Court Opinion

ID: 9763827
Source: CourtListenerOpinion
Date Created: 2023-08-29 02:56:50.14118+00
Date Added: 2024-06-11T07:29:49.928846
License: Public Domain

RAKER, Judge,
concurring in result only:
These appeals present the narrow question of whether the Circuit Courts erred in granting summary judgments to appel-lee, the Kennedy Krieger Institute, a research entity, on the ground that, as a matter of law, it owed no duty to warn appellants, Ericka Grimes and Myron Higgins, et al., human *115subjects participating in its research study. I concur in the judgment of the Court only and join in the Court’s judgment that the Circuit Courts erred in granting summary judgments to appellee. These cases should be remanded for further proceedings.
I concur in the Court’s judgment because I find that appellants have alleged sufficient facts to establish that there existed a special relationship between the parties in these cases, which created a duty of care that, if breached, gives rise to an action in negligence. See Ashburn v. Anne Arundel County, 306 Md. 617, 630-31, 510 A.2d 1078, 1083 (1986). I would hold that a special relationship giving rise to a duty of care, the breach of which would be the basis for an action in negligence, existed in these cases and would remand the cases at bar to the Circuit Courts for further proceedings. I agree with the majority that this duty includes the protection of research subjects from unreasonable harm and requires the researcher to inform research subjects completely and promptly of potential hazards resulting from participation in the study. See maj. op. at 93, 98-99, 113. As a result of the existence of this tort duty, I find it unnecessary to reach the thorny question, not even raised by any of the parties, of whether the informed consent agreements in these cases constitute legally binding contracts. See maj. op. at 46 (stating that “the consents of the parents in these cases under Maryland law constituted contracts creating duties”); id. at 89 (stating that “we hold from our own examination of the record that such provisions were so contained, mutual assent, offer, acceptance, and consideration existed, all of which created contractual relationships imposing duties by reason of the consent agreements themselves ...”); id. at 113 (stating that “[w]e hold that informed consent agreements in nontherapeutic research projects, under certain circumstances can constitute contracts . . .”).
I have some concern with the mixed message sent by the majority as to whether the existence of a tort duty arising from a special relationship existed is a question of law for the *116court or a question to be determined by the trier of fact. For example, the majority states that “the creation of study conditions or protocols or participation in the recruitment of otherwise healthy subjects to interact with ... hazardous conditions ... would normally warrant or create ... special relationships as a matter of law.” Maj. at 92-93 (emphasis added). The majority also concludes that “informed consent agreements in nontherapeutic research projects ..., under certain circumstances, ... can, as a matter of law, constitute ‘special relationships’ giving rise to duties, out of the breach of which negligence actions may arise.” Id. at 113 (emphasis added).
On the other hand, citing Williams v. Baltimore, 359 Md. 101, 753 A.2d 41 (2000), the majority ultimately concludes that the determination as to whether a duty of care existed between the parties is a question to be determined by the trier of fact on a case-by-case basis. See maj. op. at 113. I disagree with that conclusion. The holding in Williams relied upon Ashbum, which stated only that “[i]n order for such a [special] relationship to be found between police and perpetrator, it must be alleged that there was some type of ongoing custodial relationship between the police officer and the actor.” Ashburn, 306 Md. at 631 n. 2, 510 A.2d at 1085 n. 2. Prior to Williams, Maryland case law established that existence of a duty of care is a legal question to be determined by the trial court, in the first instance, and this Court on appeal. See Rosenblatt v. Exxon Co., 335 Md. 58, 76, 642 A.2d 180, 189 (1994) (stating that “the question whether Exxon owed a duty to Rosenblatt is an issue of law, to be determined by the court”); Jacques v. First Nat’l Bank, 307 Md. 527, 533, 515 A.2d 756, 759 (1986) (stating that “the duty with which we are here concerned is a duty imposed by law as a matter of sound policy, for the violation of which a person may be held to respond in damages in tort.”); cf. W. Page Keeton et al., Prosser and Keeton on Torts § 45, at 320 (5th ed.1984). I see no principled reason to create an express exception to this rule for tort duties arising out of special relationships, particularly in cases like those sub judice where there are no material *117facts relating to the existence of a special relationship in dispute. In contrast, it is the question of whether such duty was breached in the two cases presented that is a factual determination to be made by the finder of fact after a trial on the merits on remand. Cf. maj. op. at 57 n. 21.
