Needle and the Damage Done

The Supreme Court botches a drug preemption case

Gregory Conko | March 18, 2009

The Supreme Court handed down its decision this month in the case of Wyeth v. Levine, ruling that federal law did not bar plaintiff Diana Levine from suing pharmaceutical maker Wyeth over allegedly insufficient drug safety warnings, even though the warnings had been approved by the Food and Drug Administration (FDA). This decision establishes the troubling precedent that a sympathetic jury can now supersede the expert opinions of the FDA on what qualifies as adequate safety labeling. Ultimately, that means drug firms face higher costs and greater uncertainty. Both are bad for patients.

Levine lost an arm to gangrene after a physician's assistant injected the Wyeth drug Phenergan in such a way that it came into contact with oxygen-rich arterial blood. Although the drug's label explicitly warned that doing so poses a high risk of tissue damage, Levine claimed that the label should have instructed physicians not to use this intravenous "IV-push" method at all. A Vermont jury agreed, and awarded Levine $7.4 million, which the court reduced to $6.7 million.

On appeal, Wyeth could not challenge the jury's fact finding, but argued that the FDA's extensive regulation of drug labeling should preclude claims of negligent failure to warn. The Supreme Court held, by a 6-3 majority, that federal law does not preempt Levine's claim.

According to Justice John Paul Stevens' majority opinion, "The history of the [Food, Drug, and Cosmetics Act] shows that Congress did not intend to preempt state-law failure-to-warn actions." Although true in a general sense, the Court failed to recognize that this is not a typical failure-to-warn case. As Justice Samuel Alito's dissenting opinion notes, Levine conceded that, in 1988, Wyeth proposed a label change that "if followed, would have prevented the inadvertent administration of Phenergan into an artery," but the FDA rejected that language.

Nevertheless, Levine alleged not only that the warning on Phenergan's label wasn't strong enough, but that Phenergan was "not reasonably safe for intravenous administration"—and that the label should have said so. That, however, poses a question regarding FDA's approval of the product for that use, not Wyeth's alleged negligence in drafting the label.

The FDA first approved Phenergan in 1955. And, as the risk of arterial injection became apparent over the years, the agency approved several changes to the drug's label, which now contains six statements (two in all capital letters and bold face type) warning doctors about the exact nature of that risk.

The doctor and physician's assistant who treated Levine nevertheless administered a dose twice as high as indicated, injected it into the inner crook of her arm where the risk of accidental arterial injection is very high, and continued to push in the syringe's plunger despite Levine's protestations of pain, each in direct contravention of explicit label warnings. It was this negligent administration that caused the massive tissue damage that led to the amputation of her arm.

Levine settled a claim against the physician's assistant and the prescribing doctor, then turned her sights on Wyeth. At trial, Levine's attorney argued that, despite the FDA's approval of Phenergan's label, the drug firm acted negligently by failing to add even sterner warnings or changing the label to rule out intravenous injection altogether. But doing the latter would have overruled a FDA decision that permits IV-push injections when that method could provide more benefits than the alternative.

Furthermore, there are no allegations that Wyeth hid any information about the risks of IV injection, nor has any new information regarding the risks arisen that would call the FDA's decision into question. So, the decision in Levine is tantamount to letting a group of laymen overrule the FDA's expert opinion regarding safety. In his closing arguments at trial, Levine's attorney told the jury, "Thank God we don't rely on the FDA to...make the safe[ty] decision...The FDA doesn't make the decision, you do."

A majority of the Supreme Court agreed, concluding that FDA regulation should be seen as a floor, but should not preempt stricter state tort laws. That, however, conflicts with longstanding Court precedent regarding implied pre-emption of state laws that conflict with federal regulatory decisions. As Justice Alito's dissent notes, "the ordinary principles of conflict pre-emption turn solely on whether a State has upset the regulatory balance struck by the federal agency." That is exactly what has happened here.

The Supreme Court could have and should have held in Wyeth's favor with a narrowly tailored opinion confined to the facts of this case. Doing so would not have insulated wrongdoers from punishment, but would have recognized that Congress gave FDA statutory authority over questions of safety and efficacy because it believed a federal expert body could most effectively balance the benefits and risks of new medicines. Empowering lay juries to override those decisions means that fewer patients will benefit from important medicines in the future. Not only is the majority's decision bad law, it's very bad for patients.

Gregory Conko is a senior fellow with the Competitive Enterprise Institute in Washington, DC.

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|3.18.09 @ 3:32PM|#

So if the drug makers are getting sued for not labeling their products above and beyond what the FDA says they should put on them...whats the point of the FDA? Why shouldn't the drug makers decide the warning labels themselves and reap the consequences if they cock it up?

