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OCTOBER 15, 2007 VOLUME 85, NUMBER 42 PP. 44-45
Weighing Toxic Torts
Book outlines the gulf between science and the law
Reviewed by Bette Hileman
Individuals or groups who claim harm from a pharmaceutical or chemical may
sue the manufacturer or other responsible party in court in what is known as a
toxic tort—or personal injury—lawsuit. In the popular imagination, often inspired
by movies and TV shows, experts for the plaintiff explain to a jury the scientific
reasons why the injury was caused by a particular substance. The defendant's
experts, in turn, lay out their side of the story. After both sides are presented, a
jury decides whether the defendant is responsible for the injury.
In his careful y reasoned book, "Toxic Torts: Science, Law and the
Possibility of Justice," Carl F. Cranor paints a different picture of reality in the
courtroom today for toxic tort suits involving chemicals. In contrast to the ideal
situation, judges in these civil suits don't always know how to weigh scientific
evidence and sometimes fail to admit valid data, he explains. The expense of
gathering scientific evidence that can withstand judicial scrutiny can scuttle
cases before they even begin.
TOXIC TORTS: SCIENCE, LAW AND THE POSSIBILITY OF JUSTICE , by Carl F.
Cranor, Cambridge University Press, 2006, 398 pages, $99 hardback (ISBN 0-521-
86182-9)
In many toxic tort cases, Cranor argues, some expert witnesses, especial y
those hired by the plaintiff, are not al owed to present their case to the jury.
Before 1993, he says, judges had the right to exclude expert evidence, but few
took advantage of this right. But since 1993, when the Supreme Court handed
down the decision known as Daubert, judges in civil toxic tort cases have far
more frequently prevented experts from presenting scientific evidence to a jury,
Cranor says.
The Daubert v. Merril Dow Pharmaceuticals Inc. ruling instructed federal judges
to act as "gatekeepers" in the courtroom and to review evidence before it is
presented to a jury. It directed judges to examine the method or reasoning
underlying expert evidence and to admit only evidence that is both reliable and
relevant. Evidence must be based on a testable peer-reviewed theory with a
known error rate and must be general y accepted by the scientific community.
The Supreme Court said that judges could no longer defer entirely to the jury to
decide whether data are reliable. The court cautioned, however, that the criteria
are not to be used as a checklist on each component of the testimony.
Cranor, a philosophy professor at the University of California, Riverside, claims
that Daubert and two follow-on Supreme Court decisions have resulted in
mistaken reviews of scientific evidence that have in many cases led judges to
bar experts from presenting valid scientific arguments to a jury. Instead of
examining scientific evidence as a body of knowledge, judges often apply the
Daubert criteria to each individual component of that knowledge and refuse to
admit those components that don't satisfy al the criteria, Cranor says. This
practice has led to a gulf between science and the law, he argues.
Rather than looking at studies in isolation, toxicologists general y take a weight-
of-evidence approach in deciding whether a chemical or drug causes cancer or
some other adverse health effect. They look at epidemiological studies, if such
are available; lab animal studies; in vitro and DNA data; mechanistic studies that
reveal how substances act in human or animal physiology; chemical structure-
biological activity relationships; and published human case reports of harm from
a drug or other chemical.
For most chemicals and drugs, no single study provides a convincing case that
a substance harms human health. Toxicologists look at this entire body of
evidence, giving greater or lesser weight to different studies, to decide about
health effects. The procedure is complicated but wel -accepted among
toxicologists and among researchers working on drug discovery.
A minority of judges, Cranor says, understands this science of causation and
knows that al owing a jury to hear evidence in a variety of toxicological areas wil
lead to the most valid assessment of whether a plaintiff has been harmed by a
particular chemical or drug. They realize that applying Daubert criteria in a rigid,
formulaic way to each piece of evidence violates science. But most judges do
not employ the Daubert criteria properly, Cranor says. The majority admits
epidemiological data and a few selected animal studies and tends to bar al
other types of toxicological evidence, he says. They are likely to exclude
evidence if it fails to meet a single one of the Daubert standards, even though
the Supreme Court ruling warned judges not to use them as a checklist. Many
judges eliminate animal studies if they appear weak or if the animals were
exposed to doses several times higher than what humans are exposed to.
