Medical Research Cases/Consent and Informed Consent

Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001) - Motion for Rehearing Denied.

Full Case - Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08-16-2001)

Case Brief Maryland Court Imposes Judicial Review on Non-Therapeutic Research on Children - Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08-16-2001)

PER CURIAM OPINION along with its dissent on MOTION FOR

RECONSIDERATION follows:

IN THE COURT OF APPEALS OF MARYLAND
September Term, 2000
No. 128
ERICKA GRIMES
v.
KENNEDY KRIEGER INSTITUTE, INC.
_________________________________________
No. 129

MYRON HIGGINS, a minor, etc., et al.
v.

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KENNEDY KRIEGER INSTITUTE, INC., et al.

Eldridge
Raker
Wilner
Cathell
Harrell
Battaglia,
Karwacki, Robert L.
(retired, specially assigned),
JJ.
On Motion for Reconsideration
Per Curiam
Raker, J., Dissents.
Filed: October 11, 2001

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The Court has considered the motion for reconsideration and the submissions by the various amici curiae. The motion is denied, with this explanation. Some of the issues raised in this case, in the briefs and at oral argument, were important ones of first impression in this State, and the Court therefore attempted to address those issues in a full and exhaustive manner. The case reached us in the context of summary judgments entered by the Circuit Court, which entailed rulings that the evidence presented by the plaintiffs, for purposes of the motions, even when taken in a light most favorable to them, was insufficient as a matter of law to establish the prospect of liability. We disagreed with that determination. Although we discussed the various issues and arguments in considerable detail, the only conclusion that we reached as a matter of law was that, on the record currently before us, summary judgment was improperly granted - that sufficient evidence was presented in both cases which, if taken in a light most favorable to the plaintiffs and believed by a jury, would suffice to justify verdicts in favor of the plaintiffs. Thus, the cases were remanded for further proceedings in the Circuit Court. Every issue bearing on liability or damages remains open for further factual development, and any relevant evidence not otherwise precluded under our rules of evidence is admissible.

Much of the argument in support of and in opposition to the motion for reconsideration centered on the question of what limitations should govern a parent's authority to provide informed consent for the participation of his or her minor child in a medical study. In the Opinion, we said at one point that a parent "cannot consent to the participation of a child . . .in nontherapeutic research or studies in which there is any risk of injury or damage to thehealth of the subject." As we think is clear from Section VI of the Opinion, by "any risk," we meant any articulable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of the statement was a non-therapeutic study that promises no medical benefit to the child whatever, so that any balance between risk and benefit is necessarily negative. As we indicated, the determination of whether the study in question offered some benefit, and therefore could be regarded as therapeutic in nature, or involved more than that minimal risk is open for further factual development on remand.

Dissenting Opinion follows:
Circuit Court for Baltimore City
Case No. 24-C-000925
Case No. 24-C-95066067/CL 193461
IN THE COURT OF APPEALS OF MARYLAND
September Term, 2000

_______________________________________________

No. 128
ERICKA GRIMES
v.
KENNEDY KRIEGER INSTITUTE, INC.
______________________________________________
No. 129
MYRON HIGGINS, a minor, etc., et al.
v.
KENNEDY KRIEGER INSTITUTE, INC., et al.
_______________________________________________

Eldridge
Raker
Wilner
Cathell
Harrell
Battaglia
Karwacki, Robert L. (retired, specially assigned), JJ.
______________________________________________

Dissenting Opinion by Raker, J.

______________________________________________

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Filed: October 11, 2001

Raker, J., dissenting:

I respectfully dissent from the order denying the motions for reconsideration. I adhere to the views previously expressed in my concurring opinion filed herein on August 16, 2001. The majority's discussion of the ability of a parent or guardian to consent to the participation of a minor child in a nontherapeutic research study and the discussion regarding the ethics of the research conducted in these cases involve serious public policy considerations. The statements are a declaration of public policy that, in the posture of this case, are best left to the General Assembly. See Gaver v. Harrant, 316 Md. 17, 28-29, 557 A.2d 210, 217 (1989); Harrison v. Mont. Co. Bd. of Educ., 295 Md. 442, 460, 456 A.2d 894, 903 (1983). Inasmuch as these issues were never raised by the pleadings or the parties below, this Court had no basis to address these very complex issues; if a change is to be made in the State's policy of regulating research studies, unless clearly presented to the court, it should be made by legislative enactment. See Md. Nat'l Bk. v. United Jewish App., 286 Md. 274, 407 A.2d 1130 (1979). This matter merits the close scrutiny of the General Assembly. See Cotham and Maldonado v. Board, 260 Md. 556, 273 A.2d 115 (1971).