Court Opinion

ID: 2680997
Source: CourtListenerOpinion
Date Created: 2014-06-27 21:06:18.855524+00
Date Added: 2024-06-11T13:15:11.094606
License: Public Domain

Kevin J. Shannon, et al. v. Mafalda Fusco et al., No. 57, September Term, 2013

TORTS – NEGLIGENCE – INFORMED CONSENT – MATERIAL RISK
In discerning which risks are “material,” thereby requiring a physician to discloses them
to effectively obtain a patient’s informed consent, significant factors include the severity
of the risk and the likelihood with which it will occur.

TORTS – NEGLIGENCE – INFORMED CONSENT – NECESSITY FOR
EXPERT TESTIMONY
In an informed consent cause of action, expert testimony is necessary to establish the
material risks of the medical treatment.

TORTS – NEGLIGENCE - INFORMED CONSENT – EXPERT TESTIMONY –
QUALIFICATIONS OF A PHARMACIST TO TESTIFY ABOUT MATERIAL
RISKS
In an informed consent cause of action involving the administration of a medication, a
pharmacist may be qualified to testify about the likelihood and severity of the risks of the
medication.
Circuit Court for Prince George’s County
Case No. CAL-07-11137
Argued: February 7, 2014

                                           IN THE COURT OF APPEALS OF
                                                     MARYLAND

                                                         No. 57

                                                 September Term, 2013

                                               KEVIN J. SHANNON, et al.
                                                          v.

                                                MAFALDA FUSCO, et al.

                                                     Barbera, C.J.
                                                     Harrell
                                                     Battaglia
                                                     Greene
                                                     Adkins
                                                     McDonald
                                                     Eldridge, John C. (Retired,
                                                     Specially Assigned),

                                                                    JJ.

                                                 Opinion by Battaglia, J.
                                                  Eldridge, J., dissents.

                                               Filed: April 24, 2014
      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:

      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.

      1
        Amifostine “works by protecting against the harmful effects of chemotherapy
medications and radiation treatment.” Amifostine Injection, MedlinePlus,
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a696014.html (last visited April 23,
2014).
      2
          Two other physicians were joined in the Complaint, but claims against them did
not survive, and no appeal was taken. They are not a part of the instant action.
      3
         Cytoprotective is a “descriptive of a drug or agent protecting cells from damage
expected to occur.” Stedman’s Medical Dictionary 490 (28th ed. 2006).
      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 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

      4
          The questions presented to the Court of Special Appeals were:

              1. Did the trial court improperly grant the appellees’ motion to
              exclude the testimony of James Trovato, Pharm.D. on the basis
              that he was not able to testify as to the five elements of an
              informed consent case as outlined in Sard v. Hardy?
              2. Did the trial court’s consistent misapplication and
              misinterpretation of the holding in University of Maryland
              Medical System Corporation v. Waldt lead to the repeated
              erroneous denial of appellants’ admission of evidence relating

                                             2
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

       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

              to the approved uses of Amifostine?
       5
         We use the questions submitted in the Petitioner’s brief, because they provide
greater clarity than those submitted in the Petition for Certiorari, which were:

       1.     Whether the Court of Special Appeals erred in vacating the jury’s
       verdict in favor of Petitioners in a medical lack of informed consent case
       when Respondents’ case was void of any evidence that Dr. Shannon failed to
       disclose the “material risks, benefits, and alternatives” to the proposed
       treatment plan, and even on remand, will continue to be void of such
       evidence.
       2.     Whether summary judgment and/or judgment in Petitioners’ favor
       was mandated as a matter of law on the informed consent claim.
       2.     Whether the Court of Special Appeals erred in vacating the judgment
       in Petitioners’ favor by relying exclusively on an untimely “proffer” by
       Respondents’ counsel which was provided in violation of discovery
       deadlines, rather than the witness’ actual discovery and trial testimony.
       4.     Whether the Court of Special Appeals erred in vacating the judgment
       in Petitioners’ favor when it failed to consider the question of relevance
       and/or prejudicial effect of the Pharmacist’s limited testimony on remand.

                                             3
       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).

       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 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.

