Wednesday, February 20, 2008

Roberts Supreme Court gives medical device makers a license to kill – YOU!

The U.S. Supreme Court under Justice Roberts has decided that if a company makes a device so ineptly or negligently that the device kills you, your widow or widower and orphans have no right to sue the device maker.

At least, not if the FDA has approved the device.

This means, in effect, that some company can ram through the FDA shoddy equipment or drugs that might maim or kill you, and when you are injuured they can effectively say to you or your heirs, “Tough luck, pal. Go stuff it.”

Apparently only Justice Ruth Bader Ginsberg sees through the court’s “thinking” – actually an attempt to protect big business from the consequences of its own mistakes, carelessness and greed.

This latest strike for big business against the citizens of the USA is right up there in extreme right wing judicial activism with the decision, a little over six years ago, not to recount the misleading and Florida ballots in the Bush vs. Gore election.

You might be tempted to ask, “Well, if a device is FDA approved, doesn’t that mean its safe?”

Hell no!

The FDA under the Bush administration has been a cash-starved political arm of the White House. Examples of sloppy, questionable or downright negligent approval have been legion, but here are just a fcouple, reported on the website of the Alliance for Human Research Protection.

Poor quality control standards in American drug and vaccine manufacturing plants is a disgrace.

…rather than accelerating inspections and enforcement to ensure quality control, FDA reduced its factory compliance inspections from 4,300 in 1980 to just 1,600 last year. Fewer inspections produce fewer critical report findings, but fewer inspections mean that American consumers are at increased risk of contaminated medicines…

[There is] Evidence demonstrating that in the rush to bring new drugs to market human subjects are exposed to increased risks of harm in clinical trials-- even before their safety has been shown in animals.

..Indian researchers have complained that humans tests were being conducted at the same time as animal tests --and that animal tests revealed the drug caused tumors, first in rats, then in mice
Naturally, the Bush Administration sided with the defandants, claiming that unfavorable state jury verdicts against companies like meditronic would compel companies to alter product designs or labels that had already gotten FDA approval.

Hell, just because a product kills people, should a company have to go to the onerous trouble of changing some labels? I mean, what’s more important, human lives or a few cents less of profit due to label printing costs?

Moreover, the defandant in the Supreme Court case that caused the ruling, a company called Medtronic, has been implicated in several cases of shoddy devices and practices. Go here for stories about Medtronic devices that may have caused at least five deaths with its heart defibrillators and about Medtronic’s questionable payments to doctors in relation to a spinal surgery device.

Congress can “solve” the problem by restoring the rights of injured citizens to sue the companies that injure them. A new law would tell most of the justices of the Supreme Court to take a flying leap of their own.

Moreover, an overwhelmingly Democratic Senate and House, with a Democratic president, could begin taking steps to bring the Supreme Court back to earth where it can focus on law and justice rather than so-called “Conservative” radicalism.

All the more reason to vote for not one Republican the next election. Got that? Not-one-Republican.

Correction and addendum: A new story in the Feb. 21 New York Times states:
The food, Drug and Cosmetic Act of 1938, under which the F.D.A., regulates pharmaceuticals, does not contain a pre-emption clause. Nontheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No 06-1249, that pre-emption is implicit in the structure of the statute.

In other words, for the moment your right to sue if, say, you get poisoned by an erroneously labeled or dangerous drug still exists, but probably not for long. The Bush Administration is fighting to take your right away to sue in this case, too, and the situation is essentially the same. Be afraid. Be very afraid.

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