The Need for the Visual and the Visceral: A Dangerous Disparity in The Regulatory Approach to Eliminating Deadly Hazards in The Technology Space
The Boeing 737MAX aircraft killed 346 passengers in two separate plane crashes. Two of these airplanes crashed within 6 months of one another in 2018/2019. The global fleet was grounded and the aircraft remains under regulatory scrutiny in the US and abroad. Boeing has now halted production of the aircraft at serious peril to its corporate economic health.
Enter the medical device known as the Laparoscopic Power Morcellator.
For well over 20 years, the Laparoscopic Power Morcellator (LPM) has harmed or killed upwards of one in 300 women on whom it is used. Literally, thousands of women worldwide have been exposed to a cancer mortality risk caused by this medical device. A large majority of these women have died catastrophic, premature or unnecessary deaths from their spread cancers literally filling their abdominal cavities. But, despite FDA warnings and the clear and present death risk posed by this medical technology, companies like STORZ and LiNA continue to distribute it globally today. The death risk to women across the world from this medical device remains largely unmitigated as of this writing.
But, why such a disparity between the regulatory handling of deadly disasters caused by defectively designed technological devices in the aerospace industry versus the medical device industry?
At the start, I must beg the reader’s indulgence and ask forgiveness: In posing the above question, I am by no means attempting to diminish the magnitude of the catastrophe caused by the 737MAX defect. 346 unsuspecting souls perished tragically, because of a totally AVOIDABLE design flaw in the 737MAX aircraft, which Boeing had clearly known about.
But the scale of catastrophe imposed on unsuspecting women’s lives by the LPM device, using only the number of dead women as a metric, is simply MASSIVE compared to the 346 dead in 737MAX crashes. With millions of operations being performed on the uterus of women worldwide each year using the LPM device, the one in 300 cancer mortality risk translates into, at least, thousands of catastrophic premature or unnecessary deaths.
If one simply integrates the number of women treated using the LPM over the span of 20 years the device has been used by gynecologists worldwide, it is a certainty that hundreds of thousands of unsuspecting women have been harmed or killed by Gynecologists using the LPM device.
Compared to that of patients treated with the LPM device, the mortality risk imposed on passengers of the 737MAX aircraft is thousands of times lower. This, is a statistical certainty!
So, why is the 737MAX grounded and out of circulation after an unprecedented global regulatory response— while the LPM device is continuing to be marketed and distributed by medical device companies like STORZ and LiNA worldwide? Why are gynecologists hand-waving, minimizing and obfuscating the mortality risk involved with their morcellation practices?
The answer to this question requires some careful dissection.
First of all, are these scenarios even analogous enough to warrant such a comparison?
I think, yes.
But, at the start, many critics have stated that the market environment in which the 737MAX operates is entirely different from the one in which the LPM is used. Therefore, my argument here is nullified and of no value to a root cause analysis.
I believe this criticism is a superficial and defensive one that does NOT hold muster — neither philosophically, nor legally. And that it is based in a protectionist objective towards the interests of the gynecological industry — not protecting unsuspecting consumers’ lives from specific avoidable risks of death in the broader technology space.
My critics ignore the fact that comparability of these technological failures results from two specific similarities: 1) they both result from defective or inadequately mitigated engineering of the device being discussed and 2) they both find their way into the marketplace because of complacent corporate executives, engineers and service providers who understood the risk but viewed it as being acceptable, by virtue of a primarily economic trade-off calculus — not based on a carefully calibrated concern for consumer safety and the lives entrusted to them.
It is interesting to note that an almost identical dynamic was in play when the Ford Motor Company marketed its Ford Pinto model starting in the 1960s. The reader may recall that the Pinot’s gas tank was prone to exploding when rear-ended — that is, a deadly design defect in the vehicle was incorporated and released into the marketplace by negligent executives and engineers who bucked their ethical duty to consumers and believed the mortality risk was balanced by the economic benefit of the Pinto to both the corporation and to consumers.
