Transplant surgeon John Najarian acknowledges that, although acquitted of criminal charges, he bears significant responsibility for a troubled transplant drug program at the University of Minnesota.
The state Board of Medical Practice insisted that Najarian publicly accept responsibility for the mess with the transplant drug, ALG. The board could have pulled Najarian's license altogether.
In exchange for his admission, the board agreed to let Najarian off with 60 hours of training on ethics and management and writing a paper about the importance of following regulations.
The agreement signed in late December is a matter of public record, but was not publicized until a story in the Feb. 7 Minneapolis Star Tribune.
John Lundquist, one of Najarian's attorneys, emphasized that the agreement is for corrective action and no discipline is being imposed.
"I think the way we could respond is that he is pleased to bring this matter to resolution," Lund-quist said.
In a four-page document, Najarian agreed that:
n*He failed to ensure that federal authorities were told about adverse patient reactions to ALG, an anti-rejection drug; that informed-consent forms were gathered, as required by federal regulations; or that other rules were followed.
n*He failed in his responsibility to manage the ALG program and to effectively supervise individuals involved in administering the program.
"We believe the action is consistent with university committees' findings on these issues," said Mark Rotenberg, the university's general counsel.
Lundquist, though, said Najarian does not accept responsibility for the ALG situation in terms as sharply put as those in the agreement. He noted that the agreement states that Najarian made the admissions "for purposes of the Minnesota Board of Medical Practice proceedings only."
In this instance, Lundquist said Najarian accepts that he was ultimately responsible for ALG as chairman of the surgery department, under whose umbrella the program was run, but does not agree that he personally should have seen to the things the board mentions.
Najarian was forced out of his jobs at the university following disclosures that the ALG drug program had violated federal drug rules for two decades.
He was acquitted a year ago on criminal charges, which included a charge of earning profits on the sale of an unlicensed drug and concealing patient deaths. Testimony showed he did not personally profit from ALG sales; he had little to do with the day-to-day program; it was a highly successful drug; and federal authorities knew about violations for decades without taking decisive action to stop them.
One last major part of the case is pending. The U.S. Justice Department is suing the university, alleging fraud and ill-gotten gains (Jan. 6, p. 4).