Shannon v. Fusco

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, 1 to a patient, Anthony Fusco. 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. 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 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 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. 4 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 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: 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 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 Amifostine, either in discovery or at trial.[ 6 ] Shannon v. Fusco, 432 Md. 466 , 69 A.3d 474 (2013). ³² 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 7 and oncology, 8 to administer Amifostine, a drag 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 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, Mafalda 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 dis ³³ close 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 11 the Fuscos 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 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), 13 to take a video or de bene esse 14 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 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. Shan ³⁵ non 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, 16 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. 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 esse 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. 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 drag 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 Ste ³⁸ vens-Johnson 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 Amifostine 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 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 administered to Anthony Fusco. (emphasis in original) (citations omitted). After receiving the proffer, Judge Green notified the parties that he would not permit Dr. Trovato to testify at trial. Dr. Shannon then filed a second motion for summary judgment, arguing that, pursuant to Sard , expert testimony was required to establish the nature of the risks inherent in a particular treatment, the probabilities of therapeutic success, the frequency of the occurrence of the particular risks, and available alternatives, which were no longer available.

At the hearing, the Fuscos opposed the motion, contending that their claims could survive summary judgment because “there’s really one person ..., one doctor, who talks about the five factors more than anybody else and that’s Dr. Shannon,” and thus, they could read to the jury portions of Dr. Shannon’s deposition in which he discussed, among other things, the risks of Amifostine and their likelihood of occurrence. Judge Green agreed that Dr. Shannon’s deposition testimony did create a genuine dispute of material fact as to the materiality of the risks of Amifostine, stating “at this stage of the proceeding I do have some, there is in my view a dispute as to a material fact, i.e. is whether or not that’s a material risk or not.” At the hearing, Judge Green also explained his reasons for precluding Dr. Trovato from testifying at trial. Initially, he referred to the Fuscos’ allegation regarding the lack of informed consent regarding the “complete treatment plan” of radiation and Amifostine, about which Dr. Trovato, as a pharmacist, was not qualified to offer an opinion. Additionally, Judge Green noted that Dr. Trovato’s testimony was not consistent with our opinion in Sard .

He also noted that the ⁴⁰ proffered testimony of Dr. Trovato sounded in negligence and would, therefore, confuse the jury: And first and foremost, we must remember that this is a trial that does not have a negligence count. It has a simple count of a lack of informed consent. This is important in the Courts consideration. And the Court looks very carefully and has already given one opinion on this matter already.

And I adopt what I said earlier and will add to it today as for my reasons. I don’t want to belabor the point but when I ended my opinion before, I looked at the question of what the status of Dr. Trovato was as to what he was. And he quite frankly, he’s a pharmacist. He’s not a medical doctor.

And as such, when you look and you review of what, under Maryland Rule 5-701 and 5-702, what an expert is. In this matter it is not just the sole issue of the medicines that were used. But it is a sole and complete treatment plan that is before the Court. It is not just that sole issue that we have before us.

And remember is that the pharmacist is dealing only with a small part of the treatment plan, the medications. And that is where his expertise is. It’s not in the complete treatment plan. So he only deals with medication.

There is an entirety to the informed consent and that is not just the medications, but the entire treatment. And as such, a pharmacist does not, in the Courts opinion, have the ability to give the full demarcation of what is involved in informed consent. Quite frankly, he’s never given an informed consent. He’s not trained in informed consent.

And he, quite frankly, he is very limited in what he does with patients. And the final call is not his. It is always the doctor. That’s the way the medical system is set up.

In these matters we have to look at what exactly it is that has to be testified to. And it said in the Sard case at page 447 [ 379 A.2d 1014 ] “We are not to be holding as understood ⁴¹ as holding however, that expert medical testimony can be dispensed with entirely in cases of informed consent. Such expert testimony would be required, one to establish the nature of the risk inherent in a particular treatment.” And that’s key to me is treatment because it has to do with material risks that are involved. Two, “The probabilities of the therapeutic success.” Again, the pharmacist is really only dealing with a small part of that.