To state the absurd, if 100% of Pintos blew up, if 100% 737MAX jets crashed and if 100% of women undergoing LPM operations died catastrophically — the products would never make it into the marketplace.
It is because the desirable and affordable Pinto blew up in ONLY one in thousands of cases,
because the 737MAX might crash in ONLY one in millions of passenger-miles travelled,
because the LPM was believed to spread sarcoma cancers in ONLY One in 10,000 (in truth, One in 200–400) women…
It’s because the risk was perceived to be “so small” by the economic beneficiaries of these devices, that these products became the subject of the benefit “trade-off” equations used by the corporations and professions involved in their design and marketing.
Irrespective, both the 737MAX and the LPM were released into the marketplace to interface with the lives of millions of unsuspecting human beings — with their associated AVOIDABLE, UNMITIGATED or INADEQUATELY MITIGATED design defects, which were known to the corporate entities marketing and using them in consumers.
Of course, after the second 737MAX jet crashed in 2019, the global fleet was instantly grounded. And the US (and global) government inquiry into the problem was not small or limited to the FAA or the NTSB. Rather, in the US alone, it ratcheted all the way up to the United States congress. And most recently, after taking a beating on the global stock exchanges, Boeing has suspended any further production of these aircrafts.
346 unsuspecting souls dead, because of an inadequately mitigated product defect led to very fast removal of the danger from the global marketplace.
Impressive, Indeed!
I am in no way justifying the catastrophe by the very quick regulatory response it elicited.
But I am questioning what gives the 346 killed by Boeing’s 737MAX so much more poignancy and power to elicit corrective action — by government, the corporations and the professionals involved.
After all, the magnitude of the LPM catastrophe, just considering the sheer number of women harmed or killed by the device for over 20 years, makes the number “346” pale!
Literally, hundreds of thousands of women have been harmed or killed by the LPM device for well over 20 years, globally — compare that to 346 souls onboard the two 737MAX jets.
Yes, the number simply pales, when compared! But not the indignant regulatory response to the killings.
Why?
And, again, I beg the reader not to assume that I in any way mean to diminish the magnitude of the 737MAX tragedy.
The US Food and Drug Administration (FDA) did warn against the use of LPM devices in women. But it ONLY warned. It did not remove the product. And despite the serious efforts of a few good congressional representatives, the US congress didn’t even bat an eye at the LPM disaster in women’s health — certainly nothing like what we have seen in response to the 737MAX disaster.
And what of the large majority of Gynecologists who use the LPM on women? Compared to the vast majority of pilots who express outrage at Boeing’s negligence and the FAA’s complacency in the 737MX debacle, most Gynecologists have ignored the LPM hazard. And even now, they continue to believe that the UNACCEPTABLE and AVOIDABLE mortality hazard was a fictitious concoction of a well-organized publicity campaign — not the result of a seriously defective, but widely marketed, technology and practice algorithm in their field. They obfuscate, minimize and ignore the mortality risk with no shame or gravid sense of professional responsibility.
In stark contrast to Boeing, the culprit corporations like STORZ and LiNA Medical continue to market their dangerous and defective LPM product, still fully unmitigated, to the global marketplace and to unsuspecting women. This, despite the largest global manufacturer of the LPM, Johnson & Johnson, withdrawing its version of the LPM from the global marketplace in 2014 after the public was alerted to the deadly flaw.
Again, I ask the reader not to assume that I am minimizing the tragedy of 346 people dead in the 737MAX crashes. To the contrary, I am simply asking what is different in the Aerospace industry as compared to the Healthcare space. What allows for such intense scrutiny and corrective action when systemic safety concerns and product defects come to light in the former industry, but NOT the latter?
I think the answer is two-fold: one has to do with the visual and visceral response of a democratic marketplace to catastrophe — the other is inherent to the practicing expert professionals’ and corporations’ clarity on the scope and ethics of hazards to people’s lives.
