bridging the worlds of science and the law

1
Bridging The Worlds Of Science And The Law T he rules for admitting scientific ev- idence in federal court have been shaped by a series of Supreme Court rulings, issued since 1993, that have raised complex issues for scientists and lawyers alike. To help these profes- sionals make sense of those rulings—and to help bridge the sometimes very differ- ent worlds of science and the law—the National Academies hosted a workshop, "Scientific Evidence and the Law," earlier this month in Washington, D.C. Much of the discussion focused on civil litigation, particularly the presentation of scientific evidence in such well-known class-action cas- es as those concerned with silicone gel breast implants. Panelists dis- cussed not only the Court's deci- sions on determining the admissi- bility of evidence in such cases—it must be "relevant" and "reliable" as determined by a judge—but also how scientific evidence is perceived by juries and others. Two workshop presentations captured the differences between the worlds of science and the law. They did not present solutions—in fact, few solu- tions seemed to be on hand from any of the scientific and legal experts who at- tended the workshop. All seemed to agree that the development of case law and a continuing dialogue between sci- entists and lawyers is perhaps the best that can be achieved in the near term. Instead, the workshop presentations are snapshots of the current situation. The first gave an idea of the antiscience climate that can arise in court; the sec- ond showed how scientists who are asked to provide court testimony or evi- dence might best handle such requests. The first case involved the litigation over silicone gel breast implants. Mar- sha Rabiteau, an attorney for Dow Chemical, worked on the Dow Corning silicone implant litigation. She de- scribed an atmosphere in which distrust of science distorted the evidence while the pursuit of damages for the plaintiffs carried the litigation beyond the point that it could be supported by the scien- tific evidence. The case, Rabiteau said, shows that during the past decade courts have chal- lenged the scientific method itself. She said it is an atmosphere in which allega- tions of bias are presented as fact. And, in the implant case at least, "the media is sometimes a ready and informed co- conspirator," she added. Leading her frustration is the public perception that health research con- ducted or paid for by a company is somehow poor research. "There is a cynical belief that safety is co-opted by industry science," Rabiteau said. Rabiteau and other speakers pointed out that such industry-sponsored re- search is often of the highest quality and is used to make some of the tough- est regulatory decisions—the approval of new drugs, for example. It is a system that has served government and citi- zens well and for many years. "Americans," Rabiteau said, "are mys- tified by the nature of scientific research." What's more, she said, they are unaware that some 70% of all R&D performed in the U.S. is paid for by industry. She pointed out that science—no matter who has paid for the research— has its own mechanism for ferreting out such bias: peer review. But, Rabiteau said, for judges and juries not schooled in science, explaining the concept of peer review often falls on deaf ears after an allegation of bias. "How do we get credible testimony into the courtroom?" asked Channing Robertson, a professor of chemical engi- neering at Stanford University. He said his own experience might provide other scientists with something of a guide. Twice Robertson provided expert testimony in cases involving an intra- uterine device (IUD), the Dalkon Shield. These birth control devices were alleged to cause a dangerous con- dition in women known as pelvic inflam- matory disease. That condition could lead to sterility and other long-term health consequences for the user. First, Robertson said, he was ap- proached by defense attorneys in a class-action suit. In exchange for a dona- tion from the attorneys to Stanford, he agreed to perform tests on the device and then to testify as to his results. He made it clear, however, that the scientif- ic study would be performed on his terms and that he would publish the re- sults no matter if the outcome support- ed the defense position or not. At issue, Robertson explained, was whether a small strip of plastic that was part of the IUD could harbor colonies of bacteria that would eventually present a health threat to the woman using the device. Work in his lab showed that the strip did not colonize bacte- ria, and he presented this evidence in court But in a subsequent case, Rob- ertson continued, he was ap- proached by plaintiffs' attorneys asking him to test another IUD with a plastic strip. He said he required the same research independence. To even Robertson's surprise, this study showed that this de- vice—the "Copper 7" IUD, which was taken off the market—could indeed colonize bacteria, and thus lead to pelvic in- flammatory disease in the wearer. Robert- son said his credibility stood up in court be- cause he insisted on doing the research and publication under his conditions. Many speakers at the National Acad- emies workshop conceded that the world of science and the legal world op- erate in different ways toward different ends that are not easy to reconcile. Un- der the pressure of a court case, there is often little time to appreciate and settle those differences, they noted. Sheila Jasanoff, a professor of sci- ence and public policy at Harvard Uni- versity, offered a path toward solutions. Rather than look to any one party in a le- gal proceeding as the one in need of re- form, she said, community standards, "a culture of ethics," need to develop. "Ethical thought should not focus only, for example, on an expert wit- ness," Jasanoff said. "We should think about it in terms of all major actors" in a given legal proceeding. If everyone takes responsibility for the proper use of science in the courts, she said, and raises the standards for science used as evidence, then ethical behavior will be- come an integral part of the system. William Schulz Robertson (left) and Rabiteau at the workshop. SEPTEMBER 25,2000 C&EN 37

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Page 1: Bridging The Worlds Of Science And The Law

Bridging The Worlds Of Science And The Law

The rules for admitting scientific ev­idence in federal court have been shaped by a series of Supreme

Court rulings, issued since 1993, that have raised complex issues for scientists and lawyers alike. To help these profes­sionals make sense of those rulings—and to help bridge the sometimes very differ­ent worlds of science and the law—the National Academies hosted a workshop, "Scientific Evidence and the Law," earlier this month in Washington, D.C.

