Pharma Co. Demands Preliminary Injunction to Take Down Anesthesiology Journal Articles

Pacira Biosciences' redacted brief supporting the motion for the preliminary injunction is now available—but it says nothing about the First Amendment, or about how the injunction could escape the prior restraint doctrine.


As I blogged Wednesday, Pacira Biosciences, Inc. is suing over allegedly "false and  misleading statements made about EXPAREL, a pain medication drug," in articles in the medical journal Anesthesiology (and related materials). It's asking the court to "order Defendants to remove the challenged statements from its website, print a retraction in the next issue of Anesthesiology, and prohibit the individual defendants from publishing or circulating the challenged materials, pending resolution of this suit." (The brief arguing for this preliminary injunction, which was sealed when I first blogged about it, is now available, in lightly redacted form.)

But preliminary injunctions against libel (entered before a trial) are generally viewed as unconstitutional prior restraints, even by courts that generally allow permanent injunctions against repeating material found to be libelous at trial. And though this is a trade libel case, trade libel claims (at least ones not involving commercial advertising) are subject to the same First Amendment rules as ordinary libel claims.

In the words of the California Supreme Court in Balboa Village Island Inn, Inc. v. Lemen, the most influential recent decision allowing permanent injunctions against libel,

In determining whether an injunction restraining defamation may be issued, … it is crucial to distinguish requests for preventive relief prior to trial and post-trial remedies to prevent repetition of statements judicially determined to be defamatory…. "… The attempt to enjoin the initial distribution of a defamatory matter meets several barriers, the most impervious being the constitutional prohibitions against prior restraints on free speech and press …. In contrast, an injunction against continued distribution of a publication which a jury has determined to be defamatory may be more readily granted…."

Likewise, when the Kentucky Supreme Court authorized permanent injunctions against libel, it expressly rejected preliminary injunctions:

[T]he speech alleged to be false and defamatory by the Respondents has not been finally adjudicated to be, in fact, false. Only upon such a determination could the speech be ascertained to be constitutionally unprotected, and therefore subject to injunction against future repetition. We are mindful that the rule announced herein delays the availability of injunctive relief during the time it takes to litigate the issue. Thus, while the rule may temporarily delay relief for those ultimately found to be innocent victims of slander and libel, it prevents the unwarranted suppression of speech of those who are ultimately shown to have committed no defamation, and thereby protects important constitutional values.

The Nebraska Supreme Court took the same view:

A jury has yet to determine whether Sullivan's allegations about Dillon and his business practices are false or misleading representations of fact. For these reasons, we conclude that the temporary restraining order, as well as the permanent injunction restraining Sullivan's speech, constitute unconstitutional prior restraints in derogation of Sullivan's right to speak.

Or in the words of the Alaska Supreme Court, "Preliminary injunctions are almost always held to be unconstitutional burdens on speech because they involve restraints on speech before the speech has been fully adjudged to not be constitutionally protected." And while the court went on to say that, "A preliminary injunction barring speech may be permissible only if the trial court has fully adjudicated and determined that the affected speech is not constitutionally protected," the injunction that it was authorizing this way isn't really so preliminary.[1] The few cases that have upheld preliminary injunctions against libel have not squarely responded to this criticism.[2]

And the Third Circuit, in which this case is being litigated, seems to take a similar view; it has endorsed permanent injunctions against libel, but precisely because they are entered after a trial (emphasis in first paragraph in original, in second paragraph added):

Two of the three traditional reasons for barring equity from enjoining a defamation … are obviated once a jury has determined that the enjoined statements are indeed libelous. First, it obviously cannot be said that a defendant has been denied the right to a jury determination of the veracity of his statements if a judge issues an injunction against further statements after a jury has determined that the same statements are untrue and libelous.

Second, not all injunctions against speech constitute prior restraints. The United States Supreme Court has held repeatedly that an injunction against speech generally will not be considered an unconstitutional prior restraint if it is issued after a jury has determined that the speech is not constitutionally protected. See, e.g., Pittsburgh Press Co. v. Pittsburgh Comm'n on Human Rel., 413 U.S. 376, 390 (1973) ("The special vice of a prior restraint is that communication will be suppressed, either directly or by inducing excessive caution in the speaker, before an adequate determination that it is unprotected by the First Amendment."). Because libelous speech is not protected by either the United States or the Pennsylvania Constitutions, it follows that, once a jury has determined that a certain statement is libelous, it is not a prior restraint for the court to enjoin the defendant from repeating that statement.

I was curious how the brief supporting the injunction would overcome these objections, but the answer is that it doesn't: It doesn't seem to mention the First Amendment or prior restraints. Presumably they are saving that for the reply brief; when that is filed, I'll post something about whatever argument they make.

I also don't know of any authority for ordering a journal to print a retraction before trial; indeed, it's controversial whether even it's permissible to order a retraction even after material is found libelous at trial. I hope the reply brief will likewise elaborate on this.