       6
         Because of our disposition of the first two questions, we need not address
Petitioner’s third question.
       7
         Hematology is “[t]he medical specialty that pertains to the anatomy, physiology,
pathology, symptomatology, and therapeutics related to the blood and blood-forming
tissues.” Stedman’s Medical Dictionary 862 (28th ed. 2006).
       8
         Oncology is “[t]he study or science dealing with the physical, chemical, and
biologic properties and features of neoplasms, including causation, pathogenesis, and
treatment.” Stedman’s Medical Dictionary, 1365 (28th ed. 2006).
       9
         Diseases and Conditions, Stevens-Johnson syndrome, The Mayo Clinic,
http://www.mayoclinic.org/diseases-conditions/stevens-johnson-syndrome/basics/definiti
on/con-20029623 (last visited April 23, 2014).

                                              4
       The Estate of Anthony Fusco, Mr. Fusco’s surviving children, Carmela Dent,

Anthony J. Fusco Jr., and Michael A. Fusco; and Mr. Fusco’s widow, Malfada Fusco

(collectively, “the Fuscos”), 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 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

       10
          The Complaint also named two of Mr. Fusco’s other children, John and Paul
Fusco, as plaintiffs. Their claims, however, were voluntarily dismissed and they are not
parties to this appeal.
       11
         In their “Plaintiffs’ Designation of Experts”, the Fuscos also indicated that they
were designating experts pursuant to Rule 2-402(f) (2007), which provided:

       (f) Trial preparation—Experts. (1) Expected to be called at trial.
              (A) Generally. A party by interrogatories may require any
              other party to identify each person, other than a party, whom
              the other party expects to call as an expert witness at trial; to
              state the subject matter on which the expert is expected to
              testify; to state the substance of the findings and the opinions to
              which the expert is expected to testify and a summary of the
              grounds for each opinion; and to produce any written report
              made by the expert concerning those findings and opinions. A
              party also may take the deposition of the expert.
       12
          The other expert designated to testify at trial was Mohamed Al-Ibrahim, M.D.,
identified as an infectious disease specialist.

                                               5
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

       13
            Rule 2-419(a)(4) provides:

                Videotape deposition of expert. A videotape deposition of a
                treating or consulting physician or of any expert witness may
                be used for any purpose even though the witness is available to
                testify if the notice of that deposition specified that it was to be
                taken for use at trial.
       14
           De bene esse is defined: “[a]s conditionally allowed for the present; in
anticipation of a future need .” Black’s Law
Dictionary 430 (8th ed. 2009).

                                                 6
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

       15
           Dr. Trovato testified that approved FDA uses included: to decrease the toxicity
in kidneys for patients being treated for ovarian cancer, and for head and neck cancer
patients to prevent dry mouth.

                                               7
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

       16
          The renewed motion for summary judgment was originally filed by the other
two physicians that are not parties to this appeal. In a subsequent filing with the court,
however, Dr. Shannon indicated that he was joining in the motion.

                                              8
both motions and initially denied Dr. Shannon’s renewed motion for summary judgment,

but granted the motion in limine to exclude Dr. Trovato’s de bene essee testimony.        With

respect to the latter, however, he left open the issue of whether Dr. Trovato could testify at

trial. In so concluding, Judge Green reasoned that significant portions of Dr. Trovato’s

deposition were irrelevant and prejudicial in an informed consent case, because Dr.

Trovato is not a medical doctor, did not address the standards of Sard, and his deposition

addressed negligence rather than informed consent:

               The Court grants the motion for the following reasons. That’s not to
       say I would exclude him at trial, okay. But the testimony as given gives a
       great indifference to relevance to the issue at hand. That is informed
       consent. Secondly, he doesn’t testify as to the standard of an expert in an
       informed consent case. Third, there’s no testimony in the transcript that’s
       consistent with these standards. Four, his testimony is more in line in the
       totality when you take out all of the objections and everything else,
       testimony is more in line with negligence than that of informed consent.
       And as a result of this, it is more prejudicial than probative to the issue at
       hand. Lastly, but not - - and I use it as a last situation, is that he’s a
       pharmacist, he’s not a medical doctor. And he’s not testifying with the five
       standards that are found in Sard. Information that must be communicated.
       The nature of the ailment. The nature of risk of a treatment. The
       probability of success. The frequency of occurrence of the risk. He never
       gets into that. Is it a Risk? Yes. But he doesn’t give it and he doesn’t
       testify as to what the available alternatives to the treatment are. He testifies
       as to the risk but he doesn’t give a whole thing.
               Now would he be - - he wouldn’t be my choice of my main expert.
       And then again I’m not a Plaintiffs lawyer any more. But this is a tough
       call. As it in a totality counsel, right now, I’m not precluding you from
       calling him at trial, live and not memorex, so to speak.

