Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 1 of 45 PageID: 1
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`Kevin M. McDonough (#41892005)
`LATHAM & WATKINS LLP
`885 Third Avenue
`New York, New York 10022
`(212) 906-1200
`
`Allen M. Gardner (PHV forthcoming)
`Sarah M. Gragert (PHV forthcoming)
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, D.C. 20004
`(202) 637-2200
`
`Attorneys For Plaintiff Pacira
`BioSciences, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`Civil Action No. 2:21 Civ. 9264
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`COMPLAINT and DEMAND
`FOR JURY TRIAL
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`PACIRA BIOSCIENCES, INC.,
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`Plaintiff,
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`v.
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`AMERICAN SOCIETY OF
`ANESTHESIOLOGISTS, INC.,
`EVAN D. KHARASCH, NASIR
`HUSSAIN, RICHARD BRULL,
`BRENDAN SHEEHY, MICHAEL K.
`ESSANDOH, DAVID L. STAHL,
`TRISTAN E. WEAVER, FARAJ W.
`ABDALLAH, BRIAN M. ILFELD,
`JAMES C. EISENACH, RODNEY A.
`GABRIEL, AND MARY ELLEN
`McCANN,
`
`Defendants.
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`1
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`
`
`Kevin M. McDonough (#41892005)
`LATHAM & WATKINS LLP
`885 Third Avenue
`New York, New York 10022
`(212) 906-1200
`
`Allen M. Gardner (PHV forthcoming)
`Sarah M. Gragert (PHV forthcoming)
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, D.C. 20004
`(202) 637-2200
`
`Attorneys For Plaintiff Pacira
`BioSciences, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. 2:21 Civ. 9264
`
`COMPLAINT and DEMAND
`FOR JURY TRIAL
`
`PACIRA BIOSCIENCES, INC.,
`
`Plaintiff,
`
`v.
`
`AMERICAN SOCIETY OF
`ANESTHESIOLOGISTS, INC.,
`EVAN D. KHARASCH, NASIR
`HUSSAIN, RICHARD BRULL,
`BRENDAN SHEEHY, MICHAEL K.
`ESSANDOH, DAVID L. STAHL,
`TRISTAN E. WEAVER, FARAJ W.
`ABDALLAH, BRIAN M. ILFELD,
`JAMES C. EISENACH, RODNEY A.
`GABRIEL, AND MARY ELLEN
`McCANN,
`
`Defendants.
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`1
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`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 2 of 45 PageID: 2
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`Plaintiff Pacira BioSciences, Inc. (“Pacira”), by and through its attorneys,
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`hereby brings
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`this Complaint against Defendants American Society of
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`Anesthesiologists (“ASA” or “the Society”), Evan D. Kharasch, Nasir Hussain,
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`Richard Brull, Brendan Sheehy, Michael K. Essandoh, David L. Stahl, Tristan E.
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`Weaver, Faraj W. Abdallah, Brian M. Ilfeld, James C. Eisenach, Rodney A. Gabriel,
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`and Mary Ellen McCann, and states as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a trade libel action regarding false and misleading statements
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`made about EXPAREL, a pain medication drug, in the February 2021 issue of
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`Anesthesiology, the ASA’s “official” medical journal.1 Pacira is the manufacturer
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`of the only liposomal bupivacaine product approved by the U.S. Food and Drug
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`Administration (“FDA”), brand name EXPAREL. EXPAREL (bupivacaine
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`liposome injectable suspension)2 is a non-opioid pain medication proven to prolong
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`post-surgery pain relief.
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`2.
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`In the February 2021 issue of Anesthesiology, the ASA, reflecting a bias
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`against EXPAREL amongst the editorial staff at Anesthesiology, published three
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`
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`1 ASA Publ’ns, About the Journal,
`https://pubs.asahq.org/anesthesiology/pages/about-the-journal (last visited Apr. 13,
`2021).
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`2 The Complaint uses both “EXPAREL” and “liposomal bupivacaine” to refer to
`the bupivacaine liposome injectable suspension product manufactured and sold by
`Pacira.
