{"id":476340,"date":"2021-04-14T16:03:02","date_gmt":"2021-04-14T20:03:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/"},"modified":"2021-04-14T16:03:02","modified_gmt":"2021-04-14T20:03:02","slug":"pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/","title":{"rendered":"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology"},"content":{"rendered":"

\nComplaint challenges the American Society of Anesthesiologists for promoting biased, analytically misguided studies in its journal, on its website, and through CME activity
\n<\/h2>\n
\n

PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc.<\/a> (Nasdaq: PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL<\/a>\u00ae<\/sup><\/a> (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology<\/em>, were published in print and on the ASA website under the summary headline, \u201cLiposomal Bupivacaine Is Not Superior to Standard Local Anesthetics.\u201d This headline appeared on the cover of the publication\u2019s February 2021 print issue.<\/p>\n

The Complaint establishes that the ASA published articles that were not only scientifically unsound, but that also failed to disclose that certain authors were accepting payments from competing pharmaceutical or drug device manufacturers. Inaccurate or incomplete financial disclosures are a violation of ethical standards established by the medical and scientific research communities and raise serious questions regarding the objectivity of the published work.<\/p>\n

\u201cEXPAREL has been used in more than 8 million U.S. patients and is backed by scores of published studies that demonstrate safe and effective, long-lasting pain control, including decreased opioid requirements, improved patient outcomes, and the migration of surgical cases to outpatient sites of care,\u201d said Dave Stack, Chief Executive Officer and Chairman of Pacira. \u201cWhile pain trials are notoriously difficult to execute, and mixed evidence can be identified for all studied analgesics, the three Anesthesiology<\/em> articles overwhelmingly overlook the positive body of literature that exists for EXPAREL.\u201d<\/p>\n

Mr. Stack continued, \u201cWe cannot allow this misrepresentation of the clinical effectiveness of EXPAREL to continue to be promoted in the journal and on the website of the American Society of Anesthesiologists, at the risk of confusing stakeholders along the patient care continuum about the value of EXPAREL compared to current treatment modalities. Requests for discussion with the ASA and the editor of Anesthesiology<\/em> were repeatedly dismissed. This left us with no choice but to take legal action in order to ensure this false and misleading information is not inappropriately cited as an accurate reference in other scientific manuscripts and cannot be used to limit access to patients and providers who require low- and no-opioid care.\u201d<\/p>\n

EXPAREL is the only long-acting local analgesic approved for infiltration, field block and interscalene brachial plexus nerve block in adult patients, and the FDA recently approved it as the first and only long-acting local analgesic approved with established safety for local infiltration in children aged six and over.<\/p>\n

The product is separately reimbursed by the Centers for Medicaid and Medicare Services when used to treat Medicare surgical patients in the ambulatory surgery center environment, a policy that most major commercial payers have also adopted.<\/p>\n

\n Background on the Complaint<\/strong>
\n
Pacira seeks to address three issues in its complaint:<\/p>\n

    \n
  1. \n The published meta-analysis is deeply flawed:<\/strong> Meta-analyses should only be conducted when the studies included are similar in terms of procedure type, patient population, and outcomes evaluated\u2014this analysis combined a variety of administration techniques which included a variety of off-label uses with the largest subgroup being penile block for penile prothesis implant procedures, for which Pacira does not promote or provide educational support, and employed widely rejected methodologies. When proper methodologies are applied, the results are favorable to EXPAREL<\/li>\n
  2. \n Key financial and commercial conflicts were not disclosed: <\/strong>Financial and commercial disclosures allow transparency related to any potential bias in the publication process. Three authors and the editor-in-chief failed to disclose previous or current and ongoing relationships\u2014either between themselves or their employers\u2014with manufacturers who make products that could or would compete with EXPAREL, including over $14 million in research funding involving competing treatment modalities.<\/li>\n
  3. \n Educational tools on the ASA website\u2014including a continuing medical education (CME) course and a podcast\u2014restate as a fact, the flawed conclusions of the <\/strong>
    \n
    \n Anesthesiology<\/em>
    \n <\/strong>
    \n articles:<\/strong> Guidelines clearly state the importance of avoiding any commercial bias in CME materials in order to ensure the highest level of scientific credibility.<\/li>\n<\/ol>\n

    Pacira seeks a preliminary injunction requiring the ASA to remove materials containing these misleading statements from its website in order to prevent the continued spread of misinformation. Pacira will also file a motion for expedited discovery to enable it to obtain crucial documents exposing the ASA\u2019s unconscionable conflicts of interest and anti-EXPAREL bias.<\/p>\n

