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.
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
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:
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
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.
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,
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.
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, 9 A.3d 502 (2010) (citing Blackwell v. Wyeth, 408 Md. 575, 618, 971 A.2d 235 (2009)) (quoting Wilson v. State, 370 Md. 191, 200, 803 A.2d 1034 (2002)). We therefore review a ruling to admit expert witnesses under the abuse of discretion standard. Morton v. State, 200 Md.App. 529, 545, 28 A.3d 98 (2011) (citing Oken v. State, 327 Md. 628, 659, 612 A.2d 258 (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, 32 A.3d 2 (2011) (citing Raithel v. State, 280 Md. 291, 301, 372 A.2d 1069 (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, 919 A.2d 49 (2007) (citing Kelly v. State, 392 Md. 511, 530, 898 A.2d 419 (2006); Merzbacher v. State, 346 Md. 391, 404-05, 697 A.2d 432 (1997)). "`An appellate court
"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, 49 A.3d 359 (2012) (quoting Sard v. Hardy, 281 Md. 432, 440, 379 A.2d 1014 (1977)) [hereinafter "Sard"]. The duty to explain the procedure encompasses the following Sard factors:
Sard, 281 Md. at 448, 379 A.2d 1014 (citing Getchell v. Mansfield, 260 Or. 174, 489 P.2d 953, 956 (1971); Small v. Gifford Memorial Hosp., 133 Vt. 552, 349 A.2d 703, 705 (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, 379 A.2d 1014 (citing Miller v. Kennedy, 11 Wn.App. 272, 522 P.2d 852, 863 (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, 110 R.I. 606, 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-Picher Indus. v. Balbos, 326 Md. 179, 228, 604 A.2d 445 (1992) (quoting Tucker v. State, 89 Md. 471, 480, 43 A. 778 (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, 49 A.3d 359; Sard, 281 Md. at 444, 379 A.2d 1014 (citing Miller, 522 P.2d at 863); Goldberg, et al. v. Boone, 396 Md. 94, 123, 912 A.2d 698 (2006) (citing Sard, 281 Md. at 448, 379 A.2d 1014).
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, 983 A.2d 112 (2009) [hereinafter "Waldt II"]. Md.
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, 14 A.3d 1244 (citing Radman v. Harold, 279 Md. 167, 169, 367 A.2d 472 (1997); Casualty Ins. Co. v. Messenger, 181 Md. 295, 298, 29 A.2d 653 (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, 709 A.2d 1316 (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.
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, 976 A.2d 1020 (2009) (citing Dehn v. Edgecombe, 384 Md. 606, 618, 865 A.2d 603 (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, 45 A.3d 898 (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.
For instance, in Hinebaugh v. Garrett County Mem. Hosp. et al., 207 Md.App. 1, 16, 51 A.3d 673 (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, 51 A.3d 673. 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, 51 A.3d 673. To establish his prima facie case, the plaintiff identified a dentist, who specialized in oral and maxillofacial surgery (OMS), as his expert witness. Id. at 7-8, 51 A.3d 673.
The plaintiff was required to file a certificate of a qualified expert, in addition to his qualifications, which attested to the defendants' breach of the standard of care.
Id. at 16, 51 A.3d 673.
We affirmed the trial court's ruling, and analyzed as follows: (1) The dentist diagnosed and treated facial fractures, and taught OMS trainees, but this did not demonstrate that there was an overlap between OMS and family medicine/radiology; (2) In the dentist's certificate and his affidavit, he failed to establish his knowledge of the prevailing standard of care for family medical doctors in diagnosing patients, and for radiologists in examining x-rays; and (3) OMS dentists only specialized in limited areas concerning facial fractures. Id. at 26-29, 51 A.3d 673. We concluded that the dentist was not qualified as an expert because "the areas of knowledge and experience of board certified family medicine and radiology doctors [did] not overlap the areas of knowledge and experience of board certified OMS dentists." Id. at 26, 51 A.3d 673.