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`2
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`articles, and other related content, that seriously disparage Pacira’s product
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`EXPAREL. The challenged journal articles, as well as the related podcast and
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`Continuing Medical Education (“CME”) content on the ASA’s website, contain
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`false and misleading conclusions, based on faulty scientific research that does not
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`satisfy applicable standards within the scientific community. These conclusions
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`create the false impression that EXPAREL—a drug approved by the FDA and used
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`by over eight million patients over the past nine years—is not an effective pain
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`medication. As a result, Pacira has suffered and will continue to suffer significant
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`pecuniary harm as both existing and potential customers who have seen the
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`disparaging articles, have either canceled contracts for EXPAREL, declined to
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`purchase EXPAREL, or are considering removing EXPAREL from hospital
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`formularies.
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`PARTIES
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`3.
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`Pacira is a pharmaceutical company, and a leading provider of non-
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`opioid pain management. Pacira is the manufacturer of the drug EXPAREL, a non-
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`opioid pain medication.
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`4.
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`Pacira’s headquarters are located at 5 Sylvan Way, Parsippany, New
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`Jersey, and the company is incorporated in Delaware, making Pacira a citizen of both
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`New Jersey and Delaware.
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`3
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`5.
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`The ASA is a professional medical association centered on the practice
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`of anesthesiology. The ASA is headquartered at 1061 American Lane, Schaumberg,
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`Illinois, 60173, and incorporated in New York, making it a citizen of Illinois and
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`New York.
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`6.
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`The ASA’s membership
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`is open
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`to physicians practicing
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`in
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`anesthesiology as well as anesthesiologist assistants and scientists interested in
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`anesthesiology; other non-physicians who nevertheless provide anesthesia care may
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`join as educational members.3 Active members of the ASA must also be members
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`of a component society; component societies are located in each of the 50 states,
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`including New Jersey, as well as the District of Columbia and Puerto Rico.4 The
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`ASA has over 54,000 members,5 including members located in New Jersey.
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`7.
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`8.
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`The ASA publishes a peer-reviewed medical journal, Anesthesiology.6
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`Dr. Evan Kharasch is the editor-in-chief of Anesthesiology and a
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`Professor of Anesthesiology at the Duke University School of Medicine in Durham,
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`North Carolina, located at Department of Anesthesiology, Box 3094, 905 S. Lasalle,
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`
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`3 ASA, Membership Eligibility, https://www.asahq.org/member-
`center/membership-eligibility (last visited Apr. 13, 2021).
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`4 ASA, Component Societies, https://www.asahq.org/about-asa/component-
`societies (last visited Apr. 13, 2021).
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`5 See supra note 3.
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`6 The Complaint uses both “Anesthesiology” and the “Journal” to refer to the peer-
`reviewed medical journal published by the ASA.
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`4
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`GSRB1 Room 20031, Durham, NC 27710. He holds a Ph.D. and an M.D. from
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`Northwestern University. Dr. Kharasch oversaw the publication of the challenged
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`articles, and is a longstanding proponent of opioid-based treatments. On information
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`and belief, Dr. Kharasch knew or recklessly disregarded the fact that statements
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`contained in the February articles were false or misleading when he either approved
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`them for publication or permitted them to be published.
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`9.
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`Dr. Nasir Hussain holds an M.D. and an M.Sc., and is an anesthesiology
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`resident at the Ohio State University College of Medicine in Columbus, Ohio,
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`located at The Ohio State University Wexner Medical Center Doan Hall, Department
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`of Anesthesiology, 410 W. 10th Ave., Columbus, OH, 43201. Dr. Hussain was the
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`lead author of the meta-analysis entitled, “Perineural Liposomal Bupivacaine Is Not
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`Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia: A
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`Systematic Review and Meta-analysis.” On information and belief, Dr. Hussain
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`knew or recklessly disregarded the fact that his statements about EXPAREL were
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`false or misleading.
