Four Lessons From Product-Related Defamation Litigation for Pharmaceutical and Life Sciences Companies

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

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In the wake of these developments, we surveyed several key decisions addressing defamation, product disparagement, false advertising, and similar claims brought by life sciences companies. Though the law on these claims varies to some extent from jurisdiction to jurisdiction — and so, pharmaceutical and life sciences companies considering (or confronting) such claims ought to consider the specific jurisdiction in which their claims arise — these decisions reveal four general lessons to keep in mind.

1. For Defamation Claims, Relief Is Typically Limited to Compensatory Damages Absent Actual Malice

In product disparagement and trade libel litigation, courts have long treated commentary on product safety as a matter of public concern. As a result, plaintiffs seeking relief from speech that targets products must show that the speaker acted with actual malice to recover anything beyond compensatory damages. This is important as it is often difficult to prove compensatory damages in defamation cases.

To show actual malice, a plaintiff must prove the defendant knew the statements were false or acted with reckless disregard for the truth. This can be challenging for those in the pharmaceutical and life sciences industries. For example, the US District Court for the District of Massachusetts has held that scientifically substantiated commentary in a peer‑reviewed journal about a product’s ingredients did not demonstrate actual malice because the authors did not act in bad faith. SeeHi-Tech Pharmaceuticals, Inc. v. Cohen, 277 F.Supp.3d 236, 248 (D. Mass. 2016), as amended (Oct. 28, 2016).

Practical Takeaway: Assess whether the comments exhibit a reckless disregard for the truth or constitute good faith scientific dialogue. If the latter, consider potential limits on recovery.

2. Consumer Perception Matters as Much if Not More Than the Literal Words

Section 43(a) of the Lanham Act provides a cause of action for false or misleading representations about products. Importantly, this encompasses not only literal falsehood but also false representations made by suggestion, implication, or innuendo. In cases involving the latter, courts look at evidence like consumer-perception surveys and witness reactions to determine whether a representation is false. Marketing campaigns that argue a rival’s product is inferior without solid substantiation or consumer-perception evidence can increase exposure to, among other things, false advertising allegations. For example, in litigation over Anacin advertisements claiming superiority to Tylenol, the US Court of Appeals for the Second Circuit affirmed a judgment finding a violation of the Lanham Act, emphasizing that the “audience reaction to the advertisements” supported the district court’s judgment. Am. Home Prods. Corp. v. Johnson & Johnson, 577 F.2d 160, 165 (2d Cir. 1978).

Practical Takeaway: Pay attention to more than the words alone. Use consumer‑perception surveys and similar evidence to judge whether the words, even if technically true, are nevertheless false or misleading.

3. Scientific Discourse Enjoys More Robust Protection Than Commercial Advertising

Courts draw a sharp line between commercial advertising and scientific discourse. Pursuing claims for the commercial impact of reference works or scientific debate alone is an uphill battle. For example, the US District Court for the District of New Jersey, in a decision affirmed by the US Court of Appeals for the Third Circuit, rejected a pharmaceutical manufacturer’s libel action against a medical journal for making negative statements regarding the manufacturer’s pain medication. Pacira Biosciences, Inc. v. Am. Soc’y of Anesthesiologists, Inc., 583 F. Supp. 3d 654, 658 (D.N.J. 2022), aff’d, 63 F.4th 240 (3d Cir. 2023). In so doing, the District of New Jersey explained that peer‑reviewed scientific discourse has robust First Amendment protection. See id.

Practical Takeaway: Be cautious when considering actions involving academic or reference publications. Instead of litigation, consider making factual corrections and contextual clarifications if appropriate.

4. Privilege Protecting Fair Comment on Matters of Public Concern Can Be Overcome if Abused

Companies generally enjoy a qualified privilege to make fair comments about matters of public concern, which typically covers comments about life sciences products. However, this privilege can be destroyed if abused. For example, in a defamation suit initiated by a manufacturer of joint implants against health and dental insurers, the Tenth Circuit held that qualified privilege does not apply if the speaker makes the statement with knowledge of or reckless disregard for its truth or falsity. See TMJ Implants, Inc. v. Aetna, Inc., 498 F.3d 1175, 1199 (10th Cir. 2007).

Practical Takeaway: Implement review and sign‑off protocols for publicly accessible statements by employees to avoid claims of abuse.

Bottom Line

Scientific debate, consumer perception, and comparative statements regarding products are increasingly shaping risk for life sciences companies. The more that this discourse ventures away from academic publications and into the commercial context, the more those statements carry risk for both employers and employees. These trends reward substantiation in advance of publication, careful attention to consumer perception, a focus on scientific (rather than commercial) literature, and active monitoring of publication scope. 

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