Shannon v. Fusco, 57

CourtCourt of Special Appeals of Maryland
Writing for the CourtBattaglia
PartiesKEVIN J. SHANNON, et al. v. MAFALDA FUSCO, et al.
Docket NumberNo. 57,57
Decision Date24 April 2014


No. 57


Argued: February 7, 2014
September Term, 2013
Filed: April 24, 2014

Kevin J. Shannon, et al. v. Mafalda Fusco et al., No. 57, September Term, 2013

In discerning which risks are "material," thereby requiring a physician to discloses them to effectively obtain a patient's informed consent, significant factors include the severity of the risk and the likelihood with which it will occur.

In an informed consent cause of action, expert testimony is necessary to establish the material risks of the medical treatment.

In an informed consent cause of action involving the administration of a medication, a pharmacist may be qualified to testify about the likelihood and severity of the risks of the medication.

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Circuit Court for Prince George's County
Case No. CAL-07-11137

Barbera, C.J.
Eldridge, John C. (Retired,
Specially Assigned),


Opinion by Battaglia, J.
Eldridge, J., dissents.

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We are called upon to decide whether a trial judge abused his discretion in excluding the testimony of a pharmacist in a case in which it was alleged that a physician failed to obtain informed consent for the administration of radiation therapy and a drug, Amifostine,1 to a patient, Anthony Fusco.

The Petitioners herein, Dr. Kevin Shannon and his medical practice, Hematology-Oncology Consultants, P.A. (hereinafter, "Dr. Shannon"), were sued in the Circuit Court for Prince George's County by the Estate of Anthony Fusco and Mr. Fusco's surviving children and widow, Respondents, in survival and wrongful death actions, sounding in informed consent.2 In relevant part, the Complaint alleged:

17. On or about March 12, 2003, Fusco met with Dr. Kevin Shannon to discuss Amifostine as a cytoprotective agent.3
18. Between the dates of April 15, 2003 and May 15, 2003, Fusco received both radiotherapy and approximately 16 injections of 500mg of Amifostine and was monitored by Dr. Shannon. Dr. Shannon recorded in his follow-ups on Fusco's prostate carcinoma that he is tolerating the radiation and Amifostine during the external beam portion of his treatment well, having no nausea, dizziness or other symptoms, aside from some mild orthostatic symptoms if he does not change positions slowly.
* * * *
51. Dr. Kevin Shannon owed to Deceased, Fusco a clear and adequate explanation of the nature, benefits and risks of, and alternatives to the administration of the drug, Amifostine and the administration of radiation in order to enable him to make an intelligent decision as to whether to

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52. Dr. Kevin Shannon failed to inform Fusco of the risks that accompany the administration of the drug, Amifostine and the administration of radiation and therefore did not provide an adequate explanation.
53. The adequacy of the explanation must be measured by the patient's need, and that need is whatever is material to the decision. A material risk is one 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.
54. In the situation at hand, a patient under the same or similar circumstances as Fusco would most commonly have objected to the administration of Amifostine.
55. Deceased, Fusco would not have given his consent to the proposed administration of the drug, Amifostine and the administration of radiation, had full and adequate disclosure been made at the time consent was originally given.
56. As the direct and proximate result of Dr. Kevin Shannon's failure to obtain informed consent, Deceased Fusco was caused to sustain severe and conscious pain, permanent bodily injuries, substantial emotional pain and suffering and mental anguish and ultimately death which caused him to incur medical expenses, funeral expenses and other related expenses.

