In Wyeth v. Levine (06-1249), the Supreme Court has rendered an important decision on the right of patients to sue drug manufacturers. The tragic case of Diana Levine has been discussed on this blog earlier. Now the court has ruled 6-3 in favor of Levine, a musician from Vermont, who lost her right arm after being given a anti-nausea drug by Wyeth.
The issue was federal preemption and whether Congress effectively barred lawsuit once a drug was approved by the Food and Drug Administration. The Bush Administration entered the case on behalf of Wyeth and against Levine to try to block patients from being able to seek recovery against drug manufacturers.
Here are the facts of the case:
Phenergan is Wyeth’s brand name for promethazine hydrochloride, an antihistamine used to treat nausea. The injectable form of Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV-push” method, whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, whereby the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient’s vein. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery.
Levine’s injury resulted from an IV-push injection of Phenergan. On April 7, 2000, as on previous visits to her local clinic for treatment of a migraine headache, she received an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Because the combination did not provide relief, she returned later that day and received a second injection of both drugs. This time, the physician assistant administered the drugs by the IV-push method, and Phenergan entered Levine’s artery, either because the needle penetrated an artery directly or because the drug escaped from the vein into surrounding tissue (a phenomenon called “perivascular extravasation”) where it came in contact with arterial blood. As a result, Levine developed gangrene, and doctors amputated first her right hand and then her entire forearm. In addition to her pain and suffering, Levine incurred substantial medical expenses and the loss of her livelihood as a professional musician.
The decision by Justice John Paul Stevens upholds a nearly $7-million jury verdict against Wyeth and will clear the way for more such lawsuits Levine argued that Wyeth failed to warn of the dangers in the use of its drug. Levine noted that she would obviously had passed on an anti-nausea drug if told of this danger.
Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer joined Stevens. Stevens cited the important deterrent role presented by these lawsuits: ” “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”
Justice Clarence Thomas concurred in the result while Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. dissented. Justice Alito wrote that “This case illustrates that tragic facts make bad law” and criticized the ruling as “a frontal assault on the FDA’s regulatory regime for drug labeling.”
For a copy of the opinion, click here.
I looked up the actual warning label for Phenergan. Understanding the issue requires understanding not only the law, but something of medical terminology.
The warning label includes this:
“The proper intravenous administration of this product is well tolerated, but use of this route is not without some hazard. Not for subcutaneous administration.
“UNINTENTIONAL INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY. SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS.”
(Caps as per original.)
Some may argue, as foo did, that by this Wyeth effectively said “‘do not do X’, where X = IV push.” But in fact, as these things are normally understood by healthcare professionals, it did not.
“Contraindicated” means “don’t do it.” Sub-q administration is ruled out.
Saying “some hazard” means “be careful.” IV push is not ruled out. Considering the degree of risk – even infiltration from a pierced vein is hazardous – I personally do not consider that an adequate warning.
foo:
“If a pharma company says do not do X, and MD does X, should the pharma company be liable for damages that result of doing X?”
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The context of this preemption case is important. Since 1966 Big Pharma has gotten the courts to allow the defense of “learned intermediary” to insulate them from liability for their defective or inherently dangerous products. Basically, if the prescribing physician is warned of the risks and prescribes the drug, Big Pharma is off the hook since it may rely on the doctor to explain the risks to the patient as a “learned intermediary.” The justification for this special treatment was that since consumers may buy these drugs only with a prescription from their doctor and the doctor holds superior knowledge of its efficacy, it was reasonable to permit Big Pharma to discharge their duties to individual consumers by warning the doctor who decided to prescribe the drug, and would in turn warn the consumer. Problem is that since the 1980’s Big Pharma has changed teh rules and engaged in direct marketing of prescription drugs to consumers via TV ads–need I remind anyone of Levitra? The doctor’s role is reduced to “order taker,” since Big Pharma knows that increasing pressure on physicians to write Rx’s will move product (note their are no ads for Amoycillin but the more exotic and profitable elective drugs). No exception existed in the learned intermediary defense for direct marketing to consumers which sort of defeated the purpose of this mulligan for Big Pharma.
