IN RE ASACOL ANTITRUST LITIGATION
Judge Denise J. Casper: ORDER entered. MEMORANDUM AND ORDER - The Court DENIES the parties' motions to exclude testimony, D. 426; D. 427; D. 428; D. 429; D. 430; D. 431; D. 444, provides the reasons for ALLOWING the Plaintiffs' motion for class certification under Fed. R. Civ. P. 23(b)(3) in D. 559, D. 380, and DENIES the Defendants' motion for summary judgment, D. 445.(Hourihan, Lisa)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
IN RE ASACOL ANTITRUST LITIGATION ) Civil Action No. 15-cv-12730-DJC
MEMORANDUM AND ORDER
November 9, 2017
This is a putative class action in which the Plaintiffs, members of a putative class of end-
payor purchasers of certain pharmaceutical products,1 allege that the Defendants, manufacturers
of certain pharmaceutical products, engaged in exclusionary conduct impermissible under antitrust
laws by pulling one product, Asacol 400mg, from the market at the same that it introduced a new
product, Delzicol. For the reasons set forth below, the Court DENIES the parties’ motions to
exclude testimony, D. 426; D. 427; D. 428; D. 429; D. 430; D. 431; D. 444, provides the reasons
for ALLOWING the Plaintiffs’ motion for class certification under Fed. R. Civ. P. 23(b)(3), D.
380, as it ruled in D. 559, and DENIES the Defendants’ motion for summary judgment, D. 445.
The following facts are taken from the parties’ statements of material facts, D. 450; D. 509;
D. 510; D. 545, and accompanying exhibits unless otherwise noted.
This case also involves a separate plaintiff class of direct purchasers. The approval of the proposed settlement of
the claims of that class awaits a final fairness hearing. D. 461.
Prior to approving a product, the Food and Drug Administration (“FDA”) reviews a New
Drug Application (“NDA”) to determine whether a proposed drug is safe and effective for its
proposed uses. 21 U.S.C. § 355; D. 450 ¶ 195; D. 510 ¶ 195. Even after the FDA approves an
NDA, the agency continues to monitor the safety of the drug and retains the authority to withdraw
its approval if it finds that the drug is not safe or effective. 21 U.S.C. § 355(e); D. 450 ¶¶ 199200; D. 510 ¶¶ 199-200.
After an NDA has been approved, applicants who wish to manufacture a generic version
of the approved drug may receive permission to do so by submitting an Abbreviated New Drug
Application (“ANDA”). D. 450 ¶ 31; D. 510 ¶ 31. The FDA then determines whether the drug
proposed in the ANDA is sufficiently “bioequivalent” to the drug that was already approved –
termed the “reference listed drug.” D. 450 ¶ 31; D. 510 ¶ 31; D. 458-5 at 455. When a generic
manufacturer submits an ANDA, it makes a filing to the FDA regarding the status of patents
associated with the NDA of the reference listed drug. D. 450 ¶ 35; D. 510 ¶ 35. In that filing, the
generic manufacturer must certify: (1) that the manufacturer of the reference-listed drug did not
indicate to the FDA that there were any patents associated with the NDA of the reference listed
drug; (2) that the patents associated with the NDA of the reference listed drug have expired; (3)
that the patents associated with the NDA of the reference listed drug will expire before the generic
manufacturer will begin marketing its product; or (4) that the patents associated with the NDA of
the reference listed drug are invalid, unenforceable, or will not be infringed by the generic
manufacturer. 21 U.S.C. § 355(j)(2)(A)(vii); D. 450 ¶ 35; D. 510 ¶ 35. A generic manufacturer
certifying that it will not market the drug until the relevant patents expire is called a “Paragraph
III certification,” and certifying that the patents associated with the NDA are invalid,
unenforceable, or will not be infringed by the generic manufacturer is called a “Paragraph IV
certification.” D. 450 ¶ 35; D. 510 ¶ 35.
Under certain circumstances, the first generic manufacturer who submits an ANDA with a
Paragraph IV certification will be eligible for 180 days of market exclusivity, during which it is
the only manufacturer authorized to market a generic version of the reference listed drug. D. 450
¶ 38; D. 510 ¶ 38. Generic products typically gain market share from brand-name products by
virtue of state laws that allow or require pharmacists to substitute a generic product for the
reference listed drug that is sufficiently bioequivalent. D. 509 ¶¶ 60-62; D. 545 ¶¶ 60-62.
The filer of an ANDA with a Paragraph IV certification must provide notice to the holder
of the NDA of the reference listed drug, who may then choose to file suit in federal court asserting
its patent rights against the ANDA filer. D. 450 ¶ 39. However, the filer of an ANDA with a
Paragraph III certification need not provide the same notice. 21 U.S.C. § 355(b)(3)(A). The filing
of an ANDA with a Paragraph III certification need not be public. D. 509 ¶ 279; D. 545 ¶ 279.
The FDA does, however, publicly announce its tentative or final approval of an ANDA. D. 450 ¶
41; D. 510 ¶ 41.
The FDA Approves Asacol and Asacol HD for Ulcerative Colitis
“Ulcerative colitis is a chronic inflammatory bowel disorder that typically causes bloody
diarrhea, rectal urgency, tenesmus, and abdominal cramping.” D. 450 ¶ 1; D. 510 ¶ 1. The
condition is cyclical, such that patients will experience periods of time without symptoms
intermixed with periods of time with symptoms, termed “flares.” D. 450 ¶ 2; D. 510 ¶ 2. Due to
the cyclical nature of the condition, patients may use one mode of treatment during flares and
another mode of treatment continuously, even when the patient is not experiencing symptoms. D.
450 ¶ 3; D. 510 ¶ 3. The most common treatment for ulcerative colitis is a class of drugs containing
the active ingredient mesalamine. D. 450 ¶ 4; D. 510 ¶ 4. Mesalamine, however, is ineffective at
providing relief if it is released either too early or too late. D. 450 ¶ 6; D. 510 ¶ 6.
Proctor and Gamble Pharmaceuticals Inc. (“P&G”) submitted an NDA to the FDA,
requesting permission to sell a delayed-release oral tablet containing 400mg of mesalamine, sold
under the brand name “Asacol” (“Asacol 400mg”). D. 450 ¶ 7; D. 510 ¶ 7. There were two
patents associated with Asacol 400mg, both of which expired on July 30, 2013. D. 450 ¶ 11; D.
510 ¶ 11. The Asacol 400mg tablet contained an acrylic based delayed-release coating, such that
the active ingredient is released in the colon. D. 450 ¶ 9; D. 510 ¶ 9. This coating contained a
plasticizer known as dibutyl phthalate (“DBP”). D. 450 ¶ 47; D. 510 ¶ 47. The FDA approved
this NDA on January 31, 1992. D. 450 ¶ 7; D. 510 ¶ 7.
On May 29, 2008, the FDA approved a new NDA from P&G – this one for a 800mg, longacting mesalamine tablet, to be sold under the brand name “Asacol HD.” D. 450 ¶ 12; D. 510 ¶
12. Asacol HD differs from Asacol 400mg in two important ways: first, it is 800mg, instead of
400mg, D. 450 ¶ 13; D. 510 ¶ 13; and second, it has a dual-layer coating rather than a single-layer
coating. D. 450 ¶ 14; D. 510 ¶ 14. The coating for Asacol HD when launched contained DBP,
like the coating for Asacol 400mg. D. 450 ¶ 47; D. 510 ¶ 47. Asacol HD was launched on July 7,
2009. D. 450 ¶ 18; D. 510 ¶ 18. The patents associated with Asacol HD are due to expire on
November 15, 2021. D. 509 ¶ 24; D. 545 ¶ 24.
P&G and the FDA Discuss Removing DBP from Asacol and Asacol HD
In March 2009, after the approval of Asacol HD but before its sale, the FDA held a
teleconference with P&G regarding whether “P&G would consider removing DBP from Asacol
400mg.” D. 450 ¶ 21; D. 510 ¶ 21; D. 456-6 at 58-59. According to P&G, the FDA requested the
teleconference with P&G because it was aware of the “potential health risks associated with
exposure to DBP demonstrated in numerous studies” and wanted to “discuss the issue” with P&G.
D. 456-6 at 58. It the teleconference, P&G indicated that it was having internal discussions about
removing DBP. D. 456-6 at 59. The FDA asked about P&G’s plan to remove DBP from the
Asacol 400mg formulation, stating that the FDA felt “some urgency on this as the public is
interested in removing this chemical from products,” and indicated that the FDA was “suggesting
DBPs should be replaced.” D. 456-6 at 59. The FDA indicated that its timetable on having a
dialogue with P&G about DBP was “as fast as possible.” D. 456-6 at 60.
