September 19, 2013
Patteson v. Maloney— F.Supp.2d —, 2013 WL 5133495 (D.D.C. 2013)
Most psychiatrists don’t know about it, but the switch from Frye to Daubert in the admission of expert testimony matters for them a lot. Psychiatrists treat patients with second-generation antipsychotics: Zyprexa, Risperdal, Clozaril, Seroquel, and similar drugs. A reputable, but still controversial, body of research links those drugs to tardive dyskinesia: a serious neurological disorder involving uncontrollable facial grimacing, repetitive tongue thrusting, and other untoward bodily movements. Under Frye, expert evidence can only be admitted upon showing that it received “standing and scientific recognition” from the relevant community of experts. Absence of a solid consensus disqualifies the evidence. Expert testimony linking tardive dyskinesia to antipsychotic drugs consequently would not be admissible under Frye. Under Daubert, however, it would go into evidence because its underlying research is grounded in scientific method and procedure that can be replicated, examined, and properly explained to the jury.
This is exactly what happened in a recent case decided by the United States District Court for the District of Columbia: Patteson v. Maloney— F.Supp.2d —, 2013 WL 5133495 (D.D.C. 2013). This case featured a patient who developed tardive dyskinesia (TD) following her insomnia treatment by an antipsychotic drug, Seroquel. After acknowledging that replicable and peer-reviewed studies linking TD to Seroquel have been published in reputable medical journals, the court decided that the patient’s causation expert passes the Dauberttest. The court explained that the fact that medical community is not unanimous about these studies goes to the weight of the expert’s testimony and does not make it inadmissible. The court also underscored Daubert’s “liberal thrust” toward the admission of expert testimony in general.
Moreover, the court ruled that the expert can establish patient-specific causation by differential etiology. This method, in the court’s words, involves “the creation of a list of possible and/or most likely causes for a patient’s signs and symptoms, based on his/her medical history, examination findings, and ancillary testing. … The [expert] then eliminates options from the list until the most likely cause is found. Picture a whiteboard filled with possible medical culprits for a patient’s symptoms—familiar to fans of the medical television drama House—and then watch each being methodically crossed off the list through testing and deduction until a single diagnosis remains.”
Based on this method, plaintiffs who never experienced TD prior to taking the medication would normally be able to move their case to the jury. This ruling was also based on Daubert. The differential etiology method could hardly be admitted into evidence under Frye.
The consequent liability risk for psychiatrists is obvious, given the frequency of TD among psychiatric patients. Antipsychotic drug prescriptions follow the trial and error method. This method involves patient-specific observations, tradeoffs and adjustments that rely on the psychiatrist’s intuition. There are no hard-and-fast rules and protocols similar to those that provide legal “safe harbors” for other doctors (see here, at pp. 1208-16). As a result, plaintiffs’ experts would often be able to second-guess the psychiatrist’s drug prescription and plausibly describe it as negligent.
This new legal reality increases the liability risk for psychiatrists while limiting their ability to defeat malpractice suits summarily. Psychiatrists face this increased liability prospect in every state court that follows Daubert as well as in federal courts sitting in diversity or deciding malpractice suits under the Federal Tort Claims Act. State courts that follow Frye(as in New York and California) will protect psychiatrists against this risk.
A possible solution to this problem can be found in the rules of informed consent that deem psychiatric patients competent to consent to an antipsychotic drug prescription. Excluded from this presumption are patients proven to be “substantially incapable of applying an understanding of the advantages and disadvantages of particular medication to [their] mental illness.” See In the Matter of the Mental Commitment of Melanie L., 833 N.W.2d 607 (Wis. 2013). Based on this presumption, psychiatrists can have their patients sign an informed consent form specifying the TD risk among the anticipated side effects of the prescribed medication. The form should also explain the tradeoff recommended by the psychiatrist and agreed by the patient. Finally, the form should expressly state that the patient chooses this tradeoff over its alternatives and agrees to the drug adjustment process by trial and error. The patient will then be deemed to have assumed the risk of developing TD from taking the medication.
Admittedly, this is not a foolproof solution, and I can also think of psychiatrists who would not like it very much. This solution, however, minimizes the psychiatrists’ risk of liability for TD. Psychiatrists who feel uncomfortable about my proposed informed-consent form should read Patteson v. Maloney— F.Supp.2d —, 2013 WL 5133495 (D.D.C. 2013) and think about it again.