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“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” – Justice John Paul Stevens
Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits (Update1)
By Greg Stohr
March 4 (Bloomberg) — The U.S. Supreme Court bolstered patient lawsuits against drugmakers, upholding a $7 million award to a woman who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.
The justices, voting 6-3, said patients can use state product-liability laws to accuse companies of failing to provide adequate safety warnings. Drugmakers had argued that they were shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.
Thanks to those of you who joined the Stop Preemption cause on FB which grew to 166 members.
via People over Profits FB group.
More on the story here.
Read my prior pieces on preemption including “Corporations Get out of Free Card” and “No Redemption for Preemption”.
Listen to a radio show on the case with an interview of a reader, Sara Bostock, here. She filed a friend of the court brief on behalf of Levine (i.e. anti preemption). Note the reporting is very biased toward the pro-preemption side.
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yay! I can say I heard it here first…thanks!!
Well, congratulations on your victory!
I’ve followed this case, and I still don’t quite understand it. Specifically, I don’t understand why the medical caregiver who ignored the warning is not also culpable.
As I understand it, the argument was that the warning did not go far enough in explaining the possible consequences of ignoring the warning. But I just wonder…how far must we go in order to get care providers to pay attention? At what point must they be held accountable for their negligence?
I feel the same way about some of these medications. A label cannot educate a prescribing physician who is ignorance about the condition he/she is treating. So when, for example, a physician prescribes an SSRI without knowing that this could exacerbate bi-polar disorder (and moreover, that patients with bi-polar disorder visit the physician almost solely during depressive periods), is it the medication that needs a bigger black-box warning or the physician who needs a better education and perhaps a better appreciation of consequences?
Just a rhetorical question. Congrats.
*Excellent* news!
We won, indeed. But the fight goes on in Michigan. This decision makes our own full shield law that much more pathetic. But it will not remove it. That will take a good deal of continuing legal and political struggle.
There wasn’t necessarily any negligence by the care providers. Phenergan is a medicine given oh, probably millions of times per year in the U.S. (Just a guess – but it’s given thousands of times at any individual hospital, and there are thousands of hospitals…) The fact that there are only 20 cases of gangrene reported shows that it’s quite safe, safer than many other medicines that are widely used. Probably on a par with airline travel.
But like anything else, it’s not 100% safe. This risk of amputation is inherent to the IV form of the medicine and can’t be eliminated (except by not giving it IV, a response which is already occurring in hospitals). It can be assumed it will happen if the medicine is given enough times (like the infinite monkeys-typing-Hamlet idea).
The question from society’s standpoint is: who should bear the cost from these inevitable tragedies? Should it be the hapless migraine sufferer who trusted her doctors? The perhaps undertrained but overall professional nurse who gave the medicine? The hospital? The doctor who prescribed it? Or the drug company that is making hundreds of millions or billions of dollars from the medicine?
This is only a dramatic and therefore publicity-generating example (the arm-severing nausea medicine!!!) of a scenario that plays out on a quotidian level at hospitals every day. Medications have side effects. People get hurt after receiving them appropriately and without negligence.
An example of this banality of drug death: NSAIDS (Motrin, Aleve) are estimated to cause 30,000 deaths (yes deaths) every year due to GI bleeds (source: NEJM). These frequently occur in people taking the OTC medicines exactly as prescribed on the bottle or by their doctor, all within FDA guidelines. All of these are preventable (by not taking the drugs). All are tragic. All are also predictable and in a sense, expected from an actuarial perspective. The FDA is perfectly aware of these deaths and still allows the medicines to stay on the market because there are BILLIONS of doses taken yearly and statistically speaking, the cost benefit to society is acceptable (and who knows, maybe the drug companies have a hand in it too).
To paraphrase Stalin clumsily, 20 severed arms is a tragedy; thousands of deaths from appropriately prescribed painkillers is a statistic.
Deciding these issues on a case-by-case basis by each drug is absurd. Our legal tradition is one of the reasons the U.S. is a great place to live, but doesn’t serve our interests here. Drug-related harms should be compensated through a “no-fault” system with a set compensation schedule from a fund paid into by drug companies. (Just like if you are killed in an airline crash, your family gets $2 million or whatever, regardless of what happened.) Negligence can be decided separately and dealt with separately. Judges, juries, and the Supreme Court deciding if this drug or that drug killed this person or that avoids the central issue.
Matt:
You said:
“It can be assumed it will happen if the medicine is given enough times (like the infinite monkeys-typing-Hamlet idea). ”
Infinite monkeys-typing-Hamlet represents a completely random, improbable event. This drug, when used in this way CAUSES the gangrene, and it was known by the drug company. THAT is not random. THAT is why the patient won the suit.
It’s fair enough that there are risks to drugs, but patients ought to be alerted. For example: “Would you like to cure the nausea enough that you as a professional musician would be willing to risk amputation?”
