Opinion ID: 2345337
Heading Depth: 2
Heading Rank: 2

Heading: Informed Consent Claim

Text: The intermediate appellate court held that the issue of the trial judge's exclusion of Dr. Debrun's testimony on the issue of informed consent was not properly preserved for appeal. The court reasoned that the Waldts failed to proffer sufficiently the substance of the excluded evidence in accordance with Maryland Rule 5-103, which states that [e]rror may not be predicated upon a ruling that admits or excludes evidence unless the party is prejudiced by the ruling, and ... the substance of the evidence was made known to the court by offer on the record or was apparent from the context.... Additionally, the intermediate appellate court held that the trial judge did not abuse her discretion in ruling that Dr. Debrun did not have the necessary foundation to offer an opinion on informed consent. We affirm the Court of Special Appeals' conclusion and uphold the trial judge's ruling excluding Dr. Debrun's informed consent testimony. In an informed consent case, the scope of the physician's duty to inform is to be measured by the materiality of the information to the decision of the patient. A material risk is one which a physician knows or ought to know would be significant to a reasonable person in the patient's position.... Sard v. Hardy, 281 Md. 432, 444, 379 A.2d 1014, 1022 (1977). Expert testimony is necessary to establish the material risks and other pertinent information regarding the treatment or procedure. The Waldts offered Dr. Debrun as their expert witness for the informed consent claim. The trial judge heard testimony regarding Dr. Debrun's qualifications, including his education and experience in the field of interventional neuroradiology. Dr. Debrun testified that throughout his career he had operated on about 30 aneurysms like Mrs. Waldt's, 10-15 of which were similar in size to Mrs. Waldt's, and four or five of which were wide neck aneurysms. He also testified that he traditionally used a balloon procedure that is different from a stent and that he had never used the neuroform stent because it was not approved for use in the United States until after he retired from active practice. Maryland Rule 5-702 makes it the responsibility of the trial judge to determine whether an individual qualifies as an expert witness. [6] After Dr. Debrun's voir dire, the trial judge ruled that Dr. Debrun was not qualified to testify regarding informed consent, stating: The expert's training or experience need not be formal [for him to be qualified to testify as an expert witness]. There is no issue of that here. The witness has formal training and informal, that is, from his readings of journals and things of that nature. It must be that the witness' knowledge of the subject is significantly better than the average layperson so that the expert testimony would be of appreciable help to the jury. Any physician's testimony, I guess in this particular matter, would be helpful to the jury. The Court agrees the witness may qualify as an expert without actual experience. The Court agrees that, if the witness possesses sufficient special knowledge obtained from study or observation, the Court agrees with all of that. It is the last part. The trial judge exercises his or her discretion in determining whether the particular witness is sufficiently qualified that his or her opinion would be of assistance. The specific and appropriate grounds and basis has not been met for that to occur and that is the Court's ruling. The Waldts did not make a proffer of the substance of Dr. Debrun's anticipated testimony at that time. The only proffer that counsel for the Waldts had previously made regarding Dr. Debrun's testimony was that he would have testified about the approved uses of the neuroform stent and that it was not approved for use on an aneurysm like Mrs. Waldt's. Waldt, 181 Md.App. at 261, 956 A.2d at 248. There was no proffer as to the risks inherent to use of the neuroform stent on Mrs. Waldt's aneurysm, such as: coiling with the neuroform stent; the probability of success of the coiling procedure with the neuroform stent; the frequency of the risks inherent in coiling with the neuroform stent; what procedures were available as alternatives to coiling with the neuroform stent; what were the risks inherent in those procedures; how did the risks inherent in those procedures compare both by nature and frequency to the risks inherent in coiling with the neuroform stent; and which risks of the neuroform stent coiling procedure were disclosed to Mrs. Waldt and which were not. Waldt, 181 Md.App. at 260, 956 A.2d at 249 (citing Sard, 281 Md. at 448, 379 A.2d at 1024). The Waldts appealed the trial judge's ruling to the Court of Special Appeals. The intermediate appellate court held that the Waldts failed to preserve the issue for appeal by not making a sufficient proffer on the trial record of what the substance of Dr. Debrun's testimony would have been, had he been allowed to testify. Waldt, 181 Md.App. at 258, 956 A.2d at 247. The court held that Dr. Debrun's intended testimony concerning the approved uses of the neuroform stent did not address the issue of informed consent because it was not testimony concerning the material risks of the procedure. Waldt, 181 Md. App. at 261, 956 A.2d at 248. Without a proffer of testimony that would establish the elements of an informed consent claim, the Court of Special Appeals [did] not have before [it] the information [needed] to address whether exclusion of Dr. Debrun's testimony on the informed consent claim was prejudicial error. Waldt, 181 Md. App. at 262, 956 A.2d at 249. In addition, the Court of Special Appeals stated that the trial judge's ruling excluding Dr. Debrun was not an error or an