A 2001 Maryland Court of Appeals opinion allowed participants in Kennedy Krieger Institute’s Lead-Based Abatement Repair & Maintenance Study to file lawsuits alleging negligence. Fourteen years later, the state’s intermediate appellate court has held the so-called Grimes opinion cannot be invoked by plaintiffs filing suit against KKI for another study involving children and lead paint.
The Court of Special Appeals last week held the Treatment of Lead-Exposed Children Study was therapeutic, meaning it was designed to treat children with lead-paint poisoning, unlike the R&M study, which looked at reducing lead in households. The opinion affirmed a jury verdict last year dismissing a lawsuit filed by the family of Tyron N. White, who participated in the TLC study in the mid-1990s.
“To the extent that Grimes set forth the law, it set forth law in the factual context of nontherapeutic research,” Judge Dan Friedman wrote for the three-judge panel. “It does not apply except indirectly in the context of therapeutic research.”
The R&M study involved more than 100 homes divided into five groups, each with varying levels of lead-paint abatement, with researchers knowing where each child was living. The Grimes court described the R&M study as “presenting similar problems” as the Tuskegee syphilis experiment and tests exposing soldiers to Navajo miners to radiation. The study’s set-up, the court continued, constituted a special “special relationship,” meaning the institute had a legal duty toward the children.
The TLC study, by contrast, was designed to evaluate the effects of a medication on moderately lead-poisoned children as well as the benefits of lead-paint abatement and nutritional supplements on those children, according to the Court of Special Appeals opinion. The study also was “double-blind,” meaning neither researchers nor parents knew whether a child was given a placebo or the medication, according to the opinion.
Thomas F. Yost Jr., a lawyer for White’s family, said the court’s distinguishing between therapeutic versus non-therapeutic studies is important but that a “notable population” of human research bioethicists agree with the conclusions from the Grimes opinion.
White was just over 2 years old when he joined the TLC study in October 1995, according to the Court of Special Appeals opinion. His blood-lead level at one point in the study dropped to 29 after being as high as 47 prior to the study, according to the opinion. The Centers for Disease Control, since 2012, has said there is no safe level for lead exposure and that a blood-lead level of 5 indicates a child requires case management.
White and his family filed suit against KKI and others in 2011, alleging he suffered a significant brain injury due to lead exposure, some of which was caused by KKI’s “tortious design and implementation of the TLC study,” according to the opinion.
The Court of Special Appeals sided with White on the two other issues before it: that White, even though he was an infant, could prove fraudulent misrepresentation based on the statements made by KKI to his mother; and that KKI could be held liable under the state’s Consumer Protection Act even though there was no commercial transaction between the parties.
But while appellate court did not agree as to why the trial court dismissed the claims, it held they should have been dismissed for a lack of evidence.
Michael A. Brown, a lawyer for KKI, did not respond to a request for comment. Brown is a principal with Miles & Stockbridge P.C.
The case is Tyron White v. Kennedy Krieger Institute Inc., No. 1015, Sept. 2013 Term.