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The
Practical
Practitioner
Bill Daniels
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the Advocate
Magazine APRIL 2009
A Touch of Spring
Fever
At The Supreme
Court?
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It’s Springtime
and a young
lawyer’s
thoughts turn to
nine men and
women in black
robes.
Spring is one of
my favorite
times of the
year. Birds
sing. The air
feels fresher.
Flowers bloom
brightly in the
garden and
there's that
almost
irresistible
temptation to
power down the
laptop, drop the
top on the
convertible and
go for a drive
along the ocean
beach or country
road.
I got a sort of
springish tingle
just the other
day while
reading the U.S.
Supreme Court's
decision in
Wyeth v. Levine
2009 WL 529172 (U.S.Vt.)
.
In case you're not familiar, Wyeth was widely awaited by the
product
liability bar,
which feared a
conservative
court would
latch onto the
Bush
administration's
push to preempt
state safety
laws using
language slipped
into regulatory
preambles (a
process that
gets you around
the normal
vetting process)
and wipe out yet
another area of
consumer rights.
Instead, the high court came in six-three against preemption.
Justice Stevens
wrote a
beauteous
opinion
explaining why
state consumer
protections
remain an
important part
of modern
American tort
law. Justice
Thomas, in a
concurring
opinion, came
out strongly in
defense of the
states playing a
key role in
protecting their
own. Oddly, he
left his friend
Justice Scalia
alone with the
Chief Justice in
joining Justice
Alito's
irritated
dissent.
Too cool! Could the end of tort reform winter be
closing in ?
Predictably, The Wall Street Journal, immediately blasted the
decision in a
scathing
editorial,
calling the high
court's decision
to allow the
states to play a
role in consumer
product safety a
"plaintiff
lawyer's dream."
It loudly
praised the
dissent's
objection that
submitting drug
safety issues to
the laws of the
50 states is an
inherently
inefficient way
to run a
national
regulatory
scheme. It
parroted the
dissent's view
that an expert
FDA is better
suited to making
decisions on
drug safety than
a lay jury
reasoning that a
regulatory
agency can weigh
the big picture
risks and
benefits of a
particular
product more
effectively than
a lay jury,
which sees only
one injured
victim in the
single case.
Then, the very next day, a headline on the front page of that very
same Wall Street
Journal shouted,
"Extra extra!
FDA process
stinks of
corruption!"
Well, actually,
the precise
story began:
Political
Lobbying Drove
FDA Process
By Alicia Mundy
WASHINGTON - The recent approval of a new device to treat knee
injuries
followed a
lobbying
campaign that
overcame
repeated
rejections by
scientists
within the Food
and Drug
Administration,
agency documents
show.
The FDA's internal dissent over Menaflex, which targets the
most-common knee
injury
afflicting
everyone from
high-school
athletes to baby
boomers, is
straining a
government
agency that
oversees a
quarter of the
U.S. economy.
Some senior FDA
staff members
complained in
documents that
the handling of
Menaflex,
made by ReGen
Biologies,
Inc., shows how
political and
industry
pressure can
influence
scientific
conclusions.
At issue isn't just the efficacy of the device - that remains in
dispute - but
the nature of
the FDA's own
approval
process.
Like I said. A beautiful spring day.
What's going
on here?
Okay, so what's really going on here, since even the once
predictable
Journal editors
can't seem to
get their
philosophical
ducks in a row?
In my mind, it's pretty simple. After a long period where America
fooled itself
into thinking
that the wisdom
of ages needed
reworking and
the laws of
gravity had been
repealed, we're
getting back to
basics. I
believe I see
signs that
common sense is
slowly creeping
back into the
national
Zeitgeist. Don't
ever forget,
civil juries are
in the federal
and state
constitutions
for a reason.
There are many possible motivators for what I would argue may be a
transformation
in national
thinking about
the best way to
safeguard our
persons.
The November elections signaled voters are ready for a change in
our social
status quo. It
wasn't that long
ago (1963,
actually) that
an Irish builder
in San Francisco
was able to back
out of selling
my family a home
when he learned
my mother was
born in Asia.
Under the
miscegenation
laws in place at
that time, it
would have been
illegal for me
to marry my wife
(good thing we
were both too
young). Now
Obama lives in
the White House,
and he is
popular. A
sign of spring?
The bursting credit bubble has clearly shaken America's confidence
in the notion
that we can
safely place our
fate in the
hands of an
elite few.
People are
starting to
question their
belief that
overprotecting
profit
institutions is
the best way to
safeguard their
own well being.
Flowers poking
their heads
through the ice?
If you want some more tangible evidence of a sea change in thinking
even at our
Supreme Court,
compare last
term's decision
upholding
federal
preemption for
medical devices
(Riegel v.
Medtronic, Inc.
(2008) 128 S.Ct.
999 [169 L.Ed.Sd
892]) with
Wyeth, where
preemption was
overruled.
In Riegel, the majority accepted that a "cost-benefit analysis"
performed by
experts at the
FDA was a
superior means
of effecting the
greater good to
a lay jury. One
year and a
market crash
later, the
Wyeth
majority reached
precisely the
opposite
conclusion. "The
Court holds that
a state tort
jury rather than
the [FDA] is
ultimately
responsible for
regulating
warning labels
for prescription
drugs,"
complained the
dissent.
Okay, maybe I have a touch of spring fever. But maybe our long tort
reform winter is
finally giving
way to a change
in the seasons.
Cross your fingers.
The Advocate
Magazine APRIL
2009
LEARNING
CENTER
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