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Pharma Co. Suing American Society of Anesthesiologists, Seeking Removal of Criticisms in Anesthesiology Journal + Retraction

Pacira Biosciences, Inc. is suing over allegedly "false and misleading statements made about EXPAREL, a pain medication drug."

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You can see the Complaint (filed in New Jersey federal court) and the press release—but not their brief explaining why they think they are entitled to a pretrial preliminary injunction, because that brief was filed under seal, though plaintiffs' counsel tells me that a very lightly redacted version will be available soon.

I obviously can't speak with any confidence about whether the allegations in the Anesthesiology article are true, or were said with the requisite mental state. But here are three legal observations:

  1. New Jersey law (and the First Amendment) seems to allow permanent injunctions requiring the takedown of material after it is found to be libelous at trial.
  2. In principle, libel lawsuits over academic research papers are potentially viable, especially if the court concludes that the papers included knowingly or recklessly false statements of fact, rather than just critical opinions or honest mistakes. (I oversimplify here slightly.) So are "trade libel" lawsuits, which are like libel lawsuits but allege damage to the reputation of a product rather than of a person or company.
  3. But pretrial injunctions are generally not allowed, and are indeed seen as quintessential "prior restraints," because they are entered prior to a conclusive decision that the material is indeed libelous.

I expect the District Court will be especially likely to reject a request for a takedown injunction (and the accompanying request for a retraction) in a case such as this, which is against a reputable establishment publisher. I don't think the defendant's identity should matter, but as a practical matter the First Amendment rules tend to be especially effectively policed when the defendant looks serious, plus I imagine these defendants will be well-represented.

This having been said, plaintiff is also well-represented, by megafirm Latham & Watkins (the fifth largest in the U.S.), so I do look forward to seeing their brief.

NEXT: Classes #24: Second Amendment II and Leaseholds II

Free Speech Libel

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40 responses to “Pharma Co. Suing American Society of Anesthesiologists, Seeking Removal of Criticisms in Anesthesiology Journal + Retraction

  1. One wonders if the lawyer advised the publication of articles rebutting the allegedly false conclusions or if they just took big money from Pharma. This claim seems frivolous. If the plaintiff lawyers failed to explain the potential consequences to the plaintiffs of this lawsuit, they committed lawyer malpractice.

    1. Again, this case illustrates the failure of the lawyer dumbass. People publish an article. Others then stop using or paying for the product, like government payers, doctors, insurance companies. The journal did not cause the real damage. The payers and users did. If this case is totally won, the damage will not be repaired, since the journal did not cause it. Is this hard for the lawyer to understand?

      If I am falsely accused of sinful behavior, and a church kicks me out. Who has damaged me? The accuser or the church? Is this hard for the lawyer to understand?

      Biggest winners no matter the real defendants, no matter the outcomes? The lawyers and their high fees. The judge who kept a job. That explains the anomalies.

      1. When what’s her name, the cute Congresswoman, one sued the boyfriend and the newspapers for publishing her cute nude photos, who caused the resulting damage of forcing her to resign? It was not the husband or the newspaper. It was Nancy Pelosi. Why was Nancy Pelosi not sued? Lawyer stupidity and Nancy is not paying out any money. It is not about repairing damage or justice. It is about lawyer rent seeking.

        1. Get. A. Life.

          1. Hi, David. I am so lonely. I really appreciate that you are the only one stupid enough to reply to me.

  2. I took a look at the complaint….and I’ll be very surprised if Pacira manages to win this.

    I thought there may be fraud, or clearly wrong primary research studies, deliberately miscited statements, or something…and there’s not anything there.

    It’s a meta analysis, a review, and an editorial about the analysis and review.

    And Pacira appears to be arguing that they don’t like the methodology in the meta-analysis, and that certain elements weren’t included in the review that they would’ve liked. Not that anything is clearly a lie.

    The best they have is one coauthor didn’t report a $2500 consulting fee from a secondary company from a few years ago for their potential financial conflicts section. Which, all things considered, is pretty minimal. And they have the gall to try to imply a DOD grant is going to be a financial conflict that should’ve been reported.

