Sunday, April 6, 2008

Terrifying News of the Week: You Can't Sue Drug Companies for Making Products That Kill You

By Quill

Via the New York Times:

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.

Make no mistake of what this means for you and your loved ones: If the FDA, a chronically underfunded and overburdened bumble-fuck of a bureaucratic institution says that a product is safe, it preemptively prohibits you from any compensation you or your family is due if in fact ::GASP:: the medical product is not safe.

But why would the FDA ever approve a product it knew wasn't safe, you ask? Well, the Great and Almighty infallible FDA seems to have no godforsaken clue every time a product is indeed unsafe. Drug companies (as they are often wont to do for profit) have been known to 1) straight up lie to FDA 2) submit misleading trials to the FDA 3) manipulate the FDA into approving its product prematurely.

The only protection consumers had in case the FDA failed to do its job properly and/or the drug companies misled the public was the ability to file suit against the product makers and manufacturers, until a Supreme Court ruling in February prohibited most suits against the makers of medical devices (e.g. pacemakers, etc.). Meanwhile, a case appearing before the court next term may grant immunity to drug makers as well. This is the kind of gross negligence on the part of the court you get when, apparently,
The Bush administration has argued strongly in favor of the doctrine [of medical preemption], 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 NYT article details the suit against the Johnson&Johnson product the Ortho Evra birth control patch, which is thought to have lead to at least 50 deaths -including that of an 18 year old girl - due to its absurdly (and illegally) high estrogen levels. Although its use has dropped 80% after 3,000 people filed lawsuits against its makers, Ortho Evra is still a widely available option for birth control. Meanwhile, the FDA is still sitting on its ass, scratching its head about what possibly could have gone wrong in this case as it becomes increasingly clear that Johnson&Johnson gave the FDA a misleading amendment to a trial result that showed the patch to have dangerously high estrogen levels.

How many people will have to die or become seriously injured before the court realizes that public health and well-being cannot rest solely on the shoulders of a politically manipulated, overstretched and incompetent bureaucracy? For that matter, when will public health and well-being come before the interests of shameless, greedy corporations and self-serving government officials?

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