As they hear arguments in the case of Diana Levine against the drug company Wyeth, the U.S. Supreme Court is set to make a historic ruling on drug liability. Diana Levine is a Vermont musician who lost her arm because of a botched drug injection is squaring off against the drug maker and the Bush administration in one of the most interesting and controversial cases of the Supreme Court.

The case of Diana Levine was heard this morning. Diana and her daughter Jessamine were in the courtroom surrounded by almost 150 lawyers from drug and medical device companies, consumer groups, and the government.

Apparently the prescribing instructions for the drug, Phenergan, "plainly comprehended and warned about the specific risks" of giving the drug in the way Levine received it, attorney Seth Waxman, arguing for Wyeth, told the court. Moreover her lawyer called this a "catastrophic" and well-known risk of injecting Phenergan, a drug made by Wyeth. She sued the drug maker and won $6.7 million before a Vermont jury, which agreed the drug maker should have warned doctors and nurses against injecting this drug under any circumstances.

Seth P. Waxman, the attorney for Wyeth, argued the FDA already knew that improperly administering Phenergan through an IV-push method, which happened to Levine, could result in problems and said the drug's label carried warnings about that. "The labeling plainly comprehended and warned about the specific risks of IV administration," Seth Waxman told the justices.

But this is really part of a larger battle, with the Bush Administration stacking regulatory agencies and courts with allies who don’t want people to have the right to sue business. 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 Bush plan has been to get rid of regulation then say you can’t sue because the shoddy regulations preempt it. Dangerous side effects are often found only after drugs are approved. This data goes to the drug companies who may choose to cover it up. But now we’re being told they can get away with it.

Moreover 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.
"Considering the huge number of drugs, is the FDA really monitoring every one of these?" Justice Ruth Bader Ginsburg seemed wondered.

Nevertheless 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. The case is currently pending.