live in fear they or their spouses have been exposed to a deadly disease. He seeks more than $5 million in damages for patients who received BTS tissue from 2002 to 2005.
Geigle received bone that was processed and packaged by Regeneration Technologies Inc., a Delaware corporation, and distributed by SpinalGraft Technologies of Tennessee, a division of Minneapolis-based distributor Medtronic Inc. -- all of which are listed as defendants.
The FDA ordered BTS to stop operating because of the serious nature of the violations and ordered a recall of all products, which the other defendants complied with, the lawsuit states.
The FDA and Centers for Disease Control also urged people who received BTS tissue be tested for infectious disease.