Pennsylvania Informed Consent Law: What Patients Should Know

What Is Informed Consent?

Informed consent generally requires that a patient receive the information Pennsylvania law considers material to the decision whether to undergo a covered procedure, including relevant risks, alternatives and expected benefits. The precise disclosure requirements depend on the procedure and the governing statute.

How Pennsylvania Informed-Consent Law Has Changed

In Shinal v. Toms, 162 A.3d 429 (Pa. 2017), the Supreme Court of Pennsylvania held that the physician personally had to satisfy the duty to obtain informed consent under the law then in effect. Pennsylvania later amended the MCARE Act. Under the 2021 amendment, 40 P.S. § 1303.504 permits a physician, in specified circumstances, to delegate the task of obtaining a patient’s informed consent to a qualified practitioner who has knowledge of the patient’s condition and the covered procedure and otherwise satisfies the statute. The physician remains responsible for the overall care of the patient and must determine that the practitioner is qualified to obtain the consent.

Accordingly, the broad statement that informed consent can never be delegated is no longer an accurate description of current Pennsylvania law. Whether legally sufficient informed consent was obtained depends on the procedure, the information provided, who provided it, and the circumstances of the patient’s care.

Pennsylvania Informed Consent in Medical Malpractice Cases

Section 504 of Pennsylvania’s MCARE Act does not apply to every form of medical treatment. Except in emergencies, it requires informed consent before the procedures specifically identified by the statute: surgery (including related anesthesia), radiation or chemotherapy, blood transfusions, insertion of a surgical device or appliance, and specified experimental uses of medications or devices. Consent is informed when the patient or authorized representative receives a description of the covered procedure and the risks and alternatives that a reasonably prudent patient would require to make an informed decision.

Current Section 504 permits the task of obtaining informed consent to be performed by the physician or, when the statutory requirements are satisfied, by a qualified practitioner. The statute also addresses reliance on consent information provided by another qualified practitioner and preserves a patient’s ability to request that the physician answer questions or obtain the consent personally.

Pennsylvania also enacted 40 P.S. § 1303.504a, effective January 22, 2024, addressing certain pelvic, rectal and prostate examinations performed on anesthetized or unconscious patients in professional instruction or clinical training programs. Subject to statutory exceptions, that provision requires specific informed consent in verbal and written form before such an examination is knowingly performed.

What Shinal v. Toms Still Teaches

Shinal remains an important Pennsylvania informed-consent decision and explains why meaningful communication about material risks, alternatives and the proposed procedure matters. However, the later statutory amendment changed the rule concerning who may perform the task of obtaining informed consent. Current claims should therefore be evaluated under the MCARE Act as it exists at the time of the relevant medical care, rather than relying on the 2017 decision alone.

Background of Shinal v. Toms

Mrs. Shinal and her husband sued the defendant, Dr. Toms, and Geisinger Clinic in a medical malpractice suit. Mrs. Shinal, who had been diagnosed with a recurrent non-malignant tumor around her brain, alleged that Dr. Toms failed to properly inform her of the risks associated with a surgery to remove the tumor.

Dr. Toms denied breaching his duty to inform Mrs. Shinal. He countered that in a consultation with the Shinals on November 26, 2007, he had explained the risks of the different approaches to the surgery. These risks included possible damage or injury to Mrs. Shinal’s carotid artery and optic nerve.

Dr. Toms felt that Mrs. Shinal had understood the risks and wanted him to try and totally remove the tumor, which, though risky, would give her a better shot at long-term survival. Besides, Mrs. Shinal had a telephone conversation with Dr. Toms’ physician assistant (PA) on December 19, 2007, and the PA had gone through the risks of the procedure with her again at that time.

On January 31, 2008, Mrs. Shinal had an operation to remove the tumor, during which Dr. Toms perforated her carotid artery. As a result of the perforation, Mrs. Shinal sustained a hemorrhage, stroke, brain injury, and partial blindness. This medical malpractice lawsuit ensued shortly thereafter.

Historical Jury Instruction in Shinal

The Supreme Court was invited to overrule the decisions of the trial court and the Superior Court, both of which exonerated the Defendant. The reasoning at the lower court and Superior Court had been that the Defendant was not obligated to personally inform the Plaintiff of all the facts, risks, and complications of the procedure. The Superior Court further ruled that the Defendant doctor could be assisted in this duty by his PA.

The trial court judge, before the finding of the jury, directed that the jury could consider any information provided to Mrs. Shinal by “any qualified person” working as an assistant to Dr. Toms.

At the time Shinal was decided, however, the Supreme Court held that the physician was personally required to satisfy the informed-consent duty and ordered a new trial because of the jury instruction. That aspect of Shinal must now be read in light of the General Assembly’s 2021 amendment to Section 504, which permits delegation to a statutorily qualified practitioner under the circumstances described above.

Frequently Asked Questions

Must the physician personally obtain informed consent in Pennsylvania?

Not in every circumstance under current law. Section 504 permits the task to be performed by a statutorily qualified practitioner when its requirements are satisfied, although the physician retains responsibilities specified by the statute and the patient may request physician involvement.

Does Pennsylvania’s MCARE informed-consent statute apply to every medical treatment?

No. Section 504 identifies particular procedures, including surgery and related anesthesia, radiation or chemotherapy, blood transfusions, insertion of surgical devices or appliances, and specified experimental uses of medications or devices.

Are there special consent rules for examinations performed while a patient is anesthetized?

Yes in certain training settings. Section 504a, effective January 22, 2024, addresses specified pelvic, rectal and prostate examinations on anesthetized or unconscious patients and requires specific verbal and written informed consent subject to statutory exceptions.

Questions About Pennsylvania Medical Malpractice or Informed Consent

For questions relating to an medical malpractice issue, contact Matthew R Zwick, founding partner of ZwickLaw, at (814) 371-6400 or mrz@zwick-law.com, to schedule a legal consultation and free case analysis.  Learn more about ZwickLaw’s Pennsylvania medical malpractice practice.

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