Big Pharma's legal shield. Get ready.

Steve -

An article that appears in today's New York Times covers a topic that should deeply unsettle us.

Next term, the Supreme Court is to rule on a case that could make pre-emption a legal standard for drug cases. Pre-emption means that if the Food & Drug Administration approves a drug, then a citizen cannot sue the drug company if it proves to cause injury and death. Those who favor the doctrine, such as the Bush administration, claim that the FDA is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts.

Hypothetically, even though Merck withheld negative results of studies on Vioxx showing an increase in heart attack risk, the FDA approved the drug. So the pre-emption rule indemnifies

Thud. That is the sound of my jaw hitting to the floor.

If we cannot rely on the courts for justice, our only line of defense is...

• The underfunded FDA.
• The undermanned FDA.
• The scientifically-challenged FDA.
• The special interest FDA who relies on drug makers to report the results of their own studies completely and honestly.
• The agency that relies on drug makers to report potential problems with drugs that have already been introduced into the market.
• The 10 years behind the times FDA.
• The agency whose top brass, after their tenure, move into cushy lobbying and executive positions for Big Pharma.
• The agency who "may not be adequate to regulate the food and drugs of the 21st century," according to its own commissioner.

Folks, a precedent has already been set by the Supreme Court. In February, they already ruled that lawsuits against the makers of medical devices like pacemakers are pre-empted.

________. That is me shaking my head in utter disbelief.

April 9 Update: Pfizer and GlaxoSmithKline won an appeals court ruling (2-1 opinion) shielding them from liability in lawsuits over the adequacy of warning labels on antidepressants approved by U.S. regulators.