As previously indicated, Hinebaugh is distinguishable because an informed consent action does not require that the complainant establish a breach of the physician's duty regarding the standard of care akin to a medical malpractice case. See Mahler, 170 Md.App. at 319, 907 A.2d 276 (citing Sard, 281 Md. at 447, 379 A.2d 1014).
In Parker v. Harper, 803 So.2d 76, 79 (La.Ct.App.2001), the Louisiana Court of Appeal, Third Circuit, ruled that the affidavit of a pharmacist could define the existence, nature, and the probability of a risks' occurrence. The plaintiffs filed a medical malpractice claim against the defendant-physician, alleging that he failed to inform them of the potential side effects and warning signs of the prescribed drug, Dilantin. Id. The injured plaintiff experienced daily seizures, so the physician increased the prescription to Dilantin 100 milligrams three times a day. Id. The plaintiff developed a rash on her face and was hospitalized. Id. The plaintiff's diagnosis was a possible drug reaction, resulting in Stevens-Johnson Syndrome or a varicella virus infection. Id. at 79. She lost complete vision in one eye, partial vision in the other, and sustained permanent scarring on her body. Id.
The defendant filed a motion for summary judgment, which was granted. Id. at 80. In opposition, the plaintiffs offered a pharmacist's affidavit, who averred that Stevens-Johnson Syndrome was a possible side effect and known risk of taking Dilantin. Id. On appeal, the court ruled:
Id. at 84.
In Sinkfield v. Oh et al., 229 Ga.App. 883, 495 S.E.2d 94, 95 (1997), the plaintiff experienced two previous miscarriages, and during her third pregnancy, she suffered from severe bleeding and excessive back pain. She was hospitalized, and the treating physician prescribed her Motrin 800. Subsequently, the plaintiff suffered her third miscarriage, and filed a complaint predicated on medical malpractice. See id. The defendants-physicians filed motions for summary judgment, arguing that the plaintiff failed to establish a causal connection between their conduct and the miscarriage. Id. In opposition, the plaintiff offered testimony of a pharmacologist, who was also a toxicologist. He opined that:
Id.
The trial court excluded the pharmacologist's testimony, stating that he was unqualified because he was not a medical doctor. Id. On appeal, the Court of Appeals of Georgia reversed, and reasoned that the pharmacologist was not testifying to medical malpractice, but causation. Id. at 95-96. "If [he], as a toxicologist and pharmacologist, had been offered as an expert witness against the two medical doctors for purposes of [medical malpractice], [he] would not have been a competent witness" because it was traditionally held that an expert had to be qualified in the same or similar medical specialty. Id. at 96. However, because he was not opining to the standard of care, and because a pharmacologist was the individual who "`ma[de] a study of the actions of drugs[,]'" the expert was qualified to testify regarding the scientific effect of the prescribed medicine. Id.
In Tidwell v. Upjohn, Co., 626 So.2d 1297, 1299 (Ala.1993), the decedent suffered from a sleeping disorder to which a physician prescribed him .25 milligram dosages of Halcion, and recommended him to a psychiatrist. The psychiatrist increased the dosage to .5 milligrams, and diagnosed him with severe depression. Id. The next day, the decedent expressed that he was "losing [his] mind," and subsequently committed suicide. Id. The decedent's estate filed an action against the defendant-drug manufacturer, alleging that it failed to warn of the drug's effects. To establish its prima facie case, the estate submitted deposition testimony of a pharmacist. Id. The manufacturer moved for summary judgment, averring that the expert was not qualified because he was not a medical doctor. Id. The trial court granted the motion for summary judgment. Id.