On April 16, 2009, P&G sent a proposed plan to reformulate Asacol 400mg without DBP
to the FDA. D. 450 ¶ 85; D. 510 ¶ 85. The proposed plan suggested that the FDA allow P&G to
prove bioequivalence between the then-current version of Asacol 400mg and a reformulated
version of Asacol 400mg without DBP through “in vitro dissolution testing.” D. 450 ¶ 86; D. 510
The parties dispute the extent to which there actually was a concern at P&G regarding the
premature release of mesalamine in the Asacol products caused by premature dissolution that
might have informed P&G’s aims in reformulating the Asacol products. Several years prior, in
2005, Asacol HD had been recalled in Canada due to dissolution testing problems, and as a result,
P&G had developed “Quick Test” methods to identify batches of product with microfractures,
which made the product susceptible to dissolution problems. D. 450 ¶¶ 73-74; D. 510 ¶¶ 73-74.
At some point in 2009, P&G outlined the use of “soft handling” – avoiding putting physical stress
on the tablets across the supply chain by, for example, minimizing drops – as a strategy. D. 450 ¶
77; D. 510 ¶ 77; D. 456-2 at 4. In light of this strategy, it’s not clear that P&G considered the
problem of dissolution failures to be ongoing rather than solved by the soft handling approach. D.
456-2 at 4, 54.
On April 23, 2009, the FDA held a meeting with P&G regarding Asacol HD. D. 450 ¶
66; D. 510 ¶ 66; D. 456-3 at 4. According to P&G, it proposed to the FDA a change to the
specifications for the dissolution rate (i.e., the rate set by the FDA for the percentage of tablets that
opened at a particular pH) and the FDA was supportive of that change. D. 450 ¶ 72; D. 510 ¶ 72;
D. 456-3 at 4. The specification for Asacol HD at that time required a dissolution rate of 1% at a
pH of 6, and P&G was proposing to change the specification for the dissolution rate to 4%. D.
450 ¶ 72; D. 510 ¶ 72; D. 456-3 at 4. P&G requested this change to allow for “one tablet in the
sample [to] fail,” that is, prematurely release the active ingredient, “without failing the
specification,” even though P&G “[did] not have a history of failing the 1% spec on release
testing.” D. 456-8 at 9. According to P&G, the FDA also expressed that reformulation of Asacol
HD to remove DBP “needs to proceed with urgency.” D. 450 ¶ 66; D. 510 ¶ 66; D. 456-3 at 4.
The FDA also stated that it wanted the reformulation of Asacol HD to remove DBP to “solve the
current dissolution issue.” D. 450 ¶ 72; D. 510 ¶ 72; D. 456-3 at 4.
There were further communications between the FDA and P&G on these matters. D. 450
¶ 88; D. 510 ¶ 88; D. 456-2 at 81-83. By August 6, 2009, the FDA sent a letter to P&G rejecting
P&G’s proposed use of “in vitro dissolution testing” and instead requiring P&G to perform “in
vitro methods (comparative dissolution)” to show bioequivalence between the then-currently
marketed version of Asacol 400mg and the reformulated version of Asacol 400mg. D. 450 ¶ 89;
D. 510 ¶ 89; D. 456-6 at 88. On August 24, 2009, the FDA conferred with P&G to discuss
bioequivalence testing and indicated that it might consider an approach of “combined in vitro
dissolution and PK study,” but also stated that it was in “heavy discussion internally in regard to
Division policy on reformulation changes.” D. 450 ¶¶ 94-98; D. 510 ¶¶ 94-98; D. 456-6 at 93.
On October 12, 2009, P&G again discussed the subject of bioequivalence testing with the
FDA and stated that Warner Chilcott (which by that point had agreed to purchase P&G’s Asacol
business) was “leaning towards clinical trials because [it] was ‘concerned about the impact on the
global business as well as lowering the bar for generics.’” D. 450 ¶ 99; D. 510 ¶ 99.
An October 20, 2009 Technical Report indicated that P&G tested two compounds, dibutyl
sebacate (“DBS”) and triethyl citrate (“TEC”) as potential replacements for Asacol 400mg and
Asacol HD. D. 450 ¶ 87; D. 510 ¶ 87; D. 456-8 at 16. The Technical Report concluded that DBS
was the “best match to the current DBP containing formulation.” D. 456-8 at 16.
Warner Chilcott Purchases the Asacol Products
On October 30, 2009, Warner Chilcott purchased P&G’s portfolio of pharmaceutical
products, including Asacol 400mg and Asacol HD. D. 450 ¶¶ 19-20; D. 510 ¶¶ 19-20. Warner
Chilcott was concerned about the impending expiration of the patent for Asacol 400mg, but
appeared to believe that it could manage that risk through product improvement including the
recent launch of Asacol HD. D. 509 ¶¶ 148-155; D. 545 ¶¶ 148-155. The efforts of P&G and
Warner Chilcott to convert patients from Asacol 400mg, which would lose patent protection in
2013, to Asacol HD, which would not lose patent protection until 2021, met with only limited
success. D. 509 ¶¶ 156-159; D. 545 ¶¶ 156-159. By 2011, only approximately 22% of Asacol
400mg prescriptions transitioned to Asacol HD, which was far short of Warner Chilcott’s internal
projections. D. 509 ¶ 167; D. 545 ¶ 167.
At the time of the purchase, Warner Chilcott was also aware of P&G’s discussions with
the FDA about the reformulation of Asacol 400mg and Asacol HD to replace DBP. D. 450 ¶ 22;
D. 510 ¶ 22. There is a dispute between the parties over whether P&G conveyed any specific
concerns it may have had regarding the performance of the DBP-containing coating of Asacol
400mg and Asacol HD to Warner Chilcott. Compare D. 450 ¶¶ 24-26 with D. 510 ¶¶ 24-26.
Warner Chilcott Negotiates Bioequivalence Testing with the FDA
Warner Chilcott proceeded with the discussions P&G had been having with the FDA over
the bioequivalence testing for the reformulation of Asacol 400mg to remove DBP. By November
24, 2009, Warner Chilcott had submitted a draft protocol for a clinical end point study to establish
bioequivalence to the FDA. D. 450 ¶ 101; D. 510 ¶ 101. On January 21, 2010, the FDA responded
to Warner Chilcott’s draft protocol with an Advice Letter. D. 450 ¶ 106; D. 510 ¶ 106. On
February 22, 2010, Warner Chilcott filed a citizen petition with the FDA requesting that the
“requirements for establishing bioequivalence for any reference listed delayed-release mesalamine
tablet include: a clinical efficacy endpoint study; comparative [PK] testing under fed and fasted
conditions; and rigorous in vitro dissolution testing,” and that the FDA promulgate official
guidance to that effect. D. 450 ¶¶ 108-09; D. 510 ¶¶ 108-09. On April 22, 2010, the FDA
communicated that “it will be acceptable to establish bioequivalence through special dissolution
and PK studies,” but that “if PK and dissolution testing results are not convincing, then a clinical
trial may be necessary to establish equivalence based on clinical end points.” D. 450 ¶¶ 113-14;
D. 510 ¶¶ 113-14.
The FDA’s May 20, 2010 response to Warner Chilcott’s citizen petition stated that the
“FDA continues to recommend in vitro dissolution testing but now recommends comparative PK
studies rather than comparative clinical endpoint studies to show bioequivalence for these
products.” D. 456 at 3. It acknowledged that this presented a departure from its 2007 position that
“comparative clinical endpoint studies, rather than PK studies, should be used (along with in vitro
dissolution studies) to show bioequivalence in orally administered extended or delayed release
mesalamine drugs.” D. 456 at 8. It attributed the change to “new data from PK and comparative
clinical endpoint studies in modified release mesalamine products as well as recent developments
in regulatory science concerning analysis of PK data.” D. 456 at 9. The FDA denied the request
to publish guidance regarding bioequivalence testing. D. 450 ¶ 130; D. 510 ¶ 130.
Warner Chilcott Shifts to a Capsule Formulation of Mesalamine (Delzicol)
Contemporaneous with discussions with the FDA on bioequivalence testing, Warner
Chilcott began to consider a potential “new product” that would be different from Asacol 400mg
in more ways than just removing DBP. D. 509 ¶ 114; D. 513-46 at 2-3; D. 545 ¶ 114. By October
2010, Warner Chilcott was pursuing a “capsule containing 400mg of mesalamine,” “compressed
into four 100-mg mini-tablets encapsulated into a standard gelatin capsule.” D. 450 ¶ 131; D. 510
On November 2, 2010 Warner Chilcott conferred again with the FDA about bioequivalence
testing for the reformulation of Asacol 400mg. D. 450 ¶ 132; D. 510 ¶ 132; D. 456-7 at 12. In
addition to discussing specific testing protocols, Warner Chilcott also informed the FDA that it
was “considering possible reformulation of Asacol 400-mg tablets to . . . a capsule formulation.”
