Supreme Court Rules For Injured Consumer In Big Pharma Case
The Supreme Court ruled 6-3 in favor of Diana Levine in Wyeth v. Levine. Levine, a musician, had her arm amputated when an anti-nausea drug was improperly administered in her artery, and sued the manufacturer for failing to warn of the risks on the drug's label. Wyeth claimed that her case was pre-empted by federal law.
Wyeth's Phenergan is used to treat nausea and, according to its label, can be administered several different ways, including by IV push, in which the drug is injected directly into the vein. This carries the risk that the drug will instead be injected into an artery and cause gangrene, which is what happened here.
Levine argued that Phenergan's label should have warned of this risk and prohibited IV push, instead suggesting less risky methods, such as an IV drip. Acting under Vermont law, the lower courts agreed.
Wyeth argued that because the FDA had approved Phenergan's label, it had complied with all labeling requirements, and state law claims were pre-empted, despite subsequent information that IV push administration of Phenergan had caused gangrene in several cases. Even if it had wanted to include an IV push warning, Wyeth argued, it wouldn't be able to because it would differ from the label the FDA had approved.
The Supreme Court disagreed. "The very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning . . . is difficult to accept—neither Wyeth nor the United States has identified a case in which the FDA has done so."
The decision is an important step in the fight against pre-emption, which, like binding mandatory arbitration, is designed to prevent injured consumers from getting their day in court. Although this decision bodes well for drug cases, the Supreme Court went the opposite way last year in Riegel v. Medtronic, which dealt with faulty medical devices. Congress introduced legislation last year that would forbid federal pre-emption of medical device cases, and the bill will likely be reintroduced soon.
Wyeth v. Levine [Supreme Court (PDF)]
(Photo: afagen)
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The issue with this case is that the pharmaceutical company was not at all liable for this incident - the nurse that gave the injection was. It was administered wrong. It was injected into an artery rather than a vein Liability-wise, it is no different than if the nurse injected it into the patient's brain instead of a vein.
Yes, the pre-emption ruling is good, but the case never should have made it there in the first place. The patient sued the wrong people and the courts failed to judge properly by clearing the pharmaceutical company and judging against the nurse.
@Segador: The court awarded her $7.4 million, but reduced it by whatever amount she got from the health care provider.
Sounds like a lot of money, but considering that it's her right arm and she was a professional musician, it seems about right.
Any guess who the three that voted that little old ladies losing their arm to Progress™ is acceptable? Progress™, that is, that protects huge companies skittish about putting alarming yet accurate and direly needed warning labels on their products?
I'm guessing, The Toad, his Toadie and that Bush guy who swore to interpret according to Strict Constructionism (when it favors Big Business only).
@Alex Chasick: Thanks, and yeah, it's hard to put a price tag on a limb. I would have actually guessed more.
@unpolloloco: I'd have to disagree with you here. While the nurse/doctor/whomever administered the drug was at fault for administering it via an artery instead of a vein, if it was known that the drug could cause (fairly severe) adverse reactions due to a fairly easy to make mistake, but had other, safer ways that it could be administered effectively, they should have at least put a warning on it specifying the risks involved with that particular method.
That poor woman :/
@unpolloloco: She actually sued the health care center and the nurse, and settled those claims. Her award from Wyeth was reduced by what she got from them.
And the point of the case, before it became a bellwether of the SC on preemption, was that the nurse didn't realize that the drug shouldn't be administered by IV push because Wyeth's label failed to warn against the possible complications.
So the FDA says the label was good enough and a jury in Vermont says no? And the SCOTUS decides that's the way it should be? Is that about right?
@Trai_Dep: Oddly enough, Justice Thomas wrote a concurring opinion. I'm going to read it over lunch, but I'm guessing he's just grumpy that Wyeth made him come in to work that day.
It is a little misleading to write that the label said the drug could be injected by IV push...given that the following warning was on the label.
"The warning for "Inadvertent Intra-arterial Injection" stated: "Due to the close proximity of arteries and veins in the areas most commonlyused for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection.""
The label goes on to describe the damage the drug would do if injected into an artery, and strongly caution against making this mistake. I'm not big pharma's biggest fan, but it sounds like they did their best to warn against the dangers of the drug.
The nurse made a mistake, not the drug company. It's really a bit inappropriate for the label to forbid entirely one means of injection - what if the attending physician decides the patient needs the drug fast?
On the other hand, it's good that the court ruled against pre-emption. I have to question Wyeth's motives for trying to establish that doctrine, rather than fighting the case on its merits - is the company so scared of stricter state standards?
I don't expect this to get much respect on this website but this ruling is actually bad for consumers. Companies afraid that even though they follow all the rules won't protect them from getting sued will get out of the market. Trying to make sense of all the different labeling rules for every state as they change from year to year will be nearly impossible.
The consumers that will suffer will not be the ones that get injured from the improper administration of a drug, the ones that will suffer will be the ones that die or that continue to suffer from an existing condition because the drug has never been put on the market to be administered in the first place...
And the reasoning the court used is just plain faulty. Unless there is something written out in black and white stating that making the labels stronger is permitted how can the company know what the FDA will decide to do? Just because the FDA hasn't punished companies in the past for strengthening labels doesn't mean that they can't make the arbitrary decision to do just that at some point in the future. Past performance is no guarantee of future actions...
unpolloloco: your "simile" is inappropriate.
injecting into an artery, (which generally lies next to veins) while attempting to inject into a vein is a recognized complication of giving iv medications; it is NOT like injecting into the patient's brain, a large organ located inside the skull. Anytime a medication is considered for being given IV push, the effect of inadvertent intra-arterial injection should be considered. In this case, the effects were known to the company, but were divulged to the medical/nursing staff.
The person who administered the drug, the doctor or whomever was in direct control of it, should have notified the patient of 100% of all the known possible complications. If she knew there were a couple other cases where gangrene occurred she may have opted for another method. I wouldn't say this is a problem in labeling though, because there is a good chance that only a small fraction of the possible complications would even fit on the label. The hospital should be responsible for disclosure of the remaining complications.
@Tonguetied: Weyth was not hit by some obscure state-only drug labeling law. They were sued under old-fashioned tort law.
In addition, Weyth presented no evidence that it had even tried to push through stronger labeling.
In any case, it boggles the mind that the FDA would ever do anything but rubber-stamp an upgraded safety warning. The FDA label rules are meant to regulate which uses a drug can be advertised for, and which warnings are needed. The usual tug-of-war between drug companies and the FDA has to do with the FDA either not approving new uses, or Black Boxing a warning the drug company doesn't think is serious.
To top it off, if you read the ruling, the court explicitly considered that argument, and found that FDA rules do allow the unilateral adding of warnings to the label, without even having to wait for FDA approval.
The FDA's approval of drug labels pretty much amount to: "Looks good to us!" They are not an absolute statement that no other risks or warnings could possibly exist, and in this case, the MA jury decided that an additional warning would have been appropriate here.
@Alex Chasick: Whoa, color me shocked, Thomas sided differently than Scalia.
Excuse me, I need to go find some smelling salts. :)
@Tonguetied: From the NYT article:
"The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.
A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks...
The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the FDA, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed."
I think the bolded parts argue fairly forcefully the opposite of what you're saying.
@Alex Chasick: Exactly. The idea that the drug company *knew* these risks and failed to adequately notify medical professionals and patients alike of those risks through proper labeling is the issue. It is, according to the article, fairly common for the IV push to go into an artery rather than a vein, the complication of which is gangrene which results in the rather extraordinary need to amputate limbs. Kind of a BFD.
@unpolloloco: Liability is not a black-or-white proposition. Just because the nurse made a bad stick, does not let Weyth entirely off the hook.
A nurse injecting it into the brain would have been entirely different. Phenegran is not labeled for such a use, and a nurse would certainly be wrong to do so.