On appeal, the Supreme Court of Alabama concluded that the trial court abused its discretion in excluding the expert testimony because the pharmacist's education, expertise, and training in pharmacology
In Goodman et al. v. Lipman et al., 197 Ga.App. 631, 399 S.E.2d 255, 256 (1990), the plaintiffs filed a medical malpractice complaint against the defendant-physician, asserting that he failed to exercise due care in treating the injured plaintiff's heart disease by prescribing Coumadin and Nembutal. To establish their case, the plaintiffs offered the testimony of a pharmacologist. Id. at 257. The defendant filed a motion to exclude the expert because he was not a medical doctor. Id. The trial court agreed, and granted the motion. Id. On appeal, the Court of Appeals for Georgia concluded that "`[t]he opinions of experts on any question of science, skill, trade, or like questions shall always be admissible ...[,]'" and that the evidence illustrated that the pharmacologist's testimony relating to the properties of the prescribed drugs was likely relevant to a finder of fact. Id. at 258.
In Garvey v. O'Donoghue, 530 A.2d 1141, 1142 (D.C.1987), the plaintiffs filed a
On appeal, the court stated:
Id. at 1147.
The District of Columbia ("D.C.") Court of Appeals concluded that the trial court erred in disallowing the pharmacologist to testify regarding the effects and proper dosage of the drug. Id. See also Thompson v. Carter, 518 So.2d 609, 615 (Miss. 1987) ("The instant record reflect[ed] that [the pharmacologist], who taught medical students and advised and counseled physicians as to drug use and administration, through his skill, knowledge, training, and education, knew the standard of care to which physicians adhered when prescribing Bactrim," thereby, he was qualified as an expert witness.).
We also examine federal cases that have ruled on a similar issue. In United States v. Smith, 573 F.3d 639, 653 (8th Cir.2009), the United States ("U.S.") Court of Appeals for the Eighth Circuit determined whether a pharmacist constituted an expert regarding a physician's standard of care. The defendant was convicted of several crimes
Id. at 653-54. As a result, the Eighth Circuit concluded that the pharmacist was an expert with the necessary expertise to testify regarding the defendant's standard of care. Id. at 653.
In United States v. Bek, 493 F.3d 790, 795 (7th Cir.2007), the defendant was "convicted of twenty-six counts of conspiring to distribute and distributing controlled substances, and committing health care fraud" for prescribing medications without examining his patient's medical records, performing MRIs, conducting x-rays, and failing to diagnose them. Id. at 796. During trial, the Government offered expert testimony from a pharmacist who opined that "[the defendant's] practices were dangerous and very unusual["] and that the defendant "should have conducted several diagnostic tests and reviewed patients' medical histories before prescribing drugs such as Vicodin." Id. at 796.
On appeal, the defendant did not contend whether the pharmacist was an expert, but instead averred that the Government's witness established a prima facie case for civil negligence, not criminal conduct. Id. at 798. The U.S. Court of Appeals for the Seventh Circuit concluded that the evidence was sufficient to fulfill the criminal standard. Id. at 799. See also United States v. Jones, 570 F.2d 765, 769 (8th Cir.1978) (holding that "[a]lthough not a[] [medical doctor], [the pharmacist's] twenty years of teaching at the Washington University Medical School qualifie[d] him as an expert entitled to express an opinion as to medical procedures in prescribing drugs ...").
Although we relate our ruling to the abovementioned cases, we observe that other jurisdictions and courts have ruled otherwise. In Hollabaugh v. Arkansas State Med. Bd., 43 Ark.App. 83, 861 S.W.2d 317, 318 (1993), the State Medical Board ("Board") found the defendant-physician grossly negligent for prescribing patients disproportionate amounts of harmful medications. A pharmacist, on behalf of the Board, testified about the kinds, quantities, and regularity of the medications that the physicians prescribed to the patients. Id. at 321. However, the pharmacist lacked experience in testifying whether the physician's treatment was a breach of ordinary care. Id. Because the expert could not ascertain whether the physician breached the medical community's standard of care, the Arkansas Court of Appeals reversed the trial court's ruling, and concluded that the expert was not qualified to testify. Id.
In Chandler v. Koenig, 203 Ga.App. 684, 417 S.E.2d 715 (1992), the plaintiff alleged that two physicians breached the ordinary standard of care, resulting in medical malpractice. The plaintiff provided the court with an affidavit from a professor, who possessed a Ph.D in pharmacology and toxicology, to establish the defendants-physicians' negligence.