D. 450 ¶ 133; D. 510 ¶ 133.
In early 2011, Warner Chilcott worked on the proposed capsule formulation for testing,
with the goal of having a batch prepared by July 1, 2011. D. 450 ¶ 138; D. 510 ¶ 138. By June
2011, management had confirmed that the prior “DBP replacement project” was “on-hold”
because the plan was now “to focus on the Asacol LCM [life-cycle management] projects”
including the capsule project. D. 509 ¶ 118; D. 513-45 at 2; D. 545 ¶ 118. By mid-June 2011, it
was determined that the capsules had higher water levels than expected, which could jeopardize
the July 1, 2011 production date. D. 450 ¶ 139; D. 510 ¶ 139; D. 456-11 at 8. By August 2011,
Warner Chilcott planned to proceed with one 400-mg DBS tablet in a capsule instead of four 100mg tablets.” D. 450 ¶ 140; D. 510 ¶ 140. By August 2011, Warner Chilcott appeared to be
concerned that “Asacol 400 capsule[s] would not be bioequivalent to current Asacol 400 have
shifted focus to new format” such that Warner Chilcott’s product could “be a moving target for
generics to delay their entry” and “gain time to further modify the coating for true patent
protection.” D. 509 ¶ 188; D. 514-34; D. 545 ¶ 188.
On October 21, 2011, Warner Chilcott submitted an amended protocol to the FDA, which
stated, among other things, that Warner Chilcott was going to submit a capsule formulation, with
a single 400-mg tablet, and without DBP, for bioequivalence testing. D. 450 ¶ 143; D. 510 ¶ 143.
In that same document, Warner Chilcott stated that the tablet was encapsulated in a
“hydroxypropyl methylcellulose (HPMC) capsule to provide a protective layer to maintain the
integrity of the delayed-release coating under the mechanical stresses of handling and packaging.
This capsule layer will dissolve earlier in the gastrointestinal (GI) tract and will not interfere with
the delayed release mechanism.” D. 450 ¶ 144; D. 510 ¶ 144; D. 456-9 at 6. Between that point
and March 2, 2012, the FDA and Warner Chilcott communicated regarding the specifications of
the bioequivalence testing that would necessary. D. 450 ¶¶ 145-150; D. 510 ¶¶ 145-150.
Ultimately, on June 13, 2012, the FDA agreed that Warner Chilcott had satisfactorily shown
bioequivalence. D. 450 ¶ 157; D. 510 ¶ 157.
Notwithstanding a delay in obtaining validated experimental data to support Warner
Chilcott’s hypothesis regarding the relative stability of the capsule, D. 509 ¶¶ 199-213; D. 545 ¶¶
199-213, on July 30, 2012, Warner Chilcott submitted an NDA to the FDA for the 400mg
mesalamine delayed release single tablet in a capsule, without DBP, which was later sold under
the name Delzicol. D. 450 ¶¶ 51-52; D. 510 ¶¶ 51-52. Warner Chilcott requested an expedited “6
month priority review” from the FDA on the NDA for Delzicol on the grounds that the FDA had
expressed a safety concern with DBP, which was granted. D. 450 ¶ 53; D. 510 ¶ 53. On February
1, 2013, the FDA approved the NDA for Delzicol. D. 450 ¶ 54; D. 510 ¶ 54. In approving the
label for Delzicol, the FDA recommended a removal of certain warning language regarding DBP.
D. 450 ¶¶ 173-176; D. 510 ¶¶ 173-176.
Warner Chilcott Launches Delzicol, Pulls Asacol, and Shifts to a Patented
Capsule for Delzicol
On March 18, 2013, Warner Chilcott launched Delzicol. D. 450 ¶ 55; D. 510 ¶ 55. On the
same date that Warner Chilcott launched Delzicol, Warner Chilcott stopped selling and marketing
Asacol 400mg. D. 450 ¶ 57; D. 510 ¶ 57. The “hard switch” – that is, pulling Asacol 400mg from
the market once Delzicol was launched – meant that patients who had been taking Asacol 400mg
no longer had the option of continuing with that product – they had to choose between switching
to Delzicol, switching to Asacol HD (which was still on the market but had a different dosage), or
switching to a different product. D. 509 ¶ 79; D. 545 ¶ 79.
In an earnings call in February 2013, Roger Boissonneault, the chief executive of Warner
Chilcott, explained that the result of pulling Asacol 400mg from the market at the same time as
the Delzicol launch would be that “the generic company doesn’t even get launched because the
reference product will be Delzicol.” D. 509 ¶ 71; D. 545 ¶ 71. “There won’t be any Asacol out
there. We’ve seen that happen with Doryx [another Warner Chilcott product], when the generic
company got the product approved and, by that time, the product had moved on.” D. 509 ¶ 71; D.
545 ¶ 71.
When Warner Chilcott pulled Asacol 400mg from the market, sales of Asacol 400mg and
of the Asacol-branded products as a whole declined. D. 509 ¶¶ 331-32; D. 545 ¶¶ 331-32. There
is a dispute between the parties regarding whether the sales of oral mesalamine drugs generally
declined. D. 509 ¶ 333; D. 545 ¶ 333.
When Delzicol first launched, the capsule on the tablet was an unpatented design. 450 ¶
178; D. 510 ¶ 178. On March 12, 2013, Warner Chilcott submitted a supplemental NDA to the
FDA requesting permission to use a patented capsule, termed the “Qualicaps capsule” for Delzicol.
There is a dispute between the parties regarding whether Warner Chilcott experienced any cost
savings as a result of the switch to the Qualicaps capsule. D. 450 ¶ 182; D. 510 ¶ 182. The FDA
approved the NDA for the Qualicaps capsule on July 9, 2013. D. 450 ¶ 180; D. 510 ¶ 180. Warner
Chilcott represented to the FDA that it had begun manufacturing Delzicol with the Qualicaps
capsule in August 2013, but as of March 7, 2014, it had not yet begun selling Delzicol with the
Qualicaps capsule. D. 450 ¶ 181; D. 510 ¶ 181.
By 2015, Warner Chilcott introduced a 4x100mg formulation for Delzicol which was
approved for pediatric use, and allows patients to open the capsule to swallow the 100mg tablets,
allowing for flexible dosing. D. 450 ¶¶ 331-34; D. 510 ¶¶ 331-34.
Subsequent Conduct by the Defendants
Unlike for Asacol 400mg, Warner Chilcott’s removal of DBP from the Asacol HD
formulation was not accompanied by other changes. Warner Chilcott filed a supplementary NDA
to the FDA regarding the new, DBP-free formulation of Asacol HD on September 24, 2015. D.
509 ¶ 125; D. 545 ¶ 125. The reformulation of Asacol HD did not go through expedited review.
D. 509 ¶ 125; D. 545 ¶ 125. Asacol HD contained no less DBP than Asacol 400mg; in fact, it
contained twice as much DBP per tablet. D. 509 ¶ 125; D. 545 ¶ 125. The FDA approved the
supplementary NDA on May 5, 2016. D. 509 ¶ 125; D. 545 ¶ 125. In the United Kingdom,
Allergan, Warner Chilcott’s successor, launched a version of Asacol 400mg without DBP but also
without a capsule. D. 509 ¶ 228; D. 545 ¶ 228.
On October 1, 2013, Actavis PLC, which is now known as Allergan PLC, acquired Warner
Chilcott, including the Asacol line of products. D. 509 ¶ 9; D. 545 ¶ 9.
FDA Policy Regarding DBP Generally
The FDA maintained a policy of encouraging manufacturers to discontinue the use of DBP
and to require clearer warnings regarding the risks of DBP, but did not prohibit the use of DBP.
