Doctors, Off-Label Prescriptions, and A New Legal Precedent (Cont.)
Jun 17, 2009 in Drugs and Devices
Ben Cade brought up some strong points in response to the first post of Doctors, Off-Label Prescriptions, and A New Legal Precedent. In summary, he argued that the case of Dr. Ames v. Wash. State MQAC could not be used as legal precedent for considering off-label (non-FDA approved) prescribing of drugs and devices as malpractice. If some evidence of efficacy could be presented, then the burden of harm would not be reached, he suggested. Below is an excerpt of his aguemnts followed by my response:
“The legal precedent set by this ruling means the MQAC could potentially charge doctors with malpractice merely for promoting off-label treatments regardless of their actual effectiveness.”
I think you overlook a vital clause of the court ruling and in so doing exaggerate the extent to which malpractice lawsuits will increase. The justices did not write that the usage of the device in question represented malpractice “simply” because it was not FDA approved, but additionally that Dr. Ames:
“Led patients to believe LISTEN could treat and diagnose allergies, when in fact it could do neither, placing these patients at risk of harm.”
This statement is crucial, because it implies that if LISTEN would have held some type of legitimacy or effectiveness towards treating allergies–whether FDA approved or not–then the burden of harm may not have been reached. The efficacy of many off-label drugs, treatments and devices while not possessing the FDA stamp of approval, has been noted in reputable medical journals, demonstrated through lab studies, or largely accepted within a specific field of medicine–i.e. amongst a majority of doctors and practitioners.
If an off-label treatment held wide spread support amongst a large portion of the medical community–for instance the use of aspirin you noted before it was sanctioned–then any harm the treatment may happen to cause would have to be weighed against its observed benefits. As a matter of public policy, this is true even if the drug in question was not designed for that specific purpose.
In future cases which argue malpractice turns merely on the presence of FDA approval, the judges will surely also look to the evidence concerning the drugs’ merits.
“Led patients to believe LISTEN could treat and diagnose allergies, when in fact it could do neither, placing these patients at risk of harm.”
This argument can be used in the case of just about any off-label pioneering. I recall a recent medical case in which physicians experimentally injected Botox into the larynx of a young girl with Tourette syndrome. Their theory was that it would calm her vocal cords and lessen her ticks. The treatment didn’t work. Also, there was no scientific evidence to back up this usage (other than the theory post by the physician). On top of that, the treatment had real potential to harm the patient (and much more than that presented by a diagnostic tool measuring electrical resistance at that).
Although I do see your argument, and if a doctor actually made it past the first one or two cases and was able to justify some clinical effectiveness, then I can see where a judge might rule in favor of the physician. However, the true barrier to innovation lies in the impedance inherent in taking the risky step of pioneering a new method of treatment on that first patient. In such a case, where neither FDA approval nor anecdotal evidence of efficacy would be present, a physician would be hard pressed to provide evidence that his treatment was both effective and did not present a potential for harming the patient.
However, this all still presumes that the physician (or his attorney) could argue past the other clauses stating “that medical review boards are able to rely on their own expertise in evaluating medical practices” and that no other evidence was necessary to convince “a layperson that he was using a machine for purposes for which it was not designed and for which he was not specifically trained.” The evidence consisted of a lack of FDA approval and one contradictory expert opinion.
Furthermore, the ruling states that “Generally, Washington law does not require that expert testimony be provided to MQAC” and that the MQAC can “draw inferences from the evidence presented to them.” Furthermore, “it is not inappropriate for MQAC to draw its own conclusions as to the acceptable standard of care.” So, the expert testimony regarding efficacy would not have been necessary for MQAC to make their decision anyway.
I would hope that this case isn’t used as precedent for claims of malpractice. However, the wording of the affirmation still appears to loosen the reigns on what type of behavior actually constitutes malpractice. In my opinion, the Supreme Court would have been better off leaving out “the lack of FDA approval” as proof of ineffectiveness. In the case of Dr. Ames, it would have been simple enough (and less consequential) to affirm the ruling on the basis of supplemental expert testimony affirming the lack of clinical efficacy of LISTEN in treating allergies.
June 17th, 2009 on 9:53 pm
I am a lawyer. Ben’s argument would make sense if the Supreme Court had based its decision entirely on expert medical testimony that the LISTEN device could not treat or diagnose allergies. Even though I am a lawyer, and not trained in the medical field, it seems to make intuitive sense to me that the LISTEN devise could do neither. However, I have no specialized knowledge of the medical field. How would judges know this? Judges do have not specialized knowledge or training in the medical field. Most judges graduated from college with history or English degrees, and they received no medical training in law school. The only way for a judge to know whether a device could be medically effective is either (a) based on expert testimony that was not effective or (b) a presumption that it was not effective due to the fact that the device was not FDA approved for treatment or diagnosis of an allergy.
Based on the expert medical evidence at the MQAC hearing, the Supreme Court could have affirmed the decision by the MQAC. The Supreme Court should have done that. There actually was expert medical testimony at the MQAC hearing that the device was not effective for treatment or diagnosis of allergies. The Supreme Court referred to that expert testimony when it stated:
“When some expert testimony has been offered to an adjudicative board, as in this case, and the board issued findings of facts based on the expert testimony, this court does not inquire whether the expert testimony fits within some preconceived formulation.”
And
“Another expert, Dr. Richard Sherman testified that galvanic skin recorders like LISTEN do not have the ability to diagnose ailments or treat allergies.”
The Supreme Court should have stopped there. Unfortunately, the court went further. The Supreme Court appeared to state that in fact no expert testimony was needed at all regarding the efficacy of the device for the diagnosis or treatment of allergies. Instead, all that was needed to prove misconduct was mere fact that the device had not been approved by the FDA for treatment or diagnosis of an allergy. The court drove this point home when it held:
“Substantial evidence leads to the conclusion that Ames was using LISTEN for purposes for which the machine was not designed or approved. As such, no additional expert testimony was necessary to demonstrate the elements of professional misconduct alleged in the statement of charges.”
The first sentence merely states that Dr. Ames had used a device off-label. In the second sentence, the court then concluded that having used the device off-label, “as such, no additional testimony was necessary to demonstrate . . . professional misconduct.”
In my humble opinion, the court should not have included these two sentences. Having added these two sentences, it will lead to arguments by plaintiff’s lawyers and the MQAC that no “expert testimony [is] necessary to demonstrate the elements of professional misconduct” whenever a device or drug is used off-label, i.e., for a purpose that has not been approved by the FDA.
I read the unpublished opinion by the Court of Appeals. That decision was more carefully drafted. In a hurry to affirm the MQAC, the Supreme Court needlessly included two sentences that will likely lead to more litigation until such time as a later Supreme Court opinion clarifies its opinion in the Ames case. Until that happens, doctors in Washington appear to be at risk if they prescribe devices or medications for purposes that have not been approved by the FDA.
May 17th, 2013 on 7:20 pm
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