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Mafalda Fusco, et al. v. Kevin J. Shannon

March 20, 2013


The opinion of the court was delivered by: Hotten, J.


Meredith, Hotten, Leasure, Gary G., (Specially Assigned), JJ.

Opinion by Hotten, J.

Following the death of Anthony Fusco, Sr. ("Mr. Fusco"), appellants, Mafalda Fusco and the surviving children, filed a complaint in the Circuit Court for Prince George's County against appellees, Kevin Shannon, M.D. ("Dr. Shannon") and his practice, Hematology- Oncology Consultants, P.A. ("H.O. Consultants"). Appellants alleged that Dr. Shannon failed to obtain Mr. Fusco's informed consent regarding the risks associated with the administered drug, Amifostine. Appellants further contended that the direct and proximate result of appellees' failure caused Mr. Fusco to sustain injuries and ultimately his death. During discovery, appellants identified James Trovato, Pharm.D. ("Dr. Trovato"), a pharmacist, but not a medical doctor, as an expert witness to support their lack of informed consent claim.*fn1

In addition to their motion for summary judgment, appellees filed a motion in limine to exclude Dr. Trovato's de bene esse deposition, alleging that appellants failed to present an expert witness who could testify that appellees breached their duty of obtaining Mr. Fusco's informed consent. In opposition, appellants argued that appellees failed to demonstrate that Dr. Trovato was not qualified to testify as an expert witness. Following a hearing on December 21, 2010, the trial court denied the motion for summary judgment, but granted the motion in limine. Pursuant to the court's order, appellants filed a proffer of Dr. Trovato's anticipated trial testimony.

During the hearing on January 7, 2011, the court disallowed Dr. Trovato's testimony in its entirety. Appellees renewed their motion for summary judgment, but it was denied. Following the trial on January 10 through January 19, 2011, the jury returned a verdict for appellees. Appellants noted an appeal on February 15, 2011, and presented two questions for our review:

1. Did the trial court improperly grant the appellees' motion to exclude the testimony of James Trovato, Pharm.D. on the basis that he was not able to testify as to the five elements of an informed consent case as outlined in Sard v. Hardy?

2. Did the trial court's consistent misapplication and misinterpretation of the holding in University of Maryland Medical System Corporation v. Waldt lead to the repeated erroneous denial of appellants' admission of evidence relating to the approved uses of Amifostine?

For the reasons that follow, we reverse the judgment of the circuit court.


On June 26, 2001, Mr. Fusco, eighty-two years of age at the time, was diagnosed with prostate cancer. On December 27, 2002, Walid Mufarrij, M.D. ("Dr. Mufarrij"), a urologist, examined Mr. Fusco and determined that the cancer was "low-risk," so Mr. Fusco selected "watchful waiting" as his treatment plan. On February 21, 2003, Dr. Mufarrij and Mr. Fusco discussed additional options, to which Mr. Fusco elected a combination of radiotherapy and hormone treatment. Dr. Mufarrij conducted the hormone regimen, but referred Mr. Fusco to Lawrence Shombert, M.D. ("Dr. Shombert") for radiotherapy.

On March 6, 2003, Mr. Fusco consulted Dr. Shombert, who explained the nature of radiation, including the need for a commonly used radiation protectant, which would possibly eliminate inflammation of the urinary bladder and rectum. Dr. Shombert referred Mr. Fusco to Dr. Shannon, and on March 12, 2003, they discussed a radiation protectant regimen. While testifying at trial, Dr. Shannon insisted that he discussed the following with Mr. Fusco:

Very generally, with respect just to the [A]mifostine, we discussed the potential benefits which, again, is to, is a cytoprotective agent to reduce the risk of radiation induced injury to the organs of the, the bladder and the rectum. The potential side effects, the significant side effects, which, very briefly, can affect, [A]mifostine can affect blood pressure. It can affect the GI system in the way of causing nausea, and it can cause a local or slightly more extensive skin reaction and the alternatives, which, unfortunately, are none. We still don't have any alternatives to [A]mifostine, and, and I explain[ed] a little bit about how our office works. How the, the dose would be given which is to say subcutaneously, an injection in the arm, rather than an intravenous formation, and other general things to come well hydrated, that it would have to be given on a daily basis prior to radiation. So, the mechanics of administration I spoke of, and with respect to [A]mifostine, that, in general, was, was it.

