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.

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:

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 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

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

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

After the case was joined, a scheduling order was issued requiring the parties to identify any expert witness expected to be called at trial. In response11 the Fuscos designated a pharmacist, Dr. James Trovato, in addition to a physician,12 as an expert. Dr. Trovato was offered, in his deposition, as "an expert in drug therapy, generally and specifically in drug therapy as it applies to oncology."

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

The Fuscos elected, pursuant to Rule 2-419(a)(4),13 to take a video or de bene esse14 deposition of Dr. Trovato, in lieu of having him appear at trial. During this deposition, Dr. Trovato offered his opinion that, "amifostine was inappropriately used or should not have been used for the reason of a patient getting radiation therapy for prostate cancer." To support his opinion, Dr. Trovato testified that the Food and Drug Administration had not approved Amifostine to supplement radiation treatment in prostate cancer patients, but rather, only for two uses not applicable to Mr. Fusco's condition.15 Likewise, Dr. Trovato explained that an insert contained in the Amifostine packaging provided by the manufacturer advised against its use in elderly patients, because its effects on an older population were not yet known. Additionally, he also testified that common side effects included nausea, vomiting, hypertension, dizziness, respiratory affects, and "various skin reactions," including Steven-Johnson's Syndrome. He did not testify about radiation therapy.

After the video deposition, Dr. Shannon filed a motion in limine to exclude Dr. Trovato's testimony, arguing, again, that Dr. Trovato was not qualified to render an opinion, because "he had no experience as a medical doctor, and has never diagnosed a patient; admitted a patient to a hospital;... prescribed medication to a patient" and because he had never obtained a patient's informed consent. In addition, Dr. Shannon 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.

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.

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:

(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 proffered testimony of Dr. Trovato sounded in negligence and would, therefore, confuse the jury:

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 claim that, "to the extent that counsel intends to articulate what the approved FDA uses were for [A]mifostine, 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 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:

Id. at 428, 63 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:

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. 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 plaintiff's 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 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 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:

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:

McQuitty v. Spangler, 410 Md. 1, 18-19, 976 A.2d 1020, 1030 (2009). Because the two causes of action are distinct, we have 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:

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 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, "[e]xpert 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 "[e]xpert 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, 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:

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 appropriate and safe use of medications, oncology related medications". He further explained:

Based on his qualifications, he was offered as an expert in "drug therapy, generally and specifically in drug therapy as it applies to oncology." Thereby he may have been qualified to testify about the likelihood and severity of risks caused by the administration of Amifostine.

In so concluding, we find succor in the decision of Parker v. Harper, 803 So.2d 76, 78 (La.Ct.App.2001), in which the Louisiana intermediate appellate court reversed a trial court's grant of summary judgment in favor of a physician in an action alleging lack of informed consent for administration of the drug Dilantin for seizures. The plaintiff had contracted Stevens-Johnson Syndrome and alleged that the treating physician had failed to warn her of the material risks of Dilantin, including Stevens-Johnson Syndrome. Id. at 79. In opposition to the physician's motion for summary judgment, the plaintiff attached an affidavit of a pharmacist, who attested that Stevens-Johnson Syndrome, a potentially fatal disease, and other skin rashes were risks of Dilantin which occurred in two-to-five percent of its users. Id. at 84. The pharmacist's affidavit, the appellate court reasoned, was sufficient to provide the requisite expert testimony to establish the material risks of the drug. In addressing the pharmacist's qualifications under Article 702 of the Louisiana Code of Evidence,25 which stated that a witness may be qualified by "knowledge, skill, experience, training, or education," the court opined that he was qualified to offer an opinion about the risks, their nature, and the likelihood with which they occur:

Id.26

Accordingly, we reject Dr. Shannon's argument that a pharmacist is per se unqualified to testify in an informed consent action when a physician has been sued. Dr. Trovato was never offered as an expert to testify about the types of information Dr. Shannon had a duty to disclose to effectively obtain Mr. Fusco's informed consent, and thus, his lack of experience in obtaining informed consent is not a bar to his testimony in the instant case.27 The relevant inquiry, rather, is whether Dr. Trovato had the requisite expertise to testify about the material risks of the administration of Amifostine; he did.

Despite agreeing with our intermediate appellate court that Dr. Trovato may have been qualified to testify about the material risks of the administration of Amifostine, we part ways with our brethren regarding whether Dr. Trovato's testimony addressed the material risks of the administration of Amifostine. The intermediate appellate court emphasized that the proffer of Dr. Trovato's testimony expressed his opinion regarding the material risks of the administration of Amifostine:

Id. at 434-35, 63 A.3d at 166 (alterations in original).