In Bell v. Hart, 516 So.2d 562, 564 (Ala. 1987), the plaintiffs filed a medical malpractice action against the defendant-physician for prescribing the injured plaintiff a drug, which caused her to sustain injuries. The plaintiffs identified a psychologist and a pharmacist as their expert witnesses.
Id. at 570.
In Rodriguez v. Jackson, 118 Ariz. 13, 574 P.2d 481, 482 (Ct.App.1977), the injured plaintiff brought a medical malpractice action against the defendants-physicians who prescribed an excessive amount of Streptomycin to address the plaintiff's tuberculosis diagnosis, resulting in permanent neural damage. Among other experts, the plaintiffs designated a pharmacologist to testify concerning the physician's breach of the standard of care.
Rodriguez, 574 P.2d at 485 (quoting Shea v. Phillips, 213 Ga. 269, 98 S.E.2d 552, 555 (1957)) (internal quotations omitted). Although the pharmacologist was qualified to
We surmise that the jurisdictions and cases that hold differently from our ruling conclude otherwise because they held that a pharmacist did not qualify to testify regarding a doctor's negligence, which differs from the case at bar. Our case is akin to Parker, Sinkfield, Tidwell, Goodman, and Garvey, which hold that the pharmacist was qualified to testify about the drug's properties, possible side effects, and known material risks, which are factors in informed consent actions.
Appellees support their contentions with Waldt II, 411 Md. 207, 983 A.2d 112 (2009). There, the defendant-physician utilized a device, the "neuroform stent," to treat an aneurysm in the injured plaintiff's brain. Id. at 214, 983 A.2d 112. During the procedure, an artery was perforated, causing the injured plaintiff, Rebecca Waldt ("Ms. Waldt"), to sustain a stroke. Id. The plaintiffs filed a complaint, alleging that the defendants failed to properly obtain the injured plaintiff's informed consent before performing the procedure. Id. at 213, 983 A.2d 112. During trial, the plaintiffs called an expert witness, Gerard Debrun, M.D. ("Dr. Debrun"), to testify regarding the issue of informed consent. Id. The trial court excluded Dr. Debrun's testimony, finding that he lacked sufficient experience with the neuroform stent to be qualified as an expert. Id. The defendants moved for summary judgment, arguing that without expert testimony on the informed consent issue, there was no question for the jury. Id. The court agreed, and granted the defendants' motion. Id.
Our Court and the Court of Appeals affirmed the trial court's decision. Id. at 237, 983 A.2d 112. Dr. Debrun testified that he traditionally utilized a balloon procedure, and that he never used the neuroform stent because it was not approved for use until after he retired from active practice. Id. at 232, 983 A.2d 112. The Court held that the trial court evaluated Dr. Debrun's testimony and his qualifications, and correctly based its ruling on his inexperience with the neuroform stent. Id. at 232, 983 A.2d 112.
Appellants attempt to establish their assertions through Wantz v. Afzal, 197 Md.App. 675, 685, 14 A.3d 1244 cert. denied 420 Md. 463, 23 A.3d 895 (2011), contending that Waldt II was inapposite, since it has long been established that a proposed medical expert "need not be a specialist in order to be competent to testify on medical matters." In Wantz, 197 Md.App. at 677, 14 A.3d 1244 the plaintiff filed wrongful death and survival actions against the defendants-physicians for her mother's death, which was caused by a staph infection that developed during the spinal fusion surgery. The plaintiff designated a board-certified neurosurgeon as her expert witness,
The trial court granted the defendants' motion to strike, finding that the expert was not qualified to render such an opinion.
We perceive that the case at bar is akin to Wantz v. Afzal, not Waldt II because similar to the expert witness in Wantz, Dr. Trovato possessed sufficient experience to opine about the material risks of Amifostine. In Waldt II, Dr. Debrun had no experience with the neuroform stent, but this is not a common factor regarding Dr. Trovato's knowledge of Amifostine therapy. As previously stated, the Health Care Malpractice Act requires that "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., 205 Md.App. at 524, 45 A.3d 898 (internal quotations omitted). However, concerning a qualified expert witness in an informed consent case, the "qualification" restrictions that apply to a medical malpractice action do not pertain in an informed consent case because "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, 976 A.2d 1020 (citing Sard, 281 Md. at 444, 379 A.2d 1014).