    The company\u2019s motion for a preliminary injunction, which will be filed subsequent to the complaint, will be supported by several key declarants and experts, including William Rayburn, MD, former president of the Society for Academic Continuing Medical Education and former Associate Dean of Continuing Medical Education and Professional Development at the University of New Mexico School of Medicine, and Thomas Trikalinos, MD, PhD, Director of the Center for Evidence Synthesis in Health at Brown University.<\/p>\n

    The case, Pacira v. American Society of Anesthesiologists<\/em>, was filed in the United States District Court for the District of New Jersey. Pacira is represented in this lawsuit by Latham & Watkins LLP. Copies of the pleadings and declarations are available at www.pacira.com\/legal\/ASAComplaint<\/a>.<\/p>\n

    \n About\u00a0Pacira BioSciences<\/strong>
    \n
    Pacira BioSciences, Inc. (Nasdaq: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients\u2019 journeys along the neural pain pathway. The company\u2019s long-acting local analgesic, EXPAREL\u00ae<\/sup> (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam\u00ae<\/sup>, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera\u00b0 system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit     www.pacira.com<\/a>.<\/p>\n

    \n About EXPAREL<\/strong>
    \n
    \n \u00ae<\/strong>
    \n <\/sup>
    \n
    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam\u00ae<\/sup>, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at\u00a0    www.EXPAREL.com<\/a>.<\/p>\n

    \n Important Safety Information <\/strong>
    \n
    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting.<\/p>\n

    In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and\/or loss of muscle movement. How much and how long the loss of feeling and\/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and\/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.<\/p>\n

    \n Forward-Looking Statements<\/strong>
    \n
    \n Any statements in this press release about the company\u2019s future expectations, plans, outlook, projections and prospects, and other statements containing the words \u201cbelieves,\u201d \u201canticipates,\u201d \u201cplans,\u201d \u201cestimates,\u201d \u201cexpects,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201ccan\u201d and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of the company\u2019s sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company\u2019s ability to serve those markets; the company\u2019s plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of\u00a0MyoScience; the ability to successfully integrate iovera\u00b0\u00a0and any other future acquisitions into the company\u2019s existing business; the commercial success of iovera\u00b0\u00a0and other factors discussed in the \u201cRisk Factors\u201d of the company\u2019s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the\u00a0SEC. In addition, the forward-looking statements included in this press release represent the company\u2019s views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company\u2019s views as of any date subsequent to the date of this press release.<\/em>\n <\/p>\n

    \n Company Contact:<\/strong>
    \n
    Pacira BioSciences, Inc.
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com<\/a><\/p>\n

    \n Media Contact:<\/strong>
    \n
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com<\/a><\/p>\n


    \n
    \n \n <\/div>\n

    <\/div>\n","protected":false},"excerpt":{"rendered":"

    Complaint challenges the American Society of Anesthesiologists for promoting biased, analytically misguided studies in its journal, on its website, and through CME activity PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL\u00ae (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology, were published in print and on the ASA website under the summary headline, \u201cLiposomal Bupivacaine Is Not Superior to Standard Local Anesthetics.\u201d This headline appeared on the cover of the publication\u2019s February 2021 … <\/p>\n

    Continue reading “Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-476340","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nPacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Complaint challenges the American Society of Anesthesiologists for promoting biased, analytically misguided studies in its journal, on its website, and through CME activity PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL\u00ae (bupivacaine liposome injectable suspension) is not an effective analgesic. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/","og_locale":"en_US","og_type":"article","og_title":"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology - Market Newsdesk","og_description":"Complaint challenges the American Society of Anesthesiologists for promoting biased, analytically misguided studies in its journal, on its website, and through CME activity PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL\u00ae (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology, were published in print and on the ASA website under the summary headline, \u201cLiposomal Bupivacaine Is Not Superior to Standard Local Anesthetics.\u201d This headline appeared on the cover of the publication\u2019s February 2021 … Continue reading \"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/","og_site_name":"Market Newsdesk","article_published_time":"2021-04-14T20:03:02+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIxNzEyMCM0MTIxMDQzIzIwMDg5MTE=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology","datePublished":"2021-04-14T20:03:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/"},"wordCount":1722,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIxNzEyMCM0MTIxMDQzIzIwMDg5MTE=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/pacira-biosciences-seeks-court-injunction-to-protect-clinical-integrity-of-exparel-in-the-face-of-scientifically-flawed-and-misleading-information-published-in-anesthesiology\/","name":"Pacira BioSciences Seeks Court Injunction to Protect Clinical Integrity of EXPAREL in the Face of Scientifically Flawed and Misleading Information Published in Anesthesiology - 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