Another Kind Of Pre-Emptive War

2 comments April 6th, 2008at 11:40am Posted by Eli

Only this one is against the consumer:

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.


A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

So, in other words, the pharma companies would get off scot-free because the FDA approved their dodgy drugs… and the FDA’s oversight capability has been so gutted and crippled by the Bush administration (where have we heard that before) that it would approve pure arsenic if Johnson & Johnson told it their lab tests looked brilliant.

If the FDA is forced to rely on the drug companies to provide honest test results, then the drug companies should be 100% liable if they falsified those tests to get approval.  Period.  Either that, or the Bush administration should be liable for turning the FDA into an ineffectual joke.

(h/t Elliott)

Entry Filed under: Bush,Corruption/Cronyism,Healthcare,Judiciary,Republicans,Wankers


  • 1. Interrobang  |  April 6th, 2008 at 11:59 pm

    For those of you patch users out there, please bear in mind this warning only applies to the US version of the patch. The European and Canadian versions (which were approved later and have a different formulation) have less of the hormone in them. The risk of using the patch in these countries is still slightly higher than using the microdose pills now, but not severely. Whether or not you choose to trade off the higher risk for other reasons is between you and your doctor.

    (Me, I use the Canadian version of the patch because I can’t take the pills — they’re all bound with lactose and I’m that lactose intolerant — and I really need some kind of hormonal intervention to keep that stuff running properly. I’m low risk anyway; I don’t smoke, I’m not overweight, I’m under 35, and I exercise regularly, so trading a couple of points of aggregate risk for excellent symptom control was something I was willing to do. Your mileage may vary.)

  • 2. Eli  |  April 7th, 2008 at 12:03 am

    Because Canada and Europe presumably have real regulatory agencies rather than rubber-stamping shells…

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