Pre-emption: don’t be sick

by Walter Olson on March 5, 2009

Now that its settled that every jury should be a new regulator deciding in hindsight whether label warnings should have been stronger, some who worry about the future of the drug business are inclined to feel nauseous. Resist that feeling, points out emergency room blogger White Coat: should your condition grow so severe as to call for medical attention, the arsenal of antiemetic treatments available to doctors keeps dwindling under the legal pressure.

P.S. More: Throckmorton’s Other Signs. And, from before the decision, from Yale-affiliated neurologist Peter McAllister in the Providence Journal.

{ 12 comments }

1 Christopher Eckel 03.05.09 at 8:29 am

This is not really a pre-emption case at all.

A cheap generic drug was ordered IV; it is safe IV, but it was erroneously administered in the artery. There is a warning. In ourlegal system, you just can’t be warned enough. Whatever there is, there should have been more.

Everyone knows that intra-arterial is dangerous. It was not supposed to go intra-arterial. The drug company is not responsible for a mis-administration. (Any drug accidently injected in the eye, for example, causes blindness…)

This is a deep pocket case.

All generic drugs just got a lot more expensive. How many doses at a few ollars a dose will it take to make up the tens of millions this case will cost?

PS : Another thing you can count on: She collected policy limit from every other party which was even tangentially involved.

2 Joe 03.05.09 at 9:32 am

So now we have juries deciding that the standards for warning labels set up by lawmakers are too lax? Not that I like drug companies, but everyone seems too inclined to stick it to them whenever possible.

3 Soronel Haetir 03.05.09 at 9:55 am

(Any drug accidently injected in the eye, for example, causes blindness…)

I would just like to point out that the above statement is not entirely correct, as I have actually endured numerous interocular injections. (It’s not a procedure I recommend if you can avoid it, there is a point to that saying about better than a poke in the eye with a sharp stick).

While injecting too much of any fluid into the eye cavity will cause blindness, whether permanent or temporary the procedure itself need not invariably do so. There are in fact medications approved for direct interocual administration. Over the five plus times I’ve experienced such treatments I have witnessed symptoms ranging from total blindness and excrutiating pain lasting about 45 minutes to very little visual degregation. It has always been extremely irritated afterward however.

4 BG 03.05.09 at 11:04 am

Call it a health care reform business model. Put pharmaceuticals out of business, nothing is available to the patient, there won’t be any costs and we can all afford it.

I may need some ipecac.

5 Ron Miller 03.05.09 at 11:28 am

This is a gut level anti plaintiff reaction from this blogger. Plaintiff wins=must be bad. The New England Journal of Medicine wrote an amicus brief for the plaintiff. Total number of amicus briefs in their history: one. Does that tell us anything?

One of the commenters is arguing the merits of the case. The jury found the way they did. It has nothing to do with the Supreme Court’s decision.

6 Anonymous Attorney 03.05.09 at 3:27 pm

A person experiencing nausea is “nauseated,” not “nauseous.” “Nauseous” is the adjective for something that causes nausea.

Thus, Sen. Chuck Schumer is nauseous, and after listening to him, I feel nauseated.

7 Walter Olson 03.05.09 at 3:55 pm

>The New England Journal of Medicine wrote an amicus brief for the plaintiff.

I would not mistake the NEJM for either the voice of opinion among typical doctors or for some sort of oracle of timeless truth. It seems to bear about the same relation to opinion among American doctors as the New York Times bears to opinion among Americans generally.

>This is a gut level anti plaintiff reaction from this blogger. Plaintiff wins=must be bad.

On the contrary, blogger White Coat in the original quote was upset because a useful medication was being withdrawn from the list available to him. That’s not a knee-jerk ideological reaction, that’s a thoroughly practical one.

I think you will find numerous doctor-bloggers who are not afraid to be critical of the pharmaceutical industry on all sorts of issues but who also fear, with open litigation season on the wording of labels, a rash of new contraindication labelings, black boxes and product withdrawals that will deny them access to therapies they find useful.

8 853 OKG 03.05.09 at 3:58 pm

Are we really supposed to be surprised that some doctors, represented by the NEJM and the anti-pharma Dr. Marcia Angell, want to make sure that drug companies (with their deep pockets and big insurance policies) can be named as co-defendants?

9 Christopher Eckel 03.05.09 at 4:12 pm

The NEJM amicus brief was filed against pre-emption in general, and it really didn’t apply to this case. They were upset about vioxx like cases where new information was not diseminated by the drug company. Phenergan is over fifty years old. It is well known to all practicing physicians. This complication is well known. The tragic accident was just that: an accident. The drug company had nothing to do with it. The warning issue is just the entry point to pay “Queen for a Day” with the jury. Drug warnings can never be strong enough for a jury faced with a disfigured young woman

I don’t think people are anti-plaintiff in this case. It is very tragic. ( Not so tragic, I am guessing, that the plaintiff’s attorney waived or reduced his gigantic fee. ) But she is already a wealthy woman as a result of this horrible situation. She has already cleaned out the insurance of at least three other defendants. Is there a point at which staggering compensation is too much compensation? Is there a point at which the lawayer’s contigency fee is too high? I didn’t think so.

This certainly won’t stop all future disasters. The idea that a different warning would have changed anything is absurd on the face of it. It will mean generic drugs like aspirin will cost hundreds of dollars a dose to offset the risk of a freak accident.

10 Larry Reilly 03.05.09 at 9:26 pm

Thanks Christopher. I’ve been wondering what to do in this crazy stock market. I’m going to put every penny I can scrape up into aspirin stocks. From your lips to Jim Kramer’s ear.
Who woulda known?

BTW, do you think if they’d just decided that the artery/vein thing was problematic enough that they’d have said stick to intramuscular?
How many amputations because of this accident sorta thing? A bunch.

11 Christopher Eckel 03.05.09 at 10:02 pm

It doesn’t work as well IM as IV. It is a tradeoff. One way is safer but not as effective, another is the reverse. Not taking any drugs is even safer.

She had failed a previous treatment with IM, and returned with persistent severe nausea. The plan was reasonable. The excecution was flawed. There was an error; it just wasn’t Wyeth’s error.

12 B Rad 03.05.09 at 10:13 pm

Penicillin has been around at least as long as phenergan, probably longer. Over the years, penicillin and it’s derivative antibiotics have probably caused more morbidity and mortality due to allergic reactions than all other pharmaceuticals brought to litigation combined. And I doubt penicillin will be taken off the formulary.

The whole case is a crock.

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