Kolohe|3.18.09 @ 3:35PM|#

It has seemed to me that for a long time now one can file a tort against an entity even if they met every regulatory requirement

I don't care for it (pick one - regulation or tort system, but not both - and not neither), but this case is hardly breaking new ground imo.

|3.18.09 @ 3:37PM|#

his decision establishes the troubling precedent that a sympathetic jury can now supersede the expert opinions of the FDA on what qualifies as adequate safety labeling, writes Gregory Conko

AHAHAHAHAHHA.

So let me get this straight.

Reason's position on the FDA is that it is full of experts whose opinions should not be questioned/superseded by the rubes? Is that correct?

|3.18.09 @ 3:38PM|#

Thanks Matt, you said it before I could.

And if doctors, nurses, PAs and other medical professionals are negligent in their administration of treatment, and we can STILL hold the makers of those treatments accountable, then...skies the limit for lawsuits. What a party the fucking lawyers must be having, salivating and cavorting over the corpses of old lawsuits they can now raise from the dead to extort more money from pharmaceutical manufacturers - because this situation does set precedent, doesn't it? Is no one safe from being responsible for the unfortunate things that happen to other people?

The next time my child's pediatrician touches her with a too-cold stethoscope, I might sue BD for not putting a label on it warning a doctor to warm it up or the cold might make infants cry. After all, a doctor with all his/her years of education and experience cannot be trusted to make judgements or listen to patient concerns.

|3.18.09 @ 3:39PM|#

This drives me fucking insane. You can meet every regulatory requirement, and it gets you absolutely nothing.

Really, you have a choice here: either the regulatory agency sets the standard of care, or it doesn't. If it does, then compliance should be a defense. If it doesn't, then what the fuck is it there for?

Dello|3.18.09 @ 3:45PM|#

This bottle used to contain a 30 day supply of medication. Now the same sized bottle contains a single dose, and freaking manual of warnings to avoid lawsuits.

ed|3.18.09 @ 3:51PM|#

When a regulatory agency sets minimum standards, that's precisely what they get. It makes little sense under such a regulatory regime for manufacturers to exceed those standards, as less reputable competitors will shave their expenses to the bone to meet this arbitrary "standard," put forth by bureaucrats and their political pimps.

Doc Strangeluv|3.18.09 @ 3:55PM|#

Number 1: Agreeing with Chicago Tom - since when is the FDA an infallible rulemaking body and why is Reason defending it?

Number 2: This case is good law being held on unfortunately bad facts.
-Is it bad that some chick is suing a pharmacy for millions because a doctor couldn't read? Yes, that's terrible.
-Is it good that the State's ability to choose to legislate on the matter of food and drug laws has been upheld? YES.
There is no issue of implied preemption here: One, the state law does not conflict with the federal law; two, there is no frustration of federal purpose; and three, as stated, there is no valid argument for implied preemption because the legislative intent made clear that the FDA would only provide the floor, the minimum regulation, and the state's would augment.
This ruling recognizes State's rights, which in my mind is far better than the alternative.

Doc Strangeluv|3.18.09 @ 3:56PM|#

Correction: Pharmaceutical company, not pharmacy.

|3.18.09 @ 4:00PM|#

When a regulatory agency sets minimum standards, that's precisely what they get. It makes little sense under such a regulatory regime for manufacturers to exceed those standards, as less reputable competitors will shave their expenses to the bone to meet this arbitrary "standard," put forth by bureaucrats and their political pimps.

Unless of course you can get sued for doing just the bare minimum. Then it would make much sense to exceed those standards if you know of an issue (like the manufacturers in this case did) but don't address it in your labeling because the bare minimum doesn't require it.

I don't see why FDA approval should shield someone from liability. FDA approval is not infallible nor is it bullet proof re risks to the user. In fact the number of non-FDA approved supplements that are consumed would seem to indicate that consumers don't think FDA approval carries that much weight. At the end of the day, the FDA is a political organization with political appointees (see Plan B). Why should a political organizations minimum standards shield a company from liability?

Eli|3.18.09 @ 4:00PM|#

Definitely a strange choice for Reason. When did this become a corporate apologist rag with fedgov leanings?

|3.18.09 @ 4:01PM|#

since when is the FDA an infallible rulemaking body and why is Reason defending it?

