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Wyeth v. Levine – Hide The Soda Straws

Yesterday I posted about the facts behind the Wyeth v. Levine case. Today I delve into my impressions of implications of the case.

First, let me tell you what this case should not be about. This case should not be about compensating Ms. Levine. She sued several parties and settled with all but one of those parties. The concept of a settlement is that the defendant has offered money to the plaintiff and that the plaintiff deems the offer(s) as sufficient compensation for the plaintiff’s injuries. Medical negligence occurred and Ms. Levine accepted compensation for it.

The overriding theme in the Wyeth v. Levine case is preemption. The idea of preemption in the medical industry is not a novel concept. For example, if you have health insurance through your employer, federal ERISA laws preempt all state laws relating to that “employee benefit.” If you try to sue your insurance company for denying care (or denying payment for care), the case gets kicked to federal court and then usually gets dismissed.

Before commenting on preemption, I think that we have to consider a few other issues that may affect the preemption question in this case.

1. Safety
Just how “safe” does a product have to be?
Here, Phenergan caused up to 20 cases of skin necrosis/gangrene in 220 million doses. Those are at least 11 million to 1 odds. Even Ms. Levine’s attorneys admit that it is acceptable to administer Phenergan via an IV – they just recommend that the medication be given by IV drip instead of IV push.
Ms. Levine stated that she wasn’t properly informed of the possibilities of harm from IV Phenergan. Do Ms. Levine’s attorneys expect us to believe that she would have refused the medication if the PA went up to her and said “this medication will help your nausea, but there are 11 million to 1 odds that this medication could cause gangrene of your skin and fingers”?
“Nope. No thanks. Sorry. I’d rather vomit incessantly. Those odds just scare me too much.”
You are twice as likely to win the Vermont lottery as you are to develop gangrene in your fingers from Phenergan.

Let’s look at the safety profile of another medication: Aspirin.
Aspirin has saved thousands, if not millions of lives from the complications of heart attacks, but it also can cause ulcers, perforated ulcers, and death – in a lot more than 1 in 11 million patients. Should aspirin manufacturers now be subject to liability because their aspirin labels do not say “Warning: aspirin can cause perforated ulcers and death”?

At the trial, the plaintiff’s attorney was quoted as telling the jury “the FDA doesn’t determine safety, YOU determine the safety.”
But the determination made by a jury is made while using “20/20 hindsight.” A standard in which lay jurors made a determination of whether a product was dangerous while having an injured plaintiff paraded in front of them would allow thousands of sympathetic juries in 50 different states to arbitrarily determine the safety profiles for hundreds of different drugs. In doing so, the safety profile of a given medication in a given state would become a moving target, changing daily, yearly, or perhaps not at all – subject to the whims of multiple juries.
Absent a federal standard and using the standard set forth by the Vermont Supreme Court in Wyeth v. Levine, how could any drug company deem any medication “safe” for use in all 50 states?

2. Warnings
There are several warnings in the Phenergan product labeling stating that Phenergan should not be given into an artery or exposed to arterial blood. Yet arterial administration of Phenergan is just what happened in the Levine case. The medication was given in a method that was specifically against the manufacturer’s recommendations and caused a specific injury that the manufacturer warned about.
Now the plaintiff’s attorney pulls out a retrospectoscope and convinces a jury that the warnings should have been more strict. Don’t use the medication via IV push even though IV administration has been proven safe and effective, and even though we admit that IV administration is acceptable via an IV drip. But we can’t stop there. Who knows whether someone might inject the medication into their eyeball with an insulin syringe? Shouldn’t we specifically warn against that, too? Oh, and we should probably warn people not to stick soda straws up their urethras and squirt the medication into their bladders. I don’t know what would happen, but it can’t be good. Phenergan may no longer be used in any area in which soda straws are accessible.
Where do the warnings stop? Can the plaintiff attorneys in the Wyeth case create a product insert for Phenergan that they believe adequately warns the public of the possible adverse effects from the medication? Would they then accept full responsibility for any patient injury that flows from using their warnings under the current system?

3. Causation
How much should manufacturers be liable for the misuse of their products?
Ms. Levine’s attorneys argue that this court decision only applied to whether Phenergan should be allowed to be given IV push. The problem is that once you open this door, the next lawsuit can be for any reason.
Are we going to start filing products liability lawsuits against Wusthof because their knives are used to stab people in the neck? Gun manufacturers liable when their guns are used to rob banks? Hockey stick manufacturers liable when someone loses a tooth? Will this spill over into tort law? Will attorneys sue Strathmore if they lose a motion and the briefs are typed on Strathmore’s premium bond paper?
Once the ball starts rolling down this hill, when will it stop?

