Yay. The Supreme Corporation of the United States rules that generic drug makers can't be sued

[cali]

over defects.

Supreme Court rules generic-drug makers can't be sued over defects

Americans who are badly hurt by a generic drug may not sue the drug maker for compensation, the Supreme Court ruled Monday, giving manufacturers a shield from liability for the medications taken most commonly in this country.

The 5-4 decision tossed out a $21-million jury verdict in favor of a New Hampshire woman who suffered horrible skin burning over most of her body and was nearly blinded after taking a pill to relieve shoulder pain.

The court majority said the federal Food and Drug Administration had approved this drug for sale, and that federal approval trumps a state’s consumer-protection laws.

In the case decided Monday, Karen Bartlett, the woman who suffered the severe reaction to sulindac, sued Mutual Pharmaceuticals, and a jury decided the pain pill was unreasonably dangerous.

<snip>

http://www.latimes.com/news/politics/la-pn-supreme-court-generic-drug-defects-20130624,0,5846473.story

[graham4anything]

1. The five that disented were picked by Reagan/Bush41/Bush43 and indirectly Ralph Nader.

from the above article-once showing again that well, yeah, it sure does.
Make sure to vote straight democratic so that President Obama and Clinton after him get to pick each justice.
Because, ah, NO Ralph Nader, Al Gore and Jimmy Carter wouldn't have picked the following five-

(Bill Clinton's and Barack Obama's picks were the four that dissented)

http://www.latimes.com/news/politics/la-pn-supreme-court-generic-drug-defects-20130624,0,5846473.story

Bartlett’s “situation is tragic and evokes deep sympathy, but a straightforward application of preemption law requires that the judgment [in her favor] be reversed,” Justice Samuel A. Alito Jr. wrote for the court majority. Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas agreed

[cali]

2. You mean the 5 in the majority

and yes, letting republicans choose SCOTUS judges is huge and reason enough to always vote for a dem for president.

[graham4anything]

4. Those 5- in the 5 to 4, all picked by Bush,Bush,Reagan, Ford and Nader(indirectly)who lied.

Nader lied saying both are the same

Gore and Obama and Kerry and Carter and Clinton wouldn't have picked the 5.

C

[cali]

7. Yes, the 5 is called the majority. learn the difference between the majority opinion and the

dissenting opinion.

[graham4anything]

27. No, the five that disented from what should have been if Al Gore won New Hampshire's 4 votes

so it is the 5 that dissented.

It could have been 6 to 3 by now, but NOOOOOOOOOOOOOOOOOOOOOOOO as someone used to say on SNL (can't remember who)

[msongs]

5. ralph nader does not nominate supreme court injustices ya know nt

[graham4anything]

9. Nader said both sides are one and the same.Yet the 4 done by democratic candiates vote opposite 5

so yes, Ralph is the cause of this court and John Anderson and those voting for Reagan and Anderson were to blame for the others.

actions lead to consequences.

And what are they going to announce tomorrow?

[noiretextatique]

11. illogical conclusion based on irrational thinking

nader'[s claim that there is no difference between democrats and rebuplicons did not CAUSE anything...except a continuous stream of irrationality from democrats against democracy. get this: republicons, and republicons alone are the blame for gore's "loss" and everthing horror that happened because of the republicon court's selection of bush. and nader was sort correct: there is no difference between corporatist who have a D or R behind their names.

[Fuddnik]

13. Nader was right.

And just who chaired the Senate Judiciary Committee when they were confirmed?

I'm not going to mention any names, but his initials are Joe Biden.

NADER-SNOWDEN 2016!

[Apophis]

8. Since when is Hillary a Democrat?

Putting a "D" next to one's name doesn't make it so.

[Yo_Mama]

3. That's a terrible misrepresentation of this case

Which, btw, is awful. The woman suffered horrendous injury.

The issue here and in a preceding line of cases involved whether a generic drug maker could be sued under state law for not including certain risks in its disclosures. The SC has consistently ruled that they may not, because by US law the generic drug maker must include the same things in its disclosures as the patent drug maker did. Therefore, the state court had ruled this drug maker was negligent for NOT DOING SOMETHING IT WAS FORBIDDEN TO DO UNDER FEDERAL LAW.

To rule differently would require all generic drug makers to stop making their drugs, which was what the state court in this case said was the remedy.

However if that became the case, then effectively patent drug makers would have an infinite monopoly on their drugs in the US - which would greatly raise drug costs and kill a huge number of people (who wouldn't be able to afford the drug).

