US foundation, university, and drug company are sued for alleged role in Guatemala study

A $1bn (£0.7bn; €0.9bn) class action suit has been filed in a Maryland court against the Rockefeller Foundation, Johns Hopkins University, and Bristol-Myers Squibb for their alleged roles in a study on sexually transmitted infections conducted in Guatemala in the 1940s and 1950s.

The lawsuit alleges that physicians, scientists, and other employees of the foundation and the university helped run a notorious study conducted in Guatemala from 1945 to 1956 in which children, prison inmates, psychiatric patients, soldiers, and orphans were intentionally infected with syphilis, gonorrhea, chancroid, and other diseases. It alleges that Bristol-Myers Squibb is culpable because its predecessor companies supplied penicillin for use in the studies.

The 774 plaintiffs that filed the suit, in the Circuit Court for Baltimore City, Maryland, on 1 April, included surviving study participants and their spouses, children, sexual partners, and descendants. The suit alleges that participants in the Guatemala experiment were not informed that they were being exposed to diseases and that the researchers engaged in an “intentional effort” to keep the true nature of the experiments a secret.

“The Guatemalans were not told about the nature of the experiments, warned about the consequences of being exposed to and infected with these sexually transmitted diseases, or given any follow-up care, treatment, or education to minimize their pain and suffering,” the complaint said. “Nothing was done to prevent them from passing the diseases on to their spouses, children, and other descendants. As a result, Guatemalans have suffered and died, and will continue to suffer and die, from the venereal diseases with which they were intentionally infected.”

The Guatemala study was led by the US Public Health Service and overseen by researchers who had been involved in the Tuskegee experiment, in which African American men with syphilis were not treated with penicillin so that the progression of the disease could be studied. The Guatemala study became widely known in 2010 when President Barack Obama formally apologized to the people of Guatemala for the US supported research and directed the US Presidential Commission for the Study of Bioethical Issues to conduct an investigation of the study.1

In its report, released in 2011, the commission concluded that the Guatemala experiment “involved gross violations of ethics as judged against both the standards of today and the researchers’ own understanding of applicable contemporaneous practices.”2 The report found that the leaders of the Public Health Service, the National Research Council, the National Institutes of Health, and the Venereal Disease Research Laboratory, “as well as leading academic scientists, encouraged and supported the work.”

A class action lawsuit was initially filed against federal officials but was dismissed in 2012 on the technical grounds that the US government officials could not be held accountable for actions that took place outside of the United States. Such protections may not apply to the university, foundation, and corporate employees who participated in the trial’s design and administration, but it is questionable whether these institutions can be held responsible for actions of individual employees serving on government committees and panels.

The lawsuit argues, however, that academics’ participation in the study design and oversight “occurred within the scope of their employment with Johns Hopkins, and Hopkins paid them. Hopkins knew of, supported, and benefited from the participation of its agents, servants, and employees.” The suit alleged that Johns Hopkins and the Rockefeller Foundation, through their employees, “created and designed the Guatemala experiments: approved and recommended them for funding; oversaw, monitored, encouraged, directed, and aided and abetted them while they were ongoing; and helped conceal their unethical, immoral, and tortuous nature.”

In an email to members of the university community, Ronald J Daniels, president of the university, Paul B Rothmans, dean of the Medical Faculty, and, Michael J Klag, dean of the Johns Hopkins Bloomberg School of Public Health, called the Guatemala experiment “unconscionable and unethical” but denied that the university was responsible. “This was not a Johns Hopkins study. Johns Hopkins did not initiate, pay for, direct, or conduct the study in Guatemala. Participation in the review of government research was then and is today separate from being a Johns Hopkins employee, and no non-profit university or hospital has ever been held liable for a study conducted by the US government,” the email said.

The email acknowledged that several prominent faculty members of the university had been linked to other unethical government studies, including the Tuskegee study. But it added, “It is important to confront and learn from the past. At the same time, we cannot let unfounded allegations go unchallenged. We will defend the institution vigorously in court against legal responsibility for the government’s Guatemala study.”

Bristol-Myers Squibb officials declined to comment, and the Rockefeller Foundation had not answered a request for comment by the time this story was filed.