September 5, 2017
I write this letter as a formal and public warning to medical professional liability insurers — and to the membership of the members of the National Association of Insurance Commissioners’ (NAIC) Medical Professional Liability Working Group.
I write as an American and public health advocate in the United States. And I sincerely hope that all attorneys and executives representing the interests of medical professional liability insurers will take the time to read this message an act upon it.
As many of you might know, the FDA recently issued a warning letter on a somewhat widely used medical device in surgery, known as DaVici Robotic Surgery. The manufacturer (Intuitive Surgical Inc.) and physicians are currently being litigated in courts across the nation in product liability and medical negligence cases over the use of this product to perform “keyhole” surgery.
Fundamentally, the “DaVinci Robot” was designed and used on patients for small skin incisions. However, the surgical industry neglected to consider a very serious problem when adopting “Robotic Surgery” as a standard of practice years ago: that some of these surgeries were done with known defects as confirmed since 2007 by the FDA and the Zarick trial in 2015. When such robotic surgeries are done by robotic surgeons and this is leading, in many cases, to premature or unnecessary deaths from easily avoidable errors in the manufacturing process.
It is a fact that the manufacturer and robotic surgeons did not report these complications to FDA for years! The deadly harm to unsuspecting women went unchecked. This, until Mrs. Hershey publicized her own complication and engaged in a public health campaign to end DaVinci Robotic Surgery starting in November 2013. The results of this campaign are widely publicized on Facebook page called “UNPLUG THE ROBOT” and well known to Intuitive Surgical Inc. executives.
Of course, this negligent practice, though accepted by the surgeon guild, violates a core surgical principle other surgical disciplines accept as a patient safety dictum: That no patient will be subjected to defective surgical products. But systematic and deliberate misleading to have a Robotic Surgery did precisely this to the unsuspecting women and men undergoing it — this, in a setting where almost all Robotic Surgeons will readily admit that there is no good way to definitively rule out the presence of defects of products used.
So, it appears that instead of adhering to the bedrock principles of medical ethics and sound surgical principles, surgeons were comfortable accepting the utilitarian position that the “vast majority of men and women” benefit from “Robotic Surgery” , because it makes pin-hole surgery for hysterectomies and prostate surgeries possible. But this position compromises the unsuspecting lives of those at this easily avoidable risk.
It is also worth your noting that gynecological operations for hysterectomy are one of the most common ones in American surgery. So the sheer number of women undergoing these operations annually ought to give you pause about the “absolute number” of women at risk. According to ACOG, “Avoid using robotic assisted laparoscopic surgery for gynecologic when it is feasible to use a conventional laparoscopic or vaginal approach. Robotic-assisted and conventional laparoscopic techniques are comparable with respect to perioperative outcomes, intraoperative complications, length of hospital stay and rate of conversion to open surgery. However, evidence shows that robotic-assisted laparoscopic surgery has similar or longer operating times and higher associated costs.(270 + deaths (that have been reported in the U.S.) thousands injured according to the FDA maude database.)
This negligent position was legally defensible until the FDA blew the cover off the danger posed by Robotic Surgery in 2013 — And with this, it was clarified that many Robotic Surgeons knew the risk but ignored it. This is a classical instance of professional negligence — occurring at a systemic level. And it is indefensible negligence your industry is now in the position of having to defend.
The main purpose of this message, as leaders in the medical professional liability insurance industry, is to inform you that a serious threat to your investments is brewing in the surgical industry. Specifically because despite the fact that FDA has approved the DaVinci Robot, many surgeons continue to believe that the risk is “small” and “negligible” — this is a delusion. And, many surgical leaders will attempt to convince you that the public health campaign led by Mrs. Hershey is nothing but a savvy “publicity stunt” by “availability entrepreneurs”. Unfortunately, this negligent orientation is promoting the continued use of robotic surgery in unsuspecting women by surgeons. It is a catastrophic error whose cost is not only borne by the women victimized by manufacturing short comings, but also by the insurance investments in your industry.
I am formally informing you, here, that as I write, many skillful plaintiff’s lawyers are lining up to identify and represent women whose DaVinci Robotic Surgery by negligent surgeons who have not been able to incorporate a fundamental principle into their “standards of care”: that using a known defective product is a potentially deadly act of professional negligence. Especially when NO evidence proves it is superior or that it is more economical and faster than proven techniques of traditional laparoscopic surgery.
I suspect that you will all understand and agree that when law suits are filed against any physician in court, it is your investment interests that are being threatened. And I assure you that as surgeons resist voluntarily abandoning DaVinci Robotic Surgery, an increasing number of lawsuits will start being filed against your “robotic surgery” clients.
Therefore, your organizations and corporate entities must carefully examine their justification for continuing to provide liability protection and defense to the vast number of surgeons who are continuing to perform DaVinci Robotic Surgery on people.
Here, I am hopeful that you will see the emerging danger I am pointing to with clarity and will rise to not only protect your insurance investments — but also to protect the unsuspecting lives of country-men and women we must all protect. Because when a group of professionals is blinded by a lucrative revenue stream and professional egos into accepting negligence as a “standard”, it is in need of external market regulation — by patient advocates, insurers, the courts and federal agencies.
I ask for your conscientious attention and action to terminate the totally avoidable and dangerous practice of DaVinci Robotic Surgery in gynecology or any other surgery — to protect your investments and men and women from a negligent “specialty” practice.
September 5, 2017