By David C. Gibbons –
An August 28, 2015 letter to Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, from the attorneys representing Amarin, Inc. (“Amarin”) indicated that the parties on both sides of Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. filed May 7, 2015), may be engaged in settlement discussions. See Joint Letter, Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 28, 2015), ECF No. 75 (“Joint Letter”). We previously discussed the court’s decision granting Amarin’s Motion for Preliminary Injunction (“PI Motion”) against FDA prosecution for Amarin’s off-label promotion of Vascepa here. In an Order issued three days after the court’s decision, Judge Engelmayer directed the parties to confer no later than August 24 and submit a joint letter no later than August 28 regarding “the future course of and next steps in the case.” Order, Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 10, 2015).
The Joint Letter stated that “[t]he parties have agreed to explore the possibility of settlement” in the case and requested that further proceedings be stayed until October 30, 2015. At that time, the parties would file another joint letter to the court, providing notice regarding the next steps they plan to take.
Certainly FDA, on the heels of losing the PI Motion, may believe it is likely to lose the case on the merits if the case proceeds to final judgment. Settlement may allow FDA to cut its losses at this point and regroup on its strategy concerning the regulation of off-label promotion.
Amarin too may have something to gain if it settles. With the leverage of its victory on the PI Motion, Amarin may be able to obtain FDA approval for Amarin to continue to promote the use of Vascepa in patients with persistently high triglycerides, perhaps through at least the reporting of results from the REDUCE-IT trial in approximately 2018. The court, in its decision on the PI motion, was not prepared to extend its injunction for any given period of time, given that the court’s Opinion was based on the “current record,” thus the court recognized that statements Amarin may make today that are fair and balanced “may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired.” Opinion and Order at 66, Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 7, 2015).
One important question now is: what happens if Amarin is settled? The most significant effect might be that the parties agree, as a term of settlement, to jointly request that the court vacate its August 7, 2015, Order granting Amarin’s PI Motion. We certainly think vacating the court’s August 7 Order could be a term on the table during settlement negotiations, but it remains to be seen whether Amarin and the other plaintiffs would agree to such a term, if they agree to settle at all.
Even if the August 7 Order is vacated, it may, like other significant rulings, live on. Readers may recall the Washington Legal Foundation (“WLF”) line of cases that challenged FDA’s regulations concerning off-label promotion. In particular, WLF filed a lawsuit claiming that certain FDA Guidance documents violated First Amendment protection of commercial speech. Washington Legal Foundation v. Henney, 202 F.3d 331, 332-334 (D.C. Cir. 2000). In that case, the district court granted WLF’s summary judgment motion, holding that FDA’s applicable Guidances violated the First Amendment, and enjoined FDA from prohibiting manufacturers’ dissemination of “enduring materials” as well as suggesting content to Continuing Medical Education program providers. Id. at 334. On appeal, during oral arguments before the Court of Appeals for the D.C. Circuit, FDA conceded that neither the Federal Food, Drug, and Cosmetic Act (“FDCA”) nor FDA Guidance documents gave FDA authority to restrict manufacturer speech in these areas. Id. at 335. With that admission on the record, there was no longer a “constitutional controversy between the parties that remain[ed] to be resolved,” and the court dismissed FDA’s appeal and vacated the district court’s decisions and injunctions declaring parts of the FDCA and FDA guidance documents unconstitutional. Id. at 335, 336. However, the district court’s reasoning and holding as it applied to FDA regulation of the dissemination of off-label information continued to carry weight and perhaps provided the impetus for later challenges to such regulation.
Similarly, a case involving a district court interpreting the Hatch-Waxman 180-day exclusivity provisions that was vacated as moot on appeal continued to carry some weight. Inwood Laboratories, Inc. v. Young, 723 F. Supp. 1523 (D.D.C. 1989), vacated as moot, 43 F.3d 712 (D.C. Cir. 1989). Despite being vacated, the Inwood decision has been cited in numerous recent cases on the subject of 180-day exclusivity. See, e.g., Ranbaxy Labs., Ltd. v. Leavitt, 459 F. Supp. 2d 1, 3-4 (D.D.C. 2006).
Ultimately, we cannot Predict whether the Amarin case will be settled or, if so, whether the principles articulated by the court expounding and expanding on United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), will carry future weight. But, we continue to watch the Amarin case and its further developments.