I Sense a Pattern

Drug Makers Near an Old Goal: A Legal Shield

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.

What Bush et al have done is deliberately gutted the FDA and had their political cronies overrule agency scientists. The previous commissioner appointed by Bush, Lester Crawford, had to resign just 2 months after confirmation because of lying and conflict of interest.

The commissioner Bush appointed before him, Mark McClellan, was former White House Press Secretary Scott McClellan's brother, whose main work was in economics.

These are not people who you want deciding whether anything they let a drug company do is legal thereby removing the companies from all liability. Especially since the political hacks have a record of overruling the actual professionals.

This approach isn't isolated to the FDA, this has been a constant approach by Bushco in all sections of the Executive.

From the FAA not inspecting airplanes and allowing them to fly, even with known deficiencies, to the EPA ignoring the Supreme Court, to the DOJ asserting unconstitutional powers to the White House, (of course all these roads lead to the White House), asserting they have the right to ignore laws, ignore international treaties and ignore the Constitution.



Cross posted at VidiotSpeak