Editor02.20.09
A U.S. Justice Department investigation into the marketing of human bone growth products by Stryker has resulted in guilty pleas by two of the medical device maker’s former sales representatives, according to court documents.
The pair pleaded guilty to charges they had promoted off-label use of the products, even though they knew such use had earlier caused problems in some patients.
The inquiry, which began last year, raised questions about whether Kalamazoo, Mich.-based Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for “humanitarian” reasons, according to the documents.
The products in question are used by surgeons to foster in the growth of bones that fail to heal properly. One Stryker product, called OP-1, is a naturally occurring protein that promotes bone growth. The other product called OP-1 putty, is a moldable compound that includes the protein. Neither has been formally approved by the U.S. Food and Drug Administration for widespread medical use.
The F.D.A. grants a “humanitarian device exemption” when it believes that a small group of patients may benefit from a treatment whose effectiveness has not been fully proved. Under such a waiver, a device can be used in up to 4,000 patients a year.
The pair pleaded guilty to charges they had promoted off-label use of the products, even though they knew such use had earlier caused problems in some patients.
The inquiry, which began last year, raised questions about whether Kalamazoo, Mich.-based Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for “humanitarian” reasons, according to the documents.
The products in question are used by surgeons to foster in the growth of bones that fail to heal properly. One Stryker product, called OP-1, is a naturally occurring protein that promotes bone growth. The other product called OP-1 putty, is a moldable compound that includes the protein. Neither has been formally approved by the U.S. Food and Drug Administration for widespread medical use.
The F.D.A. grants a “humanitarian device exemption” when it believes that a small group of patients may benefit from a treatment whose effectiveness has not been fully proved. Under such a waiver, a device can be used in up to 4,000 patients a year.