During trial, the court made the following statement:
As previously stated, the issue is not whether Dr. Trovato was qualified to opine about Dr. Shannon's advisement to obtain informed consent, but whether he, as a pharmacist, was qualified to testify regarding
"... [B]eing neither a [medical doctor] nor experienced in the day-to-day treatment of [informed consent] is not sufficient to block testimony by a pharmac[ist] about the drug itself. The border between what is peculiarly the province of medical doctors and that of pharmac[ists] or other professionals whose fields of expertise are closely related to the medical profession, has not, and we think cannot, be drawn with precision." Garvey, 530 A.2d at 1147 (footnote omitted).
As the trial court recognized, Dr. Trovato was well qualified in oncology pharmacy practice, as he received a Bachelor of Science in Pharmacy from Massachusetts College of Pharmacy, a Doctor of Pharmacy degree from Purdue University, and completed an oncology pharmacy residency training program at the University of Texas. He was an associate professor with the Department of Pharmacy Practice & Science at the University of Maryland School of Pharmacy and was the director the University's residency program. "[Dr. Trovato] provide[d] teaching and lectures to ... pharmacy students in the areas of oncology therapeutics. [He] [was] also an oncology clinical specialist," and was involved in countless aspects of oncology medication at the University's cancer center.
Dr. Trovato testified that he had "counselled [sic] some patients on Amifostine. It was like a handful of cases...." In appellants' proffer, they indicated that Dr. Trovato would have testified that "as part of his teaching and clinical responsibilities, [he] educate[d] and advise[d] patients on the appropriate and safe use of oncology medications, including the use of Amifostine." Although Dr. Trovato was not a medical doctor, he proffered that he was familiar with Amifostine therapy. Thus, we hold that the trial court abused its discretion in ruling that Dr. Trovato did not qualify as an expert witness on the issue.
Although we constitute Dr. Trovato as a qualified expert regarding Amifostine,
Our Court stated:
Waldt I, 181 Md.App. at 261, 956 A.2d 223. Furthermore, we ruled that the proffer was insufficient because it did not attest to the following Sard factors:
Id. The Court of Appeals agreed with our conclusion that the plaintiff's proffer was insufficient, as the expert would have testified to the approved uses of the neuroform stent. Waldt II, 411 Md. at 235, 983 A.2d 112.
Similar to the expert in Waldt, Dr. Trovato's de bene esse testimony centered on the inappropriate use of Amifostine. Dr. Trovato believed that his purpose in testifying was to explain the appropriate use of Amifostine and, that in his opinion, the use of Amifostine was not appropriate for Mr. Fusco. The following colloquy ensued over appellees' objections at the de bene esse deposition:
Although portions of Dr. Trovato's testimony sounded in negligence, the other aspects of his testimony focused on the material risks associated with a regimen of Amifostine therapy in connection with radiation therapy, particularly for this patient, including that the use of this drug under these circumstances was not previously approved by the FDA.
In Nolan v. Dillon et al., 261 Md. 516, 519, 276 A.2d 36 (1971), the defendant-physician administered two injections of Sparine to the plaintiff while she was delivering her baby. The plaintiff was allergic to the dosage, and subsequently, her left hand suffered from gangrene. Id. As a result, her fingers required amputation. Id. The plaintiff filed a negligence action against the defendant-drug manufacturing company, as well as the physician. Id. During trial, the physician offered testimony from his expert that "the warnings given on the package insert provided reasonable directions as to dosage and concentration of [the drug] and represented the standard of care followed by physicians practicing in Montgomery County." Id. at 522, 276 A.2d 36. Despite this testimony, the jury returned a verdict against the physician, but in favor of the manufacturer. Id. at 520, 276 A.2d 36.