Further I go back to the same things that I would say that I said before. And not in particular order is that testimony is more in line, after I read it, in negligence rather than informed consent. And therefore, would be prejudicial rather than probative to the trier of fact. It would not — I think in other ways it would confuse and disenchant the jury in their ability to determine what the doctrine of informed consent really is if they listen to this sole expert on pharmacology.

The testimony that Dr. Tróvate both in the proffer and in the de bene esse deposition touches upon the five criteria that I listed in Sard but doesn’t completely analyze, completely give a completeness to what has to be done to this patient. That’s another reason why I’m disallowing him. And again I go back to the relevance of where that particular experts expertise is relevant but not material to the material risks that involved in this matter. So for these reasons and the reasons that I gave when we were before the Court on December 21, 2010, Court will disallow the testimony of James Tróvate, a doctor of pharmacology, at trial for those reasons.

Just prior to opening statements, Dr. Shannon moved in limine to exclude the introduction into evidence of a package insert included with Amifostine, as well as any reference to the fact that the Food and Drug Administration had not approved Amifostine for treatment of prostate cancer patients, relying on our decision in University of Maryland Medical System Corp. v. Waldt, 411 Md. 207 , 983 A.2d 112 (2009), to ⁴² claim that, “to the extent that counsel intends to articulate what the approved FDA uses were for [AJmifostine, we would argue and ask that they be excluded in opening statements as irrelevant.” Judge Green granted the motion in limine, but the two issues were resurrected when the Fuscos offered portions of Dr. Shannon’s deposition in which he had responded to questions regarding the use of Amifostine for treatment of prostate cancer and its efficacy in an elderly population. 17 Dr. Shannon objected again and argued that Waldt precluded such evidence, with which Judge Green agreed. The jury returned a verdict in favor of Dr. Shannon, by answering that a reasonable person, having been informed of the material risks of Amifostine, would not have refused treatment. 18 The ⁴³ Fuscos filed a timely notice of appeal to the Court of Special Appeals, challenging the exclusion of Dr. Trovato’s testimony, as well as evidence related to FDA approved uses of Amifostine and the package insert. In a reported opinion, the Court of Special Appeals reversed, concluding that the trial judge erred in excluding not only Dr. Trovato’s testimony, but also references to the FDA-approved uses of Amifostine and the package insert. With respect to the issue of whether Dr. Trovato should have been permitted to testify, the intermediate appellate court opined that, “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 Amifostine,” Fusco, 210 Md.App. at 427 , 63 A.3d at 161-62 , and reasoned that Dr. Trovato was, because he had prior experience teaching and counseling patients regarding oncology medications, including Amifostine: 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. ⁴⁴ Id. at 428 , 68 A.3d at 162 (alterations in original). The intermediate appellate court, however, stated that, on remand, Dr. Trovato could not testify as to material risks and alternative treatment plans, because it would exceed the extent of his expertise: 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. Id. at 437-38, 63 A.3d at 168 . The trial judge also erred, according to the Court of Special Appeals, in excluding evidence relating to the FDA’s approved uses of Amifostine as well as the package insert that contained information regarding the use of Amifostine in elderly patients, explaining that, “this information could have been a material consideration regarding Mr. Fusco’s decision whether to consent to the use of Amifostine.” Id. at 436 , 63 A.3d at 167 .

