Synthes Inc. and four of its former executives involved in an illegal clinical trial of bone cement were sued Thursday in California Superior Court by the families of two patients who died on the operating table.
Ryoichi Kikuchi and Barbara Marcelino were both 83 when they died after surgeons at the John Muir Medical Center in Northern California injected bone cement into their spines.
Both died after their blood pressure dropped precipitously and doctors could not revive them, though the bone cement could not be definitively identified as the cause of death. Among the allegations are wrongful death and elder abuse.
Synthes, with U.S. headquarters in Chester County, paid about $24 million in fines and penalties to settle criminal charges brought by the U.S. Attorney's Office in Philadelphia.
Prosecutors argued that Synthes promoted the bone cement and trained doctors in its use even though it wasn't approved by the FDA for that specific spinal procedure.
As part of the settlement with the U.S. Justice Department, Synthes had to divest the assets of its wholly owned Norian subsidiary, which originally made the bone cement. Kensey Nash Corp. in Exton bought those assets and was also named in the suit, as was Hansjorg Wyss, chairman of Synthes and its largest shareholder.
Four Synthes executives - Michael Huggins, Thomas Higgins, Richard Bohner, and John Walsh - pleaded guilty to one misdemeanor count each for their roles in the case. U.S. District Court Judge Legrome D. Davis called their conduct and that of the company "shameful" and sent the four men to prison.
The attorneys for the four men and Kensey Nash could not be reached for comment. A Synthes spokesman could not be reached for comment.
The surgeons involved were not named as defendants in this suit.
Pending final approval by the European Commission, Johnson & Johnson will pay $21.3 billion to buy Synthes.
Attorney Gregory Rueb, 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."
Contact David Sell at 215-854-4506, firstname.lastname@example.org, or follow on Twitter @phillypharma.
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