# University of Maryland Medical System Corp. v. Waldt

> Court of Appeals of Maryland · November 10, 2009 · 411 Md. 207

URL: https://www.frixlaw.com/law-library/cases/9756772

## Case

- **Full name:** UNIVERSITY OF MARYLAND MEDICAL SYSTEM CORPORATION, Et Al. v. Rebecca Marie WALDT, Et Al.
- **Court:** Court of Appeals of Maryland
- **Decided:** November 10, 2009
- **Citations:** 411 Md. 207; 983 A.2d 112; 2009 Md. LEXIS 846
- **Precedential status:** Published
- **Opinion:** Dissent by Adkins
- **Judges:** Greene, Adkins, Raker
- **Cited by:** 20 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/9756772

## How later opinions describe it (automated extraction)

- 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.”
- stating, “[information 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.”
- noting that expert testimony is necessary to establish the risks, the harm, and the likelihood of occurrence
- stating that "the trier of fact, in passing upon the credibility of witnesses, is free to believe all, part, or none of the evidence"

## Opinion text

ADKINS, Judge,
dissenting.
I.
I join the majority opinion with respect to the first issue.
*238 II.
I respectfully dissent from the majority opinion with regard to the Waldts’s informed consent claim. In my estimation, it was error for the trial court to find that Dr. Debrun was “not qualified as an expert to testify with regards to informed consent in reference to this procedure or this device.” 1 As a result of this ruling, the trial court granted judgment against the Waldts for failure to prove a lack of informed consent, on the grounds that the Waldts had no expert to testify “with regards to the nature of the risks inherent in this particular treatment [or] the probabilities of therapeutic success.” The Waldts proffered that Dr. Debrun would testify about Dr. Zoarski’s failure to inform Ms. Waldt that the Neuroform stent had only been approved by the FDA in the limited instance when the patient’s aneurysm is not amenable to surgical clipping, an alternative procedure. I believe that in this instance, knowledge concerning the limited extent of FDA approval of the Neuroform stent could be material to Ms. Waldt’s consent. Materiality of this information was a fact to be determined by the jury.
The majority clothes its decision rejecting the Waldts’s informed consent claim in a procedural wrap, i.e., as a non-preservation issue. Yet, in holding that “a sufficient proffer was not made as to the substance of Dr. Debrun’s testimony,” the majority actually makes a substantive ruling, one that could have a widespread impact on informed consent claims. Majority Opinion, supra, at 235, 983 A.2d at 129. The majority maintains that the proffer falls short because it did not include testimony about the actual risks of using the Neuroform stent or the probabilities of therapeutic success. In doing so, it implicitly rejects as insufficient the Waldts’s proffer that Dr. Debrun would testify “that the neuroform *239 stent device was not approved for use on Mrs. Waldt’s type of aneurysm.” Waldt v. Univ. of Md. Med. Sys. Corp., 181 Md.App. 217, 261 , 956 A.2d 223, 248 (2008). This implicit rejection constitutes a holding that expert testimony about FDA approvals is immaterial unless it expressly identifies the risks that would cause the FDA to withhold approval.
But this holding undermines our decision in Goldberg v. Boone, 396 Md. 94 , 912 A.2d 698 (2006), in which we held that obtaining a patient’s informed consent may require a broader range of disclosures than those merely addressing risks. See Goldberg, 396 Md. at 125 , 912 A.2d at 716 (quoting Dingle v. Belin, 358 Md. 354, 370 , 749 A.2d 157, 165 (2000)) (holding that although “ ‘[r]isks ... must be disclosed routinely,’ we also have made clear that ‘other considerations ... may also need to be discussed and resolved.’ ”). In Goldberg , the information withheld by the doctor was that he had performed the unusually complicated surgical procedure only once in the previous three years, and there were more experienced doctors in the region. We held that information could be found by the jury to be material, and was part of the doctor’s disclosure obligation.
In Goldberg we held that “there is no bright-line test [for] items that must be disclosed by a physician in order to procure an informed consent from a patient.” 396 Md. at 125 , 912 A.2d at 716 . Rather, a physician is obligated to disclose any information that “would be material to a reasonable person in the position of the patient having to decide whether to submit to the medical treatment in issue.... ” Id. The focus of the informed consent inquiry is therefore a patient’s perspective, and not the judgment of a treating physician. See Sard v. Hardy, 281 Md. 432, 442 , 379 A.2d 1014, 1021 (1977) (“[T]he appropriate test is not what the physician ... thinks a patient should know[;] ... rather, the focus is on what data the patient requires in order to make an intelligent decision.”).
