Re: Supreme Court accepts bought and old FDA rulings
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Re: Supreme Court accepts bought and old FDA rulings         

Group: mn.politics · Group Profile
Author: Billy
Date: Feb 27, 2008 08:30

In article , "mcs" yahoo.com>
wrote:
> John, Can I suggest to you, that this incident only indicates superficially
> what the real powers are in USA and everyone knows it. Whats equally
> disconcerting is the power that money and power does to its victims. Chances
> are the people in Philly are being more harmed from policies of the rich
> then most people know here, not just because of the way a relatively minor
> case like this is absolved but how people are being set up by pollution and
> other things and just maybe the health care companies know and health
> departments know why we are targeted so often with health care commercials
> ( like no other city I have been in the last 30 years) and nothing is done
> to immediately lower the causes we need those hospitals and meds. This is
> the real power of money.- Harming people greatly and thats what I know is
> happening to our area as we get little or no concern about things like
> getting less and less clean air and its affects .
>
> This is the power of hedge funds with judges who recently ruled legal to
> take you to the cleaners if you invested in stocks! This is the power of big
> oil that can rape you at will and credit card companies to charge you more
> fees then even the orginal charges you rung up just for being late in
> payments. The discrepency between the rich and poor keeps growing which is
> why companies that control the press here keeps wanting the ability to
> consolidate. Its not about race or religion or terror, its about the same
> things that have corrupted societies and led people to write books like the
> Tale of Two Cities..only this time its happening in the USA. The only places
> you can really expect people to write about it is on the net.
>
> "CarlSwanson" nospam.frontiernet.net> wrote in message
> news:0b5rr35ckcm4sjtt5efhi3gtlo2ksubjju@4ax.com...
>> ..I told you Christian Right dummies that you were being used by the
>> Republican Party to expand a Supreme Court not to overturn Roe vs Wade
>> or protect the constitution and individuals rights. The Supreme
>> Court is being restructured to prevent any backlash against the
>> greediest among us when they hurt people. Vote for any Republican
>> these days and you are traitor to your country.
>>
>> No one respects absurd lawsuits, but the facts are that " those that
>> have" can defend themselves...ask Erin Brockovitch
>> http://en.wikipedia.org/wiki/Erin_Brockovitch
>>
>> http://www.nytimes.com/2008/02/21/washington/21fda.html?_r=1&th&emc=th&oref=
>> slogin
>>
>> News Analysis
>> Justices Add Legal Complications to Debate on F.D.A.'s Competence
>>
>> By GARDINER HARRIS
>> Published: February 21, 2008
>> WASHINGTON
>>
>>
>> Diana Levine won a suit against Wyeth over a drug she blamed for
>> gangrene in her hand and forearm. Wyeth appealed.
>> THE Supreme Court's ruling on Wednesday limiting lawsuits by patients
>> over medical devices comes just as independent groups have raised
>> questions about the Food and Drug Administration's ability to ensure
>> the safety of these products.
>>
>> The Institute of Medicine, the Government Accountability Office and
>> the F.D.A.'s own science board have all issued reports concluding that
>> poor management and scientific inadequacies have made the agency
>> incapable of protecting the country against unsafe drugs, medical
>> devices and food.
>>
>> A result, said David Vladeck, a professor at Georgetown University Law
>> Center, is that the public is facing the worst of both worlds: a
>> government health agency that cannot protect them and rules that block
>> them from winning compensation when injured.
>>
>> Randall Lutter, the F.D.A.'s deputy commissioner for policy, said that
>> the agency was responding to reports of its deficiencies and
>> improving. And advocates for the administration's position say that
>> regardless of the recent reports, the F.D.A. is a far better judge of
>> product safety than the courts.
>>
>> "Anyone who is in favor of a strong F.D.A. cannot also be in favor of
>> unlearned, unscientific state juries second-guessing F.D.A.'s
>> science-based decisions," said Daniel Troy, a former F.D.A. general
>> counsel who helped push the new policy.
>>
>> Before President Bush took office, F.D.A. officials said that courts
>> provided patients additional protection. In a 1997 brief, the agency's
>> chief lawyer wrote that "even the most thorough regulation of a
>> product such as a critical medical device may fail to identify
>> potential problems."
>>
>> But the administration argues that the courts interfere with rather
>> than bolster agency oversight and it has undertaken a concerted effort
>> to protect drug and device makers from lawsuits by filing briefs in
