Health

Hopkins faces $1B lawsuit over role in government study that gave subjects STDs

Victims of a 1940s government study that gave subjects STDs are suing Johns Hopkins for $1 billion.

Nearly 800 former research subjects and their families filed a billion-dollar lawsuit Wednesday against the Johns Hopkins University, blaming the institution for its role in 1940s government experiments in Guatemala that infected hundreds with syphilis, gonorrhea and other sexually transmitted diseases.

The lawsuit seeks to hold Hopkins responsible for the experiments because its doctors held key roles on panels that reviewed and approved federal spending on the experiments. Filed in Baltimore Circuit Court, the suit also names the Rockefeller Foundation and drugmaker Bristol-Myers Squibb as defendants.

It is the victims' latest effort to be compensated for the experiments, which government officials including President Barack Obama called "clearly unethical" and apologized for in 2010. A federal judge dismissed the victims' claims against top U.S. officials in 2012 on a legal technicality, but encouraged them to appeal to politicians for the compensation they deserve.

Johns Hopkins officials called the experiments "deplorable" and "unconscionable," while a Rockefeller spokesman labeled them "morally repugnant," and both institutions said they had no role in designing, paying for or carrying out the research and would fight the lawsuit.

Bristol-Myers Squibb officials declined to comment.

"For more than half a century since the time of the Guatemala study, scholars, ethicists and clinicians have worked with government officials to establish rigorous ethical standards for human research. Johns Hopkins welcomes bioethical inquiry into the U.S. Government's Guatemala study and its legacy," Hopkins spokeswoman Kim Hoppe said in an email. "This lawsuit, however, is an attempt by plaintiffs' counsel to exploit a historic tragedy for monetary gain."

The Guatemala experiments have been compared to the infamous Tuskegee syphilis experiment, which prompted creation of much of the ethical and legal standards that now protect human research subjects. In the Tuskegee experiment, the U.S. Public Health Service was studying the progression of syphilis in black men in rural Alabama, and researchers were faulted for failing to treat the men even after penicillin was discovered as a treatment for the disease.

In Guatemala, however, researchers deliberately infected subjects with syphilis, gonorrhea, and chancroid from 1946 to 1948. In some cases, when male subjects did not become infected with syphilis after having sex with prostitutes who had the disease, researchers exposed the bacteria to wounds on their faces or penises. Participants in the study included psychological patients and prison inmates. Orphans and children who attended state-run schools also were included but not intentionally exposed to the diseases.

The experiments came as government researchers looked for ways to prevent sexually transmitted diseases from spreading, particularly among soldiers at war. They included the Guatemala and Tuskegee experiments, as well as the Terre Haute prison experiments, in which inmates at an Indiana prison were exposed to gonorrhea.

A committee of the National Research Council dedicated to venereal diseases was responsible for reviewing the studies' designs and approving them for federal funding, according to the 2011 report on the Guatemala experiments by the Presidential Commission for the Study of Bioethical Issues. A Johns Hopkins doctor chaired the panel, and three others with ties to Hopkins were members in 1946 when it reviewed a proposal for the Guatemala research, according to the report.

The lawsuit seeks to use those roles to connect Hopkins to the study. While the review panel included representatives from the U.S. Public Health Service, Veterans Affairs and military, the plaintiffs argue only the "non-governmental" members of the 11-man body had voting power. Other academics on the panel included a University of Pennsylvania professor and another from Harvard University, according to the commission report.

The lawsuit says the experiments were conducted with the "support, knowledge and approval of agents, servants and employees of Hopkins and The Rockefeller Foundation."

Hopkins doctors also had input once the experiments began, with one professor studying a possible syphilis vaccine requesting that subjects be exposed to a particular bacterium, the lawsuit says.

In a letter to Hopkins employees and students, university President Ronald J. Daniels, Johns Hopkins Medicine CEO Paul B. Rothman and Bloomberg School of Public Health Dean Michael J. Klag rejected the lawsuit's arguments linking the institution to the experiments.

"The plaintiffs' essential claim in this case is that prominent Johns Hopkins faculty members' participation on a government committee that reviewed funding applications was tantamount to conducting the research itself and that therefore Johns Hopkins should be held liable," they wrote. "Neither assertion is true."

The lawsuit seeks to connect the New York-based Rockefeller Foundation to the study by arguing that it worked closely with Hopkins on sexually transmitted disease research and paid for it, and that it employed a doctor who in January 1947 was designated "responsible investigator" for the Guatemala experiments.

Calling the lawsuit "without merit," a foundation spokesman said the organization "did not design, fund, or manage any of these experiments, and had absolutely no knowledge of them."

Bristol Laboratories and Squibb Institute, predecessors to the New York-based pharmaceutical company, used the experiments as clinical trials for their products, the lawsuit says.

The lawsuit seeks at least $75,000 in actual damages for each of nine counts, including negligence and the wrongful deaths of 124 of the plaintiffs, and $1 billion in punitive damages.

Legal experts said the lawsuit's arguments could be a stretch. Today, professors who frequently serve on a volunteer basis with the National Institutes of Health, for example, are generally considered to be acting independently and not in their capacity as university faculty, said Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard University Law School.

The lawsuit presents questions over whether the institutions have "sufficient control or authority" over the individuals to be held accountable for their decisions, and whether the institutions were the cause of the victims' injuries, said Terrence Collingsworth, managing partner with Conrad & Scherer LLP in Washington, who represented victims of the experiments in a federal lawsuit in 2011 and 2012.

That lawsuit was dismissed because of a technicality that the U.S. government cannot be held responsible for actions committed in other countries. But in issuing his decision, Judge Reggie B. Walton encouraged the victims to seek help from "the political branches of our government."

Though U.S. justice officials expressed support for the victims, Collingsworth said their subsequent efforts for reparations have been fruitless.

"I'm impressed and I wish them the best in their creative approach," he said of the lawsuit against Hopkins. "These people are still waiting for something."

Though Collingsworth called a lawsuit a legitimate means to prompt resolution, whether by a settlement or some political act of reparations by the U.S. government, Paul Bekman, the victims' attorney in the case filed Wednesday, said that isn't the goal. Bekman, a lawyer with Salsbury, Clements, Bekman, Marder & Adkins LLC in Baltimore, said he was pulled into the case by an international lawyer working with the victims because of the case's ties to Hopkins and Baltimore.

"This is about accountability and responsibility," Bekman said.

Others argue court may not be the best place to resolve these injustices.

Because the experiments occurred so long ago, most if not all of the subjects are dead, and it could be difficult for someone to prove that a relative was part of the study, Lynch said. She and colleague I. Glenn Cohen, a professor at Harvard Law School, argued in a 2012 New York Times opinion piece that the Tuskegee experiment and others provide precedent for a fair recourse.

In the Tuskegee case, a legal settlement included lifetime medical benefits for study subjects and their wives, widows and children, as well as federal grants to promote research and health care ethics, they said. U.S. aid applied directly to Guatemalan health could be appropriate in this case, Lynch said.

"Congress and the [Obama] administration must step up more than they have, by offering financial restitution to Guatemalans with plausible claims of harm," Lynch and Cohen wrote. "Even if the lawsuits were appropriately dismissed, justice has not been done."

Baltimore Sun reporter Luke Broadwater contributed to this article.

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