KEVIN J. SHANNON, et al.
MAFALDA FUSCO, et al
[Copyrighted Material Omitted]
Certiorari to the Court of Special Appeals (Circuit Court for Prince George's County. Case No. CAL-07-11137) Leo E. Green, Jr., JUDGE.
ARGUED BY Michelle R. Mitchell (Robert J. Farley, Wharton, Levin, Ehrmantraut & Klein, PA. of Annapolis. MD) on brief FOR PETITIONERS.
ARGUED BY Megan E. Oleszewski (Michael J. Belsky, Henry L. Belsky, Schlachman, Belsky & Weiner, P.A. of Baltimore. MD) on brief FOR RESPONDENTS.
Brief of Amici Curiae American Medical Association, Maryland State Medical Society and Medical Mutual Liability Insurance Society of Maryland in support of Kevin J. Shannon, M.D.
Edwin J. Keating, III, Esquire; Siobhan R. Keenan, Esquire, Baxter, Baker, Sidle, Conn. & Jones, P.A. FOR PETITIONERS.
ARGUED BEFORE: Barbera, C.J., Harrell, Battaglia, Greene, Adkins, McDonald, Eldridge, John C. (Retired, Specially Assigned), JJ. Opinion by Battaglia, J. Eldridge, J., dissents.
[438 Md. 28] Battaglia, J.
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, to a patient, Anthony Fusco.
[438 Md. 29] 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. 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.
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 proceed.
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 [438 Md. 30] 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. In a reported opinion, the Court of Special Appeals reversed the judgment 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 [438 Md. 31] 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:
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 error.
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 [438 Md. 32] Amifostine, either in discovery or at trial.
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 hematology and oncology 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, and 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" ), 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 [438 Md. 33] 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 response the Fuscos designated a pharmacist, Dr. James Trovato, in addition to a physician, 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 [438 Md. 34] 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), to take a video or de bene esse  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. Likewise, Dr. Trovato explained that an insert contained in the Amifostine packaging provided by the
manufacturer advised against its use in elderly patients, because its effects on an older population were not yet known. Additionally, he also testified that common side effects included nausea, vomiting, hypertension, dizziness, respiratory affects, and " various skin reactions," including Steven-Johnson's Syndrome. He did not testify about radiation therapy.
After the video deposition, Dr. Shannon filed a motion in limine to exclude Dr. Trovato's testimony, arguing, again, that Dr. Trovato was not qualified to render an opinion, because " he had no experience as a medical doctor, and has never diagnosed a patient; admitted a patient to a hospital; . . . prescribed medication to a patient" and because he had never obtained a patient's informed consent. In addition, Dr. Shannon [438 Md. 35] alleged that Dr. Trovato's testimony addressed negligence, rather than informed consent and was, therefore, irrelevant. The Fuscos opposed the motion, contending that Dr. Trovato's status as a pharmacist did not disqualify him from offering an opinion in this matter: " Precisely because he is a pharmacist . . . Dr. Trovato, is eminently qualified and perhaps more so than the defendant doctors themselves, to discuss the risks, benefits, and alternatives of Mr. Fusco's proposed course of treatment", Amifostine.
Dr. Shannon also renewed his earlier motion for summary judgment, arguing that the Fuscos had failed to prove by expert testimony the material risks of Amifostine, reiterating many of the arguments set forth in the motion in limine, namely that Dr. Trovato was not qualified to offer an opinion in this matter. Additionally, Dr. Shannon argued that Dr. Trovato had not testified to the nature of the risks of Amifostine, the probability of success of Amifostine; the frequency of occurrence of risks of Amifostine, and the availability of alternatives to Amifostine, which Dr. Shannon asserted was required by this Court's decision in Sard v. Hardy, 281 Md. 432, 379 A.2d 1014 (1977).
The Fuscos countered, arguing that Dr. Trovato's testimony did meet Sard's criteria, and moreover, the " lack of clinical evidence regarding the use of Amifostine . . . in the treatment of prostate cancer in elderly patients . . ., the fact that Amifostine was not FDA-approved . . . and the knowledge of the then-known side effects of Amifostine amounted to a material risk such that a reasonable person in Mr. Fusco's position, having been fully informed, would have withheld consent to this form of treatment." They alleged, therefore, that a material dispute of fact existed as to whether Dr. Shannon had disclosed all material risks that rendered summary judgment inappropriate.