In 2009, the FDA requested a revision to the label of Asacol 400mg and Asacol HD to provide
information on the “effects of DBP in animals and humans.” D. 450 ¶ 111; D. 510 ¶ 111. Warner
Chilcott released an updated label containing that information in May 2010. D. 450 ¶ 112; D. 510
¶ 112. In March 2012, the FDA issued Draft Guidance in which it outlined its “current thinking
on the potential human health risks associated with exposure to . . . DBP.” D. 456-3 at 109. In
December 2012, the FDA released Final Guidance on the subject. D. 450 ¶ 50; D. 510 ¶ 50. Like
the Draft Guidance, the Final Guidance communicated the FDA’s thinking on the health risks
associated with exposure to DBP and clarified that it merely provided recommendations rather
than directives. D. 456-11 at 178. The Division of Gastroenterology and Inborn Errors Products
recommended that “it was prudent to change the professional labeling of Asacol [400mg] to
provide information on the effects of DBP in animals and humans, as well as requiring the sponsor
to reformulate their product without DBP.” D. 450 ¶ 67; D. 510 ¶ 67; D. 456-6 at 64. The FDA
did not at any point pull Asacol HD from the market despite the fact that Asacol HD continued to
have a DBP-containing coating until May 5, 2016. D. 509 ¶ 125; D. 545 ¶ 125.
The parties dispute whether generic entry for Asacol 400mg would have occurred but for
Warner Chilcott’s decision to pull it from the market. The following facts relevant to that
determination, however, are undisputed.
First, Warner Chilcott was concerned about generic competition for Asacol 400mg. D. 509
¶ 248; D. 515-10 at 2; D. 513-17 at 2; D. 509 ¶ 241; D. 545 ¶ 241; D. 514-39 at 6.
Second, Warner Chilcott had an agreement with Lupin Pharmaceuticals, Inc. (“Lupin”), a
generic manufacturer, to be an “authorized generic” – that is, Lupin would distribute Asacol
400mg supplied by Warner Chilcott as a generic product. D. 509 ¶ 266; D. 545 ¶ 266; D. 456-12
at 3. Under the terms of that agreement, Lupin was authorized to sell generic Asacol 400mg
supplied by Warner Chilcott as soon as it was able, but only after another generic manufacturer
had already entered the market for Asacol. D. 456-12 at 9. Lupin was to submit its first purchase
order for generic Asacol 400mg from Warner Chilcott within 30 days of another manufacturer
selling a generic version of Asacol 400mg. D. 456-12 at 10.
Third, there is limited information regarding which, if any, generic manufacturers had filed
ANDAs with a Paragraph III certification for Asacol 400mg. The FDA never filed any notice of
either tentative or final approval of an ANDA for a generic version of Asacol 400mg. D. 450 ¶
211; D. 510 ¶ 211. The parties agree that neither Lupin nor another manufacturer, Zydus
Pharmaceutical (USA) Inc. (“Zydus”), filed an ANDA for Asacol. Lupin believed that nine
manufacturers had filed Drug Master Files (“DMFs”), a filing regarding manufacturing processes
for a product that might be used to support an ANDA filing. D. 509 ¶¶ 274-275; D. 545 ¶¶ 274275; D. 515-14 at 3.
There is no evidence about whether any of the following generic
manufacturers had filed ANDAs with a Paragraph III certification for Asacol 400mg: Actavis
Pharma. (“Actavis”), Mylan Pharmaceuticals, Inc. (“Mylan”), Teva Pharmaceutical Industries Ltd.
(“Teva”), Watson Pharmaceuticals (“Watson”); Pendopharm, Sanis Health, Aspen Pharmacare,
Dr. Falk GmBH, Merckle GmBH, Tillotts Pharma, Sandoz (Novartis), Aurobindo
Pharmaceuticals, Torrent Laboratory Inc., West Coast, Zota Healthcare Ltd., Ipca Laboratories,
Bracco, Chiesi, Crinos, Dorm, SOFAR, Wellpharma. D. 450 ¶¶ 206, 267; D. 510 ¶¶ 206, 267.
Roxane Laboratories, Inc. (“Roxane”) and Par Pharmaceutical, Inc. (“Par”) had filed ANDAs with
a Paragraph IV certification – certifying that their products did not infringe the patents associated
with Asacol 400mg – but neither manufacturer proved bioequivalence to the FDA and those
ANDAs were withdrawn. D. 509 ¶¶ 304-314; D. 545 ¶¶ 304-314.
Fourth, it is not clear how long the FDA would have taken to approve an ANDA for generic
Asacol 400mg once any ANDA was submitted. According to the FDA, its “median review time
from ANDA receipt to approval” was 27.85 months in 2010 and 29.52 months in 2011, but the
time for individual drugs might be significantly above or below that median. D. 450 ¶¶ 212-215;
D. 510 ¶¶ 212-215. The FDA could have expedited review of the first ANDA for generic Asacol
400mg, as FDA policy allows expedited review of “first generic products for which there are no
blocking patents or exclusivities on the reference listed drug.” D. 509 ¶¶ 316-17; D. 545 ¶¶ 31617
Fifth, generic manufacturers had significant economic incentives to produce a generic
version of Asacol 400mg if Warner Chilcott did not pull Asacol 400mg from the market and there
is a dispute regarding whether they had the technical capacity to do so. D. 509 ¶¶ 284-85, 295297; D. 545 ¶¶ 284-85, 295-297; D. 426-5 at 20. Generic manufacturers had already produced
internationally delayed-release mesalamine oral tablets with a Eudragit S coating, similar to the
Asacol 400mg tablet. D. 509 ¶ 296; D. 545 ¶ 296. Additionally, the FDA’s decision to focus on
PK testing rather than on clinical studies was considered by the Defendants to be “lowering the
bar” to generic entry. D. 509 ¶ 289; D. 545 ¶ 289. The FDA had already approved two other oral
mesalamine products based on bioequivalence, and, on July 21, 2017, approved a generic version
of Asacol HD. D. 509 ¶¶ 318-19; D. 545 ¶¶ 318-19.
After Delzicol launched, Mylan, Teva and Zydus filed ANDAs for Delzicol with Paragraph
IV certifications. D. 450 ¶ 328; D. 510 ¶ 328.
Other Ulcerative Colitis Treatments
There is a dispute between the parties regarding the extent to which Asacol 400mg is a
product competing with other ulcerative colitis treatments. Before discussing the various facts
relevant to that determination, however, it is useful to provide a brief overview of the way
pharmaceutical products are purchased.
Typically, a prescription drug is prescribed by a physician to a patient, who then takes that
prescription to a pharmacy to fill. D. 453-1 at 18. The pharmacy typically orders the drug
wholesale from the manufacturer and resells the drug to patients. Id. When a patient purchases a
drug, if the patient has insurance, the patient will generally pay a portion of the cost of the drug,
called a co-pay, and the insurer will pay the remainder. Id. Some health insurers contract with a
pharmacy benefit manager (“PBM”) to manage the business of providing coverage for
pharmaceutical products. Id. The PBM will determine the list of drugs that it will cover, known
as the formulary, and determine what steps a patient must go through to receive coverage for a
drug. Id. at 19. Some PBMs will establish a higher co-pay for some drugs than others; generic
drugs typically have a lower co-pay than brand-name drugs. Id. Some PBMs rely on a “tiered”
system, wherein the PBM requires the patient to try one drug, usually a cheaper drug, before
providing coverage for another, usually more expensive drug. Id. Drug manufacturers set prices
by determining the wholesale price it will charge to pharmacies, providing rebates to PBMs, and
providing rebates to patients. Id. at 18.
Asacol 400mg, Asacol HD and Delzicol were not the only drugs throughout this period
that were approved as ulcerative colitis treatments. D. 450 ¶ 268; D. 510 ¶ 268. Other drugs
approved by the FDA for the treatment of oral ulcerative colitis were, like Asacol 400mg, Asacol
HD, and Delzicol, mesalamine-containing drugs: Apriso, generic mesalamine (including a generic
version of Asacol HD authorized by Warner Chilcott), Lialda, and Pentasa; others still are
treatments based on compounds that are, like mesalamine, a type of 5-aminosalicylic acid or 5ASA: Colazal, generic balsalazide disodium, Giazo, Azulfidine, generic sulfasalazine, Azulfidine
EN-tabs and generic sulfasalazine SR. D. 450 ¶ 268; D. 510 ¶ 268; D. 452 at 24. Between 2009
and 2017, the percentage of oral dosage 5-ASA drugs sold that were Asacol-branded products
(Asacol 400mg, Asacol HD, or Delzicol) fell from 42.9% to 8.4%, and, by some measures, the
total output fell as well. D. 450 ¶ 269; D. 510 ¶ 269; D. 509 ¶ 332; D. 545 ¶ 332. At the same
time, the percentage of oral dosage 5-ASA drugs sold that were Lialda-branded products increased
from 12.1% to 28.3%. D. 450 ¶ 270; D. 510 ¶ 270.
