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Wyeth Vs. Levine: FDA Labeling Overuled By Jury Of Lay People

Bert Rein

Bert Rein

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here’s a podcast of our interview:

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Here are the highlights from the interview…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

Dr. Val: So basically this means that juries can decide whether or not a drug label is sufficiently caveated?

Rein: It goes farther than that. Juries don’t have to determine what the label should say, they merely have to decide that the label isn’t “good enough.”

Dr. Val: So jurors without any medical background are supposed to determine whether or not a drug label offers physicians sufficient warning about medication risks?

Rein: Correct. You’re asking lay people not only to make the decision, but to step into the shoes of physicians and say, “Do I think that label is good enough from a physician’s point of view?” By definition, drug labels are not written for lay people, but healthcare professionals. This is asking a lot of lay people, and I think this case is a good illustration of why juries get it wrong. They see an injured person and say “How could the labeling be adequate because somebody’s been hurt?”

Dr. Val: What impact will this court ruling have on the pharmaceutical industry?

Rein: It means that pharmaceutical companies will have to get “clear records” from the FDA on every drug label controversy going forward. This puts a tremendous burden on their already taxed resources. Also if juries can simply say “this drug label is inadequate” then how will the drug company know how to make it better? What drug companies will have to do is forbid the administration of drugs in circumstance that might incur increased risk. That shifts liability to the physician if they administer the drug outside of the prescribed method – and essentially makes the risk benefit decisions on their behalf.

Dr. Val: So won’t drug companies have to create really long drug inserts to prevent juries from misunderstanding the language?

Rein: Yes, that’s the direction that labels were going before the FDA tried to reform the system. When drug labels are that long, no one reads them. Then professionals really don’t get educated on the true risks and benefits of the drug. Long labels are not designed for provider education but for law suits. Jury dominance always results in risk aversion.

Dr. Val: And isn’t this risk aversion going to slow down the drug approval process in general?

Rein: The industry shies away from developing drugs that have massive liability. That’s why we don’t develop drugs for pregnant women, for example. Any time you unleash a potent liability system, it’s going to factor in to where research dollars are spent. The more the FDA is criticized, the more it tries to protect itself with long drug labels – which ends up slowing down the drug approval process and shifting liability to doctors.

Dr. Val: And phenergan has been safely administered over 200 million times… and so the risk aversion is pretty high, even now with this rather safe drug.

Rein: Right, it’s not as if the drug is rampantly causing injury. Twenty incidents out of 200 million applications is not a very high risk profile. And the few cases where it caused injury, the drug was administered incorrectly. But if you have an injured person sitting in front of a jury of lay people, it seems as if the logical conclusion is that if the warnings were adequate, this wouldn’t have happened.

If we take the American Foundation for Justice at its word, their next move is to try to change the law on medical devices so we can go after those as well. The Wyeth vs. Levine case is good for one industry – the lawsuit industry – and not really anyone else.


The Supreme Court decision text may be found here.

What Do Cigarettes and Phenergan Have In Common? Hint: Nothing

For some reason, people just love to misrepresent the issues underlying the Wyeth vs. Levine case. I have written extensively about this case here and here because I found it so amazing that the media has bungled the story so badly – and that no one is really calling them on it.

In case you don’t recall – Ms. Levine was the victim of medical malpractice. An anti-nausea drug (phenergan) was injected into (or very near) her artery by accident (the potential consequences of such an error are clearly indicated on the drug label). Tragically, the resulting chemical reaction with the oxygen in her artery caused such severe tissue irritation that her arm eventually had to be amputated. Ms. Levine settled out of court for $700,000 with the clinic where the injection occurred. Unfortunately the story doesn’t stop there.

Ms. Levine’s attorney counseled her to sue the drug manufacturer for inadequate label warnings (the potential hazard is in fact mentioned on the label six times – though it does not forbid IV administration of the drug, though it recommends a low dose and slow push). In a precedent-setting judgment, a jury in Vermont decided that the FDA-approved label was inadequate, and that it should have fully contraindicated administration via IV push. The jury awarded Ms. Levine $6.8 million and Wyeth contested the judgment, bringing the case to the US Supreme court in November, 2008. The case has not yet been decided, though it has been compared to deceptive labeling of “light cigarettes.”

How on earth is a drug that has been successfully administered (without harmful side effects and with good efficacy) over 200 million times in the U.S. equivalent to cigarettes (a known carcinogen with no therapeutic value)? It’s an exceedingly poor analogy.

To put it another way, if a nurse took an insulin syringe and injected it into a diabetic’s eyeball, causing blindness, should I say that the insulin manufacturer (because it did not forbid the injection into the eye) was engaging in deceptive labeling and should be at fault for the patient’s loss of vision?  The PA who injected the phenergan into Ms. Levine’s artery, and our hypothetical nurse who injected insulin into an eyeball are the ones to blame.