In the book, Cranor cites many cases in which judges have mistakenly
excluded animal studies, as wel as in vitro and structure-activity data, from the
courtroom. For example, he explains, in a 1996 case involving exposure to
ethylene oxide and brain cancer, the plaintiff's experts were not al owed to
present a variety of animal and limited epidemiological studies suggesting that
ethylene oxide causes brain cancer. In other cases, judges have mistakenly
demanded that the plaintiff's case be supported by a series of consistent
epidemiological studies and an animal model that duplicates the effects
al egedly seen in humans. For example, in a 1994 case involving the over-the-
counter asthma medication Primatene, the judge did not al ow the case to go to
trial unless the plaintiffs' experts could present consistent epidemiological
studies and experiments with lab animals showing the same birth defect that
was seen in the children prenatal y exposed to Primatene.
This practice of not al owing juries to hear about a variety of relevant
toxicological studies has led to a disconnect between science and the law,
Cranor says, and has kept many citizens who have been harmed by toxic substances from being justly compensated. In fact, Cranor cites statistics showing that scientific evidence is being chal enged and thrown out before trial much more frequently since the Daubert ruling. If the plaintiff's experts are not al owed to testify, the plaintiff cannot prove harm from a chemical or drug, and the judge wil then grant a summary judgment for the defendant. That ends the case. According to a study by the RAND Institute for Civil Justice, the percentage of summary judgments granted after the Daubert decision in 1993 more than doubled, with 90% of them going against plaintiffs. Since Daubert, judges have also been highly inconsistent with the kinds of evidence they have excluded from toxic tort cases, Cranor says. He describes three lawsuits filed in the early 1990s involving Parlodel, a drug used to suppress lactation after childbirth. In two cases, the judge did not admit animal evidence showing that Parlodel constricts blood vessels, which would increase the risk of heart attack and stroke. But in another very similar case, the judge admitted the evidence. Another problem for plaintiffs is that most chemical products—except for pharmaceuticals, food additives, and pesticides—enter the marketplace with little or no premarket testing. So a chemical that is the subject of a lawsuit may have undergone very limited testing. The combination of inadequate toxicity data and judges' lack of understanding of how to assess and weigh the data that are available can make it very difficult for injured plaintiffs to win compensation in court, Cranor claims. Although Cranor presents a bleak view of how judges evaluate scientific evidence in toxic tort cases, he maintains that there are many practical, but not simple, ways to improve the situation. First, he writes, courts must become "knowledgeable, sensitive, thoughtful consumers of scientific studies and inferences." Judges need to avoid using overly restrictive criteria for reviewing evidence. Simple rules cannot easily accommodate the evidentiary picture in science, he explains. Judges need to conduct admissibility reviews that recognize "the multifaceted, varied nature of scientific evidence." They need to recognize that, according to the Supreme Court ruling, the Daubert criteria are not to be applied to each component of the evidence. Judges should avoid demanding ideal evidence or insisting on epidemiological studies, Cranor says. They should admit animal studies and structure-activity evidence, as wel as relevant individual human case reports, he writes. A single case report may indicate an extremely rare phenomenon, but a series of similar case reports may point to a serious problem. The Food & Drug Administration uses case reports of adverse reactions to vaccines or pharmaceuticals to alert the agency to problems that did not show up in clinical trials. In short, judges should "review scientific evidence as an integrated whole," Cranor says. To aid in tort law admissibility reviews, judges should make greater use of court-appointed scientific experts, Cranor suggests. Just as scientists at the Environmental Protection Agency adjudicate the claims of opposing parties,
independent scientists, if chosen careful y, could serve an important purpose in
toxic tort cases, he writes.
Cranor proposes another remedy that would avoid many cases of harm from
toxic substances and therefore numerous lawsuits. This would be to change the
laws and require much more testing of chemicals before they appear in the
marketplace. "There is simply too little science required up front before
substances enter commerce and people are exposed," he writes.
This careful y documented book should be required reading for al judges who
deal with tort law and for law students or lawyers planning to specialize in the
defense of citizens who claim they have been harmed by drugs or toxicants. It
should also be read by chemistry students who are interested in the societal
problems sometimes created by the production and use of chemicals. No other
book that I have encountered so careful y delineates the great gulf between the
science of toxicology and what is now happening in the judicial system.
Bette Hileman is a senior editor in C&EN's Government & Policy Department.
Her coverage includes climate change, pharmaceutical regulation, and health
effects of environmental chemicals.

Source: http://philosophy.ucr.edu/wp-content/uploads/2013/07/ChemEngNews.pdf