United States District Court, N.D. Illinois, Eastern Division
In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to all cases)
CASE MANAGEMENT ORDER NO. 124 (RULING ON BESINS
DEFENDANTS' MOTION FOR SUMMARY JUDGMENT, DKT. NO.
MATTHEW F. KENNELLY UNITED STATES DISTRICT JUDGE
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).
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.
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.
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.
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
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.
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.
MacAllister worked in research and development at a Besins
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)
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.
Healthcare 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
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