But wait, it gets worse.

The attorney (David C. Frederick) who is arguing Ms. Levine’s case in front of the Supreme Court is being considered by our President elect for the position of Solicitor General of the United States. Yes, this very man who is engaged in a law suit that could potentially set a precedent that would allow all 50 states to set up their own mini-FDAs with the lay public (i.e. juries) deciding what drug label language should say.

The pro-Levine camp argues that a court ruling in favor of Wyeth would preempt consumers from being able to sue drug companies for damages related to incomplete disclosure of risks (such as the Vioxx case) but in reality, the Wyeth vs. Levine case has no bearing on pharmaceutical non-disclosure, since Wyeth did not hide the irritant risks of phenergan from the FDA. They have been known for decades.

So Wyeth vs. Levine is NOT about deceptive labeling or non-disclosure of risks – it’s about whether medically uneducated juries should have the power to set arbitrary drug labeling language standards in order to facilitate litigation against deep-pocketed pharmaceutical manufacturers whenever a patient is harmed in a case of medical malpractice.

I understand that many folks are frustrated with pharmaceutical wrong doing (and there are many cases of it), but this is just not one of them. In America, we are not supposed to bring pre-conceived notions to bear on law suits, but objectively review the facts in each case, separate from our general feelings about those involved. I do think that Wyeth isn’t getting a fair shake in the media because of the general mistrust/dislike of Big Pharma. But everyone has a right to a fair trial. I sure hope they get it.

Who Should Determine Drug Labeling Language: Juries Or The FDA?

Photo of FDA

Wyeth vs. Levine is an important legal case being tried before the US Supreme Court. You may have read about the lawsuit in the New York Times, NEJM, JAMA, the Wall Street Journal, or my own blog. It revolves around the tragic story of a woman (Ms. Levine) who experienced an extremely rare side effect (severe tissue damage resulting in the amputation of her right arm) because a drug was administered improperly (into an artery rather than a vein). Ms. Levine is arguing that her injury could have been avoided if the drug label had stronger warning language, and the Vermont Supreme Court ruled in her favor, awarding her $7 million. The court ruled that a jury in the state of Vermont had the right to hold Wyeth accountable for a different labeling standard than the one approved by the FDA.

The plot thickens, however, in that Wyeth’s FDA-approved label very clearly discourages injection of their drug into or near an artery, and it also describes the potential consequence (including gangrene) of such an action. The FDA approved Wyeth’s label in full knowledge of the potential risks and benefits of the drug. In fact, Wyeth asked to strengthen the language of the label before Ms. Levine was injured, and the FDA declined to make the change because label changes are based on new information about a drug’s frequency or severity of risks. Wyeth had nothing new to disclose. Read more »

Unexpected Consequences: Wyeth Law Suit Could Limit Patient Access To Medications

Photo of Bert Rein

Bert Rein

On November 3, 2008 the US Supreme Court will hear opening arguments in the Wyeth vs. Levine case. This highly publicized lawsuit has been discussed by the New York Times and the Journal of the American Medical Association and will likely be the most important case during the upcoming Supreme Court term. However, neither source has fully explained the unexpected consequences to the consumer if Wyeth loses.

To get to the bottom of the issue, I interviewed Bert Rein, attorney for Wyeth. Bert has conducted interviews with NPR and the three major TV news networks. Please enjoy this exclusive podcast interview here at Getting Better with Dr. Val, or read my summary of our conversation below.

Dr.Val: Bert, please summarize for our listeners what has happened so far in the Wyeth vs. Levine case.

Rein: Ms. Levine is a guitarist who suffers from migraine headaches and associated nausea. One day she sought pain management therapy at a clinic in northeast Vermont – the same clinic where she regularly received care.  They elected to treat her with a combination of demerol (for pain) and phenergan (for nausea). They delivered the drugs intramuscularly, but several hours later Ms. Levine returned, complaining of an unrelieved migraine headache.

The clinic’s physician realized that the drugs would be more potent if they were injected intra-venously so he asked the PA (physician assistant) to give another dose of the drugs through Ms. Levine’s vein. Unfortunately, the PA inserted a butterfly needle (rather than the usual heplock for an IV) into what she thought was Ms. Levine’s vein, and delivered the phenergan into or near a punctured artery. Phenergan’s label clearly states that the drug can cause tissue necrosis if it comes in contact with arterial blood. Ms. Levine experienced a necrotic reaction to the medication which resulted in the eventual amputation of her arm. She sued the clinic for negligence and was awarded $700,000 dollars in a cash settlement.

Ms. Levine then brought a separate lawsuit against Wyeth, claiming that the phenergan label did not offer sufficient instructions about how to administer it safely, though the risks of necrosis from arterial blood exposure to phenergan are well known and labeled in capital letters as a warning on the drug’s label. Read more »

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