Should preemption apply?
Wyeth v. Levine should have been a plain vanilla medical malpractice case. The medical providers made a catastrophic mistake and caused a horrible injury. Ms. Levine accepted the settlement that the providers offered.
It didn’t stop there, though. Her attorneys then pursued a products liability claim against Wyeth.
I agree with others that preemption probably isn’t the best argument to use in this case, but preemption is the question that kicks the case into the jurisdiction of the federal courts.
Preepmtion is necessary, if nothing else, for the sake of public policy.
How can we say that medications are less safe in one state than they are in another just because a jury with presumably little medical knowledge says so? Will those same juries now be required to vote on the safety profiles of all new medications coming to market?
Imagine logistic nightmares if each state were allowed to (or even required to) set its own standard for safety of every drug on the market. Suppose oral potassium could get stuck in your throat and cause esophageal perforation in 1 out of 5 million patients. Which states should declare oral potassium unsafe? Only those in which the injury occurred, or all 50 states? Where should aspirin be outlawed for its “ulcerogenic” properties? I know that the chances of dying from a narcotic overdose are waaaay more than 1 in 11 million. Are all narcotic prescription medications next on the hit list?
Will we have to create fifty state-specific copies of the PDR? If so, who’s going to be responsible for writing and updating them after each trial judgment?
Will physicians be subject to liability when patients take medications on the airplane in the airspace over Vermont but suddenly be off the hook once patients hit the tarmac in New Hampshire? Will locum tenens physicians be forced to memorize the safety profiles of each medication they prescribe in each state in which they practice? Is this concept going to trickle down to other products as well? I can’t drive a Ford Pinto in Vermont, but it’s OK to drive it in Maine? Bubble Yum bubble gum is only OK to chew in states that end in a “Y” if you have an allergy to spiders?

Allowing random juries to decide the “appropriate” safety profile of each and every medication in each and every state will hopelessly mire the medical system in needless litigation and will decrease the willingness of manufacturers to leave medications on the market.

The current system isn’t perfect, but the alternative system, with 50 different standards of care, is frightening.

Picture credit here

10 Responses to “Wyeth v. Levine – Hide The Soda Straws”

  1. MonkeyGirl says:

    Wow.

    I’m not giving my patients straws anymore. And they’re the good bendy kind.

  2. rlbates says:

    I have enjoyed both this post and the one yesterday. Nothing to add as you have done a good job. Watching for the outcome.

  3. Robin says:

    Then there are those who would stuff that straw in rectally, and BAM! –colostomy time!

    Just my 2 cents, but I’ve found that most of the problems with IV irritation from Phenergan have occured because some nurses aren’t diluting it before administering it. I dilute EVERYTHING to death, with very few exceptions. IV sites last longer and aren’t as painful. I’ve given more Phenergan than my entire house would hold, and have never ever ever had a problem (knock on wood)……

  4. ERP says:

    A friend of mine had a Mercury Bobcat (same as a Pinto) in high School. I was terrified to ride in it. Now, just think if every time we gave an IV med, people felt the same fear!

  5. marcia (2) says:

    So, how many cases have there been of inadvertent arterial injection of Phenergan? If this is the only, or one of only a few cases, it would seem the manufacturer’s instructions are adequate to prevent harm (after all, the nurse didn’t intend to inject into an artery; it was an accident).

    Maybe the instructions could include a recommendation to dilute the product when given intravenously (per Robin’s comments). But I don’t see how the lawyers can conclude from an accidental IA push that an IV push is also inappropriate.

    The idea of individual states having dominion over instructions for the administration of drugs is completely insane.

    Imo, this has the scent of lawyers trying to line their pockets. I don’t see how Wyeth could be held accountable for what happened.

  6. HyperAl says:

    Lawyers always go after the deeper pocket. They are not after justice most of the time. The bottom line is almost always the mighty dollar.

    Now if the law can limit the amount they can make like 30% or $10.000.00 per case, whichever one is smaller, that may slowdown their gungho lottery mentality. But as long as they can make 30% of the award, they will go after the deeper pocket.

    This case has no merit at all just a nuisance which we’ll all end up paying for with our taxes.

  7. Elizabeth says:

    For example, if you have health insurance through your employer, federal ERISA laws preempt all state laws relating to that “employee benefit.”

    This is not correct or supported by your link, which states that “Under ERISA, the regulation of employment-based
    health benefit plans has evolved into a system in which both federal and state laws play important roles.” ERISA preempts state insurance regulations if your company is self-insured, not if it provides you insurance. While increasing number of companies are self-insured, the distinction is still important.

  8. Tiny Shrink says:

    I personally feel that preemption is a dangerous precedent. While I certainly think having 50 state drug administrations that can each rule over the FDA’s head is ridiculous, I think it is dangerous to state that final responsibility for anything related to a drug’s safety lies solely with the FDA, and that so long as a medication passes the FDA’s approval, the manufacturer cannot be sued. After all, many drugs are removed from the market for side effects which weren’t appreciated prior to approval from Phase II or III trials, but only revealed in after-market monitoring. Or, in the case of Zyprexa, the manufacturer knew and deliberately hid serious side effects from the FDA and the public, so if preemption applied could Lilly not be sued, because the drug was approved, even though fraudulent activity took place?

    Another blogger (I forget who) pointed out that a vote against preemption is not necessarily a vote for 50 state mini-FDA’s but simply a vote against preemption and for the current system. I think there are ways to vote on this case that do not necessarily involve invoking preemption OR unleashing 50 states’ worth of madness and increased litigation; I don’t think it’s the black or white vote I initially thought upon reading the case.

  9. Tiny Shrink says:

    Loved the soda straw analogy, by the way.

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