November 11, 2008

The Supreme Court Hears Arguments That Warning Labels Should Include Things Done Correctly

A handy rule of thumb, good for reading published clinical trials and court cases is this: if you can't understand the basics in fifteen seconds, you are being lied to.


Diana Levine had a migraine, and at the doctor's office a physician's assistant gave her a Phenergen injection, IV push.  Unfortunately, it resulted in gangrene, and the arm had to be amputated.

Inexplicably-- and I'll explain "inexplicably" in a moment-- she chose to sue Wyeth for an inadequate warning label, specifically that it should prohibit IV push because it could lead to gangrene.  As it stood, the FDA warning label only warned against IV push and gangrene.

Wyeth's response was: um, why would we prohibit the use of something that is approved by the FDA for that use?   The FDA knew the risks of gangrene and IV push, and approved IV push, with the warning of gangrene.

She won the case and $6.7M.  (Why? Vermont.)  It was upheld in appeal: FDA standards are a minimum, and if the company sees reason to have a stronger label, they do not need new FDA approval to put one on.  Wyeth should have known IV push was dangerous, and prohibited it even though the FDA approved it.

It is now being argued before the Supreme Court.  The legal question is whether federal regulations preempt state requirements; i.e., if it's good enough for the Feds, should it be good enough for the states?   This is already true for medical devices. If it is, then Levine should never have been allowed to sue in state court in the first place.

So far, the Justices have bantered about whether FDA review is adequate, or if it could ever be adequate enough with such a major side effect as gangrene.  Scalia observed that if the doctors at the FDA made a risk benefit analysis for IV push, a jury of laymen shouldn't be in a position to second guess it.

Justice Souter disagreed: "Wyeth could have gone back to the FDA at any time and said, either based on experience or just our rethinking of the data that we have, we think the label ought to be changed to say, 'Don't use IV push.'" Of course, that implies Wyeth thought that IV push was actually dangerous, which it didn't.

I am not a Supreme Court Justice yet, and it's likely President Obama will not choose me; but while everyone is arguing the relative dangers of IV push, a simple and important fact is being ignored: the drug went in an artery.


Clearly, what happened here is that the PA made two mistakes: wrong injection; wrong administration.  Why didn't she simply inject it into the muscle like everyone else on the planet does?

It's not wrong to do IV push, it happens in hospitals when an IV is already in place, but why bother to do it in an office?  Let me be as clear as possible:  the gangrene wasn't a result of IV push, this is not the rare case of IV push induced gangrene-- the med was not administered IV push.  This is a case of medical malpractice.   The PA messed up.  Exactly how is that Wyeth's fault?  Oh, I know: it's their fault because they're rich and we're in Vermont.  Got it.


So now the discussion about warning labels actually has a deeper meaning.

When the various people argue about the "risks of IV push," they are including in that risk the risk of not doing IV push.  In other words, the manufacturer is asked to be responsible for the incompetence of the clinician.  Here's an example: many meds are clearly labeled "Do Not Crush."  Crushing it, for example, could release all of the chemical into your body too fast.  Following Levine's logic, this drug should not only carry a warning label "Do Not Crush," but the drug company should say it shouldn't be used orally at all, because someone might  crush it.

Amazingly, in regular news articles I have not seen this argument anywhere.  All reporting and discussion never even asks whether this is the PA's fault, and not Wyeth's.  I do, however, see that every single article talks about how she is a guitarist.  Is that relevant?   Actually, it is: it makes a good enough story to get 9 people to award her $6.7 million.


Leave it to the crypto-socialists at the New England Journal to recast med mal into a call to arms against corporate America.

Dr. Drazen, editor-in-chief of the NEJM, wants the court to side with Levine.  He says he needs state level product liability suits, for two reasons. 

1. Drazen writes in "Why Doctors Should Worry about Preemption" that product liability litigation is important as information:

Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.

It is beyond human capacity to comprehend how an editor-in-chief of the NEJM can argue that he needs lawsuits to get information about a drug.  Does he expect lawyers to gather the required information, and laymen jurors to properly evaluate it, and then off to his desk for approval?  Drazen isn't satisfied with 50 years of Phenergan use, research, and data.  He needs to check with lawyers. I'll add that it simply isn't true that litigation has provided medicine with new information.

Drazen has the audiacity to cite Vioxx as an example of a drug that got FDA approval when the risks were not known, that resulted in litigation. Never mind that doctors continued to prescribe it even after the risks were known.  Never mind that the NEJM, with its crack squad of peer reviewers, is the journal that let the flawed Vioxx study that minimized the risks get published in its pages.


Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices.
How confident do you want doctors to be?  So confident that they don't have to worry about the difference between a vein and an artery?  Not surprisingly, Drazen nowhere mentions "artery" or any negligence on the part of the PA; he doesn't even mention the name of the drug.  Becuase to mention any of these real things would ruin his sophistry. 

It's hard to be simultaneosly hypocritical and ignorant-- hypocrisy requires at least some awareness of reality-- but Drazen pulls it off.   In pretending to be for the "consumer" by worrying that:

In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people.
He hides the fact that the real risk to patients-- to Levine-- isn't bad or unsafe drugs (that are 50 years old), but egregious mistakes by clinicians.  Not to mention preposterously biased and uninformative medical journals.

I suspect the Supreme Court does not read this blog, but if you see them at lunch please pass this along: find for Wyeth.  This case is not really about preemption, and they should make that clear.  Otherwise this case will become a dinner table anecdote for Big Business, not to mention conservatives, to seethe over, so that the moment they get power back-- think Newt Gingrich in 1994-- they unleash a backlash of tort reform so dizzyingly vicious you'll beg for Pherengan IV.