Former Synthes North America President Michael Huggins will serve 9 months in prison for his role in a clinical trial to test bone cement that resulted in the deaths of three people, the AP reported today.
Thomas Higgins also received a 9-month sentence. But the sentencings came to a dramatic halt after defendant Richard Bohner's lawyer collapsed and hit his head on a table. The case was adjourned without Bohner being sentenced, the Philadelphia Inquirer reports. A fourth executive, John Walsh, was sentenced to 5 months in jail.
The Justice Department had sought a full-year sentence for the executives in an effort to hold individual executives criminally responsible for corporate violations of food and drug laws. "It does seem as if the government wants to send a strong message about corporate integrity, and this is one way to do it," said former Justice official Lisa Krigsten, who is currently a defense lawyer with Husch Blackwell LLP, as quoted by The Wall Street Journal.
Synthes Norian unit, whose assets were picked up earlier this year by Exton, PA-based Kensey Nash for $22 million, manufactured osteobiologic medical devices. Between 2002 and 2004, Norian conspired to conduct unauthorized clinical trials of Synthes' Norian XR in surgeries to treat vertebral compression fractures (VCF) of the spine, according to the government. These surgeries were allegedly performed despite a warning on the label for Norian XR against this use. Pilot studies had demonstrated the bone cement reacted chemically with human blood in a test tube to cause clots. The research also showed that in a pig such clots became lodged in the lungs.
Despite knowing this, the company marketed the product for VCFs without putting it through required testing. The company failed to stop marketing the product until after a third patient had died on the operating table. And even after the third death, the companies didn't recall Norian XR from the market, but instead made false statements to the FDA, the government maintains.
Earlier this year, Synthes and Johnson & Johnson entered a merger agreement. J&J agreed to buy the company for roughly $21.3 billion. But the EU regulators instigated a probe earlier this month to ensure the proposed merger doesn't harm competition. It has until early March to make the determination.
Editor's Note: Update reflects trial proceedings that occurred after the story's publication.