by David Gutierrez
November 3, 2008
(NaturalNews) The Supreme Court may rule that pharmaceutical companies cannot be
sued for dangerous or even deadly side effects from their drugs 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 drugs. The administration argues that only the FDA is
equipped to regulate drugs 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
blood 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
bloodstream, 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
breast 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 blood 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.
http://www.naturalnews.com/index.html