Synthes Indicted Over Unapproved Study of Bone Cement

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From OutpatientSurgery.net:


Federal indictment alleges that bone filler was used in spine surgeries without FDA authorization.

Synthes, the world's largest maker of implants to mend bone fractures, conducted an unapproved study of the use of its Norian XR injectable cement bone filler that led to the deaths of 3 patients during spinal surgery and then lied to the FDA about it, prosecutors said yesterday after a federal grand jury in Philadelphia handed down a 52-count indictment.

Prosecutors allege that between 2002 and 2004, Synthes and its subsidiary, Norian, conspired to conduct unauthorized clinical trials on 2 versions of the product in spinal surgeries to treat vertebral compression fractures — an application of the bone filler explicitly prohibited by the FDA, according to a published report. The 3 patients who allegedly died during the trials died from rapid drop in blood pressure. The company marketed the cement for spinal fractures even after pilot studies showed it caused blood clots that could become lodged in the lungs, prosecutors said.

"Synthes has fully cooperated with the government’s investigation," and "believes that its marketing practices in connection with Norian XR were proper," a Synthes spokesman says in a statement. Synthes "intends to vigorously defend itself against the charges," he said.

The indictment includes 52 felony counts against California-based Norian, 44 misdemeanor counts against its Switzerland-based parent company, Synthes Inc., and 1 criminal misdemeanor count each for 4 Synthes executives accused of shipping an adulterated and misbranded product.

The indictment also accuses the companies of "allegedly carrying out a cover-up in which they lied to the FDA during an official inspection in May and June 2004." In a statement, U.S. Attorney Michael Levy says the companies and executives "put their profits ahead of responsible business practices and the truth."

Synthes, with North American offices located in West Chester, Pa., acquired Norian in 1998. If found guilty, Norian could face $28 million in fines; Synthes could face $8 million in fines; and the 4 executives charges could face 1-year prison sentences.

—Irene Tsikitas