Some PBMs excluded Asacol products from their formularies while including other oral
5-ASA drugs or gave other 5-ASA drugs preferential treatment on their formularies with respect
to tiers. D. 450 ¶¶ 294-301, 306, 310; D. 510 ¶¶ 294-301, 306, 310. In some cases, the PBMs
explicitly drew comparisons between the pricing and effectiveness of various 5-ASA drugs in
determining what drugs would be on formulary or how they would place in the tiers. Id. Certain
medical literature and certain gastroenterologists identified the various oral 5-ASA drugs as
“therapeutically interchangeable.” D. 450 ¶¶ 313-14; D. 510 ¶¶ 313-14.
Warner Chilcott continued to earn profits on the sale of Asacol-branded products. From
2009 to 2012, Warner Chilcott’s gross margins on Asacol 400mg and Asacol HD ranged from
87% to 95%, and from 2013 to 2016, Warner Chilcott’s gross margins for Asacol HD were 88%
to 91% and for Delzicol were 86% to 90%. D. 509 ¶¶ 334-35; D. 545 ¶¶ 334-35.
The named Plaintiffs in this action are the Teamsters Union 25 Health Services & Insurance
Plan (“Teamsters”), the NECA-IBEW Welfare Trust Fund (“NECA-IBEW”), the Wisconsin
Masons’ Health Care Fund (“Masons”), and the Minnesota Laborers Health and Welfare Fund
(“Laborers”). The Teamsters are headquartered in Massachusetts, and the Plaintiffs contend that
the Teamsters made purchases of Asacol 400mg, Asacol HD, or Delzicol in Massachusetts, New
Jersey, Missouri, and New Hampshire during the relevant time period. D. 124 ¶¶ 13-14; D. 450
¶¶ 335-336; D. 510 ¶¶ 335-336. The NECA-IBEW are headquartered in Illinois and made
purchases of Asacol 400mg, Asacol HD, or Delzicol during the relevant time period in Indiana,
Missouri, Wisconsin, Alabama, Florida, Illinois, Kentucky, and Kansas. D. 124 ¶ 15; D. 450 ¶
337; D. 510 ¶ 337. The Masons are headquartered in Wisconsin and made purchases of Asacol
400mg, Asacol HD, or Delzicol in Wisconsin during the relevant time period. D. 450 ¶ 339; D.
510 ¶ 339. The Laborers are headquartered in Minnesota and made purchases of Asacol, Asacol
HD, or Delzicol in Minnesota, Ohio, Wisconsin, Iowa, and Arizona during the relevant time
period. D. 450 ¶ 340; D. 510 ¶ 340.
The procedural history of this case is recounted in detail in the Court’s Memorandum and
Order on the motion to dismiss, D. 110. Currently pending before this Court are the parties’
motions to exclude expert testimony, D. 426; D. 427; D. 428; D. 429; D. 430; D. 431; D. 444, the
Plaintiffs’ motion for class certification under Fed. R. Civ. P. 23(b)(3), D. 380, and the Defendants’
motion for summary judgment, D. 445. The Court held a hearing regarding these pending motions
on October 26, 2017. D. 556.
Motions to Strike Expert Testimony
Standard of Review
Pursuant to Fed. R. Evid. 702, a qualified expert witness can testify “in the form of an
opinion, or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony
is the product of reliable principles and methods, and (3) the witness has applied the principles and
methods reliably to the facts of the case.” United States v. Mooney, 315 F.3d 54, 62 (1st Cir.
2002) (quoting Fed. R. Evid. 702). The district court is tasked with “ensuring that an expert’s
testimony both rests on a reliable foundation and is relevant to the task at hand.” Daubert v. Merrell
Dow Pharm., Inc., 509 U.S. 579, 597 (1993). “[T]he district court must perform [this] gatekeeping
function by preliminarily assessing ‘whether the reasoning or methodology . . . properly can be
applied to the facts in issue’” by examining multiple factors through a case-specific inquiry.
Seahorse Marine Supplies, Inc. v. P.R. Sun Oil Co., 295 F.3d 68, 80-81 (1st Cir. 2002) (quoting
Daubert, 509 U.S. at 592-93). “As long as an expert's scientific testimony rests upon good grounds,
based on what is known, it should be tested by the adversary process—competing expert testimony
and active cross-examination—rather than excluded from jurors' scrutiny for fear that they will not
grasp its complexities or satisfactorily weigh its inadequacies.” Ruiz-Troche v. Pepsi Cola of P.R.
Bottling Co., 161 F.3d 77, 85 (1st Cir. 1998) (citations omitted). “Vigorous cross-examination,
presentation of contrary evidence, and careful instruction on the burden of proof are the traditional
and appropriate means of attacking shaky but admissible evidence.” Daubert, 509 U.S. at 596.
Motion to Exclude Testimony of Todd Clark
The Defendants move to exclude the testimony of Todd Clark (“Clark”), an expert in the
pharmaceutical industry, D. 426-5 at 3-4. Clark opines that “one or more generic versions of
Asacol 400mg would have entered the market at or within a short time period after the product’s
July 2013 patent expiration if Warner Chilcott had not executed the Asacol-to-Delzicol hard
switch.” D. 426-5 at 9.
The Defendants first contend that Clark’s opinion is speculative because it is impermissibly
based on general industry information rather than actual data about which companies filed ANDAs
in preparation for launch of a generic version of Asacol 400mg. D. 426-1 at 7-8. Specifically, the
Defendants contend that information concerning whether generic manufacturers were
technologically capable of producing a generic version of Asacol 400mg is “irrelevant” to the
question of whether a generic manufacturer would have entered. D. 426-1 at 7.
In forming his opinion, Clark relied upon “industry norms, [his] experience, the nature of
the product, the number of companies that we do know were interested, [and] the number of
companies that would typically be interested in a product of this size,” in a “holistic approach”
rather than a quantitative simulation. D. 426-3 at 21. In drafting the report, Clark reviewed
historical data regarding generic entry, D. 426-5 at 16, both generally and specifically with respect
to treatments for ulcerative colitis, D. 426-5 at 17; developments in the international market for
mesalamine products, D. 426-5 at 21-22; the technical capacities of generic manufacturers to
produce the drug, D. 426-5 at 35; the incentives for generic manufacturers to consider entering the
market, D. 426-5 at 20; the ability of generic manufacturers to obtain FDA approval, based on
guidance released by the FDA on the standards for bioequivalence, D. 426-5 at 42; and public
statements by generic manufacturers, D. 426-5 at 51. In Clark’s experience of twenty five years
in the pharmaceutical industry, D. 426-3 at 11, these are relevant factors in predicting the
likelihood of generic entry. D. 426-3 at 21.
The Defendants acknowledge that the publicly available ANDA information is incomplete,
because the publicly available information does not show which generic manufacturers had
ANDAs with a Paragraph III certification pending at the time that Warner Chilcott pulled Asacol
400mg from the market, D. 509 ¶ 279, decreasing the incentives for a generic manufacturer to see
that ANDA through to the tentative or final approval which would have been made public.
Because the available information on ANDA filings is incomplete in this respect, excluding
Clark’s testimony because it does not focus on the ANDA filings does not seem warranted. The
Defendants provide no reason to conclude that the technological capabilities of generic
manufacturers, or any other factors relied upon by Clark, are wholly irrelevant to the forecast of
generic entry. The factors relied upon by Clark constitute a sufficiently reliable foundation for
forecasting generic entry. Clark’s choice not to rely on whatever publicly available ANDA filings
existed goes to the weight, rather than the admissibility, of his testimony. See Packgen v. Berry
Plastics Corp., 46 F. Supp. 3d 92, 110 (D. Me. 2014).
Second, the Defendants contend that Clark’s testimony is inadmissible because Clark chose
not to use a quantitative simulation to forecast generic entry. D. 426-1 at 9; D. 426-3 at 21. Even
assuming a quantitative simulation might have been a superior method of forecasting generic entry,
Clark’s failure to do so does not render his testimony inadmissible. The standard for admissibility
is not whether Clark’s methodology is the best; only whether it is “methodologically reliable” and
rests on “good grounds,” Milward v. Acuity Specialty Prods. Corp., 639 F.3d 11, 15 (1st Cir. 2011)
(citations omitted), which the Court concludes it does.
Finally, the Defendants contend that Clark may not opine on what intention the Defendants
had in pulling Asacol 400mg from the market. D. 426-1 at 12. The Plaintiffs agree that Clark will
not opine on the Defendants’ intentions. D. 502 at 18. For all these reasons, the Court denies the
motion to exclude Clark’s expert opinion.