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`10. Dr. Richard Brull holds an M.D. and is a Professor of Anesthesia at the
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`University of Toronto, and Chair in Ambulatory Anesthesia and Women’s Health at
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`Women’s College Hospital in Toronto, Ontario, located at University of Toronto,
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`Women’s College Hospital, 76 Grenville Street, Toronto ON, M5S182. Dr. Brull
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`co-authored “Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal
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`5
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`Bupivacaine for Peripheral Nerve Block Analgesia: A Systematic Review and
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`Meta-analysis.” On information and belief, Dr. Brull knew or recklessly disregarded
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`the fact that his statements about EXPAREL were false or misleading.
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`11. Dr. Brendan Sheehy is a resident in anesthesiology at The Ohio State
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`University College of Medicine in Columbus, Ohio, located at Ohio State University
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`Wexner Medical Center, Doan Hall, Department of Anesthesiology, 410 W. 10th
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`Ave., Columbus, OH, 43201. He holds an M.D., and is a co-author of “Perineural
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`Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral
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`Nerve Block Analgesia: A Systematic Review and Meta-analysis.” On information
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`and belief, Dr. Sheehy knew or recklessly disregarded the fact that his statements
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`about EXPAREL were false or misleading.
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`12. Dr. Michael K. Essandoh is an anesthesiologist at The Ohio State
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`University’s Wexner Medical Center in Columbus, Ohio, located at Ohio State
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`University Wexner Medical Center, Doan Hall, Department of Anesthesiology, 410
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`W. 10th Ave., Columbus, OH, 43201. He holds an M.D., and is a co-author of
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`“Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine
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`for Peripheral Nerve Block Analgesia: A Systematic Review and Meta-analysis.”
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`On information and belief, Dr. Essandoh knew or recklessly disregarded the fact that
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`his statements about EXPAREL were false or misleading.
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`6
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`13. Dr. David L. Stahl also co-authored “Perineural Liposomal
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`Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve
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`Block Analgesia: A Systematic Review and Meta-analysis.” Dr. Stahl is an
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`intensivist and anesthesiologist at The Ohio State University Wexner Medical Center
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`in Columbus, Ohio, located at Ohio State University Wexner Medical Center, Doan
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`Hall, Department of Anesthesiology, 410 W. 10th Ave., Columbus, OH, 43201. He
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`holds an M.D. On information and belief, Dr. Stahl knew or recklessly disregarded
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`the fact that his statements about EXPAREL were false or misleading.
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`14. Dr. Tristan E. Weaver is an anesthesiologist at The Ohio State
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`University in Columbus, Ohio, located at Ohio State University Wexner Medical
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`Center, Doan Hall, Department of Anesthesiology, 410 W. 10th Ave., Columbus,
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`OH, 43201. He, too, holds an M.D., and co-authored the meta-analysis “Perineural
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`Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral
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`Nerve Block Analgesia: A Systematic Review and Meta-analysis.” On information
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`and belief, Dr. Weaver knew or recklessly disregarded the fact that his statements
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`about EXPAREL were false or misleading.
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`15. Dr. Faraj W. Abdallah is the final co-author of “Perineural Liposomal
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`Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve
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`Block Analgesia: A Systematic Review and Meta-analysis.” Dr. Abdallah is an
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`Associate Professor of Anesthesiology and Pain Medicine at The Ottawa Hospital
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`7
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`in Ottawa, Ontario, located at University of Ottawa, Department of Anesthesiology
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`& Pain Medicine, the Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa,
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`ON, K1H8L6. He holds an M.D. and M.Sc. On information and belief, Dr. Abdallah
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`knew or recklessly disregarded the fact that his statements about EXPAREL were
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`false or misleading.
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`16. Dr. Brian Ilfeld is the lead author of the second article in question,
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`“Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or
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`Peripheral Nerve Block to Treat Postoperative Pain: A Narrative Review.” Dr.
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`Ilfeld holds an M.D. and an M.Sc., and is Professor of Anesthesiology In Residence
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`at the University of California, San Diego (UCSD) in La Jolla, California, located at
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`University of California, San Diego, Jacobs Medical Center at UC San Diego Health,
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`Department of Anesthesiology, 9300 Campus Point Drive, La Jolla, CA 92037. On
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`information and belief, Dr. Ilfeld knew or recklessly disregarded the fact that his
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`statements about EXPAREL were false or misleading.