    If Pacira wants to issue a statement to the contrary, or try to get a different editorial out there, that’s the proper response to not liking the articles and the methodology. This type of legal action should be shot down without mercy by the courts.

    1. Can anyone say “Streisand effect”? I can’t imagine a better way to harm your client than to sue an academic journal over a peer-reviewed paper.

      1. Never heard of EXPAREL. If I have an operation, I will be asking my anesthesiologist to not use it, thanks to this lawsuit.

        1. Luckily there appear to be several cheaper alternatives!

    2. I agree with all this.

      For fun, I did a little extra digging. The linked article below (under “A few concerns”) notes that Exparel is basically Pacira’s only product, so a decline in Exparel sales could be quite damaging to the company. It also points out that a number of other products compete in the same space as Exparel. (One competing product is even a generic version of the same API in Exparel, so you have to wonder a little what extra value the latter provides.)

      https://www.fool.com/investing/2021/03/27/after-a-label-expansion-is-this-under-the-radar-bi/

      As noted in the Pacira press release, the title of the allegedly offending journal paper is “[Exparel] Is Not Superior to Standard Local Anesthetics”. Presumably those “standard local anesthetics” are basically the same as the competing products mentioned in the linked article. So even if its legal case is fairly weak, Pacira may see this as “bet the company” litigation because its effectively sole revenue source is at risk if people follow the recommendations of the journal paper. And as Prof. V. notes, it appears to be a top journal in the field, so there’s plenty of reason to think the recommendations will carry weight.

      On the DoD grant point, it seems that the military is one of Exparel’s biggest customers, so that may explain why Pacira tried to make something of it.

      1. On the DOD grant, it just beggars beliefs that the lawyers think this should be included as a needed financial disclosure/financial conflict and this is a reason for libel charges.

        These things (government grants) are typically siloed very well from any procurement operations by the government and are typically competitive as well. That the grant may “improperly bias” past or future research, and thus require disclosure is an astounding claim. It would be akin to claiming a judge can’t rule on a case regarding a government matter, because the judge is paid by the government.

        1. That makes a lot of sense to me. I was just pointing out a possible motive for Pacira to be playing it up, even though it’s a losing argument.

      2. I find myself wondering why the complaint bothers to take all the trouble it does to allege that the article writers and journal editors are biased in favor of opioids.

        I don’t see why saying it’s no better than cheaper opioids would damage its reputation. Its main selling (and investing) point appears to be, as the Motley Fool article you linked to points out, that it’s the only non-opioid alternative for certain conditions. The journal articles don’t seem to do anything to dispute or damage this claim. There are doubtless lots of people willing to pay big bucks to take an expensive non-opioid alternative that avoids the life-altering addiction risks opioids have, even if its pain relief isn’t any better. The articles say it doesn’t give you any better pain relief, but they don’t say its pain relief is worse. If they just retorted with “even if we won’t give you better pain relief, it’ll be just as good, and you won’t get addicted and risk destroying your life if you go with us,” I suspect they could is get people to continue opening their checkbooks and forking over big money.

        I suspect the real problem is comparing it to the cheaper generic. The generic would have the same non-opioid benefits and be cheaper. For that, however, I suspect that a claim that there’s no value in paying more money for the brand name when the generic gives you the same benefits and is cheaper, is going to be very, very hard to prove false, let alone intentionally false.

    3. I know enough to be suspicious of a meta-analysis. Does the average reader of the journal Anesthesiology? The complaint (¶ 37) admits mixing medications “is a common problem with many pain studies.” If it’s so common, surely the average reader of the journal Anesthesiology knows to take care interpreting results.

      1. Here’s the issue though. Just because you’re suspicious of it, it doesn’t mean it’s libel.

        Disagree with it? Sure. Criticize it? Absolutely. Point out methodology flaws? If you want.

        But libel implies something stronger, that there were outright lies within the analysis. And those aren’t there.

