Product News and Recalls

Synthes accused of illegally testing Norian bone cement on people

Fortune magazine recently published an article called “Bad to the Bone: A Medical Horror Story.”

The story concerns a Pennsylvania-based company called Synthes, which developed and marketed a bone cement called Norian XR for the ostensible purpose of repairing spine injuries. Norian led to the deaths of at least five patients, and jail time for four high-ranking Synthes executives.

As Fortune describes it, Synthes illegally marketed Norian despite increasing evidence that it might be dangerous. In effect, the company created a situation in which patients served as unwitting test subjects for dangerous medical experiments.

“The case offers a rare, sometimes disturbing, glimpse inside the shrouded world of medical devices,” where financial considerations often trump the well-being of patients and surgeons have been known to turn to 20-something sales representatives for advice, the report says.

Fortune says that the U.S. Food and Drug Administration directly told Synthes not to promote Norian for certain spine surgeries, but the company aggressively pursued those promotions anyway.

Norian is a calcium-phosphate-based cement. When implanted in the skeleton, it not only fills cracks but also gradually transforms itself into actual human bone.

It had previously been approved for use in the arm and the skull. Synthes officials saw a potentially lucrative avenue in promoting the product for use in vertebroplasty, a spinal surgery that involves repairing compression fractures in the vertebrae that are a common side effect of osteoporosis.

After the FDA indicated that approval would likely require clinical studies, the report says, the company tried to do an end-run around the process by promoting the procedure directly to surgeons.

Physicians, who aren’t regulated by the FDA, can use procedures and products for purposes other than those specifically allowed by their federal approval. But companies are prohibited by law from marketing products for “off-label” uses, or those not specifically permitted by the FDA.

According to Fortune, a surgeon raised concerns early on that the spine contains multiple blood vessels, and any leakage into them could send cement to the lungs and heart. That, in turn, could cause a fatal clot.

Surgery on human patients and testing on animals both pointed to the attendant dangers in using Norian for spinal surgery. But company executives continued to promote it for that purpose anyway.

“Most of all, this is a story about a company that repeatedly ignored evidence of potential lethal consequences,” the report states. “Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists’ cautions that the cement could cause fatal blood clots.

See the story here: