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Is There Nothing Lobbyists Can't Do?
March 6, 2009 12:33 PM   Subscribe

FDA says your company's medical device isn't safe to market? No problem. Just hire a lobbyist. Afraid of being sued? Don't worry. The Supreme Court says you are immune.
posted by expriest (40 comments total) 5 users marked this as a favorite

 
GAAAAH, FILLED WITH INTENSE FURIOUS ANGRY RAGE

Excuse me, I need a lie-down for a moment....
posted by JHarris at 12:42 PM on March 6, 2009


Take heart, JHarris. If you follow the second link you'll see that there is some hope. Congress is considering a bill called the Medical Device Safety Act which will undo the Supreme Court's disaster of a decision.
posted by expriest at 12:47 PM on March 6, 2009


Not surprisingly, Henry Waxman is one of the sponsors of the new bill.
posted by Mister_A at 12:48 PM on March 6, 2009


U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, today introduced legislation in the House that will reverse a U.S. Supreme Court decision that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.

I fucking LOVE Henry Waxman and his Mustache of Justice.
posted by dersins at 12:49 PM on March 6, 2009 [2 favorites]


a U.S. Supreme Court decision that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.

This must be the work of those activist judges I hear so much about.
posted by rocket88 at 12:51 PM on March 6, 2009 [4 favorites]


From the second link:
The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court's flawed interpretation of the MDA (Medical Device Amendments of 1976). The legislation explicitly clarifies that state product liability lawsuits are preserved.
And sadly, lobbyists have shaped a lot of policy in many fields, against better judgment and previous decisions. The link highlights this in a particular case, along with a faulty "fast-track" system in place within the FDA. Your rage is founded, but things could change soon.
posted by filthy light thief at 12:53 PM on March 6, 2009


I occasionally have the urge to paste nasty signs all over shops that visibly hawk alt-tard products.
posted by kldickson at 12:58 PM on March 6, 2009


This must be the work of those activist judges I hear so much about.

Scalia, J., delivered the opinion of the Court, in which Roberts, C. J., and Kennedy, Souter, Thomas, Breyer, and Alito, JJ., joined, and in which Stevens, J., joined except for Parts III–A and III–B. Stevens, J., filed an opinion concurring in part and concurring in the judgment. Ginsburg, J., filed a dissenting opinion.

So 8-1.
posted by gyc at 1:01 PM on March 6, 2009


Afraid of being sued? Don't worry. The Supreme Court Congress says you are immune.
posted by brain_drain at 1:05 PM on March 6, 2009


Congress said no such thing, brain_drain. If you really want to get into a debate over the topic, I'm happy to discuss why the expansive definition of the word "requirements" that the Supreme Court retroactively applied to the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in Riegel v. Medtronic is neither consistent with Congress' understanding of that word, nor consistent with the underlying purpose of the statute which was to protect consumers from dangerous medical devices.
posted by expriest at 1:13 PM on March 6, 2009 [1 favorite]


Look, if they have to make sure their devices "won't explode" or "work reliably", they couldn't afford to do business.
posted by boo_radley at 1:13 PM on March 6, 2009 [3 favorites]


expriest: would your argument track Justice Ginsburg's lone dissent from the 8-1 majority opinion that held Congress's act explicitly pre-empted state law claims? If so, I'm not even sure she would say that the Supreme Court held that "product manufacturers are immune." Rather, I think she would concede that the legal question is whether Congress says you are immune or not (and thus pre-empted). She just happens to disagree. Saying "product manufacturers are immune" was a proclamation from the Supreme Court is a bit disingenuous.
posted by dios at 1:17 PM on March 6, 2009 [2 favorites]


"Not surprisingly, Henry Waxman is one of the sponsors of the new bill."

Surely, Minority Leader Boehner will co-sponser it!

HAHAHA AHAHAHAHHA AHHAHAHHHA HAHAHAHHHAHHAHHA AHHAHAHHAHAAHHH HAHAHA!

Seriously, Republicans, do you even remember when your party wasn't a sick joke? (Hint: that was way back when you gave a damn about Main Street. Back when my whole family pretty much voted a straight Republican ticket, because the Dems were corrupt and you guys were responsible.)
posted by orthogonality at 1:19 PM on March 6, 2009 [1 favorite]


Also, as is always the case in these kinds of threads, it would be super great to actually link the opinion at issue instead of talking about it without everyone having read it.
posted by dios at 1:20 PM on March 6, 2009 [4 favorites]


You liberal bastards are destroying everything with your "volcano monitoring" and "human rights" and "marginally more equitable distribution of the burden of taxation" and your "legal safeguards against unscrupulous deployment of dubious devices in human people" and your "foreign policy that does not begin and end with war" and your "jokes involving words like 'chthonic' and 'rugose' and 'glabrous'."
posted by Mister_A at 1:20 PM on March 6, 2009 [2 favorites]


How old are you, orthogonality? 150?
posted by goethean at 1:22 PM on March 6, 2009 [2 favorites]


Dios, the power to preempt state law (which, in this case, does render medical device manufactures immune from suit) is supposed to rest with Congress. When the Supreme Court misconstrues an congressional act, however, the result is the same as if Congress actually intended to do what the Supreme Court wrongly said it intended to do.
posted by expriest at 1:24 PM on March 6, 2009


expriest: the statute clearly preempts state law. Ginsburg admits it in her dissent. It's explicit in the statute. The only question is the degree of pre-emption.

So to claim that it was the "Supreme Court" who granted "immunity" instead of Congress is ludicrous. Clearly Congress intended some, if not all, pre-emption. This was not a Supreme Court created rule, so not even Ginsburg would take your position.
posted by dios at 1:28 PM on March 6, 2009


You liberal bastards are destroying everything with your... "legal safeguards against unscrupulous deployment of dubious devices in human people"
posted by Mister_A at 3:20 PM on March 6

Seriously, Republicans, do you even remember when your party wasn't a sick joke?
posted by orthogonality at 3:19 PM on March 6


Good lord. Could you talk about the issue here instead of playing partisan warfare?

Plus, FYI, the statute which explicitly offers some pre-emption and legal safeguards to medical device manufacturers that is at issue here? It was passed in 1976. Do you know who sponsored it? Ted Kennedy. Do you know which party controlled Congress? We could do without the egg on your face stuff.This is why playing DvR WARGAMES is unproductive and does nothing to address the issue at hand.
posted by dios at 1:32 PM on March 6, 2009 [3 favorites]


Just to be clear. The Bill you are chastising as a Republican protection of Medical Device Manufacturers was passed in 1976.

Lone Senate Sponsor? Ted Kenndy (D)
Composition of Senate that passed it? 61 Democrats, 37 Republicans, 2 Independents

House Sponsor? Henry Waxman (D)
Composition of House that passed it? 291 Democrats, 144 Republicans

Now that we have that nonsense clear, lets move beyond partisan sniping and address the real issues here:

Does the pre-emption provision in the statute pre-empt all claims or not? And should it? Is there merit in the new legislation revising the pre-emption provision?
posted by dios at 1:39 PM on March 6, 2009 [1 favorite]


That was a joke, dios. And look, I don't really care who is responsible for this situation, I just want to see it remedied. And if members of the republican party sign on to help find an equitable solution, that'd be great too. I appreciate that the decision, like most things in life, is a bit more complicated than it might seem at first blush; but I lack the legal scholarship to get in there and really figure out what's going on. Maybe you could explain it to me?
posted by Mister_A at 1:40 PM on March 6, 2009


Dios, you are correct that the federal law preempts some state laws, but the word "requirement," which is used in the statute, was never understood to preempt state tort law until the Supreme Court's 1992 decision in Cipollone v. Liggett Group, and Congress did not understand that word to preempt state law when it drafted the statute in 1976. A correct decision in Riegel would have held that state statutes and regulations are preempted, but state common law claims are preserved, as the intent of the 1976 law was not to prevent state tort law, but rather to ensure that a single regulatory agency, the FDA, would be responsible for all pre-market approvals of medical devices.

Instead, the Court ignored the longstanding rule providing both that the intent of Congress (not the meanings which the Court assigns to words 16 years after a statute is drafted) is the cornerstone of deciding preemption cases, and that, when considering an area in which states traditionally regulate, the Court should always apply a presumption against preemption.

Think of it this way: in 1920 the word "gay" was consider a synonym of "happy." Today, that word has a different meaning. If in 1920, Congress had enacted a law saying that "public schools shall ensure that their students are well-educated and gay," it would not be appropriate for the Supreme Court to decide today that public schools must mandate that all their students engage in same-sex coupling.

