P.I.S.S.D. — Personal Injury, Social Security Disability. Dallas Texas Lawyers

I wrote recently about the legal doctrine of pre-emption that is threatening to steal legal rights from American consumers. Now the New York Times has published a lengthy but excellent article on the subject of the legal shield sought by drug manufacturers. Here are excerpts, but I encourage you to read the article.

The Supreme Court appears to be on the verge of endorsing a doctrine that the F.D.A. should not be second-guessed by courts.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen
than standard birth control pills, potentially increasing the risk of
blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration
approved the patch, the company is arguing in court that it cannot be
sued by women who claim that they were injured by the product — even
though its old label inaccurately described the amount of estrogen it
released.

This legal argument is called pre-emption. After
decades of being dismissed by courts, the tactic now appears to be on
the verge of success, lawyers for plaintiffs and drug companies say.

The
Bush administration has argued strongly in favor of the doctrine, which
holds that the F.D.A. is the only agency with enough expertise to
regulate drug makers and that its decisions should not be
second-guessed by courts. The Supreme Court
is to rule on a case next term that could make pre-emption a legal
standard for drug cases. The court already ruled in February that many
suits against the makers of medical devices like pacemakers are
pre-empted.

A
series of independent assessments have concluded that the agency is
poorly organized, scientifically deficient and short of money. In
February, its commissioner, Andrew C. von Eschenbach, acknowledged that
the agency faces a crisis and may not be “adequate to regulate the food
and drugs of the 21st century.”

The F.D.A. does not test
experimental medicines but relies on drug makers to report the results
of their own tests completely and honestly. Even when companies fail to
follow agency rules, officials rarely seek to penalize them. “These are
scientists, not cops,” said David Vladeck, a professor at Georgetown
Law School.

The Ortho case, however, suggests that
Johnson & Johnson, like other drug makers, is not always quick to
tell the F.D.A. about potential problems with its medicines.