Fallout from PLIVA v. Mensing

Something I’ve been keeping an eye on is the effects of the SCOTUS ruling in PLIVA v. Mensing, limiting liability of generic drug makers for side effects of the drug that are not included on the warning label from the brand-name drugs.

A couple of links.


In the wake of Mensing, state courts in Pennsylvania, California, and New Jersey have been considering what to do with thousands of suits by metoclopramide users who claim they weren’t warned about the long-term risks of developing a neurological disorder. (The cases were mostly filed in state courts after the Judicial Panel on Multidistrict Litigation denied a bid to consolidate the metoclopramide litigation at a federal level.) What’s notable is that judges in those states have taken markedly different approaches to their metoclopramide dockets: In Philadelphia and San Francisco, judges have allowed thousands of personal-injury suits against the generics to move forward despite Mensing. But on Friday Superior Court Judge Carol Higbee in Atlantic City, New Jersey, ruled that generics are largely off the hook in her court.

Alison Frankel at Thomson Reuters. In addition to the Higbee decision, there was another case in NJ (in re Fosamax)

A likely case for eventual SCOTUS review, to reconcile the decisions in PLIVA v. Mensing and Wyeth v. Levine, which provided for damages to plaintiffs who suffered side effects from brand-name drugs.

On Wednesday, the Court of Appeals for the First Circuit upheld a $21 million verdict awarded to a woman who suffered grievous injuries as a result of taking a generic pain medication prescribed by her doctor. In its appeal to the First Circuit, the generic drug manufacturer, Mutual Pharmaceutical Company, argued that the design defect claims were preempted by the Hatch-Waxman Amendments to the Federal, Drug, and Cosmestic Act (“FDCA”) under the Supreme Court’s 2011 decision PLIVA v. Mensing.

Bartlett v. Mutual

A NYT article about people suffering from side effects of the generics. Included in the article is a mention of a Public Citizen petition of the FDA to allow generics to use the Changes Being Effected process to change their warning labels. The FDA has apparently postponed their decision on this petition.

And Sen. Leahy has introduced a bill to address the PLIVA/Levine discrepancy. The bill is here with its House counterpart, introduced by Rep. Van Hollen here.

25 Responses

  1. Thanks Mike. It’s an interesting dilemma I think. I probably fall on the side of consumers of generics but I do understand the value of lower costs for those of us who cannot afford name brands. I’m wondering though how much of the price discrepancy is really due to personal injury suits. Doesn’t it really seem that the best solution would be to allow them to change the labeling if they’re aware of a problem not already covered in the warnings, even if the name brands are slow to act?

    After taking a generic for Flagyl recently, I’m acutely aware of the difference between the warning labels and reality.


  2. I saw that but commerical law and liability are not my fields to I didnt have anything to contribute.


  3. Mike, thanks for this post. I’ll be spending my coffee time reading the links to try to catch up.

    Basic questions re PLIVA without having read the links: If established law requires generic manufacturers only to mimic brand name labeling, is there an issue with the brand name labeling? If so, does something preclude these plaintiffs from refiling, or amending, or whatever, to pursue their claims against the brand name manufacturers? Or have they already litigated against the brand name manufacturers, and what is the status or disposition of those cases? Is labeling the only issue?

    Sorry, ruminating out loud before having educated myself.


  4. I see everything is in italics again, lol.

    Most of my questions were answered in the links. I’ve never really followed products liability, even though I have done some limited work on some cases in the past. I see I have much educating to do. Anybody have a primer recommendation?


  5. Okie:

    The SCOTUS decision in Wyeth v. Levine established that FDA approval of drug warning labels for brand-name manufacturers does not bar state lawsuits for “failure-to-warn” lawsuits. So, the brand name manufacturers are liable for side effects that they haven’t put into the labels.

    There was a recent case in the 6th Circuit (Smith v. Wyeth — different Smith) that tried to hold Wyeth liable for damages due to the generic version of Reglan. But the 6th affirmed the district court judgment dismissing that claim because the plaintiff admittedly didn’t ingest Reglan. So, basically, the name brand manufacturers cannot be held liable for damages that occurred due to the generic version.

    Finally, the Bartlett case held that a design defect claim can be made against the generic maker, even though the design of the drug is exactly the same as the brand name which is still FDA-approved. The question is whether the labeling protections for generics of PLIVA extend to design defect as well since the generics are required to make the exact same molecule.


  6. banned:
    This stuff is way out of my field too — this is QB’s area of expertise. Perhaps he’ll return to correct my misinterpretations.


  7. Okie:

    Glad the links cleared things up.

    I’m seeing things in italics too. I think Scott said that it was a problem with an unclosed italics in the Quotation for the Day last time. Do you have access to fix that?