As I have indicated, this case presents a narrow question of whether a duty in tort exists between the plaintiffs and the defendants. The majority recites the standard of review on summary judgment, and iterates' that “[t]he purpose of the summary judgment procedure is not to try the case or to decide the factual disputes, but to decide whether there is an issue of fact, which is sufficiently material to be tried.” Maj. op. at 73. Nonetheless, the majority appears to have decided the issue of whether such duty of care was, in fact, breached as a matter of law, without a hearing or a trial on the merits.
I cannot join in the majority’s sweeping factual determinations that the risks associated with exposing children to lead-based paint were foreseeable and well known to appellees and that appellees contemplated lead contamination in participants’ blood, see id. at 97-98 103; that the children’s health was put at risk, see id. at 43-43; that there was no complete and clear explanation in the consent agreements that the research to be conducted was designed to measure the success of the abatement procedures by measuring the extent to which the children’s blood was being contaminated and that a certain level of lead accumulation was anticipated, see id. at 37-38, 56-57, 63, 97-98; that the parental consent was ineffective, see id. at 46, 97; that the consent form was insufficient because it lacked certain specific warnings, see id. at 90; that the consent agreements did not provide that appellees would provide repairs in the event of lead dust contamination subsequent to the original abatement measures, see id. at 114 n. 43; that the Institutional Review Board involved in these cases abdicated its responsibility to protect the safety of the research subjects by misconstruing the difference between therapeutic and nontherapeutic research and aiding researchers in circumventing federal regulations, see id. at 38-40, 45-46; that Institu*118tional Review Boards are not sufficiently objective to regulate the ethics of experimental research, see id. at 45-46; that it is never in the best interest of any child to be placed in a nontherapeutic research study that might be hazardous to the child’s health, see id. at 104; that there was no therapeutic value in the research for the child subjects involved, see id. at 109; that the research did not comply with applicable regulations, see id. 97; or that there was more than a minimal risk involved in this study, see id. at 97. I do not here condone the conduct of appellee, and it may well be that the majority’s conclusions are warranted by the facts of these cases, but the record before us is limited. Indeed, the majority recognizes that the record is “sparse.” Maj. op. at 46. The critical point is that these are questions for the jury on remand and are not properly before this Court at this time.
I emphasize that we are deciding the propriety of granting summary judgment. Therefore, upon remand, appellee is free to offer evidence to support its position.
Unfortunately, the majority chooses to go far beyond the narrow question presented in these appeals and addresses a number of ancillary issues in dicta. I cannot join the majority in holding that, in Maryland, a parent or guardian cannot consent to the participation of a minor child in a nontherapeutic research study in which there is any risk of injury or damage to the health of the child without prior judicial approval and oversight. See id. at 41, 46-47, 100-101, 108-109, 113-114. Nor can I join in the majority’s holding that the research conducted in these cases was per se inappropriate, unethical, and illegal, see id. at 41-42, 46, 96-97, 105, 108-109, 112. Such sweeping holdings are far beyond the question presented in these appeals, and their resolution by the Court, at this time, is inappropriate. I also do not join in what I perceive as the majority’s wholesale adoption of the Nuremberg Code into Maryland state tort law. See id. at 98-99,100. *119Finally, I do not join in the majority’s comparisons between the research at issue in this case and extreme historical abuses, such as those of the Nazis or the Tuskegee Syphilis Study. See id. at 43-44.
Accordingly, I join the majority only in the judgment to reverse the Circuit Courts’ granting of summary judgments to appellees.
ON MOTION FOR RECONSIDERATION
PER CURIAM.
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.
*120Much 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 the health 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.