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White v. Kennedy Krieger Institute, Inc.

Court of Special Appeals of Maryland

February 26, 2015


Meredith, Kehoe, Friedman, JJ.


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 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.


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 poisoned 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 pre-enrollment 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 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 pre-enrollment 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 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 "[v]acuum 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 p]rovide 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 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.

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.

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 pre-enrollment 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 completing 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 mcg/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 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 KKI pursuant to Md. Rule 2-519 at the close of plaintiff's 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.


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 (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 Grimes 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 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. 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.

The R&M Study consisted of five test groups of homes with varying levels of lead and lead intervention. Id. at 50. Groups 1 through 3 were homes with known lead paint contamination that received different levels of repair and maintenance. Id. at 53. 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.

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. 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. "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. In short, on the facts before the Court of Appeals, [7] the R&M Study actively recruited healthy children to move 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. The Court of Appeals concluded that the rights of each individual child unknowingly subjected to dangerous conditions outweighs any interests of the ...

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