It was agreed that the merits of this case were not that great. It was the precedant that was most relevant. And the main thing is to have a deterrant against drug cos. glossing over risks.
According to one report:
The case involved a lawsuit over the injection of an anti-nausea drug which Wyeth sells under the trade name Phenergan. The manufacturer’s label allowed the drug to be administered by direct injection as a highly potent way of delivering the drug to get prompt effects. It also warned that if the drug entered an artery, it could cause gangrene. However, it did not tie that risk to direct injection. That label, and the method of administration, won FDA approval in 1997.
———-
Why isn’t that enough? I don’t get it.
I’m sorry but a patient (not to mention the hospital) has to take some responsibility, too. Someone suffering from migraines goes to the emergency room and allow them to do these extreme things for a migraine?
I’ve had migraines in the past and took responsibility for learning how to prevent them. (Yes, I know, that doesn’t work for everyone, but too few even try. They view our “medical system” as the system that’s in charge of taking care of our health when in fact we are in charge of our health.)
But the one time I did go to the ER — for a migraine — it was after following a physician’s misguided advice to take bc pills, which in fact exacerbated the migraines by an order of magnitude. I just wanted a heavy-duty painkiller . In between waves of nausea and pain, I tried to tell the ER physician why this headache “was the worse I’ve ever had” (their routine question to decide if you need a lumbar puncture), but he refused to believe me. He was “by the book” and, frankly, a tunnel-visioned proceduralist who would rather risk giving me a lumbar puncture than listen to the patient and integrate information. (Perhaps because he could do neither?)
Fortunately, a nurse friend was on staff in the ICU. I had them page her and she told the doc to listen to me and give me something for the pain.
He did.
Later, I stopped the BC pills and took preventive measures for migraines (magnesium supplementation, among other strategies) and have been fine ever since.
I shudder to think that I’d ever agree with Alito and Roberts, but I’m so inclined on this one. The more we make pharma the scapegoat, the more we let careless simpletons on the front line lapse into even more lack of accountability. Moreover, the more we send the the message that Big Pharma is the ultimate caretaker of yourself, not you and your physician.
My point is — and I’m sorry to always bring it back to this — but too many physicians are just plan ignorant. And no number of warnings on labels is going to protect us from their ignorance. We have to get smarter and take more responsibility for our own health.
But Dr. B, how much more explicit must it be for the medical simpletons and slackers: IF THIS GOES INTO AN ARTERY, GANGRENE CAN RESULT.
How on earth can it be any more plain? Must they resort to stick figures with little x’s for eyes in case the people administering the medication can’t read?
They settled separately with the hospital and clinician. And like I said the merits of the case itself were not that great as recognized by all, the issue was whether or not FDA approval preempts the ability of individuals to have a day in court, so it was a precedant setting case. Medically I think the point was as I understand it that you shouldn’t be using iv push, so that there should have been a stronger warning, which Wyeth argued they couldn’t change because it was FDA approved, an argument that was not, in fact, correct.
Okay, Dr. B. I get your point, which is well-taken.
I just get disgusted with the lack of common sense in our medical system. Habitually visiting the ER to treat a migraine with demerol and anti-nausea is bad enough, but when the ER doesn’t even follow any kind of migraine-treating protocol, using a very outdated drug and then disregarding caustions, well, it’s just a sad commentary all the way around.
Wow.
The pharmaceutical industry needs to take responsibility for the dangers of its products instead of trying to minimize them or pass the buck to a weak (already disempowered) regulator over which it has great influence. Yes, there are scores of ignorant practitioners out there including the ones in the Levine case but the fact is Ms. Levine herself was not apprised of the dangers of allowing a nurse to inject her with that drug. If she had been told do you think she would have allowed the injection?!
If the FDA were really onmipotent and had perfect access to all the information then perhaps pre-emption might be valid, but we all know they are being kept in the dark as much as the rest of us. There are reams of information that are not being disclosed in a forthright manner making assessments of labeling imperfect at best. The pharmaceutical manufacturer must be primarily responsible for what goes on the label not a regulator who does not have access to all the information. Tort law isn’t the ideal solution but it does provide some check on the system as it stands now. If preemption had passed the pharmaceutical industry would have had unprecedented opportunity and incentive to conceal and postpone the disclosure of the risks of their products to the great detriment of public health.
The interview of which I was a part was obviously produced by a right wing, pro-industry thinker who chose to have two career professionals on one side and two “survivors” on the other. He interviewed both of us for about an hour each and only included very short segments while allowing Pitts and Merrill to go on at length. In addition he could have sought out lawyers and academics on the anti-pre-emption side and chose not to do so. That being said I think Pitts portrayal of how all this is going to play out is patently absurd and I hope others see it that way as well.
[...] for injuries despite FDA approval—striking down preemption. For further information, check out Doug Bremner’s and Philip Dawdy’s blogs that have already covered this. In the meantime, I leave you with [...]