The Christian Science Monitor May 13, 4:20 PM EDT
Bush administration rules limit lawsuits
By PETE YOST Associated Press Writer
WA****NGTON (AP) -- Faced with an unfriendly Congress, the Bush
administration has found another, quieter way to make it more
difficult for consumers to sue businesses over faulty
products. It's rewriting the bureaucratic rulebook.
Lawsuit limits have been included in 51 rules proposed or
adopted since 2005 by agency bureaucrats governing just about
everything Americans use: drugs, cars, railroads, medical
devices and food.
Decried by consumer advocates and embraced by industry, the
agencies' use of the government's rule-making authority
represents the administration's final act in a long-standing
drive to ****eld companies from lawsuits.
President Bush has campaigned for lawsuit reform since his
days as Texas governor. As president, he has made little
headway on the issue in Congress. He's been thwarted by
Democrats every time he's tried to tackle the issue head-on.
Turns out there was another way, one little-noticed step at a
time.
If the rulemaking at the various agencies had been a
centralized effort in the White House or the Justice
Department, "it would have failed because immediately
everybody would have mobilized resistance," said Michael Greve
of the American Enterprise Institute, a conservative
Wa****ngton think tank.
Limits on lawsuits have been ordered or proposed for drug
labeling and packaging - one issue that will get a big airing,
on Wednesday, because of a case involving actor Dennis Quaid's
newborn twins - and for rules ranging from mattress
flammability standards to school bus passenger seating to
dietary sweeteners and roof-crush requirements in car
rollovers.
Of the 51 regulations, 41 came from the Food and Drug
Administration and the National Highway Traffic Safety
Administration, or NHTSA.
Ten of 15 federal traffic safety regulations from last year
have been finalized by NHTSA and are now in force or soon will
be, a development that has gotten minimal public attention.
Underlying this bureaucratic version of lawsuit reform is the
concept of federal preemption - a legal idea that is hard to
build widespread public interest in.
Rooted in the Supremacy Clause of the Constitution, federal
preemption refers to cir***stances in which federal law and
regulation trump state law, in this instance state laws that
govern when one person may be held liable for another's
injury.
Frequently filed in state courts, where juries often are more
receptive to plaintiffs' claims against cor****ations, product
liability lawsuits are often moved at the request of business
defendants to more restrictive federal courts.
Regardless of where the suits end up, the issue is
increasingly whether companies can use broad preemption
language in regulatory preambles to get cases thrown out.
The preambles are the agencies' interpretation of whether the
federal regulatory law permits preemption of lawsuits. An
expansive interpretation of preemption leaves little room for
consumers to sue, and that is what the national trial lawyers
group, the American Association for Justice, says is taking
place.
Jon Haber, AAJ's chief executive officer, says the agencies
are engaging in "a brazen end run around Congress, the
Constitution and the states in an effort to let negligent
cor****ations off the hook and knowingly put consumers at
risk."
The real-world impact of preemption will be on display
Wednesday when a congressional committee hears from actor
Dennis Quaid and his wife, who have sued a maker of the blood-
thinner heparin in Illinois state court.
The Quaids sued after their newborn twins were given massive
doses of the blood thinner at a hospital. The Quaids claim the
manufacturer was negligent in packaging different doses of the
product in similar vials with blue backgrounds.
The company - Baxter Healthcare Corp. - is seeking to use the
doctrine of preemption to ****eld it from any civil liability,
claiming that once FDA approved the labeling and packaging at
issue in the case, the company is immune from civil suits for
money damages.
Joan Claybrook, former head of NHTSA during the Carter
administration, says her former agency is using regulatory
preambles in a campaign against lawsuits.
"What the companies want is complete immunity and the
regulators in the Bush administration are helping them," says
Claybrook, now head of the consumer advocacy group Public
Citizen.
NHTSA denies that it has designed rules to undercut lawsuits.
"After considering both the purposes of each safety rulemaking
and possible state actions that might arise, in most cases we
have concluded that there are no presently identified factual
situations that would create a conflict or frustrate federal
objectives," says the agency. "We cannot, however, rule out
the possibility that such a factual situation might arise in
the future."
Georgetown University law professor David Vladeck calls
NHTSA's position "mumbo jumbo that understates considerably
the language in the preambles."
"The preambles say that, in the future, once the NHTSA rule
takes effect, the agency believes that the rule should have
the effect of displacing state tort law," said Vladeck.
The FDA echoes NHTSA's position.
"The preambles to these rules do not seek to preempt, but
instead describe the scope of preemption under operation of
federal law," said FDA spokesman Rita Chappelle.
Later this year, the Supreme Court will wade into the issue of
federal preemption as it relates to lawsuits and prescription
drug labeling. The defendant drugmaker contends it should not
be in the lawsuit because the FDA had approved the warning
label on the drug.
The company is trying to overturn a $6.8 million award given a
woman whose arm had to be amputated after anti-nausea
medication was inadvertently injected into an artery.
In some instances, judges seem as exercised as consumer
advocates about the FDA's undermining of lawsuits under state
tort law.
In a recent decision, a federal appeals court judge wrote that
the FDA has for over three-quarters of a century viewed state
tort law as complementary to the agency's safety warnings on
prescription drug packages and "only for the last two years
has it claimed otherwise."
The judge, Thomas Ambro, was dissenting from a ruling by two
of his colleagues throwing out lawsuits in New Jersey and
Pennsylvania. The allegations in the suits against
pharmaceutical companies linked two suicides to
antidepressants.
Judges have cited FDA's regulatory preamble in its
prescription drug rule in more than a dozen favorable rulings
for pharmaceutical companies. Despite the FDA frequently
showing up on the side of industry, judges have ruled for
consumers' right to sue about as often as they have ruled
against them in cases touching on the regulatory preamble for
prescription drug labels.
One expert in the field says the trend may be ****fting to
industry's favor, in part due to the FDA's regulatory
preamble.
"The last four or five cases, industry has been on a roll,"
says Chicago attorney Mark Herrmann, who defends
pharmaceutical companies in liability cases.
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But all things that are reproved are made manifest by the
light:
for whatsoever doth make manifest is light.
The light ****neth in darkness;
and the darkness comprehended it not.
The light of the body is the eye: if therefore thine eye be
single,
thy whole body shall be full of light.
But if thine eye be evil, thy whole body shall be full of
darkness.
If therefore the light that is in thee be darkness, how great
is that darkness!
Awake thou that sleepest, and arise from the dead,
and Christ shall give thee light.
For my yoke is easy, and my burden is light.
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