White v. Kennedy Krieger Institute, Inc.

FRIEDMAN, J. As a minor, Appellant Tyron White participated in a lead reduction treatment study facilitated by Appellee Kennedy Krieger Institute. White alleges that while enrolled in the study, and as a result of the tortious conduct of Kennedy Krieger Institute, he was exposed to harmful levels of lead that caused irreparable brain injuries. The trial court dismissed several of White’s claims on motions and the jury rejected those that survived. On appeal from the Circuit. ⁶⁰⁷ Court for Baltimore City, White raises three issues that we have reordered and reworded: 1.

Whether the trial court erred by providing insufficient jury instructions regarding the duty of care owed by a research institution to a research subject. 2. Whether the trial court erred in concluding that White cannot maintain an action for fraudulent or negligent misrepresentation because, as a two-and-a-half year old at the time, White cannot demonstrate that he relied on any alleged misrepresentation. 3. Whether the trial court erred in concluding that Kennedy Krieger Institute cannot be liable under the Maryland Consumer Protection Act because there was no direct commercial transaction between it and White. For the reasons that follow, we shall affirm the judgments of the circuit court.

FACTUAL AND PROCEDURAL HISTORY I. The Treatment of Lead-Exposed Children Study This case arises out of a research study conducted by Kennedy Krieger Institute (“KKI”) in Baltimore City in the 1990s called the Treatment of Lead-Exposed Children Study, which was known as the “TLC Study.” The TLC Study originated as a partnership between the National Institute of Environmental Health Sciences (“NIEHS”), the Office of Research and Minority Health of the National Institutes of Health, and four separate Clinical Centers in separate cities managed by different entities. KKI oversaw and managed the TLC Study at the Baltimore City Clinical Center. The TLC Study was designed to study methods of addressing the high incidence of lead poisoning in inner cities. The TLC Study involved two components: (1) to evaluate the effects of the oral chelating agent, succimer, 1 on moderately lead poi ⁶⁰⁸ soned children; and (2) to evaluate benefits of residential lead clean-up and nutritional supplementation for these children.

For present purposes, there were two criteria for a child to be eligible to participate in the TLC Study: (1) the child, aged between 12 and 32 months, had to have a moderate existing blood lead level (between 20 and 44 micrograms per deciliter); 2 and (2) the child had to reside in a home that was structurally sound and capable of being cleaned. The children were referred to the study by their pediatricians, or because they were already participating in the KKI Lead Clinic, which operated separately from the TLC Study. Prior to a child’s participation in the TLC Study, KKI required parents 3 to give informed consent to participation both during pre-enrollment screening and at the enrollment stage. Once a child was referred to the TLC Study, a KKI investigator would review the TLC Study pre-enrollment informed consent form (“pre-enrollment consent form”) with the parents of the eligible child.

The relevant sections of the preenrollment consent form are as follows: Your child has been exposed to a moderate amount of lead ... We do not know if giving a child medicine to get rid of some of the lead in her/his body will keep the lead from harming her/him.... Your child may be eligible for our study ... We want to see whether a medicine prevents lead in children’s bodies from harming them as they grow older.

This medicine is called succimer, and it gets rid of some of the lead in ⁶⁰⁹ children’s bodies. It is now used for children who have more lead in their bodies than your child has. All children in the TLC Study will have their homes repaired and/or cleaned to get rid of lead dust and chipped paint. We will take a careful look at your home to see if it can be repaired and/or cleaned to reduce lead paint and dust hazards.

The person that takes a look at your house may collect dust samples from your home to check for lead. All children will get vitamins and minerals, will get regular checkups and blood tests from a doctor, and will get tests of their thinking, learning and development.... Every child will be in [the placebo] group or the [succimer group]. Unless there is a problem, you and the TLC doctor who takes care of your child will never know which group your child is in.

There will be another doctor at the hospital who does know your child’s group in case of problems. The pre-enrollment consent also described what the preenrollment process entailed: 1. Clinic visits and blood tests: Today we will do a blood test and check up of your child ... We will measure the amount of lead [to determine eligibility]....

Specifically, the pre-enrollment consent forms explained how KKI would conduct an initial assessment of the child’s home at the pre-enrollment stage as part of the environmental component. 2. Home visits and Cleanup: Trained workers will come to your home to look at painted surfaces, including porches, walls, floors, windows and trim; this is to find out whether your house can be cleaned or repaired to reduce lead hazards in paint and dust.... Some houses will qualify straightaway based on condition. If repairs are needed to qualify your house, the owner or landlord must give his/her permission for the repairs, with our help apply for a state loan and be approved for the loan for special repair funds.

If your house does not qualify at ⁶¹⁰ all, the person checking your home will explain why and provide further information on “lead safe” housing---- 3. Vitamins and minerals: We will give you vitamins with minerals tablets[.] If KKI determined that a child was eligible for the study, the pre-enrollment consent form explained that KKI would arrange for trained workers to return to the child’s house and “[vjacuum and wet-wash floors, window sills, window wells and other surfaces ... to remove as much lead dust and loose chips of paint as possible, [m]ake some repairs, if the owner has special approval for a loan, [and pjrovide you with information on how you can reduce lead exposure in the home.” Assessment guidelines were governed by the TLC Protocol. KKI used the same standardized home assessment forms that were used at all Clinical Centers. Depending on the results of the assessment, the home was either professionally cleaned to remove existing lead dust and paint chips, or parents were provided with information on relocating to “lead safe” housing. 4 After the cleaning and repairs, KKI provided parents with cleaning supplies and instructions on how to further reduce lead exposure in the home.