Not being ones to adhere to the adage that one cannot make their cake and eat it too, Big Pharma lobbied to keep this defense along with the other panoply of defenses (like the preemption doctrine argument in this case) usually brought to bear in this area, despite the fact that it had changed the playing field in its favor. In that context, the Courts are more and more reluctant to give Big Pharma a pass since they already get one when they warn the doctor.
From the comments, it doesn’t look like anyone actually read the full opinion, or the dissent. Even though I’m sympathetic to the appellant, I found the dissent persuasive. Maybe that’s a function of Alito’s writing, however. Thomas only concurred in the judgment, not in the Court’s reasoning.
The interesting thing about this case is that Levine sued the hospital and physician’s assistant (who didn’t come off as being particularly with it) for malpractice, and settled out of court. Subsequently, the PA and her supervising MD testified on Levine’s behalf against Wyeth.
Also, phenergan is not a new drug. It’s also OTC in Europe, which I find incredible.
If a pharma company says do not do X, and MD does X, should the pharma company be liable for damages that result of doing X? MD’s often prescribe drugs “off-label”. I guess in this case I’m not as certain as everyone else seems to be that Wyeth did not effectively say “do not do X”, where X = IV push.
Rush is human? 😀
Bron98:
“It could have just been a missquote, he is only human after all.”
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Likely it was a misquote, but when the speaker projects smugness, and omniscience in matters of state, it is difficult to feel any sympathy.
Mespo:
I think I am feeling a song coming on for the lack of intellectual vigor on the part of the right:
“The Meekness of the Right” (with apologies to Andrew Lloyd Webber.)
CCD,
One lives to be of service. Good ideas are like a virus. I’m glad you’re passing along the infection. 😀 Especially to a future doctor. Congratulations on that too! I’m sure she’ll make a fine physician.
Mespo:
It could have just been a missquote, he is only human after all.
Although I do agree with you on the GOP intellectual shortfall, Newt was there for a time at the forefront but he isnt all that intellectual. It really is a shame, maybe you and I can write a book – “Musings from the Right, Aphorisms from the Left”. Then we could sell twice as many books and the left could hate me and the right could hate you. We would provide a public service, although we both, probably, better get unlisted phone numbers first.
Hopefully, in such a collaboration, I would be able to rise to your level of prose and thoughtfulness or the right would hate me too.
BIF thanks for the Steve Friend article posted again. It’s so realistic. I shared it with my oldest daughter who is a chem major and pre-med too. (accepted to GW med school, the ivory towers in the East. I’m proud she’s keeping her eye on the prize.)
Her email response to the article was wow I know about this it’s amazing, and medicine needs to be more more transparent. Then the rub, how do you know about this? I told her it’s nice to have friends. 🙂
Yes bravo mespo, and stay hydrated too.
Well said, mespo.
Keiff:
” …someone else’s teeny-tiny mistakes…”
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Well let’s see how the self-proclaimed leader of the GOP did with his “teeny-tiny mistake” while lecturing the faithful about the documents he claims to love,and know so well. What patriot wouldn’t have committed the important parts to heart before the biggest speech of his rather extensive demagoguery, which he calls a career.
The great man said:
“We [conservatives] love and revere our founding documents, the Constitution and the Declaration of Independence. We believe that the preamble to the Constitution contains an inarguable truth that we are all endowed by our creator with certain inalienable rights, among them life, Liberty, Freedom. And the pursuit of happiness.”
Problem is you see, the poorly quoted (sorry no word “freedom” in the document) language is from the Declaration of Independence (a document he dearly loves, but astonishingly forgot),and not the most famous preamble in Western thought. Well it’s really not that bad for a college dropout with no academic credentials who seeks to lead the party that wallows in it’s anti-intellectualism.
If that porcine face is the face of the Republican party,I suggest shorting GOP stock to get us out of the financial crisis brought about by another one of its intellectual heavyweights, “Martial Law” George Bush.