[438 Md. 36] Judge Leo E. Green Jr. of the Circuit Court for Prince George's County decided both motions and initially denied Dr. Shannon's renewed motion for summary judgment, but granted the motion in limine to exclude Dr. Trovato's de bene essee testimony. With respect to the latter, however, he left open the issue of whether Dr. Trovato could testify at trial. In so concluding, Judge Green reasoned that significant portions of Dr. Trovato's deposition were irrelevant and prejudicial in an informed consent case, because Dr. Trovato is not a medical doctor, did not address the standards of Sard, and his deposition addressed negligence rather than informed consent:
The Court grants the motion for the following reasons. That's not to say I
would exclude him at trial, okay. But the testimony as given gives a great indifference to relevance to the issue at hand. That is informed consent. Secondly, he doesn't testify as to the standard of an expert in an informed consent case. Third, there's no testimony in the transcript that's consistent with these standards. Four, his testimony is more in line in the totality when you take out all of the objections and everything else, testimony is more in line with negligence than that of informed consent. And as a result of this, it is more prejudicial than probative to the issue at hand. Lastly, but not - - and I use it as a last situation, is that he's a pharmacist, he's not a medical doctor. And he's not testifying with the five standards that are found in Sard . Information that must be communicated. The nature of the ailment. The nature of risk of a treatment. The probability of success. The frequency of occurrence of the risk. He never gets into that. Is it a Risk? Yes. But he doesn't give it and he doesn't testify as to what the available alternatives to the treatment are. He testifies as to the risk but he doesn't give a whole thing.
Now would he be - - he wouldn't be my choice of my main expert. And then again I'm not a Plaintiffs lawyer any more. But this is a tough call. As it in a totality counsel, right now, I'm not precluding you from calling him at trial, live and not memorex, so to speak.
[438 Md. 37] With the possibility remaining that Dr. Trovato could testify at trial, Dr. Shannon requested his proffer, arguing " if he is going to remain consistent with his deposition testimony and his de bene esse deposition and there are no new opinions, then we would again move in limine for him testifying at trial." Judge Green granted the request for a proffer, and thereafter, the Fuscos submitted a written proffer, stating Dr. Trovato would testify to, inter alia, the risk factors associated with Amifostine; that Amifostine has only been proven to benefit patients suffering from head, neck and kidney cancer; that the efficacy of Amifostine in treating prostate cancer was unknown; that the package insert cautions against use in elderly patients; that there are no other known alternatives to Amifostine, and that Amifostine was not approved by the Food and Drug Administration for the treatment of prostate cancer:
1. Dr. Trovato is an associate professor with the Department of Pharmacy Practice & Science at the University of Maryland School of Pharmacy and is the Director of the University's Residency program. Dr. Trovato is board certified in oncology pharmacy practice.
2. In addition to his teaching responsibilities, Dr. Trovato has a clinical practice which focuses on " insur(ing) appropriate or safe use of medication in oncology patients."
3. As a part of his teaching and clinical responsibilities, Dr. Trovato educates and advises patients on the appropriate and safe use of oncology medications, including the use of Amifostine. Dr. Trovato plays a pivotal role in educating patients and physicians about the risks and side effects of particular modes of treatment as well as the potential benefits of the treatment and, ultimately, in selecting said treatment. Dr. Trovato makes recommendations to the physicians and patients as to what drug therapy is best for each patient, and plays a direct role in obtaining informed consent from a patient.
4. Dr. Trovato will testify that the risk factors associated with Amifostine include nausea, vomiting, low blood pressure or hypotension, skin changes, allergic or immunologic reactions including a rash, hives, toxic necrolysis, and Stevens-Johnson [438 Md. 38]
Syndrome, fever, shortness of breath, and dizziness.
5. Dr. Trovato will testify that the most common risks of Amifostine are hypotension, nausea, vomiting and skin changes.
6. Dr. Trovato will explain the properties of Amifostine as a cytoprotective agent and how it is used to protect certain normal tissues from damage either from chemotherapy or from radiation therapy. Dr. Trovato will testify that Amifostine has been proven to provide this type of benefit to normal tissues in patients only with head and neck cancer and kidney cancer.
7. Dr. Trovato will testify that it is unknown whether or not Amifostine protects the normal cells of a patient with prostate cancer.
8. Dr. Trovato will explain that there have only been phase I and phase II clinical trials relative to the administration of Amifostine in patients with prostate cancer. Therefore, he will testify that there is no medical literature or clinical trials that demonstrate the efficacy of Amifostine for treatment in prostate cancer, only its toxicity.
9. Dr. Trovato will testify that " the risks of using Amifostine in this particular patient (Mr. Fusco) outweigh the potential benefits ..." and " there is no evidence to support the benefit of Amifostine in this patient, but we do have evidence of the toxicities or adverse effects of this agent" .
10. Dr. Trovato will testify that the package insert of Am.ifostine gives a precaution as to the administration of the drug to an elderly patient, like Plaintiff, because the toxic effects of the drug have not been tested on an elderly population.
11. Dr. Trovato will testify that the alternative to the administration of Amifostine is to refrain from its administration and treat solely with radiation therapy. He will further testify, based upon his experience in making treatment recommendations and engaging in the informed consent process with patients, that there is no detriment to [438 Md. 39] advising the patient fully about the risks associated with this medication.
12. Dr. Trovato will testify that there are no known alternative cytoprotective agents for prostate cancer.
13. Dr. Trovato will testify about the approved FDA uses at the time that Amifostine was ...