Big Pharma shirks responsibility for drug that killed
Once again, a Big Pharma company has proven that it can’t be trusted to do the right thing. And now, it seems the drug companies are on the verge of getting legal carte blanche to make any error they wish – errors for which they will not be held legally or financially responsible.
Outraged? Good. Read on!
Apparently, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered a higher dose of estrogen than the more standard pill form of birth control on the market. According to the company’s own internal documents, the higher dose increased the risk of blood clots and strokes. That didn’t stop them from slapping a label on the product that was completely inaccurate as to the amount of estrogen it released in its dosage.
Yet after all of that, J&J is arguing that since the FDA approved the patch, the company is not legally liable and cannot be sued by women who have been injured by it.
Sounds incredible, right? A company can knowingly make a dangerous product, but government approval removes them from any legal responsibility. Is this possible? Sadly, the answer is yes. This is the legal argument known as “pre-emption.” Courts have dismissed this tactic for decades. But now, it seems it could become a new trend.
How is “pre-emption” possible?
Blame the government’s view of the FDA. Since the federal government has imbued the FDA with so much power, and has deemed this government agency as the ONLY regulatory body with enough expertise to oversee drug makers, the theory is that the FDA’s determinations cannot and should not be second-guessed by courts. In fact, there’s a case pending before the U.S. Supreme Court that could make pre-emption the legal standard for drug cases.
And it’s not just drugs, either. In February, the Supreme Court ruled that many lawsuits against the makers of medical devices such as pacemakers are pre-empted.
At stake are suits by more than 3,000 women and their families that are suing J&J for suffering heart attacks and strokes – 40 of these women died as a result. Indeed, between ‘02 and ‘06, the FDA received reports of no less than 50 deaths associated with the use of J&J’s Ortho Evra patch.
What’s wrong with this picture? Is Big Pharma’s lobby so all-powerful that it can even get the FDA and the U.S. taxpayers to pick-up the tab on its deadly miscalculations? It’s a dangerous precedent. Putting the financial burden on a cash-strapped government agency instead of a multibillion-dollar private company seems cockeyed to me.
According to plaintiff’s lawyer Janet Abaray, J&J knew full well that the FDA was already overwhelmed by its many responsibilities – and the company took advantage of that fact.
I’m not the only one who’s been sounding the alarm about how overburdened the FDA has become. Recent independent assessments have indicated that the federal agency is under-funded, scientifically deficient, and poorly organized. Even FDA Commissioner Andrew C. von Eschenbach admits that the agency is facing a crisis and that its current level of performance may not be “adequate to regulate the food and drugs of the 21st century.”
The FDA did not get around to warning the public of the potential risks of Ortho Evra until SIX YEARS after J&J’s own company records recorded the dangerously high estrogen levels.
It’s scary that the FDA is our last line of defense – it’s completely ill prepared for this role. And if the Supreme Court allows pre-emption, there are dark days ahead. I’ll be keeping an eye on this developing situation.