The other remedy in this case would be for Congress to CHANGE the law to allow generic drug makers to include additional warnings.

To allow a situation in which anyone in the United States can be held legally liable for obeying federal law is unconstitutional, flat and simple.

Here is a link to the Supreme Court's opinion and the dissents in this case:
http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

[cali]

10. so how do you explain such a different finding in Wyeth v Levine?

http://en.wikipedia.org/wiki/Wyeth_v._Levine

[hack89]

19. Wyeth v Levine was a failure to warn claim

while MUTUAL PHARMACEUTICAL CO., INC. v . BARTLETT was a claim.

The issue is New Hampshire's design-defect regulations. Wyeth v Levine was Vermont's warning label requirements.

[Yo_Mama]

21. It's quite a different issue, isn't it?

Federal regulatory approval has never shielded a drug maker for liability, under state or federal law.

The issue in this case is really narrower:

State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. Pp. 6–20.
(a)
Under the Supremacy Clause, state laws that conflict with federal law are “without effect.” Maryland v.Louisiana , 451 U. S. 725,
746.
Even in the absence of an express preemption provision, a statelaw may be impliedly pre-empted where it is “impossible for a private party to comply with both state and federal requirements.” English v General Elec. Co. , 496 U. S. 72, 79. Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the
warnings on sulindac’s label or change sulindac’s design.

The best criticism of this ruling is going to be in the dissents (there are two), which are at the end of the decision in the link. I haven't finished them yet.

[magellan]

12. Fascinating, but what a horrific muddle it creates for consumers

...who are hurt by these drugs. Would there be any downside to Congress changing the law to allow drug makers to include additional warnings?

Thanks for sharing your insight.

[Yo_Mama]

24. I think this is an important case and Congress needs to act

That, of course, is just my opinion.

I would encourage everyone to read the opinion and the two dissents, however. Issues like this have the capacity to affect almost anyone.
http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

First, the plaintiff here was harmed - very harmed. Second, the year after she was prescribed the drug which caused her so much pain, suffering, and disability, the FDA did amend the drug's labeling to specifically name the syndrome that affected her, although the previous label did refer to that potential risk in less specific terms. Not that it would have helped her, however, because her doctor said he didn't read the label or the insert. The original court specifically threw out the "failure to warn" piece of the claim, but left standing the design-defect claim.

What's interesting in this is that the District Court (original court, because case was moved to federal court although the design-defect stuff is a claim under NH law), however included the label warning in the instructions to the jury. That's because of NH state law, which provides that the determination of design-defect includes an assessment of unreasonable danger and whether the danger was obviated by warnings. So a lot depends on interpretation of state law and trial procedure - I don't think this is that simple a case.

In the opinion, they are suggesting that Congress should look at a different regulatory regime. It seems like everyone who looks at this situation thinks that something is wrong.

The reality is that there is virtually no drug out there that won't kill or badly injure a few unfortunate people. In the opinion they refer to the federal law on vaccines, which was written to deal with just such a circumstance - manufacturers won't make the vaccines if they are going to be sued for the liability, but to deal with the inevitable injuries, a federal compensation scheme has been set up so that those injured have some recourse.

I haven't finished all of it yet, and I'd like to do that before commenting further.

The reality is that generic medications are cheap. The way the federal law on them is written, the manufacturer of these drugs doesn't have any choices about content or labeling. If the manufacturer is nonetheless held liable for absences in labeling or unavoidable reactions, then of course the generic manufacturers won't make them.

As a matter of law, although I am sympathetic to the dissents, I cannot accept Sotomayer's theory that in order to comply with the law a manufacturer must pay damages under the law. The damages are imposed for breaking the law! Therefore glancing through her dissent made me support the decision, but not to feel that the outcome is actually acceptable. However, to get better outcomes Congress probably needs to act.

[magellan]

28. Thanks, Yo.

I can see this is very complicated. It would seem at first glance to be a bad decision -- it certainly is for the complainant -- but if I understand you right, this comes down to a battle between State and Federal law? In any case, we can hope Congress will take another look at this FDA regulation.

Part of me wonders why the poor litigant didn't sue her doctor. I've had several doctors prescribe me drugs without mentioning side effects, some of which, when I investigated on my own, were the source of such horrendous complaints I decided not to take the med. (Nothing my life depended on, I should add.) As patients we ought not have to do that; it's just a habit I got into after being similarly let down by a vet, of all things.

I have yet to read the entire decision myself. Perhaps later, when I'm trying to feel sleepy for bed!