Before us, Dr. Shannon contends that because Dr. Trovato is not a medical doctor and has never obtained a patient’s informed consent, he is unable to offer an opinion as to whether Dr. Shannon breached his duty to warn Mr. Fusco about the material risks of Amifostine; even assuming Dr. ⁴⁵ Trovato was qualified to offer an opinion, he alternatively argues that Dr. Trovato’s testimony focused on an inappropriate use of the drug, which, they contend, may be relevant in a negligence action, but not in an informed consent case. Dr. Shannon argues, moreover, that Judge Green properly excluded evidence pertaining to the package insert and FDA-approval status of Amifostine, because such evidence is not relevant in an informed consent cause of action. The Fuscos disagree, contending that although Dr. Trovato is not qualified to offer an opinion as to whether Dr. Shannon breached his duty to inform Mr. Fusco of the material risks inherent in Amifostine therapy, he is qualified, as a pharmacist, to testify about the nature and frequency of the risks of Amifostine, probabilities of its success, and the available alternatives to the use of the drug, all of which, they argue, are relevant in an informed consent action. They assert, also, that Judge Green erred in excluding evidence pertaining to the package insert and the FDA-approval status of Amifostine, reasoning that such information is a necessary component of an informed consent discussion, because it is information that a reasonable person in Mr. Fusco’s position would want to know.

We considered the doctrine of informed consent in the seminal case of Sard, 281 Md. 432 , 379 A.2d 1014 , in which a patient alleged that her surgeon failed to disclose to her the potential failure rate and alternative treatment options to a surgical sterilization procedure called a tubal ligation. The trial court had granted a motion for judgment at the end of the plaintiffs case, because it had concluded that a written consent form signed by the patient barred her recovery. In considering the propriety of the trial judge’s decision, we elucidated the various elements of an informed consent cause of action, which, generally, include the duty to disclose to the patient 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 or procedure”; breach of that duty by failing to make an adequate disclosure; and that the ⁴⁶ breach was the proximate cause of the patient’s injuries. Sard, 281 Md. at 444 , 379 A.2d at 1022 .

In Sard we opined that informed consent is predicated on the notion that a patient has a right to exercise control over her own body. Because a patient, however, generally does not possess the expertise necessary to understand the consequences of submitting to a particular medical treatment, she, necessarily, relies on the physician for such information. Accordingly, the doctrine of informed consent imposes on a physician 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 or procedure,” id. at 444 , 379 A.2d at 1022 , including “the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment.” Id. at 440 , 379 A.2d at 1020 . We then adduced the scope of a physician’s duty, rejecting a standard embraced by some of our sister courts by which a physician must disclose information that is customarily disclosed by other physicians. 19 We, rather, adopted a more patient-oriented standard by which a physician must disclose “material risks”, those risks “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 at 1022 .

We further explained that, under the material risk standard, a physician is not “burdened with the duty of divulging all risks” of which he knew or should have known, but rather, only those that are necessary to the rendering of an intelligent decision by a reasonable patient. Id. at 444 , 379 A.2d at 1022 (emphasis in original). In Wilkinson v. Vesey, 110 R.I. 606 , 295 A.2d 676 (1972), a case upon which we relied in Sard to define material risks, the ⁴⁷ Rhode Island Supreme Court identified two factors of significance in the discernment of what is a material risk, those being “the severity of the risk and the likelihood of its occurrence.” Id. at 689. In Sard , we also consulted Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 NW.

L.Rev. 628, 640-41 (1970), which described the material risk factors, stating: [T]he basic factors to be considered are the nature of the overall risk, its severity and its likelihood of occurrence. Each factor must be weighed in combination with the others to determine whether a particular risk is material and therefore subject to disclosure.... Id. at 640-41. Many of our sister courts with the same patient-centric view of informed consent have embraced the same factors.

See, e.g., Flatt v. Kantak, 687 N.W.2d 208, 213 (N.D.2004) (“The materiality of information about the risk of a potential injury is a function of the severity of the potential injury and of the likelihood it will occur.”); Feeley v. Baer, 424 Mass. 875 , 679 N.E.2d 180 , 181 (1997) (“The materiality of information about a potential injury is a function not only of the severity of the injury, but also of the likelihood that it will occur.”, quoting Precourt v. Frederick, 395 Mass. 689 , 481 N.E.2d 1144 (1985)). Since Sard , we have opined that, while a cause of action for informed consent sounds in negligence, it is distinct from a medical negligence claim: In a count alleging medical malpractice, a patient asserts that a healthcare provider breached a duty to exercise ordinary medical care and skill based upon the standard of care in the profession, ... while in a breach of informed consent count, 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 or procedure. McQuitty v. Spangler, 410 Md. 1, 18-19 , 976 A.2d 1020, 1030 (2009). Because the two causes of action are distinct, we have ⁴⁸ also opined, in dicta, that evidence that a medical procedure or treatment is contraindicated for a patient is not relevant in an informed consent action.