[* * *]

[1] See also Mishler v. MAC Systems, Inc., 771 N.E.2d 92, 98–99 (Ind. Ct. App. 2000) (condemning a preliminary injunction issued "after only the most preliminary of determinations by the trial court"); St. Margaret Mercy Healthcare Centers, Inc. v. Ho, 663 N.E.2d 1220, 1223–24 (Ind. Ct. App. 1996) (dissolving a preliminary injunction on First Amendment grounds, because speech cannot be restricted "before an adequate determination that it is unprotected by the First Amendment"); Hartman v. PIP-Group, LLC, __ S.E.2d __ (Ga. Ct. App. 2019) ("We have found no Georgia case upholding an interlocutory injunction prohibiting speech. Our Supreme Court has noted that although 'it has never been held that all injunctions against publication are impermissible,' such an injunction has been upheld only when it 'was entered subsequent to a verdict in which a jury found that statements made by [the defendant] were false and defamatory.'"); Anagnost v. Mortgage Specialists, Inc., 2016 WL 10920366, *3 (N.H. Super. Ct.) ("[B]y asking for a preliminary injunction, the plaintiffs seek to enjoin Gill from making statements that have not yet been found to be unprotected."); Paradise Hills Assocs. v. Procel, 1 Cal. Rptr. 2d 514, 519 (Cal. Ct. App. 1991) ("A preliminary injunction is a prior restraint."); Cohen v. Advanced Med. Group, 496 S.E.2d 710, 710-11 (Ga. 1998) (overturning a preliminary injunction against libel on the grounds that the injunction was not "'entered subsequent to a verdict in which a jury found that statements made by [defendant] were false and defamatory'" (quoting High Country Fashions, Inc. v. Marlenne Fashions, Inc., 357 S.E.2d 576, 577 (Ga. 1987))); Auburn Police Union v. Carpenter, 8 F.3d 886, 903 (1st Cir. 1993) (stressing that an injunction of charitable solicitation was permitted only "after a final adjudication on the merits that the speech is unprotected").

[2] But see Gillespie v. Council, 2016 WL 5616589, *3 (Nev. Ct. App. Sept. 27) (reluctantly allowing preliminary injunction in libel case, because a 1974 Nevada Supreme Court had allowed such injunctions); San Antonio Community Hosp. v. Southern Cal. Dist. Council of Carpenters, 125 F.3d 1230, 1233–39 (9th Cir. 1997) (concluding that a preliminary injunction in a labor union libel case was not a prior restraint because the statements were so misleading as to be fraudulent, and "[t]he First Amendment does not protect fraud"); Bingham v. Struve, 591 N.Y.S.2d 156, 158-59 (Sup. Ct. App. Div. 1992) (ordering a preliminary injunction against a libel on a matter of private concern, concluding that the libel was constitutionally unprotected but not considering the prior restraint problem); Parland v. Millennium Const. Servs., LLC, 623 S.E.2d 670, 673 (Ga. Ct. App. 2005) (allowing a preliminary injunction so long as there is a showing of irreparable harm); Barlow v. Sipes, 744 N.E.2d 1, 10 (Ind. Ct. App. 2001) (allowing preliminary injunction as to speech on matters of "primarily private concern").

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  1. “In contrast, an injunction against continued distribution of a publication which a jury has determined to be defamatory may be more readily granted….”

    Of course, now in the 21st Century, once the cat is out of the bag it stays out forever.

    1. Nope, some countries recognize a Right To Be Forgotten. They are still working out one of the troublesome kinks where not everyone voluntarily forgets, but they will probably have a pill and/or brain electrode for that before too long.

      1. So say I make a screen shot of our comments.

        Then I post it on several social media sites, e-mail it to everyone I know (including myself), and also make several back ups (USB, external hard drive, etc.).

        Go ahead and force me to remove anything.

  2. Again, lawyer dumbass, the Journal has caused no damage. Try suing the payers, doctors, and patients who have refused to use the medication based on the review of the scientific evidence.

    I cannot believe the stupidity of these judges. They are to blame most of all. They should dismiss this frivolous claim upon receipt.

    1. The aim of these judges in failing to do their duty is to generate lawyer fees. This justifies arrested these judges for fraud.

  3. LOL. Latham probably billed 250-500k for this exercise in futility. Not even addressing such an obvious issue in the opening brief is very bad lawyering. If I’m client, I want my money back

    1. Unless they thoroughly discussed the legal analysis and the likely outcomes, the law firm should be reported to the Disciplinary Counsel. All partners are fully responsible. All associates failed to report this lawyer malfeasance to the DC. All should lose their licenses.

      1. The licensed lawyers here are mandated reporters as well. If a lawyer reads a news story of lawyer malfeasance, is he in violation of the reporting mandate by failing to report the lawyer in the news story? How about in another state than that of his license?