Beacuse at the end of the day Reason and CATO are corporatist. They will contort their principles like Cirque du Soleil in order to defend the rights of corporations to do what they want and to defend them from liability for their actions.

|3.18.09 @ 4:03PM|#

It's even more ironic because one would think libertarians would celebrate the Supreme Court limiting the scope of Federal pre-emption.

|3.18.09 @ 4:06PM|#

Dear ed,

The problem with your argument is that FDA not only sets minimum standards, it at times sets maximum standards as well. In paragraph three of the article I explain that, in 1988, Wyeth proposed strengthening Phenergan's label in such a way that Levine acknowledged would have prevented her injury. FDA rejected that change because it wanted to retain IV-push injection as an available treatment option for patients.

I'm certainly not pimping for the bureaucrats here, and few have been as critical of the FDA as I have been over the years. But, as several of the other commenters have put it, if our government is going to create a federal regulatory body that tells us what to do, state courts ought not be permitted to punish us for failing to do something different.

Kolohe|3.18.09 @ 4:08PM|#

Unless of course you can get sued for doing just the bare minimum.

Is the standard 15 pieces of flair, or isn't it?

Joshua Holmes|3.18.09 @ 4:11PM|#

Sue the pharmaceutical company and the FDA.

kinnath|3.18.09 @ 4:14PM|#

The problem with your argument is that FDA not only sets minimum standards, it at times sets maximum standards as well. In paragraph three of the article I explain that, in 1988, Wyeth proposed strengthening Phenergan's label in such a way that Levine acknowledged would have prevented her injury. FDA rejected that change because it wanted to retain IV-push injection as an available treatment option for patients.

The real problem is that the victim cannot sue the party that is actually responsible for the problem.

|3.18.09 @ 4:18PM|#

Sue the pharmaceutical company and the FDA.

That's what I was thinking too. That would be the appropriate remedy, not shielding the pharma company.

A better article would have been one attacking Soveriegn Immunity rather than advocating for shielding Wyeth from liability.

in 1988, Wyeth proposed strengthening Phenergan's label in such a way that Levine acknowledged would have prevented her injury. FDA rejected that change because it wanted to retain IV-push injection as an available treatment option for patients.

Im no expert so I am throwing this out the the group. Could Wyeth have sued the FDA to force them to allow the stronger warning? I believe there is some kind of appeal / review process to FDA rulings is there not?

|3.18.09 @ 4:24PM|#

I don't get it. Did everyone come in here to bitch before RTFA?

|3.18.09 @ 4:25PM|#

"""Reason's position on the FDA is that it is full of experts whose opinions should not be questioned/superseded by the rubes? Is that correct?"""

Uh, no. The issue is can she sue the drug maker when the Feds say it's ok. The drug company was following the rules. One can argue the rules suck, but one shouldn't be punished for following the rules. That isn't too difficult to understand.

If anything, she should be allowed to sue the maker of the rule.

ed|3.18.09 @ 4:31PM|#

Unless of course you can get sued for doing just the bare minimum.

But that's the point. If you comply with Official Government Standards (however arbitrary and wrong-headed), how can you be prosecuted for obeying those standards? Manufacturers are damned if they do and damned if they don't. And more to the point, juries of their "peers" might at any time arbitrarily wipe out years of work and millions or billions of dollars. The imprimatur of "Government Agency" and its authority is the root of this evil.

|3.18.09 @ 4:41PM|#

ChicagoTom,

You asked, "Could Wyeth have sued the FDA to force them to allow the stronger warning?" Yes. A regulated firm may sue a federal agency under the Administrative Procedures Act for decisions that are "arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law."

It is highly unlikely that Wyeth could have won the case, however, since Congress charged FDA with balancing the risks and benefits of medicines on the public's behalf. Here, FDA specifically considered the risk of intra-arterial injection, and made a reasoned determination on the record that the benefits of IV-push injection far outweighed the risks. In such a case, courts will defer to the agency's expertise.

Importantly, you earlier (at 4:00) wrote that, "it would make much sense to exceed those [FDA's minimum] standards if you know of an issue (like the manufacturers in this case did) but don't address it in your labeling because the bare minimum doesn't require it." As my article makes very clear, both the manufacturer and the FDA were well aware of the risks presented by IV-push injection, and Wyeth made these risks very clear in its label.

When a federal regualtory agency charged with making such discretionary decisions pays due consideration to both the risks and benefits of its proposed action, courts almost never set aside decisions as arbitrary and capricious, or an abuse of discretion.

|3.18.09 @ 4:43PM|#

I'm in favor of this ruling. It takes the guarding of the henhouse out of the hands of the wolves, being that many "experts" are in the pockets of the pharm industry. I'd trust the average citizen, who has no existing bias, way before I'd trust a lobbyist.

kinnath|3.18.09 @ 4:43PM|#

Justice Stevens's majority opinion asserts that the FDA can't keep track of all safety issues that arise after a drug is approved and that the agency never specifically made a determination regarding the safety of IV-push administration. Consequently, Wyeth could have changed its label without the FDA's pre-approval upon receiving information regarding the risk of arterial injection of Phenergan. But that assertion is plainly wrong. The case record shows that the FDA repeatedly and intensively investigated this exact question and determined that IV-push injection provided important medical benefits.