Motion to Exclude Testimony of Rena Conti
The Defendants move to exclude the testimony of Dr. Rena Conti (“Conti”). D. 427. The
Plaintiffs have proffered Conti’s opinion in predicting the effect of generic entry of Asacol 400mg
on the members of the putative class if Warner Chilcott had not pulled Asacol 400mg from the
market. D. 427-3 at 2. Conti is an Associate Professor of Health Economics at the University of
Chicago with a Ph.D. from Harvard University in Health Policy. D. 427-3 at 3-4. She has
published articles in peer-reviewed journals regarding the effect of generic entry on
pharmaceutical markets. D. 427-3 at 3-4.
Conti gathered data on the pricing and sales of the
Asacol-branded products and other ulcerative colitis drugs and data on the historical effect of
generic entry on the prices and sales of products sold for other comparable drugs (termed
“yardstick products”) to model the effect on the class based on certain scenarios of generic entry
provided by the Plaintiffs’ counsel. D. 427-3 at 13-26.
First, the Defendants contend that Conti’s model does not align with the class definition
and, therefore, does not meet the standard laid out by the Supreme Court in Comcast Corp. v.
Behrend, 569 U.S. 27, 35 (2013) that “any model supporting a [putative class representative’s]
damage case must be consistent with its liability case.” D. 427-1 at 6-9. These arguments do not
go to the admissibility of Conti’s testimony, but rather the appropriateness of certifying the class,
and are addressed below.
Next, the Defendants argue that Conti impermissibly relies on assumptions provided by
the Plaintiffs’ counsel regarding generic entry scenarios, D. 427-1 at 10-11; that Conti does not
remove uninjured class members from her analysis and therefore exaggerates the total damages,
D. 427-1 at 11-14, 18-19; that Conti impermissibly extrapolates the effect of generic entry on the
market for Asacol 400mg based on other products that are not comparable to Asacol 400mg, D.
427-1 at 14-17; and that Conti failed to limit damages to the four states in which the named
Plaintiffs made purchases, D. 427-1 at 17.
Assumptions Regarding Generic Entry
Conti’s choice to rely on scenarios provided by the Plaintiffs’ counsel, supported by the
expert testimony from Clark and McGuire, does not provide a basis for excluding her testimony.
“When facts are in dispute, experts sometimes reach different conclusions based on competing
versions of the facts.” Advisory Committee Notes to Rule 702 of the Federal Rules of Evidence.
As the Court will discuss below, there remains a genuine dispute of material fact regarding the
possibility of generic entry. It is up to the factfinder to determine whether the assumptions relied
on by Conti are accurate, and thus whether to accord any weight to her testimony. See Fontenot
v. Safety Council of Sw. La., No. 2:16-cv-84, 2017 WL 3588200, at *8 (W.D. La. Aug. 16, 2017).
Failure to Remove Uninjured Class Members
Conti’s purported failure to remove uninjured class members from her damages calculation
is similarly not grounds to exclude her testimony under Rule 702. The Defendants contend that
Conti’s model overestimates damages in the following ways:
Conti does not exclude the
“substantial percentage” of third party payors that would have been uninjured because they would
have paid less for the brand-name product than the generic product due to the higher co-pays
charged to consumers for brand-name products and manufacturer rebates, D. 427-1 at 12-13; that
Conti failed to account for brand-loyal consumers who would have stayed with Asacol 400mg
even if a generic version had been available, D. 427-1 at 9; that Conti failed to exclude consumers
who paid no co-pay or used coupons, D. 427-1 at 13; and that Conti failed to account for consumers
who would have shifted to Asacol HD or other drugs in the but-for world, D. 427-1 at 18-19.
The Defendants’ contention that there is a substantial percentage of uninjured third-party
payors rests on the estimate of Dr. Bruce Strombom (“Strombom”), the Defendants’ expert, on the
price of generic Asacol 400mg in the but-for world. D. 427-5 at ¶ 33. That estimate is based on
the application of assumptions based on actual data from the entry of a generic version of Asacol
HD, which Conti contends is not an appropriate comparator because there is currently only nine
months of data available on prices of generic Asacol HD, while full penetration of a generic
product usually takes over a year and the market for Asacol HD was smaller and, therefore, would
attract less price competition than the market for Asacol 400mg would have. D. 427-5 at 14-15.
Nevertheless, the disagreement between Conti and Strombom over which drugs constitute
appropriate comparators is not grounds to exclude Conti’s testimony. The but-for prices provided
by the two experts are based on their different perspectives on the various characteristics of Asacol
400mg, which guided the choice of different comparator products. This dispute appears to be
within “the range where experts might reasonably differ,” and thus the jury should “decide among
the conflicting views of experts.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 153 (1999).
Conti’s assumptions about the percentage of “brand-loyal” consumers are not very
different from the ones presented by the Defendants.
The Defendants’ expert, Strombom,
estimated that approximately 5,000 consumer class members would be “brand-loyal” (i.e., would
have chosen to continue purchasing Asacol HD or Delzicol even in the presence of a generic
version of Asacol 400mg). D. 401-1 at 24. Strombom utilized data from benchmark products
indicating that 30-40% of consumers continue to purchase the brand-name product in the first year
of generic availability, dropping to 10% by the third year of generic availability. D. 401-1 at 2324, 86. Conti, using benchmark data from other products, concluded that approximately 12.2% of
class members would have purchased Asacol HD or Delzicol even in the presence of a generic
version of Asacol 400mg on the market by the end of the first year of generic availability, dropping
to approximately 8.6% at the end of thirty-one months of generic availability. D. 384-1 at 75; D.
384-1 at 29. Thus, between the two reports, both experts conclude that the percentage of “brandloyal” consumers after 31 months would be between 8.6% and 10%; the experts conclude that
there would be different rates of attrition over the course of that period. This dispute, again,
appears to be within the range in which experts might reasonably disagree, as opposed to a way in
which Conti’s testimony is “so fundamentally unsupported that it can offer no assistance to the
jury.” In re Neurontin Mktg., Sales Practices, & Prods. Liab. Litig., 612 F. Supp. 2d 116, 131 (D.
Mass. 2009) (citation omitted).
Conti’s purported failure to account for customers with no co-pay or whose co-pay was
effectively reduced to zero because of a coupon is similarly not a basis to exclude her testimony.
Conti estimated the percentage of consumers with zero co-pay plans and excluded them from her
analysis. D. 427-3 at 28. Conti also estimated the impact of coupons provided to consumers by
taking data from the Defendants’ financial statements. D. 427-3 at 30. She estimated that 6% or
fewer of prescriptions were affected by a coupon – and because each patient filled multiple
prescriptions, fewer than 6% of patients would have had all of their purchases subject to a coupon
that reduced the price to zero. D. 427-3 at 30. Neither the Defendants’ briefing nor Strombom’s
report sufficiently explain why these adjustments are so flawed as to undermine the reliability of
her proffered opinion. D. 427-1 at 13; D. 427-8 at 25-26.
Finally, the Defendants contend that Conti’s testimony should be excluded because her
model does not account for the percentage of consumers who are uninjured because they would
have responded to an increase in the price of Asacol 400mg by switching to either Asacol HD or
another ulcerative colitis drug. D. 427-1 at 18. But, as discussed below, there continues to be a
genuine dispute of material fact over the elasticity of consumer demand for Asacol 400mg and
other ulcerative colitis treatments. Like Conti’s assumptions about generic entry, her assumptions
about the substitutability of other ulcerative colitis treatments is supported by the testimony of
another of the Plaintiffs’ experts, and will be subject to findings by the factfinder, and thus does
not constitute a reason to exclude her testimony.
Choice of Yardstick Product
The Defendants contend that Valcyte, the “yardstick product,” or product based on which
Conti made assumptions about the likely effect of generic entry, was inappropriate because, unlike
Asacol 400mg, the yardstick product does not involve safety concerns associated with DBP. This
argument is unpersuasive, as the Plaintiffs contend that a generic version of Asacol 400mg might
also have been formulated without DBP, meaning that any opinion supporting their claims would
not need to account for patient safety concerns regarding DBP.
The Defendants next contend that Valcyte is different from Asacol 400mg in that it is more
expensive; it did not have the same active ingredient as any other treatment on the market; and it
is not an ulcerative colitis treatment. D. 427-1 at 19. The Defendants contend that Conti should
have used Asacol HD as a yardstick instead. D. 427-1 at 19. However, Conti chose Valcyte as a
yardstick product because, unlike Asacol HD, Valcyte had, before generic competition, similar
total sales as Asacol 400mg and Valcyte had multiple generic entrants rather than a single
authorized generic entrant. D. 427-3 at 23-24. This dispute over which features of Asacol 400mg
are most salient, and therefore are most important to select for in a yardstick product, are within
the range of reasonable disagreement by experts, and fall short of the standard required to exclude
Limiting Calculation to Four States
The Defendants contend that Conti’s opinion must also be excluded because her model
includes damages estimates from more than the states in which the named Plaintiffs made relevant
purchases. D. 427-1 at 17. As discussed below, however, the Court concludes that the Plaintiffs
have standing to bring claims under the laws of states in which any class member made purchases
and, therefore, rejects this basis for excluding or limiting Conti’s anticipated testimony.
