VERITAS
AA
The motto at Harvard, where Hugh Calkins attended medical school, is Veritas. As a serious and determined young physician in the making, the future Professor of Medicine at
Johns Hopkins University (Veritas vos liberabit), must have laid eyes on that motto thousands of times—so often that he probably stopped seeing it after a while, its impact literally diminished by degrees until it became intellectual white noise. What likely did stick in his mind was the Statue of Three Lies. It is a bronze sculpture of a founding father type looking out over Harvard Yard.
Everyone supposes it to be a likeness and tribute to the founder of all things
Crimson, John Harvard, since that is what is engraved in stone on the base of the statue: John Harvard, Founder, 1638. But the nickname has it right. Each finely chiseled line is a lie. The likeness is not that of John Harvard, who did not found the institution, which was not founded in 1638. And it would have been there in Harvard Yard at the the Statue of Three Lies where, as is the custom, a young Hugh Grosvenor Calkins rubbed his hand on the bogus founder’s shoe for luck before turning to take on the world.
∞
The narrative presented by Johns Hopkins via their muscular and able stable of attorneys goes something like this:
Pam Walter grabbed Hugh Calkins by the lapels one day and demanded a catheter ablation procedure. He tried to talk her out of it. He told her that he didn’t know if the procedure was safe. Hell, he didn’t even know if it worked. Calkins warned my wife that catheter ablation for atrial fibrillation is the most dangerous procedure out there.
He told her that what he was really doing up there at Hopkins was conducting a de facto medical trial. He was experimenting with two new ablation techniques and testing out a couple of new mapping catheters. He was trying out the new Biosense Webster Lasso® mapping Catheter and the new basket catheter put out by EP Technologies, a division of Boston Scientific. He was also collecting performance data on Boston Scientific’s new Chilli® ablation catheter.
He told Pam that he was getting paid in one way or another by all of these outfits, but that Johnson & Johnson was kicking down for the salary for the Fellow who would be working on her, so her body would probably be used to experiment with the Lasso® catheter. These procedures are sort of like a shake-out cruise for new instruments and their operators.
He was not running any of this by the FDA, which he considered to be irrelevant, and he was not running any of it by the Hopkins Internal Review Board either, because they’d rather not know what went on in his EP Lab.
He told Pam that contrary to public perception, going to Hopkins for an ablation was akin to going to the barber college for a haircut—except you don’t get the discount. And since it is a teaching hospital, he would hand the job off to a trainee whom she would never meet. The most he could promise was that he would try to stop by at some point during the procedure. All this was made very clear. The smart play would be for her to stick with drug therapy.
But she had the temerity to insist, and they acceded to her wishes. And then when her mitral valve got itself tangled up in their mapping catheter and things didn’t turn out so well for her, she had the gall to blame Johns Hopkins.
∞
When he’s out on the circuit, giving talks at various cardiology gatherings at resorts around the country, Calkins presents his findings with the air of a storied combat vet speaking at the local American Legion luncheon. “I learned a lot of things the hard way about the Lasso® catheter,” he tells the green horns, “One thing is you can Lasso a lot of things with it, including the mitral valve and if you happen to Lasso the mitral valve it’s hard to untangle the valve. When we tried to untangle the valve we wound up ripping the valve and having to replace the valve, and I can tell you that was one memorable Lasso experience…”
Of course, the fog of litigation can cloud up even the most pristine memories. The lawyer here might as well have been deposing the Magic 8-Ball: Did you tell Pam Walter that you did not know if the benefits of the procedure outweighed the risks? Reply hazy, try again.
Nevertheless, thanks to court ordered depositions, we have a permanent and public record of how Richard Wu and Hugh Calkins recall the unfolding events of March 25, 2002. On the subject of who
was actually performing the procedure, Calkins puts forth cloudy scenarios. Contrary to his customary “showing up to be there during the burn,” as he confided to colleagues at an FDA hearing, on this particular day he would have scrubbed out after the procedure was set in motion, leaving the trainee at the wheel. “I would descrub when it’s time to analyze the figures to find out if the vein was isolated. This isn’t just looking at something. It’s very tricky to do this. This is the critical part of the procedure. That’s the part I was performing. That’s what I was doing and then the catheter got entrapped.”
