Preemption could be coming to pharmaceuticals. Supreme Court considers the reach of drug warning labels, reads the LA Times headline, which gives barely a hint of how profoundly things might change with the Robed Nazgul’s ruling.
From the news report:
The Supreme Court justices sounded closely split today on whether to shield drug makers from being sued if they fail to warn patients and doctors of all the risks of a prescription drug.
The justices heard the case of Diana Levine, a Vermont woman whose arm was amputated after she was injected with an anti-nausea drug. The injection struck an artery and caused gangrene.
Her lawyer called this a "catastrophic" and well-known risk of injecting Phenergan, a drug made by Wyeth. She sued the drug maker and won $6.7 million before a Vermont jury, which agreed the drug maker should have warned doctors and nurses against injecting this drug under any circumstances.
But lawyers for Bush administration lawyer and for Wyeth urged the high court to throw out her lawsuit and others like it because the Food and Drug Administration had approved a warning label for the drug that merely urged physicians to be cautious when injecting the drug.
The case could have a wide impact on drugs and the rights of consumers. The Bush administration has argued that if a federal agency such as the FDA regulates a product, injured consumers should not be allowed to sue and to seek damages because the product is dangerous and defective.
Think about what that could mean for pharmaceuticals. As long as a substance has FDA approval, the company could be home free despite any adverse events, including death. Would that be the case even if the drug was administered improperly? Maybe. Would preemption cover so-called off-label use of drugs—when a physician prescribes a certain drug for something for which the drug does not have approval? Maybe.
In other words, there could be no accountability for any use or misuse of a drug administered by a “medical professional” for the pharmaceutical companies. FDA approval would become the ultimate gift that keeps on giving—it would be a perpetual “reset” button for them. Just rake in the profits without any worry about damages done by their products.
That’s plenty frightening to contemplate as it is. But there’s more to this story. The FDA’s track record is less than stellar, and seems to be trending in the wrong direction of late. Remember Vioxx? The headlines from a few years back screaming about newer antidepressant meds contributing to suicides, because they trigger suicidal thoughts? Or, if one is older, remember thalidomide? Clearly the issue of approved drugs causing harm is not a new phenomenon.
The approval process is obviously not perfect—and there have been allegations leveled at more than one pharmaceutical company suggesting that cherry-picking of data and/or complete studies occurs. To have FDA approval be treated as an infallible process that protects companies from liability is insane. Companies cheat and game the approval system already. Knowing that there’d be no accountability once a drug gets approved, how much more tempting would it become to try to cheat? The FDA approval process is a highly political one, besides. Wasn’t it that agency that issued a report decades ago claiming that marijuana had absolutely no beneficial effects? And while there is some postmarket monitoring of drugs, it’s also political and subject to gaming and/or cheating as well. There are over 11,000 drugs currently approved by the FDA, according to the report quoted above. Do you really think they can make more than a pretense of monitoring each and every one of them? The entire system is a fucking, insane sham.
If this case is decided in favor of Wyeth, what recourse will people have? None, as far as I can see. And given the FDA’s punitive stance toward unapproved therapies and the professionals who want to use them to help people, a perfect Catch-22 seems to be shaping up. Use FDA-approved drugs, get hurt, and you’re screwed. Try to use other means of treating yourself, get caught, and you’re screwed. It is well past time to stop relying on drugs as much as possible—especially drugs that treat conditions a better lifestyle would completely eliminate [sez the fat snake who spends entirely too much time typing away at various windmills].
If anything, the healthcare field should be held to a higher standard than other sectors of business. Individuals who seek their services are at their most vulnerable and often, most uninformed (although the internet is helping remedy that). Just the prospect of allowing the pharmaceutical industry to skate on their responsibilities is harrowing to me.
And here’s an even scarier thought: If preemption comes to the pharmaceutical sector, how long will it take for it to spread to all regulated business sectors? A reminder for you, while you ponder that—the “F” in FDA stands for “food”.
Catch 22? Maybe
As a nurse, I gave thousands of injections of Phenergan over the years, all without incident. There is no excuse for this kind of incompetence and it is the person who gave the injection - and his/her employers who need to be held accountable for it, not the manufacturer who had no control whatsoever over any of it. More writing on a label certainly isn't going to make a particle of difference. And neither is another lawsuit against the pharmacy company - as tempting a target as they are to so many people.
If someone misuses marijuana, who do they sue?
The ultimate answer is, as you say, to learn about and build a healthy body and lifestyle to reduce or eliminate the chemical medicines so many rely on.
I wondered about that.
I, too, have given many injections of promethazine (Phenergan), and noticed the article mentions that “the injection struck an artery”. Using proper siting technique that should happen very rarely (just on individuals with very unusual anatomy); and it is never good when it does. Maybe promethazine is especially irritating to vasculature. And, irrespective of the real cause, the Robed Nazgul are going to make a decision that could radically change a lot of things in this country.
I read more...
I looked at this a little more closely, and would have to go into the nursing literature to get more real facts, but the problem seems to be that those who had adverse effects were those who had been given this drug by IV push.
This product is given only by nurses (in hospitals), and any nursing drug book spells out very clearly that Phenergan must not be given in any concentration above 25 mg/ml or RATE above 25 mg/minute. This totally rules out ANY IV push administration for anyone, at any time, so whoever ordered it that way - as well as any nurse stupid enough to give it that way - is personally liable for all damages.
As for IM injections, there is absolutely no excuse for hitting an artery, for pity sake. Even half ass technique would spot that very quickly.
There is just no excuse for this kind of thing. As bad as the pharmacy companies are and can be, this particular problem is not of their making, and nothing they could do would change poor technique or people who don't follow protocol. If they won't do those things, what good would more words on a label do? Or more lawsuits that only lawyers win?
As always, we need to be able to hold the proper people personally accountable, not more "laws."
News from a reader in the area supports you.
I just received an email from an anonymous reader in Vermont, who pointed me to this news report: Vt. case may affect suits vs. drug firms. The key sentence is this one:
So it wasn’t even a nurse who administered the drug, it was a PA—a professional who is supposed to be up the ladder from nurses, training-wise.
Your comments support my recollections, too: I don’t recall ever seeing promethazine being given IV push. IV drip, yes; intramuscular (IM) injection, yes; but not push.
The fact that this has become a case before the Robed Nazgul focusing on manufacturer liability after receiving the state’s blessings is even more depressing. It does appear to be a fairly straightforward case of malpractice.
And thanks again to our shy friend in Vermont for bringing the article to my attention.
It's all on the label, label, label...
Which, of course, confirms the old ploy that the very people who NEED to read the label that says "keep your fingers out of the whirling blades," are the very people who don't read any labels!! LOL
I can't imagine where that PA's head was that day, of course, but I have seen doctors do some of the most insane things a nurse would never dream of doing and suspect it is at least partly due to the "god complex" so many of them develop. They are so sure of themselves they sometimes fail to think, especially under stress where it is most needed, and make horrible mistakes.
A PA with a "god complex?" Spare me!!!