Motion to Exclude Testimony of Richard Frank
The Defendants move to exclude the testimony of Dr. Richard Frank (“Frank”). D. 428.
The Plaintiffs proffer Frank as an expert in defining the relevant market of products with which
Asacol 400mg competes. D. 428-3 at 2. Frank is a Professor of Health Economics at Harvard
University Medical School and has been engaged in health economics for over thirty years. D.
428-3 at 4.
Frank began by surveying the market for anti-inflammatory therapeutics, including
multiple treatments for ulcerative colitis and all 5-ASA drugs. D. 428-3 at 30. Relying on FDA
data, among other sources, Frank charted the differences between these products in approved
indications, formulation, timing, and adverse effects. D. 428-3 at 32. After excluding certain
drugs, Frank analyzed the relative wholesale prices over time of the various products and
concluded that “price patterns suggest no real evidence of price changes that could lead to product
substitution among the branded drugs in the analysis.” D. 428-3 at 39. Rather “the relative prices
for these drugs were relatively constant over time,” indicating that “price competition was
relatively unimportant in shifting demand away from the Asacol drugs to Lialda and/or Apriso,
and rather that attribute competition (differentiated product competition) was the primary driving
force.” D. 428-3 at 39. Frank concluded, based on a full review of the cited data, that if Warner
Chilcott had raised the prices of its Asacol products by 5%, it would not have appreciably reduced
sales or profits – an example of the “hypothetical monopolist” test used by the Department of
Justice in evaluating the antitrust impact of horizontal mergers. D. 428-3 at 70-71. Frank then
examined the gross margins earned by the Defendants for the Asacol products and concluded that
the gross margins were significantly higher than the gross margins for either generic products or
products facing generic competition, providing evidence of a monopoly. D. 428-3 at 75-79. Frank
concluded that “the fact that virtually all branded firms pay rebates to insurers and PBMs
(especially for tier placement on formularies) does not alter a branded firm’s ability to increase
and sustain higher supra-competitive branded prices.” D. 428-3 at 79. Finally, Frank noted that
Warner Chilcott’s promotional spending on Asacol HD and Delzicol accounted for over 10% of
net revenues and “high levels of promotional spending imply that firms have high enough margins
to provide a return to their promotional spending.” D. 428-3 at 80.
As to Frank’s opinion, the Defendants first argue that gross profits and promotional
spending are irrelevant to the analysis of the Defendants’ market power in the relevant market. D.
428-1 at 5-9. The Court disagrees; while they may not be sufficient alone to prove market power,
they are certainly relevant to an analysis of market power. See Coastal Fuels of P.R., Inc. v.
Caribbean Petroleum Corp., 79 F.3d 182, 196 (1st Cir. 1996) (stating that “market power . . . arises
when the defendant (1) can profitably set prices well above its costs” (citation omitted)).
Moreover, Frank does not rely exclusively on these factors in reaching his conclusions, but
combines an analysis of those factors with the pricing over time of the Defendants’ product and
the evidence of switching between products. D. 428-3 at 2-7.
Second, the Defendants contend that historic price increases are irrelevant and the ability
of the hypothetical monopolist to exact a five percent price increase profitably has no place outside
of the horizontal merger context. D. 428-1 at 9-10, 16-17. But the hypothetical monopolist test is
the “touchstone of market definition,” even in contexts outside of horizontal mergers. Coastal
Fuels of P.R., 79 F.3d at 198.
Third, the Defendants contend that Frank inappropriately uses wholesale prices without
accounting for rebates to third-party payors, leading him to ignore competition between brandname manufacturers for formulary placement with PBMs. D. 428-1 at 12-16. While Frank did
use wholesale prices, he also concluded that it was not necessary to account for rebates because
rebates were smaller than the price increases. D. 428-3 at 79. The only evidence the Defendants
have offered to support their contention that Frank erred in this conclusion is the statement of an
Allergan employee, indicating that PBMs that he negotiated with told him that rebates for Lialda
exceeded forty or fifty percent of list price. D. 428-15 at 3. This is not sufficient to show that
Frank’s use of wholesale prices and rationale for doing so are an unreliable basis for his opinion.
Finally, the Defendants argue that Frank inappropriately provided a medical opinion
regarding the differences between competing ulcerative colitis treatments that he was not qualified
to give. D. 428-1 at 17-18. This argument is unavailing; Frank compiled and reviewed reports
documenting certain characteristics of various drugs, including FDA sources, to inform his expert
economic analysis, and the Defendants will be permitted to challenge the validity of the bases of
his opinion at trial.
Motion to Exclude Testimony of Irwin Jacobs
The Defendants move to exclude the testimony of Dr. Irwin Jacobs (“Jacobs”). D. 429.
The Plaintiffs first proffer Jacobs as an expert regarding the therapeutic characteristics of Asacol
400mg and Delzicol and the potential for creating a version of Asacol 400mg with DBP without
using a capsule. D. 429-3 at 9. Jacobs, in formulating his opinion, relied upon documents provided
by Warner Chilcott; a report submitted by the Defendants’ expert on the subject, Dr. Robbins;
experience with the pharmaceutical industry; documents from the FDA’s communication with
Warner Chilcott; and his own expertise in the field. D. 429-3 at 9-19. Jacobs concluded that “[i]t
was possible to achieve safety and bioequivalence to original Asacol 400mg tablets with
reformulated Asacol 400mg tablets that replaced DBP with DBS without changing the dosage
form to a capsule;” that there was no need to address the problem of microfractures by means of
encapsulation; and that “[t]here is no technical or scientific reason why a company would need to
encapsulate the tablet to accommodate a change to DBS formulation.” D. 429-3 at 10-11.
The Plaintiffs also proffer Jacobs as an expert on the potential challenges that generic
manufacturers would face in trying to create a generic version of Asacol 400mg. Jacobs concluded
that “no major scientific or technological hurdles existed to prevent drug companies from
developing a generic version of Asacol [400mg] that could meet [the] FDA’s bioequivalence
requirements and enter the market after Asacol [400mg]’s patents expired.” D. 429-4 at 5. He
reviewed the conclusions of the Defendants’ expert, Dr. Juergen Siepmann, regarding certain
purported difficulties in developing a generic version of Asacol 400mg, and concluded that none
of those purported difficulties were valid or material. D. 429-4 at 5.
The Defendants next contend that Jacobs’ testimony is speculative because Jacobs does
not identify a particular generic manufacturer with the capability of producing a generic version
of Asacol 400mg. D. 429-1 at 6. Jacobs, however, used sufficiently reliable information about
the technological capabilities of generic manufacturers generally, based upon other products they
produced and the specific characteristics of the Asacol 400mg product, in reaching his conclusion.
The Defendants next contend that Jacobs impermissibly took account of the fact that generic
manufacturers produced generic versions of two other mesalamine products – Asacol HD and
Lialda – in reaching his conclusions, despite the fact that Asacol HD and Lialda are different
products from Asacol 400mg. D. 429-1 at 7. But Jacobs relied on those products because they
were similar to Asacol 400mg in ways that made it reasonable to draw an inference about the ease
of creating a generic version of Asacol 400mg from information about Asacol HD and Lialda. D.
429-5 at 28.
The Defendants also argue that Jacobs’ conclusions regarding the feasibility of formulating
a version of Asacol 400mg without DBP and without a capsule are inadmissible. The Defendants
first contend that Jacobs, in concluding that the FDA would have approved P&G’s Asacol 400mg
tablets made with DBS and without a capsule, relied only on P&Gs in vitro dissolution studies,
whereas the FDA would have required more thorough testing. D. 429-1 at 11. But this contention
is not at odds with Dr. Jacob’s testimony. Rather, Jacobs opined that, based on his expertise, the
academic literature and the experiments that were completed by P&G, “human trials had a very
high likelihood of success.” D. 429-3 at 20.
