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.
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