Three physicians disciplined over non-disclosure of financial interests in clinical trials

NEWARK – The State Board of Medical Examiners has publicly disciplined three doctors who did not disclose their personal financial interests in the success of a medical device while they participated in clinical trials of the device, the Attorney General’s Office announced Tuesday.

The Board of Medical Examiners, a licensing agency, reprimanded Drs. Richard A. Balderston, Thomas J. Errico, and Jeffrey A. Goldstein for committing professional misconduct by not disclosing to their research institutions their financial interests in the ProDisc spinal disc device, according to a release.

The ProDisc device was a spinal disc replacement developed to eliminate the need for spinal fusion surgery. The doctors received payments tied to certain milestones including FDA approval achieved in the clinical study, according to the Board. The Board also ordered each physician to complete a medical ethics course. It assessed civil penalties plus cost reimbursements against Errico and Goldstein.

“Impartial and objective diagnoses and treatment recommendations are essential to maintaining the public’s trust in their doctors,” Attorney General Paula Dow said in the release.

“The undisclosed conflicts of interest on the part of these doctors undercut public trust in the medical profession. The Board has acted to maintain the integrity and high ethical standards that the public rightfully expects from their doctors.”

Goldstein and Errico were involved in clinical studies of the ProDisc device at the NYU Medical Center and Hospital for Joint Disease but failed to disclose their financial interest in the device to the University as required. Balderston failed to disclose his financial interest in the ProDisc device to the University of Pennsylvania’s Pennsylvania Hospital as it required while he was the clinical investigator of the device there.

Physicians are required to disclose any financial payments in excess of $10,000 that they have received from medical device manufacturers when applying for renewal of their licenses. Goldstein and Errico answered “no” to the question asking whether each had received such a payment when, in fact, they had, according to the Attorney General’s office.

“Let there be no doubt that doctors are obligated to provide truthful responses on their license renewal forms,” said Thomas R. Calcagni, Acting Director of the State Division of Consumer Affairs, “or face the consequences.”

The Board assessed $60,000 in civil penalties and $17,500 in cost reimbursements against Errico. Goldstein was assessed $30,000 in civil penalties and $10,000 in cost reimbursements. All three must provide proof of successfully completing a Board-approved ethics course.

Deputy Attorney General Kim D. Ringler represented the State in reaching Consent Orders with the physicians.

Three physicians disciplined over non-disclosure of financial interests in clinical trials