Much of the discussion focused on civil litigation, particularly the presentation of scientific evidence in such well-known class-action cas­es as those concerned with silicone gel breast implants. Panelists dis­cussed not only the Court's deci­sions on determining the admissi­bility of evidence in such cases—it must be "relevant" and "reliable" as determined by a judge—but also how scientific evidence is perceived by juries and others.

Two workshop presentations captured the differences between the worlds of science and the law. They did not present solutions—in fact, few solu­tions seemed to be on hand from any of the scientific and legal experts who at­tended the workshop. All seemed to agree that the development of case law and a continuing dialogue between sci­entists and lawyers is perhaps the best that can be achieved in the near term.

Instead, the workshop presentations are snapshots of the current situation. The first gave an idea of the antiscience climate that can arise in court; the sec­ond showed how scientists who are asked to provide court testimony or evi­dence might best handle such requests.

The first case involved the litigation over silicone gel breast implants. Mar­sha Rabiteau, an attorney for Dow Chemical, worked on the Dow Corning silicone implant litigation. She de­scribed an atmosphere in which distrust of science distorted the evidence while the pursuit of damages for the plaintiffs carried the litigation beyond the point that it could be supported by the scien­tific evidence.

The case, Rabiteau said, shows that during the past decade courts have chal­lenged the scientific method itself. She said it is an atmosphere in which allega­

tions of bias are presented as fact. And, in the implant case at least, "the media is sometimes a ready and informed co­conspirator," she added.

Leading her frustration is the public perception that health research con­ducted or paid for by a company is somehow poor research. "There is a cynical belief that safety is co-opted by industry science," Rabiteau said.

Rabiteau and other speakers pointed out that such industry-sponsored re­

search is often of the highest quality and is used to make some of the tough­est regulatory decisions—the approval of new drugs, for example. It is a system that has served government and citi­zens well and for many years.

"Americans," Rabiteau said, "are mys­tified by the nature of scientific research." What's more, she said, they are unaware that some 70% of all R&D performed in the U.S. is paid for by industry.

She pointed out that science—no matter who has paid for the research— has its own mechanism for ferreting out such bias: peer review. But, Rabiteau said, for judges and juries not schooled in science, explaining the concept of peer review often falls on deaf ears after an allegation of bias.

"How do we get credible testimony into the courtroom?" asked Channing Robertson, a professor of chemical engi­neering at Stanford University. He said his own experience might provide other scientists with something of a guide.

Twice Robertson provided expert testimony in cases involving an intra­uterine device (IUD), the Dalkon Shield. These birth control devices were alleged to cause a dangerous con­dition in women known as pelvic inflam­matory disease. That condition could

lead to sterility and other long-term health consequences for the user.

First, Robertson said, he was ap­proached by defense attorneys in a class-action suit. In exchange for a dona­tion from the attorneys to Stanford, he agreed to perform tests on the device and then to testify as to his results. He made it clear, however, that the scientif­ic study would be performed on his terms and that he would publish the re­sults no matter if the outcome support­ed the defense position or not.

At issue, Robertson explained, was whether a small strip of plastic that was part of the IUD could harbor colonies of bacteria that would eventually present a

health threat to the woman using the device. Work in his lab showed that the strip did not colonize bacte­ria, and he presented this evidence in court

But in a subsequent case, Rob­ertson continued, he was ap­proached by plaintiffs' attorneys asking him to test another IUD with a plastic strip. He said he required the same research independence.

To even Robertson's surprise, this study showed that this de­vice—the "Copper 7" IUD, which

was taken off the market—could indeed colonize bacteria, and thus lead to pelvic in­flammatory disease in the wearer. Robert­son said his credibility stood up in court be­cause he insisted on doing the research and publication under his conditions.

Many speakers at the National Acad­emies workshop conceded that the world of science and the legal world op­erate in different ways toward different ends that are not easy to reconcile. Un­der the pressure of a court case, there is often little time to appreciate and settle those differences, they noted.

Sheila Jasanoff, a professor of sci­ence and public policy at Harvard Uni­versity, offered a path toward solutions. Rather than look to any one party in a le­gal proceeding as the one in need of re­form, she said, community standards, "a culture of ethics," need to develop.

"Ethical thought should not focus only, for example, on an expert wit­ness," Jasanoff said. "We should think about it in terms of all major actors" in a given legal proceeding. If everyone takes responsibility for the proper use of science in the courts, she said, and raises the standards for science used as evidence, then ethical behavior will be­come an integral part of the system.

William Schulz

Robertson (left) and Rabiteau at the workshop.

SEPTEMBER 25,2000 C&EN 3 7