St.Jude; Using studies as a sales tool to get business

Jude Whistleblower: ‘This Wasn’t Patient Care’
By Ed Silverman // January 28th, 2011 // 9:52 am

Last week, St. Jude Medical agreed to pay $16 million to resolve allegations the device maker used post-marketing studies and a data registry to pay kickbacks to induce docs to implant pacemakers and defibrillators (read the settlement).

The allegations were contained in a qui tam, or whistleblower lawsuit filed by Chuck Donigian, who worked for St. Jude as a technical service specialist between 2004 and 2007. His job was to provide support to the sales force by helping to market the devices, visiting cath labs and operating rooms, and assisting with paperwork for enrolling patients. But he didn’t like what he saw – St. Jude staff would sometimes fill out paperwork for follow-up visits instead of docs, sign forms on behalf of physicians, patients were enrolled improperly and scientific posters were allegedly ghostwritten. Then there were bottles of wine and sporting tickets given some docs. In all, St. Jude allegedly handed out millions of dollars around the country to bolster use of its devices. For his trouble, Donigian will receive $2.6 million, plus interest, but before paying his attorneys and taxes. We spoke with him about his experience…

Pharmalot: What behavior prompted you to blow the whistle on your employer?

Donigian: When I started realizing they were using studies as a sales tool to get business. At first, I was kind of excited to get involved with clinical work. But when the patients weren’t meeting criteria for inclusion in the trials, I started raising questions. But they told me to enroll anybody and everybody or the physicians weren’t going to implant the devices. That’s when I started realizing we weren’t doing science.

Pharmalot: What happened then?
Donigian: At first, I brought it up with my team members and was told by manager that it was my job to do this. So I later called the corporate hotline and spoke with an attorney, who said he wouldn’t speak with me unless I told him who I was. He said I was protected. And then he went on to tell me we’re not supposed to do the paperwork. He proceeded to contact my boss to let him know I was raising hey…And so during my review in April 2006, I sat down with my regional manager and he brought up all my conversations with corporate, the attorneys. He wrote in my review that I was insubordinate and questioning what was happening. I was constructively discharged. I received threats.

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