Medical Device Company Settles with NJ Attorney General

Medical device manufacturer, Synthes, has settled a conflict of interest inquiry with the New Jersey Attorney General. The inquiry was pursued to protect consumers from fraud involving doctors who are paid consultants to the medical device company while also paid to test and recommend these same medical devices for consumer use.
As part of the settlement agreement, Synthes, manufacturer of Pro Disk artificial spinal disk, may pay the AG’s office $236,000 for its investigation as welll as full disclosure of doctors who are on their payroll. The agreement calls for full disclosure of medical professionals who are testing medical devices for approval while at the same time being remunerated by the same company as consultants.
In her letter to the FDA and Congress, New Jersey Attorney General Ann Milgram was highly critical of the FDA for doing nothing to police and monitor these conflicts. She cited instances where doctors signed and dated disclosure forms but left the rest of the forms blank.
The FDA has to make this a priority. Too often doctors and other medical professionals are caught in serious financial conflicts with the medical device companies and pharmaceutical companies. When they are paid company consultants, it’s hard to imagine that their testing and recommendations will be negative if they stand to lose money if the device or drug is not approved. This is clearly not good for consumers who must rely on FDA approval as assurance that the particular drug or medical device is safe and effective.