        1. My point was meant to be, if the target audience is going to be suspicious of a meta-analysis that weakens the case for libel.

          Here are the conclusions of the meta-analysis, which is the only free article of the three: “Perineural liposomal bupivacaine provided a statistically significant but clinically unimportant improvement in the AUC of postoperative pain scores compared with plain local anesthetic. Furthermore, this benefit was rendered nonsignificant after excluding an industry-sponsored trial, and liposomal bupivacaine was found to be not different from plain local anesthetics for postoperative pain and all other analgesic and functional outcomes. High-quality evidence does not support the use of perineural liposomal bupivacaine over nonliposomal bupivacaine for peripheral nerve blocks.” (https://pubs.asahq.org/anesthesiology/article/134/2/147/114786/Perineural-Liposomal-Bupivacaine-Is-Not-Superior)

          “High-quality” looks like opinion. They disclosed the reasons for excluding the industry-sponsored trial and the reader is able to decide whether that was good or bad.

  3. This is a successful permanent injunction blocking the release of videos of abortion people talking money for parts. Video are not controversial unless they were deep fakes. They were true depictions. The feminist lawyers now in total control of the three branches of government are suppressing my Free Speech Clause right to receive information.

    https://thomasmoresociety.org/wp-content/uploads/2021/04/210407-DD-NAF-Ord-re-MSJ-Permanent-Inj-dkt-720.pdf

  4. Forgive me, but I am in a really cynical mood right now.

    Right & Wrong are no longer linked to a judicial outcome, and that is why I not only thing we are inexorably approaching a second civil war, but we will all be better off if it was sooner rather than later.

    1. Doctor. All revolutions and civil wars have been bad, including the American Revolution. The hard political work of overcoming the power of the billionaire owners of the media and of the Democratic Party. Their interest lays in the Chinese market. The Democrat Party wants to make us a colony of China for their enrichment.

      Do not kill millions of hapless people. Antifa the homes of these billionaires. Seize their assets in civil forfeiture. Arrest them and their agents. To deter.

    2. Right and wrong are NEVER linked to a judicial outcome.

      In law, something is either legal or illegal.

      I had a case where an airmen slept with a young lady the day after she turned 16.

      We confirmed the dates/times and even interviewed the young lady, and everything was legal.

      When I talked with her parents, I started the conversation with, “We don’t investigate if something is right or wrong, we investigate if something was legal or not. In this case, there was no illegal activity – regardless if you think the action was wrong.”

      1. Apedad. Yet another dumb, disruptive and costly lawyer myth. The age of adulthood is 14, according to biology, the religions of the world, and 10000 years of human civilization. That 18 age is fake for the rent seeking enrichment of your clients, to keep out totally superior performers from the job market.

        Result? Trillions in losses of job performance to the economy. Your profession must be crushed to save this country. And, maturity comes from experience, not from time, to all you lawyer dumbasses. You would not know, since you are big baby bookworms who haven’t done anything except study for tests and read minute details in tiny print, ruining your vision.

  5. This kind of request would have been absurd just a few years ago. This is how we do business now. You just shut down anyone who disagrees with you.

    1. Except you also prevent certain people from being able to do so…

  6. VC comments from DavidBehar, Dr. Ed 2, and Brett Bellmore, sum to what percent of all comments?

    VC OPs from Josh Blackman, what percent?

    If there is strength in diversity, seems like the VC gets weaker the more those guys take over.

    1. Stephen, thank you for your comment. I always learn something visiting this blog.

  7. Prof. V, the most interesting thing to me about this post is your link to the list of the hugest law firms. The firm at which I spent most of my legal career is now #4, with over 2,600 lawyers. When I joined (the predecessor of) that firm as an associate in 1969, I was the 69th lawyer in the firm. Hogan & Hartson, as it then was, was the second largest law firm in DC (Covington & Burling was #1, with about 100 lawyers). I cannot imagine what it is like today for young lawyers joining firms of the size of the ones on that list. As Maurice Chevalier sang, “I’m glad I’m not young anymore.”