In Waldt , the patient underwent a procedure to treat an aneurysm in her brain in which a device called a neuroform stent was used, which caused Mrs. Waldt to suffer a stroke. Mrs. Waldt and her husband filed an action against the surgeon based upon a lack of informed consent. In support of their claim, the Waldts offered a neuroradiologist as an expert witness, but the trial judge excluded him from testifying, because the neuroradiologist lacked sufficient evidence. On appeal, the Court of Special Appeals concluded that the propriety of the trial judge’s decision to exclude the neuroradiologist from testifying was not preserved for appellate review pursuant to Rule 5-103, 20 because the only proffered testimony was that the stent had not been approved by the Food and Drug Administration for the treatment of the type of aneurysm from which Mrs. Waldt had suffered.

Waldt v. Univ. of Maryland Med. Sys. Corp., 181 Md.App. 217, 261 , 956 A.2d 223, 248 (2008). We granted certiorari to consider, among other issues, whether the issue had properly been preserved for appeal.

We then quoted with approval the Court of Special Appeals’s opinion, in which our brethren had stated whether a procedure is contraindicated may be relevant in a negligence action to establish that a physician’s conduct fell below the standard of care, but not relevant to a cause of action in informed consent: The Waldts’ proffer was that Dr. Debrun would testify about the approved uses of the neuroform stent. The intermediate appellate court explained, The excerpts from the record the Waldts argue constituted a proffer reveal that the only proffered (albeit ⁴⁹ vaguely) substantive testimony of Dr. Debrun was that the neuroform stent device was not approved for use on Mrs. Waldt’s type of aneurysm. This is not a proffer of a risk inherent to the procedure that Mrs. Waldt underwent. It is a proffer of expert testimony that the procedure was contraindicated for Mrs. Waldt, and therefore should not have been performed on her.

That expert testimony would be relevant to an ordinary negligence claim, ie., that the doctors breached the standard of care in their treatment of Mrs. Waldt by performing a contraindicated procedure on her. It is not relevant to an informed consent claim. Waldt, 411 Md. at 235-36 , 983 A.2d at 130 , quoting Waldt, 181 Md.App. at 261-62 , 956 A.2d at 248, 249 . Affirming on procedural grounds, we agreed with the intermediate appellate court that the issue had not been properly preserved for appellate review because “no testimony was proffered concerning the material risks of the procedure that would make out a prima facie case for informed consent.” Id. 21 The issue queued up by the instant case is whether Dr. Trovato, a pharmacist, was qualified to testify in this informed ⁵⁰ consent action against Dr. Shannon.

We begin by addressing the necessity of expert testimony in an informed consent action, specifically with respect to material risks, because we have not squarely addressed this issue in the past. In Sard we opined in dicta that, “[s]uch expert testimony would be required to establish the 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 , 379 A.2d at 1024 . Likewise, in Waldt, we opined, again in dicta, that, “[ejxpert testimony is necessary to establish the material risks and other pertinent information regarding the treatment or procedure”, and observed that the Waldts had relied on the neurologist to establish the material risks of the neuroform stent procedure. Waldt, 411 Md. at 232 , 983 A.2d at 127 .