The label is somewhat interesting: It warning section, it mentions the dire consequences of getting the drug in arterial blood, and then in the same paragraph mentions there is no reliable way to tell if this has occurred prior to the push. The question begs to be asked: how could the nurse have prevented the bad stick if there is no way to tell one has happened when making a push?
This, in turn, led to the question: Why does Weyth market the drug to be administered in this way at all, given both the irreducible risk, and the availability of alternate administration methods? The jury decided that the warnings were inadequate against an IV push vs. the safer IV drip. (The guidance the label gives on this consists of "It is usually preferable to inject it through [a known working IV drip]." Nary a word on how to choose, or under what circumstances a push is worth the risk, leaving that up to the imagination of the person administering the drug.
@Gokuhouse: so every nurse should have working knowledge of every possible drug that a hospital "could" prescribe to be given, as well as complete knowledge of any and all reported and non reported side effects....
Have you had any interaction with America's health care system in the last 10 years?
@Alex Chasick: I'm just an amateur musician, and I could probably do my "day job" minus an arm, assuming I got the right adaptations for a PC, but I would still be wanting much more than $7.4M if I lost an arm.
The thought of never playing guitar again, let alone all the other activities that get harder, assuming they can be done at all, makes me shudder. I'd be out for blood.
@unpolloloco: As a side-note, if I were on the jury, I likley would have ruled differently, given what I can read about the case, and given what is on the drug label. However, I do not consider the jury's ruling to be unreasonable, and neither did Weyth, at least not at this level of appeals.
Weyth argued for pre-emption, and lost. Yes, perhaps they should have won on the facts at the trial level, but that time is long past, and they rightfully have lost on the law here.
In no way was the pharmaceutical corporation any way, shape, or form in the wrong. You'd think that as a medical professional you would have the training to know things that would be general knowledge to those in the health profession. The nurse committed an error and it was her fault.
Do they have to start putting ridiculously long labels and warnings on everything now? How specific does the labeling need to be? There are things that we can reasonably expect our doctors and nurses to be knowledgeable about and not blame it on big pharma for not putting enough disclaimers and warnings on the bottle.
@Gokuhouse: Are you nuts? Have you ever actually read a formal drug label? If a nurse was required to reel off every side effect of every drug to a patient prior to administration, no drugs would ever be administered.
@full.tang.halo: No, you're right, the nurse should just blindly give out meds she or he has no idea what they do. And then they can mix the drugs together to see what happens! Are you crazy? Do you honestly think that drugs are given without thought of what the side effects are? They, the hospital, know what the side effects are of all the drugs they use. Doctor's know what a drug is and they know the possible side effects before prescribing it to the patient. It would be malpractice to just blindly give out drugs without understanding their consequence...
Seriously, how do you put a price on someone's arm. Until we are able to regrow people's limbs (there's research in this area) or provide prosthetics like Luke Skywalker's (which are very close to reality). Losing an arm does have a very significant impact on a person's life. Moreso than I think even losing a leg does.
I also completely agree that Wyeth played their own role in this incident. They knew that the drug caused severe complications when used in the manner the Nurse administered it, yet the label still reccomended IV push in spite of those severe risks. Had they said explicitly not to administer it via IV push then they'd be off the hook.
@Tonguetied: Well, now similar laws regarding medical devices, and this ruling as common-law will allow companies to add warnings, in addition to the existing regulations that would have allowed them to.
The only time the labels can't be change is to REMOVE warnings or information, or to add contradictory information to the FDA approved label. So saying IV push should be avoided at all costs is not removing a warning, or being contradictory.
The drug did have warning language, and it was written as follows (from the decision):
"Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection.Reports compatible with inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs. . . . Aspiration of dark blood does not preclude intra-arterial needle placement, because blood is discolored upon contact with Phenergan Injection. Use of syringes with rigid plungers or of small bore needles might obscure typical arterial backflow if this is relied upon alone. When used intravenously, Phenergan Injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient complains of pain during intended intravenous injection of Phenergan Injection, the injection should be stopped immediately to provide for evaluation of possible arterial placement or perivascular extravasation.”
