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Expert Testimony Necessary For Informed Consent Claims

Expert Testimony Necessary For Informed Consent Claims

In Shannon v. Fusco, 438 Md. 24 (2014), the Maryland Court of Appeals held that expert testimony was required to establish the “material risks” of a procedure to recover in an action for a physician’s failure to obtain informed consent. “Material risks” is the patient-oriented standard adopted by Maryland appellate courts in which a physician must disclose those risks which a physician knows, or ought to know, would be significant to a reasonable person in the patients position in deciding whether or not to submit to a particular medical treatment or procedure.

Writing for the Court, Judge Lynn A. Battaglia held that, in such informed consent actions, a plaintiff must designate an expert with the requisite expertise to establish the severity and risks involved in a procedure or treatment.  Judge Battaglia reasoned that expert testimony is necessary to assist the trier of fact in understanding the severity and the likelihood of a risk so that the trier of fact may assess the material risks of the proposed treatment. The court’s holding follows well-settled case law that requires complex medical issues to be presented through the testimony of qualified experts. Judge Eldridge dissented.

The case arose out of the death of Anothy Fusco. Mr. Fusco had been diagnosed with prostate cancer and had been referred to Dr. Shannon and his medical practice (the “Defendants”) for the administration of Amifostine, which would aid with inflammation caused by radiation therapy. After taking the Amifostine, Mr. Fusco developed Steven-Johnson Syndrome – a skin disorder – and later died of pneumonia. Mr. Fusco’s estate and survivors (the “Plaintiffs”) subsequently filed suit in the Circuit Court for Prince George’s County for failure to obtain informed consent for the administration of Amifostine. In support of their case, the Plaintiffs designated Dr. James Trovato, a pharmacist who specialized in oncology. Dr. Trovato opined that the drug had not been approved by the Food and Drug Administration to supplement radiation treatment in prostate cancer patients, and had been inappropriately used. Dr. Trovato also testified that its packaging insert advised against its use by elderly patients, and side effects included “various skin reactions” such as Steven-Johnson’s Syndrome.

Defendants moved for summary judgment on grounds that Dr. Trovato was not qualified to offer an opinion on the standard of care that a physician must exercise because Dr. Trovato was a pharmacist and not a medical doctor. The motion was denied. After the de bene esse deposition of Dr. Trovato, Defendants again moved for summary judgment, and again the motion was denied. However, Dr. Travato was subsequently excluded from trial when Plaintiffs submitted a written proffer that failed to establish that Dr. Travto would testify as to the risks inherent with Amifostine. Following trial, the jury found for the Defendants.

On appeal, the Court of Special appeals reversed the verdict, finding error in the exclusion of Dr. Trovato’s testimony. After granting certiorari, the Court of Appeals reversed the intermediate court with instructions to affirm the verdict for the Defendants. Of significance, the Court stated in dictum that an action for failure to obtain informed consent, while similar to an action for negligence, is separate and distinct.

The Court rejected Defendants’ argument that a pharmacist is per se unqualified to testify in an informed consent action when a physician has been sued and instead found Dr. Trovato sufficiently qualified to testify about the material risks of the administration of Amifostine.  However, the Court determined that Dr. Trovato’s de bene esse testimony itself was insufficient on grounds that the pharmacist only attested to the existence of risk and failed to address the severity and likelihood of the risks of the administration of Amifostine. Therefore, the court affirmed the trial court’s decision to exclude Dr. Trovato’s testimony, as well as the FDA Amifostine label inserts, and remanded the case to the Circuit Court with instructions to affirm the verdict for the Defendants.

Informed consent claims have important ramifications for health care providers.  For more information on informed consent claims, contact the attorneys at Walker, Murphy & Nelson, LLP today.

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