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FDA immunity

This week's New York Times contained several related articles and an excellent dramatization of why Michigan's "reform" of liability matters should offend all consumers.  Several years ago, Republican legislators in Michigan granted complete immunity to all drug manufacturers who had secured FDA approval of their product.  In the May 11 NYT, the reporters recounted the Federal Court guilty pleas of three drug company executives who admitted misleading doctors, patients and the FDA about the addictive properties of OxyContin.  The article also contained a reminder that Bristol-Myers Squibb pleaded guilty on May 10 to making false statements to the government about its anti-clotting agent Plavix.

The FDA approval process is only as good as its component parts.  Where approval is based on false safety documentation; where it is secured through biased approval panels made up of drug manufacturing reps or their consultants; where it is policed by politicians who either don't believe in regulation or have placed the wolves in charge of the henhouse, it is unsafe and inexcusable  to grant a  drug manufacturer immunity from suit.  It is a special-interest favor purchased by large multi-national corporations at the expense of individual victims, and one more abuse of the Constitutional right to a jury trial.

What's more, where the Federal government allows companies caught red-handed to buy peace by simply re-paying part of what they stole, and when doctors are paid six-figure "bonuses" by manufacturers simply for administering a particular company's drugs, the entire system of regulating drugs has come undone.  [Refer to the NYT OpEd  of May 14, confirming that some cancer treatment facilities and oncologists add 25 percent to their gross income by providing anemia drugs to patients and then receiving so-called "rebates" from the manufacturer:  turns out, not only were they making a fortune (an Oregon group of six doctors earned $1.8 million in last year, alone), but by administering higher doses, they were increasing the risk of infarct and stroke to an unacceptable level.]  I'd be shocked if it turned out that their patients knew their medical decisions might be influenced to the tune of 300K per doctor.

Sadly, these drug manufacturing companies and their consultants make so much money by these practices that ordinary consumers and victims will never shake their hold on the Federal and State government and the cash-swollen political election and regulatory process.  That is bad enough.  When the same income-tainted process also blocks the entrance to the courthouse for injured patients, "reform" becomes a description worthy of Orwell or Kafka.

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
Fax: 231-929-7262