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. Effective in 2022, 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 procedure and the risks and alternatives required by 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.

PA Law on Informed Consent in Medical Malpractice Lawsuits

Under Pennsylvania law, before a physician conducts any proposed, non-emergent treatment on a patient, the patient must receive information about the nature of the proposed procedure, as well as the expected and possibly unexpected risks and results. Generally, in Pennsylvania, similar to the majority of other jurisdictions, a physician has an affirmative duty to advise a patient of the facts, risks, complications, and alternatives to a procedure. This duty is required under Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act. With this information, a patient can make an educated or “informed” decision regarding the available options and/or alternatives to medical procedures.

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 Case

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.

Jury Instruction: Informed Consent

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.

However, the Supreme Court, with a majority of four justices concurring, held that a doctor was personally obligated to inform a patient of the risks and benefits of the procedure, as well as obtain her informed consent to proceed with the proposed treatment. The case was, therefore, ordered to be retried because, in the opinion of the Supreme Court, the trial court judge was wrong in his instructions to the jury.

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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