In the year 2019 a large proportion of the world’s population can imagine being a passenger on an airliner. We can all imagine that lack of control and fear when the airplane we’re on goes through turbulence — and that sinking “what if” fear of a crash. And when crashes do happen, in the VERY rare instances that they do, we visually see the wreckage and the carnage — we thank God it was not ourselves or our loved ones on board. We do not want ourselves or anyone we love to be one of those on board a doomed flight. So when we find out that the crash may be caused by corporate or professional negligence about a known design defect, we become indignant — and our representatives in government respond indignantly in turn, rising up to literally skewer the guilty. And they do!
Just look at the close and furious attention every branch of the United States federal government has paid to 737MAX disasters — and the two airliners weren’t even American!
In rather stark contrast, in the US alone, the LPM device was (and perhaps is) harming or killing somewhere in the range of two airliners worth of women every year — and more globally. Yet the distributed nature of the LPM harm and the fact that the deaths could not be visualized and related-to by most consumers. Not with the immediacy and visceral potency of an airliner crashing. The LPM disaster in the lives of countless American women was and is masked well from the public view.
It is telling that the few congressional representatives who rose up to speak to the LPM catastrophe on Capitol Hill were ones whose constituents were personally affected — and who had the understanding and ability to make their voice heard. The rest in congress, including some prominent physicians congressmen on powerful committees, appeared bored or unable to comprehend the size of the specific disaster.
The LPM hazard, despite its sheer size compared to the 737MAX hazard, is (and remains) very well masked from public understanding — because the carnage it causes is distributed over time and over geography and because the average citizen could not visualize or understand it easily.
Indeed, the average citizen cannot visualize what it looks like when a woman whose cancer is spread using the LPM device, dies from a cancerous tumor filling her abdominal cavity — slowly choking off her blood flow and killing her kidneys and liver. I assure you that it is as horrific, if not more, than what happens to people who perish in a plane crash. In anything, perhaps the latter is a bit more humane. In the latter, the victim sees her end VERY quickly, in seconds— but not in the former! It is pure HELL!
And then we have the professionals involved with using such defective technological devices to provide services to consumers. Most of us in the western hemisphere, engage in the purchase or exchange of goods and services with an underlying assumption of trust. We trust in the good faith, professionalism and expertise of the professionals whose highly specialized and presumably well-regulated services we purchase and use: be they Airline Companies, Hospitals, airline pilots, or Gynecologists. But these are all human economic constructs or agents. And in order for an economically powered entity to correct its errors efficiently, it must be able to grasp the magnitude of any given problem efficiently. If a problem is perceived astigmatically with the distant lens of “rare” statistics and “trade-off”, economically advantageous, but avoidable, deadly hazards will be accepted and sustained — by the very professionals and experts who should be protecting their customers. Sadly, more often than not, when a trusted professional accepts an avoidable hazard as being justifiable, the trusting consumer also accepts it as negligible. Our market economy is built on trust — without it, all will be lost.
Of course, there is no better mechanism for a body of professionals to be tuned in to the truth of an unacceptable catastrophic hazard, but the purity and clarity imparted by risk exposure to their very own persons.
In the case of the pilots on board the 737MAX aircraft, EVERY one of the pilots was also a passenger. When the 737MAX aircrafts crashed, with all on board, the pilot and his/her crew perished too.
In the case of the Gynecologists using LPM devices on the women they treat, there is NO personal risk to the survival or health of the physician. In fact, even when the woman is harmed or killed by the use of this device, the Gynecologists still get paid for their service. And, even if a patient or her family complains that she was mortally harmed (or killed), the Gynecologist has access to a well-fortified legal defense system and team to protect against financial liability.
But, IMAGINE, if when using the LPM device, one in 200–300 Gynecologists were being electrocuted themselves. Or, if they were being irreparably harmed or killed by a projectile flying off the device. We all know what would happen to the culprit device — immediately!
What’s worse in the case of the LPM is that even after a Gynecologist has used the LPM to mortally harm a woman, he/she almost never gets to see that patient’s horrific death. There is no “immediacy of consequence”, as Dr. Amy J. Reed said, in the catastrophe the Gynecologists create for the morcellated patient.