    • I am in the airport–traveling all day again. I have not seen the Mensing discussion but will look. It is an area I know in great depth.


      • Wow, interesting stuff, Mike. I only have time for a couple of quick notes before run ing to my plane. I have litigated these and related issues for many years, am friends with some of the lawyers handling most of those cases, and actually just saw Judge Higbee this week.

        The Bartlett decision will almost certainly be reversed. It is simply wrong, and everyone knows it.

        What Mensing did was not bar generic manufacturers from changing labels but hold state tort law claims against them preempted because they may not change their labels (that is based on some particular FDCA language and FDA interpretation.

        More later.


  8. Mike, fixed it, at least from my view. Let me know if yours is different.


  9. Looks good to me. Thanks, Okie.


  10. Scott, it was a stray close bold code at the very end, which I deleted. Was it the same last time? It seems to me that should have no effect.


    • Yeah, last time there was a close bold command instead of a close italics command, which left the open italics command in effect for everything after it. Since the quote is the first thing on the site after the header, virtually everything ends up in italics.

      It’s a long and complicated explanation, why this happens, and probably not worth going into, but it starts with limitations of the iPad and ends with my habit of using bold in my comments.


  11. What was odd to me was that the close italics code was there but followed by a close bold code. That’s why I couldn’t see why that would make a difference.


  12. QB:

    I’m glad you checked in, knowing that this is the kind of work you do. I’m particularly interested in your take on the legislation introduced by Leahy/Van Hollen, when you get a chance to look at the links.


  13. Someone, John or NoVa I think, keeps talking about the cost of oil/energy eventually going down (significantly). This link cites GAO testimony that the amount of recoverable shale oil under CO and WY is EQUAL to the world’s proven oil reserve.


    As they say over at HotAir, Dude!


    • McWing:

      Someone, John or NoVa I think, keeps talking about the cost of oil/energy eventually going down (significantly).

      I’m pretty sure that’s Brent.


  14. george:

    yes, gasoline is down 40 cents in my area right now. However this is temporary. The obstacles to bringing more shale oil to market are still high. furthermore we are about to see heavy currency expansion by the end of this year.


  15. I’m guessing the highest obstacle will be political. It’s almost all on Fed land.


  16. Troll, would you consider environmental objections to be political obstacles to development in that area?


  17. Considering that production occurs off of Federal land and subject to the same environmental regulations, if exploitation of the shale oil doesn’t occur or is very slow in occurring then I’d say yes. Time will tell.


  18. If so, does something preclude these plaintiffs from refiling, or amending, or whatever, to pursue their claims against the brand name manufacturers?

    Give okie a cookie for thinking like a plaintiff’s lawyer. This theory of liability was adopted in one (infamous) case known as Conte in California but has been rejected almost everywhere else as inconsistent with basic principles of product liability law (it does not satisfy basic principles of causation). If it were widely accepted, you could bet on brand-name drugs’ becoming more expensive.

    The Leahy legislation is viewed in the legal community as having questionable chances of passage. It would substantially undermine the framework of Hatch-Waxman, and I frankly think the clamor of Democrats to “fix” Mensing is more political than principled. The truth is that it is Levine that makes little sense under existing federal law. As a practical matter, using the CBE process to add or increase warnings is … not very practical. The FDA is very picky about warnings and other labeling information. It is a basic principal of FDA regulation not to over-warn.

    What people should really think about is why it makes sense to allow states to impose liability for inadequate warnings that the FDA has approved after its rigorous application process. The FDA weighs the risks and benefits and says, this is the label and warnings you must use–no more, no less. To me, this is all a classic case of people who want to have their cake and eat it too, and also not gain weight and get the cake for free.


  19. The following from the link is one reason why Bartlett or at least its reasoning will probably be reversed by the Supreme Court:

    The court concluded that while a generic drug manufacturer could not choose to alter the chemical composition of the drug under the FDCA, it could simply decide not to make the drug at all due to the risks involved.

    If this reasoning worked, Mensingitself would have been decided the other way, but that reasoning is inconsistent with a significant body of precedent. In fact, it was rejected in Mensing. Do not be surprised if this decision is summarily reversed.


  20. QB:

    Thanks for your comments.

    I went back to have a look at the Levine opinions. I was struck that both Thomas and Breyer emphasized in their concurrences that the FDA approval does not pre-empt state law.

    Breyer’s concurrence:
    “I write separately to emphasize the Court’s statement that ‘we have no occasion in this case to consider the preemptive effect of a specific agency regulation bearing the force of law.'”

    Thomas’ concurrence in judgment:
    “I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyeth’s drug Phenergan does not pre-empt the state-law judgment before the Court.”

    Clement’s amicus for petitioner is worth a read too.


Be kind, show respect, and all will be right with the world.

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: