ABA [American Bar Association] Journal  [Printer-friendly version]
November 7, 2005


Industries Are Using a Landmark Case and a 2001 Law to Block
Regulation, Critics Say

[Rachel's introduction: We need a precautionary approach because the
regulatory system has become paralyzed by the search for the holy
grail of scientific certainty.]

By Mark Hansen

Since 1986, every aspirin bottle sold in this country has carried a
label warning that consumption by children with viral illnesses
increases the chances of contracting Reye's syndrome, a rare but
potentially deadly disease.

The Food and Drug Administration mandated the warning after scientific
studies showed that children with colds, flu or chicken pox who took
aspirin were more likely to develop Reye's syndrome than those who

Experts regard that development as a public health triumph, but a
bittersweet one. The warning labels have helped save lives. But, they
say, many children became disabled or died from Reye's syndrome while
the aspirin industry fought the government's efforts. The industry had
argued that the scientific evidence for such a warning was incomplete,
unclear or uncertain.

The aspirin industry didn't invent the strategy of questioning the
underlying science, says David Michaels, an epidemiologist at George
Washington University. Corporations have successfully used that tactic
for decades, says Michaels, an assistant secretary of energy in the
Clinton administration who is writing a book on the subject.

But the strategy has become so common that it is almost unheard of for
the science behind a proposed public health or environmental
regulation to go unchallenged, no matter how strong or conclusive the
evidence is, according to Michaels and other experts in public health
and environmental law.

A Lot On The Line

"When there's a lot on the line financially," says Wendy Wagner, a
University of Texas law professor who specializes in environmental and
regulatory law, "it's always going to be in a corporation's interest
to challenge the underlying science -- sometimes illegitimately."

Industry officials say it is ludicrous to suggest that corporations
raise scientific uncertainty to delay or defeat government regulation.
The uncertainty is real, they say. And it ought to be acknowledged.

"Our position is that every ounce of scientific information that is
part of the public debate should be open, available and accessible to
everyone," says Bill Kovacs, vice president for environment,
technology and regulatory affairs for the U.S. Chamber of Commerce.

But academics are taking a closer look at two legal developments that,
they say, may have exacerbated the trend. Both have altered people's
understanding of how scientific evidence is gathered.

One is the U.S. Supreme Court's landmark 1993 decision, Daubert v.
Merrell Dow Pharmaceuticals, 509 U.S. 579, which requires federal
judges to act as gatekeepers and to admit only evidence that they find
relevant and reliable.

The other is the 2001 Data Quality Act, which allows anyone who
believes that information disseminated by a federal agency is not of
sufficient "quality, objectivity, utility or integrity" to request
that the information be corrected.

Those two developments, the critics argue, allow -- if not encourage
-- a piece-by-piece examination of scientific evidence rather than the
weight-of-the-evidence approach that most scientists prefer. The
result, they say, is that opponents of regulation can pick and choose
pieces of data to attack the entire premise of a regulation.

For example, Michaels says, take the cases involving Parlodel, a
lactation-suppressing drug taken by non-nursing new mothers in the
1980s and early 1990s.

Citing case reports and animal studies showing that Parlodel can cause
a rapid rise in blood pressure in humans, the FDA asked the drugmaker
in 1985 to include warning labels. Yet when several women later sued
the drugmaker, claiming Parlodel was responsible for their injuries,
their cases essentially were thrown out of court for lack of
scientific certainty, Michaels says.

"Applying the Daubert rule, those judges demanded a level of certainty
that was virtually impossible to provide," he says.

Emboldened, antiregulatory interests are expanding the application of
Daubert principles to judicial review of federal regulations, experts

Michaels cites the chamber's 2002 call for an executive order
requiring all federal agencies to apply the Daubert standards in the
administrative rule-making process.

