12/01/2015

The Price of Thankfulness

We have a lot to be thankful for this season. We’re in a home we like, in a town we’ve loved for two decades, with new friends and a close family nearby. Financially, we’re better off than most people our age and who were without any significant kind of inheritance or hand-up from our parents. While I was marveling at our good fortune this morning, some not-so-pleasant memories of how we got here came back to me.

In my 30+ year career in music and manufacturing music equipment, I pretty much broke even, economically. The ten years I burned in medical devices—first with Telectronics in Denver followed by Guidant in Arden Hills—were pretty much the source of our current financial stability. After a move to Indiana to work for Washburn/Soundtech turned to crap, a friend opened the door for me into medical devices. Mostly, I took the job because I’d thought medicine had actually done my father some good when he had a heart attack and several bouts with cancer. In retrospect, I probably misread/misinterpreted that event, too. I jumped into medical devices with both feet and as little head as possible. After a 25 year career in manufacturing and field service, I felt that I had a lot to learn and a lot to give to my new employer. Five years later, Telectronics Pacing Systems was all but dead, due to a series of FDA Class I recalls and stupid management decisions and I was looking for a new employer.

I had, however, learned a lot. I’d been part of teams that studied drug and device clinical trials and helped write Tele’s ICD submission. I’d been tossed into the field to learn how to assist in pacemaker implants as part of a trial-by-fire “training system.” I was included in the training department’s line-up of “experts” who trained sales representatives and doctors and nurses on the company’s products. I took a large hit in income to get into a new industry, but my temporary single marital status and Colorado’s cost of living was so far below California’s that I made up for a lifetime of living-on-the-edge in a year. Suddenly, I was a homeowner and had savings. My starting wage at Telectronics was pretty sad, but I made up for it by living cheap and repairing a crap-load of audio gear and selling it until I had a stake for a down-payment on a house.

Five years later, Tele was in shambles but I had a “career” and some expertise in Tele’s unusual technology that was marketable. So I marketed it. I hustled myself to several pacemaker/ICD companies and ended up getting a good offer from CPI which was about to become Guidant. There were some glitches, CPI leaving Lilly and the pitched and promised pension vanishing before I arrived was one. The company hired me like I was a fairly experienced journeyman AAA pitcher, though. A signing bonus, a generous moving allowance, living quarters assistance and assistance in buying a home in Minnesota, and a return to the kind of income I’d made in California, plus bonuses.

I’ve been poor and I’ve been middle class. My “depression years” were long, instructive, and sobering. Anytime I’ve been paid more than minimum wage I’ve assumed something, sooner or later, will go wrong and I’ll be back on the streets without notice.

The something that went wrong with Guidant was Guidant. The company had a reputation, as CPI, of making solid, reliable, long-lasting devices with no flash, a little too much size and weight, and basic features. The new Lilly/Guidant management was—empowered by way of outrageous stock options and bonuses—to drive that car over a cliff. They pushed marketing and features over the traditional CPI product and corporate qualities and disconnected the link between manufacturing, quality control, and product development. I moved, a couple of times, departments and my last assignment—quality assurance engineer—was where I finally realized that nothing I could do would affect any outcome in that suicidal and mismanaged corporation. My last assignment was to decouple the product failure database I’d built from component and field failure descriptions so that the FDA would not be able to easily determine relationships between similar and reoccurring product failures.

The Fortune Magazine article, rating Boston Scientific’s acquisition of Guidant as the “2nd worst deal ever” said this about the company’s misfortune, “Guidant CEO Dollens agreed to postpone his retirement to shepherd the transaction with Johnson & Johnson. But what should have been a victory lap turned into a slog through the swamp. In March of 2005 a 21-year-old student named Joshua Oukrop, who had a Guidant defibrillator implanted in his chest, died of a heart attack while bicycling. The defibrillator short-circuited, failing to release the shock that could have saved his life.