        1. If the lawyer is mandated, but fails to report, can the 10000 lawyers subscribing to the NY Times then be reported and lose their licenses for failing to report the lawyer in a NY Times article?

  4. It appears that Pacira’s law firm has engaged an intellectual cousin of Mr. Norman Voles of Gravesend, who appeared in Monty Python’s “Stake Your Claim.” Their strategy, like Mr. Voles’, appears to rely on “hoping you would not make that particular point.”

  5. One element of medical fraud is lack of medical necessity. If a $190 dose of Exparel is no more effective than a cheap generic alternative, or whatever it was compared to in the studies, then the intimidation of this lawsuit is suborning medical fraud. I understand the litigation immunity. But, the judge should understand this policy question.

  6. The injunction brief appears to do worse than just ignore First Amendment law. The basic claim of falsehood that the injunction brief makes appears to grossly mischaracterize the three articles.The introduction clearly states that “all three articles create the false inpression that EXPAREL is not an effective product.”

    But the articles say no such thing. All they say is that EXPAREL is not more effective than other more conventional, and cheaper, effective products. The first article says that it is “not superior to” other products. The editorial says that because it’s not more effective, it’s not worth the extra money. Saying it’s not more effective is very different from saying it’s not effective at all. Accordingly, the injunction brief’s core libel claim appears to be, itself, objectively false.

    I again don’t understand why a major law firm with fairly deep pockets would risk getting itself mixed up in a lawsuit like this, or agree to put its name on a brief that both mischaracterizes the publication it is claiming to be libelous in an obvious way, and ignores First Amendment law.

    If it believes sanctions are unlikely and this behavior carries no risks, I would hope the court would educate it that this belief is false.

  7. I read the editorial and associated article February of 2020. Summarized accurately the literature for the preceding decades, and properly relegates this drug to the dustbin of history.
    And now I must thank the legal team for the Streisand effect to make certain that anyone in the field of anesthesiology and pain medicine who did not first pay attention to that article will give it the attention it deserves.

    Exparel contains a 40 year old local anesthetic, bupivacaine, compounded into a lipid emulsion; think of the emulsion of fats in milk, processed by homogenization, and stabilized from turning to butter by the presence of buffers and proteins. The local anesthetic is more soluble in fats than water, and thus much can be present per unit volume, while a limited amount, enough to produce numbness, is present in the water part of the emulsion continuously numbing nerves. The presence of large amounts of bupivacaine allows for slow transfer to nerves, and because of this slow uptake prevents systemic toxicity. Such toxicity is particularly nasty with bupivacaine, as cardiac arrest might be the first sign of too much drug. With other local anesthetics(lidocaine, ropivacaine, etc.) dying(cardiac arrest) is more likely the last sign that something is wrong, not the first.

    I know several of the researchers who had much of their career in the basic lab work on this delivery method more than two decades ago. I had hoped for the better part of my career that this new drug delivery would be a win for patient care. Such a drug delivery system held much promise as a one-and-done nerve injection, being far less cumbersome than placing a tiny infusion catheter next to a nerve for continuous infusion using plain old bupivacaine. In the later, a tube must be placed near the nerve, through the skin, and attached to a pump of some sort; no infusion, then the numbness wears off in a matter of hours. Or with some types of blocks might last until you are asleep for the night only to have one awaken to excruciating pain at 3am. The infusion method costs in the range of 300-500 in pump hardware(disposable one time use pump), and while plain bupivacaine is cheap, pharmacy charges can add a few hundred for their professional charges to fill the pump (special sterile facilities, state licensure and monitoring, etc. It’s enough of a cost sink that even at those pharmacy fees, my hospital pharmacy won’t deal with bupivacaine pumps.)

    So overall disappointing that this new preparation appears to be of no advantage. I had noted the review article when it came out in February 2021.
    The data as summarized accurately reflect the general state of evidence presented over the decades. This stuff seemed like a great idea, but for what advantage it might add, just isn’t worth it. For the many hundreds of dollars for the drug, hospital markup on the drug, my professional fees (about the same as price of drug), and added operating room time fees (it takes me typically 5-15 minutes to get a block done), it just isn’t worth it. If this could be delivered for a total added cost of $100, perhaps, but not for a $1,000. I would not be opening my own wallet to shell out that much knowing that I would not get anywhere near that much value. I can be a little more sore and have nice dining experiences every weekend for a month instead.

    And as noted at the start of this post, I will now bring the cited article and editorial to my departments ‘journal club’ next month for a proper clubbing; Streisand ya know.

  8. To Gasman,
    You you make a very valid point.
    Exparel has become very popular at my hospital.
    I had heard nothing about the article in “Anesthesiology” showing it to be similar to plain bupivicaine.
    Now Volkkh covering this lawsuit has made me aware of this research.
    I will now return to using bupivicaine with Decadron for my TAP blocks

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