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`17. Dr. James C. Eisenach co-authored “Clinical Effectiveness of
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`Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to
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`Treat Postoperative Pain: A Narrative Review.” Dr. Eisenach holds an M.S. and an
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`M.D. He is a Professor of Anesthesiology at Wake Forest University School of
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`Medicine in Winston-Salem, North Carolina, located at Wake Forest University
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`School of Medicine, Bowman Gray Center for Medical Education, 475 Vine Street,
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`8
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`Winston-Salem, NC 27101. On information and belief, Dr. Eisenach knew or
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`recklessly disregarded the fact that his statements about EXPAREL were false or
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`misleading.
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`18. Dr. Rodney A. Gabriel also co-authored “Clinical Effectiveness of
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`Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to
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`Treat Postoperative Pain: A Narrative Review.” Dr. Gabriel is an Assistant Clinical
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`Professor of Medicine at the University of California, San Diego in San Diego,
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`California, located at University of California, San Diego, Jacobs Medical Center at
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`UC San Diego Health, Department of Anesthesiology, 9300 Campus Point Drive
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`MC7770, La Jolla, CA 92037. He holds an M.D. from the University of California,
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`San Francisco. On information and belief, Dr. Gabriel knew or recklessly
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`disregarded the fact that his statements about EXPAREL were false or misleading.
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`19. Finally, Dr. Mary Ellen McCann holds an M.D. and is a Senior
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`Associate in Perioperative Anesthesia in the Boston Children’s Hospital’s
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`Departments of Anesthesia and Critical Care and Pain Medicine, and an Associate
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`Professor of Anesthesia at Harvard Medical School. Her place of business is located
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`at Boston Children’s Hospital, Department of Anesthesiology, Critical Care & Pain
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`Medicine, 300 Longwood Avenue, Bader, 3rd Floor, Boston, MA, 02115. Dr.
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`McCann authored the third piece, “Liposomal Bupivacaine: Effective, Cost-
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`effective, or (Just) Costly?” and appeared as a guest on Anesthesiology’s podcast to
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`9
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`discuss her editorial. On information and belief, Dr. McCann knew or recklessly
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`disregarded the fact that her statements about EXPAREL were false or misleading.
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`JURISDICTION AND VENUE
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`20. This Court has subject matter jurisdiction pursuant to 28 U.S.C.
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`§ 1332(a)(1). Pacira is incorporated in Delaware and its principal place of business
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`is located in New Jersey, making Pacira a citizen of Delaware and New Jersey. The
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`ASA is incorporated in New York, and its principal place of business is in Illinois,
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`making the ASA a citizen of New York and Illinois. On information and belief,
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`none of the individual defendants reside in New Jersey. Complete diversity
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`therefore exists between the parties, and the amount that Pacira seeks in damages
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`exceeds $75,000.
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`21. This Court has personal jurisdiction over the ASA by virtue of the
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`activities it conducts in New Jersey. On information and belief, the ASA has
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`members located in New Jersey, as well as subscribers to its official journal
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`Anesthesiology located in New Jersey. On information and belief, the ASA has
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`purposefully availed itself of the benefits and protections of New Jersey state law by
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`conducting activities here.
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`22. This Court has personal jurisdiction over the individual defendants
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`Kharasch, Hussain, Brull, Sheehy, Essandoh, Stahl, Weaver, Abdallah, Ilfeld,
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`Eisenach, Gabriel, and McCann because, on information and belief, the individual
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`10
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`defendants have sufficient minimum contacts with New Jersey and because the
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`effects of their conduct have been felt in New Jersey. Trade libel is an intentional
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`tort, and the individual defendants’ disparaging statements regarding liposomal
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`bupivacaine were directed at Pacira, the only FDA-approved manufacturer of
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`liposomal bupivacaine, brand-name EXPAREL. Pacira is headquartered in New
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`Jersey, and has felt the effects of the individual defendants’ conduct—lost revenue,
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`lost customers, and damage to EXPAREL’s reputation as an effective product—in
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`New Jersey. The individual defendants likewise targeted the forum by publishing
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`their false and misleading statements about EXPAREL in Anesthesiology, a national
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`publication available in New Jersey, and on information and belief, with subscribers
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`in New Jersey.
