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I read the unpublished opinion by the Court of Appeals.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.