Our specialized medical system has become so fragmented, it shifts the care of these harmed women to medical oncologists, then Hospice services and then to the undertaker — and each of these downstream stops exist in a professional silo well-hidden from the Gynecologists and corporations doing the harm.
When my wife died, because of the STORZ LPM device used by the Gynecologists at Brigham and Women’s Hospital, neither the GYN-oncologist who missed her diagnosis, nor the GYN would used the LPM device to spread her cancer, nor the STORZ executives who are still marketing and distributing this dangerous device, were are her bedside watching the catastrophe they had created for her and her family. They simply could NOT visualize what they had done. They have no idea of the disaster they created and sustained! And, even now, their defense teams and their industry leaders are attempting to sugarcoat and whitewash the catastrophe.
So, the defective 737MAX is grounded and gone — hopefully for good. It is so because: 1) the marketplace of consumers visually and viscerally grasps the unacceptable nature of the hazard the product defect has caused and 2) because the very survival of the operators and providers of the service are themselves invested in each of the susceptible jets. Neither the consumer, nor the professional, want to be exposed to the deadly hazard of the 737MAX.
But, the defective LPM device, from companies like STORZ and LiNA, is still being used, literally, in millions of women worldwide. It is so because: 1) the marketplace of consumers CANNOT easily, visually and viscerally, grasp the unacceptable catastrophic nature of the hazard the product defect causes and 2) because the LPM does not in any way pose a risk to the health and wellbeing of the gynecologists who use it on trusting women.
The mortality risk posed to consumers by the 737MAX is thousands of times smaller than the one women are exposed to, by the LPM device. The risk of dying in a 737MAX jet is one in millions of passenger-miles travelled — where the death risk of LPM to women is on the order of one in 200–500.
But neither of these mortality hazard levels are acceptable risks to any consumer or patient. Because it is not the size/incidence of the death risk or whether it imparts some economic benefit to the involved corporate entities or the consumer that determines whether a mortality risk is acceptable. Rather, it is that the death risk is caused by a specific design defect that is both avoidable and inadequately mitigated (i.e., the 737MAX) or not mitigated at all (i.e., the LPM) that makes it UNACCEPTABLE.
When a lack of public understanding, as well as, the negligence of corporate executives and professional providers are able to collude to sustain such defective and deadly technologies in an active marketplace, severe federal regulatory failure is at hand — and the literal cost of this failure is to the lives of unsuspecting citizens interfacing that economic sector.
When confronted with AVOIDABLE, but deadly defects and risks in the technology space, it should not fall solely on the civil courts to protect the population — though imposition of serious legal and financial liability on culprit corporations by harmed consumers is an important component of evolving a well-balanced marketplace.
The trouble is that relying on the persistence and understanding of individual plaintiffs and the snail’s pace of the civil court system to prove product defects and demonstrate corporate liability, won’t protect the population in any meaningful or efficient way — especially when systemically harmful products and services are identified and alleged.
Despite the tragedy that Boeing’s marketing of 737MAX aircrafts became, it is fair to say that the regulatory response has been very robust, fast and effective.
The LPM device in Gynecology, however, remains an example of failed corporate ethics and negligence — in the face of an impotent federal regulatory response and reckless professional standards in Gynecology.
Perhaps, in time, the civil courts will deliver the appropriate blow to LPM manufacturers and providers, with the public watching — though the civil courts and the stamina of individual citizens should NEVER be the only standing barrier to population level harm in Medicine or any other American economic sector.
There is a lot to be fixed in the medical establishment’s regulatory process and ethics in the year 2019 — if we are to tolerate it as a for-profit business in America. And there is certainly a lot to think about in the technology interface with society, if we are to sustain the health and wealth of out nation. This is why, far from being “the enemy of the people”, the press and public advocates, must be allowed to balance the imbalanced healthcare and technology marketplaces — no matter how astigmatic, and even incorrect and biased, some so-called journalists and advocates might be at times.
This fight is for a balanced, just and safe marketplace.
