Pre-emptive strike
Patent medicine manufacturers may get legal protection from lawsuits filed against drugs approved by the FDA.
When I was a kid, I hated the word “pre-empted.” Back then, it meant that I wasn’t going to get to see my favorite TV shows because some boring speech or news report was on instead. Obviously, I’ve come to appreciate those “boring” speeches and news reports over the years. But my loathing of the term “pre-empted” is here to stay. And my reasons now are much, much more serious: Big Pharma is attempting to use a legal version of pre-emption to protect itself against lawsuits filed by patients who have been harmed by side effects associated with pharmaceutical products.
Pre-emption would make these sorts of lawsuits illegal on the basis that a pharmaceutical company can’t be sued over a drug or other product once it has been approved by the FDA.
Now for the really scary part: Pre-emption protects Big Pharma even if a company has suppressed information about potential dangers associated with its products. Which is precisely what Johnson & Johnson did with its OrthoEvera birth-control patch, which contained higher levels of estrogen than stated on its labeling information. That increased dosage of a space-alien version of estrogen also increased women’s risks of the side effects associated with the Pill, like blood clots and strokes. But now Johnson & Johnson is arguing that pre-emption should protect them against being sued by a woman who experienced problems from OrthoEvra because the FDA had approved the drug.
The FDA makes plenty of bad calls and puts plenty of people at risk as a result, but it hardly seems fair to point the finger at them here, or for Johnson & Johnson to use them as a scapegoat, when the agency wasn’t even given the full story to begin with. And for the past several decades, courts in the U.S. have agreed, dismissing claims of pre-emption. But, according to The New York Times article I read, that may change very soon.
According to the Times, “The Bush Administration has argued strongly in favor of the doctrine, which holds 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.”
Is the Bush administration talking about the right FDA? The same agency that took six years to warn the public of the potential risks of OthroEvra after it finally DID discover that Johnson & Johnson had concealed the truth? And the one that admitted recently it can’t keep up with scientific advancement and has a hard time making decisions under the “pressure” of deadlines?
Apparently, these self-incriminating admissions and the plethora of mistakes the FDA has made over the years at the expense of our health and safety don’t bother los Federales. According to the Times article, “The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases.”
Considering the likelihood that the FDA will suddenly change its ways and make a more concerted effort to keep potentially harmful drugs off the market, I’d say we’d better start making our own case — against pre-emption — before the Supreme Court hands it to Big Pharma on a silver platter.
Write and call your state and local representatives and tell them you oppose pre-emption in patent drug cases and that you expect them to represent those views in Congress. Granted, it may not affect the outcome of the upcoming Supreme Court case, but the fact is, you never know until you try. And the more voices there are speaking out against pre- emption, the more likely los Federales are to hear them
To find the names and contact information of your Congressmen, contact Capitol Advantage at (800)659-8708 or www.capitoladvantage.com.
Source:
“Drug makers near old goal: A legal shield,” The New York Times (www.nytimes.com), 4/6/08
