The families of two people who died during clinical trials for a bone cement that was being tested for spinal surgery by Synthes Inc. have filed a lawsuit against the Swiss device maker and some of its executives. The lawsuit, which was filed in California Superior Court, alleges that a clinical trial for Norian XR Bone Cement was illegal, and constituted an off-label use of the product.
Both of the decedents named in the lawsuit are women in their 80s who died on the operating table during a procedure in which Norian XR was injected into their spines. As we’ve reported previously, Norian XR was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. Synthes and its Norian unit agreed last year to plead guilty to federal charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials using the bone cement in a type of spinal procedure. The company agreed to pay $24 million in fines to settle the charges, while four former Synthes executives pleaded guilty to one misdemeanor count each for their roles in the case.
The FDA-approved label for Norian XR warns against use in the spine, and studies have shown that such use can cause clots that could become lodged in the lungs, leading to death. Federal prosecutors pursuing the criminal case against Synthes said that three people had died on the operating table during the company’s illegal tests for Norian XR, though the bone cement could not be definitively tied to the fatalities. Norian XR was pulled from the market after Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures.
Now, the families of two deceased patients who underwent spinal procedures with Norian XR are suing Synthes. According to a report in the Philadelphia Inquirer, both decedents, Ryoichi Kikuchi and Barbara Marcelino, were 83 years old when they died. Both deaths occurred on the operating table after their blood pressure dropped precipitously and doctors could not revive them. Both women underwent their procedures at the John Muir Medical Center in Walnut Creek, California. Ms. Kikuchi died in 2003, while Ms. Marcelino passed away in 2004.
According to the Inquirer report, charges in the lawsuit include wrongful death and elder abuse. The surgeons who performed the procedures are not named in the complaint, according to the Inquirer.