The jury ruled this wasn't good enough, despite being fairly clear about the dangers and despite:
"The record contains evidence that the physician assistant administered a greater dose than the label prescribed, that she may have inadvertently injected the drug into an artery rather than a vein, and that she continued to inject the drug after Levine complained of pain."
In short, there was extensive warning about the dangers of the injection method used, the attending physician didn't follow the label or (apparently) read the warnings and messed up badly. But Wyeth's labeling isn't good enough, in some vague manner:
"as the Vermont Supreme Court explained, the jury verdict established only that Phenergan’s warning was insufficient. It did not mandate a particular replacement warning, nor did it require contraindicating IV-push administration"
Legally, the decision looks pretty solid so far, though I haven't gotten through all of it (or the dissent), and "the jury were idiots" was not a claim before the court. As a policy I'm more ambivalent about preemption - having to follow a dozen different rules about labeling will happen without preemption, but given the ability of any one rule to mess up the strict limits of preemption law seem out of place.
But man, this case is nothing but targeting the big bad pharma company with its big pockets. Levine deserved - and got - cash from the clinic, but didn't deserve a cent from Wyeth.
@sirwired: I must be the only one here that likes to know what a drug does to my body before I take it.
@Adhominem: your suggesting that the relationship between hospital staff and drug companies should be a "caveat emptor" approach? there is no shared responsibility here? specific dangers should not be listed on a drug that could cause irreversible damage? and if a company knew of said danger, they wouldn't adequately place the warning on their product?
i suggest you read the other comments that clarify the facts of the case that extend beyond the blog posts because your issues are covered there.
This is just going to transfer more $$$ away from the American people and to the trial lawyers. How a Vermont jury is deemed to be more qualified to discern the adequacy of a drug label than the FDA seems to be just silly reasoning to me... on top of that, if preemption does not apply, all you'll see is even greater costs for drug develpment and lawsuit defense passed on to the American consumer. It's a win for this unfortunate patient, but a loss for the rest of us.
Nice job on the recap - it's an emotionally and legally complex issue, and I think your summary was really on target. I'll still probably read the ruling, but now I don't feel so bad about putting it off.
@PhiTauBill: Yup. How dare consumers be able to file suit. Only corporate lawyers should be able to!
@Gokuhouse, I'm going to have to agree with you. If the possible side effect of an IV push of a certain drug is as serious as gangrene, then for damn sure the nurse should be aware of it and convey it to the patient.
Right before my doctor administered a general allergy shot to me in my butt, he told there is the extremely remote chance of bone death in my pelvis.
To me, it seems that with such a serious side effect (gangrene), that the IV push method would be abandoned. But I am not an expert in the field by any means. It may be possible that potentially harmful drugs are administered with an IV drug all the time and we are simply unaware...and very lucky!
@PhiTauBill: Sorry to let you know, but juries are deemed "qualified" to render judgments on all sorts of things all the time. Juries were "qualified" to render opinions on DNA that got OJ off the hook on murder, but on the hook for civil damages.
Sure its possible that Wyeth (or actually their insurance company) will pass on the judgment to consumers by raising prices (or insurance premiums), but if we have to pay a little bit more for drugs that aren't going to cost people their limbs, I'm all for it.
@Trai_Dep: I don't think he said the woman couldn't file suit.
Wyeth should be able to rely on the FDA's decision on the label. The nurse made the mistake, not the drug company, but the drug company probably had deeper pockets and that's far more important than culpability these days.
@Gokuhouse: Obviously you are not a health care practicioner. Doctors, and especially nurses, have NO CLUE as to all the side effects, interactions, etc with all drugs. Certainly they know some, probably most, but never could you say everyone involved in treating a patient knows every bit of copy in the official labeling. Even if they did, in this case, we are talking about (A) a nursing error and (B) a one-in-ten-million reaction.
