The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications. The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA sought and received a stay of that case through October 30, 2015, so the parties can discuss settlement, commentators have begun to speculate about what comes next.
The immediate answer, not surprisingly, seems to be “more lawsuits.”
Taking a page out of the Amarin playbook, Pacira Pharmaceuticals, Inc. has now filed its own lawsuit in the Southern District of New York seeking “to establish its right to speak in a truthful and non-misleading fashion about lawful uses of its product EXPAREL.”
According to Pacira’s complaint, EXPAREL combines a local anesthetic used for controlling postsurgical pain (bupivacaine) with a “novel delivery platform called DepoFoam that allows the drug to be administered with precision and provide[s] more extended pain relief than plain bupivacaine.” Two successful clinical trials involving “two very different surgical procedures” (bunionectomies and hemorroidectomies) are alleged to have “provide[d] a valid basis . . . to determine that EXPAREL can be used safely and effectively in any surgical site.”
The FDA approved the New Drug Application (NDA) for EXPAREL with a broad “Indications and Usage,” for “administration into the surgical site to produce postsurgical analgesia.” And with that in hand, according to the complaint, “Pacira spoke with physicians, surgeons, and anesthesiologists about use of EXPAREL to produce postsurgical analgesia in different surgical sites” in “truthful and non-misleading ways.” It also shared “the actual experiences that other physicians had administering EXPAREL in different surgical sites.” In doing so, Pacira submitted its promotional materials to the FDA for review. After three years, however, the FDA issued a Warning Letter criticizing promotion of EXPAREL for use outside of bunionectomies and hemorroidectomies, and cautioned that some of Pacira’s promotion was criminal. A July 24, 2015, letter from the FDA closing out the Warning Letter declared Pacira’s promotion to be “violative” of the FDCA, and noted that Pacira had stopped disseminating materials with statements referenced in the Warning Letter.
As the complaint makes clear, Pacira and the FDA are in disagreement over the scope of the approved indications for use of EXPAREL, and thus in disagreement over whether Pacira is even engaged in so-called “off-label” promotion. Nevertheless, seeking a preliminary injunction like that issued by Judge Paul Engelmayer of the Southern District of New York in Amarin Pharm, Inc. v. FDA, No. 15 Civ. 35888, 2015 WL 4720039, 2015 U.S. Dist. LEXIS 103944 (S.D.N.Y. Aug. 7, 2015), Pacira seeks its own declaration that the FDA cannot take action against it for truthful, non-misleading statements about EXPAREL. Whether Judge Ronnie Abrams will follow suit, of course, remains to be seen, but Pacira has Second Circuit precedent—United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)—on its side as well.
The Amarin and Pacira lawsuits provide one proactive strategy that other manufacturers might consider if the FDA has taken action over—or threatens to take action over—what the company believes to be truthful, non-misleading statements about its FDA-regulated product. If this trickle of litigation turns into a torrent, however, courts might start to resist their new role in adjudicating the truthful, non-misleading nature of particular promotional statements, and Article III standing issue—and whether a given lawsuit seeks an improper advisory opinion—may come under closer scrutiny.
As with Amarin, there surely will be more to come on Pacira as well.