Upon completion of the pre-enrollment screening stage, KKI representatives would then provide parents with the TLC Study enrollment informed consent form (“enrollment consent form”) to complete the child’s enrollment in the study. For our purposes, the relevant portions are set out below. 2. Blood lead results: You and the TLC doctor taking care of your child will not know the results of the blood lead tests done during the first six months after your child starts taking capsules, but another doctor will know in case there ⁶¹¹ is a problem ... You may have the blood lead results after these treatment periods if you want them.... 5.

Damage at home or moving to a different home: It is important for you to tell us if you move, or if a plumbing leak or anything else damages the walls or ceilings in your home, because we will need to come out and inspect and clean up as we did at the beginning of the study. If the doctor who sees the results of the blood lead tests finds that the amount of lead in your child’s blood has gone up too much, we may want to come and inspect or clean your home again. Very rarely, a child’s blood lead level might go up so high during the study that they might receive additional treatment outside of the study. The enrollment consent form also highlighted the various benefits that KKI expected all children participating in the TLC Study to receive.

Specifically, KKI told parents that it would inspect the home for the presence of lead dust and chipped paint, “clean-up the lead dust in your home,” provide the child with vitamins and minerals, provide regular medical check-ups for the child, check the child’s blood lead levels “regularly and carefully,” and test the child’s thinking and development. In the medical treatment component of the study, KKI sought to determine whether succimer, which had previously been used only for children with extremely elevated blood lead levels (in excess of 44 mcg/dL), could also be used to treat children with moderately elevated blood lead levels between 20 and 44 mcg/dL. All study participants received one to three rounds of either succimer or the placebo during the six-month treatment period, and their blood lead levels were measured two weeks after every round of treatment. The entire study period lasted three years.

After completion of the six-month treatment period, participants continued to receive vitamins and mineral supplements, regular medical check-ups, blood testing, and various cognitive tests for the remainder of the study. ⁶¹² The medical treatment component of the TLC Study was “double blind,” meaning that neither KKI nor the parents of the children knew whether the child was given the placebo or the succimer until the completion of the treatment period. To maintain the double blind nature of the TLC Study, blood test results were reviewed by a separate physician who did not have any contact with the parents during the treatment period. That physician did not report the results to KKI, but rather to the central TLC Data Coordinating Center run by the Harvard School of Public Health in Boston. If, after the first round of succimer treatment, a participant child’s blood lead level remained above 15 mcg/dL, the Data Coordinating Center was required to advise KKI to conduct a retreatment for both placebo and succimer recipients (to maintain the double blind nature of the study).

According to the TLC Study Protocol, there were two circumstances where the Data Coordinating Center was required to notify KKI of an individual child’s blood test result. First, if the child’s blood lead level was 45 mcg/dL or higher, the Data Coordinating Center was required to direct KKI to retest the child’s blood within three days. If the child’s blood lead level measured 45 mcg/dL or higher after the retesting, the child’s participation in the TLC Study treatment would have paused, and the child would have been treated in accordance with KKI’s normal protocol for children with lead levels above 44 mcg/dL, including succimer treatment. Second, if the child’s blood lead level measured above 60 mcg/dL, participation in the TLC Study would have ended immediately and the child would have been treated according to KKI’s treatment protocols for children with lead levels above 60 mcg/dL.

Ultimately, in 2001 the results of the TLC study were published. The researchers found that: Treatment with succimer lowered blood lead levels but did not improve scores on tests of cognition, behavior, or neuropsychological function in children with blood lead levels below 45 mg per deciliter. [Because] succimer is as effective as any lead chelator currently available, chelation therapy is not indicated for children with these blood lead levels. ⁶¹³ Walter J. Rogan, MD et al., The Effect of Chelation, Therapy with Succimer on Neuropsychological Development in Children Exposed to Lead, 344 New Eng. J. Med. No. 19, 1421 (2001).

The researchers ultimately concluded that because “lead poisoning [is] entirely preventable, our inability to demonstrate effective treatment lends further impetus to efforts to protect children from exposure to lead in the first place.” Id. at 1426.

II

Tyron White Appellant Tyron White (“White”) was two years old when a blood test revealed that he had a blood lead level of 43 mcg/dL. His physician at East Baltimore Medical Center then referred White’s mother, Carolyn Riddick, to the TLC Study. In August of 1995, Ms. Riddick met with KKI research investigator, Dr. Cecilia Davoli, who reviewed the preenrollment consent form with Ms. Riddick and explained the objectives and the process of the study. Ms. Riddick signed the pre-enrollment consent form and KKI performed another blood test to verify White’s blood lead levels.

The test revealed that his blood lead levels had increased to 47 mcg/dL, which was too elevated for White to be eligible for the study. After receiving the test results, Ms. Riddick scheduled White for another pre-enrollment visit that was conducted on August 21, 1995. At that time, Ms. Riddick signed another pre-enrollment consent form that was identical to the first. White was retested and his blood lead level measured 39 mcg/dL, which was within the TLC Study eligibility range.

White’s rental home at 1107 Gorsuch Avenue was then inspected by KKI on August 23, 1995, but it was determined not to be cleanable because of its poor condition and high levels of lead contamination. As a result, White remained ineligible for the TLC study. Ms. Riddick relocated to 3215 Tinges Lane in October of 1995. She contacted KKI and a KKI inspector determined the new property to be cleanable.

At this point, White was eligible for enrollment in the TLC Study. Ms. Riddick signed the enrollment consent form on October 3, 1995, thus complet ⁶¹⁴ ing White’s enrollment. KKI hired a contractor to perform a “lead clean” of the Tinges Lane property shortly thereafter. In January of 1996, only four months later, Ms. Riddick decided to move again.

