Legal News

On Bone Cement and the Law

By Ashby Jones

Rest assured, we’ll give a close look to any article containing repeated references to “bone cement.” But because this WSJ article also has a legal angle, we’re going to tackle it first thing this morning.

The news: A federal grand jury in Philadelphia on Tuesday handed down an indictment against medical technology company Synthes Inc., alleging the company conducted clinical trials of, yes, bone cement without FDA approval.

The FDA approved Synthes’ Norian XR bone cement in 2002 for use in certain defects but not for use in surgeries to treat vertebral compression fractures of the spine, a painful condition commonly suffered by older people.

According to the indictment, the West Chester, Pa.-based company allegedly marketed its bone cement for spinal surgery without putting it through FDA-required testing. Further, the indictment claims the company didn’t stop the marketing until after a third patient had died on the operating table and failed to order a recall because it “would have required them to disclose details of the three deaths to the FDA.”

The Justice Department said Norian Corp., which Synthes acquired in 1999, was charged with a total of 52 felony counts, including conspiracy to impede the functions of the FDA, making false statements in connection with an FDA inspection, and shipping adulterated and misbranded Norian XR bone cement in interstate commerce.

Synthes faces 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce between 2002 and 2004.

In response to the indictment, Synthes said it fully cooperated with the U.S. Attorney for the Eastern District of Pennsylvania’s investigation and “believes that its marketing practices in connection with Norian XR were proper.” The company said it intends to “vigorously defend itself against the charges.”

Full post as published by Law Blog - WSJ.com on June 17, 2009 (boomark / email).