Similarly, if Congress uses a word which, in 1976 was understood to encompass state positive law but not state tort law, the Court does not get to retroactively change the meaning of that word to produce a result Congress never intended.
posted by expriest at 1:42 PM on March 6, 2009 [3 favorites]


I left a word out of my last comment. The phrase "Congress did not understand that word to preempt state law when it drafted the statute in 1976" should say "Congress did not understand that word to preempt state tort law when it drafted the statute in 1976."
posted by expriest at 1:45 PM on March 6, 2009


What expriest says. the fact that waxman is setting out to fix this bill now (i.e., to return it to its original intent) really speaks volumes about what the law was and was not intended to do.
posted by zpousman at 1:48 PM on March 6, 2009


These babies are okay though, right?
posted by No Robots at 1:49 PM on March 6, 2009


That was a joke, dios.

I'll give you the benefit of the doubt.

But ortho does not get the same benefit ;)

Maybe you could explain it to me?

I think the opinion does a decent job of explaining it. But the issue here is one of federal preemption. And it is a necessary issue in a federal system where we have one sovereign federal government, and 50 sovereign state governments. The states all have different rules for civil law claims.

To make the issue as simple as possible, let's take the example of the age a patient can give consent to medical treatment. Suppose that all the 50 states used different dates ranging from 13 to 22. We could just leave it to the state, so in that state, as long as the patient is of the legal age, a doctor could rely on the patient's consent.

But suppose we pass a federal law which states that no patient can give consent until they are 18 in any state in the country.

Well, if a person in State X (which requires patients to be 22) meets the state requirement of 22, then they will meet with the federal requirement too.
But if a person in State Y (which requires patients to be 14) meets the state requirement of 14, then they will not be within the federal requirement.

What to do? We have a conflict?

Preemption law has developed. Basically, when the federal government enters the arena of a specific issue and standardizes law across the states, then it preempts any state claim. So a person in State Y who is 16 is refused treatment and tries to pursue a cause of action under the state's law (14+ is all that is needed), that claim would be pre-empted because the federal law (18+) preempts the state law (14+).

So the question is whether there is preemption. In this case, the statute explicitly preempts at least some thing. The question is whether the statute prempts all state tort law claims that a device is protected.

The problem is this: if the federal government says "this product is safe" and a jury in Idaho says "under Idaho law, this product is not safe," the question is who gets to determine that between the conflicting opinions. Because federal government established this agency to determine what products are safe, the question is to what extent they wanted to preempt law and prevent a court in Idaho from disagreeing with the federal government's determination.

That make sense?
posted by dios at 1:54 PM on March 6, 2009 [3 favorites]


the fact that waxman is setting out to fix this bill now (i.e., to return it to its original intent) really speaks volumes about what the law was and was not intended to do.
posted by zpousman at 3:48 PM on March 6

Possibly. Or possibly he has simply changed his mind on the topic. Regardless, calling this law a "Republican" or "Democratic" law is not productive, and that was my point.
posted by dios at 1:56 PM on March 6, 2009


Thanks, that helps. I don't know the legal precedents, etc. that would apply, but thank you for framing the dispute.
posted by Mister_A at 1:58 PM on March 6, 2009


calling this law a "Republican" or "Democratic" law is not productive, and that was my point.

I'll agree that I really don't care that much which party gets credit for the bill. Congress just needs to pass the Medical Device Safety Act
posted by expriest at 1:58 PM on March 6, 2009


expriest: yeah, I read the opinion, so I get the argument. At the end of the day, the Court has to interpret the plain meaning of the statute and the Court had to follow Lohr under stare decisis. That's why you get an 8-1 decision. The nice thing about it is if the Court is wrong, then Congress can fix it with this legislation.

I'm the first to admit that preemption doctrine is bordering on unworkable. It is really worth reading this case in unison with Wednesday's Wyeth decision.
posted by dios at 2:03 PM on March 6, 2009


Mister_A: There exists a federal statute ("Fed Law") that says, in effect:
- These are the requirements for medical devices
- States are not allowed to have different or additional requirements for medical devices
There exists a prior case that says, in effect:
State common-law "duties" count as "requirements."
General products liability law says, in effect:
A manufacturer is liable if and only if
- They had a duty to you;
- they breached that duty;
- that breach-of-duty caused whatever it is you're talking about; and
- whatever it is you're talking about consists of judicially cognizable damages.
The plaintiff sued under state products liability law. But Fed Law means there can be no additional state requirements, which means there can be no state duty, which means they cannot breach a state duty to you, which means that you cannot satisfy the conditions of state product liability law, which means there can be no product liability.

