Saturday, December 15, 2007

Good Ethics/Bad Law in Massachusetts

Last week the Massachusetts Supreme Judicial Court published its decision on Coombes vs Florio, a case with important implications for medical liability law. The case is also deeply interesting from the perspective of medical ethics.

On March 22, 2002, David Sacca, a 75 year old patient of Dr. Roland Florio, suffering from cancer of the lung and several other ailments, lost consciousness while driving and hit and killed a 10 year old boy, Kevin Coombes. The Coombes family sued Dr. Florio, claiming that he failed to inform David Sacca about the side effects of the many medications he was taking, and failed to warn him against driving.

A lower court found that Dr. Florio owed no duty to Kevin Coombes, and therefore could not be sued for the alleged failures. The Massachusetts Supreme Court was asked to review the lower court’s decision to dismiss the case. The question was whether Kevin Coombes's estate had standing to sue Dr. Florio.

By a 4-2 decision, the court concluded that Dr. Florio owed a “duty of care” to Kevin Coombes. On reading the decision and viewing a video of the Supreme Court session, I believe the decision was bad law but good ethics.

Judge Ireland, joined fully by two colleagues, and in part by a third, concluded that Dr. Florio owed any and all of those who might be injured by David Sacca’s driving a “duty of care,” with the result that Coombes was entitled to bring the suit. I agree with the ethical perspective the finding is based on. We physicians should consider our patients as part of a social world, not as isolated atoms. When we discuss, for example, a medication we are prescribing, we should refer to the potential for harm to others as well as to the patient, just as with a patient infected with HIV we counsel against unprotected sexual contact, not just for harms that might come to the patient, but for the harm the patient could cause to others.

Justices Cordy and Marshall, in dissent, argue persuasively that the majority finding is not justified by the precedents the majority cites. Further, they point out significant harms that can come from the finding, including a massive increase in litigation, violation of patient-doctor confidentiality from suits brought by third parties, and more defensive medicine. In my view, they show that the finding is bad law. Here is some of Justice Cordy's reasoning:

"There is no debate that it is foreseeable that the victims of an impaired driver are not only the driver but other drivers, pedestrians, or cyclists. The impaired driver plainly has a duty to all potential (foreseeable) victims. But extending the duty of the driver's physician, grounded in the doctor-patient relationship, to all those whom the driver encounters is entirely different. Because A has a duty to B, and B has a duty to C, it does not necessarily follow that A has a duty to C. The duty of A to C must be established on its own terms."

Unfortunately, the dissenting justices base their conclusion, in part, on bad ethics. Justice Cordy argues that the doctor-patient relationship should be:

"…autonomous, free from the influence of concerns beyond the patient's well-being. This reflects long-held norms about the relationship between doctor and patient and the sound social policy that a doctor's interest be solely in the well-being of his patient."

This perspective, widely held in the U.S. but much less so elsewhere, is patently wrong. If we took it seriously, if our HIV positive patient says "I know about the risks unprotected sex poses for me, and I am not daunted by them," we would keep silent about the risks created for others. Of course we wouldn't do this -- we would weasel out of the inconsistency by saying "it would be harmful to you to expose others to risk."

But the atomistic view of the physician's moral responsibilities is a major contributor to our ongoing paralysis with regard to managing health care costs. If our sole responsibility is to the patient, with no regard whatsoever for the impact of our actions on wider society, the sole basis for not offering an intervention is that it would harm the patient. However useless it might be, if it is not harmful, and the patient wants it, the view that "the doctor's interest [should] be solely in the well-being of his patient" requires us to offer it. Societal opportunity costs be damned.

My speculation is that the four justices who reached a faulty legal conclusion may have been swayed by the correct ethical argument that physicians should think about all of those who their interventions affect, not "solely" about their patients. Unfortunately, in Coombes vs. Florio, good ethics may have encouraged a bad legal decision.


Anonymous said...

