WASHINGTON, March 4 (Reuters) - The U.S. Supreme Court on Wednesday ruled against the drugmaker Wyeth in a closely watched case, holding that pharmaceutical companies can be held liable for harm from medicines which carry warnings approved by federal regulators.
By a 6-3 vote, the high court ruled that labeling approvals by the U.S. Food and Drug Administration does not preempt state laws and shield companies from legal damages as part of liability claims.
This is huge. If this case had gone the other way, the same drug companies that get their drugs approved by the FDA by submitting cherry picked studies and heavily massaged data, the FDA run by executives who go right back to the drug industry when they leave the FDA, would have been protected from lawsuits from those patients their drugs harmed.
Instead, the court ruled that the company still has a responsibility to protect the people who use their drugs no matter what the FDA says.
WILD CHEERS!
While the business press is treating this as a victory for trial lawyers, it is worth noting that trial lawyers don't take cases unless someone has been seriously maimed or killed. If they are maimed or killed by a drug because the company that provides that drug omitted to mention that the drug could maim or kill in the information it gives doctors, the drug company should pay a price. It will be far less than that paid by the victims of their negligence.
The real benefit of this decision is not for trial lawyers. It is for you, the patient. The drug companies have known all along about the studies they have kept hidden from the FDA and from the public. They also know how the data has been massaged to hide certain findings when they earned product approval. We saw this when Avandia's connection with heart attack finally was made public many years after the company had suppressed this information. We just saw this in the case against the makers of Seroquel who also hid data showing their drug to be less effective than older drugs and more likely to cause diabetes in people who otherwise would not have gotten it.
Now thd drug companies whose drugs' hidden dangers have not been revealed have been put on warning. They will be subject to ruinous law suits if they don't do something to protect the public against the dangers that they already know their drugs present.
Like, for example, the likelihood that Januvia's inhibition of DPP-4 is turning off the tumor suppressor gene you need to survive prostate cancer, melanoma, lung cancer, and ovarian cancer.
There are studies that could be done to determine if this is the case. They have not been done. The only screening done currently when the FDA approves a drug, to rule out that it causes cancer, is screening to see if the drug causes cancer in test tube cells or rodents. No one is saying Januvia causes cancers, only that it turns off our cancer fighting mechanism.
Most of us develop one or two cancerous cells many times throughout our lifetimes, but our tumor suppressor genes kill them. There is no research to see what happens to people harboring one or two cancerous cells when you give a drug that turns off the anti-cancer genes, and that is exactly what Januvia is doing.
It may take ten years until the Januvia-related cancer epidemic becomes evident. At least, with this latest Supreme Court case decided, the company selling it, whose scientists must know of the tumor suppressant features of DPP-4 will not be able to say, "The FDA approved Januvia, so we're off the hook."
8 comments:
The court case was the most ridiculous thing ever, and I strongly disagree with the court's ruling. The warning was very clear, and the drug was administered by a route it was strictly warned against (intra-arterial). The PA was an idiot for administering the drug that way, and should be, and was, held liable, but holding the drug manufacturer responsible for a drug that has been safely administered IV millions of times, is ridiculous.
I'm also wondering if you're familiar with the case, as the article mentions very little about it.
Essentially a PA gave a patient phenergan, an anti-emetic, who didn't have IV access by just injecting in what he thought was a vein, when it fact it was an artery. The patient ended up losing their arm. Phenergan is safe when given IV, and the warning label warned again IA use, which is exactly what happened.
The PA and hospital have already been held liable, but the patient sued the manufacturer liable also.
It's essentially like holding Clorex responsible because you sustained damage drinking their bleach.
Christine-Megan,
That's not at all the way Nina Tottenberg reported this case and I'd trust her as she has been specializing in reporting Supreme Court cases for decades.
As she reported it, the issue was that the label on the drug did not include clear warnings about the problem that caused the woman to lose her arm. The drug company's defense was that because the FDA had approved the label, they had no more liability.
If their defense had been the argument that the label was adequate, it would have been a different case. They didn't make that defense. They argued that the inadequate label had been approved by the FDA.
The current label which does have the black box warning is not the one that was in place when the events covered by the suit occurred.
When I read news of this yesterday, I couldn't contain my glee, as it is a very important victory not only for patient rights, but also for the states' to mandate something over and above the lowest-common-denominator protections offered by the Federal Government. An important victory indeed!
Anyone who made it through 1 year of nursing school knows that phenergan is a strong vesicant. Everyone who's dealing with medications knows that you need to be sure you have a solid IV before giving phenergan IV push.
It's not like patients are shooting up phenergan at home. Then it would need stronger warning labels.
All in all, every health care professional I've talked to feels this is a bull case. It's bull cases like this that drive up health care costs and taxes.
The label made it clear that it can't be given IA, and it was given IA. I'm not sure what you want. Should we make the whole box bigger so we can put every potential problem in 20 point, boldface, red font? Do not squirt drug in eye, do not feed drug to dogs, do not add food coloring to drug, do not give IA, do not give IO, do not use drug to wax your car.
I'm also not sure how you think this will make drugs any safer.
Keep in mind that Phenergan has been in routine use since the 1940s. It's not like this is a new drug and no one was familiar with it.
The Supreme Court held Wyeth was strictly liable for the damages that flowed from the release of a defective product. The product was defective because the KNOWN risk of amputation from the IV-Push method warranted a stronger warning.
I thought the decision was a masterpeice of legal reasoning: the risk of harm so great, the cost of a warning so little. A victory for common sense.
I do not know of any drug that could not be used improperly and cause injury or death to a patient. This includes insulin which I am dependent on. If some jerk gave me 10 times as much as I am supposed to get I would likely die. Is insulin and the drug company that made it at fault or is the jerk that gave it at fault? How could a company prevent someone from using insulin improperly? You, I am sure believe insulin is wonderful drug. Should we as users pay x times as much because companies have to protect themselves from liability from stupid users? I certainly agree that there is biased research that is used by drug companies {statins} but this is not one of those cases and may cost us a lot of money and do us no good.
Harold,
The law as interpreted here is only that the company must provide warnings of dangers it is aware of. The insulin companies cover their patient and doctor materials with warnings. It was the lack of warning provided with the drug that was the specific issue in this case.
But the decision has huge implications far beyond this particular case, because it says that a company that knows of a problem with its drug but does not make an effort to warn patients and doctors is at fault.
There are many other cases working their way through the courts where the drug companies had actively hidden information they had internally that their drug was harming people. Had they been able to claim that FDA approval protected them against suits, it would have huge implications in these cases.
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