[telclaven]

14. Thank you for that cogent and pithy explaination

Was pretty sure there was more to it than initially presented. This makes a lot of sense. You can't find someone at fault for obeying a law.

[cali]

15. so what about Wyeth v Levine?

Wyeth v. Levine, 555 U.S. 555 (2009),[1] is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.

<snip>

If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling? Wyeth presented two arguments in favor of FDA preemption:

It is impossible for Wyeth to comply with both the state-law duties and federal labeling regulations, see Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, since the latter forbids it from changing its label without FDA approval.
Permitting states to require stronger warnings creates an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, because it substitutes a lay jury's decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA.

Holding

Justice John Paul Stevens, writing on behalf of a 6-3 court, rejected both Wyeth's argumen

<snip>

http://en.wikipedia.org/wiki/Wyeth_v._Levine

[cali]

17. So it seems, the more research I do, that it's more complex than your explanation

http://www.nytimes.com/2013/03/20/business/justices-explore-fine-line-on-generic-drug-injuries.html?_r=0

In 2011, the Court held 5-4 in PLIVA v. Mensing that FDA approval of a generic prescription drug and its labeling generally preempts a state-law damages claim premised on a failure to warn of the drug's hazards. In 2009, the Supreme Court held 6-3 in Wyeth v. Levine that, in general, FDA approval of a brand-name prescription drug and its labeling does not preempt a state-law damages claim premised on the drug manufacturer's failure to warn of the drug's hazards. Taking today's decision along with PLIVA and Wyeth, we have a nonsensical scheme of access to the civil justice system for people harmed by prescription drugs. If you (the patient) happen to have been prescribed a brand-name drug and that drug injures you, your suit against the manufacturer can go forward; but if you were prescribed the brand-name drug's generic copy -- which public policy has favored for three decades -- your suit against the generic manufacturer is kaput. Got that?
http://pubcit.typepad.com/clpblog/2013/06/another-preemption-loss-for-consumers-injured-by-generic-drugs.html

[geek tragedy]

18. The question then becomes what's more important, keeping generic prices low or allowing

for large recoveries for plaintiffs in cases like this.

Because if the answer is just "pony up the cash as an operating expense" then there's exactly one guess who picks up that expense.

[cali]

20. but is it an either/or quandary?

[geek tragedy]

22. The alternatives are to pay extra or to not sell the drugs in the first place.

Without preemption, they'd have to find a way to obey the federal law (no extra disclaimer/warning language) or state law (need a disclaimer/warning language).

Since disobeying federal law is not an option, they need to disobey the state law. Which means paying a financial penalty (either formally or through the courts) or just not selling generic drugs in that state.

[cali]

25. that makes no sense.

I'm in agreement with this NYT editorial:

<snip>

Justice Clarence Thomas, writing for the majority in 2011, acknowledged that the distinction “makes little sense” in the eyes of consumers, and Justice Sonia Sotomayor, writing the dissent, predicted “absurd consequences” depending on the “happenstance” of whether a prescription was filled with a brand-name or generic drug.

Congress should fix the disparity by amending the law to make it clear — as Representative Henry Waxman, a co-author of the statute contends — that the act did not intend to pre-empt all failure-to-warn claims. Alternatively, the F.D.A. should fix the liability problem by amending its regulations to allow generic manufacturers to change the warning labels.

Generic drugs have rapidly expanded their reach, and, by one estimate, from one-third to one-half of all generic drugs no longer have a brand-name competitor. The regulatory system needs to hold generic companies, many of them large multinationals, accountable for labels on the products they sell.

<snip>

http://www.nytimes.com/2012/03/24/opinion/a-bizarre-outcome-on-generic-drugs.html

[geek tragedy]

26. What part doesn't make sense?

Brand name drug manufacturers choose the warning used not only on their products, but also on the products sold by generic manufacturers.

Generic manufacturers aren't allowed to change a letter of the warning on the brand name manufacturers' bottle.

So, if the state determines that the federally approved warning is insufficient, the generic manufacturer has to choose between obeying the federal rule (must not change) and the state rule (must change).

So, they're left with the choice of paying the state penalty, or just not selling that drug in that state.

The statute is not artfully put together, but Congress needs to fix it.

[liberal_at_heart]

23. Funny how everything corporations and the government does these days is backed up by law.

I guess lobbying really does pay off.

[blkmusclmachine]

6. .

[HiPointDem]

16. all protection for the corporations, none for the people.