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

                                              9
limine for him testifying at trial.” Judge Green granted the request for a proffer, and

thereafter, the Fuscos submitted a written proffer, stating Dr. Trovato would testify to, inter

alia, the risk factors associated with Amifostine; that Amifostine has only been proven to

benefit patients suffering from head, neck and kidney cancer; that the efficacy of

Amifostine in treating prostate cancer was unknown; that the package insert cautions

against use in elderly patients; that there are no other known alternatives to Amifostine, and

that Amifostine was not approved by the Food and Drug Administration for the treatment

of prostate cancer:

       1. Dr. Trovato is an associate professor with the Department of Pharmacy
       Practice & Science at the University of Maryland School of Pharmacy and is
       the Director of the University’s Residency program. Dr. Trovato is board
       certified in oncology pharmacy practice.
       2. In addition to his teaching responsibilities, Dr. Trovato has a clinical
       practice which focuses on “insur(ing) appropriate or safe use of medication
       in oncology patients.”
       3. As a part of his teaching and clinical responsibilities, Dr. Trovato educates
       and advises patients on the appropriate and safe use of oncology
       medications, including the use of Amifostine. Dr. Trovato plays a pivotal
       role in educating patients and physicians about the risks and side effects of
       particular modes of treatment as well as the potential benefits of the
       treatment and, ultimately, in selecting said treatment. Dr. Trovato makes
       recommendations to the physicians and patients as to what drug therapy is
       best for each patient, and plays a direct role in obtaining informed consent
       from a patient.
       4. Dr. Trovato will testify that the risk factors associated with Amifostine
       include nausea, vomiting, low blood pressure or hypotension, skin changes,
       allergic or immunologic reactions including a rash, hives, toxic necrolysis,
       and Stevens-Johnson 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

                                              10
       Amifostine has been proven to provide this type of benefit to normal tissues
       in patients only with head and neck cancer and kidney cancer.
       7. Dr. Trovato will testify that it is unknown whether or not Amifostine
       protects the normal cells of a patient with prostate cancer.
       8. Dr. Trovato will explain that there have only been phase I and phase II
       clinical trials relative to the administration of Amifostine in patients with
       prostate cancer. Therefore, he will testify that there is no medical literature
       or clinical trials that demonstrate the efficacy of Amifostine for treatment in
       prostate cancer, only its toxicity.
       9. Dr. Trovato will testify that “the risks of using Amifostine in this
       particular patient (Mr. Fusco) outweigh the potential benefits ...” and “there
       is no evidence to support the benefit of Amifostine in this patient, but we do
       have evidence of the toxicities or adverse effects of this agent”.
       10. Dr. Trovato will testify that the package insert of Am.ifostine gives a
       precaution as to the administration of the drug to an elderly patient, like
       Plaintiff, because the toxic effects of the drug have not been tested on an
       elderly population.
       11. Dr. Trovato will testify that the alternative to the administration of
       Amifostine is to refrain from its administration and treat solely with radiation
       therapy. He will further testify, based upon his experience in making
       treatment recommendations and engaging in the informed consent process
       with patients, that there is no detriment to 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,

                                              11
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:

       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.

                                               12
        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 “We are not to be
holding as understood 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. Trovato 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 Trovato, a doctor of pharmacology, at trial for those reasons.

                                       13
       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

       17
        The specific portions of Dr. Shannon’s deposition pertaining to approved uses of
Amifostine that Dr. Shannon objected to were:

       [COUNSEL FOR THE FUSCOS]: Do you know whether or not the FDA has
       approved Amifostine in the treatment of prostate cancer?
       [DR. SHANNON]: I do know.
       [COUNSEL FOR THE FUSCOS]: What is the answer to that question?
       [DR. SHANNON]: The indications are for conditions that don’t include
       prostate cancer.
       [COUNSEL FOR THE FUSCOS]: Okay. So the FDA has not approved
       Amifostine as a drug for prostate cancer. I’m not saying it can’t be used off
       label, but it’s not a drug that the FDA has approved for that use, is that
       correct?
       [DR. SHANNON]: That’s correct.