She testified at trial that a KKI social worker not involved with the TLC Study, Kristy Council, provided her with a list of “lead safe” properties and drove Ms. Riddick around to view the homes. From the list provided, Ms. Riddick selected a property at 642 Gorsuch Avenue. Ms. Council assisted Ms. Riddick to obtain $375 to pay for the security deposit. A KKI inspector looked at the Gorsuch property in February 1996 and determined that it qualified for TLC Study purposes.

KKI hired a contractor to perform a “lead clean” of the 642 Gorsuch Avenue property in April of 1996. According to KKI records, lead dust sampling conducted by KKI before and after the professional cleaning revealed that after the professional cleaning, lead dust levels actually increased in four of the seven sampled areas. 5 In June of 1996, White’s blood lead level was 29 meg/dL, which was nine points higher than when he first moved into the 642 Gorsuch Avenue property, but lower than when he first entered the TLC Study. 6 At the time these measurements were taken, White was still in the double blind treatment period of the TLC Study. White remained at the Gorsuch property until July 1996. On July 13, 2011, White filed suit against numerous defendants, including KKI, alleging that he suffered significant brain injury as a result of toxic lead exposure.

In his complaint against KKI, White alleged that he suffered toxic lead ⁶¹⁵ exposure resulting from KKI’s tortious design and implementation of the TLC Study. In Counts 40-42, White alleged that KKI negligently and intentionally misrepresented the lead-based paint hazards in his home during the time that he was in the TLC Study, as well as the risk of harm to White as a result of participating in the study. In Count 43, White also alleged that KKI was negligent in failing to properly review and oversee the TLC Study. Lastly, in Count 44, White alleged that KKI is liable under the Maryland Consumer Protection Act (“CPA”) for misrepresentations made when assisting Ms. Riddick to find “lead safe” housing.

The trial court granted judgment in favor of KKT pursuant to Md. Rule 2-519 at the close of plaintiffs case in White’s claims of negligent and intentional misrepresentation (Counts 40-42), and violation of the CPA (Count 44). The only issue presented to the jury was whether KKI negligently failed to properly review and oversee the TLC Study. On April 29, 2014, after a lengthy trial, the jury returned a verdict in favor of KKI, finding that KKI did not act negligently in planning and implementing the TLC Study. This appeal followed.

DISCUSSION I. Background Although lead paint cases are not new to Maryland courts, this case is rather unique in light of White’s claims against KKI and, as a result, his heavy reliance on the Court of Appeals’s decision in Grimes v. Kennedy Krieger Institute, 366 Md. 29 , 782 A.2d 807 (2001), to inform much of his argument. To our knowledge, the applicability of the Grimes decision has not been revisited in depth by a Maryland court since the Court of Appeals denied reconsideration of its G'times decision in October 2001. Because of the central role that the Grimes opinion plays in the case at hand, we begin our discussion with an in-depth look at the facts of that case and the conclusions reached by the Court of Appeals. The facts giving rise to the Grimes litigation arose from another research study facilitated by KKI in the 1990s — the ⁶¹⁶ Evaluation of Efficacy of Residential Lead Based Paint Repair and Maintenance Interventions, (“R & M Study”) — that sought to test the effectiveness of varying levels of lead abatement procedures in rental housing units in Baltimore City.

Grimes, 366 Md. at 36 , 782 A.2d 807 . The R & M Study aimed to find cheap, yet effective, environmental lead clean-up interventions that would still protect children but be economically feasible for landlords of low income rental housing units. Id. at 51 , 782 A.2d 807 . The R & M Study consisted of five test groups of homes with varying levels of lead and lead intervention.

Id. at 50 , 782 A.2d 807 . Groups 1 through 3 were homes with known lead paint contamination that received different levels of repair and maintenance. Id. at 53 , 782 A.2d 807 . Group 4 consisted of fully abated homes that required no additional repair or maintenance, and Group 5 homes were constructed after 1980 and did not have any lead paint.

Id. at 54 , 782 A.2d 807 . To measure the success of the various abatement levels, KKI needed families with young children to live in the R & M Study homes, and consent to routine blood lead level tests for their small children for a period of two years. Id. at 37, 49-50 , 782 A.2d 807 . In some instances, KKI helped landlords receive federal funding for the abatements, and then encouraged or required the landlords to rent partially abated homes to families with young, otherwise healthy children.

Id. at 36-37 , 782 A.2d 807 . “It was anticipated that the children, who were the human subjects in the program, would, or at least might, accumulate lead in their blood from the dust, thus helping the researchers to determine the extent to which the various partial abatement methods worked.” Id. at 38 , 782 A.2d 807 . In short, on the facts before the Court of Appeals, 7 the R & M Study actively recruited healthy children to move ⁶¹⁷ into and reside in housing with known lead contamination risks, and measured the effectiveness of abatement procedures by the extent to which the children’s blood levels became contaminated with lead. Placing healthy children in environments where KKI knew that the children could face the risk of lead poisoning prompted an outraged and angry response from the Court, which compared the R & M Study to the Tuskegee Syphilis Study, as well as other notorious human experiments such as: ... the deliberate use of infection in a nontherapeutic project ... to study the degree of infection and the rapidity of the course of the disease in the Rose and Mrugowsky typhus experiments at Buchenwald concentration camp during World War II. These programs were somewhat alike in the vulnerability of the subjects; uneducated African-American men, debilitated patients in a charity hospital, prisoners of war, inmates of concentration camps and others falling within the custody and control of the agencies conducting or approving the experiments.

