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Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?

It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors) have missed the salient points.

I think that a close review of the case is instructive in two ways. It shows: 1) the dangers of making legal decisions based on the perspective of the victim (a risk of harm equal to 1 in 20 million is unacceptable to that one person who suffered the consequence, but tolerable to the other 19,999,999 others) and 2) that a simple case of medical malpractice has made it all the way to the US Supreme Court because (as I discussed in my last post) a democratization of knowledge (juries reading a drug label) was believed to democratize expertise (how a physician would understand the label).

Background

My research for this blog post included the following: a review of the 66 page transcript of the opening arguments presented at the US Supreme court on November 3rd, careful consideration of an editorial written by Catherine DeAngelis in JAMA, an opinion piece published in NEJM, and several perspectives from bloggers whom I admire (including Maggie Mahar and the Wall Street Journal), and a 1:1 phone interview with Wyeth’s attorney Bert Rein. While it’s true that I did not have the opportunity to personally interview the opposing counsel (for Ms. Levine), I did review his arguments via the Supreme Court transcript. I am not an attorney, and have done my best to understand the facts in this case. Feel free to correct me if you believe I am in error.

First, let me say that it’s very easy to become emotionally involved in this case and let that color one’s view of the facts. A musician lost her arm in a tragic manner – a physician assistant accidentally administered phenergan into (or around) her artery, rather than vein, as part of a narcotic and anti-emetic treatment for a migraine headache. The result was localized tissue necrosis, gangrene and eventual amputation of her arm. I have the utmost sympathy for Ms. Levine and I’m sincerely sorry that this happened to her. However, it is estimated that phenergan has been successfully administered (without incident) over 200 million times in the US. Ms. Levine had a one in a 20 million chance of a gangrenous adverse reaction, and those are really low odds.

However, Ms. Levine is arguing that Wyeth should have included stronger warning labeling language in the phenergan box – because the drug company should have known that providers could mistakenly inject the drug into an artery, and that they should have forbidden the drug from being injected via IV push (into veins) to completely protect against this potential error. She argues that the risk of administering phenergan via IV push outweigh the benefits to the point where IV push administration should be contraindicated by the manufacturer.

Furthermore, the state of Vermont has ruled that a jury can hold the drug company liable for damages because it failed to adequately warn physicians about the dangers of phenergan, even though the label was approved by the FDA in full knowledge of the risks.

The US Supreme Court

In the opening arguments made before the Supreme Court, Ms. Levine’s counsel argued that 1) the FDA did not specifically consider the potential risks of an IV push versus IV drip administration of the drug – he argued that it didn’t happen because they could find no correspondence specifically mentioning this analysis. 2) Wyeth should have strengthened the warnings on the label without obtaining the FDA’s input – because that is the company’s “duty of due care.” 3) Wyeth’s attempts to strengthen the drug label warning (which were rejected by the FDA because there was no new information to require a change in the label) were not substantive or sufficient. 4) Because Pfizer’s anti-nausea drug (vistrol) had caused gangrene when injected into arteries, which resulted in Pfizer’s contraindication of IV push administration, Wyeth should have lobbied for a similar label change.

Justice Scalia responded that if Ms. Levine felt that the FDA acted irresponsibly, she should consider suing the FDA rather than Wyeth. Justices Breyer and Alito clarified that the FDA required new information to justify changing the warning on a label, and that Ms. Levine’s case of gangrene did not represent a change in the average frequency of this adverse event. Scalia also argued that overturning the FDA’s decision on adequate labeling (in the absence of new information) would be a slippery slope.

The preemption law (the argument that federal law supersedes state law) applies to cases where no new information is available. In other words, if new information becomes available (either a previously unrecognized harm or a harm undisclosed by the drug company), patients have the right to sue the drug company (at the state level) for damages. If there is no new information, then the federal law stands (a point made by Scalia, but not clearly acknowledged by the recent NEJM article on the subject). Scalia argued that removing preemption (in cases of known harms) would result in drug companies listing all possible damages (in an attempt to protect themselves from lawsuits) and put an undue burden on the FDA to investigate and weigh all of them. The result would be extreme risk aversion and reduced choice for consumers.

