Bone Cement

Bone Cement Company Accused Of ‘Human Experimentation’ Goes Ahead With Spinal Surgeries Without Approval From FDA

A Seattle-based bone cement manufacturer is accused of using unapproved products on patients, leading to five deaths, CBS News is reporting.

Reba Golden fell down from two floors and hurt her back while renovating her house in Honduras. She relocated to Seattle to undergo spinal surgery, but died from blood clots and severe bleeding on the operating table in 2007. Joan Bryant had a bothersome back from an automobile accident in 1990. In 2009, she sought assistance from the same Seattle-based spinal surgeon. She bled profusely on the operating table and could not be resuscitated. Golden and Bryant are just two of five patients who have died after their doctor infused bone cement into their spine, and the substance leaked into their bloodstream.

The patients were not informed that the Norian bone cement injected into their bodies had not been approved by the Food and Drug Administration (FDA). Norian and its parent company, Synthes, are being accused of “human experimentation.”

The families of Golden and Bryant have filed lawsuits against the doctor — Jens Chapman, Norian, and its parent company, Synthes, Harborview Medical Center, the University of Washington, and the State of Washington. The lawsuits state that Chapman was fully aware of the risks of using bone cement for spinal surgeries and that it caused lethal clotting, but yet refused to inform his patients. The lawsuit is also alleging that the hospital and university where Synthes president was made chair should have known that the product had not been approved by the FDA.

The first trial is penciled for June in Seattle.

Cynthia Wilson, daughter of Reba Golden, accused Chapman, the university, and Synthes president, Hansjorg Wyss, of running an illegal enterprise under the auspices of Washington’s Criminal Profiteering act.

In 2009, Norian and Synthes, alongside four management executives, were indicted on charges of going ahead with unapproved clinical trials despite warnings that the injection of bone cement could cause lethal blood clotting. Norian got a penalty of $22.5 million. Synthes was slammed with a $669,800 fine. All the executives were sent to prison.

Tina Mankowski, a spokesperson for Chapman, the medical center and university, said all parties “vigorously deny any wrongdoing.” Jodie Wertheim, spokesperson for Synthes, said the company was withholding all comments for the duration of the litigation.

Synthes bought the Norian Corporation, based in California, when it saw an opportunity in 2000, when spinal surgeons, who wanted to use cement products to take care of vertebral-compression fractures to cut down pain, had very few options. The Norian Corporation developed bone cements for use in arm-bone and skull surgeries, but Synthes wanted to alter the product so that it could also be used for spinal surgeries. But it did not have the patience to wait for a lengthy FDA endorsement process.

According to court records, they opted for another route.

Over 60-80 procedures to use Norian bone cement was approved by Wyss. He recruited a team of doctors, led by Chapman, to eventually test the product on humans and publish the clinical results. Chapman and the doctors started conducting experiments in 2002, using bone cement on pigs. The procedure killed all the animals. The doctors went on to test it on human blood, the result was the same: lethal clotting. Despite their findings, the company still pushed ahead to “test-market” the product on humans.

In 2003, a patient died in Texas after bone cement was injected into her vertebrae. A California patient died seven months later, and another followed four months after that.

When Golden had the domestic accident at her home, she suffered spinal fracture compressions. She was scheduled for surgery in August, 2007; records show that Chapman never told Golden about the risks involved and that he planned to use a bone cement product that had not been endorsed by the FDA for spinal injuries. Her blood pressure plummeted and she bled to death.

Norian and Synthes were penalized and four management officials were convicted for conducting criminal clinical trials on June 16, 2009. Thirteen days after the convictions. Chapman used the same controversial bone cement on another patient, Joan Bryant. Court records show that Bryant bled severely the first time and almost died, Chapman refused to stop the medical procedure, trying two more times. The third time, Bryant died.

[Image via Shutterstock/transylvania]

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