Supreme Court Deals Blow to Big Pharma
Another Bushite attempt to place the interests of the pharmaceutical industry ahead of the rights of consumers has been shot down by the Supreme Court.
In the case of Wyeth v. Levine:
The Supreme Court today ruled in favor of a woman who had her arm amputated after an improper injection of an antinausea drug and said drugmakers could not rely on federal regulation to protect them from lawsuits brought under state consumer protection laws.
The court ruled 6-3 that Congress did not mean to shelter drugmakers such as Wyeth Pharmaceuticals from the kind of lawsuits brought by Diana Levine of Vermont, who developed gangrene after a physician’s assistant injected the drug Phenergan into an artery.
The opinion by Justice John Paul Stevens said that even though the Food and Drug Administration had approved label warnings about complications from the drug, the company could have done more to prevent what happened to Levine, a children’s musician who played guitar.
Wyeth contends that “once the FDA has approved a drug’s label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue,” Stevens wrote. “The most glaring problem with this argument is that all evidence of Congress’ purposes is to the contrary.”
El Somnambulo was especially intrigued to see that Clarence Thomas actually voted with the majority on this one. Is it possible that Obama winning the White House might enable Thomas to shed the racial self-hatred with which he seems to have been afflicted?
Big pharma is facing loads of cases similar to this one in state courts. Bush’s efforts to screw consumers have failed.
Elections matter.
Medical Protocols matter.
The makers of drugs should indeed be protected of a drug has been through trials and is deemed safe.
The key is the use of the drug. The FDA does not issue a get out of jail free card, it offers guidance and approval concurrently.
By the way, I am sure Justice Thomas bears no sort of racial hang ups although the person who made this post surely does.
You have your nerve criticizing anyone here, Protack, after your transparent and stupid lying about shopping for mortgages.
We note that you still have not provided the names of the companies that you called so we could fact check your silly claims.
Rebuild never lets the activity of reading get in the way of making a point w/o supporting documentation.
Here is but one of many articles that a simple Google search turned up on the matter of Thomas and racial self-loathing:
http://www.jackandjillpolitics.com/2008/12/afro-clarence-thomas-questions-obama-citizenship/
Here are a couple of excerpts. Remember this?:
“In a highly unusual move, U.S. Associate Supreme Court Justice Clarence Thomas has asked his colleagues on the court to consider the request of an East Brunswick, N.J. attorney who has filed a lawsuit challenging President-elect Barack Obama’s status as a United States citizen.
Thomas’s action took place after Justice David Souter had rejected a petition known as an application for a stay of writ of certiorari that asked the court to prevent the meeting of the Electoral College on Dec. 15, which will certify Obama as the 44th president of the United States and its first African-American president.”
“(Thomas’) instinct is always to punish the race whose mark he shares to please those who flatter him to his face and scorn him with ridicule behind his back. He’s a sad case of self-hatred indeed.”
The problem here is that the drug companies are not allowed by law to change labeling without FDA approval. This is to ensure that drug companies do not make false claims about safety or efficacy.
So if a drug company or a state wants to go to a stronger label, it cannot do so unless the FDA says it is OK. So, in this case, Wyeth said they couldn’t change the label without government approval, which was true, therefore they should not be liable since they were following the law.
Very tough case, in my opinion. Maybe Wyeth could have done something else relative to warnings, but then the government might have fined them for breaking FDA regulations.
Interesting point anonone. I know that the same issue has haunted hybrids. Car companies cannot advertise any mileage ratings except the ones that Uncle Sam gives them. Those ratings often overestimate the efficiency of the hybrids, but the dealer cannot state anything but the official rating.
According to the way the law was interpreted by the Court, there was absolutely nothing to prevent nor discourage Wyeth from placing a warning about IV administration of the medication on the label.
Of course, with the Bushites in charge, the FDA might well have applied Alice In Wonderland logic to challenge a stronger warning. Except Wyeth was perfectly happy with the inadequate warning, and there is nothing to suggest otherwise. Wyeth did as little as they thought was legally necessary. The courts saw it otherwise.
Sorry, El Som, I gotta disagree with you here. There was a warning about IV administration of the medication on the label that the FDA approved.
The court did not say that they could have specifically changed the label or added an additional warning label. They said Wyeth could have “unilaterally strengthen its warning”.
The question is how Wyeth could have “unilaterally strengthen its warning” without breaking very strict FDA labeling requirements. One way might have been via a “Dear Doctor” letter.
