It’s a unique relationship based largely on knowledge and trust. Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient. Knowledge that often develops overtime through trust. Patients want and need to be able to trust their doctors. Sometimes patients share information with their doctors before anyone else in their lives. It’s a consensual relationship but it’s also a fiduciary relationship where the doctor takes on certain obligations. And, it’s a relationship that has been evolving over the last several decades which numerous influences such as managed care, direct-to-consumer advertising, internet medical information. Things that can interfere in the traditional doctor-patient relationship. Some of that, like more knowledgeable patients who want to partner in their healthcare, can be good developments. Managed care – removing a patient’s choice of physician or a physician’s choice of treatment – perhaps not so much.
Here, in the DDL world, we are firm believers in the independent practice of medicine. Doctors making patient-specific medical decisions based on all known and available information, but not dictated by either drug/device manufacturers or the FDA. That means doctors are free to use drugs and devices in ways other than their approved uses. Doctors can use drugs and devices off-label. And, that is what is at the core of the decision in Smith v. Surgery Center at Lone Tree, LLC, 2020 WL 6066273 (Col. Ct. App. Oct. 15, 2020).
This is a hospital liability case. Plaintiff received a series of epidural steroid injections at defendant hospital that left her permanently paralyzed below the waist. Id. at *1. Plaintiff’s doctor used a corticosteroid that had not been FDA approved for epidurals. Id. at *2. Plaintiff sued and settled with the physician who performed the procedure. Id. at *1. Plaintiff proceeded with her claims for corporate negligence, uninformed consent, and negligence per se against the hospital.
Plaintiff argued that the hospital had a duty to “prevent” the doctor from using the drug off-label or to ensure that the plaintiff gave her informed consent to the off-label use. Id. at *2. Colorado applies the corporate practice of medicine doctrine, “which prohibits a corporation that employs a physician from interfering with the physician’s medical judgment.” Id. at *3. It may be a hospital case, but we’ve argued the following in products cases as well:
The decision to administer a certain medication to a patient in a certain situation is, without question, a medical decision made by a physician alone.
Id. at *4. Not the drug manufacturer, not the sales rep, not the FDA, and not the hospital. Plaintiff claimed that simply by making the drug available in the hospital, the hospital had an obligation to dictate how physicians used it. Fortunately, the court rejected the argument. A decision to the contrary would have us wondering about the ramifications for manufacturers. You get a drug approved for one use and that makes you the watchdog to make sure doctors don’t use it off-label. If hospitals can’t interfere with the practice of medicine, neither can manufacturers.
On the issue of informed consent, the court ruled that providing the patient with the necessary information to obtain informed consent is the practice of medicine, and therefore not the hospital’s responsibility. If the hospital undertook to advise the patient, it would be unlawfully practicing medicine. If it didn’t, it would violate the duty of care plaintiff wanted to impose. The court was unwilling to put the hospital in that no-win situation. The court also recognized that forcing the hospital to interfere in the doctor-patient relationship was problematic because it is “the surgeon, and not the hospital, who has the technical knowledge and training necessary to advise the each patient of the risk of the surgery.” Id. at *6. That’s why we have the learned intermediary rule in products cases. It would be just as problematic for a drug manufacturer to step in the shoes of the doctor and give a patient advice about whether or not she should undertake a certain course of treatment.
There is also the question of whether informed consent is necessary for an off-label use. While that question wasn’t before the court, id. at *7, the decision does include a footnote that indicates sympathy for the proposition that the FDA regulatory status of a drug is not a proper subject for informed consent. Id. at *10n.3.
The court also dismissed plaintiff’s claims for negligence per se for off-label use that supposedly violated certain state and federal regulations because those regulations related to licensing. To be the basis for negligence per se, the regulations needed to have been enacted for public safety and intended to protect people like plaintiff from the type of injury plaintiff suffered. Without that, plaintiff could not sustain her negligence per se claim.
Big win for hospitals, physicians, and off-label use in general.