Hi Jim,

I agree with your assessment of "bad law, good ethics" 100%. What I found fascinating about this case is the absence of the role of the pharmacist, and, through further research, the legal precedents for this exclusion.
In reading the court’s decision in Cottam v. CVS (referenced in the Florio decision), I was amazed to find out how little legal responsibility rests upon the pharmacist in regards to consulting patients as to the potentially harmful side effects of the medication(s) being dispensed. Here’s what’s fascinating: through a legal precedent called the “learned intermediary doctrine”, pharmacies are essentially absolved of the duty to warn their customers about a medication’s potentially negative side effects. It essentially designates the prescribing physician as, in essence, the ‘retailer’ of the medication, not the pharmacy. This doctrine is applied to the Florio case through reference to McKee v. American Home Prods. Corp, in which the decision was reached that “the reasons for applying the learned intermediary doctrine to drug manufacturers apply with equal force to pharmacies. In both instances, the physician is in a better position to decide the information that is most pertinent to each particular patient because the physician has superior knowledge of the patient's medical history and unique condition.”
This is, frankly, not true. From my experiences working in a pharmacy, I can attest that by virtue of customer records, a pharmacist and their staff are at least as, and in my opinion, much more likely to have a more complete prescription history of a given patient than said patient’s physician. This is simply because of the fact that physicians, through no fault of their own, lack the networking capabilities readily available to pharmacists. Patients receiving prescriptions from Drs. X, Y, and Z do not necessarily inform the different physicians of the various other medications they are prescribed. Granted, there is an inherent oneness on the individual to present this information to physician, but nowhere can I find it stated that a patient’s failure to do so relieves the physician of responsibility or liability.
Here’s where it gets further complicated: A pharmacy IS legally responsible, and holds liability for failure to warn against the interactions of two or more medications against each other (Lasley v. Shrake's Country Club Pharmacy). All major pharmacies have computer systems that automatically flag harmful interactions, but they can only draw from prescriptions filled within the same chain, sometimes only within the same store. Insurance companies have access to all medications billed to them, regardless of prescribing physician or pharmacy chain, but they cannot account for prescriptions run through for “cash,” not billed to a 3rd party.
The question is who, then, is ultimately responsible for the coordination of a patients care in regards to medication? I believe this responsibility must rest with the pharmacist. The case laid forth for the establishment of the “learned intermediary doctrine” ignores the fact that a physician may not be aware or in possession of a patient’s full medical history, including current medications. Whereas the point of liability legislation is to defer said liability from the individual to a professional caretaker, the individual must therefore be excused from the responsibility of accuracy. Where it would be unrealistic to then expect a physician to present every possible medical scenario, including side effects, to a patient upon dispensing every new prescription, it is totally plausible that a pharmacy counsel the customer time a medication is dispensed.
Currently, the law states that a pharmacist, or staff representative, must make the offer to counsel every time a prescription is dispensed. Customers sign a ‘consultation log’ affirming that such an offer was made, and either waived or accepted. These logs are kept as record to accordance with the law.
Why then, if it is the physician, and not the pharmacy, that bears liability, do patients not sign such a log that attests to their counsel, or waving of counsel, from the prescribing physician? The only case I can see that begins to explain this is Morgan v Wal-Mart – Texas- in which the courts decided that if presented with all of the potential warnings accompanying every prescription at the point of purchase, the patient/customer may choose not to fill the prescription. I disagree with this assertion, and would argue that it is the inherent duty of any retailer to explain any and all potential side effects of the products it dispenses. I would further contend that the retailer of prescription medications is the pharmacy and it’s staff, not the physician – as defined by the “learned intermediary doctrine” – due to the increased likelihood that a pharmacist is in possession of a greater amount of relevant historical information, and therefore in a better position to advise the patient of any side effects.
To borrow your phrase, Jim, I see this as No Ethics/ Bad Law.

Anonymous said...

For now....I have time only to strongly concur. I add that there are some grey lines in medicine and dispensing of pharmaceuticals. Pardon me , more soon.

ClinkShrink said...

I read your comment on our blog about the Coombes vs Florio case and I just had to stop by and thank you for your contribution. My co-bloggers don't have the fascination for case law that I have, but I've been waiting for someone like you to chime in. Thanks so much. I'm adding that case to our fellowship's journal club when we get to the Tarasoff issues.

Thanks for reading Shrink Rap.

Jim Sabin said...

Hi ClinkShrink -

FYI, some years back I co-taught an elective in "ethics and law in outpatient psychiatry" several times at the Harvard Longwood Psychiatry program. Patricia Illingworth, my co-teacher(a lawyer/philosopher), and I found that case law was very engaging for the residents, and for us. Garamella, Jaffee v Redmond, Joyce Brown (or Billie Boggs), Meinhard v Salmon (about professionalism, not psychiatry per se) and Wickline were all of great interest.



Anonymous said...

Thanks for the note.
I have a crazy notion of contacting Obama and proposing to be part of his healthcare rebuilding. What can be more important and more of an incremental part of the greatly needed change in healthcare in this country!! What do you think? haha

Jim Sabin said...

Hi Donna -

I'd say - go for it. The worst that could happen is that you get no response. But the Obama campaign has been inclusive, and let's hope and expect the Obama/Biden administration to be the same!



Anonymous said...

To Jim know I think I will!! haha
Donna A