Human Experimentation-Bone Cement

Bone cement company blamed for multiple deaths, accused of human experimentation.

The injection of bone cement is a procedure that is most-often used to anchor prostheses or artificial joints, but is sometimes used for the treatment of spinal injuries (via vertebroplasty or kyphoplasty) to reduce pain related to vertebral-compression fractures. Unfortunately, at least one company is under investigation for using an unapproved bone cement to treat spinal injuries after multiple patients have died as the cement leaked into their bloodstreams.

A history of patient deaths.

Medical Company Accused of Human Experimentation

One woman, who had injured her back after she fell two floors while creating an addition to her house, suffered from serve bleeding and blood clots during surgery. She died on the operating table in 2007. Another patient had suffered from back problems since a previous car accident. She also bled out during surgery and the medical team was unable to save her.

There were a minimum of three other patients who had undergone spinal surgery prior to these two patients who also died after the bone cement was injected into their spine. The problem was that some of the material leaked into their bloodstreams, which caused clotting.

Lack of information.

These patients, who were treated with the NoriaN® bone cement, were never told that the FDA had not approved it for use in spinal surgery. Instead of being honest with the patients, the manufacturer and its parent company allegedly conspired with surgeons to engage in “human experimentation.” According to federal prosecutors, they were attempting to avoid the long and costly regulatory process.

Norian is no stranger to lawsuits and was sued in 2012 in a wrongful death and negligence lawsuit. The lawsuit was the result of the death of a 70-year-old woman who died after back surgery in 2003. During the surgery, bone cement was injected into the woman’s spine in the presence of a sales representative for the manufacturer. The woman died after some of the product leaked into her blood and caused clotting. The companies never filed a report with the FDA and simply told the family, “She didn’t make it.” The family later settled their lawsuit with Synthes and Norian through private mediation.