@Adhominem: The company admitted that an IV push, while recommended by them, risky in that it can cause the medicine to go into the artery instead of vein, but that there was also no way of telling if that happened, and that the risk was AMPUTATION. Its not like it was a risk of sores, or headaches, or mudbutt.
Good ruling. It puts some of the responsibility back on the pharma companies instead of just permitting whatever they can get away with.
@Gokuhouse: I'm not sure how much medicine you've taken in your life, but if it ever involved a hospital stay and you aren't a pharmacist, it's a safe bet that you don't know EVERY possible side effect of every medication you've taken, especially if injected into the wrong place. Has a doctor ever told you that "if I accidentally inject this penicillin into your eyeball, you might go blind?" Probably not.
There's some basic assumptions about the level of medical care you receive; one of them is that the people putting needles into you are putting them in the right place. I'm not even sure how the discussion you're proposing should go:
NURSE: "By the way, if I put this in your artery instead of your vein, you might get gangrene."
PATIENT: "Wait, you're putting it in my vein though, right?"
NURSE: "Yeah, that's right."
PATIENT: "Then why are you telling me I might get gangrene? Are you planning on screwing this up?"
NURSE: "No, but I just have to tell you. I mean, JUST IN CASE I screw it up..."
Confidence-inspiring, no?
@Tonguetied: Your argument starts with a crap statement:
"Companies afraid that even though they follow all the rules won't protect them from getting sued will get out of the market."
Companies are NOT going to "get out of the market" based on this case. Weyth knew their label was faulty and didn't feel like going through the (admittedly lengthy) trouble of getting it changed, especially changed to something that is more restrictive.
To say this is going to cause other Pharmas to "get out of the market" is both naive and rediculous. They will just be more diligent about their labelling.
@Trai_Dep: And after reading it, I'm actually impressed with his consistency. The concurrence says he's opposed to pretty much all pre-emption, states' rights, rah rah. Good on him for being a Federalist (in the modern sense) even when it's against big business.
@Beerad: Luckily I've never had to receive an IV of any sort in my life, but I would still like to know there is a chance that they could place the needle in the wrong spot. How would I, as a patient, know there is a chance that the person working on me could stick me in the wrong spot and not catch it until after the medicine is in me.
@Alex Chasick: Isn't Scalia supposed to be the same, a strict constructionist/states rights person? I'll have to read his dissent to see his support for big pharma.
From the sounds of it, the Nurse screwed up. Consent was not given in a meaningful fashion, as in here are the side effects if we do this...do you agree. She pushed it into the wrong place, which is a pretty common complication and usually does not result in loss of limb...but still her fault more then theirs.
On the other hand, they should not hide behind the FDA if their drugs cause problems. If the FDA independent tested the drugs I could see this explanation, but these manufacturers test the drugs and run the trials themselves and then send the data to the FDA.
@Gokuhouse: BTW, the "label" here does not refer to the sticker on the bottle. It refers the the 10-15 page book that details all the instructions, indications, warnings, and even a copy of the molecular diagram.
The idea of you sitting down, in agony, doubled over from trying to vomit, while the nurse reads you the contents of this booklet is untenable.
Here's a taste: (under "Adverse Reactions", Central Nervous System)
Central Nervous System
Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
If you are curious, the label for Phenergran is here: [dailymed.nlm.nih.gov]
@Gokuhouse: But that's the point -- there's always a chance they could stick the needle in the wrong place. Or even amputate the wrong limb or remove the wrong organ! [consumerist.com] But that's the point -- no amount of labeling will be able to prevent those sorts of human errors, and simply piling on the information isn't likely to help reduce the problem. I would suggest that by providing too much information, it actually exacerbates the issue by overloading people with non-helpful surplusage that makes it more likely they'll overlook the warnings that do matter.
If we really need a warning to medical providers that "if you inject this in the wrong place really bad things could happen," then our health care system is in even worse shape than anyone imagined.
Anyone know what she was asking for?