abuse of discretion. Waldt, 181 Md.App. at 262, 956 A.2d at 249. Acknowledging that, under Radman v. Harold, 279 Md. 167, 172-73, 367 A.2d 472 (1977), an expert need not necessarily have actually performed a procedure to qualify as an expert witness, the court then went on to hold that the trial judge had sufficient grounds for excluding Dr. Debrun. Given Dr. Debrun's limited experience with similar procedures and his failure to disclose any specific scientific or factual underpinnings for any knowledge about the material risks of the neuroform stent coiling procedure, the court did not err or abuse its discretion in excluding his testimony on this issue. Waldt, 181 Md.App. at 267-68, 956 A.2d at 252. In their petition to this Court, the Waldts argue that the Court of Special Appeals erred in holding that a sufficient proffer was not made to preserve the issue for appeal and that the trial judge erred in refusing to qualify Dr. Debrun as an expert. On the preservation issue, the Waldts contend that a sufficient proffer was made when counsel for the Waldts made it clear that Dr. Debrun intended to testify that the neuroform stent was not approved for use on an aneurysm like Mrs. Waldt's. According to the Waldts, this is information that would be material to a patient in making an informed decision concerning the surgery. In Sard, this Court acknowledged the doctrine of informed consent, identifying general categories of information that must be communicated to the patient: (1) the nature of the ailment, (2) the nature and the risks of a treatment, (3) the probability of success, (4) the frequency of occurrence of risks, and (5) available alternatives to the treatment. 281 Md. at 438-40, 379 A.2d at 1019-20. The Waldts acknowledge that testimony about approved uses of the stent would not have fit neatly into one of these five categories. Notwithstanding, they rely on this Court's decision in Goldberg v. Boone, 396 Md. 94, 912 A.2d 698 (2006), holding that certain other considerations may also need to be discussed and resolved on a case by case basis. The Waldts argue that the approved uses of the neuroform stent and the fact that it was only approved for aneurysms that were not amenable to surgery (of which Mrs. Waldt's was not one) would have been a material factor in Mrs. Waldt's decision concerning the surgery. The purpose of Rule 5-103(a)(2) is to allow adequate review by the appellate courts. Without a proffer, it is impossible for appellate courts to determine whether there was prejudicial error or not. See Merzbacher v. State, 346 Md. 391, 416, 697 A.2d 432, 444 (1997). We agree with the Court of Special Appeals that a sufficient proffer was not made as to the substance of Dr. Debrun's testimony. 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.     Indeed, what little information was imparted to the court about the substance of Dr. Debrun's anticipated testimony was so sketchy that, on review, we are unable to determine even the theory of the Waldts' informed consent claim. Were they seeking to prove that the risk of bleeding in the brain was inherent in the neuroform stent coiling procedure and occurred with greater frequency in that coiling procedure as opposed to the cardiac stent coiling procedure, so that there was a more significant risk of bleeding in the brain with the neuroform stent coiling than with the cardiac stent coiling? Or were they seeking to prove that the risk of bleeding in the brain was inherent in the neuroform stent coiling procedure but not in the clipping procedure, or, if inherent in the clipping procedure, of a lower frequency than would be material to a reasonable person? As we can ascertain none of this from the proffer, we do not have before us the information we need to address whether exclusion of Dr. Debrun's testimony on the informed consent claim was prejudicial error. Accordingly, the issue is not properly before this Court for review. Waldt, 181 Md.App. at 261-62, 956 A.2d at 248, 249. We agree with the intermediate court that no testimony was proffered concerning the material risks of the procedure that would make out a prima facie case for informed consent. In addition, it is within the discretion of the trial judge to qualify witnesses as experts. As this Court has previously held, [i]t is the general rule that the admissibility of expert testimony is within the sound discretion of the trial judge and will not be disturbed on appeal unless clearly erroneous. In this regard, the trial judge has wide latitude in determining whether expert testimony is sufficiently reliable to be admissible. Wilson v. State, 370 Md. 191, 200, 803 A.2d 1034, 1039 (2002). The trial judge evaluated Dr. Debrun's testimony and qualifications and concluded that he did not have a sufficient factual basis on which to render an expert opinion on informed consent. The Waldts were allowed more time for voir dire and were not able to present sufficient testimony to convince the trial judge that Dr. Debrun should be allowed to testify. We agree with the Court of Special Appeals that [g]iven Dr. Debrun's limited experience with similar procedures and his failure to disclose any specific scientific or factual underpinnings for any knowledge about the material risks of the neuroform stent coiling procedure, the court did not err or abuse its discretion in excluding his testimony on this issue. Waldt, 181 Md. App. at 267-68, 956 A.2d at 252. We therefore affirm the judgment of the Court of Special Appeals and uphold the ruling of the trial judge. JUDGMENT OF THE COURT OF SPECIAL APPEALS REVERSED IN PART AND AFFIRMED IN PART. RESPONDENTS TO PAY THE COSTS. ADKINS, J., dissents and files opinion. RAKER, J. dissents and files opinion, in which ELDRIDGE, J., joins. ADKINS, Judge, dissenting.