Pay Attention to Wyeth V. Levine In Supreme Court
An anti-nausea drug called Phenergan, made by Big Pharma giant Wyeth, gave singer and guitarist, pianist and reord-label executive Diana Levine gangrene in her right arm, which then had to be amputated. This all happened in 2000, when Levine experienced crippling migraines so bad that she needed to be hopsitalized. She received Demerol for the pain and Phenergan via an IV for the nausea. It is thought that the IV was stuck into an artery.
Levine sued Wyeth because Wyeth knew that Phenergan carried a risk of giving people gangrene and yet still sold the drug.
Eight years later, the case has now gone all the way to the US Supreme Court in Washington, DC, even though Levine was awarded $6.7 million in a Vermont court, which Wyeth then appealed.
Wyeth’s argument? It was all the FDA’s fault for not including the risk of gangrene on the label, because “they have the final say” over what goes on the label of any drug. They also claim that federal law overrides (preemepts) state law, so if the FDA says it’s safe, Vermont (or any other state) can’t argue.
Today’s Word: Preemption
The Bush administration is under the view that only the FDA is best qualified as to what drug could prove to be risky to the general public. Drug makers are just the innocent bystanders here, caught in the crossfire. I wonder how much money they paid various members in the Bush administration to bend over for them.
Point is that Wyeth knew about all the risks associated with their product. They are responisble. They’re the makers, the pushers and the marketers. Drug companies have been known to purposefully withhold information from the FDA. Considering how understaffed and underfunded the FDA is, this is a really easy thing to do.
Why This Is A Big Deal
Pay close attention to the results of Wyeth v. Levine. If the Supreme Court decided in favor of Wyeth, then we all can all kiss ourselves goodbye. We as patients, as people who need the drugs and have no other choice but to go to drug companies for them, will be worse than slaves. We will be lab rats, completely at the mercy of our overlords and expected to like it.
And the drug companies will tell us that we better like it — or else.
It’s enough to give you a migraine, isn’t? I’ve got a beauty coming on now.
November 19th, 2008 at 7:02 pm
Stupid article. There WAS warning about the risk of gangrene on the label.
This is gangrene that Wyeth repeatedly warned about — if the drug is incorrectly administered. And it was incorrectly administered by Levine’s healthcare provider — into her arteries (something Wyeth specifically said NOT to do) instead of into her veins. This is malpractice.
Levine’s argument is that the FDA-required label shouldn’t have allowed administering the drug via “push IV” at all, because some screwup along the way may push it into the arteries instead of into the veins even after being warned about it.
If a car is incorrectly driven, you could hurt yourself too. Why should the car company be liable?
There is nothing in the record to suggest that Wyeth withheld anything, and Levine doesn’t make that claim.
What reeks is your sense of entitlement. You think you’re a “slave” to drug companies because why, you’re entitled to their drugs? Except no no one is forcing you to buy their products. How did people cope before the era of big pharma I wonder?
November 19th, 2008 at 7:43 pm
Thank you, Wyeth publicity department.
November 19th, 2008 at 8:13 pm
Try again. I have nothing to do with Wyeth. I’m just someone interested in Supreme Court cases.
Paranoia like yours just about sums up why some of what you write is both inaccurate and slightly kooky.
November 19th, 2008 at 8:59 pm
But Wyeth’s argument is NOT that any malpractice was involved. Their argument is that it’s all the FDA’s fault. Otherwise, I wouldn’t have mentioned this case.
Besides, it would have cost Wyeth much less to settle the issue then have this get national press and drag on for 8 years.
November 19th, 2008 at 10:00 pm
Actually, that is part of Wyeth’s argument. Read the briefs.
Their argument is that the FDA required a specific type of label approving how the drug may be administered. The FDA makes that call, and Wyeth have to comply. Again, there were plenty of warnings saying that accidental injection of the drug into arteries (instead of veins) will likely cause gangrene. The FDA nevertheless retained that mode of administration, accompanied by relevant warnings.
Levine’s healthcare provider disregarded those warnings specifically saying not to inject the drug into the artery, and she suffered limb-loss as a result. Levine’s argument is that (a) the warnings were still not strong enough (b) it shouldn’t have been an allowable way of delivering the drug in the first place, regardless of what the FDA says.
If Levine is right, then state law trumps federal law and the determinations of a federal agency. Unfortunately for her, under the Supremacy Clause of the federal Constitution, it is the other way round: federal law is supreme and ought to trump state law determinations when they come into conflict.
The problem with Levine’s argument is that it applies to all 50 states. If state common law second-guesses the FDA at every turn, then it makes for unpredictable litigation for drug companies, not to mention multiple standards for medical professionals across states. Drug infusion methods that might be allowed in one state may not be allowed in another, leading to less uniformity, etc.
It’s not about “cost” but a point of principle.
Whichever side you come down on, it’s not really an easy case at all. Levine’s sympathetic plight clouds judgement; but it really is hard to see how the main fault does not lie with her healthcare provider to begin with.
November 20th, 2008 at 2:34 pm
Well, I’m kinda wacky. I wonder how I would feel if something like this happened to me — and my case won in state court. I’d feel pretty bad.
“Principle” and the Constitution means nothing in law — if it did, then the Native Americans would still be running the country.
November 22nd, 2008 at 12:35 am
Excellent content and style…keep up the good work!
March 4th, 2009 at 5:57 pm
[...] 2009, the Supreme Court of the United States rules in favor of the case of migraineur and musician Diana Levine, who had to have her arm amputated because the anti-nausea drug Phenegen was administered [...]
October 17th, 2009 at 10:17 am
But Wyeth’s argument is NOT that any malpractice was involved. Their argument is that it’s all the FDA’s fault. Otherwise, I wouldn’t have mentioned this case.
Besides, it would have cost Wyeth much less to settle the issue then have this get national press and drag on for 8 years.