CARDIAC
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`.^1
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`Five Heart-Stopping Years
`as a CEO on the Feds' Hit-List
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`■IL*I
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`I-
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`V
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`v
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`Howard Root
`with Stephen Saitarelli
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`; -5
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`Page 1
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex.1773
`Medtronic v. Teleflex
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`

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`CHAPTER 4
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`DOJ BLIND DATE
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`FEBRUARY 5.2013
`
`While I was being served up by DeSalle and Eddie, Vascular Solu
`
`tions was serving up another banner year. That was the conclu
`sion of our glossy 2012 annual report, which showed double-dig
`it sales growth for the ninth straight year, a feat none of our competitors
`could match. This year's success owed largely to a breakout year for what was
`becoming our first true blockbuster product — the GuideLincr catheter.
`Three years since its launch, the GuideLiner had become the premier tool
`for interventiona! cardiologists working in hard-to-rcach areas in the heart. It
`rose to prominence in September 2010, when a top cardiologist went before
`a packed crowd at the world's biggest cardiology conference and gushed, un
`prompted, that "the GuideLiner makes impossible ca.ses possible and difficult
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`cases easier.
`
`He was right; the GuideLiner was revolutionary. Wltere the strategy be
`fore was "push as hard as you can and see if you can force the stent into the
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`DOJ Blind Date
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`21
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`artery," GuideLiner now allowed doctors to easily deploy stents like a Push
`Pop into areas they couldn't before access. Today, I'd say that 99% of interven-
`tional cardiologists know how to use GuideLiner to deliver a stent, and you
`wouldn't want to be treated by the other 1%.
`
`But when I invented the GuideLiner in 2006, doodling in the audience
`of a boring medical meeting, I never imagined it would be used how it is to
`day. I thought I had a $10 million product that would help doctors position
`their guide catheter into the opening of the coronary artery. But shortly after
`we released the product in 2009,1 watched it go viral. One doctor used it to
`place a stent, then told another, who told his colleagues, then the big confer
`ence speech, and all of a sudden it was 2012 and I had a $20 million monster,
`well on its way to $50 million a year.
`
`As I drove downtown on February 5, 2013, I was thinking about that
`annual report. But not about the GuideLiner or our sales growth. No, I was
`thinking about a single paragraph in the "Legal Proceedings" section.
`On June 28, 2011, we received a subpoena from the U.S. Attome/s
`Office for the Western District of Texas requesting documents related
`to the use of the Vari-Lase* Short Kit for the treatment of perforator
`veins. The Short Kit has been sold under [FDA] clearance since 2007
`with total U.S. sales through December 31, 2011 of approximately
`$410,000 (0.1% of the Company's total U.S. sales) and has not been
`the subject of any reported serious adverse clinical event. We are frilly
`complying with this inquiry.
`I wanted that paragraph gone. And I was headed to the Minneapolis U.S.
`Attorneys Office to see what it would take to make that happen.
`Although no federal prosecutors from Minnesota would be attending,
`the Minneapolis federal courthouse was chosen for our convenience. An early
`sign of good will and cooperation, perhaps. With my Dorsey legal team of
`Bill Michael and Tom Vitt at my side, we arrived at the obsidian courthouse
`and made our way up to the U.S. Attorney's Office, whose quarters were even
`nicer than Dorsey's. After waiting 18 months and getting stood up on my
`offer to meet to explain this matter, I was finally getting my first date with the
`suits behind the government's investigation, even if it was only to hear what
`they wanted from us.
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`22
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`CARDIAC ARREST
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`Waiting for ua in the conference room was Charl« Biro, a dour-feced
`iunior lawyer with DOJ's Civil Frauds Section. Kinrberly Johnson, his Tex
`partner who'd sent us the subpoena, joined in by videoconference.
`Biro led things off with his theory of what happen^. VSFs
`didn't cover perforators, he said, hut our competitor - WUS
`the word "perforator" right there in their indications. Because WUS had it.
