Trasylol Recall: Pre-emption could give Bayer an escape from Trasylol case

Pre-emption could give Bayer an escape from Trasylol case

November 11th, 2008 by Kurt Niland

Zero accountability for drug companies?

Bloomberg recently ran an article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s second inauguration in 2005, allow federal law to trump state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

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 highly toxic.

Bayer is claiming immunity in the Randone case because Trasylol was approved by the FDA. Also, language in the preamble to the FDA’s prescription drug labeling rule also may turn out to be an easy escape route for Bayer.

Who are the government and the FDA really protecting? Pharmaceutical companies and medical device manufacturers are businesses; they need to make profits and their pipeline must look promising to investors. Loosening regulations and excusing corporations from accountability, however, seems to be as shortsighted as it is callous.

As scores of people become injured or die from taking newer, barely tested medications, doesn’t it stand to reason that doctors and patients would want to stick with the tried and trusted generics? How long will it be before the regulations intended to help corporations cause them to implode?

Tags: Bayer, FDA, pre-emption, Trasylol

This entry was posted on Tuesday, November 11th, 2008 at 10:43 am and is filed under Legal, News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.