In the present case, children, especially young children, living in lower economic circumstances, albeit not as vulnerable as the other examples, are nonetheless, vulnerable as well. Id. at 44-45 , 782 A.2d 807 . The Court of Appeals concluded that the rights of each individual child unknowingly subjected to dangerous conditions outweighs any interests of the researcher in promoting the public good. Id. at 104 , 782 A.2d 807 .

The Court of Appeals in Grimes was particularly outraged by what it understood to be KKI’s failure to warn parents of the risks of participating in the R & M Study both at the informed consent stage, and as risks became known or foreseeable during the study. Id. at 99 , 782 A.2d 807 . The consent forms signed by the parents did not explain that the success of the various levels of abatement was to be measured, in part, by the extent to which their children’s blood was contaminated with lead. Id. at 38 , 782 A.2d 807 .

Additionally, KKI failed to warn parents during the study that their children’s blood lead levels were increasing. In the case of ⁶¹⁸ Ericka Grimes, appellant and one of the child subjects, KKI tested her home for the presence of lead after performing a partial abatement. Id. at 58 , 782 A.2d 807 . However, KKI did not reveal the results of the test that identified several lead “hot spots” until nine months later, after Ericka Grimes had already been lead poisoned.

Id. at 59 , 782 A.2d 807 . The central legal question addressed by the Court of Appeals was what duty of care a researcher owes to the study participants. The Court specifically limited its holding to a nontherapeutic research study, which it defined as one that “generally utilizes subjects who are not known to have the condition the objectives of the research are designed to address ... [and] is not designed to directly benefit the subjects utilized in the research, but, rather ... the public at large.” Id. at 36 n. 2, 782 A.2d 807 . In addressing the scope of the researcher’s duty to research subjects in such a nontherapeutic study, the Court of Appeals in Grimes reached several conclusions: We hold that in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject.

We hold that informed consent agreements in nontherapeutic research projects ... can, as a matter of law, constitute “special relationships” giving rise to duties, out of the breach of which negligence actions may arise. We also hold that, normally, such special relationships are created between researchers and the human subjects used by the researchers. Additionally, we hold that governmental regulations can create duties on the part of researchers towards human subjects out of which “special relationships” can arise.... The determination as to whether a “special relationship” actually exists is to be done on a case by case basis.

The determination as to whether a special relationship exists, if properly pled, lies with the trier of fact. ⁶¹⁹ Id. at 113-14 , 782 A.2d 807 . The Court of Appeals reversed the trial court’s grant of summary judgment and remanded based on the grounds that there were material facts in dispute as to whether a special relationship existed which would have imposed certain duties on KKI. Id. at 48 , 782 A.2d 807 . Judge Irma Raker concurred in the result only.

Judge Raker criticized the “mixed message” sent by the Grimes majority “as to whether the existence of a tort duty arising from a special relationship existed is a question of law for the court or a question to be determined by the trier of fact.” Id. at 115-16 , 782 A.2d 807 . Specifically, Judge Raker highlighted the following two self-contradictory pronouncements of the Court: (1) “We hold that informed consent agreements in nontherapeutic research projects ... can, as a matter of law [as determined by the trial judge], constitute ‘special relationships’ giving rise to duties;” and (2) “The determination as to whether a special relationship exists, if properly pled, lies with the trier of fact [in this case, the jury].” Id. at 113-114 , 782 A.2d 807 . The majority did not clarify this aspect of the decision in response to Judge Raker’s criticism. After the Grimes opinion was issued, KKI filed a motion for reconsideration, which was supported by a joint amicus brief from the Association of American Medical Colleges, the Association of American Universities, the University of Maryland Medical System, and Johns Hopkins University.

Appellee’s Br. in Supp. of Mot. to Recons., Grimes, 366 Md. 29 , 782 A.2d 807 (2001), recons, denied (Oct. 11, 2001), available at chttp:// perma.cc/WJ82-9NHY>; Br. of Amici Curiae Assoc. of Am. Med. Coll., Ass’n of Am. Univ., Johns Hopkins Univ., and Univ. of Md. Med.

Sys. Corp. in Supp. of Appellee’s Mot. for Recons., Grimes, 366 Md. 29 , 782 A.2d 807 (2001) recons, denied (Oct. 11, 2001), available a,t <http://perma.cc/ET6ZGUVQ>. The research community was concerned that the Grimes decision would effectively prohibit any research involving children even if the research institution complied with all applicable federal regulations regarding research using children. Id.; Anna C. Mastoianni and Jeffrey P. Kahn, Risk and Responsibility: Ethics, Grimes v. Kennedy Krieger, and Pub ⁶²⁰ lic Health Research Involving Children, 92 Am.

J. Pub. Health 1073, 1074 (Jul.2002). This concern stemmed from the Grimes majority’s apparent conclusion “that parents in the state of Maryland could not consent to their minor children’s participation in research that posed even a minimal risk of harm if it offered no prospect of direct medical benefit to the subjects.” Id. at 1073. Critics noted that “[this] statement, which the Court referred to as a holding, was also puzzling because the issue was raised by the Court rather than at the request of the parties.” Diane D. Hoffmann & Karen H. Rothenburg, Whose Duty is it Anyway?: The Kennedy Krieger Opinion and its Implications for Public Health Research, 6 J. Health Care L. & Pol’y 109, 109-10 (2002) [hereinafter, “Whose Duty is it Anyway?”].

