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Columnist Evelyn Pringle examines the consequences, in terms of deaths and injuries, in the wake of the Bush Administration’s enabling of the virtual takeover of the Food and Drug Administration by the pharmaceutical industry. Pringle cites the FDA’s announcement that its approval of drugs and prescription labels preempts the rights of consumers to file product liability lawsuits against drug companies. The changes went into effect in 2006, and have been used by drug company lawyers all over the country to challenge civil tort claims in court.

Bush-Controlled FDA Moonlights as Big Pharma Pusher

Date Published:

Jul 16, 2007 01:00 AM

Author: Evelyn Pringle

Source: OpEd News

Americans need to stop and consider how many consumers will be killed
and injured by dangerous drugs by the time George Bush heads back to
Texas at the end of his Presidency, as a direct result of his allowing
the interests of the pharmaceutical industry to take control of the

For nearly 70 years, the common-law tort systems in the individual
states have provided a remedy for citizens injured by prescription
drugs. However, in one of the most blatant paybacks for political
contributions in US history, in January 2006, Bush-appointed officials
at the FDA announced that the agency’s approval of a drug and its
labeling acts to preempt product liability lawsuits filed by patients
against the pharmaceutical giants.

On February 23, 2006, Democratic lawmakers Rep Henry Waxman, of the
Committee on Government Reform, and Reps John Dingell and Sherrod
Brown of the Committee on Energy and Commerce, sent a letter to the
Secretary of Health and Human Services, and voiced their outrage.

“The announcement,” the lawmakers wrote, “provides unfortunate
evidence that the Bush Administration is more committed to protecting
drug industry profits than to building a sound system for ensuring
drug safety.”

“The FDA’s preemption announcement,” the letter said, “is particularly
troubling at a time when FDA’s own ability to protect Americans from
unsafe drugs has been called into question by a series of cases in
which the FDA was slow to warn consumers of significant drug risks.”

The new rules went into effect on June 30, 2006, and preemption is now
being used in litigation all over the country in an attempt to dismiss
lawsuits filed by private citizens against drug companies.

Unbeknownst to average Americans, the administration’s gift of
preemption is not limited to industries regulated by the FDA.
Bush-appointed officials in all federal regulatory agencies are
working in concert to ensure that major corporations subject to
product liability lawsuits can claim that federal regulation of their
products preempts any recovery for consumers harmed, whether the
injury involves defective automobiles, pesticides or whatever.

In return, the major corporations are ganging up on private citizens
by filing amicus briefs in support of pharmaceutical companies
involved in litigation. For instance, the drug giant Wyeth is arguing
preemption in a petition currently pending before the US Supreme Court
in a case involving one lone woman in Vermont, in an attempt to
overturn a jury verdict that was affirmed by the Vermont Supreme

Amicus briefs to support Wyeth’s preemption argument are piling up,
including one filed by the Product Liability Advisory Council on
behalf of just about every major product manufacturer in America.

The plaintiff, Diana Levine, a professional musician, has the support
of the Public Citizen Litigation Group. Ms Levine went to the hospital
to seek treatment for a headache and left with injuries that led to
the amputation of her arm after the drug Phenergan was administered by
IV to alleviate the nausea associated with a migraine headache.

Specifically, her arm had to be amputated because the drug reached Ms
Levine’s arteries, and the lawsuit alleges that Wyeth was aware of the
risk of arterial contact when the drug was administered by IV and
failed to warn against using a method to administer Phenergan that
caused the injury.

In the petition, Wyeth does not dispute that Ms Levine’s arm was
amputated because the company failed to warn about using this method.
Its sole argument is that she is not entitled to damages because the
FDA did not require Wyeth to warn about the danger of administering
the drug this way.

The Vermont Supreme Court rejected this argument. The agency’s claim
of conflict with federal law, the Court held, did not warrant
deference because it was flatly at odds with both the FDA’s regulation
permitting manufacturers “to add or strengthen a warning ‘to increase
the safe use of the drug product’ without prior FDA approval,” and
with Congress’ express directive that state law concerning
prescription drugs be superseded only when it poses a ‘”direct and
positive conflict’ with federal law.”

On May 21, 2007, the Supreme Court invited the Solicitor General to
file a brief to express the views of the government, which will no
doubt add support for a favorable preemption ruling for Wyeth,
potentially affecting tens of thousand of private citizens with cases
pending all over the country.

A favorable ruling on preemption could provide an escape hatch for
GlaxoSmithKline in lawsuits filed by patients injured by the diabetes
drug Avandia (rosiglitazone), even though the FDA is aware of the fact
that Glaxo concealed the serious cardiovascular risks known to be
associated with the drug for years.

Medical experts are now predicting another Vioxx-like disaster with
Avandia. In May 2007, prominent cardiologist Dr Steven Nissen, of the
Cleveland Clinic, reported a study in the New England Journal of
Medicine that found the drug to be associated with a 43% increase in
heart attacks and possibly a 64% increase in cardiovascular death.

In a May 26, 2007, speech on the Senate Floor, Senator Charles
Grassley (R-Iowa) said that the actual number of heart attacks
possibly linked to Avandia may be as high as 20 a day.

Since the drug came on the market about 8 years ago, he said, tens of
millions of prescriptions have been written, and Medicare and Medicaid
have paid hundreds of millions of dollars for the drug.

At a June 6, 2007, hearing of the House Committee on Oversight and
Government Reform to review the FDA’s failure to warn the public about
Avandia, Chairman Waxman (D-Cal) began the meeting by pointing out:
“It is not Congress’ role to adjudicate these medical issues.”

“But it is our role,” he noted, “to ensure that the Food and Drug
Administration is taking these concerns seriously and providing
doctors and patients with the guidance they need to make informed

“Although Avandia has been on the market for eight years and has been
used by millions of Americans,” Rep Waxman said, “the post-market
studies have not been done to say conclusively whether Avandia
increases or decreases the risk of heart attacks.”

“That’s a major failure of our system,” he said. “And it is what is
causing so much confusion and worry among the patients who are taking
Avandia today.”

Another FDA failure that will surely lead to many lawsuits was
allowing Permax (pergolide), a drug used by Parkinson’s patients, to
remain on the market until March 29, 2007, long after its link to
valvular heart damage was known.

Eli Lilly gained approval for Permax in 1988 but, at the time of the
recall, the drug was manufactured by Valeant Pharmaceuticals and
generics were sold by Par and Teva.

As early as December 2002, doctors at the Mayo Clinic reported that 3
Permax patients had developed heart valve disease similar to that
caused by the Fen-Phen diet combination. In 2004, HealthDay News
reported that a study had confirmed earlier findings that Permax was
linked to heart valve damage which required surgery to correct.