Judge Tosses Drug Company’s Libel Lawsuit Against Medical Society

— “Pharmaceutical companies are not free to intimidate the scientific process,” says ASA President

https://www.medpagetoday.com/special-reports/exclusives/97077

A federal court in New Jersey has dismissed a pharmaceutical company’s lawsuit against a medical society, its flagship journal editor, and contributing authors that claimed articles it published were libelous and damaging to the reputation of the company’s pain drug.

U.S. District Court Judge Madeline Cox Arleo ruled that statements made in articles in the American Society of Anesthesiologists (ASA) journal Anesthesiology about Pacira’s pain drug Exparel (bupivacaine) were scientific opinions that by their nature can’t constitute defamation.

“The peer-review process — not a courtroom — thus provides the best mechanism for resolving scientific uncertainties,” Arleo wrote in her opinion.

Pacira filed the suit in April 2021 against the ASA, the editor-in-chief of Anesthesiology, and 11 contributing authors, alleging that three articles about Exparel published in the February 2021 issue of the journal, along with a related podcast and continuing medical education (CME) program, created a false impression that Exparel was not an effective analgesic. Thus, the company sought retractions of the papers, in addition to unspecified damages.

Pacira’s two key allegations were that the articles were “scientifically unsound,” and that the journal failed to disclose that certain authors received payments from its competitors.

ASA President Randall Clark, MD, told MedPage Today that the judge ruled that the payments were minimal and unlikely to affect an author’s judgment.

The other allegation focused on whether the methodology used in the studies was accurate and whether studies were excluded improperly, Clark said.

“The judge clearly stated that’s a discussion for scientists to debate during the peer review process and then after publication, in either the refutation of an article through a subsequent study, or solidifying the finding by separate studies finding the same thing,” Clark told MedPage Today.

“This decision from the federal court makes clear that pharmaceutical companies are not free to intimidate the scientific process by filing lawsuits,” he said in a statement published by the ASA.

“The essence of scientific progress is conducting scientific studies, [followed by] the publication of those studies … for making it available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design,” Clark told MedPage Today. “That’s how we make medical progress. … There was a significant threat to that system of medical progress by this lawsuit. So we’re very pleased that the judge found in our favor.”

Tony Molloy, chief legal and compliance officer for Pacira, said in an emailed statement that the papers’ conclusions remain “severely flawed, plagued by personal biases and the intentional use of widely rejected analytical methods.”

“The Court reached a blanket conclusion that, even when ‘methodologically flawed,’ absent fraudulent data, a court cannot determine if a statement in a scientific journal is true or false,” Molloy said in the statement. “Pacira remains confident that continued scrutiny will only further demonstrate the falsity of Anesthesiology’s publications.”

When asked whether the company would appeal the decision, a spokesperson said via email that Pacira is “currently reviewing all of their options.”

Exparel, an extended-release bupivacaine, is a local anesthetic given at the time of surgery to control pain and reduce or eliminate use of opioids afterwards. It was first approved by the FDA in 2011 to treat postoperative pain, and then earned a subsequent indication in 2018 for brachial plexus nerve block, as well as a pediatric indication in early 2021.

Exparel is Pacira’s main product and accounted for about 96% of the company’s total revenues in 2019 and 2020, according to the original complaint.

Filed under: General Problems