Maryland high court criticizes lead paint researchers for risking children's health.

In a harshly worded opinion, the Maryland Court of Appeals rebuked a well-respected health institute for treating children like "canaries in the mines" in a federally funded study designed to test the effectiveness of lead-paint abatement.

The criticism was part of a decision holding that researchers cannot ask parents to enroll their children in medical research studies that carry health risks but offer no therapeutic benefits. (Grimes v. Kennedy Krieger Inst., Nos. 128/129 (Md. Aug. 16, 2001).)

The ruling, which prompted the U.S. Department of Health and Human Services to announce that it will investigate the study, opens the courthouse doors to the families of two Baltimore children who suffer neurological injuries allegedly caused by their exposure to lead paint dust during the course of the two-year study.

Conducted by the Kennedy Krieger Institute in conjunction with Johns Hopkins University and sponsored in part by the U.S. Environmental Protection Agency, the study was designed to determine whether partial abatement in contaminated homes is sufficient to lower the risk of lead poisoning in children who live in them. The goal was to find a less-than-complete but effective abatement measure. That, the institute thought, would be more attractive to urban landlords who had been reluctant to effect expensive complete abatement of their contaminated properties.

The research was conducted in 125 homes divided into five groups. Three groups--called the Lead Reduction Homes--received varying levels of partial abatement, and one group received complete abatement. Homes in the last group were built after 1980 and were presumed to have no lead-based paint.

Researchers "then encouraged, and in at least one [case], required, the landlords to rent the premises to families with young children," according to the court's opinion. "Success was to be determined by periodically, over a two-year period of time, measuring the extent to which lead dust remained in, or returned to, the premises after the varying levels of abatement modifications, and ... by measuring the extent to which the theretofore healthy children's blood became contaminated with lead.... "

The occupants of each house were required to sign consent forms agreeing to let their children participate and be tested for lead poisoning. They also agreed to periodically fill out questionnaires, receiving $15 for each one completed.

The lawsuit, filed by two of the families, alleges that the researchers failed to timely notify them that test results had revealed high levels of lead-contaminated dust in their homes and elevated blood levels in their children. One of the children, Ericka Grimes, had a blood-lead level of 9 at the beginning of the study and a level of 32 less than six months later. Any level above 10 is considered unacceptable.

Kenneth Strong, a Baltimore lawyer who represents the Grimes family, said researchers knew that tests in Ericka's home--which was in the group of "completely abated" homes--had revealed "hot spots" of contamination, but that the researchers did not give her family this information until well after the lead in her blood had risen to dangerous levels. As a result, Strong said, the family continued to live there, unaware of the hazards, and 9-year-old Ericka now suffers learning disabilities related to lead poisoning.

Allegations regarding the second child, 11-year-old Myron Higgins, assert that researchers failed to timely notify his mother that some tests showed high lead-dust levels in her partially abated home and instead only informed her of the results of tests conducted by a different method that indicated lower, acceptable levels. This withholding of information "gave her a false sense of security that there were no potential lead-based paint or dust hazards in her house," according to court documents.

Strong said the court's ruling was "a measure of vindication" for the plaintiffs, whose negligence claims had been dismissed by lower courts. Those courts had found that the researchers owed no duty of care to the children who participated in the study.

"These lawsuits claimed the children were allegedly harmed as a result of the [researchers'] negligence, and their answer was, `So what? We don't have an obligation to protect or forewarn of the risks involved,'" Strong said. "I think that stance is in large part what contributed to the court's strong language."

Writing for a nearly unanimous court--one of the seven judges concurred in the result only--Judge Dale Cathell likened the study to several previous experiments in which researchers intentionally exposed test subjects to infectious or poisonous substances.

"The research project at issue here, and its apparent protocols, differs in large degree from, but presents similar problems as, those in the Tuskegee Syphilis Study conducted from 1932 until 1972, ... the intentional exposure of soldiers to radiation in the 1940s and 1950s, ... the tests involving the exposure of Navajo miners to radiation, ... and the secret administration of LSD to soldiers by the CIA and the Army in the 1950s and 1960s," Cathell wrote.

The Kennedy Krieger Institute has filed a motion asking the court to modify some of the wording in the opinion, which sets a standard for parental consent in medical research that is "vastly more restrictive than that of any other state or that of the federal government," according to an amicus brief filed by several medical and academic organizations--including the Association of Medical Colleges, the Association of American Universities, and Johns Hopkins University.

If allowed to stand, the decision "would have a devastating impact on health and human development research," the brief's authors wrote. "A rule prohibiting `non-therapeutic research or studies in which there is any risk of injury' would prohibit virtually all medical and public health research involving children and other persons under a legal disability. By its plain terms, the court's broadly worded holding would prohibit even genetic studies requiring no more than needle sticks, as a needle stick presents a risk of harm."

Plaintiff attorney Strong suspects that the court may be somewhat persuaded by these arguments but that, in any event, the plaintiffs will still have their day in court. "I would imagine that [the court] would clarify its earlier ruling regarding the issue of `any' risk versus `minimal' risk. But I don't think anything the court does will have any bearing on the litigation," Strong said.