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`23. Venue is proper in this Court pursuant to 28 U.S.C. § 1391. Pacira
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`resides in this district due to the location of its headquarters in Parsippany, New
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`Jersey, and Pacira’s cause of action arose in this action due to the pecuniary harm
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`Pacira’s business suffered as a result of the ASA’s libelous and disparaging remarks
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`about Pacira’s product, which caused several of Pacira’s customers to cancel their
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`supply contracts for EXPAREL, or remove EXPAREL from their formularies. A
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`substantial part of the events giving rise to the claim therefore occurred in New
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`Jersey.
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`STATEMENT OF FACTS
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`EXPAREL (Liposomal Bupivacaine) and the Opioid Crisis
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`24. The opioid crisis facing the United States is unparalleled. Americans
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`consume and produce more opioids than any other country in the world. According
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`to the U.S. Centers for Disease Control and Prevention, the number of opioid
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`overdoses has quadrupled since 1999.7 This is unsurprising, given that opioid
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`prescriptions quadrupled during this period as well, triggering the present crisis. Id.
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`In 2015, the amount of opioids prescribed in the United States was enough for every
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`American to be medicated around the clock for three weeks. Id. In that same year,
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`nearly two-thirds of drug overdoses were linked to opioids, especially Percocet,
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`OxyContin, heroin, and fentanyl. Id. The opioid epidemic is not one that began on
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`a street corner: in many cases, it began in doctor’s offices and hospitals. Id.
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`25. Addressing the opioid epidemic will require a multi-faceted strategy,
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`but any such strategy must include changes to the way the medical community treats
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`and manages patient pain. “The era of opioids as the gold standard for pain
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`
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`7 The President’s Commission on Combating Drug Addiction and the Opioid
`Crisis, Appendix 3, at 115, available at
`https://www.hsdl.org/?search&exact=United+States.+President%27s+Commission
`+on+Combating+Drug+Addiction+and+the+Opioid+Crisis&searchfield=publisher
`&collection=limited&submitted=Search&advanced=1&release=0.
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`12
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`management is over.”8 Pacira’s corporate mission is to provide a non-opioid pain
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`management option to every patient. As noted above, Pacira is the manufacturer of
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`EXPAREL, the brand name for the sole liposomal bupivacaine product approved for
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`sale in the United States. Liposomal bupivacaine is a long-lasting, non-opioid, non-
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`narcotic pain medication used to treat post-surgical pain.
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`26. EXPAREL is used as a local anesthetic administered at the time of
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`surgery to control pain and reduce or eliminate the use of opioids for post-surgical
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`pain.9 EXPAREL contains specially formulated bupivacaine—it encapsulates
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`bupivacaine in liposomal chambers and is designed to release into the body over a
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`prolonged period of time as the chamber walls break down.10 In this respect, it is
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`able to deliver prolonged pain relief over non-liposomal bupivacaine. Because
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`EXPAREL works for longer periods of time, patients may need fewer doses of other
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`pain medications, including opioids, after surgery.11
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`27. EXPAREL is approved by the FDA for two indications. In 2011,
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`EXPAREL was approved for single-dose infiltration into the surgical site for local
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`8 Pacira, Commitment, https://www.pacira.com/commitments (last visited Apr. 13,
`2021).
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`9 Pacira, EXPAREL, https://www.pacira.com/products/exparel (last visited Apr. 13,
`2021).
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`10 EXPAREL, Frequently Asked Questions, https://www.exparel.com/patient/faq
`(last visited Apr. 13, 2021).
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`11 Id.
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`13
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`postoperative analgesia. In 2018, EXPAREL was approved as an interscalene
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`brachial plexus nerve blocking agent (blocking the nerves in the neck, near the
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`shoulder) to produce postsurgical regional analgesia.12 And just last month, the FDA
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`approved EXPAREL for use in children ages 6 to 17, making it the first long-acting
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`anesthetic ever approved for pediatric use.13 To date, over 8 million patients have
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`been treated with EXPAREL.14
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`28. Pacira sells EXPAREL to hospitals, ambulatory surgical centers, and
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`healthcare providers all over the country. The primary customers of EXPAREL are
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`the Department of Defense, hospitals, and ambulatory surgical centers. EXPAREL
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`is purchased for use by surgeons and anesthesiologists to provide long-lasting non-
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`opioid post-surgical pain relief. In 2019 and 2020, sales of EXPAREL represented
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`approximately 96% of Pacira’s total revenues.15 EXPAREL thus represents a crucial
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`part of Pacira’s business.
