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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

United States District Court, N.D. Illinois, Eastern Division

May 29, 2018

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to all cases)



         Some of the plaintiffs in this multidistrict litigation (MDL) proceeding who allege that they were injured as a result of taking AndroGel, a testosterone replacement therapy (TRT) drug, have sued defendants Besins Healthcare Inc. (Besins Inc.) and Besins Healthcare, S.A. (Besins S.A.) (collectively, the Besins defendants) for their alleged involvement in designing, manufacturing, or selling the drug. In September 2015, the Court dismissed six claims that plaintiffs conceded could not be properly asserted against the Besins defendants: strict liability-failure to warn; negligent misrepresentation; breach of implied warranty of merchantability; breach of express warranty; fraud; and consumer protection. In re Testosterone Replacement Therapy Prods. Liab. Litig., 136 F.Supp.3d 968 (N.D. Ill. 2015). In that same decision, the Court denied the Besins defendants' motion to dismiss plaintiffs' claims for strict liability-design defect; negligence; redhibition; and claims seeking damages pursuant to those causes of action, including unjust enrichment. In October 2016, the Court denied Besins S.A.'s motion to dismiss all claims against it for lack of personal jurisdiction. In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, MDL No. 2545, 2016 WL 5890022 (N.D. Ill. Oct. 10, 2016). And in May 2017, the Court granted the Besins defendants' motion for summary judgment on all claims asserted against them by Robert Rowley-one of the plaintiffs whose case has been selected for a bellwether trial and the only bellwether plaintiff to date to have sued the Besins defendants. In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, MDL No. 2545, Case Management Order No. 50 (May 8, 2017).

         The Besins defendants have now moved for summary judgment against all plaintiffs in the MDL on the remaining claims against them. For the following reasons, the Court grants the motion.


         The following facts are undisputed unless otherwise noted. Besins S.A. is a privately held Belgian corporation with headquarters in Monaco. It co-developed the pharmaceutical formulation for AndroGel and has manufactured AndroGel at locations outside of the United States, including for sale in the United States. Besins S.A. has never marketed AndroGel in the United States. Rather, it has licensed to defendant AbbVie, Inc.-and, previously, to AbbVie's predecessor entities, defendants Unimed Pharmaceuticals, LLC and Solvay Pharmaceuticals, Inc.-the exclusive right to market and distribute AndroGel in the United States.

         Besins S.A. maintains the worldwide pharmacovigilance database for AndroGel. The database contains all reported adverse events for AndroGel, including those from the United States. Besins S.A. has a pharmacovigilance department that, among other things, "[c]ollect[s] all safety information on [AndroGel] obtained from published literature, spontaneous case reports or clinical studies, " "[e]nsure[s] timely expedited reporting of adverse events, " and evaluates AndroGel's "risk / benefit ratio through signal detection activities." Pls.' Opp., Ex. 5 at 7. Besins S.A. also has a global safety committee for Besins products that, among other things, analyzes safety signals, assesses "risk / benefit ratio[s], " id., and decides whether to raise the possibility of "suspending the market authorisation of [a] Besins' [sic] product . . . to the Global Labelling Committee." Id., Ex. 6 at 9.

         In early 2013, Besins S.A. and AbbVie entered into a Safety Data Exchange Agreement (Safety Agreement) "for purposes of facilitating accurate, timely exchange of adverse events and each company's compliance with regulatory reporting requirements in each company's territories." Id., Ex. 7 at 1. Each company is responsible for reporting "to the regulatory authorities within the territories where it is the Marketing Authorization Holder (MAH)." Id. at 3. AbbVie is the MAH in the United States and Besins S.A. is the MAH in territories outside of the United States. Id. at 15-16. Both Besins S.A. and AbbVie are "responsible for the detection and evaluation of safety signals" and for communicating to each other "any identified safety signal upon confirmation of the validity of the safety signal." Id. at 9. Besins S.A. had similar pharmacovigilance agreements with AbbVie's predecessor entities.

         Jay Bua is the president and CEO of Besins Inc. He is on Besins S.A.'s board of directors and gave a 30(b)(6) deposition as Besins S.A.'s corporate representative. Bua testified during his deposition that Besins S.A. uses its pharmacovigilance database "[e]xclusively" "for ex-U.S. purposes" and that Besins S.A. does not "have any role in the reporting of adverse events or pharmacovigilance in the United States." Pls.' Opp., Ex. 1 at 103:12-104:22. That role "[is] maintained by AbbVie." Id. at 104:19-105:2.

         Besins Inc. is a Delaware corporation with its principal place of business in Virginia. It is a wholly owned subsidiary of Besins S.A. Besins Inc. co-owns the AndroGel patent with AbbVie. It has never manufactured, sold, distributed, or promoted AndroGel and is not a party to the license or supply agreements between Besins S.A. and AbbVie. Besins Inc. is, however, responsible for the relationship with AbbVie in the United States. The parties dispute the extent of Besins Inc.'s responsibilities but agree that they include managing contract and patent issues.[1]

         Thomas MacAllister worked in research and development at a Besins subsidiary.

         From approximately 2004 to January 2015, he also served as special counsel for Besins Inc. In that capacity, he was primarily responsible for managing license and patent issues with AbbVie. In a June 2014 e-mail to Besins Inc. medical affairs employees, MacAllister discussed then-recent publications about purported cardiovascular (CV) risks associated with AndroGel. He wrote, among other things:

Objectively speaking there is not sufficient evidence on either side to draw a conclusion and the community should be calling for further study. Of course, that begs the question of who has the responsibility for that. The most obvious choice would be AbbVie and I suspect they are very well keeping their heads down to avoid this discussion. Derivatively, we are the second best candidate and we should be very careful too about getting into this discussion. Our company has also benefited financially along with AbbVie and I can easily see the discussion turning towards some kind of ethical obligation to society on the parts of those who have benefited to support addressing an important (and expensive) safety concern.

Pls.' Opp., Ex. 14 at 1. When asked during his deposition whether he "believe[d] that any of the Besins entities owed an obligation to make sure that the product that was being sold in the U.S., AndroGel, did not carry the CV risks that were being purported in the studies, " MacAllister testified during his deposition that the Besins defendants have no right to conduct safety studies in the United States. Pls.' Opp., Ex. 2 (MacAllister Dep.) at 162:18-163:9; see also Id. at 163:7-9 ("This is AbbVie's product. And you know, if we wanted to run that study in the U.S., it would not be our choice."). He also testified, "We licensed the product to AbbVie while it was in formulation." Id. at 163:13-14.

         Besins Healthcare[2] is listed as a TRT sponsor of an "industry briefing book" submitted to the FDA before a September 2014 Advisory Committee meeting. Defs.' Reply at 7. The meeting's topics included TRT's indication, prescription guidelines, and purported risks and benefits. Plaintiffs contend, and the Besins defendants deny, that the Besins defendants contributed to the briefing book. The parties agree that in connection with the Advisory Committee meeting, the Besins defendants hosted an event in Virginia for U.S.-based key opinion leaders (KOLs), or testosterone experts. Bua attended the KOL meeting, as did two Besins employees who are responsible for medical affairs and pharmacovigilance outside of the United States.

         The Besins defendants meet periodically with AbbVie regarding AndroGel U.S. sales. Between 2010 and 2015, the Besins defendants received approximately $398 million in royalties from AndroGel U.S. sales. These royalties account for ...

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