The Cost of Defiance

 

I recently read Defy; The Power of No in a World That Demands Yes, by Dr. Sunita Sah and that book reminded me of the personal torment I went through in escaping from the “best job I ever had” (according to my father) and avoiding doing the wrong things for the wrong reasons.  In early 2001, I was employed as a Reliability Assurance Engineer supporting Guidant/CRM’s Ventak implantable cardioverter-defibrillator (ICD) products.  The very same products that, soon, began Guidant’s rapid decline into a collection of FDA recalls and product failures that caused injury and death to hundreds of patients. About four months before I left the company at the beginning of 2001, I was “offered the opportunity” to disable a product component failure database that I’d assembled to track specific design areas contributing to ICD failures and (sometimes) patient injury and death.  I’d spent hundreds of hours developing both the database and the product testing protocols that determined the failure mechanisms.  When an ICD fails it almost always either causes harm to the patient or puts the patient at extreme risk of injury or death. My supervisor had been told that the database needed to be “scrambled” so that an FDA inspection wouldn’t easily be able to see our products’ design flaws.   I was the only person in the company who knew how the database worked and, short of simply deleting the information, I was the obvious candidate to render it useless.

Sadly, I thought about it for a bit.  There was nobody I could talk to either privately or in the company about that amoral (at best) order and I was incredibly conflicted.  Initially, I got into medical devices because I thought there was an opportunity to do some good, as an engineer.  When I started that career, I’d just left a 15 year career in audio electronics engineering and had decided that occupation was doing nothing more than making bad music louder.  My last employer made professional audio power amplifiers and we were making music really loud.  My father had recently barely survived a series of heart attacks and some of his care in a Wichita, Kansas hospital was moderately competent and some of it was pretty terrible.  After my last employer had turned out to be a scumbag, I thought I’d give another industry a shot, an industry that purports to be one that at least, “does no harm”; medical devices.

My first employer in medical devices was Telectronics Pacing Systems in Englewood, Colorado.  When I started with Telectronics, the company was on its way from being a very conservative, high quality Australian company to becoming a minor subsidiary of a huge, mostly-incompetent British conglomerate: Pacific Dunlop (PD).  PD’s Telectronics mismanagement was a sad combination of British upper-crust fools and the shoe-scrapings exectives from a failed Florida company, Cordis, who the PD silly-walkers had bought in a recall fire-sale and installed as Telectronics’s new management. It took those overpaid, unskilled characters less than 4 years to blow up a $500M/year well-respected company and lose almost 1,000 jobs and harm too many patients to count.  By the end of my Telectronics stint, I was a reliablity engineer for the company’s spun-off recall division, often participating in lead extractions and device replacements in the field.  The upside to that position was that it had left me in place as a resident “expert” on purchased aspects of several of Telectronics’ products and designs, as the company’s design engineers had quickly abandoned ship for better climates and safer career floatation.

That largely unearned status got me several offers from Telectronics’ competitors and put me in the driver’s seat of my own career for a brief rare moment in time.  For a variety of not-necessarily-rational reasons, I found myself the focus of a bidding war for my services and in 1996, I accepted an offer from Guidant as a Technical Services Engineer with a promise that the company would find a field position for me, back in Colorado, within six months.  There was more money in that offer than I’d ever imagined I would see in my lifetime, too.  Guidant lived up to the Colorado promise, but my daughter and new grandson had moved to Minnesota in the meantime and I had to pass on the field position and promotion that came with it.  A year later, I left Technical Services for Reliability Assurance and two promotions later I was heading a small group of data entry people and technicians who were tracking some unsettling failures in our 2^nd generation ICDs.  And that is where my database came into being.   

By the fall of 2000, it was becoming obvious that the Ventak ICDs had a serious manufacturing flaw.  My database had accumulated more than 300 identical failures, based on returned product testing, and at least another 300 devices that had clearly failed in a suspicious manner but weren’t returned to Guidant because the patients had died.  At that point, I hoped that some cardiologist might recognize the connection between a device that had unexpectedly failed and a patient death or injury.  If anyone (physician, nurse, FDA inspector, or sales rep) had asked me, at that time, if I’d seen a failure like the kind I’d been monitoring, I’d have immediately given them all of the information I’d collected for them to draw their own conclusions.  I’d long given up trying to get anyone in Guidant’s mismanagement to act on what was, by then, a Class 1 Recall and a manufacturing process that was out-of-control.  I’ve told a part of this story before (“The Price of Thankfulness”), but one of the straws that broke my mind was when I’d spent a couple of weeks trying to get the billing for a young woman’s failed ICD sorted out so that she wouldn’t be bankrupted by our product failure.  After getting everyone involved to forgive her hospital “debt,” I learned that she had died when her 2^nd device failed a short time after her implant.  Then, my supervisor delivered the final blow by ordering me to disorganize my product failure database. 

Looking back, I suspect there were early warnings that came before my meltdown, but I was “up to my neck in alligators” and didn’t see them.  It seemed to me that it all happened instantly.  First, by January 2001 I had lost the ability to read . . . anything.  I couldn’t even decipher the captions under pictures in the newspaper.  I certainly couldn’t do any programming.  Not long after losing that key ability, I fell into a severe depression; physically and mentally.  Sometime early that spring, I went on medical leave and cycled through the sad sack assortment of characters who passed for “mental health professionals” at my HMO.  In April, I stumbled on to a benefit that allowed me to look for counseling outside of the HMO and I lucked into a brilliant woman who helped me realize that the money I was making in medical devices was ripping out what passed for my soul.  By June, I was being pressed to either resign or come back to work and, lucky for me, a good friend offered me good advice and alternative employment (at a substantial reduction in income).  That began the final phase of my working life and provided me with many of the best moments of my life.

I don’t know the whole story, but my database information did end up in the right hands, undefiled, in early 2002 and that began the fall of Guidant. By 2003, some of my former colleagues at Guidant began calling me at home asking “How did you know this would happen?”  I had often recounted my Telectronics experiences to them, as it became obvious to me that Guidant’s products were heading in the same direction.  I’d sat in the room with two FDA inspectors, answering questions asked by one of the inspectors while the other one twiddled his handcuffs.  It took me two years to recover from the depression, reading disability, and regain some of my confidence and restart my career in my new fields.  A few years later, I learned that my Guidant supervisor had committed suicide a couple of years after I left the company.  I could relate. 

The only people who can flourish in that kind of environment are amoral, greedy, lizard-people like the ones currently populating the Republican Party.  Everyone else will suffer, no matter what the job pays.  Worse, the victims of those people, those companies, often suffer the ultimate price: death.  Defying the monsters who filter to the top/bottom of the corporate toilet bowl is usually painful, dangerous, and too often results in the loss of everything a decent person values.  Living with them usually causes the same kind of destruction.  Now, as a nation that has ignored the vicious, greedy, amoral behavior of those who profit from the mismanagement of our country, we are all being forced to choose between accommodation and participation in the destruction of the tattered remains of “the American Experiment” in democracy . . . or defiance.  A price will be paid, either way.