Classic Catch 22 here.
Now you all have me confused, and I can’t access this case beyond a Washington Post post. I don’t understand why this was permitted to go forth against the drug company instead of the practitioner. That particular drug is NEVER given into an ARTERY, so somebody missed the mark–a vein–and hit an artery. I would suggest malpractice before mislabeling. Intravenous use vs. intra-arterial use are not interchangeable. Kinda like suppositories and pills…and I have 2 real live stories about that mix-up!
Cassandra,
Wells Fargo and Citimortgage, if you want the phone numbers let me know.
Here is the nonsense you guys dish out.
The post was about big Pharma but you have to inject race when race had nothing to with medical error or does it?
It is so sad how hateful you folks are.
🙁
*grr* PISS *grrr* OFF *grrrr* PROTAK *grrrrr*
El Somnambulo wrote the post. He knows what it was about. It was about an important Supreme Court decision.
And, he found the fact that Thomas departed from the Scalia, Alito, Roberts troika noteworthy since it is so rare for him to do so.
Nevertheless, ‘Bulo thanks ‘Rebuild’ for ‘splainin’ to ‘Bulo what ‘Bulo’s post was all about.
But Bulo…I wanna go beyond all that self-actualization stuff, and seek more insight to the case at hand….you know like the way the law and justice should be…can you give me a link? Please?
I’ll let you count it in your charity column, that some like to account for here!
So, Protack — it took you the better part of the day (your words) to speak to two mortgage companies? One of those is my own mortgage company — who I am already negotiating a refi with for a lower rate and shorter term. I got NONE of those questions. NONE. And I have no debt (except my house), a really good job, and really good credit.
Wonder why they are giving you an oh so politically sensitive runaround? It’s all good though — making shit up is your stock in trade.
You know, if you are campaigning for an office in the Delaware GOP — you really are in the wrong place.
Joanne: Anon1 seems to be pretty knowledgeable on this.
El Somnambulo would welcome deeper legal analysis of the case here, but he’s not the guy to provide it (even though he was a big Perry Mason fan, the black ‘n white episodes, when he was a kid.)
‘Bulo generally puts things up here in the hope that it will create an interesting sharing of facts and opinion. Sometimes it works, sometimes it doesn’t.
Thank you El–darn–now I’ll have to wait for Reader’s Digest.
‘Bulo may be able to help you, Joanne. Here is a ‘syllabus’ which, the Beast Who Slumbers takes to be the Reader’s Digest version, of the decision, from the Cornell Law Review:
http://www.law.cornell.edu/supct/html/06-1249.ZS.html
El Somnambulo is nothing if not well-read…
The NYT provides another summary of the news.
As far as I can tell from the NPR report this afternoon is that the Court told Wyeth that the FDA approval on their label did not provide them a shield from lawsuits. Which looks to me that it makes the manufacturer responsible for the accuracy and completeness of their labeling, not the FDA. Which makes sense to me.
But I could be misreading this.
Based on this excerpt from the syllabus, El Somnmabulo would tend to agree w/Cassandra’s analysis:
“Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer bears responsibility for the content of its label at all times.”
The manufacturer proposes its labeling and the FDA approves or not. That is true, El Som. The manufacturer also bears responsibility that the contents of its label is pre-approved by the FDA. This also includes the package insert, which must also be pre-approved by the FDA.
Changes in labeling without pre-approval can lead to expensive product recalls and fines by the FDA. Even trivial changes.
This is a classic case of the court interpreting federal regulations differently than the industry and FDA have for decades.
I am not saying that the court is wrong; I am saying it is a different interpretation than the FDA and industry have been following. I think it is begging for some clarity from the agency or needs some new legislation.
Som-THANK YOU for the Reader’s Digest–I was out for a bit, and am now seeing what you delivered–very kind of you. Meanwhile…
WYETH…which in turn means you and me will now be paying for a practitioner error. Intravenous administration is covered in this age old drug, missing a vein and injecting an artery is not covered, because it is not to be a method of delivery–is Wyeth responsible for a practitioner to essentially go “off label”? This had better be revisited, or there is a HUGE fall-out coming for all of us, in the area of competence and accountability–i.e I’d rather my arm intact, because the drug was administered according to accepted, prescribed and delineated routes all very detailed and outlined in their accompanying literature, vs. 6 million bucks because some yahoo just gave it any which way,or made a mistake and let the pharmaceutical company pay the consequences (and the patient too). But hey, that’s just me, and I only hang laundry.
.