Although our pronouncements in Sard and Waldt were dictum, it is clear, nevertheless, that expert testimony is necessary to assist the trier of fact in understanding the severity and the likelihood of a risk so that the trier of fact may assess the material risks of the proposed treatment. Pursuant to Rule 5-702, 22 “[ejxpert 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.” Likewise, in Blackwell v. Wyeth, 408 Md. 575 , 971 A.2d 235 (2009), we opined, when “ ‘complex medical issue[s]’ ... are in question, we have required a specificity of knowledge, skill, ⁵¹ experience, training, or education for qualification.” Id. at 623 , 971 A.2d at 264 , quoting In re Yve S., 373 Md. 551, 615-16 , 819 A.2d 1030, 1068 (2003). The likelihood that certain risks will occur when medicine is administered and the severity of such risks are complex medical matters that will generally fall outside the scope of lay knowledge, and thus, expert testimony is necessary to “assist the trier of fact ... to determine a fact in issue”, — the material risks of proposed medical treatment. 23 Rule 5-702. Addressing whether a pharmacist, Dr. Trovato, is “qualified as an expert by knowledge, skill, experience, training, or education” under Rule 5-702 to opine regarding material risks of Amifostine, is, of course, our main inquiry.

Dr. Shannon asserts that because Dr. Trovato is not a physician and has never obtained a patient’s informed consent, he cannot opine as to what information needed to be disclosed before administering Amifostine. The Fuscos react negatively to this per se argument, alleging that Dr. Trovato was uniquely qualified to opine about the material risks of Amifostine. As a basis for excluding Dr. Trovato from testifying at trial, the trial judge opined that Dr. Trovato’s expertise did not extend to the “complete treatment plan” involved in the treatment of Mr. Fusco’s cancer: I looked at the question of what the status of Dr. Trovato was as to what he was. And he quite frankly, he’s a ⁵² pharmacist.

He’s not a medical doctor. And as such, when you look and you review of what, under Maryland Rule 5-701 and 5-702, what an expert is. In this matter it is not just the sole issue of the medicines that were used. But it is a sole and complete treatment plan that is before the Court.

It is not just that sole issue that we have before us. And remember is that the pharmacist is dealing only with a small part of the treatment plan, the medications. And that is where his expertise is. It’s not in the complete treatment plan.

So he only deals with medication. Apparently, in this determination, the trial court considered that Dr. Trovato would necessarily have to be qualified with respect to radiation therapy rather than just with the material risks of the administration of Amifostine, which was the foundation of the informed consent action against Dr. Shannon who was not responsible for the radiation therapy. The Court of Special Appeals, on the other hand, opined that Dr. Trovato could qualify as an expert regarding the material risks of the administration of Amifostine and that he did offer such testimony. Fusco, 210 Md.App. at 428, 430 , 63 A.3d at 162 .

We agree that Dr. Trovato may have been qualified to testify about the material risks of the administration of Amifostine, but disagree that he rendered such an opinion in his de bene esse deposition or in the proffer of his trial testimony. In concluding that Dr. Trovato may have been qualified, we note that he stated in his proffer and in his de bene esse deposition that he had substantial experience and knowledge pertaining to oncological medications. He testified in his de bene esse deposition that he taught and lectured to pharmacy students at the University of Maryland and also served as an “oncology clinical specialist” at the University of Maryland Greenebaum Cancer Center, in which he provided “direct patient care activities and other clinical services”, including “rounding with the medical oncology team to help provide ⁵³ appropriate and safe use of medications, oncology related medications”. He further explained: I also work with physicians, oncologists at the cancer center in terms of supportive care issues for oncology patients.

So, oncology patients that develop complications related to oncology related treatments, chemotherapy, as well as complications related to the cancer itself. I do help to manage these complications, things, for example, like pain management ... things like nausea/vomiting, I also provide a lot of education, patient education, educating patients on oncology related medications, educating patients on adverse effects of chemotherapy, I provide education to medical residents, pharmacy residents, physicians and nursing staff at the cancer center in terms of new oncology drugs. I also play a role in terms of the development of guidelines and policies and procedures related to oncology medication at the cancer center. I also do play a role in formulating addition of oncology related drugs at cancer center.

So, in terms of reviewing literature and developing drug monographs and helping to develop guidelines for safe, appropriate use of oncology related medications[ 24 ] Based on his qualifications, he was offered as an expert in “drug therapy, generally and specifically in drug therapy as it applies to oncology.”