Two months after issuing the opinion in Grimes , and in light of the various concerns raised on reconsideration, the Court of Appeals denied the motion, albeit with a large caveat. In denying the motion, the Grimes Court claimed that “the only conclusion that we reached as a matter of law was that, on the record currently before us, summary judgment was improperly granted.” Grimes, 366 Md. at 119 , 782 A.2d 807 . Further, the Court clarified: [B]y “any risk,” we meant any articulable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of this 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. Grimes at 120, 782 A.2d 807 . Judge Raker dissented from the depial of the motion for reconsideration both restating the concerns she raised in her original concurring opinion, as well as. noting her opposition to the majority’s “declaration[s] of ⁶²¹ public policy that, in the posture of this case, are best left to the General Assembly.” Id. 8 ⁶²² In light of the Court of Appeals’s pointed effort to specifically limit its holding, we are constrained to hold fast to the narrow parameters set out by the Court of Appeals in its denial of the motion for reconsideration. With this understanding of Grimes in mind, we now address the three issues raised by White on appeal.

II

Jury Instructions The first issue that we address is whether the trial court erred by refusing to provide White’s requested jury instructions. White asked the trial court to instruct the jury on two issues regarding KKI’s duty of care: (1) the duty of care imposed by the execution of a consent form in a research study under Grimes ; and (2) on the evidence of negligence arising from the violation of federal regulations. Regarding the former, White frames his argument in large part using dicta from Grimes , and asks us to find that Court of Appeals’s discussion of a researcher’s duty to the research subject in Grimes is both the applicable law in Maryland, and applicable to the facts of this case, thereby mandating that the trial court provide his requested jury instruction. The latter are based on the federal regulations pertaining to informed consent in research studies.

For the reasons that follow, we affirm the ruling of the trial court and hold that the jury instructions requested by White were not compelled. There are “three components that must be met to include a proposed jury instruction in the ultimate charge to .the jury: ‘(1) the instruction is a correct statement of law; (2) the instruction is applicable to the facts of the case; and (3) ⁶²³ the content of the instruction was not fairly covered elsewhere in instructions actually given.’ ” Wood v. State, 436 Md. 276, 293 , 81 A.3d 427 (2013) (quoting Dickey v. State, 404 Md. 187, 197-98 , 946 A.2d 444 (2008)); see also Gunning v. State, 347 Md. 332, 348 , 701 A.2d 374 (1997) (same). We review the denial of a proposed jury instruction under the highly deferential abuse of discretion standard, and we will hold that the trial court was within its discretion to exclude all of White’s proposed instructions. See id. at 292, 81 A.3d 427 . i.

Proposed Instruction Based on Grimes Proposed instruction 36 dealt with the duty owed by a researcher to a subject under Grimes , in particular the duty of the researcher to warn of known and foreseeable risks. White requested that KKI’s duty be described as the following: By having [Plaintiffs mother] sign the Consent Form, both KKI and [Plaintiffs mother] made representations, which created a bilateral contract between the parties. At the very least, [it suggests that Plaintiffs mother would be] informed of all the information necessary for the subject to freely choose whether to participate, and continue to participate, and receive promptly any information that might bear on their -willingness to continue to participate in the study. This includes full, detailed, prompt, and continuing warnings as to all the potential risks and hazards inherent in the research or that arise during the research....

Researcher/subject consent in nontherapeutic research can, and in this case did, create a contract. White argues that proposed instruction 36 was necessary to adequately explain to the jury the scope of the researcher’s duties under Grimes . In denying White’s instructions on the duty of care owed under Grimes , the trial court stated, “I’m willing to describe the duty, as Grimes sets forth in here, based on their special relationship as researcher and study participant. I’m just not willing to define that duty, and I don’t think Grimes does ⁶²⁴ either, based on — based on what’s in the consent form.” Instead, the jury instructions given at trial were: Now, in order to establish a claim of negligence, the plaintiff in this case must prove four elements: First, that the defendant, Kennedy Krieger Institute, was under a duty to protect the plaintiff from injury; two, that the defendant breached that duty; three, that the plaintiffs suffered actual injury or loss; and, four, that the loss or injury was caused by the defendant’s breach of the duty.

Now, scientific researchers and research entities owe a duty of care to participants in scientific research studies. This duty requires the protection of the study participants from unreasonable harm and requires the researcher to completely and promptly inform the participants of potential hazards existing during the study. If you find that the plaintiff was a study participant in scientific research by Kennedy Krieger Institute, then you must find that Kennedy Krieger owed a duty of care to the plaintiff as I have just described. Now, negligence is doing something that a person using reasonable care would not do, or not doing something that a person using reasonable care would do.

Reasonable care means that caution, attention, or skill a reasonable person would use under similar circumstances. The trial court also provided the same instructions to the jury by way of a typewritten verdict sheet. The jury specifically concluded that although Kennedy Krieger owed a duty to White, there was no breach of that duty. As described above, we must determine whether "White’s proposed Grimes instruction was a correct statement of law, applicable to the facts of the case, and not otherwise fairly covered by the given instructions.

Wood, 436 Md. at 293 , 81 A.3d 427 . For the reasons that follow, we conclude that the trial court did not abuse its discretion by refusing to provide White’s requested jury instruction. We begin our analysis by discussing whether the instruction was a correct statement of the law. As we stated above in our ⁶²⁵ discussion of Grimes , the only enduring holding in that case was that on the facts of the case before it, the trial court’s grant of summary judgment was inappropriate.

