Court Opinion

ID: 9576587
Source: CourtListenerOpinion
Date Created: 2023-08-21 21:26:09.037971+00
Date Added: 2024-06-11T13:10:04.775617
License: Public Domain

Judge McGee
concurring in part and dissenting in part.
I respectfully dissent from the majority opinion’s determination that the jury instructions on the issue of informed consent were proper.
Plaintiffs argued that Dr. Maxwell had a duty to inform them of the experimental nature of the devices used by Dr. Maxwell in Gregory Osburn’s back surgery, and that the trial court erred in refusing to instruct the jury as to this duty.
As the majority states, the pertinent statute is N.C. Gen. Stat. § 90-21.13(a)(1) and (2). “Subsection (a)(2) establishes an objective standard to determine whether the patient would have obtained a general understanding of the procedures or treatments contemplated and of the usual and most frequent risks and hazards inherent in them.” Nelson v. Patrick, 58 N.C. App. 546, 550, 293 S.E.2d 829, 832 (1982). In order to meet this standard, “the health care provider must impart enough information to permit a reasonable person to gain a ‘general understanding’ of both the treatment or procedure and the ‘usual and most frequent risks and hazards’ associated with the treatment.” Foard v. Jarman, 326 N.C. 24, 27, 387 S.E.2d 162, 164 (1990).
However, in cases where the treatment or procedure is experimental, a health care provider’s lack of knowledge of the ordinary risks may prevent the health care provider from fully informing the patient. In Estrada v. Jaques, 70 N.C. App. 627, 649, 321 S.E.2d 240, 254 (1984), our Court held
that where the health care provider offers an experimental procedure or treatment to a patient, the health care provider has a duty, in exercising reasonable care under the circumstances, to inform the patient of the experimental nature of the proposed procedure. With experimental procedures the “most frequent risks and hazards” will remain unknown until the procedure becomes established. If the health care provider has a duty to inform of known risks for established procedures, common sense and the purposes of the statute [G.S. 90-21.13] equally require *246that the health care provider inform the patient of any uncertainty regarding the risks associated with experimental procedures. This includes the experimental nature of the procedure and the known or projected most likely risks.
As noted in Estrada, “[o]ne federal court has explicitly established such a rule, that the patient ‘must always be fully informed of the experimental nature of the treatment and of the foreseeable consequences of that treatment.’ ” Id., citing Ahern v. Veterans Admin., 537 F. 2d 1098, 1102 (10th Cir. 1976).
Plaintiffs’ attorney filed a written request for a jury instruction that “the health care provider has a duty, in exercising reasonable care under the circumstances, to inform the patient of the experimental nature of the proposed procedure.” Plaintiffs’ attorney again presented the request for special jury instructions during the charge conference. The trial court declined to apply the rule in Estrada, stating that the duty of a physician to inform patients that a device is experimental is not the standard of care under N.C. Gen. Stat. § 90-21.13.
“It is well established that when a party aptly tenders a written request for a specific instruction which is correct in itself and supported by the evidence, the failure of the court to give the instruction, at least in substance, is reversible error.” Indiana Lumbermen’s Mutual Ins. Co. v. Champion, 80 N.C. App. 370, 379, 343 S.E.2d 15, 20-21 (1986) (citations omitted). The instruction requested by plaintiffs was a correct statement of the law as set forth in Estrada. Estrada establishes that a health care provider has a duty to inform patients of the experimental nature of a procedure. Further, there is substantial evidence in the record to support such an instruction, including: testimony that during 1991-1993 pedicle screw implants were investigational and had not received approval by the FDA; evidence that Dr. Maxwell contributed to an investigation by Sofamor Danek which was being submitted to the FDA; statements from the FDA to Danek requiring that patients be informed of the experimental nature of the ISF Luque and TSRH devices; and testimony that the concept of the pedicle screw and plate is new in its application to the spine.
I am not saying that a health care provider must inform the patient of the FDA classification or status of a device, an issue discussed by defendants Keith M. Maxwell, M.D. and Keith M. Maxwell, M.D., RA. As stated by a Pennsylvania court, “the FDA does not reg*247ulate the practice of medicine” and “a physician ... is generally free to use a medical device in a manner different from that for which the FDA has approved the device for commercial sale, i.e., an ‘off-label’ use.” Southard v. Temple University Hospital, 731 A.2d 603 (Pa. Super. 1999). However, the FDA classification or status is evidence in determining whether a device is experimental. After reviewing all of the evidence, and after proper instruction by the trial court as to a physician’s duty to inform a patient of the experimental nature of the device, it was for the jury to decide whether this device was experimental and whether defendants Keith M. Maxwell, M.D. and Keith M. Maxwell, M.D., P.A. breached their duty to plaintiffs.
Since plaintiffs’ request for jury instruction was correct in the law and supported by the evidence, it was reversible error for the trial court to refuse to give the requested instruction. Plaintiff is entitled to a new trial against Keith M. Maxwell, M.D. and Keith M. Maxwell, M.D., P.A. on the question of informed consent. This determination also reopens the questions of loss of consortium and punitive damages as to these defendants, and these issues should be remanded for trial.