The relevant portions of Dr. Shannon’s deposition related to the package insert were:

       [COUNSEL FOR THE FUSCOS]: Does the drug insert . . . indicate that this drug

                                            14
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

      should not be used on elderly patients because there has been inadequate clinical
      studies?
      [DR. SHANNON]: The drug insert indicates that there are several shoulds.
      Shoulds are not musts. We should run six times a day. That doesn’t mean
      we’re going to.
                                          ***
      [COUNSEL FOR THE FUSCOS]: [D]id you advise him . . . [t]hat the drug
      manufacturer recommended that it not be used because it hasn’t been fully
      tested on elderly patients yet?
                                          ***
      [DR. SHANNON]: No, I didn’t and there is additional reason why I don’t.
      We are giving in terms of a dosage spectrum as we just spoke of we’re really
      on the low end. . . .

      18
           The jury answered “no” to the following question:

               Do you find by preponderance of the evidence that a
               reasonable patient, having been informed of the material risks
               and complications associated with Amifostine therapy, would
               have refused to consent to its use.

Other questions presented to the jury on the verdict sheet, that were not answered, were:

      Do you find by a preponderance of the evidence that Kevin Shannon, MD
      failed to obtain Anthony Fusco, Sr.’s informed consent as to Amifostine
      therapy?

      Do you find by preponderance of the evidence that Amifostine was a cause
      of injury to Anthony Fusco, Sr.?

                                            15
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.

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:

       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

                                             16
       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. 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.

                                            17
        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
18
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
       19
            See, e.g., Roberts v. Young, 119 N.W.2d 627, 630 (Mich. 1963).

                                             19
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, 295 A.2d 676 (R.I. 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:

       [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, 679 N.E.2d 180, 181 (Mass. 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, 481 N.E.2d 1144 (Mass.

1985)).

       Since Sard, we have opined that, while a cause of action for informed consent

                                              20
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 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

       20
            Rule 5-103 provides in relevant part:
               Rulings in evidence.
                (a) Effect of erroneous ruling. Error may not be predicated
               upon a ruling that admits or excludes evidence unless the party
               is prejudiced by the ruling, and . . . (2) Offer of proof. In case
               the ruling is one excluding evidence, the substance of the

                                              21
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
              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, i.e., 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.

              evidence was made known to the court by offer on the record
              or was apparent from the context within which the evidence
              was offered.

                                             22
Waldt, 411 Md. at 235-56, 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

       21
           In the wake of Sard, we have also determined that the choice of surgeon, Dingle
v. Belin, 358 Md. 354, 749 A.2d 157 (2000), as well as that a surgeon is infected with the
AIDS virus, Faya v. Almaraz, 329 Md. 435, 620 A.2d 327 (1993), may be material to the
issue of informed consent. We also determined in Goldberg v. Boone, 396 Md. 94,
126-27, 912 A.2d 698, 717 (2006), 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 three time previously, may be material
information that needs to be disclosed.
       In McQuitty v. Spangler, 410 Md. 1, 976 A.2d 1020 (2009), we held that lack of
informed consent outside of a surgical context could be actionable. We reasoned that the
gravamen of an informed consent claim is a violation of a physician’s duty to communicate
adequately with the patient so as to enable her to make an intelligent decision about
whether to consent to treatment, and therefore, “requiring a physical invasion to sustain an
informed consent claim contravenes the very foundation of the informed consent
doctrine—to promote a patient’s choice.” Id. at 31, 976 A 2d at 1038.

                                             23
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 Wadt 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

       22
            Maryland Rule 5-702 provides in its entirety that:
              Testimony by experts.
              Expert testimony may be admitted, in the form of an opinion or
              otherwise, if the court determines that the testimony will assist
              the trier of fact to understand the evidence or to determine a
              fact in issue. In making that determination, the court shall
              determine (1) whether the witness is qualified as an expert by
              knowledge, skill, experience, training, or education, (2) the
              appropriateness of the expert testimony on the particular
              subject, and (3) whether a sufficient factual basis exists to
              support the expert testimony.

                                               24
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.

