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GENE-SEQUENCING AND MEDICAL MALPRACTICE

August 29, 2015

GENE-SEQUENCING AND MEDICAL MALPRACTICE

I have long since been a retired lawyer but when in the practice I had occasion to be involved in a few medical malpractice matters. Drafting or defending such complaints was relatively easy in pre-genetic testing days since case law and medical association standards of ethics provided the understanding of what proof would be needed to either win or lose such tort cases.  Factual proof involved the easy ones like a drunken surgeon who left his or her forceps in the abdomen of the plaintiff to the more difficult factual situations where there was a failure to advise of condition, overcoming the superior knowledge of the doctor to that of the patient in obtaining informed consent for surgery, no surgery or other conditions etc. As a litigant, your proof to the court and/or jury either fell within such confines of case law and ethics or it did not, in which case your suit at trial either went to the court and/or jury to assess damages or you were otherwise subject to motions for dismissal by opposing counsel.

I am not up to date on current legal standards for ordinary medical malpractice claims, but I suspect that there has been little change in such standards. The relationship between doctor and patient is a fiduciary relationship, one in which the doctor is held to a high degree of non-negligent conduct in not only treatment responsibilities but in his/her relationship with the patient given the asymmetry of his/her power and medical knowledge, which places the patients in a vulnerable position. As a result, and as one medical-legal researcher (who I will name shortly), has written: “This unequal position, often exacerbated by patient anxiety, generates the potential for clinicians’ misuse or abuse of their power. Consequently, in order to protect patients, there is a heightened ethical and legal expectation that clinicians should be loyal to patients’ interests, avoid acting in self-interest, keep patients informed, and act in good faith, within the scope of authority, and with utmost care in patient’s best interest.”

I was prompted to write this essay of commentary after reading an essay by Dr. Gabriel Lazaro-Munoz in the Winter 2014 edition of The Journal Of Law, Medicine & Ethics, a journal generously sent to me by a professor of business ethics at a Midwestern university, who himself is a contributor and sometime guest editor of the journal. Dr. Lazaro-Munoz is well-qualified to write what he did since he has a PH.D in Neuroscience, a J.D. in law and a Master of Bioethics degree in addition to his undergraduate degree.

The world has changed. Failure to advise the patient may now have morphed into liability for ADVISING the patient! The intervening culprit? Genomic sequencing. Dr Lazaro-Munoz’s lengthy essay treats many want to know and that could seriously impact the health choices of such patients in the future.

For instance, most who read this are acquainted with stories about female Hollywood stars and others who, upon being told by their doctors that their “whole genome/exome sequencing (WGS/WES) and/or its secondary target findings” show that they are likely to develop breast cancer, have had their breasts surgically removed. My discussion here is not about such patient choice and drastic response in acting or not acting upon receipt of such information, but rather that of being informed, not informed, or only informed in certain areas of risk pursuant to this new and evolving standard of what we formerly called patients’ “right to know,” which must now apparently in this day and age of genetic testing include the “right not to know” as well. Obviously, there will have to be a new fiduciary standard concocted within the broader idea of fiduciary relationship between doctor and patient to accommodate this new advance in science, so what should case law (which takes time to develop) look like in this new age?

Typically, when formulating such standards the courts will look to relevant statutes, cases (if any), government regulations, literature specific to the area and common sense realities in order to come up with a new standard for future application to specific litigation. They have not had much help in this genetic testing situation from either the government or the American College of Medical Genetics and Genomics (ACMG). The Presidential Commission for the Study of Bioethical Issues (PCSBI) and the ACMG have (per Lazaro-Munoz) released reports that refer to clinicians as fiduciaries when ordering genomic sequencing tests in clinical care, but we knew that.

That generalized reference to fiduciary status changes nothing from the current fiduciary status in doctor-patient relationships when applied, for instance, in a situation where the patient’s traditional right to know (in view of gene-sequencing) can become malpractice when seen from the perspective of the patient’s right not to know. This failure of government and the industry to be more specific in what is or is not to be considered in formulating a new fiduciary responsibility due to such new science should be remedied so that courts can have a handle on standards giving rise to liability for application in litigation sure to come from alleged fiduciary misconduct in advising or not advising patients of their genetic futures per testing (which in either event can be devastating to patients not only as to health but if known, could severely affect  job prospects, buying life insurance, homes etc.).

Thus, given self-imposed limits for discussion in this essay (since there are many other topics open for discussion with this new science and its implications), let’s zero in on the legalities of right to know and right to not know. The tradition is that the doctor as a fiduciary with superior knowledge must tell the patient everything in the best interests of the patient, but with genetic sequencing and secondary or incidental findings, telling the patient everything incidentally discovered but not ordered in the testing ordered by the doctor may not be in the best interests of the patient, so the ethical question comes down to whether the doctor should tell the patient the whole story or be secretive as to secondary findings (assuming, of course, that the patient has by way of informed consent agreed to such testing in the first place). This is a difficult question and difficult to frame legally as a benchmark to be followed in determining liability, and since the government and the medical industry have been of little help to date, what are courts to do with such lawsuits on their dockets? They need help, and it will come eventually.

The gung-ho ACMG has been in the forefront in defining the control patients have over their own genetic information. They claim to recognize that their recommendations of full reporting of ordered and incidental information should be met whether the patient has agreed that such information should be made available to his doctor or  not and admit that such a view “may be seen to violate existing ethical norms regarding the patient’s autonomy and ‘right not to know’ on grounds that laboratory personnel have a fiduciary duty to prevent harm by warning patients and their families about certain incidental findings and that this principle supersedes concerns about autonomy.” I smell a Big Brother.

So it’s a matter of choice. I agree with Dr. Lazaro Munoz on the side of patient autonomy.   GERALD    E

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