Kershaw v. Reichert

445 N.W.2d 16, 1989 N.D. LEXIS 156, 1989 WL 82328
CourtNorth Dakota Supreme Court
DecidedJuly 26, 1989
DocketCiv. 880214, 880249
StatusPublished
Cited by24 cases

This text of 445 N.W.2d 16 (Kershaw v. Reichert) is published on Counsel Stack Legal Research, covering North Dakota Supreme Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Kershaw v. Reichert, 445 N.W.2d 16, 1989 N.D. LEXIS 156, 1989 WL 82328 (N.D. 1989).

Opinion

MESCHKE, Justice.

Larry Kershaw appealed judgments dismissing his suits against H.L. Reichert, M.D.; St. Alexius Medical Center; R.S. Gruby, M.D.; R.D. Anderson, M.D.; Richard Tschider; Jack Eakman; Wm. Bianco, Sr.; and Mary Neigum. We consider the effect of federal regulations on the responsibility of medical providers for unsuccessful surgery. We affirm.

Dr. Reichert performed an intraocular lens implant on Kershaw on March 2, 1983. *17 The implant was unsuccessful and Ker-shaw later suffered retinal detachment.

Kershaw sued Dr. Reichert and St. Alexi-us Medical Center, alleging, among other things, that they had not secured his informed consent to the surgery. The trial court dismissed St. Alexius Medical Center by summary judgment. Kershaw then sued Dr. Reichert again, together with the members of the Institutional Review Committee for St. Alexius Medical Center, made up of Gruby, Anderson, Tschider, Eakman, Bianco, and Neigum, alleging they failed to assure that Kershaw gave his informed consent to the surgery. The district court dismissed this second suit. The first suit against Dr. Reichert was tried to a jury, which returned a verdict for Dr. Reichert, and a judgment of dismissal was entered. Kershaw’s appeals were consolidated for our review.

While Kershaw raised a number of issues on appeal, we address only three: 1

(1) Did federal regulations authorize a private action against St. Alexius Medical Center, the members of its Institutional Review Committee, or Dr. Reichert?
(2) Must a hospital obtain a patient’s informed consent for an operation?
(3) Did the trial court abuse its discretion in refusing evidentiary use of certain federal regulations?

Intraocular lens implants were regulated by the Federal Food, Drug and Cosmetic Act (FDCA) administered by the Food and Drug Administration (FDA). 21 U.S.C. § 301 et seq. FDA regulations at 21 CFR, part 813, allowed investigational surgery for intraocular lenses, required the appointment of institutional review committees by hospitals, and generally prescribed responsibilities of institutional review committees and investigators.

The FDCA does not expressly or inferentially authorize a private action for violations. Pacific Trading Co. v. Wilson & Co., Inc., 547 F.2d 367 (7th Cir.1976). Griffin v. O’Neal, Jones & Feldman, Inc., 604 F.Supp. 717 (S.D.Ohio 1985) carefully analyzed the FDCA and held that a private action may not be implied from it. Griffin used the accepted four-part analysis for ascertaining if a private action is implied from a federal statute. This four-part analysis was first developed in Cort v. Ash, 422 U.S. 66, 95 S.Ct. 2080, 45 L.Ed.2d 26 (1975). We have followed the Cort analysis in interpreting other federal enactments. See Hillesland v. Federal Land Bank Ass’n, 407 N.W.2d 206 (N.D.1987). We agree with Griffin in applying the Cort analysis to FDCA and to FDA’s regulations. Conforming to that analysis, we conclude that FDA’s regulations adopted pursuant to the FDCA did not authorize a private action against hospitals, institutional review committees, or doctors for unsuccessful intraocular implants.

“Generally there exists as an integral part of the physician’s overall obligation to his patient the duty of reasonable disclosure of the available choices with respect to the proposed therapy and of the material and known risks potentially involved in each.” Winkjer v. Herr, 277 N.W.2d 579, 587 (N.D.1979). However, a hospital generally has no duty to obtain a like informed consent from the same patient. Krane v. Saint Anthony Hospital Systems, 738 P.2d 75 (Colo.App.1987). As the court explained in Krane:

“It is the surgeon, and not the hospital, who has the technical knowledge and training necessary to advise each patient of the risks of the surgery prior to the patient giving his consent. Further, the hospital does not know the patient’s medical history, nor the details of the particular surgery to be performed.” 738 P.2d at 77.

Nothing about this case impels a deviation from the general rule. St. Alexius Medical *18 Center had no duty to secure Kershaw’s informed consent.

Because FDA’s regulations did not authorize a private action and because the hospital had no duty to obtain his informed consent, Kershaw’s suits against St. Alexi-us Medical Center and the members of its Institutional Review Committee were properly dismissed.

Violation of a statutory duty can be evidence of negligence. Keyes v. Amundson, 391 N.W.2d 602 (N.D.1986). Compare Ross by Kanta v. Scott, 386 N.W.2d 18 (N.D.1986). Kershaw argued that this rule applies to violation of a federal regulation and that the trial court abused its discretion in refusing to admit 21 CFR §§ 813.120 and 813.130 as evidence. 2 Kershaw contended that Dr. Reic-hert did not comply with these regulations, particularly § 813.130(a)(10), which called for disclosure that the investigational lens was being used for research purposes. To decide this case, we assume, without deciding, that violation of a federal regulation can be evidence without implying a private claim from the federal enactment. 3

Trial courts have broad discretion in determining the relevancy of proffered evidence [B ank of Steele v. Lang, 399 N.W.2d 293 (N.D.1987) ] and in controlling the introduction of cumulative evidence [Williams County Social Services Board *19 v. Falcon, 367 N.W.2d 170 (N.D.1985)]. Our review is limited to determining if the trial court abused its discretion. Williams County Social Services Board v. Falcon, supra. “The exclusion of admissible evidence does not constitute reversible error when the excluded evidence is merely cumulative of other properly admitted evidence.”

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Bluebook (online)
445 N.W.2d 16, 1989 N.D. LEXIS 156, 1989 WL 82328, Counsel Stack Legal Research, https://law.counselstack.com/opinion/kershaw-v-reichert-nd-1989.