A Medical Device Daily

A Texas man has filed a lawsuit against med-tech giant Medtronic (Minneapolis, Minnesota) for fraud and negligence in a “body-snatching” scheme that left him with a stolen piece of bone in his neck.

The complaint, filed in the Supreme Court of the State of New York, names as defendants Sofamor Danek (Memphis, Tennessee), Spinalgraft Technologies (Knoxville, Tennessee), Regeneration Technologies (Alachua, Florida), the now-defunct Biomedical Tissue Services (BTS; Fort Lee, New Jersey), Michael Mastromarino and Joseph Nicelli.

Mastromarino and Nicelli, were charged last year with operating a $4.6 million enterprise to harvest human tissue from funeral homes and sell it for use in transplants and research. This came after the FDA ordered BTS to cease all manufacturing operations (Medical Device Daily, Feb. 7, 2006). Hospitals nationwide received these illegally harvested and potentially dangerous tissues.

In September 2005, doctors at Baylor All Saints Medical Center (Fort Worth) removed a portion of a cervical disc from James Livingston, 44, of Weatherford, Texas, and replaced it with a bone graft supplied by Regeneration Technologies.

Several months later, Regeneration recalled the transplanted bone due to its ties to a wider investigation into stolen and tainted body parts that made their way to hospitals around the country.

Since then, authorities have indicted the owner of BTS, former dentist Mastromarino, and several others on charges they removed bone and tissue from more than 1,000 human bodies without the families’ permission, and then sold the body parts without proper screening for diseases such as HIV, hepatitis and cancer.

Livingston will continue to undergo testing to determine whether he has contracted these or other diseases, according to the complaint.

BTS sold bone and tissue to Medtronic, Regeneration Technologies and Spinalgraft Technologies, which then sold them to hospitals.

“To say this is ghoulish or ghastly just isn’t strong enough,” said Livingston’s attorney, John David Hart of Fort Worth. “This is an unconscionable example of corporate profit over patient safety.”

Last year the Ferraro Law Firm (Miami) reported filing suit in connection with the illegally harvested and unscreened body parts used in transplant surgery, in Alachua County, Florida, on behalf of Los Angeles resident Ralph Steadman, who allegedly was implanted with illegally harvested and untested tissue as part of routine dental surgery in Eugene, Oregon (MDD, March 17, 2006).

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