New York Governor Eliot Spitzer resigned after it came to light that he'd been partaking of some very expensive local prostitutes, but the reaction and the commentary that followed that revelation was at least as disturbing as the incident itself. The prostitute in question became an overnight celebrity with more than five million hits on her web page. Discussion forums across the country buzzed with debate about whether or not Spitzer's wife should be standing by him. And, as if that weren't all enough, "experts" like Dr. Laura Schlessinger and Erica Jong appeared on camera to share their opinions with us.
The content of their statements was bad enough: Dr. Laura told us that men were bound to be susceptible to the charms of other women if their wives didn't attend to their personal and sexual needs and make them feel like men, successes and heroes. And Erica Jong followed that up by diagnosing Spitzer as a sex addict.
Dr. Laura’s statement surprised me a bit, given her reputation for insisting on fidelity and personal responsibility. Turns out those poor men just can't be expected to stay faithful if their women aren't acting right at home. Does that apply to Eliot Spitzer? Did his wife fail to make him feel like a man, leaving him vulnerable to the "charms" of another woman? I don't know. Neither does Dr. Laura, despite the prestige of her doctorate in…um…Physiology. Nor, of course, can Erica Jong possibly know whether Eliot Spitzer is a sex addict based on what's been revealed in news reports.
It would be professionally questionable for a mental health professional to reach such a conclusion (and announce it) without any firsthand knowledge or professional records on which to base her conclusion. Fortunately, Erica Jong is off the hook because she's…well…a novelist. She wrote a famous novel about sex, which apparently qualified her in the minds of a certain television station to speak on the larger meaning of Spitzer's actions.
Unfortunately, Jong's famous novel isn't as famous as it once was. What was controversial and widely reported in the seventies has become fairly standard fare today, and the world is full of people who have never heard of Erica Jong. I happened to watch her pronouncement on an airport television with several of those people, and what I witnessed was troubling: because she announced a diagnosis, they assumed that she was a psychologist or some other kind of mental health professional.
Of course, people are free (within legal bounds) to say any fool thing they want to. But wouldn't it be nice if they just…didn't? Wouldn't it be nice if people didn't make declarative statements about things they didn't really know much about, and if television stations and magazines and other media didn't hold people out as experts who just…weren't? |
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Legal Outrage
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Written by Tiffany Sanders
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Monday, 24 March 2008 23:26 |
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Earlier this month, the United States Supreme Court ruled that federal law pre-empted state lawsuits based on negligent design or manufacture of medical devices that had received pre-market approval from the Food & Drug Administration (FDA).
In theory, pre-emption makes sense. The Medical Device Amendments specify that states can’t add requirements; it’s easy to see the kind of complications that would ensue if each state had different—and possibly conflict--requirements for medical device approval. But in determining that allowing state courts to apply common-law negligence standards would amount to “additional requirements”, the Supreme Court has effectively declared that a medical device manufacturer that secures pre-market approval is in the clear.
Even that, on the surface, might seem logical. After all, the device has already gone through rigorous screening, right? Can’t we assume that it wasn’t negligently designed if the FDA thoroughly reviewed and approved it?
Perhaps, if the FDA conducted its own tests or used outside experts to approve medical devices, there might be some reason to that perspective. In fact, however, the pre-market approval process is based on data submitted by the manufacturer itself, based on its own testing.
So, in essence, the manufacturer says, “We tested it out and it works great. No problems.” The FDA reviews all of the reports that say “we tested it out and it works great” in more detail, and then grants approval. And then, if it turns out that the device DOESN’T actually work great…that, perhaps, it kills people…those people (and their heirs) are barred from filing lawsuits against the manufacturer because it would be “imposing additional requirements” for the state court to say that medical devices should be manufactured in such a way as to not kill people.
Think the FDA has a handle on that in the pre-market approval process? Here are just a few of the drugs and devices that have received FDA approval in recent years and gone on to be recalled and/or formed the basis for nationwide lawsuits:
Vioxx
Seroquel
Risperdal
Baycol
Ortho-Evra
Viagra
Cialis
Certain Cordis Balloon Catheters
Certain Guidant Defibrillators
Certain Medtronic Implantable Infusion Pumps
Somehow, it doesn’t look like that pre-market approval is a sure thing. Just maybe, some “additional requirements” (try not to kill the patient) would be helpful. As it stands, medical device manufacturers have little at risk if their devices fail.
While it might be nice to believe that these corporations will want to avoid killing their customers out of the goodness of their hearts, or concern for public relations, or just because doctors might stop using their devices if they don’t work out, the recent history of drug litigation tells us that isn’t the case at all. Well-documented information in recent trials has made it clear that major corporations are making conscious decisions to sacrifice certain numbers of consumers in the interest of higher profits—civil litigation that might have cut into those profits might have been the last protection standing for patients reliant on their products. |
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