We disagree that Dr. Trovato, in his de benne esse deposition or the proffer of his trial testimony, addressed the severity and the likelihood of the risks of the administration of Amifostine; rather, he opined in both only about the existence of risk:

In his written proffer, Dr. Trovato simply enumerated the myriad of risks associated with the drug:

Because Dr. Trovato did not opine about the likelihood and severity of the risks implicated in the administration of Amifostine,28 we cannot say that Judge Green abused his discretion in excluding Dr. Trovato's testimony.29

We address, next, Judge Green's decision to exclude evidence pertaining to the package insert accompanying the Amifostine and evidence regarding the use of Amifostine in an off-label manner. Evidence pertaining to the package insert was offered three times, the first of which occurred with Dr. Trovato's de bene esse testimony in which he testified:

At trial, moreover, the Fuscos offered a copy of the package insert itself. In a dialogue with the judge, Dr. Shannon argued that the package insert was irrelevant, pursuant to our decision in Waldt, because it listed the approved uses of Amifostine, which, Dr. Shannon asserted were not relevant pursuant to Waldt. Judge Green agreed that Waldt precluded admission of the package insert, and the insert was never admitted into evidence.

Finally, the Fuscos sought to introduce Dr. Shannon's deposition testimony, in which he stated that he had not advised Mr. Fusco about warnings on the package insert pertaining to use in an elderly population:

Again, relying on Waldt, Judge Green excluded such testimony.

Dr. Shannon contends that evidence pertaining to the package insert was properly excluded, because Dr. Trovato testified about the warnings only in support of his ultimate conclusion that Amifostine was inappropriately used, and thus, the testimony sounded in negligence, and was, therefore, irrelevant. The Fuscos disagree, arguing that the warnings in the package insert "could have been a material consideration regarding Mr. Fusco's decision whether to consent to the use of Amifostine." Dr. Shannon counters, arguing that there was no expert testimony or evidence adduced that the insert's warning was a "material risk" of the administration of Amifostine, and therefore, there was no evidentiary basis from which a jury could conclude that the insert's warnings required disclosure.

Our intermediate appellate court agreed with the Fuscos, citing our decision in Nolan v. Dillon, 261 Md. 516, 276 A.2d 36 (1971) and decisions from other courts in which package inserts have been admitted in negligence cases, to conclude that this information could have been material to Mr. Fusco's decision to consent to the use of Amifostine. See Fusco, 210 Md.App. at 431-32, 63 A.3d at 167.

We disagree with the Court of Special Appeals and agree with Judge Green that, based on Waldt, evidence regarding the package insert, which pertained solely to the fact that it warned against use in an elderly population, was properly excluded. In Waldt, in dicta, we cited with approval language from the intermediate appellate court that had opined that, whether a procedure or treatment is contraindicated is relevant and admissible evidence in a negligence cause of action, but not in informed consent case. Although it was dicta, our pronouncement finds support in our jurisprudence. In McQuitty, we elucidated the distinction between negligence and informed consent; in a negligence cause of action, the relevant inquiry is whether the physician "breached a duty to exercise ordinary medical care and skill based upon the standard of care in the profession," whereas, in an informed consent cause of action, the focal point is whether the physician made an adequate disclosure of information regarding the procedure or treatment. McQuitty, 410 Md. at 18-19, 976 A.2d at 1030. With regard to the administration of pharmaceutical drugs, one commentator has observed, "[a] typical medical malpractice claim in the prescription drug realm would deal with the administration of the wrong medicine, the incorrect dosage, or some other similar error. Negligence under informed consent, by contrast, is based on the theory that the patient was not apprised of all material risks, and was therefore unable to properly consent to the administration of drugs". John G. Culhane et al., Toward a Mature Doctrine of Informed Consent: Lessons From A Comparative Law Analysis, 1 Brit. J. Am. Legal Stud. 551, 567 (2012). The package insert's warning, which suggested that Amifostine should not be administered to an elderly patient, may have supported a claim of negligence in the administration of the drug to Mr. Fusco.31

We address, finally, Judge Green's decision to exclude evidence regarding the FDA-approved uses of Amifostine. The issue was first presented in Dr. Trovato's de bene esse deposition, in which he testified:

The issue of FDA-approval then was resurrected when the Fuscos sought to introduce the deposition testimony of Dr. Shannon at trial, in which he had testified that he was aware that Amifostine was not approved by the FDA for the treatment of prostate cancer patients:

As with the package insert, Judge Green relied on Waldt to determine that such evidence was not admissible.

The parties advance similar arguments pertaining to the admissibility of Amifostine's FDA-approval status as they did to the package insert. Dr. Shannon asserts that the FDA-approval status was only offered in support of Dr. Trovato's opinion that Amifostine was inappropriately used, and thus, sounded in negligence and argues, moreover, that pursuant to our decision in Waldt, FDA-approval status is irrelevant in an informed consent cause of action. As with the warnings in the package insert, the Fuscos contend that the regulatory status of a drug may be material information that a reasonable patient would want to know prior to consenting to treatment. The Court of Special Appeals agreed that FDA-approval or lack thereof could have been a material consideration to Mr. Fusco's decision to consent to treatment involving the administration of Amifostine. Fusco, 210 Md.App. at 436, 63 A.3d at 167.

