Proving yet again that protecting the profiteers is the prime directive of his administration, President Bush’s Justice Department has begun going to court to block patient lawsuits stemming from faulty prescription drugs and medical devices. Patients, according to the Bush administration, cannot recover damages for injuries caused by products that have been approved by the Food and Drug Administration (FDA).
The administration’s doublespeak is highlighted in Robert Pear’s article in this morning’s New York Times:
Allowing consumers to sue manufacturers would “undermine public health” and interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.
Nevermind that even the logic of this latest move is faulty. The hyenas with which Bush surrounds himself are constantly howling about the benefits of a government small enough to drown in the bathtub, yet one would presume that the FDA would grow alarmingly large in this scenario. That presumption would be wrong, cowboy. Bush will block patient lawsuits with one hand and shrink the FDA right along with the other federal agencies with the other. It’s lunacy and it concerns me greatly that the citizenry fails to see through this.
More than ever, actions like this underscore the immediate need for a patients’ bill of rights that includes the right to sue. This is clearly a play by the Bush administration to protect the profits of drug companies and medical device manufacturers at the expense of patients.
What’s especially egregious about Bush’s move is that his administration acknowledges this to be a radical policy shift. As Pear reports, in 1997 the U.S. government argued before the Supreme Court that FDA “approval of a medical device set the minimum standard, and that states could provide ‘additional protection to consumers.’ Now the Bush administration argues that the agency’s approval of a device ‘sets a ceiling as well as a floor.’”
Another facet of the Bush administration’s pathologically defective logic is apparent in this passage of the Pear article:
The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers.
The threat of lawsuits, it said, “can harm the public health” by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to “underutilization of beneficial treatments.”
I’ve been a dialysis patient since—oh, the irony of it—Presidents’ Day 2000. Over the past four years I’ve seen conditions and quality of care in the dialysis center drop precipitously. It got so bad that last month I filed a complaint with the state health department which prompted an unscheduled inspection. The dialysis center was cited for 13 serious violations; unconscionable corner-cutting from a company that last year reaped net profits of more than US$175 million solely on the misfortune of others.
Under the Bush strategy, if the dialysis machine which keeps me alive failed by oh, let’s say releasing air into my bloodstream, I’d be blocked from recovering damages because the device had been approved by the FDA. Or there could be a manufacturing defect in the needles or in the dialyzer itself (like the 2001 deaths related to Baxter dialyzers). Too bad, so sad; profit is the sole metric of success and must be protected from the wretched source of those profits.
Yours is the first blog I’ve ever stumbled across—it was an accident borne of a near-totally unrelated word-search—to talk about living w/kidney disease. I was diagnosed w/PKD some three years ago, and am always on the prowl for more info. As yet I have no symptoms. Just wanted to say “Thanks,” and I’ll be back to read in more depth a bit later.
:)