Between April 15, 2003 and May 15, 2003, Mr. Fusco underwent approximately twenty-three injections of 500 milligrams of Amifostine. On May 16, 2003, Mr. Fusco was administered an Amifostine shot, and Dr. Shannon recorded that Mr. Fusco denied "headaches, visual disturbances, sores in the mouth, difficulty swallowing . . . . No nausea,

vomiting, diarrhea and no dysuria. He has no known drug allergies . . . . No evidence of rash or inflammation."

The next day, on May 17, 2003, Mr. Fusco was hospitalized at Doctors Community Hospital in Lanham, Maryland for symptoms of acute onset of systemic rash and lip swelling. Dr. Shannon was notified, and theorized that Mr. Fusco had a reaction to the Amifostine.

The reaction resulted in Stevens-Johnson Syndrome.*fn2

On May 20, 2003, Mr. Fusco was transferred to Johns Hopkins Burn Center in Baltimore, Maryland for further treatment. He was informed that his condition advanced to Toxic Epidermal Necrolysis Syndrome.*fn3 On August 5, 2003, Mr. Fusco was admitted into Magnolia Center Nursing Home in Lanham, Maryland for physical and occupational therapy and wound care. On October 6, 2003, he was re-admitted to Doctors Community Hospital due to an onset of acute pneumonia and fever. He was described as being at "a high risk for aspiration."*fn4 As a result, the hospital performed a tube insertion procedure. Unfortunately, the hospital's treatments proved to be unsuccessful, and Mr. Fusco died on December 4, 2003, from a stroke. No autopsy was performed, but the medical examiner listed arteriosclerotic cardiovascular disease with a contributing factor of Toxic Epidermal Necrolysis Syndrome as the cause of death.

On April 23, 2007, appellants filed wrongful death and survival actions against Dr. Mufarrij, Dr. Shombert, Dr. Shannon, and H.O. Consultants. On December 21, 2010, the court granted motions for summary judgment relating to Drs. Mufarrij and Shombert, finding that "the duty to obtain informed consent only arose to the physician who provided the treatment." Hence, the claims against Drs. Mufarrij and Shombert were dismissed, and they are not parties to this appeal.

The event giving rise to this appeal occurred when appellees filed a joint motion in limine to preclude Dr. Trovato's de bene esse deposition. In pertinent part, Dr. Trovato opined that Amifostine was inappropriately used or should not have been used for Mr. Fusco, since he was undergoing radiation therapy for prostate cancer. Appellees argued that Dr. Trovato's testimony should have been excluded because (1) he was not a physician, and thereby not qualified to render opinions concerning a physician's advisement to obtain informed consent and (2) his testimony offered criticisms sounding in standard of care.

On December 16, 2010,*fn5 appellants filed a response to appellees' joint motion in limine, asserting that (1) case law did not require that Dr. Trovato be a medical doctor, and

(2) his testimony regarding the use of Amifostine established the drug's risks, benefits, and alternatives. On December 21, 2010, the court granted appellees' motion in limine, finding that (1) Dr. Trovato did not testify regarding the standard of care for an expert in an informed consent case; (2) his testimony was more aligned with negligence than informed consent;

(3) his testimony did not incorporate the Sard v. Hardy factors; and

(4) he was a pharmacist, not a physician. After the ruling, the court offered appellants the opportunity to file a proffer of Dr. Trovato's anticipated trial testimony, which was submitted on December 27, 2010. On January 7, 2011, during the second motion's hearing, despite Dr. Trovato's extensive qualifications, the court ruled that he would not be permitted to testify because (1) he was a pharmacist and "[did] not have the ability to give the full demarcation of what [was] involved in informed consent[,]" and (2) his testimony would "confuse and disenchant the jury in their ability to determine what the doctrine of informed consent" denoted because the proffer did not give a completeness to the overall treatment plan. Appellees then renewed their motion for summary judgment, which was denied. On January 10 through January 19, 2011, following a jury trial, a verdict was returned in favor of appellees.*fn6 Appellants filed this timely appeal, to which appellees filed a cross-appeal that we need not resolve.