As we have explained, our decision in Waldt was based on the procedural inadequacy of the proffer of expert testimony, and thus, language quoted from our intermediate appellate court, which opined that the FDA-approval status is not relevant in an informed consent cause of action, is dicta. In Waldt, we quoted the following language from our intermediate appellate court:

Waldt, 181 Md.App. at 236, 956 A.2d at 248. Although dicta, as we opined earlier, we find the language persuasive and consistent with our informed consent jurisprudence.

In the context of medical devices, many of our sister courts have opined that the FDA-regulatory status is not relevant to an informed consent cause of action. See, e.g., Blazoski v. Cook, 346 N.J.Super. 256, 787 A.2d 910, 913 (2002); Alvarez v. Smith, 714 So.2d 652, 653 (Fla.Dist.Ct. App.1998). Indeed, in the instant case, although our intermediate appellate court determined that the FDA-approval status is a pertinent part of an informed consent discussion, it cited to only one case that considered the relevance of the FDA's regulatory status in an informed consent cause of action that came to the opposite conclusion, Southard v. Temple University Hospital, 566 Pa. 335, 781 A.2d 101, 102 (2001), in which the Supreme Court of Pennsylvania considered "the issue of whether the doctrine of informed consent requires surgeons to advise their patients of the Food and Drug Administration's ... regulatory status of a medical device." In concluding that no such obligation exists, the Pennsylvania court reasoned:

Id. at 107 (citation omitted). Although addressing the regulatory status of a surgical device, the Supreme Court of Pennsylvania's reasoning is equally applicable to the regulatory status of a drug; it also is not a "material fact, risk," or "complication" of a drug.

The Fuscos argue, however, that simply because the FDA-status is not a "risk," such as nausea and vomiting, it is nonetheless relevant, because in Maryland, physicians are required to disclose "other pertinent information regarding the treatment or procedure". Likewise, the intermediate appellate court opined:

Fusco, 210 Md.App. at 436, 63 A.3d at 167 (footnote omitted) (alterations in original).

A review of the "other pertinent information" that we have determined may require disclosure as part of an informed consent discussion, however, reveals that this information is limited to that which, in some way, will impact the medical treatment. See, e.g., Faya v. Almaraz, 329 Md. 435, 448-50, 620 A.2d 327, 334 (1993) (opining that a surgeon may need to disclose his HIV-status as part of an informed consent discussion, because, inter alia, it was foreseeable that the physician might transmit the HIV virus to the patient during surgery); Dingle v. Belin, 358 Md. 354, 370-71, 749 A.2d 157, 165-66 (2000) (opining that the identity of the physician who will be performing a surgery may require disclosure as part of an informed consent discussion); Goldberg v. Boone, 396 Md. 94, 125-27, 912 A.2d 698, 717 (2006) (opining that the availability of more experienced surgeons to perform a surgery than the treating physician, at least when the surgery is complex and the treating physician had only performed it once in the previous three years, may be material information that needs to be disclosed).

Information pertaining to an "off-label" use provides the patient with no information about the treatment itself. As the Pennsylvania court recognized in Southard, "`[t]he mere fact that the FDA has not cleared a product for a particular use does not mean that the product is not in fact suitable for that purpose; it simply means that the FDA has not cleared it.'" Southard, 781 A.2d at 107, quoting Holland v. Smith & Nephew Richards, Inc., 100 F.Supp.2d 53 (D.Mass.1999). Because it provides no information regarding the medical treatment, it cannot, therefore, be considered material information to an informed consent discussion.33 We note, finally, with respect to this issue, that the FDA-approval status does not provide any information regarding the materiality of the risks of the administration of Amifostine; it does not inform the fact-finder of the likelihood or severity of any risk.

Having concluded that Judge Green did not abuse his discretion in excluding Dr. Trovato's testimony nor in excluding evidence related to the package insert or the FDA-approval status of Amifostine, we reverse the judgment of the Court of Special Appeals and affirm the judgment of the Circuit Court.

JUDGMENT OF THE COURT OF SPECIAL APPEALS REVERSED; CASE REMANDED TO THAT COURT WITH INSTRUCTIONS TO AFFIRM THE JUDGMENT OF THE CIRCUIT COURT FOR PRINCE GEORGE'S COUNTY. COSTS TO BE PAID BY RESPONDENT.

ELDRIDGE, J., dissents.

ELDRIDGE, J., dissenting.

I dissent. See Univ. of Md. Medical System Corp. v. Waldt, 411 Md. 207, 238-242 (Adkins, J., dissenting), 250 (Raker, J., joined by Eldridge, J., dissenting), 983 A.2d 112, 130-133, 138 (2009).