Devicemaker Synthes and four of its executives face felony charges for allegedly misleading the Food and Drug Administration and conducting unapproved marketing and clinical tests of a bone cement in spine surgeries, during which three patients died on the operating table.
According to a 52-count federal indictment handed down by a grand jury in Philadelphia, the company enlisted surgeons to test Norian bone cement in the treatment of vertical compression fractures although the products FDA-approved label expressly warned against that use. A call to the U.S. headquarters in West Chester, Pa., seeking comment was referred to an e-mail address for the companys investor relations office in Switzerland.
The company issued a written statement in response to the allegations: Synthes has fully cooperated with the governments investigation, which began in 2006, and believes that its marketing practices in connection with Norian XR were proper. The company intends to vigorously defend itself against the charges.
The statement added that Synthes sold about 200 units during the two years the product was marketed, realizing total net sales of approximately $400,000 only.
Among procedures performed between 2002 and 2004, three patients died in Texas and California from a rapid drop in blood pressure, and the surgeons were unable to rule out the Norian product as the cause, according to FDA Special Agent Kim Rice, who appeared with Michael Levy, the U.S. attorney in Philadelphia, to announce the charges.
In laboratory tests conducted before Synthes embarked on its unapproved pilot study, the cement showed a tendency to cause clots when mixed with blood, according to the indictment. Notwithstanding this knowledge, the company proceeded to market without putting it through FDA-approved testing, Levy said. After the deaths the company lied to FDA investigators, Levy said.
Personally named as defendants are Michael Huggins, who was president of Synthes North America and then president of Synthes Spine; Thomas Higgins, who was president of Synthes Spine and then senior vice president of global strategy; Richard Bohner, who was vice president of operations; and John Walsh, who was director of regulatory and clinical affairs in the spine division.
Norian Corp., acquired by Synthes in 1999, faces a $26 million fine if convicted, and Synthes faces another $8.8 million. The executives could each spend a year in prison.