Writing in a June FDA Voice blog post on the agency’s Web site, Office of Criminal Investigation (OCI) director John Roth cites enforcement actions against medical device manufacturer Synthes as demonstration that OCI’s work can deter industry misbehavior.

In the case, he says, the company tried to avoid a $1 million, three-year clinical trial of its Norian XR bone cement by persuading doctors to use it in the spine as part of a mixture, a use specifically warned against in the approved labeling.
“Synthes had reasons to understand the risks,” Roth writes. “Before the marketing program began, pilot studies showed that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such cement-caused clots became lodged in the lungs.”

Roth further notes that the ensuing tragedy was inevitable: “Three patients injected with the medication died on the operating table. “

Despite this, says Roth, Synthes “did not recall the product from the market, an action that would have required them to disclose details of the three deaths to FDA. Equally egregious, Synthes officials deliberately misled FDA during an official inspection in May and June 2004.”

Roth says the company pled guilty in 2010, thanks to his office's "painstaking work" and paid a fine of more than $23 million. And in 2011, four executives were convicted and sentenced to prison terms.