`Biro nervously argued, we needed it. We asked FDA to add the word but
`when FDA said we needed a study hefbre putting petforatot onourlahel,
`and we didn't have one with good enough data, he claimed that high-ran ng
`executives (readi me) hatched this secret plot: keep the lahel the same, hut tell
`the sales force, through coded instructions, to iUegally market the new Short
`Kit for perforators anyway.
`Biro proudly announced that he'd personally combed through the sales
`records and sales reps' weekly activity reports and determined that there were
`hundreds of potentially fraudulent Medicare claims. Biro had a habit ot paus
`ing when he got to a number, seemingly impressed with himself for wielding
`power over a case in which literally hundreds of thousands of dollars were at
`stake. And then he got to his final number - the one he said represented Vas
`cular Solutions' total civil liability in this case ...
`Twenty million dollars.
`There it was again. The number. I looked over at Bill Michael, whose face
`wrinkled in disbelief. "How'd you get that?" he asked, knowing the answer
`was that they'd ripped it from DeSalle's "information and belief. Biro fum
`bled through his spreadsheets, before Kimberly Johnson piped up to ^sist
`him. In contrast to Biro, Johnson seemed confident in her grip on both the
`process and the fects. "That's not our resolution offer," she clarified, ^ats
`what we believe a verdict could bring at trial, worst-case scenario. Bill Mi
`chael's brow remained furrowed.
`Next up was a 30-something government attorney with a prematurely re
`ceding hairline, seated at the end of the table. He'd introduced himself when
`we walked in but hadn't said a word since then. Frankly, I'd forgotten he was
`there. "I'm Tim Finley," he said, re-introducing himself as a trial attorney
`from DOJ's Consumer Protection Branch. Bill Michael had explained to me
`that these guys usually handle things like fireworks safety and lottery fraud,
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`DOJ Blind Date
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`23
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`but a jurisdictional quirk also gives them power over criminal violations of
`FDA laws.
`Finley didn't have much to say, admitting he'd just been assigned to the
`case because the hot-tempered Lauren Hash Bell was on maternity leave. He
`nevertheless agreed with Biro's analysis. After that borrowed conclusion, Fin-
`ley speculated as to what it would take to resolve the criminal case. With a
`$2.3 million fine and a criminal misdemeanor plea, he said, the case might go
`away. But he was at pains to say he was waiting for Hash Bell to return before
`making any real offer - those figures were just his personal impression.
`I had the numbers written down on a pad in front of me. Twenty for the
`civil lawsuit, two-and-change for the criminal penalty, plus a federal criminal
`guilty plea. They added up to a shakedown.
`It was our turn now to talk, and the plan was for Bill Michael to lead a
`charge of reason that would convince the government to back off. He began
`by saying that in his many years as a prosecutor and private attorney, he'd nev
`er seen a prosecution - civil or criminal — reach the terms described over half
`a million in sales and no patient harm. "As you'll see from the documents," he
`told them, "this is an insignificant product in every sense of the word."
`
`But as I measured the faces across the table, they had the look of poker
`players who didn't care what their opponent's hand was, because they were
`holding aces.' What's going on here? Sensing Bill Michael's failure to get trac
`tion, Tom Vitt chimed in to remind the prosecutors that they were meeting
`with a company that, in over 15 years, had no criminal history and never so
`much as received a warning letter from FDA, usually the first step in this sort
`of case. Again, they didn't care. Johnson checked her watch and announced
`through the slight lag of the videoconference that our time was up. We con
`cluded the meeting with tepid handshakes, unmoved prosecutors, and no real
`settlement offers. Not good.
`
`This was getting hairy. We'd given them the documents, plead our case in
`person, and we were still no closer to reaching a resolution or even building
`up good will with the other side.
`
`On paper. Bill Michael was the perfect defenise lawyer. He knew the pro
`cess, knew the law, and commanded credibility. But he wasn't a charmer. In
`fact, in our meeting with the government, he was kind of a jerk. I was he-
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`CARDIAC ARREST
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`ginning to worry that a career calling shots in a prosecutor's uniform meant
`he'd never developed the soft negotiating (read: ego-stroking) skiUs that even
`a small-time criminal defense attorney needs.
`But I still needed him, somehow, to get these
`come to their senses before it was too late.
`
`government attorneys to
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`Page 6
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