         23
          Our sister courts utilizing the same patient-centric standard also have opined that
expert testimony is necessary to define a material risk. See, e.g., White v. Leimbach, 959
N.E.2d 1033, 1040 (2011), quoting Univ. of Maryland Sys. Corp. v. Waldt, 411 Md. 207,
232, 983 A.2d 112 (2009) (“[E]xpert testimony is necessary to establish the material risks .
. . regarding the treatment or procedure.”); Thibodeaux v. Jurgelsky, 898 So. 2d 299, 314
(La. 2005) (noting that expert testimony is necessary to establish the risks, the harm, and
the likelihood of occurrence); Marsingill v. O’Malley, 58 P.3d 495, 504 (Alaska 2002)
(requiring expert testimony on the existence, nature, and likelihood of the risk to establish
the material risks); Flatt v. Kantak, 687 N.W.2d 208, 213 (N.D. 2004) (“Expert testimony
may be necessary under the lay standard, at least to establish the existence of a risk, its
likelihood of occurrence, and the type of harm in question.” (internal citations and
quotations omitted)).

                                             25
       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 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

                                              26
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:

       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]
       24
            Dr. Trovato’s subsequent written proffer similarly stated:

                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.

                                               27
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

              Trovato educates and advises patients on 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.

                                            28
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:

                Though we recognize that he is not a neurologist, the potential
         development of Stevens-Johnson syndrome is not peculiar to the practice of
         neurology. Mr. Stewart does not need to have treated patients with
         neurological problems to discuss the frequency of risks associated with
         Dilantin. His opinions represent to this court that he is an “other qualified
         expert” with regard to drugs and potential reactions thereto and is capable of
         judging what risk exists, its nature, and the likelihood of its occurrence.
         There would be a serious question as to the sufficiency of Mr. Stewart’s
         affidavit if he were opining regarding Dr. Harper’s compliance with a
         neurologist’s standard of care. However, we do not view his affidavit as
         being employed for this purpose.

Id. 26

         25
              Louisiana Code of Evidence, Article 702 provides in its entirety:

                  Testimony experts.
                  If scientific, technical, or other specialized knowledge will
                  assist the trier of fact to understand the evidence or to
                  determine a fact in issue, a witness qualified as an expert by
                  knowledge, skill, experience, training, or education, may
                  testify thereto in the form of an opinion or otherwise.
         26
           Dr. Shannon directs us to a number of cases relied upon by the Court of Special
Appeals in which some of our sister states determined that a pharmacist or a
pharmacologist was not qualified to testify against a physician in a negligence cause of
action. See Hollabaugh v. Arkansas State Med. Bd., 861 S.W.2d 317, 318 (Ark. Ct. App.
1993); Chandler v. Koenig, 417 S.E.2d 715, 716 (Ga. Ct. App. 1992); Bell v. Hart, 516
So. 2d 562, 565 (Ala. 1987); Rodriguez v. Jackson, 574 P.2d 481, 486 (Ariz. Ct. App.1977).
In all of these cases, however, our sister courts opined that the pharmacist was not qualified
to testify about the standard of care in a negligence cause of action. As we have
explained, negligence and informed consent are distinct causes of action, and moreover,
Dr. Trovato was not testifying about whether Dr. Shannon’s informed consent discussion
fell below the standard of care. We, therefore, find these cases inapposite.

                                                29
       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

        The Court of Special Appeals did, however, rely on a number of other negligence
cases in support of its conclusion that Dr. Trovato was qualified to testify in this case. See,
e.g., Sinkfied v. Oh et al., 495 S.E.2d 94, 95-96 (Ga. Ct. App. 1997); Tidwell v. Upjohn Co.,
626 So. 2d 1297, 1300 (Ala. 1993). Because negligence and informed consent are two
distinct causes of action, we do not, so as to avoid blurring the line between the two.
       27
          Dr. Shannon’s assertion that Section 3-2A-02(c)(1) of the Courts and Judicial
Proceedings Article, Maryland Code (1974, 2013 Repl. Vol.), part of the Health Care
Malpractice Claims Act, renders a pharmacist per se unqualified to testify in an informed
consent action against a physician is without merit. Section 3-2A-02(c)(1) provides that
“the health care provider is not liable for the payment of damages unless it is established
that the care given by the health care provider is not in accordance with the standards of
practice among members of the same health care profession”. Dr. Shannon posits,
therefore, that because Dr. Trovato is not a member of the same health care profession as
Dr. Shannon, he is not qualified to testify as an expert. In this, Dr. Shannon conflates
negligence with informed consent, thus blurring the distinction between these two causes
of action.

                                              30
emphasized that the proffer of Dr. Trovato’s testimony expressed his opinion regarding the

material risks of the administration of Amifostine:

       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.”