The physician appealed, and our Court affirmed. Id. The Court of Appeals determined "whether the warnings which [the manufacturer] gave regarding the use of [the drug] were adequate to warrant the granting of a directed verdict in its favor." Id. The Court concluded that the manufacturer's package insert completely released its duty to warn, and thereby the manufacturer was not negligent. Id. at 523, 276 A.2d 36. See also Ragin v. Porter Hayden Co., 133 Md.App. 116, 144, 754 A.2d 503 (2000) (stating "[i]t is apparent ... that a continuing duty to warn may emanate from either a negligence or a strict liability theory").
In Southard v. Temple Univ. Hosp., 566 Pa. 335, 781 A.2d 101, 102 (2001), the Pennsylvania Supreme Court determined whether the doctrine of informed consent required surgeons to advise their patients of the FDA regulatory status of a medical device. The court concluded that there was no such requirement. Id. at 102-03. The plaintiffs filed a complaint against the defendants, alleging that the defendants failed to obtain informed consent because they were not advised of the FDA regulatory
Id. at 107.
In Garvey, 530 A.2d at 1142, infra, the plaintiffs filed a medical malpractice action against the physicians for prescribing an antibiotic, which allegedly caused the injured plaintiff to contract tinnitus. The plaintiffs attempted to offer a package insert into evidence, but the trial court stated it constituted hearsay, and ruled that it was inadmissible evidence. Id. at 1144. On appeal, the D.C. Court of Appeals ruled that "[w]hen the package insert ... [was] offered in conjunction with expert testimony..., that combination may be sufficient to establish the standard of care." Id. at 1146 (citing Riffey v. Tonder, 36 Md.App. 633, 375 A.2d 1138, 1148 (1977)).
In Thompson v. Carter, 518 So.2d at 610, the plaintiff was diagnosed with a kidney infection to which the defendant-physician prescribed Bactrim and penicillin for the plaintiff's subsequent influenza symptoms. The plaintiff's body became swollen with blisters, and she suffered from blurred vision. Id. at 610-11. The defendant then diagnosed her with Stevens-Johnson Syndrome. The plaintiff filed a medical malpractice action against the defendant. Id. at 611. During trial, the plaintiff was not permitted to admit a package insert into evidence because the court deemed it hearsay. See id. at 611-12. On appeal, the Supreme Court of Mississippi ruled that the package was admissible pursuant to a hearsay exception, id. at 612, and that although it was not conclusive evidence, it could demonstrate that the physician deviated from the standard of care. Id. at 613.
In Rodriguez, 574 P.2d at 482, infra, the injured plaintiff sued the defendants-physicians regarding medical malpractice for prescribing an excessive amount of Streptomycin to cure the plaintiff's tuberculosis, which resulted in permanent neural damage. The plaintiffs' expert, a pharmacologist, indicated that a package insert recommended lower dosage amounts of the drug. Id. at 484. The Court of Appeals of Arizona stated that "[w]hile the package insert [was] admissible into evidence, it [did] not establish conclusive evidence of the standard or accepted practice in the use of the drug by physicians and surgeons, nor that a departure from such directions [constituted] negligence." Id. at 486 (citing Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal.App.2d 560, 317 P.2d 170, 180 (1957)).
Our Courts have traditionally held that, "[e]xpert testimony is necessary to establish the material risks and other pertinent information regarding the treatment or procedure." Id. at 232, 983 A.2d 112. As stated previously, in Waldt II, the plaintiffs offered Dr. Debrun as their expert witness to opine regarding their informed consent claim. Id. at 213, 983 A.2d 112. However, in affirming the judgment of our Court and the ruling of the trial court, the Court of Appeals recognized the limits of
Id. at 233-34, 983 A.2d 112 (citing Waldt I, 181 Md.App. at 260, 956 A.2d 223; Sard, 281 Md. at 448, 379 A.2d 1014).