There are two separate questions in play.

First, meeting the regulations is obviously necessary to put a product on the market. But is it sufficient to argue that all safety measures have been taken and that a producer is immunized against lawsuits?

Second, did the plaintiff have a legitimate gripe in this specific case.

The first question is complicated. I would argue that meetings regulations is normally both necessary and sufficient; HOWEVER . . . and here we have lots of issues with new information coming out, etc, etc, etc . . .

In this specific case though, it appears the FDA had a direct role to play in squashing the additional warnings that the plaintiff wanted the producer to add to the box. So, I think it was both unfair to hold the producer liable and bad law for the court to set a precendent that for a problem that wasn't really in play.

Godwhacker|3.18.09 @ 4:48PM|#

Every time you wonder why libertarians don't win elections, look to articles like this for the answer why. We know that the FDA is largely a rubber-stamping operation for the pharmaceutical industry, who's data usually relies on studies done on the big pharma payroll.

Now Gregory Conko thinks the right of patients to sue drug makers for faulty products should be abrogated as well?

Give me a break. Conko would leave us in a world without proper safety regulations OR legal recourse for faulty products and warnings.

Just call this LHUA syndrome - (libertarian with head up ass)

ed|3.18.09 @ 4:48PM|#

Lazy John | March 18, 2009, 4:43pm | #

...I'd trust the average citizen, who has no existing bias, way before I'd trust a lobbyist.

You think "average citizens" have no existing biases, Lazy John? Wow.

kinnath|3.18.09 @ 4:50PM|#

We know that the FDA is largely a rubber-stamping operation for the pharmaceutical industry, who's data usually relies on studies done on the big pharma payroll.

I can't speak to the FDA, but I do work in a heavily-regulated business that kills people if things go wrong.

Government agencies are far from rubber-stamping fools. In fact, they are frequently irrational in pursuit of the most trivial risks.

|3.18.09 @ 5:01PM|#

Unless of course you can get sued for doing just the bare minimum.

Why should you be sued for doing the bare minimum? Isn't doing the bare minimum, by definition, doing enough? If the regulatory standard isn't even the bare minimum, isn't it redundant dead weight?

The first question is complicated. I would argue that meetings regulations is normally both necessary and sufficient; HOWEVER . . . and here we have lots of issues with new information coming out, etc, etc, etc . . .

Which is an indictment of the fundamental premises of the regulatory regime. If the regulators can't keep up, then aren't they just redundant dead weight?

Who, me? A libertarian?|3.18.09 @ 5:05PM|#

Godwhacker | March 18, 2009, 4:48pm | #

Every time you wonder why libertarians don't win elections, look to articles like this for the answer

I'd counter that statement with my opinion that most voters are politically and philosophically ignorant fence-sitters who tend to choose the charlatan most likely to deliver the post-election loot, but that would make me a cynic, wouldn't it? I retire to bedlam.

kinnath|3.18.09 @ 5:10PM|#

Which is an indictment of the fundamental premises of the regulatory regime. If the regulators can't keep up, then aren't they just redundant dead weight?

I'm not ppposed to regulations that define generally-accepted development and testing practices; minimum transparency requirements for public reporting of product safety and risks; minimum standards for third-party auditing (I'd trust United Labs over the FDA for example); etc.

However, the current FDA is a mess. And if you pick a fight with the regulator regarding labelling rules and lose, then yes that should immunize you from lawsuits regarding those labelling rules.

|3.18.09 @ 5:13PM|#

Godwhacker,

How do you justify your claim that "Gregory Conko thinks the right of patients to sue drug makers for faulty products should be abrogated as well," given what I wrote in the article above?

For example, I specifically wrote that "there are no allegations that Wyeth hid any information about the risks of IV injection, nor has any new information regarding the risks arisen that would call the FDA's decision into question." And, "The Supreme Court could have and should have held in Wyeth's favor with a narrowly tailored opinion confined to the facts of this case. Doing so would not have insulated wrongdoers from punishment ..."

I find it difficult to believe that most people would find the selling of a product that has been used safely and to great benefit by millions of people, with six very stern warnings on the label (two in all capital letters and bold face type) cautioning users not to engage in the precise behaviors that the treating doctor and physician's assistant engaged in, to be negligent even though approximately 20 have been injured by using that product improperly during the 45 years it was on the market (Levine's injury was suffered in 2000.).

