Sunday, April 14, 2013

Robotic surgery: New medical malpractice underwriting risk

If I am a medical malpractice insurance company, should I be concerned about a new underwriting risk?

The question is prompted by a recent story in the Denver Post.  The lede:

The Colorado medical board has charged Dr. Warren Kortz with 14 counts of unprofessional conduct after a series of failed procedures with Porter Adventist Hospital's robotic surgery arm, as federal officials launch a wider review of the highly touted procedures. 

The state alleges that from 2008 to 2010, Kortz cut and tore blood vessels, left sponges and other instruments inside patients after closing, injured patients through improper padding and positioning, subjected some to overly long surgeries, and had to abort kidney donations because of mistakes.

Now, one surgeon does not an actuarial trend make.  The article notes:

The U.S. Food and Drug Administration said it is stepping up interviews of surgeons about the devices after a new series of mishap reports, although the agency said it has not yet identified a trend. Hospitals spend more than $1 million on each of the da Vinci-brand surgery units and are under pressure to keep them busy.

The lack of a trend, however, does not protect doctors and hospitals from malpractice cases.  If I were a plaintiff's attorney, here's the way I would frame the medical malpractice argument to a judge and jury:

A hospital and its doctors decide to purchase and employ a surgical robot, notwithstanding a lack of peer-reviewed evidence as to its clinical efficacy vis-à-vis other forms of laparoscopic or open surgery.

There is evidence that the hospital has spent significant sums of money in marketing the availability of the robotic surgery in its service territory.  There is evidence, too, that ties the marketing campaign to a change in that hospital's market share for the particular procedures advertised.  The profit-and-loss statements of doctors in the hospital show the income gained from this change in market share.

The doctors in that hospital present poor documentation as to why they chose to employ the robot on particular patients, failing to show in the medical records--or in the patient consent forms--a clear demonstration of relative risks and benefits vis-à-vis other forms of laparoscopic or open surgery.  At the hospital governance level, the medical executive committee of the hospital has failed to adopt specific rules and regulations concerning such documentation in the medical records or patient consent forms.

Even if there is a record of simulation or other training by the doctor using the machine, the evaluation of his or her performance in that training session is not carried out by an objective observer.  Maybe the extent and type of training are not even documented.  Perhaps, too, the general pedagogical efficacy of the training has not been subjected to peer review by experts in clinical process education.  At the hospital governance level, the medical executive committee of the hospital has failed to address the issue of granting privileges for use of the robot that sufficiently address these pedagogical and documentation concerns.

(In some cases,) the doctor has employed the robot in novel settings, beyond those used by the preponderance of physicians.  At the hospital governance level, the medical executive committee of the hospital has failed to systematically address the issue of granting privileges for use of the robot for these purposes.

Each of these opportunities to enhance the plaintiff's case can be offset by an appropriate risk management approach.  But how many medical malpractice insurance companies have recognized this new vulnerability and taken steps among their insured entities to ameliorate the risks?

Apparently not many, if these ads from a simple Google search on "medical malpratice robotic surgery" are any indication.

4 comments:

Robert Bates said...

From G+:

As a urologist our group has seen the full spectrum of DaVinci outcomes...the good the bad and the ugly.
Fundamental questions are (among many): Is it efficacious? Is it effective? What is the moral hazard in recommending/doing this procedure in the absence of clear clinical advantage? How are practicioners being certified and monitored for their outcomes? When does profit motive in medicine overshadow concern for patient care and well being? Can we afford to release treatments like this on the general public before adequate testing? 

David Bell MD said...

As the Head of Urology at Dalhousie University in Nova Scotia we have not adopted the Davinci system as of yet. In Canada most of the academic centers as well as some community hospitals in the Toronto area(clearly competition demanded) have bought into this technology. Surprisingly all of these have been donated by foundations or private individuals. Government funding has been lukewarm and as these approach the end of the initial 5 year "business plan" ongoing funding remains unclear.
The impact on residency training is significant and many will not have access to this technology in their future practice.
Give me 5M and I could change the delivery of Urology care for many many patients not just the 70-100 prostate cancer patients who are well serveved with current approaches to Radical Prostatectomy. I remember your post "Uncle" when you decided to acquire the robot. Market pressures and medicine are a bad mix

Medical Negligence Claim (Australia) said...

I think the fact Kortz "cut and tore blood vessels, left sponges and other instruments inside patients after closing, injured patients through improper padding and positioning, subjected some to overly long surgeries, and had to abort kidney donations because of mistakes" say it all. Very sad situation irrespective of the viewpoint on DaVinci outcomes. Thanks for the article - Medical Negligence Claims

Mitchell Sexner said...

I think as an insurance company, yes you should be the party to be involved with any new underwriting risks because they are all part and parcel of any medical malpractice cases. You should be concerned about it since affected patients have the right to seek your assistance should they suffer any of such unwanted circumstances as you are covering for them 100% more or less. However, you can read up on each individual policies and counter check with every client to see how far their personal policy goes.