Under Md. Rule 5-702, supra, "the admissibility of expert testimony is within the sound discretion of the trial judge and will not be disturbed on appeal unless clearly erroneous." In re Adoption/Guardianship of Tatianna B., 417 Md. 259, 263 (2010) (citing Blackwell v. Wyeth, 408 Md. 575, 618 (2009)) (quoting Wilson v. State, 370 Md. 191, 200 (2002)). We therefore review a ruling to admit expert witnesses under the abuse of discretion standard. Morton v. State, 200 Md. App. 529, 545 (2011) (citing Oken v. State, 327 Md. 628, 659 (1992)).

Because admittance or exclusion of expert testimony is a matter substantially within the trial court's discretion, the court's ruling will seldom constitute a reason for reversal. Gutierrez v. State, 423 Md. 476, 486 (2011) (citing Raithel v. State, 280 Md. 291, 301 (1977)). Moreover, the court's exclusion of evidence will not be reversed in the absence of a clear abuse of discretion. Thomas v. State, 397 Md. 557, 579 (2007) (citing Kelly v. State, 392 Md. 511, 530 (2006); Merzbacher v. State, 346 Md. 391, 404-05 (1997)). "'An appellate court will only reverse upon finding that the trial judge's determination was both manifestly wrong and substantially injurious[,]'" Wantz v. Afzal, 197 Md. App. 675, 682, cert. denied 420 Md. 463 (2011) (citing Brown v. Contemporary OB/GYN Assocs., 143 Md. App. 199, 252 (2002)) (additional citation omitted), or "may be reversed if founded on an error of law or some serious mistake, or if the trial court has clearly abused its discretion." Gutierrez, 423 Md. at 486 (citing Raithel, 280 Md. at 301).


"The doctrine of informed consent . . . imposes on a physician, before he or [she] subjects his [or her] patient to medical treatment, the duty to explain the procedure to the patient and to warn of any material risks or dangers inherent in or collateral to the therapy, so as to enable the patient to make an intelligent and informed choice about whether or not to undergo such treatment." Schwartz v. Johnson, 206 Md. App. 458, 484 (2012) (quoting Sard v. Hardy, 281 Md. 432, 440 (1977)) [hereinafter "Sard"]. The duty to explain the procedure encompasses the following Sard factors:

[T]he nature of the risks inherent in a particular treatment, the probabilities of therapeutic success, the frequency of the occurrence of particular risks, the nature of available alternatives to treatment and whether or not disclosure would be detrimental to a patient.

Sard, 281 Md. at 448 (citing Getchell v. Mansfield, 489 P.2d 953, 956 (Or. 1971); Small v. Gifford Memorial Hosp., 349 A.2d 703, 705 (Vt. 1975)). "A material risk is one which 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 or procedure." Id. at 444 (citing Miller v. Kennedy, 522 P.2d 852, 863 (Wash. Ct. App. 1974)) ("[W]hen a reasonable person in the patient's position probably would attach significance to the specific risk in deciding on treatment, the risk is material and must be disclosed."). See also Getchell, 489 P.2d at 956; Wilkinson v. Vesey, 295 A.2d 676, 689 (1972) (additional citation omitted).

Similar to a presumption of due care, there is a presumption of proper consent, which arises from "'the natural instinct of human beings to guard against danger . . . .'" See Eagle-

Pincher Indus. v. Balbos, 326 Md. 179, 228 (1992) (quoting Tucker v. State, 89 Md. 471, 480 (1899)). For a complainant to establish a prima facie case of failure to obtain informed consent, the complainant must illustrate (1) an existence of a material risk, which the physician must explain to the patient; (2) the failure of the physician to inform the patient of the material risk; (3) the physician knew or ought to have known of the material risk; and (4) a causal connection between the lack of informed consent and the harm. See generally Schwartz, 206 Md. App. at 484; Sard, 281 Md. at 444 (citing Miller, 522 P.2d at 863); Goldberg, et al. v. Boone, 396 Md. 94, 123 (2006) (citing Sard, 281 Md. at 448).

