Bush Wants Immunity for Drug Companies

The Bush Administration is at it again. This time working to protect drug companies. For years, when under a lawsuit, drug companies claimed that since their drug was “approved” by the FDA, they were immune from lawsuits citing damages. For years their defense argument failed. Now the horizon may show a change for them in using this defense.

In an article posted by the New York Times, it appears the Bush Administration is strongly favoring and supporting immunity for the drug companies using the argument that the FDA knows best and the courts shouldn’t challenge the FDA’s approval. This would pave the way for drug companies to be immune from lawsuits by consumers that were damaged by drug side effects.

This is more than unbelievable, doesn’t this lessen the drug companies’ motivation for vigilance, and doesn’t this pave the way for “favors” from the FDA? The FDA is in place as a first line public protection agency. With Bush’s efforts, they will become the gold seal end all for the drug companies. What would they all care if they felt truly immune from public action? Where is public recourse when the drug company and the FDA have made a mistake or have worked a deal? One such mistake was made in this family and it cost a life at a young age. It is hard to believe that such companies and agencies would be offered immunity. Additionally, if one were diagnosed with cancer and a certain procedure were recommended, would you not get a second opinion, or third before proceeding? Why would fully rely on the FDA if thousands of people suffered from a deadly side effect that was previously hidden by the drug company?

Bush appears on the road to provide immunity to all corporations as the slides out of office. Add this to the list of immunity for telecommunications corps, immunity for himself and his administration, little concern for subpoenas from Congress, little concern for the American outrage over Iraq, blind eye to folks facing foreclosure while the bailed out Bear Sterns gets our tax dollars, and the continual documented dishonesty where he displays no shame, one would have to wonder who he is representing other than himself. We certainly don’t need another Republican in government if this is where our nation goes under their watch.

Here’s the NY Times article:

“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.

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Tom Uhlman for The New York Times

An Ortho Evra birth control patch from Johnson & Johnson.


Times Topics: Food and Drug Administration; U.S. Supreme Court

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”. more

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