• Maryland Court of Appeals Finds That Expert Testimony Is Necessary to Establish “Material Risks” in Action for Failure to Obtain Patient’s Informed Consent
  • May 27, 2014
  • Law Firm: Semmes Bowen Semmes A Professional Corporation - Baltimore Office
  • Shannon v. Fusco, --- Md. ----, --- A.2d ---, No. 57 (Md. April 24, 2014)

    In Shannon v. Fusco, the Maryland Court of Appeals held that expert testimony was required to establish the “material risks” of a procedure necessary to recover in an action for a physician’s failure to obtain informed consent. Writing for the Court, Judge Lynn A. Battaglia held that a plaintiff must designate an expert with the requisite expertise to establish the severity and risks involved in a procedure in order to recover in an informed consent action. The Court also distinguished an action seeking to recover for a physician’s negligence from an action seeking to recover for a physician’s failure to obtain a patient’s informed consent. The Court found that evidence of a contraindicated use for a treatment may be relevant in a negligence action, but not in an informed consent action. Judge Eldridge dissented.

    This case arose out of the death of Anthony Fusco. Mr. Fusco had been diagnosed with prostate cancer, and was referred to Dr. Shannon and his medical practice (collectively, “Defendants”) to be administered the drug Amifostine, which was to protect Mr. Fusco’s bladder and rectum from inflammation caused by radiation therapy. After taking the Amifostine, Mr. Fusco developed Steven-Johnson Syndrome and died as a result of pneumonia. Mr. Fusco’s estate and survivors (collectively, “Plaintiffs”) filed suit in the Circuit Court for Prince George’s County against Defendants for failure to obtain informed consent from Mr. Fuscos for the administration of Amifostine. Plaintiffs designated Dr. James Trovato, Pharm.D., as an expert in drug therapy. In his de bene esse deposition, Dr. Trovato opined that Amifostine was inappropriately used, and that the Food and Drug Administration (“FDA”) had not approved Amifostine to supplement radiation treatment in prostate cancer patients. In addition, Mr. Trovato testified that the insert contained in the Amifostine packaging advised against its use in elderly patients, and that side effects included “various skin reactions” like Steven-Johnson’s Syndrome.

    Defendants moved for summary judgment when Plaintiffs designated Dr. Trovato, on the grounds that Dr. Trovato was not qualified to offer an opinion on the standard of care that a physician must exercise in obtaining a patient’s informed consent. Defendants position was based on the fact that Dr. Trovato was a pharmacist, rather than a medical doctor. Defendants’ motion was denied. Defendants renewed their motion after the taking of Mr. Trovato’s de bene esse deposition, and also filed a motion in limine to exclude Dr. Trovato’s deposition testimony. Defendants argued that Dr. Trovato’s testimony addressed issues relevant to claims of negligence, rather than informed consent. Furthermore, Dr. Trovato did not testify as to the nature of the risks of Amifostine, alternatives thereto, the frequency with which risks occur, or the probability of the drugs success, which, according to Defendants, was required under the Court of Appeals decision in Sard v. Hardy, 281 Md. 432, 379 A.2d 1014 (1977). The circuit court granted Defendants’ motion in limine, but again denied their motion for summary judgment. The trial judge left open the possibility that Dr. Trovato could testify at trial, but later excluded his testimony after Plaintiffs submitted a written proffer that failed to demonstrate that Dr. Trovato would testify as to the risks inherent in treatment with Amifostine. Immediately prior to trial, Defendants moved in limine to exclude evidence of Amifostine’s package insert, and any reference that the FDA had not approved Amifostine for treatment of prostate cancer patients. The trial judge granted Defendants’ motion. The jury returned a verdict in favor of Defendants. Plaintiffs appealed to the Court of Special Appeals, and argued that no expert testimony was required in a failure to warn case and that, even if expert testimony was required, the trial court erred in excluding Dr. Trovato. The Court of Special Appeals reversed the jury’s verdict. Defendants filed for certiorari to the Court of Appeals, which was granted.

    The Court of Appeals reversed the intermediate appellate court’s decision, and remanded the case to the circuit court with instructions to affirm the verdict for Defendants. The Court noted that a physician has a duty to disclose “material information” that a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to submit to a particular medical treatment. The Court held that “material risks” were characterized by the severity of the risk involved, and the likelihood with which that risk could occur. The Court held that expert testimony was necessary to establish these material risks because the trier of fact must understand the severity and likelihood of a risk in order to assess whether a reasonable person would have consented to the procedure. The Court rejected, however, Defendants’ argument that a pharmacist could never render expert testimony in an informed consent action. Rather, a pharmacist may serve as an expert in an informed consent action so long as he or she has the requisite expertise to testify about the material risks of the procedure. In addition, the Court emphasized that, while a cause of action for informed consent sounds in negligence, it is distinct from a medical negligence claim. Whether a procedure is contraindicated may be relevant in a negligence action to establish that a physician’s conduct was not within the standard of care, but such evidence is not relevant in a cause of action for informed consent.

    Applying its rules of law to the facts of this case, the Court held that the trial court appropriately excluded both Dr. Trovato’s testimony and the FDA Amifostine label inserts. The fact that Dr. Trovato was a pharmacist, rather than a physician, did not, certiorari, render him unqualified to render expert testimony. Rather, it was the Plaintiffs’ written proffer, indicating that Dr. Trovato’s testimony was limited mainly to those uses for which Amifostine had not been approved, that made Dr. Trovato’s irrelevant to the Plaintiffs’ informed consent action. The packaging insert was likewise irrelevant. Therefore, the Court remanded the case to the circuit court with instructions to affirm the judgment of the Circuit Court for Prince George’s County.