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:

       [COUNSEL FOR THE FUSCOS]: What are some of the risk factors that are
       - - what are the risk factors that are included in the drug insert that has been
       approved by the FDA?
                                             ***
       [DR. TROVATO]: The most common clinical side effects do include
       nausea/vomiting, they include low blood pressure or hypotension, there are
       various skin reactions, such as cutaneous reactions associated with
       amifostine, some of these could be mild rash to, again, very severe skin
       eruptions, things that we mentioned like Stevens-Johnson, TEN, are side
       effects of amifostine. There also could be some central effects in terms of
       dizziness with amifostine. There could be some respiratory effects,
       shortness of breathe, for example. So, there’s a variety of different systems
       that could be affected by amifostine. But, again, the more common ones
       include the skin changes and the nausea/vomiting and hypotension.
                                             ***
       [COUNSEL FOR THE FUCSOS]: Could you explain to the ladies and

                                              31
       gentlemen of the jury what Stevens-Johnson syndrome is?
                                             ***
       [DR. TROVATO]:Stevens-Johnson Syndrome is basically a severe rash that
       forms on the patient’s skin. So, that basically a skin eruption, presents as
       red, it could involve peeling of skin or itching.
       [COUNSEL FOR THE FUSCOS]: What is TEN?
                                             ***
       [DR. TROVATO]: TEN stands for toxic epidermal necrolysis. So, it
       implies that the severity of the skin damage can progress to the point that the
       patient can experience necrosis, tissue - permanent tissue death of the skin,
       sloughing of the skin, and so forth due to that reaction.

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

with the drug:

       4. Dr. Trovato will testify that the risk factors associated with Amifostine
       include nausea, vomiting, low blood pressure or hypotension, skin changes,
       allergic or immunologic reactions including a rash, hives, toxic necrolysis,
       and Stevens-Johnson 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.

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

       28
          Severity and likelihood of risk are defined by the use of empirical data and are
phrased in terms of statistical probability. Severity of illness is defined as “the degree of .
. . risk of disease manifested by patients, based either on clinical data from the medical
records or on hospital discharge/billing data.” Stedman’s Medical Dictionary 947 (28th
ed. 2006). Likelihood, moreover, relates to the chance or probability that an injury or
consequence will occur. See Precourt v. Frederick, 395 Mass. 689, 694-95, 481 N.E.2d
1144, 1148 (Mass. 1985) (“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.
Regardless of the severity of a potential injury, if the probability that the injury will occur
is so small as to be practically nonexistent, then the possibility of that injury occurring
cannot be considered a material factor in a rational assessment of whether to engage in the
activity that exposes one to the potential injury.”); see also Harbeson v. Parke Davis, Inc.,
746 F.2d 517, 523 (9th Cir. 1984) (opining that testimony about empirical research that

                                              32
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:

       [COUNSEL FOR RESPONDENT]: [D]oes the drug insert . . . speak to the use of
       amifostine in elderly patients?

indicated that certain birth defects are two-to-three times more likely to occur in those
taking the drug Dilantin supported the trial court’s conclusion that the birth defect was a
material risk); Barcai v. Betwee, 50 P.3d 946, 962-63 (Haw. 2002) (opining that expert
testimony that the allegedly undisclosed risk manifested itself in one out of every eight
thousand patients provided the necessary expert testimony regarding likelihood to submit
the question of whether the undisclosed risk was material to the jury).
         Dr. Trovato’s testimony embraced only the relative terms of “most common,”
when he opined about which adverse effects were “most common,” and “severe,” when he
described certain adverse effects as “very severe skin eruptions.” The terms “most
common” and “severe” are relative terms, lacking foundation in empirical research and
definition in statistical realities. In this regard, we find helpful the Massachusetts
Supreme Court’s decision in Precourt, 481 N.E.2d at 1149, in which the court opined that
expert testimony that the allegedly undisclosed risk of the drug Prednisone, aeseptic
necrosis, was “high,” was “no evidence of the likelihood that a person would develop
aespectic necrosis after taking Prednisone,” because “‘[h]igh’ is a relative word. It could
mean one in ten, but it could just as well mean one in a million.”
       29
          We also would note that, both Dr. Trovato’s de bene esse testimony and written
proffer pertained, primarily, to his opinion that Amifostine was inappropriately
administered to Mr. Fusco, because of the fact that the FDA had not approved Amifostine
to supplement treatment of undergoing radiation therapy for prostate cancer and that the
package insert warned against use in an elderly population, because its effects were not yet
known. As a basis for excluding Dr. Trovato’s testimony, Judge Green reasoned that the
testimony would confuse the jury because it sounded in negligence. We agree. As we
explained, supra, informed consent and negligence are distinct causes of action and
whether a treatment is contraindicated for a patient may be relevant evidence that the
physician’s actions in treating the patient fell below the standard of care, but it is not
relevant in an informed consent action. See Waldt, 411 Md. at 236, 983 A.2d at 128-29.