I have written elsewhere, and I believe the implication is clear in this article, that preemption would not be appropriate in a case in which actually new information had arisen after approved the label warnings, or in a case in which there are legitimate allegations that the drug manufacturer concealed or misrepresented relevant information about the product's risks. That's not the case here. The facts in this case indicate that Wyeth did everything appropriately, that the FDA fully understood the risks posed by IV-push injection of Phenergan, and that the agency made a determination that the label should look more or less as it did on the day Diana Levine was injured.

kinnath|3.18.09 @ 5:16PM|#

Greg, you must be new to H&R. It's generally not productive to explain things to the cranks that show up and post with amusing handles like "Godwhacker".

|3.18.09 @ 5:19PM|#

R C Dean wrote "here we have lots of issues with new information coming out, etc, etc, etc . . ."

This is incorrect. Read the article. Or, alternatively, read the case decision. There was no new information about the relevant risks between the time that the label was last updated and the time of Diana Levine's injury.

Michael Ejercito|3.18.09 @ 5:22PM|#

It has seemed to me that for a long time now one can file a tort against an entity even if they met every regulatory requirement

Why can't the regulatory agency be sued as well?

ed|3.18.09 @ 5:23PM|#

cranks that show up and post

"Cranks"? Aren't they (and we) the very fuel that is firing the engines of the blogosphere?
Not that we aren't crackpots...
Just saying...
Carry on.

!|3.18.09 @ 5:24PM|#

Why can't the regulatory agency be sued as well?

In general, private citizens don't get to sue government agencies for doing their jobs.

kinnath|3.18.09 @ 5:27PM|#

"Cranks"? Aren't they (and we) the very fuel that is firing the engines of the blogosphere?

Yes, cranks are an integral part of the blossoming blogosphere, and it's normally not productive to engage them in detailed discussions ;-)

ed|3.18.09 @ 5:33PM|#

Are we not cranks?
We are...um...
Yes, cranks.

|3.18.09 @ 5:50PM|#

Mr. Conko:

R C Dean wrote "here we have lots of issues with new information coming out, etc, etc, etc . . ."

That quote was cut and paste from kinnath's earlier post defending liability even when regulatory minimums have been met (hence, my use of italics). I was taking issue with the general premise that the possibility of new information somehow justified redundant and inconsistent regulatory and liability regimes.

|3.18.09 @ 5:51PM|#

Why can't the regulatory agency be sued as well?

Sovereign immunity.

Why sovereign immunity? Err, umm. . .

Actually, there are some good justifications for it in many circumstances. I, personally, would like to see it dramatically narrowed.

|3.18.09 @ 6:19PM|#

I can't speak to the FDA, but I do work in a heavily-regulated business that kills people if things go wrong.

Government agencies are far from rubber-stamping fools. In fact, they are frequently irrational in pursuit of the most trivial risks.

I work in the pharmaceutical industry, though not in anything like drug development. But these big pharma companies bend over backwards to please the FDA. Without FDA approval, they can't manufacture or sell their drugs, and so there is no profit. So if the FDA tells you that it won't accept your labelling, you'll go with it because that's what your incentive is.

Isn't this ruling showing that the FDA assumes no risk, even as it incentivizes pharmas to listen to the FDA's decisions? So the people's protection from dangerous drugs failed them, so they are going after the companies who they told what to do? Where's the responsibility? Shouldn't people be pissed at the FDA who's supposed to protect them? Personally, I'd rather dump the FDA, and push all responsibility on the Pharmas. I don't doubt that more varied and superior products would result, and that there'd be less accidents like this case.

Basically, I'm with Kinnath

zoltan|3.18.09 @ 6:44PM|#

RC Dean, in what kind of cases do you support sovereign immunity for federal agencies? Just curious.

|3.18.09 @ 8:04PM|#

i want godwhacker to explain why he thinks phenergan is a faulty product. do you hear me troll? how is phenergan a faulty product with 45 years of use in medicine and an extremely low number of adverse effects? just because you say it, troll, doesnt make it so.

i have to side with the author, and the minority here. the drug company did everything that was asked of them, and even attempted to get the 'IV push' method of administering the drug removed. The FDA shot them down. Now if the drug company was to issue a label that said not to administer the drug via an IV push, guaranteed that the FDA would have a problem with that, and sue or penalize them. So if they remove the warning, they get sued or penalized by the government, if they keep the warning, some greedy wench who already got paid off by the doctor's insurance company will sue. talk about being stuck between a rock and a hard place. i want to know what all those in support of the ruling would do if they were in charge of the pharmaceutical company. do you change it and get sued or do you keep it and get sued?

|3.18.09 @ 8:11PM|#

R C Dean,

You're right, and I apologize for the mix up. I see now that I should not have attributed the statement, "here we have lots of issues with new information coming out, etc, etc, etc ..." to you.

|3.18.09 @ 8:37PM|#

Chicago Tom speaks for me. He is spot on.

