Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe. In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs. When he proposed a song for The Life of Brian, he ran into resistance. The song seemed insufficiently catchy. That song was “Always Look on the Bright Side of Life,” one for the ages. It manages to be simultaneously profound and absurd. In honor of Idle, we decided today to discuss a case that is similarly profound and absurd. The case is New York v. Richard Z., 20 I 7 N. Y. Misc. LEXIS 9 I 8; 20 I 7 N Y Slip Op 30498(U) (Oneida Cty March 9, 2017), and has nothing to do with product liability. Or does it?
Our clients get vilified anytime there is a hint of off label use. Never mind that off label use can be enormously beneficial for patients. It can even be the standard of care. We’ve said that several times and the point is made in Bexis’s book. But now we have the ultimate proof: in Richard Z, a court ordered prison doctors to make off-label use of a medicine available to a prisoner. The facts are weird and icky, but the point is nonetheless unmistakable. The prisoner was apparently in prison for some sort of sexual assault. The opinion supplies no details, but since the prisoner had been in civil confinement for over nine years, and in prison for 30 years before that, we are guessing he had done something(s) really bad. It is well known that sexual assaulters have a very high rate of recidivism. That probably accounts for all those years of civil confinement.
The prisoner wanted to get out of stir, and requested a particular chemical therapy. That therapy involved an antiandrogen that would substantially reduce his sexual urges, and that has been proven in scientific tests to assist in the reduction of recidivism to less than 3%. A couple of outside experts supported the chemical treatment, opining that such treatment would likely place the prisoner “at a low risk for future sexual offense recidivism and violent recidivism to the point that he could be released to the community on strict supervision”. But a prison doctor opposed administering the particular requested/recommended therapy, the use of which for these particular purposes would have been off label. The prison scheduled an “informed consent” conference relative to the chemical treatment of the prisoner. The prison doctor elicited responses that suggested the prisoner would be taking the drug under compulsion and that “he would not have chosen to take this medication by himself” and “that he knew he had other choices.” But to the court it was “abundantly clear” that these responses were “coaxed” from the prisoner via “a carefully guided inquiry” by the prison doctor in an effort to dissuade the prisoner from taking the off label treatment. The doctor “was acting according to her own subjective views and beliefs thereby substituting those views and opinions” for the prisoner’s . It was also clear to the court that the prisoner was intelligent, educated, and engaged, and that he “clearly understands the off-label use of this prescription and its risk.”
The court concluded that the prison doctor lacked “experience and training in this area,” had misinterpreted her duties in this case, and that she and the prison were attempting “to avoid compliance with the clear and unequivocal expert opinions.” The court relied on “many studies that show that antiandrogens greatly assist in repressing sexual urges and allow release of sex offenders safely into the community.” The prison doctor had “substituted her subjective opinion” for the prisoner’s informed consent, and was “both inexperienced in the field of treating sexual offenders and has not kept current with medical advancements and evolving scientific understanding.” That evolving scientific understanding supported the off label use of the drug, and denying that off label use to the prisoner would be “precluding him from attaining his liberty.”
Off label use was not only permissible, it was ordered.