The effects of the illegal clinical study involving a Synthes bone cement product are still being felt. The families of two patients who died after receiving the cement are suing the company and four former executives in the California Superior Court, alleging wrongful death and elder abuse.
Ryoichi Kikuchi and Barbara Marcelino died on the operating table after their blood pressure dropped to dangerous levels; however, the cement hasn't been definitively named as the cause of their deaths, The Philadelphia Inquirer notes. No trial date has been set.
Trouble for the company began in 2002 when its Norian unit conspired to conduct unauthorized clinical trials of Synthes' Norian XR in surgeries to treat vertebral compression fractures of the spine, according to the U.S. government, which subsequently sought prison sentences for the execs. These surgeries were allegedly performed despite a warning on the label for Norian XR against this use because of safety concerns. Yet the company marketed the product for VCFs without putting it through required testing, the government alleged. The company failed to stop marketing the product until after a third patient had died on the operating table.
As part of a settlement with the government, Synthes agreed to divest itself of the Norian unit. Last spring, Exton, PA-based Kensey Nash ($KNSY) agreed to buy the Norian assets for $22 million in cash.
The four execs charged by feds included former Synthes North America President Michael Huggins, who received a 9-month prison sentence for his role in the clinical trial last November. Also sentenced were Thomas Higgins, who got 9 months, and John Walsh, who received 5 months. Richard Bohner ultimately received 8 months after his sentencing was delayed because his lawyer collapsed in the courtroom.
An attorney for the families in the California suit didn't say how much his clients were seeking. "The victims' families are furious and deeply hurt over their recent discovery of the true cause of their loved ones' deaths," Attorney Gregory Rueb said, as quoted by the Inquirer. "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."
- get more from the Inquirer