So the catheter went and got itself entrapped. How did that happen?
“If you ask how is it possible for this catheter to get caught in the mitral valve, the answer is it is possible. It occurred. And you may ask, ‘How can that possibly be?’ And the answer is, One, the atrium is a small structure. And B, [sic] all the pulmonary veins are relatively close to the mitral valve. Three, we don’t have our hands in the atrium. As a surgeon, we’re working from the leg, we’re four feet away. So you have a small structure, the heart’s beating, you have a catheter in the heart, the structures are all relatively close together, and obviously the mitral valve dipped back and caught on the catheter. One way or the other, we know for sure the Lasso catheter was stuck in the valve. So it happened.”
This is perhaps the reason that Hugh Calkins is not a surgeon, despite his Freudian desires. All the experts—and quite a few laymen—stand solidly behind the principle that it’s physically impossible for a heart valve to make a lunge for anything.
Did the catheter get caught in the mitral valve during repositioning to another site?
“It’s hard to know if it was during the positioning, the repositioning or exactly when. What was the question? I don’t know exactly when. I don’t know how the catheter got caught in the valve. That is unknown to me. I know that it did. That’s a fact. How it got caught, I don’t know.”
And who actually repositioned the catheter?
“I don’t know for sure, but I suspect that it was Dr. Wu.”
That was a pretty good hunch since Calkins wasn’t even scrubbed in when Wu blundered into the wrong heart chamber. And despite all the hemming and hawing and the dancing, Hugh Calkins knew exactly how the catheter got caught in the mitral valve. He wrote about it two years earlier, two years before he swore truthfulness at a deposition.
“Entrapment of the mitral valve apparatus by a mapping catheter results from inadvertent positioning of the catheter into the ventricle with counterclockwise rotation,” he wrote in 2007.
At last, a simple true statement.
Richard Wu must have had help with his orchestration of the day’s history.
“How many times, before Mrs. Walter, did you participate in a similar procedure in which you were the primary operator…”
“I know I did about 500 procedures…”
“How many where you were operating the catheter …”
“I did somewhere between 250 to 300…”
“How many where you were were the primary operator…”
“I think between 30 to 50…”
“With you as the primary operator? Is that what you’re saying?”
“Less than 30.”
I would point out here that ZERO qualifies as fewer than thirty, and that you or I or SpongeBob SquarePants could legitimately claim likewise. Mr. Wu does admit that he first laid eyes on Pam Walter on the morning of the procedure. “I have records stating that I wrote a history and a physical for Ms. Walter at 7 a.m. on March 25th 2002,” he said. He’s not necessarily swearing to the facts, just to what the record states. By design, reality and the record are two different things.
Did you discuss the risks of the procedure with Pam Walter?
“Oh, yes. We went over the consent form before the procedure and we discussed the risks of the procedure. There on the consent form it lists pain and infection and bleeding, damage to blood vessels which may cause a blood clot or require surgical repair, nausea or vomiting from the sedation. The other things we discussed were perforation of the heart or lung which may require emergency intervention, respiratory risks that may require intervention, stroke, myocardial infarction or death. We also specifically discussed a unique complication of the procedure know as pulmonary vein stenosis. I specifically discussed this with Mrs. Walter because she had a pacemaker…”
He went on like that for a while.
Pam’s daughter Kristi and I were with her at 7 a.m. in a patient receiving area. I stayed until Pam was taken to the pre-op room, which was at 7:30, according to nurses’ notes. Kristi went with her and stayed with her in the pre-op room until 8:10 when, according to the record, Pam was taken to Room One at the EP Lab. She was in the lab at 8:20 and by 8:27 had she been administered narcotics. None of us saw Wu or Calkins that morning.
And how long did it take Richard Wu to review the history, give her a physical examination and ensure that the informed consent process was faithfully discharged on the morning of the procedure?
“About a half hour,” says Dr. Wu, under oath.