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Synthes Indicted Over Unapproved Study of Bone Cement (Update3)
By Sophia Pearson and Jef Feeley
June 16 (Bloomberg) -- Synthes Inc., the world’s largest maker of bone-related medical devices, and its Norian Corp. unit were indicted for conducting an unapproved study of the use of bone-mending cement that led to the deaths of three patients.
The companies and four Synthes executives conspired to conduct unauthorized clinical trials of Norian-brand cements used in surgeries to repair spinal fractures between May 2002 and late 2004, prosecutors said today after a federal grand jury in Philadelphia handed down the 52-count indictment.
Executives at West Chester, Pennsylvania-based Synthes bypassed U.S. Food and Drug Administration approval of the trials, knowing that the Norian XR and Norian SRS cement products “posed potentially significant risks,” U.S. Attorney Michael Levy said at a press conference.
“The companies completely circumvented all of the safeguards the FDA had in place,” Levy said. Synthes and Norian face maximum fines of $8.8 million and $26 million, respectively, prosecutors said.
The spinal surgeries were performed although an FDA-cleared label for Norian XR warned against such use, according to the indictment. 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.
‘Test Market’
“Synthes has fully cooperated with the government’s investigation,” and “believes that its marketing practices in connection with Norian XR were proper,” Gilgian Eisner, a company spokesman, said in a statement. Synthes “intends to vigorously defend itself against the charges,” he said.
The U.S. Department of Veterans Affairs was involved in the investigation because “some of the procedures were at VA hospitals,” said Patricia Hartman, a spokeswoman for the U.S. Attorney in Philadelphia. Officials aren’t releasing the names of the hospitals, she said.
“The Department of Defense is outraged by a company that potentially puts our military personnel, their family members, and veterans at undue risk for serious medical complications or even death, just to increase their corporate bottom line,” Assistant Special Agent-in-Charge
Kenneth Maupin, of the Defense Criminal Investigative
Service, said in a statement.
Norian and Synthes conducted the clinical trials at various hospitals across the U.S. after approaching selected spine surgeons about using the products, prosecutors said. Norian conducted two XR “Test Market Kick-Off” surgeon meetings and one surgeon forum from August 2003 through mid-January 2004, training about 52 spine surgeons, prosecutors said.
Patient Deaths
Three patients died from a rapid drop in blood pressure during surgeries. After the third patient died in January 2004, the company canceled future forums but rejected the idea of recalling or removing XR from the market, the indictment said. Company executives then lied to FDA investigators during an inspection at the Norian plant in West Chester around April 2004, prosecutors said.
Synthes said in April that first-quarter sales increased 3.1 percent to $805 million, less than analysts expected. Synthes reported a 6 percent increase in sales to $500.2 million in North America, its largest market. European sales fell 2.8 percent as currency swings eroded revenue.
Synthes rose 10 centimes to 107.4 Swiss francs ($98.63) in trading today in Switzerland.
The case is U.S. v. Norian Corp., U.S. District Court, Eastern District of Pennsylvania (Philadelphia).
To contact the reporters on this story: Sophia Pearson in Philadelphia spearson3@bloomberg.net; Jef Feeley in Wilmington, Delaware jfeeley@bloomberg.net.
Last Updated: June 16, 2009 18:36 EDT
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