    1. I know somebody who was a young lawyer in a top 20 firm in the 1990s. I heard the stories of dominance games and burnout. At the time living far out in the suburbs provided some protection at night. Now everybody is reachable at all times when the boss needs somebody to abuse.

    2. What I don’t see is the economy of scale in an industry where skilled labor is so much of your cost.

  8. I am wondering why a large, reputable law firm is taking the case, given the likelihood of (richly deserved) sanctions for filing a completely frivous case. Ethical lawyers should advise clients that suing people is not a remedy for geelibg desparate.

    The complaint’s first and main point involves a study comparing Pacira’s product to cheaper alternatives. Pacira’s complaint is that patients could also get other pain meds and the study didn’t adjust for them.

    It hardly seems libelous for an academic paper to argue that if expensive meds plus other meds get you no better results than (“not superior to”) cheap meds plus other meds, then the expensive meds aren’t adding value worth paying the extra money for.

    The rest of the complaint dorsn’t get any better. Whether the journL articles here used the best methodology or not, whether the coauthors disclosed every minute potential conflict of interest or not — the complaint nitpicks all of this thorougjly — there’s nothing in them that comes even close to what libel law is supposed to be about.

    The complaint reeks of drsperation. It shows.

    I hope the court imposes stiff sanctions. Hiring large law firms to attack non-profit professional societies and academic journals with lawsuits this patently frivolous has got to be aggressively detered. There have got to be consequences for behavior like this.

    1. I have no opinion on whether the journal articles used the best methodology or not. Perhaps Pacira’s experts are right on some of these points. But a libel case is no place to air a dispute about what is the best methodology. And the methodology disputes, like the minor disclosure issues, don’t come anywhere close to the intentional falsification the complaint is alleging.

      1. See above. I agree with all this, but Pacira may be so desperate to avoid a hit to its sales that it’s willing to risk sanctions etc.

        1. That’s a good reason for Pacira to risk it. But why is the law firm risking sanctions over it? Remember that they too are potentially liable for sanctions and their liability could be independent of the client’s.

          1. Thanks for pointing that out. I am aware of that. Maybe I should have been a little more circumspect with my words. I didn’t mean “sanctions” in the precise sense of Rule 11 penalties, but more in the sense of things like having to pay costs and attorney’s fees.

            There is no way on earth a prestige firm like Latham is going to sign on to a case where they perceive appreciable exposure to Rule 11 sanctions. As weak as this complaint is, we all know the Rule 11 bar is quite high, and I don’t think this case really clears it, at least based on the observations stated in the OP.

            Fees and costs in contrast do seem like a possibility. The OP didn’t seem to mention it, but I was curious about anti-SLAPP in NJ. That doesn’t exist precisely, but there is a “malicious use of process” claim that the Journal might be able to deploy.

            https://www.dmlp.org/legal-guide/anti-slapp-law-new-jersey

  9. The complaint alleges actual malice and that defendants “knew or recklessly disregarded” various facts, so I assume the plaintiff Pacira counts as a public figure.

    1. Reader Y has the correct analysis.

    2. It probably does, but the plaintiffs are also seeking punitive damages, which require a showing of actual malice even for non-public figures.

  10. Is it libel to criticize the plaintiff’s product but not the plaintiff himself?

    If I complain about this blog post, could that libel Prof. Volokh?

    1. The lawyer is allowing litigation to intimidate by ruinous costs, even to get to a summary dismissal with prejudice. I support the American Rule and oppose loser pays. However, judges should be able to read the filed complaint, and dismiss them on the spot, like those of a litigious prisoner. The judge also has an obligation to report the law firm to the disciplinary counsel. Their licenses should be pulled. The DC never ever enforces the Rule against claims without merit. The DC should be punished.

  11. The complaint linked in the blog post uses the phrase “trade libel”.

    The online law dictionaries I checked have no such term.

    1. Archibald Tuttle: You might try to find a better online law dictionary. “Trade libel” is definitely, as they say, a thing.