The Media Gets It Wrong

Some members of the media have erroneously compared Wyeth vs. Levine to the Vioxx case. Wyeth vs. Levine is not the same because the Vioxx case involved a drug company withholding knowledge of potential risks from the FDA. Patients sued Merck for undisclosed risks that harmed them. But Wyeth didn’t fail to disclose harms or risks in this case. Nonetheless, Catherine DeAngelis incorrectly argued that if Wyeth wins this case, patients will be preempted from suing for drug-related injuries in the future. The truth is that the oral arguments presented to the Supreme Court specifically outline that this case would not, in fact, influence a patient’s right to seek damages from drug companies in the case of undisclosed or newly discovered harms. The issue is whether or not a local jury has the right to reinterpret drug labels and overturn FDA rulings on adequate warnings in the face of full disclosure by drug companies and without new information about harms.

Litigation Frenzy And Deep Pockets

In my view, the Wyeth vs. Levine case is a malpractice suit gone wild. The risks of the drug were fully known, the drug’s label made it very clear that phenergan was not to come in contact with arterial blood (through injection or extravasation) or else severe tissue damage could occur (feel free to read the drug label in its entirety here). The FDA approved the drug label’s description of the known risk, and a physician assistant accidentally injected the drug into Ms. Levine’s arm with tragic consequences.

Ms. Levine settled the malpractice case out of court for $700,000. She then sought damages from Wyeth in the Vermont Supreme Court, and the jury ruled in her favor – arguing that juries should be able to hold drug companies to different labeling standards as they see fit. Ms. Levine was awarded $7 million. Wyeth appealed the case to the US Supreme Court. The final ruling will likely be decided in several months’ time.

Who Should Perform Risk Benefit Analyses: Drug Companies Or Physicians And Patients?

No drug is without risk. Every time we receive a therapy, we must engage in a risk benefit analysis with our healthcare professionals, and choose to accept the known risks in favor of the known benefits. Ms. Levine had a 1 in 20 million chance of tissue necrosis. She and her doctor (assuming that her doctor reviewed the risks and benefits with her as he should have) believed that the rapid migraine pain relief was worth that risk. Due to a PA’s error, Ms. Levine suffered an extremely rare consequence. As a result, Ms. Levine is now arguing that a drug company should be required to make the risk benefit analysis for patients and physicians, thus limiting their individual choices.

Some sources argue that states should be able to hold pharmaceutical companies to their own standards because the FDA cannot possibly catch and categorize all the possible risks of a drug when it first comes to market. That’s an interesting argument – but irrelevant in Wyeth vs. Levine because it is NOT a case of a risk missed by the FDA. The phenergan toxicity was a known risk – no new information about risk was raised by this case.

The Final Analysis

So it boils down to this: should we allow juries to set drug labeling rules at will, or should we rely on a federal agency with clear scientific expertise to manage it? Of course the FDA is not perfect and it has its limitations (post market surveillance of each of the 10,000 FDA-approved drugs is a challenge with finite staffing – which is precisely why pharmaceutical companies should be incentivized, not penalized, to bring forward new risk information when it becomes available). But if I had to choose between a group of non-professionals trying to figure out what’s appropriate for a drug label (and awarding unlimited millions to anyone who experiences an adverse outcome), versus a team of scientists who have been provided with all the facts to make a judgment… I think I’m going with option B.

If Wyeth loses this case there could be an increase in lawsuits which would trigger pharmaceutical risk aversion, decreased patient access to medications, and give inappropriate decision-making power to untrained juries. It is the beginning of a slippery slope that would potentially condone legal action against pharmaceutical companies for any known drug side effect.

The risk of taking a medication is never zero. Avoid taking them if you can, understand your risks if you do, and feel free to sue pharmaceutical companies if they are intentionally deceptive or withhold information about your safety. I do not see compelling evidence of either in the Wyeth vs. Levine case. Do you?

Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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