During the course of discovery, the Fuscos designated Dr. James Trovato, a pharmacist, as an expert witness, but the trial judge excluded Dr. Trovato's testimony based upon his deposition and proffer. Dr. Shannon and his practice group prevailed after a jury trial, and the Fuscos appealed, alleging, inter alia, error in the exclusion of Dr. Trovato's testimony.4 In a reported opinion, the Court of Special Appeals reversed the judgment

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and remanded the case for a new trial, having determined that Dr. Trovato may have been qualified to offer an opinion because he had substantial experience studying and advising patients regarding oncology medications, including Amifostine, and therefore, should have been permitted to testify. Fusco v. Shannon, 210 Md. App. 399, 428, 63 A.3d 145, 162 (2013). Dr. Shannon and Hematology-Oncology Consultants, thereafter, filed a petition for certiorari, which we granted, to consider the following questions:5

1. Whether the trial court properly exercised its broad discretion in granting Petitioners' Motion in Limine to preclude James Trovato's testimony at trial, and whether the Court of Special Appeals decision holding otherwise was error.
2. Whether the trial court properly exercised its broad discretion in precluding the use of, or reference to, the drug insert and FDA approval, and whether the Court of Special Appeals' decision holding otherwise was

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3. Whether the trial court erred in denying Petitioners' Motion for Summary Judgment and/or whether the trial court erred in denying Petitioners' Motion for Judgment given that Respondents' did not adduce evidence that Dr. Shannon failed to advise Mr. Fusco of "material risks" to Amifostine, either in discovery or at trial.6

Shannon v. Fusco, 432 Md. 466, 69 A.3d 474 (2013).

After Anthony Fusco had been diagnosed with prostate cancer he consulted with a radiation oncologist and decided to undergo treatment, which involved a combination of hormone therapy and radiation. The radiation oncologist referred Mr. Fusco to Dr. Kevin Shannon, a physician who specialized in hematology7 and oncology,8 to administer Amifostine, a drug which, according to Dr. Shannon's trial testimony, was designed to protect the bladder and rectum from inflammation caused by radiation therapy. Mr. Fusco was later diagnosed with Stevens-Johnson Syndrome, a disease involving skin irritations and blisters, which ultimately causes the top layer of skin to die and shed,9 and

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died shortly thereafter from pneumonia.

The Estate of Anthony Fusco, Mr. Fusco's surviving children, Carmela Dent, Anthony J. Fusco Jr., and Michael A. Fusco; and Mr. Fusco's widow, Malfada Fusco (collectively, "the Fuscos"),10 filed wrongful death and survival actions against Dr. Shannon and the medical group of which Dr. Shannon was a member at the time. The thrust of the informed consent action was that Dr. Shannon failed to disclose the material risks of administering radiation therapy as well as Amifostine before obtaining Mr. Fusco's consent to the treatment plan.

After the case was joined, a scheduling order was issued requiring the parties to identify any expert witness expected to be called at trial. In response11 the Fuscos

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designated a pharmacist, Dr. James Trovato, in addition to a physician,12 as an expert. Dr. Trovato was offered, in his deposition, as "an expert in drug therapy, generally and specifically in drug therapy as it applies to oncology."

Dr. Shannon, thereafter, moved for summary judgment, alleging that he was entitled to judgment as a matter of law because the Fuscos had failed to produce expert testimony to establish that Dr. Shannon had breached his duty to obtain Mr. Fusco's informed consent. In this first motion, Dr. Shannon alleged that Dr. Trovato was not qualified to offer an opinion on the standard of care a physician must exercise in obtaining the informed consent of a patient, because he was a pharmacist and had never obtained a patient's informed consent. The Fuscos opposed the motion, arguing that Dr. Trovato was not offered to testify about the standard of care in this case; he was offered, rather, to testify about Amifostine, including its risks and alternative treatments. They contended, moreover, that expert testimony is not required to establish a breach of the standard of care in an informed consent case. The motion was denied.

The Fuscos elected, pursuant to Rule 2-419(a)(4),13 to take a video or de bene

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esse14 deposition of Dr. Trovato, in lieu of having him appear at trial. During this deposition, Dr. Trovato offered his opinion that, "amifostine was inappropriately used or should not have been used for the reason of a patient getting radiation therapy for prostate cancer." To support his opinion, Dr. Trovato testified that the Food and Drug Administration had not approved Amifostine to supplement radiation treatment in prostate cancer patients, but rather, only for two uses not applicable to Mr. Fusco's condition.15 Likewise, Dr. Trovato...

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