Complainants usually offer expert testimony to establish their prima facie case. An expert witness is required to ascertain the material risks and other significant factors concerning the medical therapy. Univ. of Maryland Med. Sys. Corp. v. Waldt, 411 Md. 207, 232 (2009) [hereinafter "Waldt II"]. Md. Rule 5-702 governs the admissibility of expert witness testimony. It provides:

Expert testimony may be admitted, in the form of an opinion or otherwise, if the court determines that the testimony will assist the trier of fact to understand the evidence or to determine a fact in issue. In making that determination, the court shall determine (1) whether the witness is qualified as an expert by knowledge, skill, experience, training, or education, (2) the appropriateness of the expert testimony on the particular subject, and (3) whether a sufficient factual basis exists to support the expert testimony.

Concerning the first factor, a trial court ought to contemplate whether the subject matter is within the expert's knowledge to which he or she could aid the trier of fact in ascertaining the evidence. Wantz, 197 Md. App. at 683 (citing Radman v. Harold, 279 Md. 167, 169 (1997); Casualty Ins. Co. v. Messenger, 181 Md. 295, 298 (1943)) (quotations omitted). "The trial court is free to consider any aspect of a witness's background in determining whether the witness is sufficiently familiar with the subject to render an expert opinion, including the witness's formal education, professional training, personal observations, and actual experience." Massie v. State, 349 Md. 834, 851 (1998) (citations omitted).

As previously stated, appellees assert that the trial court properly exercised its discretion to preclude Dr. Trovato's testimony because he (1) was not a physician or clinician; (2) was not licensed to practice medicine; (3) did not prescribe or write prescriptions; and (4) had never obtained a patient's consent to treatment or had experience obtaining informed consent from patients. Appellants contend that Maryland's case law did not require Dr. Trovato to be a medical doctor who routinely provided the basis for informed consent. However, the more pressing issue was whether Dr. Trovato, as a pharmacist, was qualified to testify regarding Amifostine.

I. Whether The Trial Court Abused Its Discretion In Ruling That Dr. Trovato Was Not Qualified To Testify Concerning The Material Risks of Amifostine In An Informed Consent Action.

In an action alleging medical malpractice, a patient avers that a healthcare provider breached his or her duty of medical care and skill based on the medical community's standard of care. McQuitty v. Spangler, 410 Md. 1, 18 (2009) (citing Dehn v. Edgecombe, 384 Md. 606, 618 (2005)) ("Medical malpractice is predicated upon the failure to exercise requisite medical skill and, being tortious in nature, general rules of negligence usually apply in determining liability."). According to the Health Care Malpractice Act, "when a defendant health care provider is board certified in a specialty, an expert witness attesting that the defendant deviated from (or complied with) the standard of care must be board certified in the same or a related specialty[ ] with certain exceptions." Demuth, et al. v. Strong, 205 Md. App. 521, 524 (2012) (internal quotations omitted).

However, regarding informed consent actions, this "qualification" restriction does not apply because a breach of informed consent action occurs when "a patient complains that a healthcare provider breached a duty to obtain effective consent to a treatment or procedure by failing to divulge information that would be material to his/her decision about whether to submit to, or to continue with, that treatment of procedure." McQuitty, 410 Md. at 18-19 (citing Sard, 281 Md. at 444). The complainant ". . . is not required to establish either the scope or the breach of the physician's duty [of the standard of care] to disclose all material risks." Mahler v. Johns Hopkins Hosp., Inc., 170 Md. App. 293, 319 (2006) (citing Sard, 281 Md. at 447).

For instance, in Hinebaugh v. Garrett County Mem. Hosp. et al., 207 Md. App. 1, 16 (2012), our Court determined whether a dentist was board certified in a medical specialty. There, the plaintiff sustained injuries to his left cheek and jaw while incarcerated. Id. at 6. He was evaluated by three defendants-medical doctors, a family medicine physician and two radiologists. Id. The plaintiff filed a medical negligence claim against the defendants, alleging a breach of care when they failed to perform a maxillofacial CT scan. Id. at 7. To establish his ...

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