A Medical Device Daily

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

Defendants in the case include allograft distributor Tutogen Medical (Alachua, Florida) and the now-defunct Biomedical Tissue Services (BTS; Fort Lee, New Jersey), along with two of its founders.

The suit says that in June of 2005, Steadman underwent what should have been routine dental surgery, receiving a Tutogen tissue implant in his mouth. In December of 2005, he received a letter from his doctor informing him that the tissue used in his surgery was processed and packaged by Tutogen and that the parts were part of a recent recall by Tutogen because they were potentially tainted with numerous diseases.

“Ralph will have to be tested every three months for the most serious diseases known to mankind,“ said James Ferraro, a partner of the Ferraro firm. “Could you imagine living every day knowing any day you could become positive for HIV, syphilis, or Hepatitis because of a routine dental procedure?“

Two of the defendants, Michael Mastromarino and Joseph Nicelli of BTS, were recently charged 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.

The law firm said that due to poor industry regulations, the problem may extend far beyond what has been included in the recent BTS case.

Ferraro said it also is representing family members of those whose bodies were unlawfully stolen and harvested.

In other legalities: Sentillion (Andover, Massachusetts), a provider of identity and access management solutions for the always-on healthcare industry, reported filing a patent infringement suit against Carefx (Mesa, Arizona) in the U.S. District Court of Delaware. Sentillion asserts that Carefx has infringed U.S. patent 6,941,313, which relates to context management technology with advanced audit capabilities developed by Sentillion.

Sentillion says that its intellectual property portfolio includes three U.S. patents with several more in the pipeline.

Sentillion is a provider of identity and access management solutions to the always-on healthcare industry.

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