Why shouldn't a multi-billion dollar multi national rent seeking pharmaceutical snake oil sales outfit be held accountable for its actions and omissions? How about all of the goodies that the multi billion dollar multi national pharmaceutical companies get in rent seeking payola. They are not practioners, nor are they advocates of, free enterprise. They have, and continue, to push for the criminalization of alternative treatment modalities both at the state and federal levels.

How about calculating the enormous inefficiencies and drags on the economy resulting from the subsidies/public sector contracts/harassment of alternative health care providers/cost of the poison peddled including the inevitable increased health care costs due to taking the posion from pharma. What a horrendous misallocation of resources.

But, put all that aside. What about personal and institutional accountability? If you hawk, hype, market and sell a wonder treatment and tout that its got FDA approval and then side effects a through z ensue with all sorts of negative ramifications, up to and including, death, you should not be able to disclaim liability on the basis that if you get sued you won't want to invest any more money in researching tomorrow's wonder pill because you might get sued. That is just rank speculation unsupported by any comprehensive empirical data. It is the type of juvenile speculation that squares with Chicago Tom's analysis.

Further, to evade responsibility upon the basis that you warned folks about possible side effects is no argument for the person who took the wonder pill and suffered in ways differing from the GENERAL advisory.

Not buying the irrational pity party.

Dave W.|3.18.09 @ 9:02PM|#

1. the FDA regulations greatly reduce the amount of injuries / lawsuits that would otherwise happen. This means that the FDA is useful, even though we cannot identified the people whose bodies they have saved and whose tort suits they have prevented.

2. However, the FDA is not as strict as it could be, which still leaves the door open for additional injuries and lawsuits. These are dealt with by tort law. If the drug is valuable, then the drugmaker can pay the suits and still have profits left. If the drug is not so valuable that the lawsuit budget can't be taken out of the profits, then the drugmaker should not have been making the drug in the first place and needs to do the right thing and yank the drug (or improve warnings to doctors).

3. Belt and suspenders. Navy, air force and marines. Redundancy. Etc. etc., etc. When we are talking about people's hands, or even lives, it ain't a bad approach.

Preacher|3.18.09 @ 9:13PM|#

"If it doesn't, then what the fuck is it there for?"

Jobs.

|3.18.09 @ 9:20PM|#

Whoa everyone. Those of you bashing Reason's mention of this issue are overlooking the underlying point; the FDA is charged with setting minimum standards for labeling. The plaintiff in question sued Wyeth on the argument that Wyeth failed to set a minimal standard in its labeling, even though by law it's the FDA that sets the minimum standard. What this ruling declares is that any company can be sued for the failed actions of government, and without the government baring any responsibility. Does that sound fair to you?

Oh yeah, by the way. We Libertarians are a lot smarter than you think.

Preacher|3.18.09 @ 9:26PM|#

"When a regulatory agency sets minimum standards, that's precisely what they get. It makes little sense under such a regulatory regime for manufacturers to exceed those standards, as less reputable competitors will shave their expenses to the bone to meet this arbitrary "standard," put forth by bureaucrats and their political pimps."

Here's what folks like you fail to understand. Business people have grandmothers. They have mothers. They have spouses, sons and daughters. They do not worship the dollar above all. They care about their neighbors. They have no desire to or motive to establish a business model designed to counter the impact of "less reputable competitors [who] will shave their expenses" by emulating those same practices.

It's a projected caricature. A canard.

Good luck with that.

BTW, all black folk are inherently criminal and antisocial. And most, if not all, Latinos. And certainly all American Indians. And the gays. And damn those North Africans and Hmongs. Bastards. Trying to fuck me over every chance they get. And don't get me started on the Jews. Killing Christ should at least cost ya six million.

|3.18.09 @ 11:55PM|#

Wow. And I thought I was just spouting off when I implicated Reason as a corporate shill.

And wow look at all the libertarians defending this argument.

Methinks some rights are more important than others. Especially when they benefit big pharma. Jesus.

|3.19.09 @ 6:58AM|#

Go, Tony, Go!!!! Nice!!! You obviously don't have an agenda!!!

As someone else who used to work as a regulator for an industry that could kill LOTS of people (nuclear power), I can tell you that the government regulators really do care about risks, but there are often cases where the risks are not clear-cut black and white. There are cases, like this one, it appears, where if you push too far in one direction, you will see risks increase in some other situation. And, you really don't have any "control" over this, because the regulators do not watch everything that everyone does in their regulated industry. It is not possible for the nuclear regulators to watch every operator or maintenance man 24/7. It is not possible for the FDA to watch every doctor or nurse 24/7. It is not possible for the FAA to watch every pilot or ATC 24/7.

