Device maker enters settlement for failing to disclose payments to physicians
May 8, 2009
Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement with the New Jersey Attorney General (AG) to resolve allegations the company failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products, according to the AG.
As part of the settlement agreement, Synthes will:
- Prohibit compensation of clinical investigators tied to the outcome of the clinical trial
- Pay clinical investigators fair market value compensation for their clinical trial and consulting work
- Collect information on financial interests from clinical investigators
- Record all financial interests related to clinical investigators in a financial interest information database
- Disclose all financial interests of all clinical investigators on the company’s Web site
- Provide complete disclosure of financial interests to the FDA
- Disclose all financial interests directly to healthcare facilities serving as clinical trial sites
- Train employees on financial interest and disclosure