Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap.

According to the U.S. Constitution, any decision to pre-empt state law must be authorized by Congress. However, several federal agencies have navigated around that obstacle (probably whining that it takes an act of Congress to trump state law) by inconspicuously writing language into the preamble of federal regulations and then using those preambles to change the law.

The issue, however, is not as clear cut as it would seem. Some trial courts have ruled the regulatory preambles to be permissible. The American Association for Justice on the other hand belies them to be unconstitutional. In any case, pre-emption effectively strips state government and courts – and the U.S. Congress – of its authority.

Not exactly the antithesis of “big government,” yet some politicians would whisk away any concerns as tort reform. To get a clearer picture of the dangers posed by corporate immunity, look at the individual cases – the examples of real people who are grappling with greatly diminished protection.

Look at Joe Randone and his family, who are suing Bayer. Randone was a 52-year-old heart patient when he was given Trasylol in an IV drip. Immediately after the surgery, Randone suffered from two heart attacks and kidney failure. His gall bladder had to be removed and he was so swollen he couldn’t close his eyes, which were eventually sewn shut to protect his corneas. Gangrene set in to his lower extremities and both of his legs had to be amputated. Randone held on like this for 8 months but ultimately passed away in his hospital bed. All of this happened while Bayer, the manufacturer of Trasylol, was aware of the drug’s dangers and took no measures to prove its safety one way or another, even after smaller tests indicated the drug was extremely dangerous.

Bayer is claiming immunity in this case because Trasylol was approved by the Food and Drug Administration. However, language in the preamble to the FDA’s prescription drug labeling rule may provide the easiest escape route for Bayer.

Who are the government and the FDA protecting? If pharmaceutical companies and medical device manufacturers receive complete immunity from the law, then they can knowingly market and sell dangerous drugs that leave scores of people injured or dead.

It is through the courts, and litigation, that the voice of the consumer is heard, and his rights protected. A recent editorial by the editors of the New England Journal of Medicine supports this idea.

SOURCE: Trasylol Recall › Zero accountability for drug companies?

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Trasylol Recall › physicians favor drug safety litigation