Public health advocates should be wary, Michaels and others say. "The
legal, economic and political obstacles faced by regulators will
increase dramatically when Daubert-like criteria are applied to each
piece of scientific evidence used to support a regulation," Michaels

The Data Quality Act also gives antiregulatory interests a new tool,
experts say. The statute, which began as a little-noticed rider in a
thick appropriations bill, has opened the door to contest every piece
of evidence considered by regulators. What's more, the act contains no
equivalent Rule 11 sanctions for filing a frivolous claim.

"There's no cost or penalty to mounting such a challenge, whether
there's any merit to it or not," Wagner says. "But the potential
rewards can be huge. At the very least, it can delay regulation or
liability. At best, it can succeed."

Already, Michaels says, the salt industry has used the statute to
challenge government recommendations that Americans consume less salt.
It has also been used by the food industry to oppose dietary
guidelines that suggest reduced sugar consumption, and by the
manufacturers of toxic chemicals that do not want their products
labeled as cancer-causing.

Junk Science?

Steven Milloy, a lawyer and biostatistician who runs a Web site
devoted to exposing what he calls junk science, JunkScience.com,
concedes there is an inkling of truth to what Michaels and others are
saying. But he dismisses much of it as "exaggerations, distortions and
manipulations of the truth" by those who are anti-industry.

All Daubert does is allow judges to set up panels of experts to advise
them on scientific matters in litigation, Milloy says. "It's not a
tool to deprive plaintiffs of whatever relief they merit." And all the
Data Quality Act does, Milloy adds, is allow the public to question
the reliability of scientific data used to establish public policy.

Opponents "view it as a way of harassing well-meaning scientists," he
says. "We view it as a way of checking up on the people who want to
use junk science to regulate how we live."

Milloy also questions Michaels' objectivity because his work is
supported by the Project on Scientific Knowledge and Public Policy,
which receives funding from the Common Benefit Trust, a fund that he
says was created to pay the expenses of plaintiffs lawyers in silicon-
gel breast-implant litigation.

"As far as him throwing rocks at everyone," Milloy says, "you know
what they say about people who live in glass houses."

The chamber's Kovacs says Daubert has helped improve the quality of
science used in court by giving judges a "little bit of control" over
so-called experts who are willing to testify to anything.

"It means they can't violate the laws of physics anymore," he says.
"It puts some measure of science into the process so they can't just
make things up."

And Kovacs says the Data Quality Act helps ensure that studies that
form the basis for government policies are evenhanded, free of bias
and reliable. The act is also supposed to help ensure that the public
has meaningful access to the data needed to test and reproduce the
government's results, he says.

The latter point is being tested in court. The chamber has joined the
Salt Institute in a lawsuit charging that the government violated the
act by failing to release the scientific data that led to its
recommendation that Americans reduce their salt intake to avoid the
risk of high blood pressure. The plaintiffs contend that a diet with
too little salt may actually increase the risk of cardiovascular and
other health ailments in some people.

Last year, a federal district judge in Virginia granted the
government's motion to dismiss, holding, among other things, that the
plaintiffs lacked standing to sue. An appeal is pending before the 4th
U.S. Circuit Court of Appeals at Richmond, Va.

Georgetown University law professor Paul Rothstein, who specializes in
criminal law and evidence, says it is in an industry's interest to
raise questions about the science underlying a proposed government
rule or regulation. And since science is never absolutely certain, he
says, such questions can always be raised.

Rothstein agrees that some courts have taken Daubert too far,
rejecting evidence that suggests a causal relationship because
scientists demand more before they are willing to conclude that a
relationship has been proved. Other courts have gone the opposite way,
finding a causal link between a substance and an injury when the
science supporting such a link is tenuous.

But Rothstein thinks it is a misreading of Daubert to suggest that it
requires a piece-by-piece examination of the evidence and not a
weight-of-the-evidence approach.

"Daubert specifically says it means to require that the evidence
conform to the scientific method. Nowhere does it say anything about a
'piece-by-piece approach,"" he says.

Copyright 2005 ABA Journal