Claims defendant promises not to repeat won't cause irreparable injury

Ferring Pharmaceuticals Inc. v. Watson Pharmaceuticals, 2013 WL 1405226 (D.N.J.)

The parties compete in the market for progesterone supplements used for in vitro fertilization/assisted reproductive technology (ART).  The traditional method of supplementation is through intramuscular injections, but the parties’ products (Endometrin and Crinone, respectively) are vaginal inserts to supplement or replace daily intramuscular shots. Endometrin is a capsule applied two or three times a day, while Crinone is a gel delivered via applicator once daily. There are no other FDA-approved vaginal inserts.

Ferring sued Watson over ads allegedly painting Endometrin as dangerous, not effective, disliked by consumers, and inferior to Crinone.  Watson hosted and invited doctors and healthcare professionals to two events (in-person and webcast) on September 11, 2012, at which Dr. Silverberg, a paid Watson consultant, detailed the qualities and success rates of Crinone in an effort to influence attendees to purchase the product.   Silverberg’s key claims were (1) reference to a “Black Box warning” on Endometrin; (2) that patients preferred Crinone; and (3) that Endometrin hasn’t been proven effective for women over 35.

During one webcast, Silverberg indicated that “if you read the package insert for Endometrin there is a Black Box warning showing the efficacy has not been demonstrated with [ ... ] Endometrin for patients 35 years of age and older.” Though the packaging does state that efficacy in women 35 and older hasn’t been clearly established, Endometrin doesn’t have a Black Box warning.  A Black Box is the strongest warning required by the FDA, and signifies that medical studies indicate the drug carries a significant risk of serious or life-threatening adverse effects.  Silverberg, informed of the error, didn’t repeat this misstatement on the second webcast and certified that he wouldn’t repeat it in the future.

Silverberg also said that, comparing Crinone to Endometrin based on a phone survey, 94% of patients thought that Crinone was easier to incorporate into their daily lifestyle, and gave similarly high percentages for comparative convenience/comfort.  Ferring argued that there was no evidence that the women interviewed used both products and were therefore able to compare the two; the percentages were instead just percentages of women who liked Crinone  Other women in the study allegedly liked Endometrin, but Silverberg didn’t report those results.  Ferring contended that this was not a head-to-head comparative study, despite Silverberg’s claims, which therefore allegedly violated FDA requirements for making preference claims about pharmaceuticals.  Watson conceded that the percentages were inaccurate, and the survey showed 68.1% preference, but argued that the survey was in fact head-to-head.

Silverberg also said in one session that Crinone, unlike other products, had been established in women 22-47, including women 35 and older.  Ferring argued that the studies he cited didn’t stand for that proposition. At the same time, he said that Endometrin “was not found to be efficacious for women over the age of 35.” Watson disagreed about the meaning of the data.

The court denied Ferring’s motion for a preliminary injunction for want of showing likely irreparable harm.  Ferring argued that information on the internet was likely to endure and continue to do harm, but Silverberg agreed that he misstated the black box warning and removed it for his second webcast, and certified that he wouldn’t say it again.  Further, at Watson’s request, in future presentations he’ll only make specified statements as to the efficacy of Endometrin for women over 35, in accordance with the package insert.  Ferring didn’t show that the webcasts were still available online.

The court then briefly considered likely success on the merits, though it didn’t have to do so.  While a completely unsubstantiated ad claim is literally false without further affirmative evidence from the plaintiff, Novartis Consumer Health, Inc. v. Johnson & Johnson–Merck Consumer Pharm. Co., 290 F.3d 578 (3d Cir.2002), it wasn’t clear that the claim at issue here was “completely unsubstantiated.” Rather, Watson showed that there was at least some support for the claims.  (As establishment claims, they could be falsified by showing that the evidence didn’t in fact support them—but that’s an issue for later.)