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`12 See supra note 9.
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`13 EXPAREL, Pediatric, https://www.exparel.com/hcp/specialty/pediatrics (last
`visited Apr. 13, 2021).
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`14 EXPAREL, Non-Opioid EXPAREL, https://www.exparel.com/patient/non-
`opioid-pain-medication (last visited Apr. 13, 2021).
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`15 Press Release, Pacira, Pacira BioSciences Reports Full-Year 2019 Preliminary
`Revenue of $421.0 Million (Jan. 9, 2020), https://investor.pacira.com/news-
`releases/news-release-details/pacira-biosciences-reports-full-year-2019-
`preliminary-
`revenue#:~:text=Full%2Dyear%20EXPAREL%20net%20product,to%20%241.3%
`20million%20in%202018; Press Release, Pacira, Pacira Reports Record Revenue
`
`14
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`Anesthesiology
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`29. Anesthesiology (the “Journal” or “Anesthesiology”) is the “official
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`journal of the American Society of Anesthesiologists.”16 As such, it claims to “lead[]
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`the world in publishing and disseminating the highest quality work to inform daily
`
`clinical practice and transform the practice of medicine in the specialty.”17 The
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`Journal publishes 12 issues a year, and has a top impact factor ranking of 1 out of 32
`
`in the field of anesthesiology.18 An impact factor ranking is one metric used to
`
`measure the importance of an academic journal within its field, measuring the
`
`frequency with which the journal is cited.19
`
`30. The Journal is available in both print and online forms; indeed, the ASA
`
`provides free online access to certain highlighted articles, and free access to many
`
`
`for 2020 of $429.6 Million (Jan. 7, 2021), https://investor.pacira.com/news-
`releases/news-release-details/pacira-reports-record-revenue-2020-4296-
`million#:~:text=Full%2Dyear%20EXPAREL%20net%20product,to%20%24407.9
`%20million%20in%202019.&text=Full%2Dyear%20iovera%C2%B0%20net,to%2
`0%247.9%20million%20in%202019.
`
`16 See supra note 1.
`
`17 Id.
`
`18 Wolters Kluwer, Anesthesiology,
`https://www.wolterskluwer.com/en/solutions/lippincott-audience-solutions/media-
`kits/anesthesiology (last visited Apr. 13, 2021).
`
`19 Clarivate, Journal Citation Reports: Learn the Basics,
`https://clarivate.libguides.com/jcr (last visited Apr. 13, 2021).
`
`15
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 16 of 45 PageID: 16
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`
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`previously published articles.20 A subscription is included as a free benefit for ASA
`
`
`
`
`
`members, but subscriptions are also available to any individual for a fee, as well as
`
`to institutions.21 The Journal has approximately 51,502 subscribers in total,
`
`including 43,332 print subscribers, and 8,170 online subscribers. The website
`
`receives, on average, 422,964 visits per month.22
`
`Bias of the Editor-in-Chief of Anesthesiology
`
`31. Dr. Evan Kharasch, the Editor-in-Chief of Anesthesiology appears to
`
`have a significant bias against EXPAREL, in favor of opioids for treatment of pain.
`
`As Editor-in-Chief, he has final say over the content published in each issue, and on
`
`information and belief, is using his position to advance a pro-opioid agenda and
`
`disparage competitive alternatives like EXPAREL. In fact, Kharasch has previously
`
`made public statements disparaging products like EXPAREL. For example, Dr.
