Synthes execs plead guilty to improper testing
Two senior executives of a West Chester-based manufacturer of medical devices pleaded guilty yesterday in connection with illegal clinical trials of a bone cement on about 200 patients, three of whom died.
Two senior executives of a West Chester-based manufacturer of medical devices pleaded guilty yesterday in connection with illegal clinical trials of a bone cement on about 200 patients, three of whom died.
The company, Synthes USA Inc., did not tell the patients that they were participating in what amounted to human experimentation, according to a 97-count indictment filed June 16 by the U.S. Attorney's Office in Philadelphia.
Michael D. Huggins, 51, of West Chester, was president and chief operating officer of Synthes' spine division from late 1994 to January 2008.
John J. Walsh, 46, of Coatesville, has served as director of regulatory and clinical affairs in the same division since August 2003.
Before U.S. District Judge Laurence F. Stengel, each pleaded guilty to a single misdemeanor count of introducing adulterated medical devices into interstate commerce. They face $100,000 fines and a year in prison when they are sentenced Oct. 22.
Two more Synthes executives, Thomas B. Higgins and Richard A. Bohner, are expected to plead guilty to the same charge in coming weeks, according to Huggins' plea memorandum.
From December 2001 to late 2004, Synthes marketed the products Norian SRS and Norian XR, which had been approved by the FDA to fill bone defects in some parts of the body but not the spine.
Norian XR's label explicitly warned that the product was "not intended to treat vertebral compression fractures," spinal injuries that often result from osteoporosis.
About 700,000 vertebral compression fractures are diagnosed annually in the U.S.
"The aging baby boomer generation makes the market for treatment of VCFs a large and lucrative one," court papers stated.
Manufacturers are forbidden to market new uses for a medical product without notifying the FDA. Winning FDA approval to use the Norian products to treat spinal injuries would have taken 36 months and cost Synthes at least $1 million, according to court papers.
At one point, according to the plea memo, Synthes promised the FDA it would not promote Norian XR for use on the spine.
But despite the company's own labeling, Synthes executives ordered Norian to be "test marketed" by training about 50 spine surgeons to use Norian XR to treat fractures in the vertebrae.
Huggins was aware of, and involved in, the process of approving the test marketing of Norian SRS and Norian XR, according to his plea memo.
Walsh's plea agreement states he approved the continued promotion of Norian XR for spinal surgery even after three elderly patients died on operating tables.