You people who complain about events like this need to understand that LIFE itself has risks, and you are not going to eliminate all of them. People who insist on trying to eliminate all risk just make life more expensive, inconvenient, and unpleasant for the rest of us. This unfortunate woman lost her arm - this is bad. She recovered from the people who were actually responsible, but she then decided to go after Wyeth, and her success here is going to cost someone else, somewhere, money and aggravation at a minimum, and maybe even their life. But that will be OK, because a jury of people who have no real understanding what the word "risk" means, decided she should be compensated by the one entity that was truly blameless here.

This was a really bad SC decision.

|3.19.09 @ 7:15AM|#

Articles like this make me ashamed to use the word 'libertarian' to describe my thinking. Corporate capitalism is a completely corrupt and collusion cushioned fascist system. I support any and all attempts to rip big pharm to shreds. Their drugs are omnipresent in the manipulation (destruction is not too harsh a word) of children's minds in schools. Their attempts to control everything from the seed industry to herbal medicine make a mockery of the old 'free enterprise' shibboleth. To read such sycophantic prose in a the context of a supposedly politically radical journal is disturbing. Seems to me that with the candidacy of someone like Bob Barr, and perspectives like this, real advocates of freedom need to move on. The first task of any real advocate of liberty is to revisit corporate law, and eliminate the provision of

|3.19.09 @ 7:17AM|#

(oops) individual rights to corporations.

scineram|3.19.09 @ 8:02AM|#

Should you be unable to sue someone driving over you because he has drivers license?

|3.19.09 @ 8:47AM|#

Inapt comparison.

|3.19.09 @ 9:23AM|#

As someone who had IV push Phenergan twice in the past two years, this article scared me a bit. All limbs in tact though, for those interested.

The issue here is not how evil pharmaceuticals are, because they simply represent companies in general. In companies in effect represent people. One cannot be held responsible for a violation of rights if that right is not recognized by the enforcer of rights. It is in the same fashion that you cannot be arrested for a law that does not exist.

In this case, the enforcer, the FDA, specifically detailed the safety risks on this product. They acknowledged the problems with the drug, considered them, then made a ruling on its safety and labeling. When the company attempted to strengthen the label, it was rebuffed. There is nothing more that it should have done.

Imagine if there were a red box and blue box drawn on the floor. The government then says that you will be criminally liable if you stand in the red, yet civilly liable if you stand in the blue. This creates a paradox, leaving you open to governmental punishment one way or the other, that effectively prohibits the action, or at least severely increases costs. This is not effective governing, and does not preserve the rights of the one put into this situation. In this case, the big evil pharmaceutical companies.

The rights of the consumer are still preserved in this case assuming two things. One, that no new information had come to light that the company knew about that no one else did. And two, that there had been adequate research done by the pharmaceutical company on the product regarding its safety, if it is legally the responsibility of the company to do the research. I believe it is, at least for followup tests, so discussing regulatory regimes where the FDA constantly checks all drugs all the time for new defects is unnecessary. If both these conditions are met, and the pharmaceuticals comply with the laws, then it is a violation of their rights to be held civilly liable.

|3.19.09 @ 10:34AM|#

I thought the reason there were all those state medical boards, high medical school admissions standards ect was to insure that the people we mindless drones hired would be able to read and interpret the labels on the packaging. Maybe all those medical boards just serve to raise the cost, and even lower the quality of medical care.

If there were more less competent practitioners, a few board underemployed individuals might actually spend the extra 10 min to read a label.

This is 100% the fault of the pratitioners who either did not, would not, or could not read the label. I doubt different wording would have made a difference.

My suggestion: you know those annoying singing birthday cards. Why not use the same technology to have talking medical packaging.

Tyler|3.19.09 @ 10:55AM|#

I don't agree with this nonsense. Treat FDA officials just like other people when it comes to liability. I don't like the idea of giving public officials immunity from the law.

Since when were libertarians all for supporting the infallibility of some BS regulatory agency like the FDA?

The main point here should be that administrations like the FDA are pointless and at best create a false sense of security.

|3.19.09 @ 11:10AM|#

The spirit of 1776 is not reflected in the proposition that rent seeking multi-national organizations should be shielded from liability when its products harm people. The imprimatur of some totalitarian regulatory body upon the product that harms others is no defense at all.