Clearly this is the correct, logical result for the court to reach.

Congress could fix this by amending the statute from
"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."
to
"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device; and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter; unless that requirement arises out of long-standing common-law general duties from the laws of negligence and/or products liability."
or something similar, but better-drafted. ;-)
posted by jock@law at 2:05 PM on March 6, 2009 [3 favorites]


Mister_A: jock@law is also correct. Between those two comments, you pretty much have most of what you need to know about what the opinion is about.
posted by dios at 2:17 PM on March 6, 2009


States are not allowed to have different or additional requirements for medical devices
Looking at this as a non-lawyer, this is where the unexpected consequences seem to come in. What's the historical context of this restriction? Why did Congress think states should not be able to impose additional requirements, even in the narrower 1976 sense of “requirement”?
posted by hattifattener at 3:35 PM on March 6, 2009


jock@law, you did a very nice job of explaining the situation. I appreciate such a clear and concise exposition.
posted by Mental Wimp at 3:37 PM on March 6, 2009


Why did Congress think states should not be able to impose additional requirements, even in the narrower 1976 sense of “requirement”?

Having been in the device industry, I know what was believed by my colleagues. Prior to the amendments, devices were essentially unregulated. In order to get enough votes to pass the device amendments, a sop was offered to the device companies and their supporters that would prevent the possibility of a patchwork of regulatory requirements throughout the country, giving companies a single set of standards to meet. Hence, the restrictions.

I personally believe that law suits should be allowed in addition to Federal regulation, if only to keep the regulators honest. The regulations represent a floor that must be exceeded, but the law suits represent a need to address the community standards regarding the obligations of the companies to protect patients. I know that the industry sometimes forgets that physicians aren't their customers, patients are. Physicians select the device, by and large, but the patient suffers the consequences of errors.

That said, it is unreasonable for patients to expect perfect performance from devices. As long as companies take all reasonable precautions to find errors before marketing, they should not be held liable for occasional failures. The problem is that the amount of testing it would take to make sure that out of, say, 300,000 pacemakers, none would fail cannot be done in a lifetime.

On the other hand, companies that ignore problems and stonewall when evidence begins to appear that they have a device problem should be sued into bankruptcy.
posted by Mental Wimp at 3:45 PM on March 6, 2009


Mental Wimp: Thanks! Interesting thing about your comment that "[t]he regulations represent a floor." As dios said, "It is really worth reading this case in unison with Wednesday's Wyeth decision." That's because in Wyeth, the court affirmed a Vermont Supreme Court decision, that says, inter alia, that "federal labeling requirements create a floor, not a ceiling, for state regulation." The floor-not-ceiling idea comes up again and again in the law, especially in cases, like the one discussed in this thread, where you're talking about civil liability and whether federal regulations constitute the standard of care.

posted by jock@law at 4:10 PM on March 6, 2009


Check out Drug and Device Law for interesting discussions about this case the recent Wyeth case as well as other related decisions.
posted by Arbac at 6:12 PM on March 6, 2009


But, unless I'm mistaken, an amendment to the current law wouldn't restore the liability in this case, as the court has found that from '76 to whenever this new bill gets passed, no such responsibility existed, correct? Clarifying the language still doesn't get around the prohibition on ex post facto law, correct?
posted by klangklangston at 6:53 PM on March 6, 2009


Thank you dios for injecting rational thought into what is merely an emotional rant type post. If you guys have a problem with the disparity between the device/drug decisions start writing to your congress critters. You could argue that the Supremes got it wrong on devices, but they had ample ammunition for their position in the statute. The legislature makes the policy and now is the time for them to act. Anyway, if you actually read the decision, the immunity provided to devices is far, far from complete. If all you do is listen to some news media that hype stories to enhance readership you might be deceived, and not just about immunity.
posted by caddis at 4:49 AM on March 7, 2009


You don't have one? Everyone should have a lobbyist these days!
posted by Smaaz at 3:18 AM on March 8, 2009


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