Grimes, 366 Md. at 119 , 782 A.2d 807 . The Court of Appeals remanded for further factual development on all issues pertaining to liability and damages. Id. While Grimes is useful in “attempting to address” the potential issues raised in the context of a nontherapeutic research setting “in a full and exhaustive manner,” the Court did not set forth absolute and determinate standards regarding the creation of a special relationship or the duty owed by a researcher to the subject.

Id. at 119 , 782 A.2d 807 . We, therefore, disagree with White’s assertion that proposed instruction 36 accurately reflected the state of the law in Maryland because Grimes does not set a specific standard. Even if we were to incorporate the pre-reconsideration “holdings” of the Grimes Court, White’s proposed instruction 36 was still not required by law because Grimes did not definitively specify the scope of a researcher’s duty. The duty to warn identified by White in his proposed instruction 36 is discussed by the principal Grimes opinion in dicta, and within the limited context of a factual finding that a special duty may be created when a researcher is in a superior position to identify risks.

To this point, the Grimes court explained: A special relationship giving rise to duties, the breach of which might constitute negligence, might also arise because generally, the investigators are in a better position to anticipate, discover, and understand the potential risks to the health of their subjects.... This duty requires the protection of the research subjects from unreasonable harm and requires the researcher to completely and promptly inform the subjects of potential hazards existing from time to time. Grimes, 366 Md. at 102 , 782 A.2d 807 (emphasis supplied). Thus, at most, pre-reconsideration Grimes stood for the proposition that in certain circumstances, a duty may exist between the researcher and research subject.

In the context of ⁶²⁶ a special relationship resulting from the execution of an informed consent agreement (the context in which White frames his proposed jury instruction), Grimes did not define the scope of the duties owed by the researcher. Id. at 113 , 782 A.2d 807 . Instead, the Grimes majority found generally that under such circumstances, a special relationship may exist “giving rise to duties, out of the breach of which a negligence action may arise.” Id. Therefore, even considering the prior holdings and dicta of Grimes , White’s proposed jury instruction 36 misses the mark because the duty he identifies — to provide full, detailed, prompt, and continuing warnings — is contingent on the factual finding of the existence of a special relationship arising from the researcher’s superior position of knowledge.

The duty identified by White is not, as he asserts, a broad, over-arching duty that automatically attaches; rather, it only arises in a limited context. For this reason, White’s proposed instruction does not accurately reflect the law, and is therefore not required under the first prong of the Wood analysis. Moreover, under the second prong of the Wood analysis, proposed instruction 36 was not required by the facts of the case. We conclude that the benefits provided by KKI to all research participants in the TLC Study are sufficient to remove the TLC Study from the purview of Grimes .

In Grimes , the Court addressed the potential existence of a special relationship in the limited context of a nontherapeutic research study “that promises no medical benefit to the child whatsoever.” Grimes, 366 Md. at 120 , 782 A.2d 807 . The particular situation addressed by Grimes involved “researchers recruiting] people, especially children whose consent is furnished indirectly, to participate in nontherapeutic procedures that are potentially hazardous, dangerous, or deleterious to their health.” Grimes, 366 Md. at 93 , 782 A.2d 807 . Further, “the creation of study conditions or protocols or participation in the recruitment of otherwise healthy subjects to interact with already existing, or potentially existing, hazardous conditions, or both, for the purpose of creating statistics from which scientific hypotheses can be supported” was found by the Court to normally create a special relationship as ⁶²⁷ a matter of law. Id. at 93 , 782 A.2d 807 .

To the extent that Grimes set forth the law, it set forth law in the factual context of nontherapeutic research. It does not apply except indirectly in the context of therapeutic research. 9 We hold that the TLC Study at issue in this case was a therapeutic rather than nontherapeutic study. We come to this conclusion in large part because the TLC Study sought “to directly help or aid a patient who is suffering from a health condition the objectives of the research are designed to address.” Grimes, 366 Md. at 36 n. 2, 782 A.2d 807 (comparing and contrasting therapeutic and nontherapeutic research studies). Although White’s counsel characterizes the TLC Study as nontherapeutic, he does not dispute the underlying facts that demonstrated that it was therapeutic, thus distinguishing the TLC Study from the R & M Study.

First, while the R & M Study took otherwise healthy children and placed them in potentially hazardous conditions, the TLC Study recruited only children who already exhibited elevated blood lead levels. In Grimes , “[i]t was anticipated that the children ... would, or at least might, accumulate lead in their blood from the dust, thus helping the researchers to determine the extent to which the various partial abatement methods worked.” Grimes, 366 Md. at 38 , 782 A.2d 807 . In contrast, in the TLC Study, KKI either cleaned homes in which the children were already living, or provided them with information on how to relocate to safer housing. No research subjects in the TLC Study were placed in more harmful conditions than they were already experiencing. ⁶²⁸ Second, one of the main goals of the TLC Study was to reduce every participant’s further exposure to lead, and every participating child was provided with a number of benefits designed to improve health and reduce the effects of existing elevated blood lead levels.

All participating children received vitamin and mineral supplements, regular medical check-ups, their homes were professionally cleaned, their parents were taught how to further reduce lead exposure in the home through regular cleaning, and their parents were provided with special cleaning materials and cleaning instructions to further reduce lead dust exposures. 10 The environmental component of the TLC Study was designed to limit the participant’s exposure to lead in the home for at least six months and up to three years. As agreed to by both parties to varying degree, cognitive damage from lead exposure occurs during the early years of childhood, and exposure to lead in the home is one of the primary sources of lead contamination. KKI’s efforts to reduce the child participant’s exposure to lead during the timeframe that a child is most vulnerable to the negative effects of lead further served as an intended benefit to all participants. Third, in counter-distinction to the R & M Study, we note that under the TLC Study Protocol, if blood tests revealed that a child’s blood lead level had increased beyond 44 meg/ dL, parents would be notified and KKI would begin individualized treatment of the child.