                                            33
                                           ***
       [DR. TROVATO]: Yes, it does speak to that.
       [COUNSEL FOR RESPONDENT]: What does it say relative to the use of
       amifostine in elderly patients?
                                           ***
       [DR. TROVATO]: There’s actually - - there’s actually a precaution in the
       product package insert people with drug – amifostine studied in elderly
       patients who – should use precaution in those patients since we don’t know
       what the effects might be in those patients.[30]

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:

       [COUNSEL FOR THE FUSCOS]: Does the drug insert . . . indicate that this
       drug should not be used on elderly patients because there has been
       inadequate clinical studies?
       [DR. SHANNON]: The drug insert indicates that there are several shoulds.
       Shoulds are not musts. We should run six times a day. That doesn’t mean
       we’re going to.
                                       ***

       30
            The subsequent written proffer similarly stated:

                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.

                                                34
       [COUNSEL FOR THE FUSCOS]: [D]id you advise him . . . [t]hat the drug
       manufacturer recommended that it not be used because it hasn’t been fully
       tested on elderly patients yet?
                                          ***
       [DR. SHANNON]: No, I didn’t and there is additional reason why I don’t.
       We are giving in terms of a dosage spectrum as we just spoke of we’re really
       on the low end. . . .

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

                                            35
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

       31
            We note, in this regard, that the Court of Special Appeals relied only on

                                             36
       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:

       [COUNSEL FOR RESPONDENT]: Let’s go back and clear this up. Did
       the FDA approve the use for amifostine in the treatment of cancer?
                                         ***
       [DR. TROVATO]: Yes, the FDA did do so.
       [COUNSEL FOR RESPONDENT]: What is the FDA approved use of

negligence cases to support its conclusion that evidence regarding the package insert was
admissible in an informed consent case. See Fusco v. Shannon, 210 Md. App. 399,
431-33, 63 A.3d 145, 164-65 (2013). In Nolan, the plaintiff filed a negligence cause of
action against a physician after an injection of a drug called Sparine allegedly caused
portions of three of the plaintiff’s fingers to become gangrenous and later amputated. The
trial judge gave a jury instruction that the jury was permitted to consider warnings and
other information contained in the package insert as evidence of whether the treating
physician fell below the standard of care. We granted certiorari, to consider, inter alia,
whether the instruction was proper. We concluded that the package insert of a drug “does
not standing alone establish a standard of care,” but rather, was “prime facie proof of
proper use,” and thus, concluded that the jury instruction was “quite proper.” Nolan v.
Dillon, 261 Md. 516, 540, 276 A.2d 36, 49 (1971). In the other cases cited by the
intermediate appellate court relative to the package insert, many of our sister courts also
opined that the package insert is relevant and admissible in a negligence case as to the
standard of care. See Garvey v. O’Donoghue, 530 A.2d 1141, 1146 (D.C. 1987) (opining
that package inserts of medication “are relevant and probative evidence of the medical
standard of care for selecting, administering, and monitoring the drug”); Thompson v.
Carter, 518 So. 2d 609, 613 (Miss. 1987) (“[T]he package insert . . . should not be taken as
conclusive evidence of the physician’s standard of care, nor should a departure from the
directions contained in the package insert be considered to establish a prima facie case of
negligence. However, . . . the package insert contains prima facie proof of the proper
method of use . . . and, for those purposes, was admissible at trial.”); Rodriguez, 574 P.2d at
486 (“While the package insert is admissible into evidence, it does 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 is negligence.”). As these cases
clearly demonstrate, the package insert’s warnings are relevant evidence as to whether the
treating physician’s conduct fell below the standard of care in prescribing or administering
medication, an issue of no relevance in an informed consent action.