>> the Supreme Court and other courts and changing rules to limit
>> companies' liability.
>>
>> With Wednesday's ruling, those efforts proved successful for device
>> makers. Two more cases, one to be argued Monday and the other in
>> October, will determine whether drug makers will benefit as well. In
>> his majority opinion, Justice Antonin Scalia wrote that the F.D.A.'s
>> interpretation of its rules deserves "substantial deference." Since
>> the administration now interprets those rules to provide similar
>> liability protection to drug makers, Justice Scalia's opinion suggests
>> that the court may soon provide a liability shield to pharmaceutical
>> companies, too.
>>
>> The politics of these cases are bewildering, said Susan P. Frederick,
>> federal affairs counsel for the National Conference of State
>> Legislatures. Republican administrations generally advocate limited
>> regulation and deference to state oversight, Ms. Frederick said. But
>> in what she said was its push to reduce court damage awards, the
>> administration has written a blizzard of rules that do just the
>> opposite.
>>
>> "This is shocking to us because usually Republicans align quite nicely
>> with our federalism policy," she said.
>>
>> The administration has undertaken similar efforts in other regulatory
>> areas, including highway and consumer safety, contending that
>> strengthened federal regulations trump, or pre-empt, the decisions of
>> state courts.
>>
>> Diana Levine's suit, which will be argued in October, illustrates the
>> debate.
>>
>> In April 2000, Ms. Levine, a professional guitarist in Vermont,
>> suffered a disabling migraine and went to a health clinic for a shot
>> of Phenergan, an anti-nausea medicine. The drug was inadvertently
>> injected into her artery, where it caused an arterial spasm that led
>> to gangrene. After slowly turning black, Ms. Levine's hand and forearm
>> were amputated.
>>
>> Ms. Levine sued Wyeth, arguing that the drug's label should have
>> forcefully warned of this known risk. She won a $6.8 million judgment.
>> Wyeth appealed, contending that federal drug regulators did not call
>> for such a forceful warning and instead approved a label that simply
>> stated a preference for a less risky method of administering the drug.
>>
>> The question is who controlled the drug's label, the lengthy listing
>> of the drug's uses, dosages and risks.
>>
>> F.D.A. rules had long allowed companies, which know their products
>> better than the government and usually learn of new or worsening risks
>> first, to change labels without federal approval. Indeed, the labels
>> initially approved by regulators were seen as setting minimum safety
>> standards that companies could then bolster.
>>
>> But in January, the agency issued a proposed rule to limit when
>> companies can list new warnings without federal approval, which Mr.
>> Lutter said "improves and strengthens our control of the label."
>>
>> The administration argues that a product's approved label represents
>> not only the least but the most that the drug agency allows in
>> warnings, "both a floor and a ceiling for labeling," its brief in the
>> Levine case states.
>>
>> "If you put too much junk in the label, people don't understand it in
>> the right way," Mr. Lutter said. "There is a risk of overreaction and
>> ignoring it."
>>
>> For the administration, an unstated warning is a deliberate decision
>> by the F.D.A. to protect against undue alarm, and companies cannot be
>> held liable for such nonwarnings. Citing this argument, Wyeth contends
>> that Ms. Levine's suit punishes the company for failing to issue a
>> warning that the F.D.A. implicitly rejected.
>>
>> Ken Johnson, senior vice president of the Pharmaceutical Research and
>> Manufacturers of America, said that the F.D.A. oversees drug safety
>> and labeling because its "expert staff is the most qualified to make
>> such highly scientific and technical judgments."
>>
>> Andy Vickery, a plaintiffs' lawyer in Houston, said that without the
>> threat of litigation, companies would be less careful and patients
>> would suffer.
>>
>> "Many of the problems with drugs have been found out only because of
>> vigorous litigation," Mr. Vickery said. Phenergan's label now includes
>> a lengthy warning about the dangers of intravenous injections.
>>
This takes place against the backdrop of the Bush's administrations
pro-business tilt. From the over turning of environmental protections
against hardrock mining in 2001 that were put in place by the Clinton
administration, to Dick Cheney's secret "Energy Summit", to the denial
of California's prerogative to set emission standards, our CEO President
has sided against the people at every turn.
--

Billy

Bush, Cheney & Pelosi, Behind Bars
http://rachelcorriefoundation.org/site/
http://en.wikipedia.org/wiki/Movement_to_impeach_George_W._Bush
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