Participants in the TLC Study would benefit from the early detection of severely elevated blood lead levels resulting from their increased access to medical screenings. For all of these reasons, we hold that the TLC Study is different from the R & M Study in meaningful ways that make it a therapeutic study, thereby taking it out of the factual ⁶²⁹ scope of Grimes . Therefore, White’s requested jury instruction under Grimes is not factually applicable in the present context of a therapeutic study. White’s proposed instruction 36 is also factually inapplicable to the TLC Study because the researchers in the TLC Study lacked the special knowledge that Grimes explained may give rise to special duties.

Even if White’s proposed instruction 36 properly reflected the holding of the Grimes Court (that a special relationship may be created by the researcher’s special knowledge that in turn gives rise to a duty to warn), it would still fail on the facts of the TLC Study. In Grimes , the special knowledge that the researchers had — but that the parents lacked — was knowledge of the child subjects’ elevated blood lead levels. Here, however, the TLC Study was double blind, and pursuant to the TLC Study Protocol, KKI was not notified of the results of an individual child’s blood lead levels unless the child’s blood lead level went above 44 mcg/dL. 11 At any point that a child’s lead levels were confirmed to be higher than 44 mcg/dL during the TLC Study, KKI was required to notify the parent, end the child’s participation in the TLC Study, and begin treating the child according to KKI’s standard procedure for treating children with blood lead levels above 44 mcg/dL. Prior to a child’s blood lead level reaching above 44 mcg/dL, KKI was not notified of fluctuations in blood lead levels, and therefore could not pass along that information to the parents.

Thus, the TLC Study Protocol by design prevented KKI from having the specific knowledge of a child’s elevated lead levels that in Grimes were found to, at times, give rise to special duties. Proposed instruction 36 was also covered, although imperfectly, by the negligence instruction provided by the trial court ⁶³⁰ in satisfaction of the third prong of the Wood analysis. In fact, the trial court instructed the jury that if they found that White was a participant in a human research study, they must find that KKI owed White a duty. In our opinion, this goes beyond Grimes ’ pronouncement that a duty may arise in such circumstances where the researcher has a superior knowledge of the risks of the study.

Therefore, the instructions actually provided were more beneficial to White than that required by the law. Moreover, the jury specifically found that KKI owed White a duty. Thus, there was no harm caused by the allegedly defective instruction. We affirm the trial court’s refusal to give Wdiite’s proposed instruction 36 to the jury. 2.

Proposed Instructions Based on Federal Regulations Proposed instructions 33-33D pertained to guidelines for adequate informed consent under federal law, particularly the Federal Food Drug and Cosmetic Act, 21 CFR § 50 et seq. WTiite argues that the federal regulations pertaining to the adequacy of informed consent are relevant because, under Grimes , the informed consent process is the source of the duty of care owed to the research subject. See Grimes, 366 Md. at 113 , 782 A.2d 807 . (“[I]nformed consent agreements in nontherapeutic research projects, under certain circumstances can constitute contracts; ... that, under certain circumstances ... can, as a matter of law, constitute ‘special relationships’ giving rise to duties.”).

Therefore, White argues that any breach of the federal regulations regarding informed consent is evidence of a breach of that duty. The trial court rejected White’s proposed federal regulation instructions 33-33D primarily on the ground that they were inapplicable to the remaining negligence claim being presented to the jury. Because the only count that went to the jury was whether KKI negligently oversaw the TLC study, the trial court asked “what is the duty of the researcher towards [the subject] while they’re study participants[?] ... Because that’s what we have ...

I mean the consent has really no applicability here.” The trial court further then elaborated, “Grimes does say ... duty can be created by statute ... it ⁶³¹ seemed to me the only thing that will be applicable in this case would be some statute or regulation] that would govern how a researcher is supposed to deal with their study participants.” The trial court then declined to provide instructions 33-33D. We turn briefly to the legal sufficiency of White’s proposed jury instructions 33-33D under the first prong of the Wood analysis. Proposed instruction 33 generally explained that White was “enrolled into an FDA Drug Research Clinical Trial [g]overned in part by the Federal Food Drug and Cosmetic Act” and also subject to the legal requirements of the Baltimore City Code. Therefore, White requested that the jury be instructed that “[violations of the provisions of that law which are designed to protect people enrolled in drug studies is evidence of [n]egligence on the part of ...

KKI.” Instructions 33A-33D are taken directly from 21 CFR §§ 50.20 , 50.23, 50.55, & 46.11 respectively, and pertain to the federal requirements for informed consent when an entity solicits the participation of children in a research study. Neither party challenges that these proposed instructions accurately reflect the federal requirements for informed consent, but rather the dispute lies with their applicability to the facts of the underlying case. Having determined that the requested instructions accurately reflect the federal regulations as they pertain to informed consent, we now turn to the second prong of the Wood analysis. Under the second prong of the Wood test, we must determine whether the proposed instructions were required by the facts.

