In October 2007 Bill Hawkins was only three months into his tenure as CEO of the world’s largest pure-play medical device maker when he faced the toughest choice of his career – cancel shipment on the company’s top product, the Sprint Fidelis pacemaker lead, already implanted in some 268,000 patients – or stand pat and keep the potentially lethal products on the market.

"This is one of those things that you never want to have to face as a new CEO," Hawkins told MassDevice in an exclusive interview, one of his first since leaving the corner office at Medtronic Inc. (NYSE:MDT). "Three months after I’m named the CEO, I had to deal with a decision as to whether we were going to suspend the shipment for our number one product."

Read about his transition out of Medtronic’s corner office in part one of MassDevice’s exclusive interview with Bill Hawkins.

Hawkins, 57, stepped down in April after 10 years at Medtronic (four at the helm and three as chairman). In a wide-ranging chat in our Boston offices last week, he gave us an insider’s look at the Fidelis debacle and shared his thoughts about its far-reaching result: The U.S. Supreme Court’s 2008 decision in Riegel v. Medtronic establishing the doctrine of preemption in medical device liability lawsuits.

The Sprint Fidelis leads, used to connect pacemakers to the heart’s muscle, were prone to fracture – meaning they could either fail to deliver the shock needed to regulate a haywire heartbeat or else send unneeded shocks. The wires are implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a “possible or likely contributing factor.”

"You know, this was a device that was implanted in close to 300,000 patients around the world," Hawkins said. "It just tears you apart inside when you work so hard to bring forth products that are going to improve the lives of patients, and when you know that you’ve got a product that is not performing to the standards that you’ve set. That’s a hard thing, but these things happen. It happens all the time and it’s more important how you handle it."

In hindsight, Hawkins views his handling of the events around the recall as one of his finest moments as a CEO.

"We confronted this, we took responsibility, we were honest, we were transparent and we were prepared. When I look back now, it’s one of the things, oddly, that I am really most proud of," he said. "We were so careful to make sure that people did not just go out and start extracting leads and then putting people at risk. I think it signaled, early in my tenure, where this leadership team’s priorities were. Our priorities were on the patient, our priorities were on honesty, integrity and quality. There were people inside [Medtronic] who said, ‘Maybe we just slow down selling this new lead and just kind of don’t make a big issue out of it,’ but we said, ‘We’re going to do this right,’ and I believe that we handled it in a way that reinforced the values of trust and integrity and responsibility."

The story began to unspool about three months before Hawkins took the reins as CEO, he told us, when a single hospital reported an unusually high failure rate for the lead. That report prompted him to convene Medtronic’s outside advisory board to investigate data from other hospitals’ use of the leads. Although that probe didn’t reveal a correspondingly high failure rate, Medtronic decided to use its CareLink telemetry technology to track the leads’ performance in the real world.

"We’re dependent on people reporting these things, so what we decided – because we weren’t satisfied that we should just say, ‘It’s just bad technique at that one hospital’ – we set out to proactively interrogate 25,000 of our devices with our CareLink system," he recalled. "We had also commenced a prospective study, called the SLS study, to look at lead performance."

Six months later, with the SLS and CareLink data in hand, the newly minted chief executive faced an agonizing choice. Beyond the damage to his own company, Hawkins was concerned that an all-out recall would spark a panic, leading to a spate of un-needed revision surgeries – which are particularly complex and dangerous procedures because the leads are threaded through blood vessels on their way to the heart muscle.

"My biggest concern was for the patient. I did not want physicians to do the wrong thing and go out and pull out these devices. Lead extraction is a very tricky thing," Hawkins explained. "If you go out and you do a recall or you stop shipment, if you don’t do it right, if physicians hear that there’s a problem and decide that they ought to then maybe go and pull the lead out, the potential harm to patients in that scenario can be much greater than what we had determined were the probabilities of failure if we hadn’t done anything."

To complicate matters further, Medtronic already had a "gold standard" lead on the market, which had performed admirably for 10 years, he added.

"I’ve got a device here, a lead that’s been performing for 10 years – it’s not as small, the Sprint Fidelis was the smaller lead, but [the older lead] performs better," Hawkins said. "We now have the data from the CareLink study, and we’ve got the data from the SLS study, and it’s still somewhat ambiguous, but it looks like it may be a higher trend of failures in this new [Fidelis] lead versus our existing lead. And so I made the call that we were going to voluntarily suspend the shipment of this product."

That was the easy part. Hawkins and his team, working in "lock-step" with the FDA, gave themselves a one-week deadline to put their plan in place before making it public.

"We made the decision on a Sunday and we said, ‘We’re not going to communicate this until the following Monday.’ We had one week to get everything set up, to make sure we were able to get to all of the physicians, to be able to put together the right communication for our employees, for our shareholders, and to get everything set up," he said. "And so a week from that Monday, when we made the announcement, we literally called every physician and contacted all the patients."

The Fidelis recall became the poster child for medical devices gone bad, eventually taking center stage at the Supreme Court in the Riegel lawsuit. In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.

"Essentially, what preemption argues is that, if we did the best that we could do with the best technology and the best testing abilities and we go through all the right processes and we don’t deviate, and the FDA in partnership with us approves this product and then something unexpected happens down the road, then we shouldn’t be sued," Hawkins explained. "Because otherwise no one’s going to want to take the risk – that if you do everything right and something happens – and things happen, when you’re putting things into the human body, thing happen. There’s no other industry I know of where there is zero failure."