Randy M. Clark, MD FASA, President of the American Society of Anesthesiologists (reprinted from his weekly Monday morning outreach, Feb 14) commenting on the Exparel/ Pacira Bioscience lawsuit and the recent PAAD Mary Ellen McCann is a HERO
As mentioned last week, the District Court for the District of New Jersey has dismissed, with prejudice, the trade libel lawsuit filed against ASA, the Editor in Chief of our journal Anesthesiology, and 11 named authors of articles that appeared in our scientific journal in February 2021. The complaint was filed by Pacira Biosciences, Inc., a pharmaceutical company that makes and markets EXPAREL, an injectable suspension of liposomal bupivacaine. In simple terms, the journal articles found EXPAREL non-superior (from the standpoint of measuring clinical significance) to non-liposomal bupivacaine for peripheral nerve blocks.
To bring a trade libel action, plaintiffs must allege four elements: 1) publication, 2) with malice 3) of false allegations concerning plaintiff’s property, or product 4) causing special damages, i.e., pecuniary harm. Pacira alleged that two articles and an accompanying editorial employed flawed methodologies to arrive at the conclusion that EXPAREL is non-superior to other therapies.
In one of the most succinct and clear legal opinions this non-lawyer has read, Judge Madeline Cox Arleo found that, “Absent an allegation that the author of a scientific article falsified the data from which she drew her conclusions, a plaintiff cannot sustain a claim for trade libel by alleging that some methodological flaw led to a scientifically ‘incorrect’” answer. Stated differently, a scientific conclusion based on nonfraudulent data in an academic publication is not a ‘fact’ that can be proven false through litigation.”
I am proud of the Administrative Council and ASA Board of Directors for making the decision to defend this case with every resource available to us. Scientific integrity, indeed even scientific progress, would be severely impaired had this complaint led to a judgment against ASA and the authors. The judge herself noted the stakes in play. In her ruling she said, “By their nature, scientific conclusions published in an academic journal are ‘tentative’ and made available to other scientists who may respond by attempting to replicate the described experiment, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results. The peer review process – not a courtroom – thus provides the best mechanism for resolving scientific uncertainties.”
Congratulations to our editor and authors for standing strong during this difficult situation, to ASA General Counsel Jeremy Lewin who managed and advised on this case, and to the attorneys of Quinn Emanuel Urquhart & Sullivan LLP and Marino Tortorella & Boyle PC for their masterful representation of ASA. On behalf of our members, ASA was able to provide a strong defense that no individual author or group of authors could have mounted.
Brita M. Mittal, MD, Clinical Assistant Professor of Anesthesiology, Director of Adult Epidermolysis Bullosa Anesthesia, Department of Anesthesiology, Perioperative, and Pain Medicine,Stanford University School of Medicine commenting on EB anesthetic management in adults
I became aware that our group’s recently published narrative review (Mittal BM, Goodnough CL, Bushell E, Turkmani-Bazzi S, Sheppard K. Anesthetic Management of Adults With Epidermolysis Bullosa. Anesth Analg. 2022 Jan 1;134(1):90-101) was the subject of a recent Pediatric Anesthesia Article of the Day email. Thank you for bringing attention to our work and to this special patient population.
I would like to respond by thanking Drs. Brooks Peterson and Szolnoki for their thoughtful commentary about the differences in anesthetic management discussed in our respective papers. This discussion highlights the complex and heterogenous nature of patients with EB across their lifespan and how advanced our medical teams have become to care for special patient populations such as these. I am grateful for the increased attention brought to this topic and value the addition to our collective knowledge and experience that each publication brings.
As literature on the anesthetic management of patients (especially adults) with EB remains limited, it may be of interest to your readers that our group has recently authored a manuscript titled “Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Difficult Airway Management in Adults with Recessive Dystrophic Epidermolysis Bullosa: A Case Series”. It is currently under review and contains some interesting information that is pertinent to the commentary provided by Drs. Brooks Peterson and Szolnoki, such as laryngeal involvement, intubation route, and airway complications. We look forward to its timely publication so that we may share our experience with the rest of the community.
Anonymous
Thank you so much for spending two (I have to edit it now to say three)! days highlighting gender pay disparity. I am especially pleased to see a woman (PAAD #2), who is recognized as a clear authority and extremely well respected in our field as the author. It is clear to me that we need to continue having this conversation and adding more data. The number of times I have been told that gender bias doesn’t exist, gender pay gap doesn’t exist, or we don’t have a gender pay gap “here”, is staggering. It seems to me that institutions and divisions who deny the existence, or minimize its impact, perhaps have the biggest challenge, in that they have to acknowledge there is even a problem before they can address it. The national attention to gender bias is gaining attention – data published, gender specific support at the national level – WELI through SPA, Women in Anesthesiology group, ASA committee on women in anesthesiology. To see it addressed, and a continued work needs to be done at an institution with the national reputation and standing as Mayo, continues to highlight that we need to keep talking, and we can’t keep pretending it doesn’t exist, or that we can’t work on fixing it. The fact that Mayo has provided transparency regarding pay should be a bar that all institutions are held to, despite how difficult it may be. Lack of transparency is clearly a tool that does not work to improve equity nor collaboration.
I am writing this anonymously. It is not hard to know where I came from, and my prior institution is a striking example with HUGE gender pay disparity that refuses to be acknowledged as even occurring, with no institutional transparency. The peds community is small, and my thoughts are not directed at a single organization, however could be construed that way. I have hesitated to even respond at all to these three PAADs because I have drawn so much negative attention for even uttering the idea of gender disparity and have been reprimanded prior by former leaders for even discussing it and penalized for acknowledging its existence.
From Myron
I am working with Rebecca Margolis, Kim Strupp, Norah Janosy, Nathalia Jimenez, and Linda Hertzberg to design a SPA survey on this issue. Our working group will meet at the upcoming SPA meeting in Tampa. As soon as I get more information from Kim Battle on room availability and time I’ll post it in the PAAD. These meetings are always open so feel free to join us.