Who Reps 2012: Speaking the Same Language

Sue Reisinger

Corporate Counsel

10-01-2012

Company: Medtronic Inc. (medical technology)

Legal Matter: Federal probe into alleged off-label marketing

In-House Counsel: Brian Ellis, therapy group general counsel and chief counsel/spine division

Outside Counsel: Michael Fee, Ropes & Gray (Boston)

Corporate Counsel: What key legal matter did you and Michael Fee work on together?

Brian Ellis: We worked on an internal investigation of a product called Infuse [a bone graft used in spinal fusion surgeries]. And on the several-year federal investigation into whether there was off-label promotion of Infuse for other uses.

CC: Were your efforts successful?

BE: Yes. In mid-May the government decided not to prosecute and dropped the investigation.

CC: Besides the usual trauma of any federal probe, what special challenges did you face?

BE: You have challenges with your internal clients—our business folks—who were constantly under the threat of government prosecution. And we had to translate the efforts we were taking to protect the company into understandable issues and tactics for them. We had to be as responsive as we could to the government without crippling and hurting the business.

CC: Can you be a little more specific?

BE: I can't discuss the facts of the case. But the fundamental thing with internal clients is that we were very clear with them about what we believed the government's concerns were, and that we could address those concerns by being open and honest. At times they may have felt it was overly burdensome and distracting to those trying to run the enterprise, but in the end we were able to show the government that "there was no there there."

CC: As specifically as possible, how were you able to show that?

BE: Through very well thought-out presentations to the government. We did our best to explain what we thought the issues were, as well as the company's progress in terms of compliance. It's always an evolution. Where there maybe were some things we weren't proud of in earlier years, we took great efforts to clean up and improve and be an industry leader in compliance, and we worked hard to demonstrate that evolution.

CC: Can you give me one example of how you approached a problem together?

BE: When we would get multiple inquiries from the Justice Department, we didn't panic. We were never rattled. Our reaction was: It's natural that they are being thorough. And we always felt confident that we could dispatch each issue very quickly. We'd say, "It may look really dark at the moment, but let's get the facts, and then draw conclusions."

CC: What do you think made the relationship between you and Michael work so well?

BE: Both of us are former federal prosecutors, so we spoke the same language. We were on the same page in terms of being truthful and accurate and transparent with government; that was never a question. And Michael's counseling demeanor was very helpful. No matter how big the issue, he always had a calm demeanor. He was always able to put issues in context and help us address them in a very thoughtful, very deliberate way.

CC: Is there anything you'd like to add about your relationship?

BE: We expect to have superb lawyers. But it's rare that you find a senior lawyer as nimble with the facts and with all the nuances around those facts, and always maintaining contact and keeping the company's interest front and center. That's a special skill.

CC: Anything you would change?

BE: Well, the only black mark on our relationship is that he's a Patriots fan and I'm a diehard Chicago Bears fan. [laughing] And that's not going to change.