DOCS CAN'T DELEGATE Only a physician can obtain informed consent, the Supreme Court of Pennsylvania has ruled.

Beleaguered physicians, already fighting to find time to fulfill all of their obligations, have been hit with another haymaker — a shocking decision by the Supreme Court of Pennsylvania that prohibits anyone but a doctor from securing informed consent. In Shinal v. Toms (osmag.net/aytd6v), the court decided that in securing informed consent, doctors may no longer delegate to a nurse, a PA, a resident, another doctor or anyone else.

"Informed consent," it says, "requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange." Patients are likely to have questions, the court added, questions "the physician must answer personally before the patient feels informed and becomes willing to consent."

Never mind that in many professions, including — and somewhat ironically — the business of law, experienced practitioners (including judges) routinely rely on highly educated and well-trained assistants to help them manage their workloads.

Never mind that informed consent has traditionally been obtained by assistants who not only understand the procedures they're explaining, but who also know the surgeon very well, and know exactly what that surgeon likes to communicate to patients. Never mind that many hospitals, surgery centers and surgeons use pre-printed materials and pre-produced videos to provide patients with a general understanding of procedures, risks and alternatives. And never mind that great care goes into the production of those materials, with a goal of making sure laypeople can understand and comprehend those risks and alternatives.

The case in question involved a woman who'd had surgery to remove a benign, but growing and potentially life-threatening, brain tumor. Her carotid artery was perforated during the surgery, leading to hemorrhage, stroke, brain injury and partial blindness.

There was no question that she'd discussed some of the risks with the surgeon beforehand (she recalled "coma and death"), but the parties disagreed as to whether they'd discussed alternatives. The surgeon testified that he'd reviewed the alternatives, risks and benefits of total versus subtotal resection, and that he informed the patient that while a less aggressive approach was safer short-term, he felt that the tumor was more likely to grow back if she opted for subtotal resection.

Key to the case, the patient eventually agreed to have total resection, but that decision came after 2 additional conversations with the surgeon's physician assistant, for whom she signed the informed consent form. That opened the door for a malpractice action premised upon lack of adequate informed consent.

Fervent dissent
How surprising was the decision? Not only is it wholly inconsistent with all precedent, but, as a dissenting justice points out (osmag.net/bzny4t), it mandates a dynamic that could have serious repercussions not only for physicians, but also for patients.

In "respectfully but fervently dissent[ing]," the justice wrote, "I fear that today's decision will have a far-reaching, negative impact on the manner in which physicians serve their patients. For fear of legal liability, physicians now must be involved with every aspect of informing their patients' consent, thus delaying seriously ill patients access to physicians and the critical services that they provide."

Although the decision immediately affects physicians in only one state, it's certainly possible that the same argument could be made in other jurisdictions and that other courts could look to Pennsylvania for guidance. It's safe to presume that physicians and hospitals everywhere are now on guard, along with the American Medical Association, state medical societies and others, all of which will be keeping a close eye on this.

In fact, the AMA argued in an amicus brief that there was "simply no logical reason" as to why any information given to the patient should be discounted in a negligence case, solely because the surgeon "did not himself provide it." The idea that "the patient had the relevant information but the 'wrong person' provided it and therefore the physician has not obtained informed consent, surely places form over substance," said the AMA.

Improper touching?
One of the puzzling aspects of the decision is that informed consent has never shielded physicians from accusations of negligence or harm that occurs through negligence. From a public policy standpoint, there was already more than adequate protection afforded to patients.

But now, in the absence of properly obtained informed consent, any touching of a patient that hasn't been consented to can be considered battery, which opens the door to a scenario in which physicians potentially face liability for non-negligent harm that's an inherent risk to a given procedure. Hence, the ruling has created a new and different duty and obligation that never previously existed.

Will it stand the test of time? Hard to say. I do think it will be challenged, and my best guess is it will turn out to be an anomaly. But at least for now, it bears watching.

From a practical standpoint, it may create another impediment to quality health care. Many physicians are already being pulled in countless directions, trying to handle not just clinical responsibilities, but also duties related to administration, teaching, committees, technology, EHRs, insurance, coding and compliance. A ruling like this has the potential to impact efficiency and throughput by altering resource allocation. A physician who planned to see 10 patients in a given day may have to turn 2 or 3 away because of the time needed to personally handle a lengthy informed consent discussion.

The bottom line: Speaking to a smart, well-educated, experienced associate no longer suffices. OSM