Pacira Takes ASA to Court in Defense of Non-Opioid Painkiller

With its only approved drug product on the line, Pacira Biosciences is fighting back against what it's calling “misrepresentation of the clinical effectiveness” of its non-opioid pain reliever Exparel. 

Anesthesiology, the official medical journal of the American Society of Anesthesiologists (ASA), published three articles that Pacira claim create the impression Exparel, its post-surgical bupivacaine liposome injectable suspension, is not an effective analgesic. A headline stating “Liposomal Bupivacaine Is Not Superior” to standard local anesthetics was both printed in the journal and published to the website in the February 2021 issue, along with two additional articles that Pacira states “overwhelmingly overlook the positive body of literature that exists for EXPAREL.” 

Pacira CEO Dave Stack said in a statement, “We 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 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.” 

Complaints from Pacira involved the meta-analysis done of the drug, financial and commercial conflicts with journal staff.

According to the lawsuit, “Meta-analyses should only be conducted when the studies included are similar in terms of procedure type, patient population, and outcomes evaluated—this analysis combined a variety of administration techniques which included a variety of off-label uses... 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.” 

In addition to the met-analysis, a paper examining 76 randomized controlled trials determined evidence did not support the use of the drug. There was also an editorial, claiming the drug was not cost effective. Exparel costs about $300 per dose, while the price of generic bupivacaine is around $3 a dose.

Another key complaint of the suit was regarding three authors of the publication, as well as its editor-in-chief. The complaint claimed they failed to disclose relationships with competitor manufacturers for the Exparel product. That included $14 million in research funding involving competitor treatments. 

Pacira filed a preliminary injunction for the “removal of materials containing these misleading statements from its website in order to prevent the continued spread of misinformation.” In general, pretrial injunctions are not allowed because a legal decision has not yet been made to validate the claim of libel.  

The suit claims Pacira has lost business as a result of the ASA’s articles, due to the reputation of the drug suffering “considerably.” Ongoing and “irreparable” harm to business is the reasoning behind the preliminary injunction motion. 

The New Jersey-based pharma is going into this libel suit no-holds-barred, having hired the fifth largest law firm in the US, Latham and Watkins. The firm is also filing an expedited discovery motion to gain documents to expose what the company is calling “ASA’s unconscionable conflicts of interest and anti-EXPAREL bias.” 

“EXPAREL 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,” said Stack. 

This isn’t Pacira’s first lawsuit filed to back up Exparel. In 2015 the company accused the FDA of overstepping its authority by issuing a warning letter alleging inappropriate marketing. The FDA alleged Exparel was being promoted for surgeries in which it was not approved and also argued it should only be marketed for 24-hour pain relief, not 72 hours. 

Pacira won that one with the FDA, after the government agency took the unusual step of removing its warning letter from its website.  

Just last year the company paid out $3.5 million to get the company out of a legal scrape involving paying doctors bogus research grants to prescribe Exparel. The company had approved and funded grants from 2012-2015 despite lack of documentation of proposed research and absence of follow-up to be sure the work was actually being done.