                                              37
       amifostine in the treatment of cancer?
                                           ***
       [DR. TROVATO]: There are only two FDA approved indications for
       amifostine. One of them is to decrease the risk of nephrotoxicity or kidney
       toxicity in patients receiving specifically cisplatin, which is therapy agent,
       that was approved in ovarian cancer patients. It’s also approved for use in
       head and neck cancer patients receiving radiation therapy to protect their
       prod glands, you know, from – basically, the end result is to prevent dry
       mouth in patients receiving radiation therapy to their head and neck.
       [COUNSEL FOR RESPONDENT]: Is there any FDA approved usage of
       amifostine for prostate cancer?
                                            ***
       [DR. TROVATO]: There is no FDA approved indication for use of
       amifostine in prostate cancer.[32]

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:

       [COUNSEL FOR THE FUSCOS]: Do you know whether or not the FDA has
       approved Amifostine in the treatment of prostate cancer?
       [DR. SHANNON]: I do know.
       [COUNSEL FOR THE FUSCOS]: What is the answer to that question?
       [DR. SHANNON]: The indications are for conditions that don’t include
       prostate cancer.
       [COUNSEL FOR THE FUSCOS]: Okay. So the FDA has not approved
       Amifostine as a drug for prostate cancer. I’m not saying it can’t be used off
       label, but it’s not a drug that the FDA has approved for that use, is that
       correct?
       [DR. SHANNON]: That’s correct.

As with the package insert, Judge Green relied on Waldt to determine that such evidence

was not admissible.

       32
          Dr. Trovato’s written proffer similarly stated that “Dr. Trovato will testify about
the approved FDA uses at the time that Amifostine was administered to Anthony Fusco.”

                                             38
      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:

              The excerpts from the record the Waldts argue constituted a proffer
      reveal that the only proffered (albeit 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, i.e., that the doctors breached the standard of care
      in their treatment of Mrs. Waldt by performing a contraindicated procedure

                                            39
      on her. It is not relevant to an informed consent claim.

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, 787 A.2d 910, 913 (N.J. Super. 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, 781 A.2d 101, 102 (Pa. 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:

       The category into which the FDA places the device for marketing and
       labeling purposes simply does not enlighten the patient as to the nature or
       seriousness of the proposed operation, the organs of the body involved, the
       disease sought to be cured, or the possible results. The FDA administrative
       label does not constitute a material fact, risk, complication or alternative to a
       surgical procedure. It follows that a physician need not disclose a device’s
       FDA classification to the patient in order to ensure that the patient has been
       fully informed regarding the procedure.

Id. at 107 (citation omitted).    Although addressing the regulatory status of a surgical

                                              40
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:

              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.” Rite Aid Corp. v. Levy–Gray, 391 Md. 608, 640, 894
A.2d 563 (2006) (Harrell, J., dissenting), we disagree with our sister states,
       and perceive that this information could have been a material consideration
       regarding Mr. Fusco’s decision whether to consent to the use of Amifostine.
       See Waldt II, 411 Md. at 241, 983 A.2d 112 (Adkins, J., dissenting) (stating,
       “[i]nformation about the lack of FDA approval is something that a patient
       could reasonably want to consider in deciding whether to place her
       confidence and trust in [his or] her physician about the treatment [he or] she
       is about to undertake.”).

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

                                               41
(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 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.

       33
           Having determined that the FDA-approval status of a drug need not be a
necessary part of an informed consent discussion, we find no merit to the Fuscos’
contention that, because Dr. Shannon testified in his deposition that he advised Mr. Fusco
that the drug was being prescribed in an off-label manner, its FDA-status was necessarily
relevant evidence.

                                              42
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.

                                           43
Circuit Court for Prince George’s County   IN THE COURT OF APPEALS OF
Case No. CAL-07-11137                                MARYLAND
Argued: February 7, 2014

                                                          No. 57

                                                  September Term, 2013

                                               KEVIN J. SHANNON, et al.
                                                          v.

                                                MAFALDA FUSCO, et al.

                                                       Barbera, C.J.
                                                       Harrell
                                                       Battaglia
                                                       Greene
                                                       Adkins
                                                       McDonald
                                                       Eldridge, John C. (Retired,
                                                       Specially Assigned),

                                                                    JJ.

                                             Dissenting Opinion by Eldridge, J.

                                                Filed: April 24, 2014
       I dissent. See Univ. of Md. Medical Systems 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 (2011).