The facts of this case fit easily within the Goldberg rationale. Evidence was introduced that even though Ms. Waldt’s *240 aneurysm could have been treated with surgical clipping, she was advised that the Neuroform stent was a safe and successful treatment, widely used in Europe, and that it had the best chance of success among the treatment options available to her. The absence of FDA approval for use when other surgery was available could at least indicate to Ms. Waldt that the Neuroform stent had not undergone the full rigorous testing process that ordinarily accompanies an FDA approval. Although a patient might place her faith in her doctor despite that information, she has the right to knowingly make that choice. In a risky procedure, a patient’s knowledge that a device has not been tested by the FDA or approved for that particular use could tip the balance against going forward with the operation when alternatives are available.
I do not advance the proposition that every nuance of a surgical procedure need be disclosed to a patient in order to obtain informed consent — some information is so commonplace that it could not reasonably be expected to affect a patient’s course of treatment. For example, no reasonable patient would base a decision to pursue surgery on the type of scalpel or forceps that would be used in the procedure. Other examples abound. But the disclosure at issue here is a far cry from a commonplace surgical component.
To be sure, lack of FDA approval does not necessarily mean that a treatment is high-risk. Other courts have found this disconnect sufficient reason to hold that information about FDA approvals is not generally material to a patient’s informed decision. See, e.g., Southard v. Temple Univ. Hosp., 566 Pa. 335 , 781 A.2d 101 (2001) (holding that because FDA approval does not constitute a “material fact, risk, complication, or alternative [to treatment,]” a physician need not disclose associated information on FDA status). I do not agree with these courts, and consider their views inconsistent with Maryland’s law of informed consent.
Contrary to the trial court’s ruling, neither our holding in Goldberg nor our holding in Sard limits a doctor’s disclosure obligation to information precisely demonstrating increased *241 risk to the patient. 2 The purpose of the patient-centered standard of care established in Sard is to preserve “the patient’s fundamental right of physical self-determination — the very cornerstone of the informed consent doctrine[.]” 281 Md. at 442 , 379 A.2d at 1021 . When a patient elects to pursue a particular course of treatment on a physician’s advice, that patient is making a decision to place her trust in her physician. In order for that decision to be meaningful, the patient must possess all material facts.
Information 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 her physician about the treatment she is about to undertake. The presence of such approval is some indication of safety, although not determinative. While the absence of FDA approval does not establish a higher risk, it does mean that the device has not undergone, or not passed, normal FDA testing procedures. A person facing surgery may reasonably assume that a device critical to that surgery has received FDA approval. A physician carries the responsibility of educating her patient if that assumption is false. Petitioner’s proffer that Dr. Debrun would testify about the lack of FDA approval for use of the Neuroform stent for Waldt’s type of aneurysm was sufficient. Dr. Debrun’s testimony would “assist the trier of fact to understand the evidence or to determine a fact in issue.” Md. Rule 5-702. To exclude Dr. Debrun’s testimony and then grant judgment was error. To hold otherwise strays from the careful path that we have laid out in Sard, Goldberg, and our *242 most recent case, McQuitty v. Spangler, 410 Md. 1 , 976 A.2d 1020 (2009). Accordingly, I would vacate the judgment entered on the informed consent issue, and remand for further proceedings.
. In addressing the Waldts’s proffer of Dr. Debrun’s testimony on the informed consent issue, I have not considered whether Dr. Debrun would be disqualified under the 20% rule from giving testimony on the informed consent claim. See McQuitty v. Spangler, 410 Md. 1, 28 , 976 A.2d 1020, 1036 (2009) (holding that a informed consent claim sounds in negligence). That issue was not raised in this Court.
. The trial court noted that:
there has been no expert testimony with regards to the nature of the risks inherent in this particular treatment. There has been no testimony to indicate ... what was necessary to make an informed consent with regards to the material risks inherent in this treatment. There has been no expert testimony with regards to the probabilities of therapeutic success in this case.... There has been no expert testimony given with regards to the frequency of occurrence of particular risks____ There has been no expert testimony with regards to the nature of available alternatives to this treatment that should have been disclosed to the patient.... Sard is clear that such expert testimony is required in regards to informed consent.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/9756772. Public record. Not legal advice.