`
`Kharasch authored an editorial in an April 2020 issue of Anesthesiology in which he
`
`described using non-opioid drugs like EXPAREL, which seek to reduce opioid use
`
`post-surgery, as an “arbitrary and commercially influenced” approach to
`
`
`
`20 ASA Publ’ns, Issues: Volume 134, Issue 5,
`https://pubs.asahq.org/anesthesiology/issue (last visited Apr. 12, 2021); see also
`ASA Publ’ns, Issues: Volume 132, Issue 1,
`https://pubs.asahq.org/anesthesiology/issue/132/1 (prior publications).
`
`21 ASA Publ’ns, Anesthesiology Access Options,
`https://pubs.asahq.org/anesthesiology/pages/access-options (last visited Apr. 13,
`2021).
`
`22 See supra note 18, at Audience tab.
`
`16
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 17 of 45 PageID: 17
`
`
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`management of postoperative pain, that “presently lack[s] compelling evidence.”23
`
`
`
`
`
`Asking whether “the elimination of intraoperative opioid use [is] a reasonable goal,”
`
`Kharasch wrote that “[w]e appear poised to fundamentally change anesthesia
`
`practice without having a rational basis for doing so.”24 Kharasch’s own research
`
`interests include studies supporting opioid use in post-surgery patients.25
`
`32. The anti-EXPAREL bias of Anesthesiology and its Editor-in-Chief is
`
`also apparent from a comparison of the covers of the journal’s January 2021 and
`
`February 2021 issues. The January 2021 cover highlighted a meta-analysis that
`
`reviewed an anesthesiology procedure called a “quadratus lumborum block,” used
`
`for cesarean delivery.26 The meta-analysis—conducted by the same lead author, Dr.
`
`Hussain—reached an unfavorable conclusion regarding the effectiveness of that
`
`
`
`23 Evan D. Kharasch et al., Rational Perioperative Opioid Management in the Era
`of the Opioid Crisis, 132 Anesthesiology 603-05 (Apr. 2020).
`
`24 Id.
`25 See, e.g., Evan D. Kharasch, Opioid-Free Anesthesia: Time to Regain Our
`Balance, 134 Anesthesiology 509-14 (Apr. 2021) (arguing that “Opioid-free
`anesthesia may be feasible. Nevertheless, it appears neither logical nor beneficial to
`patients.”); James P. Rathmell et al., Frontiers in Opioid Pharmacology, 128
`Anesthesiology 865 (May 2018); Evan D. Kharasch, Intraoperative Methadone:
`Rediscovery, Reappraisal, and Reinvigoration?, 112 Anesthesia & Analgesia 13
`(Jan. 2011).
`
`26 ASA Publ’ns, Issues: Volume 134, Issue 1,
`https://pubs.asahq.org/anesthesiology/issue/134/1 (last visited Apr. 13, 2021).
`
`17
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 18 of 45 PageID: 18
`
`
`
`procedure.27 The cover of the January publication stated simply, “Quadratus
`
`
`
`
`
`Lumborum Block for Ceasarean Delivery.”28 In clear contrast, the EXPAREL meta-
`
`analysis also reached an unfavorable conclusion regarding the treatment, but the
`
`February cover contained the pejorative teaser: “Liposomal Bupivacaine Is Not
`
`Superior to Standard Local Anesthetics.” See Ex. 7, Anesthesiology Feb. 2021
`
`cover.
`
`33. On information and belief, Kharasch has also used his position as
`
`Editor-in-Chief to suppress information favorable to EXPAREL, in order to further
`
`his pro-opioid agenda. Pacira understands that Anesthesiology rejected publication
`
`of a letter to the editor that reported favorable experience with EXPAREL, and
`
`which expressed concern about the over-generalizations contained in the meta-
`
`analysis published in the February 2021 issue.
`
`The February 2021 Issue of Anesthesiology Disparages EXPAREL
`
`34. Consistent with Dr. Kharasch’s bias against EXPAREL, including the
`
`bias conveyed on the cover of the February 2021 issue of Anesthesiology, the
`
`February 2021 issue focuses on the efficacy of EXPAREL, and contains significant
`
`
`
`27 Dr. Nasir Hussain et al., Postoperative Analgesic Effectiveness of Quadratus
`Lumborum Block for Cesarean Delivery under Spinal Anesthesia: A Systematic
`Review and Meta-analysis, 134 Anesthesiology 72-87 (Jan. 2021).
