Spotlight: Counsel obtains settlement for women subjected to medical experimentation without informed consent

COUNSEL OBTAINS SETTLEMENT FOR WOMEN SUBJECTED TO MEDICAL EXPERIMENTATION WITHOUT INFORMED CONSENT

Diaz v. Hillsborough County Hosp. Auth., U.S. Dist. Ct., M.D. Fla., No. 90-120-CIV-T-25B, Mar. 10, 2000.

As a nurse working in a hospital's high-risk obstetrics unit, Kay Perrin noticed that many pregnant and mostly indigent women-some speaking or understanding only Spanish-were coming in for multiple amniocenteses. After her questions to supervisors and doctors about this remained unanswered, she asked attorney Stephen F. Hanlon of Tallahassee, Florida, for advice. He told her to press the hospital to investigate the matter.

When the hospital failed to do so, Perrin collected her own evidence. She copied the amnio-record book, contacted some of the women listed in it, and informed them that they had been part of an ongoing medical experiment. One woman, Flora Diaz, became the first plaintiff in a suit filed by Hanlon in January 1990. Approximately 5,000 women joined the resultant class action against the hospital, two doctors from an affiliated university hospital, and several others. Assisting Hanlon in the case were Elizabeth Bevington and Nina Zollo, both of Tallahassee; Lora J. Smeltzly, Tampa, Florida; and ATLA member Caroline Kresky, Atlanta, Georgia.

Defendants' conduct, Hanlon argued, violated plaintiffs' "liberty interest" -the constitutional right to be free from unwanted medical treatment. Hanlon asserted this doctrine-established by the U.S. Supreme Court in Cruzan v. Director, Missouri Dept of Health, 110 S. Ct. 2841 (1990)-covers plaintiffs' unwanted medical experiments.

Moreover, plaintiffs alleged that defendants ignored U.S. Department of Health and Human Services regulations regarding informed consent. Plaintiffs claimed that defendants (1) did not fily inform them of the risks and alternatives to the experimental treatments, (2) encouraged them to sign consent forms that were difficult to comprehend, and (3) enrolled them in the studies when their judgment was impaired.

Hanlon said that in interviews of nearly 100 women involved in the experiments, all claimed that they were given explanations similar to that of one of the plaintiffs, Tina Perritt. She was 26 weeks pregnant when her water broke. She was admitted to the hospital and given Demerol, a painkiller. Perritt alleged that, while she was still under the effects of Demerol, defendants told her to sign a paper. When she asked what she was signing, defendants responded that her signature was necessary in order to save her baby. After signing the paper, Perritt was enrolled in an experiment in which she underwent at least 10 amniocenteses. She claimed that a newspaper article reporting on the suit was the first time she became aware that she may have been part of a medical experiment.

Hanlon faced several obstacles in the case, including a crowded court docket, prolonged negotiations, and-most important-defendants' refusal to produce plaintiffs' medical records. Hanlon said defendants took the position that state confidentiality statutes trumped plaintiffs' federal civil rights interest in obtaining their records. Although he filed the suit in 1990, Hanlon said it was not until 1999 that defendants were ordered to produce the records.

Reflecting on his strategy, Hanlon noted that it was "quite simple." Plaintiffs pushed for mediation from the beginning of the suit. He said they wanted to present the case in front of the university president-an experienced official who knows when to settle a case. Hanlon said he was "confident that once [the president] heard our presentation about the facts and the law ... and the defense presentation, this case would settle." The case finally did settle for $3.8 million, pending approval from the court. Under the agreement, each named plaintiff would receive $50,000, and other class members, about $1,000 each.

Hanlon said that as a result of the suit and an investigation by the National Institutes of Health, defendants have reformed their system of medical experimentation. He believes this is the first case in which a substantial damages claim has been sustained for failure to give informed consent in medical experimentation where no physical injury has been claimed. Consequently, he hopes the result will act as a catalyst for substantial reform in medical experimentation because it will eliminate the medical profession's traditional "no harm, no foul" response to these types of claims.

Plaintiffs'' experts were George Annas, informed consent in biomedical research, and David Acker, obstetrics/gynecology, both of Boston, Mass.; Jay Katz, informed consent in biomedical research, New Haven, Conn.; Frederick R Abrams, informed consent/obstetrics/gynecology, Englewood, Colo.; and Janet L. Mitchell, perinatology, Brooklyn, N.Y.

Documents in this case are available through the Court Documents section in the back of this issue, courtesy of Mr. Hanlon.

Copyright Association of Trial Lawyers of America May 2000
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