Pre-Emption as a Legal Standard??

Today's New York Times carries an article about the new wave of drug company "pre-emption" for products later shown to be unsafe.  Under what is becoming the state of affairs under the Bush administration once the U.S. Food and Drug Administration (FDA) approves a drug for marketing, consumers lose their legal right to sue for damages when the approved medication is shown to be faulty.  The exemption may be upheld by the courts even if the data submitted to the FDA in advance of approval is shown to have been misleading or incorrect.
The particular drug under discussion today is Johnson & Johnson's birth control patch marketed as Ortho Evra.  From the website

Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills.

The increased risk is associated with the higher levels of estrogen (which are known to be associated with heart attack and stroke) released by the patch as compared to low dose pills.  When the drug was first marketed and the company released its findings, the amounts of estrogen reported were decreased by 40%.  The FDA waited six more years until November, 2005, to warn the public of the increased risk.

The FDA has come under increasing scrutiny in recent years as a result of what appears to be an overwhelming workload and management structure which does not allow full examination of drug applications.  The agency relies on drug companies to be forthright and honest in their applications.  The agency has neither the time nor the resources to test every drug for which a marketing application is made.

The real issue at work here is the legal right of an injured consumer to seek legal recourse.  The companies argue once the FDA approves a drug all legal rights to damages are lost.  In effect the company is protected by the government's shield of approval.  Plaintiff attorneys argue

Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin.

And so the battle continues.

As recently as February, FDA commissioner Andrew C. von Eschenbach

acknowledged that the agency faces a crisis and may not be "adequate to regulate the food and drugs of the 21st century."

This is a situation which must not be allowed to continue.  The government is our protector in instances like this.  The government has a place in seeing consumers are safe from the corporate marketing pressures pushing profit over all else.  If we cannot trust our government to see our drug supply is  beneficial, what ever are we to trust?

The  Bush administration has for all its time in office been a protector of corporate versus individual rights.  The time has come for a real change.  Corporations deserve a measure of protection in order to play on a level and fair field.  But the consumer deserves the same rights to protection and fairness.  We must see to the reinstitution of regulatory means which guarantee the safety of our pharmaceutical supply as well our food and environment.  

We as a nation must not allow corporate profit taking to become the final rule of law.  We must not allow the courts to be taken out of the process.  We as citizens deserve the protections of justice for all.  There can be no justice when legal recourse is removed from the process.

Peace.

Reminder for one and all.  I am running for Congress, DE-AL.  Please check out the website or the ActBlue page and support the effort.  Your help is needed for the effort to succeed.  Contributions of all sorts, both moral and monetary are most appreciated.