Re: Re: Tr: Bush administration uses bureaucracy to limit law...

[Guest guest]

,

Below is a link that explains the different types of preemption.

_http://druganddevicelaw.blogspot.com/2007/09/drug-versus-device-preemption.ht

ml_

(http://druganddevicelaw.blogspot.com/2007/09/drug-versus-device-preemption.html\

)

But to net out " conflict pre-emption " AS I UNDERSTAND IT, in regard to some

pharmaceuticals that the FDA approved, some of the pharmaceutical companies

intentionally limited the data they supplied to the FDA when getting approval

for their drugs. But now, they are attempting to claim they are exempt from

liability in state courts because their drugs were approved by the federal

government, FDA.

So...first Bush guts our government agencies and outsources control over

much of science and medicine to private sector orgs..that are funded by

corporations/industry/pharmaceutical companies. So the government agencies are

handicapped and have lost control and accept false data from the private sector

that are funded by corporations et al. When people get sick from these drugs

(Vioxx and the Ortho Evra patch come to my mind), the corporations then claim

they are not at fault because the government approved their drugs.

_http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1132822_

(http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1132822)

The Battle Over Drug Preemption Reaches the Supreme Court: How Wide the

Impact?

_MARGARET GILHOOLEY _

(http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=463685)

Seton Hall University - School of Law

____________________________________

May 7, 2008

Abstract:

The extent to which FDA decisions preempt tort liability for prescription

drugs has become an important and contentious issue. The agency has issued a

Preemption Policy that favors preemption when a drug manufacturer consults with

the agency about a risk. The Supreme Court has considered two preemption

cases this term and is expected to make an important ruling on drug preemption

next term in Wyeth v. Levine. Wyeth has some unusual factors, though, since

the label had a warning about the risks from the method of administration, and

the plaintiff's expert testified that the label should not have allowed the

method at all.

The most important and difficult preemption question is the liability for

risks that are found from use after the drug is on the market. This paper will

examine the factors that could limit the scope of the Wyeth decision. Instead

of having a broad rule that there never is preemption or there always is

preemption, a better approach is to focus preemption on matters that the agency

has specifically addressed based on current and accurate information. The

consultation process between the agency and the drug company also needs to be

made more transparent about the information available about emerging risks.

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