In recent years, orthopedic product maker Synthes Inc. chose a carefully-selected panel of surgeons and paid for them to attend training sessions on its new bone-mending cement. The cement, Norian XR, is used to fix a type of spinal fracture commonly found in the elderly.
Synthes contends that this was entirely appropriate, but the federal government disagrees. Prosecutors are alleging that the training sessions were used as a substitute for costly clinical trials for Norian XR, which has since been withdrawn from the market.
They also contend that the training sessions constituted off-label promotions encouraging surgeons to use the cement for vertebral compression fractures. Norian XR has not been approved for this use.
Since the training program began, Norian XR has been used in 200 surgeries, including three in which people died. Synthes executives didn't report the first patient death to the FDA, and failed to offer important details on the two other deaths, according to the indictment.
To learn more about this prosecution:
- read this Philadelphia Inquirer piece
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