A Medical Device Daily

A North Dakota man has filed a lawsuit related to a national body parts scandal, claiming he received transplanted bone tissue in South Dakota that might be diseased.

Charles Geigle of Oliver County, North Dakota, had back surgery April 30, 2004, at Sioux Valley Hospital (Sioux Falls, South Dakota), according to the complaint filed in U.S. District Court. His lawsuit seeks class-action status.

He received a letter in December 2005 from a doctor at the hospital telling him the bone tissue might have been illegally acquired and that he could be at risk of getting a disease.

The supplier was Biomedical Tissue Services (BTS), a now-defunct New Jersey company accused of collecting body parts from cadavers without donor consent and selling them for use in transplants across the country. BTS supplied bone, skin and tendons to various processors, who in turn provided them to distributors.

The FDA is concerned those parts could be infected with the AIDS virus, syphilis and hepatitis, but has said the risk of infection is small. The agency will not say whether any patients have ailments that might be linked with suspect tissue. It has also refused to reveal how many people received BTS tissue.

Geigle said in his lawsuit that he and perhaps thousands of others now live in fear that they or their spouses have been exposed to a deadly disease. Geigle's lawsuit seeks more than $5 million in damages for patients who received BTS tissue 2002-2005.

BTS obtained the tissue from more than 1,000 bodies, many not eligible to be donors because of age, disease or illness, thus putting recipients at risk for disease such as HIV, hepatitis and syphilis, according to the complaint.

Geigle received tissue from BTS that was processed and packaged by Regeneration Technologies (Alachua, Florida), and distributed by SpinalGraft Technologies of Tennessee, a division of Medtronic (Minneapolis) — all also listed as defendants.

BTS was owned by former New Jersey dentist Michael Mastromarino and New York embalmer Josh Nicelli, who formed the company in 2002 and, without permission, started dissecting bodies from funeral homes and harvesting body parts, according to Geigle's lawsuit.

"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," it states.

BTS 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."

Mastromarino and Nicelli, who have been charged with violating New York and New Jersey laws on the handling of dead bodies, then sold millions of dollars worth of body parts to the other defendants, Geigle's complaint alleges.

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 and Prevention (Atlanta) also urged people who received BTS tissue be tested for infectious disease.