Risk? That is right. Life is full of risks. One such risk is the near certainty of legal action taken against you if you make a crappy product that injures others.

|3.19.09 @ 12:10PM|#

The spirit of 1776 is not reflected in the proposition that rent seeking multi-national organizations should be shielded from liability when its products harm people.

I suspect the Founders would have had no problem with Wyeth being shielded from liability when the harm arose from either (a) an intervening third party disregarding its labelling or (b) a government agency prohibiting a label that would have prevented the harm.

Back in the day, it was a hell of a lot harder to tag any company with liability, due to strict application of proximate cause and assumption of the risk doctrines.

Godwhacker|3.19.09 @ 12:22PM|#

@ ceanf & Mr. Conko

First, it's important to understand what Wyeth v. Levine is about. The Supreme Court was deciding a very narrow issue, and it wasn't wether or not Phenergan is a safe drug. The issue was simply wether or not the Food, Drug, and Cosmetic Act contains an explicit preemption clause with regard to prescription drugs. The answer was no, it does not contain such a clause. That's a simple enough application of objective law and therefor the case was decided correctly. We do all believe in objective law, don't we?

What is really harming the public is our current approach to drug regulation. There are many forces at work here including; 'collectivized rights' in the form of class-action settlements that infringe upon the rights of individuals for redress of grievances, a regulatory system that is completely broken and incapable of fulfilling its mission, and a pharmaceutical industry that has run amuck with marketing and economic pressures that are clouding the line between medicine and gimmickry.

In light of those facts, it's irresponsible and completely anti-liberty to suggest that we should close access to the courts for the sole reason that someone, somewhere slapped an 'FDA Approved' sticker on something.

The courts are flooded with cases of pharmaceutical industry maleficence and obfuscation; Vioxx, Celebrex, & Zyprexa just to name a few.

It is only through the process of discovery and litigation that these crimes -- and they are crimes -- are being brought to the surface.

If the court had decided as you suggest, the only remaining avenue for the light of day to shine into these dark places would be closed -- perhaps forever.

As libertarians, capitalists, or whatever we're calling ourselves this week, we need to get over the boy-crush we have with big business. When Ayn Rand talked about the 'looters and the second-handers' she was talking about the collectivists and the welfare state.

Well, my friends, look who's doing the looting today. It's the same big businesses that we've been defending. If that doesn't make you sick, you aren't paying attention.

|3.19.09 @ 4:02PM|#

Godwhacker:

"We do all believe in objective law, do we?"

Eh, no. You're confusing Law with Science my friend. Plus, you assume that subjectivity is inherently bad, even though you yourself have made the subjective statement I just mentioned. Believe in objectivity? How contradictory!

If the government takes the charge that it alone has the responsibility to set the minimum standard on labeling, then it should bare the risks of failing to do so, not the company it regulates! It was the FDA that should had been sued for this reason!

How would one feel if I came to them and declared that I alone will dictate the safety standard of their home, not them, which also implies that I have some sort of OWNERSHIP on their property! Later on, the home catches fire and someone sues the home owner, but not me. It's not as if I had nothing to do with the safety-standard. After all, I pretty much declared that I have power over their property, didn't I?

Wow, it's amazing how so many people here can't quite connect the dots. What next? Suing the car owner because a car thief drove it into someone's home? Please!

Godwhacker|3.19.09 @ 5:44PM|#

DavidW

I'm not confusing anything. You're confusing the original case with the appeal brought to the Supreme Court. Each dealt with completely different issue. I might disagree with the original decision (I didn't hear all the evidence, and wont pretend to have an opinion on it) and still support the decision against preemption. That's not a contradiction.

In a free society, anyone can sue anyone for any reason. It's the job of the courts and the juries to determine if the suit is valid. Real capitalists don't cower behind regulations and minimum standards. Real capitalists are few and far between in modern America.

You are right, that some people can't connect the dots, but I don't think you were talking about yourself.

|3.20.09 @ 7:49AM|#

Let´s give Ms. Levine a hand for sticking it to the evil drug company.

Joe Fay|3.20.09 @ 10:25AM|#

I haven't seen anyone post a link to the opinion, so here it is:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Personally, I agree with Clarence Thomas. His concurring opinion highlights the absurdity of implied field pre-emption. That's the real issue in the case, whether Congress intended FDA regulation to pre-empt state tort laws.

The statute does not contain a clause or provision preempting state tort law. The three opinions, majority, concurring and dissenting discuss the role of courts in determining whether and how judges should determine field preemption.

Furthermore, the FDA had previously argued in court that its authority did not preempt state tort laws. Do you really want a bunch of political hacks in executive branch agencies changing their positions of such issues of law every 4 years when its not written into the statute? I recommend you all read the case.

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