For the following reasons, we will conclude that proposed instructions 33-33D were not required by the facts presented in this case. Principally, proposed instruction 33B is derived from the federal guidelines on nontherapeutic research studies, and for the reasons discussed above, we have held, and the parties do not seriously contest, that the TLC Study was therapeutic for all participants. 12 The remaining instructions, 33A, 33C, ⁶³² and 33D, deal with the federal requirements for adequate informed consent, a question that was not presented to the jury at trial, and that is not challenged on this appeal. 13 As ⁶³³ the Court of Appeals in Grimes distinguished, “the duty to a vulnerable research subject is independent of consent, although the obtaining of consent is one of the duties a researcher must perform.” 366 Md. at 101 , 782 A.2d 807 . The only claim the White jury was asked to determine was whether KKI negligently oversaw the TLC Study. It was not asked to determine the adequacy of the informed consent.

We hold that there was no abuse of discretion by the trial court in denying the requested instructions as they pertained to a federally regulated informed consent issue that was not before the jury at the time. 14 For all these reasons, we find no error in the trial court’s discretionary decision to exclude White’s requested jury instructions.

III

Fraudulent or Negligent Misrepresentation White’s second challenge concerns whether an infant can maintain an action in tort for fraudulent or negligent misrepresentation in the absence of direct, personal reliance on the false statement. White complains that the trial court erred in dismissing his misrepresentation claims on the grounds that White failed to demonstrate the necessary element of reliance to sustain the action. For the reasons that follow, we uphold the judgment of the trial court, albeit on different grounds. White alleges that KKI is liable for negligent misrepresentation (Count 40) and fraudulent misrepresentation (Count 42) by making five specific misrepresentations regarding the ⁶³⁴ premises at which White resided during his participation in the TLC Study.

In particular, White alleges that KKI misrepresented that: (1) the premises were “lead safe”; (2) the premises were in habitable condition; (3) the premises would be maintained in a habitable condition during White’s tenancy; (4) the premises were in compliance with all applicable statutes, codes, and regulations pertaining to rental properties at the inception of White’s tenancy; and (5) that the premises were safe for White’s residence. In Count 41, White also alleges that KKI negligently misrepresented the risk of harm to White from his participation in the TLC Study. Specifically, White claims that KKI knew that White’s property contained lead dust hazards and that White was at risk for lead poisoning if he remained in the property, but told White’s mother that there was no risk of harm from his continued participation in the TLC Study. At the close of evidence, the trial court granted KKI’s motion for judgment as to all claims of fraudulent and negligent misrepresentation.

The trial court’s ruling was based solely on the grounds that White failed to establish the element of reliance, which is required for both fraudulent and negligent misrepresentation claims: I just don’t find there’s any case law that’s been presented to me to excuse reliance in this case. I find that no ... reasonable jury[ ] could find that Mr. White, any two-and-a-half-year-old[,] could reasonably rely on any of the statements if there even were ... the alleged misrepresentations, assuming they were made.... And therefore that is absolutely an element of both negligent misrepresentation and intentional misrepresentation, and for that reason, I’m granting the motion. The trial court did note that in Maryland, a third party may successfully bring a misrepresentation action so long as the third party can demonstrate individual reliance.

White’s claim failed, according to the trial court, because, due to his infancy, he could not demonstrate individual reliance on any misrepresentations made to his mother. ⁶³⁵ The question before us then is whether parental reliance may be imputed to an infant in the context of misrepresentation claims. We employ a de novo standard of review when considering both a trial court’s grant of a motion for judgment and its legal conclusions. Hoffman v. Stamper, 385 Md. 1, 16 , 867 A.2d 276 (2005). For the reasons discussed below, we will conclude that parental reliance may be imputed to an infant as a form of indirect reliance.

For other reasons, however, we will hold that White is not entitled to a new trial. 1. Fraudulent Misrepresentation We address fraudulent and negligent misrepresentation in turn, beginning with fraudulent misrepresentation. To prevail on a claim for fraud, a plaintiff must prove by clear and convincing evidence that “(1) the defendant made a false representation to the plaintiff, (2) the falsity of the representation was either known to the defendant or the representation was made with reckless indifference to its truth, (3) the misrepresentation was made for the purpose of defrauding the plaintiff, (4) the plaintiff relied on the misrepresentation and had the right to rely on it, and (5) the plaintiff suffered compensable injury as a result of the misrepresentation.” Hoffman, 385 Md. at 29 , 867 A.2d 276 (emphasis supplied). The key question we must address is what constitutes adequate reliance.

Reliance at its core is the action or inaction of a party that results from the misrepresentation of another. Nails v. S & R, Inc., 334 Md. 398, 416-17 , 639 A.2d 660 (1994) (holding that reliance exists if “the misrepresentation substantially induced the plaintiff to act”). Reliance can either be direct or indirect, in part depending on whether the misrepresentation was directly made to the individual seeking relief. Maryland courts have recognized that third parties can successfully bring a misrepresentation claim “even when the allegedly fraudulent statement at issue was not made to him or her directly,” so long as the individual can demonstrate direct or indirect reliance on the false statement.

Exxon Mobil Corp. v. Albright, 433 Md. 303, 335-36 , 71 A.3d 30 (2013). ⁶³⁶ Despite the instances where recovery for fraud has been sanctioned where the allegedly fraudulent statement was not made directly to the plaintiff, we have not permitted recovery without a demonstration that the plaintiff relied, either directly or indirectly, on the relevant misrepresentation. For example, in Diamond Point Plaza, the defendant, Diamond Point, made a fraudulent misrepresentation to two lenders, Pinnacle and PaineWebber, “for the purpose of inducing Pinnacle and PaineWebber to extend a loan, aware that PaineWebber likely would sell the loan in the secondary market.” Wells Fargo bought the loan in the secondary market. Thus, we reasoned that Diamond Point had “reason to expect that the loan documents, including [the fraudulent misrepresentation], would be presented to, would be considered by, and would influence the