Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths 
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 Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths

NaturalNews.com
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Originally published November 3 2008

Big Pharma May be Handed Blanket Immunity for All Drug Side Effects,
Deaths

by David Gutierrez

(NaturalNews) The Supreme Court may rule that pharmaceutical companies
cannot be sued for dangerous or even deadly side effects from their
{*filter*} if those side effects arise from an FDA-approved use.

Under a legal argument known as "pre-emption," the FDA's approval of a
drug absolves companies of any responsibility if that drug later turns
out to be dangerous, even if information was concealed from the FDA
during the approval process. While courts have rejected this argument
for decades, the winds appear to be shifting.

In February, the Supreme Court ruled that makers of medical devices
were indeed immune from state lawsuits if their devices had received
FDA approval. But that decision hinged on the specific wording of the
law that gives the FDA authority over medical devices, and the laws
relating to drug regulation are not worded the same way.

Even so, the Bush administration has been actively urging the courts
to apply the same principle to {*filter*}. The administration argues that
only the FDA is equipped to regulate {*filter*} and decide whether a
product is safe, and that judges or juries are not able to make
informed decisions on those matters.

The FDA has also recently thrown its support behind pre-emption,
reversing a longstanding, de-facto policy of viewing lawsuits as an
extra layer of oversight to make up for the agency's time and budget
constraints. Now the agency says that lawsuits over drug side effects
could lead to a confusing state-by-state regulatory patchwork that
would cause hardship to drug companies and discourage patients from
taking certain medications.

Drug companies are using the pre-emption argument as a legal defense
in a wide variety of lawsuits, and the Supreme Court is expected to
hear such a case, concerning the company Wyeth, in the fall. Before
that, however, a lower federal court is expected to rule on whether
pre-emption can be used to dismiss lawsuits by more than 3,000 women
who claim that they were injured by using Johnson & Johnson's
OrthoEvra birth control patch according to the instructions on the
label.

When Johnson & Johnson announced its plans for a birth control patch
in 1996, one of the main benefits it claimed the product would provide
was the ability to prevent pregnancies through lower doses of estrogen
than birth control pills. High doses of estrogen are known to increase
women's risks of {*filter*} clots, heart attacks, strokes and death.

But company documents publicized as part of the lawsuits show that in
1999, the company discovered that the patch actually exposed women to
significantly more estrogen than the pill, a total of 30 to 38
micrograms per day. Because only about half of the estrogen in a birth
control pill actually enters the {*filter*}stream, this means that women
using the patch were getting as much estrogen each day as if they were
taking a 76 microgram birth control pill.

The FDA banned birth control pills containing more than 50 micrograms
of estrogen in 1988.

Rather than reporting this data to the FDA, however, the study's
author instead applied a "correction factor," reducing the estrogen
figures by 40 percent. Although the author claimed this was meant to
adjust for differing rates of estrogen absorption, such a "correction"
was a deviation from the study procedure previously submitted to the
FDA.

In the final report submitted to the FDA, Johnson & Johnson claimed
that OrthoEvra exposed women to only 20 micrograms of estrogen per
day. The "correction factor" was referenced only once in the 435-page
study report, buried in a complex mathematical formula.

According to internal company emails, other clinical trials conducted
before approval suggested that women were experiencing side effects
such as {*filter*} soreness and nausea due to high estrogen doses, but the
company did not warn the FDA that the patch might be delivering more
estrogen than advertised. Nor did it tell the agency about other
studies, in 1999 and 2003, showing that the patch exposed women to
more estrogen than the pill.

When the FDA approved the product in 2001, Johnson & Johnson marketed
it as releasing less estrogen than the pill, containing 20 micrograms
per day.

The label was not revised until a 2005 investigation by the FDA,
following reports of deaths resulting from use of the drug. At that
point, the FDA made Johnson & Johnson add a warning that the product
"exposes women to higher levels of estrogen than most birth control
pills."

But the company always knew this to be the case, several lawsuits now
allege, and is thus responsible for the side effects that resulted:
heart attacks, strokes, and even deaths in those who used the patch as
directed. Studies have since confirmed that women on the patch may
have twice the {*filter*} clot risk of women taking birth control pills,
and prescriptions have fallen 80 percent, from a high of 900,000 in
March 2004 to only 187,000 in February 2007.

But Johnson & Johnson claims that because the FDA approved the drug,
the company cannot be held responsible for its effects.

Janet Abaray, a lawyer for one of the plaintiffs, disagrees, saying
the company took advantage of the agency's shortcomings.

"Johnson & Johnson knew that FDA. does not have the funding or the
manpower to police drug companies," Abaray said.

David Vladeck of Georgetown Law School agrees that the FDA has no
ability to verify that drug companies are being truthful in their
reports.

"These are scientists, not cops," he said.

Chris Seeger, another plaintiffs' lawyer, said it would be a mistake
to allow pre-emption to let the drug companies off the hook.

"Our lawsuits are the ultimate check against the mistake made by the
government, or fraud made by the companies against the government, or
just an underfunded bureaucracy stretched thin," he said.

Sources for this story include: www.nytimes.com.

--------------------------------------------------------------------------------

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Tue, 26 Apr 2011 11:47:34 GMT
 
 [ 1 post ] 

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