In the instant case, however, appellants proffered that Dr. Trovato would testify regarding "the risk factors associated with Amifostine[,] includ[ing] nausea, vomiting, low blood pressure or hypotension, skin changes, allergic or immunologic reactions[,] including a rash, hives, toxic necrolysis, and Stevens-Johnson [S]yndrome, fever, shortness of breath, and dizziness." He would have opined concerning the properties of Amifostine as a cytoprotective agent, and how Amifostine therapy was only successful regarding patients diagnosed with head, neck, and kidney cancer, but not prostate cancer. Furthermore, Dr. Trovato would have asserted that the alternative to Amifostine was radiation therapy; and "... that the package insert of Amifostine [gave] a precaution as to the administration of the drug to an elderly patient, like [Mr. Fusco], because the toxic effects of the drug have not been tested on an elderly population."
As indicated, Waldt II's majority concluded that the plaintiffs did not submit a sufficient proffer regarding what Dr. Debrun's anticipated testimony was concerning informed consent. Unlike Dr. Debrun, in our case, there was a sufficient proffer of what Dr. Trovato would opine to as a pharmacist, including the material risks associated with Amifostine. As a result, appellants sought to further opine that Amifostine was not FDA approved for the proposed use, and that the package insert noted that it lacked testing on elderly patients, which were material risks.
During Dr. Shannon's deposition, the following colloquy ensued:
Although "patients generally do not base their decision to purchase a prescription medication on the instructions for its consumption or use or any information contained in the informational pamphlet accompanying the prescription drug."
It is well settled in Maryland that our Courts will not reverse a trial judge's ruling if the error is harmless. Barksdale v. Wilkowsky, et al., 419 Md. 649, 657, 20 A.3d 765 (2011) (citing Flores v. Bell, 398 Md. 27, 33, 919 A.2d 716 (2007)). See also Greenbriar v. Brooks, 387 Md. 683, 740, 878 A.2d 528 (2005); Crane v. Dunn, 382 Md. 83, 91, 854 A.2d 1180 (2004) (footnote omitted). The harmless error doctrine "`embod[ies] the principle that courts should exercise judgment in preference to the automatic reversal for "error" and ignore errors that do not affect the essential fairness of the trial.'" Barksdale, 419 Md. at 657-58, 20 A.3d 765 (citing Williams v. State, 394 Md. 98, 120, 904 A.2d 534 (2006) (Raker, J., dissenting) (quoting McDonough Power Equip., Inc. v. Greenwood, 464 U.S. 548, 553, 104 S.Ct. 845, 78 L.Ed.2d 663 (1984))). In a civil case, the ruling will not be reversed unless the complainant demonstrates both error and prejudice. Barksdale, 419 Md. at 660, 20 A.3d 765.
As we previously stated, the trial court erred in excluding admissible portions of Dr. Trovato's de bene esse deposition and trial testimony because he was a qualified expert witness regarding the question of the material risks of Amifostine. According to the record before us, the jury reached an unanimous verdict that by a preponderance of the evidence, a reasonable patient, having been informed of the material risks and complications associated with Amifostine therapy would have consented to its use. However, as indicated above, the jury was not presented with Dr. Trovato's testimony regarding the FDA approval and package insert, which may have been material to the jury's determination. Without this, we can neither decide whether the jury's verdict would have remained the same nor can we determine whether the jury would have
On remand, although Dr. Trovato indicated that he counseled and educated patients on the use of oncology medications, including Amifostine, informed consent encompasses more than the potential benefits and risks of Amifostine. There is an overall treatment plan, which the record indicated, including the patient's past medical, social, and family history, tobacco and alcohol intake, physical examinations, laboratory studies, anatomy demonstrations via diagrams and pictures, x-ray films, and lifestyle management, all of which are a part of a recommended course of treatment. Hence, we note that portions of Dr. Trovato's proffered testimony regarding informed consent were not admissible, as exceeding the scope of his expertise in an informed consent case. In that regard, Dr. Trovato's testimony regarding the nature of the material risks associated with the particular regimen of treatment provided to Mr. Fusco, and any alternative treatment options, would exceed the extent of Dr. Trovato's expertise relative to informed consent.
