11/3/08: Internal government documents revealed that the U.S. Food and Drug Administration and the Bush Administration have actually been at odds when it comes to preemption of lawsuits against drug manufacturers. The documents, obtained last week by Democratic California Representative Henry Waxman's office, may be instrumental in the Supreme Court's decision of the matter which is being heard today.

What the internal documents revealed

According to news reports, the documents revealed an internal debate between the U.S. Food & Drug Administration (FDA) and the Bush Administration over whether preemption and allowing lawsuits against drug manufacturers was a good or bad idea. Up until now, it seemed as though the FDA simply backed the Bush Administration. However, the FDA actually took the position that preemption was a bad idea as lawsuits often revealed critical information about drugs that manufacturers kept secret. The Bush Administration took the position that preemption was a good idea as lawsuits were too costly and ineffective. Many consumer advocate groups believe that the current administration was protecting the pharmaceutical industry from liability.

Wyeth vs. Levine

The much anticipated preemption case is being heard by the U.S. Supreme Court beginning today. The case surrounds Diane Levine, a pianist from Vermont who lost her hand after complications with Wyeth Pharmaceutical's anti-nausea drug Phenergan. According to Levine, the drug's label did not warn about the possibility of gangrene if the injection needle struck an artery. She sued Wyeth for $6.7 million in damages.

The case made it all the way to the Supreme Court where the pharmaceutical industry, consumer advocate groups and many others are waiting to see how the Court rules. Although the Court recently ruled that consumers injured by medical devices were preempted by the FDA's oversight, many believe that the Court's ruling on pharmaceuticals may be very different.

Have you been injured?

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