Families Sue Synthes after deaths during unapproved Bone Cement Clinical Trial
Families Sue Synthes Over Bone Cement (Walter Eisner @ OTW)
The families of two patients who died during surgery that used an unapproved Synthes, Inc. bone cement are suing.
A lawsuit, filed against the company and former company executives in early March in California’s Contra Costa Superior Court, alleges that 83-year olds Ryoichi Kikuchi and Barbara Marcelino died after receiving bone cement injections during surgeries in 2003 and 2004.
Synthes and former subsidiary Norian Corp. pleaded guilty to corporate health care fraud and agreed to pay $23 million in fines after the government prosecuted the company for promoting the bone cement and training doctors in its use even though it wasn’t approved by the FDA for spinal procedures. Four former Synthes executives were sentenced to jail after pleading guilty to misdemeanor charges of illegally promoting the bone cement off-label.
Both women died after their blood pressure dropped precipitously and they could not be revived. Doctors said the bone cement could not be definitively identified as the cause of death. Among the allegations are wrongful death and elder abuse.
The surgeons involved were not named as defendants in this suit.
The Philadelphia Inquirer reported that Gregory Rueb, an attorney who represents the two families in the suit, did not specify how much he was seeking for his clients. No trial date had been set.
“The victims’ families are furious and deeply hurt over their recent discovery of the true cause of their loved ones’ deaths,” Rueb said. “I have never seen such despicable conduct by a corporation so desperate to make profits and maintain a competitive edge at the expense of human lives.”
Synthes eventually divested itself of the Norian subsidiary, which originally made the bone cement. Kensey Nash Corp. bought those assets and was also named in the suit, as was Hansjorg Wyss, chairman of Synthes and its largest shareholder.