“Guidant had discovered the short-circuiting problem three years earlier and had corrected it in new models. Yet the company never informed doctors that devices already in use carried a small but potentially fatal risk of failure. Oukrop's cardiologist complained to Guidant that it should immediately warn doctors about the short-circuiting problem. With the story about to break in the New York Times, Guidant finally came clean, issuing a recall of the flawed defibrillators in June. ”

As usual, Fortune got most of the story wrong. That “small . . . risk of failure” was actually pretty substantial in the Ventak Mini I & II devices and the PRIZM I & II “fix” didn’t do much to make Guidant’s later devices better. Guidant’s ICDs failed often and catastrophically, sometimes delivering a fibrillation-inducing shock as the device’s last “act” before battery failure. Every one of those failures crossed my desk and ended up in my database. About the time I was ordered to de-link those product failures, the database contained just short of 1,000 such failures with an unknown number of related patient injuries and deaths. (Unknown, at least, to me.) Not long after I got the order to scramble my database, I had some sort of breakdown and lost the ability to read. (No, I’m not kidding. I couldn’t even sort out the text under newspaper pictures. Even sportswriters went beyond my capabilities.) For about two months, I sat at my desk watching product failure data collect dust in my file cabinet, hoping for one patient-advocate doctor to call and ask “Have you ever seen this before?” Finally, it was obvious to everyone that I was useless and I went on medical leave until I terminated my Guidant employment when that ran out.

One of those patients was a young woman, a single mother my daughter Holly’s age, who had experienced some sort of cardiac issue that gave her cardiologist an excuse to ablate much of her heart’s electrical system. As a result, she was dependent on the device for her heart rate and had been convinced that the defibrillation feature was also useful. (It rarely is.) She’d experienced one of the Mini I failures (and survived the associated shock) and had received an “under warranty” Mini II as a booby prize. Along with that “warranty replacement” came an additional $100,000+ in debt. The company had added about $20,000 to her debt load, since the Mini II was that much more expensive than her failed Mini I, and the hospital and doctors made up for the rest. She wasn’t really calling to complain, but she was hoping there was something I could do to help her find a way to something more reasonable, debt-wise. We had several conversations, as I collected information on both her product failure and the procedure’s billing history. She was the only patient/medical professional I’d talked to who could verify that the device delivered an unintentional shock before failure.

I called everyone who would talk to me about her medical and financial situation. The doctors didn’t give a shit. The company’s sales rep was downright hostile. The hospital accounting people were clueless. Finally, I lucked into discovering that hospitals sometimes have “patient advocates.” This hospital had one who actually wanted to do her job. We came up with a deal, the hospital would absorb all of the charges except the doctors’ bills if I could get the company do refund the replacement device charges. She went first, so I could use that to shame our accounting/sales assholes into doing the right thing. Finally, Guidant’s bean-counters coughed up the refund. Now, I had an ethical hospital doing the right thing and a let’s-pretend-we’re-humans company doing the right thing, so I went back to the doctors. I got the anesthesiologist to kill his bill and the cardiologist gave back a little of his. That was the best I was going to get, so the $100k bill was down to about $8k. Still way too much for a single mother who’d been kicked in the head with medical problems and expenses, but it seemed pretty good to me at the time.

I called her back and got an older woman on her phone. It was her mother. I explained why I was calling, sort of proud of myself for having done something “good” for the first time in my 10-year medical device career. She listened and said, “Thanks for calling, . . . [she] died last week. She had another heart attack.” Another “heart attack.” From what I knew, the chances were pretty good that her Guidant device had blown itself up and killed her. We talked a little more. I hung up and went home for the day. The next day, I called the sales rep and tried to get him to have the device explanted and sent back for analysis. It was cremated with her, which happened all the time even though cremating lithium batteries is a really bad idea.

You can’t beat cremation for an evidence destroying procedure, though. The doctors didn’t want to know what had happened, the sales rep sure as hell didn’t care, the company was working hard to be sure its ass was covered, and I felt like I might as well have killed her myself.

Not long after that, I left the industry and wrestled with myself for months before I went back to fixing music equipment and, later, teaching. Every Thanksgiving since, I’ve thought about her and my involvement in her “care.” If you want to know why I dislike and distrust doctors, here’s Reason #1; not one doctor in the hundreds I talked to cared why their patients’ device failed. If they’d have asked, I’d have told them. I have no idea who Joshua Oukrop’s doctor was, but he is the needle in a haystack of careless, selfish, lazy and rich doctors who don’t care about patients any more than corporations like Guidant do. Finding a good (as in “not evil”) cardiologist is harder than finding a moral and honest Republican. I kept a floppy disk with all of my device failure data until we moved this past year, in hopes that someone might ask for it for the first few years and out of habit after that. Tossing that disk into the trash was almost like a ceremony of resignation. Along with it went my medical device resume and all of the stuff I’d written for that industry over my 10 year career. I wish I could forget it ever happened, especially to me. The experience broke a few bits of me that will never heal. When my wife and I recognize how lucky we are to be where we are today, in retirement and in our home with friends and family, I can not help but remember what I did to get us here. And who paid for it.

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