`
`28 See supra note 26.
`
`18
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 19 of 45 PageID: 19
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`
`
`
`
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`
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`false and misleading representations of fact that seriously disparage Pacira’s product
`
`EXPAREL.
`
`35. As noted above, the cover of the issue states that “Liposomal
`
`Bupivacaine Is Not Superior to Standard Local Anesthetics,” with no accompanying
`
`qualifying or explanatory information. See Ex. 7, Anesthesiology Feb. 2021 cover.
`
`The issue also contains three articles—a purported meta-analysis, a so-called
`
`narrative review, and an editorial based on the meta-analysis and narrative review—
`
`that contain false and misleading statements and conclusions that disparage
`
`EXPAREL. These representations were also advanced in the ASA’s CME program
`
`and podcast. The three articles are:
`
`a.
`
`b.
`
`c.
`
`Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal
`Bupivacaine for Peripheral Nerve Block Analgesia: A Systematic
`Review and Meta-analysis, authored by Defendants Nasir Hussain,
`Richard Brull, Brendan Sheehy, Michael K. Essandoh, David L. Stahl,
`Tristan E. Weaver, and Faraj W. Abdallah (“Hussain Article”)
`(attached as Ex. 1). This article was at one point one of the “most
`viewed” articles on the ASA’s website, where the article is offered for
`anyone to view for free.
`
`Clinical Effectiveness of Liposomal Bupivacaine Administered by
`Infiltration or Peripheral Nerve Block to Treat Postoperative Pain: A
`Narrative Review, authored by Defendants Brian M. Ilfeld, James C.
`Eisenach, and Rodney A. Gabriel (“Ilfeld Review”) (attached as Ex. 2).
`
`Liposomal Bupivacaine: Effective, Cost-effective, or (Just) Costly,
`authored by Defendant Mary Ellen McCann (“McCann Editorial”)
`(attached as Ex. 3).
`
`
`19
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 20 of 45 PageID: 20
`
`
`
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`
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`
`
`36. All three articles and the Journal cover create the illusion of rigorous
`
`and reliable scientific analysis using carefully curated data and technical jargon. The
`
`truth is anything but. Each article is riddled with errors, some of which are such
`
`egregious deviations from standard practice as to make clear that the authors
`
`designed their analyses to arrive at a predetermined outcome.
`
`37. Three significant problems in particular are common to all three
`
`articles. First, the articles rely heavily on pain studies that make no attempt to
`
`account for the fact that patients receive other medication beyond the test drugs.
`
`Basic ethics dictate that patients cannot be left in pain; they are provided opioids and
`
`other pain medication as needed. Thus, it is no surprise that patients in groups
`
`receiving EXPAREL and those receiving alternative medications may report similar
`
`pain scores, because additional analgesics control the pain. This is a common
`
`problem with many pain studies. Rather, it is important to look to studies that gather
`
`the data needed to make calculations to account for the additional pain medicine.
`
`The authors of all three studies rely heavily on trials that did not do that.
`
`38. Second, all three articles (and the issue cover) reach blanket,
`
`unqualified conclusions that EXPAREL is not effective—in any type of use or any
`
`type of surgery. Without limiting their conclusions to specific infiltration methods
`
`for specific surgical procedures, the statements are false. The amount of benefit that
`
`EXPAREL provides a patient varies significantly by the type of surgery the patient
`
`20
`
`
`
`Case 2:21-cv-09264-MCA-JBC Document 1 Filed 04/14/21 Page 21 of 45 PageID: 21
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`
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`
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`underwent and how EXPAREL was used (i.e., direct infiltration near the wound site
`
`or a peripheral nerve block to the major nerves that provide sensation to the surgical
`
`area). However, even if there are some procedures for which EXPAREL may not
`
`provide much additional benefit over alternative anesthetics (e.g., procedures that do
`
`not cause pain much beyond 24 hours), there are certain procedures for which
`
`EXPAREL is undoubtedly effective—rendering the blanket conclusion false.
`
`39. Third, in order to reach their conclusions, the authors of all three articles
`
`choose to discredit industry-sponsored trials as supposedly
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