NYT: Scalia and Roberts demonstrate once again that they're morons (FDA/Supreme Court Decision)
Mort Zuckerman
Spin...@yahoogroups.com, kshe...@calea.org, fit...@gmail.com,
patrick.f...@usdoj.gov, model...@sbcglobal.net,
jdr...@nejm.org, let...@courant.com, Jgerb...@cdc.gov,
michae...@po.state.ct.us, con...@po.state.ct.us, executive-
edi...@nytimes.com, managin...@nytimes.com, news-
ti...@nytimes.com, the-...@nytimes.com, biz...@nytimes.com,
for...@nytimes.com, nati...@nytimes.com, dv...@cdc.gov,
brigidc...@optonline.net, tr...@hotmail.com, illino...@aol.com,
jle...@courant.com, tinaj...@yahoo.com, jhorn...@fff.org,
thomas...@usdoj.gov, thoma...@po.state.ct.us,
kur...@washpost.com, georg...@washpost.com, p...@allegorypress.com,
commissi...@po.state.ct.us, brans...@comcast.net,
vts...@comcast.net, o...@po.state.ct.us, freet...@charter.net,
scott....@po.state.ct.us, govern...@po.state.ct.us,
attorney...@po.state.ct.us, randall...@usdoj.gov,
Robert....@yale.edu, edi...@greenwich-post.com
Cc: fra...@ucia.gov, dr-ahma...@president.ir,
eugener...@washpost.com, afa...@niaid.nih.gov,
bmi...@newstimes.com, tr...@hotmail.com, rast...@aol.com,
billc...@gmail.com, amcg...@rms-law.com, rjmu...@aol.com,
paulcrai...@yahoo.com, sidney_b...@yahoo.com,
criminal...@usdoj.gov, karla.d...@usdoj.gov,
christophe...@usdoj.gov, richar...@yale.edu,
harol...@yale.edu, james.p...@yale.edu, inq...@aldf.com,
ly...@idsociety.org
Subject: NYT: Scalia and Roberts demonstrate once again that they're
morons (FDA/Supreme Court Decision)
Date: Mar 4, 2009 12:31 PM
Hmmm.
Lemme think:
No drugs came ever off the market as a result
of lawyers discovering that the FDA are a bunch
of Ef-ups, and no multi-million dollar lawsuits
were won ever against BigPharma.
Check.
Never happened.
Not Zyprexa, not Thalidomide, not Celexa,
and not LYMErix. In fact, everybody get
ready for their annual booster shot of
the New Great Imitator:
http://www.actionlyme.org/PAM3CYS_IMMUNE_SUPPRESSION.htm
in case you don't have Multiple Sclerosis,
Cancer or ALS, yet.
============================
http://www.nytimes.com/aponline/2009/03/04/business/AP-Scotus-Drug-Suit.html?_r=1&hp=&pagewanted=print
The New York Times
Printer Friendly Format Sponsored By
March 4, 2009
Supreme Court Rejects Limits on Drug Lawsuits
By THE ASSOCIATED PRESS
Filed at 11:44 a.m. ET
WASHINGTON (AP) -- The Supreme Court on Wednesday upheld a $6.7
million jury award to a musician who lost her arm because of a botched
injection of an anti-nausea medication. The court brushed away a plea
for limiting lawsuits against drug makers.
In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim
that federal approval of its Phenergan anti-nausea drug should have
shielded the company from lawsuits like the one filed by Diana Levine
of Vermont. Her
Levine, 63, struggled with her emotions when told of the ruling in a
phone call from an Associated Press reporter Wednesday: ''Oh, my God.
I'm so, so happy. I can't believe this phone call,'' she said.
''I've been waiting for so long, and I had no idea of what the chances
were. I'm just ecstatic. I'm going to have to sit down,'' said Levine,
once a professional guitar and piano player. She now plays with one
hand, and sings.
Levine's lawsuit said she wasn't sufficiently warned of the risks of
using Phenergan. But Bert Rein, a Washington lawyer who represents
Wyeth, said the company's label complied with federal law.
''The medical and scientific experts at FDA are in the best position
to weigh the risks and benefits of a medicine and to assess how those
risks and benefits should be described in the product's label,'' Rein
said in a statement.
Wyeth is in the process of being bought by rival Pfizer, Inc., in a
$68 billion deal that is expected to close later this year.
The decision is the second this term to reject business groups'
arguments that federal regulation effectively pre-empts consumer
complaints under state law.
A Vermont jury agreed with Levine's claim that Wyeth failed to provide
a strong and clear warning about the risks of quickly injecting the
drug into a vein, a method called IV push. Gangrene is likely if the
injection accidentally hits an artery -- precisely what happened to
Levine.
The company appealed and, backed by the Bush administration, argued
that once a drug's warning label gets approval from the Food and Drug
Administration, the label can't be changed without further FDA
approval and consumers cannot pursue state law claims that they were
harmed.
Justice John Paul Stevens, writing the majority opinion, said Wyeth
could ''unilaterally strengthen its warning.''
Stevens said he was persuaded that until a recent change by the FDA,
the agency ''traditionally regarded state law as a complementary form
of drug regulation'' because it monitors 11,000 drugs.
Justice Clarence Thomas agreed with the outcome of the case, but did
not join Stevens' opinion.
Justice Samuel Alito wrote a dissent that was joined by Chief Justice
John Roberts and Justice Antonin Scalia.
''This case illustrates that tragic facts make bad law,'' Alito said.
''The court holds that a state tort jury, rather than the Food and
Drug Administration, is ultimately responsible for regulating warning
labels for prescription drugs.''
The FDA has approved the use of Phenergan by injection, including the
method at issue in Levine's case. The drug has been available for
decades to treat nausea and when used properly, both sides agree it is
safe and effective.
The Bush administration and business groups aggressively pushed limits
on lawsuits through the doctrine of pre-emption -- asserting the
primacy of federal regulation over rules that might differ from state
to state.
The Supreme Court had largely agreed, ruling last term that FDA
approval shields medical devices from most lawsuits. That case turned
on a provision of federal law prohibiting states from imposing their
own requirements on the devices.
The Levine case drew a lot of attention because the administration and
Wyeth contended that, although the federal Food, Drug and Cosmetic Act
lacks a similar provision, drug manufacturers also are protected from
most suits over federally approved drugs.
Stevens said there could be circumstances where consumer lawsuits
would not be allowed, including if the FDA had considered and rejected
a stronger warning label.
But that was not the case with Phenergan, he said. ''As we have
discussed, the FDA did not consider and reject a stronger warning
against IV-push injection of Phenergan,'' Stevens said.
Justice Stephen Breyer agreed in a brief, separate opinion. ''It is
also possible that state tort law will sometimes interfere with the
FDA's desire to create a drug label containing a specific set of
cautions and instructions,'' Breyer said.
The case is Wyeth v. Levine, 06-1249.
------
Associated Press writer John Curran contributed reporting from
Montpelier, Vt.
Home
* World
* U.S.
* N.Y. / Region
* Business
* Technology
* Science
* Health
* Sports
* Opinion
* Arts
* Style
* Travel
* Jobs
* Real Estate
* Automobiles
* Back to Top
Copyright 2009 The Associated Press
* Privacy Policy
* Search
* Corrections
* RSS
* First Look
* Help
* Contact Us
* Work for Us
* Site Map
"[Real] scientists are *fiercely* independent. That's the good
news."-- NIH's Top Fool, Anthony Fauci