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.
If you’d like to read an excellent parallel to this story read the chapters that discuss ‘Phallanx’ from “World War Z” by Max Brooks. The medicine doesn’t have to be safe or even functional, it just has to be marketable.
MAS,
Yep. It’s all about selling it. One of the biggest mistakes EVER was to let pharmaceutical companies advertise. Chris Rock sums up the problem with Big Pharma. “They aren’t going to cure jack shit! The money isn’t in the cure! It’s in the treatment!” You never saw an ad for Viagra when it was just heart medication. But as soon as they found out it was instant wood in pill form, we were hammered with commercials abusing the music of Elvis. I’m sorry, but a bunch of middle aged guys sitting around a bar singing about their hard ons (or lack thereof) is just creepy. I had to have the same drug this woman took and under an involuntary circumstance. While my guitar skills are purely amateur, I cringe at this story. It could have been me. I hope she gets a huge payout. Huge.
Yeah, those poor pharmaceutical companies that all posted record profits. Boo hoo.
Buddha, don’t be so mean!! How are those CEO’s supposed to pay for their vacations now?
What gets me is that the side effects for so many of those drugs are often worse than the “problem”.
You’ve got an itchy rash? Take this pill and it’ll be okay. But you may end up not sleeping at night, you may have trouble breathing or speaking, you may get blood clots or even have a heart attack. But at least you won’t have that rash!!
Hmmm…I better sign back in. I did have to log off for a few moments!!
I’m not used to signing to show off my great new avatar!!
signing in….I should just quit while I’m ahead
should a drug like that even be on the market? how do you prevent the med from getting to the artery? Most drugs can be dangerous if given improperly under certain circumstances. As an example we have friends who lost there 12 year old daughter a few years ago to a laxative called golitely, the resident did not know the proper dosing in her particular case and her intestines ruptured.
But this drug appears to be one that is dangerous on its own let alone the possibility of negligence.
Yeah, right.
Open source drug development. It’s a staggeringly good idea to reduce costs and improve products. Too bad it’ll eliminate excessive profit and abuse of the IP laws. Go open source!
http://www.xconomy.com/seattle/2009/03/02/harnessing-the-crowd-to-make-better-drugs-mercks-stephen-friend-nails-down-5m-to-propel-biology-into-open-source-era/
I’m really surprised that no one has commented on the most startling fact about this case: “Justice Clarence Thomas concurred in the result.” Perhaps you were rendered mute by this astonishing event. I know I was for several minutes.
bitmo, as someone who does not handle personal injury or products liability claims, I do not have any real or potential financial interest in this sort of litigation. I offer that information to head off any claim by you that I am just another shill for the plaintiff’s PI bar. Now, to get to the point, your objection to the verdict is that you believe that the FDA’s approval of a drug label should provide the manufacturer with immunity from tort liability. In other words, if the government approves the label, the government assumes responsibility for any financial costs associated with injuries to a person using the product. To put it yet another way, taxpayers simply have to assume that financial burden, while the manufacturer is free to retain all of the profits from the product causing the injury. The question is, why should the government take on that role? Isn’t that the function of insurance? Aren’t you simply proposing a form of corporate socialism? Is it your view that individuals should be responsible for the consequences of their actions, but that actions taken in the course of conducting a business for profit should be subject to different standards of accountability? Do you believe that principles of corporate liability should differ from principles of individual liability? If so, why? Just thought I’d ask.
Bitmo0:
oh yes I have once for me and once for my daughter. Part of the problem is technology, we are on the verge of marvelous breakthroughs in medicine and we need lawyers and philosophers to make sure things dont get out of hand, the philosophers to point us in the right direction and the lawyers to make sure that people that are not going in the right direction are punished.
Most drug companies, I believe, are out for their continued existance and so do not produce bad drugs purposefully but sometimes they er either on accident or willfully. At those times they should be punished within legal boundaries. This has nothing to do with keeping drugs off the market. But with keeping companies focused on providing safe and effective drugs, it is a corrective tug on the reins.
You need to grow up and realize that life is not fair, unforgiving, and way too short. In short you are a spoiled child ranting at what is so and wishing it were not.
rofl
where did Bitmo0 go?
bitmo, one further point. I do not recall ever hearing a doctor tell me that a drug has not been developed for a particular condition due to the fear of product liability. I have, however, heard plenty of stories about people who have been told that a particular condition could be corrected through a particular surgical procedure, if only they could come up with the money. I have also heard many stories of people who could have benefited from that wonderful new FDA-approved drug, but for the fact that their insurance company wouldn’t cover the cost because it was still regarded as “experimental” or “not medically necessary.” Based upon your comments, however, I assume that you would have an objection to the government taking on responsibility for those sorts of costs. After all, isn’t that socialized medicine? Your hypocrisy makes me ill, but there’s no medication for that.
Dpeifer, you have a great point. I was startled as well, particularly given his reasoning that he is concerned with the potential expansion of the “implied pre-emption” doctrine. Maybe there is hope for him yet.
I think Justice Thomas was just confused and thought he was supposed to concur and expected Alito and the rest to concur also. Who would have guessed who dissented in this case?? Surprise, Surprise!
Because this post refers to what could be signs of the “end times” (Thomas’ vote), I’m putting this here: This was a fascinating interview from Terry Gross, leaving much to think about.
“Bible scholar {and practicing Satanist} Bart Ehrman says that the Gospels are at odds with each other on important points regarding the life, death and divinity of Jesus. In his new book, Jesus, Interrupted: Revealing the Hidden Contradictions in the Bible (And Why We Don’t Know About Them) Ehrman examines how these contradictions affect our understanding of the historical Jesus — and of the authors of the Gospels.
http://www.npr.org/templates/story/story.php?storyId=101389895
Jon, I found you intellectually dishonest this evening on MSNBC when discussing Carl Rove’s agreement to respond to a House investigation of the firing of AG attorneys.
Jon, you know as did Mr. Olbermann (I presume anyway) that the Obama administration wanted an agreement from Mr. Rove to cooperate short of White House involvement because the current President is doing everythihng he can to protect his own executive privilage for the day he and his staff are most certainly accused of wrong doing.
By the way Jon, that wrong doing has already occurred hasn’t it. The current President has an enemies list drawn up just like Nixon, is spying on Americans, and is even doing its best to silence free speech of critics. He has bombed civilians and is now adding troops to what many call illegal wars being waged all over the globe by his administration.
Jon, I am astonished you can look yourself in the mirror or face your family after your MSNBC appearances.
It is a shame that it takes the British Press to wake America up to the new and stunning crimes of the Obama administration after just over a month in power.
brad:
Don’t you hate it, brad, when people you don’t know or care about insist on using your first name in a smarmy, condescending way. And brad, don’t you really detest it when they are both factually inaccurate, and intellectually handicapped by their all-consuming hatred of men with whom they disagree. Right, brad?
Keiff:
” …someone else’s teeny-tiny mistakes…”
************
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.
Well said, mespo.
Yes bravo mespo, and stay hydrated 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.
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.
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:
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.)
Bron98:
“It could have just been a missquote, he is only human after all.”
***********
Likely it was a misquote, but when the speaker projects smugness, and omniscience in matters of state, it is difficult to feel any sympathy.
Rush is human?
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.
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?”
************
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.
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.