The Defendants additionally contend that Jacobs inappropriately discounted a December
2012 study by Warner Chilcott on microfractures because they were done in a “water
environment.” D. 429-1 at 12-13. In Jacobs’ report, he dismissed the study because “it contains
a small sample size, it is not a controlled experiment, and there is no substantiation of the
conclusions.” D. 429-3 at 31. Jacobs opined that because microfractures originate in the
manufacturing, shipping, and handling process – which are dry settings – a water environment is
not the appropriate environment in which to test for the development of microfractures, D. 429-5
at 51, even though the microfractures ultimately manifest in the water environment of the human
The Defendants also seek to exclude Jacobs’ opinions on the Defendants’ intent; the
likelihood of certain action by the FDA such as approval of a product; and the relative costs of
manufacturing an encapsulated versus non-encapsulated tablet. D. 429-1 at 15-16. But, the
Plaintiffs agree that Jacobs will not testify about the Defendants’ intent. D. 505 at 17. And, while
Jacobs is not an expert in regulatory matters, he is a scientist who reviewed the technical
documents released by the FDA on bioequivalence testing and opined on whether generic
manufacturers would be able to meet those technical specifications – which is, along with
manufacturing costs, within his scope of expertise. D. 429-3 at 5-6.
Finally, the Defendants seek to exclude Jacobs’s testimony weighing the credibility of the
evidence regarding the existence of a microfracture problem or the likelihood of generic entry,
because his testimony would usurp the role of the jury. D. 429-1 at 16. This is not the case where
an expert is doing so in explaining his review of the scientific evidence in rendering an opinion, a
function that would aid the jury pursuant to Fed. R. Evid. 702 and the jury will be instructed that
they are only required to give what weight, if any, they deem they should as to any expert or lay
Motion to Exclude Testimony of David Kessler
The Defendants move to exclude the testimony of Dr. David Kessler (“Kessler”). D. 430.
The Plaintiffs proffer Kessler, a former Commissioner of the FDA, as an expert on the FDA’s
policy with respect to DBP and the Asacol products. D. 430-3 at 26-32. Kessler reviewed the
regulatory history of Asacol 400mg, Asacol HD, and Delzicol; the physical properties of Asacol
400mg, Asacol HD, and Delzicol; the history of interactions between the FDA and P&G and its
successors about the Asacol products; and the history of FDA policy on DBP. D. 426-3 at 9-25.
Based on this information, Kessler concluded that Warner Chilcott could have reformulated Asacol
400mg to remove DBP through a supplement to the Asacol NDA and that the FDA did not require
Warner Chilcott to remove Asacol 400mg from the market or require Warner Chilcott to switch to
a capsule formulation. D. 426-3 at 26-30.
The Defendants first argue that Kessler’s deposition testimony raised new opinions not
disclosed in his initial report and those additional opinions should be excluded. D. 430-1 at 6. See
Fed. R. Civ. P. 26(2)(B); In re Zoloft Sertralinehydrochloride Prods. Liab. Litig., 176 F. Supp. 3d
483, 496 (E.D. Pa. 2016). Specifically, the Defendants contend that Kessler went beyond the scope
of his report in opining regarding the version of Asacol 400mg sold in the United Kingdom and
the swallowability of the Delzicol capsule. D. 430-1 at 6. But Kessler did opine in his report that
the Defendants could have reformulated a DBP-free version of Asacol 400mg without a capsule,
D. 430-3 at 32, and merely offered the U.K. formulation as additional rationale for this opinion in
the deposition. Because the U.K. formulation has been discussed by other experts, there is no clear
prejudice from Kessler discussing it as well, despite his failure to reference it specifically in his
report. Similarly, Kessler also opined that the FDA did not require the capsule, for any safetyrelated reason or otherwise, D. 430-3 at 30-32, and the swallowability was an explanation in the
deposition for why the capsule is not an inherently safer formulation. Compare D. 430-3 at 29-31
with D. 430-4 at 98, 126. Again, there is no prejudice to the Defendants as to this issue.
The Defendants next contend that Kessler’s opinions stating that the FDA would have
approved a formulation of Asacol 400mg without DBP and without a capsule are inadmissible
because Kessler was not the FDA Commissioner at the time and cannot speculate about what the
FDA would have done. D. 430-1 at 8-9. But, Kessler is unquestionably an expert in the process
of FDA decision-making, and to the extent that the FDA’s actions in a but-for world are matters
for the fact-finder to determine, based upon whether it chooses to credit such opinion, the Court
does not conclude that such opinion is beyond the bounds of Rule 702. See In re Yasmin & YAZ
(Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 3:09-MD-02100-DRH, 2011 WL
6302287, at *13 (S.D. Ill. Dec. 16, 2011) (finding that “[a]s the former Commissioner of the FDA,
with unquestioned knowledge of the regulatory scheme and requirements, Kessler may testify
about what a reasonable FDA official would have done . . . because his experience uniquely
qualifies for him to do so”). The cases cited by the Defendants, D. 430-1 at 8-9, do not compel a
The Defendants next seek to exclude Kessler’s opinion that the FDA never required the
Defendants to withdraw Asacol 400mg once Delzicol was launched, both for reasons similar to
those cited above (which the Court does not accept) and because the record does not support that
conclusion. D. 430-1 at 10. As to the latter point, the record does not show any evidence that the
FDA did or was about to require the Defendants to pull DBP-containing Asacol 400mg from the
market; rather, it shows that the FDA allowed DBP-containing Asacol HD to stay on the market
for some time after Warner Chilcott pulled Asacol 400mg.
The Defendants also move to exclude Kessler’s testimony regarding generic entry on the
grounds that Kessler was only offered as a regulatory expert. D. 430-1 at 12-13. But the opinions
of Kessler regarding generic entry are focused on the lack of regulatory barriers to generic entry,
and explaining why the experiences of Par and Roxane – which had submitted ANDAs with
Paragraph IV certifications and met with regulatory barriers – were not applicable to generic
manufacturers that might have submitted ANDAs with Paragraph III certifications. D. 430-10 at
27. This is a fundamentally regulatory opinion and thus within the scope of Kessler’s expertise.
Finally, the Defendants move to exclude Kessler’s testimony on technical formulation
issues; the standard of care for ulcerative colitis patients; and the intentions of the executives of
the Defendants. D. 430-1 at 16-22. The Plaintiffs, however, do not seek to have Kessler opine on
these topics. D. 506 at 12-15.
Motion to Exclude Testimony of Thomas McGuire
The Defendants move to exclude the testimony of Dr. Thomas McGuire (“McGuire”).
D. 431. The Plaintiffs engaged McGuire, a Professor of Health Economics at Harvard Medical
School, to opine regarding “if Warner Chilcott’s withdrawal of Asacol 400mg precluded
competition and harmed consumers,” and “on whether, had Asacol 400mg not been withdrawn
from the market, rational, competitively acting generic firms would have been likely to enter after
patent expiry.” D. 431-7 at 3-4.
McGuire opines that it would be profit-maximizing for Warner Chilcott to pull Asacol
400mg from the market only if doing so would lead to higher profits for Delzicol, which would
derive from consumers who preferred Asacol 400mg but were forced to switch to an alternative
and chose Delzicol. D. 431-7 at 53-54. He concluded that, based on an analysis of yardstick
products, generic entry for Asacol 400mg would have been likely if Warner Chilcott had not pulled
Asacol 400mg from the market. D. 431-7 at 76.
The Defendants first contend that McGuire impermissibly assumed the possibility of
generic entry without pointing to any particular potential entrants. D. 431-1 at 7. That argument
fails for the same reason it was rejected above for Clark’s testimony. Second, the Defendants
contend that McGuire did not calculate the quantity of lost profits, but only calculated the lost
revenue and inferred the lost profits from that. D. 431-1 at 8. But the Defendants do not explain
why that inference is flawed – especially given the other evidence in the record, provided by Frank,
that Asacol 400mg was a highly profitable drug. Third, the Defendants contend that McGuire
impermissibly ignored the safety hazards of DBP. D. 431-1 at 9. But, as discussed above, this is
not a reason to exclude his testimony.
Fourth, the Defendants challenge McGuire’s model, which indicates that a hard switch by
a brand-name manufacturer generally suppresses generic entry because the brand-name
manufacturer would not pull a profitable product from the market unless it could make up those
profits by increased sales of the new product that would come from consumers who preferred the
old product and would likely have adopted a generic competitor to that product. D. 431-7 at 58.
The Defendants contend that this model has no “limiting principle” and thus would not be useful
to a jury. D. 431-1 at 11. But this type of objection goes to the weight, rather than admissibility,
of McGuire’s testimony, and can be raised before a fact-finder in cross-examination.
Fifth, the Defendants contend that McGuire impermissibly failed to incorporate into his
analysis the pro-competitive benefits of Delzicol. D. 431-1 at 11-12. However, the presence of
any pro-competitive benefits of Delzicol is a disputed issue of material fact here. The Defendants
are free to challenge McGuire’s assumption that there were no procompetitive benefits to Delzicol
before the jury, but it is not grounds for excluding his testimony.
Sixth, the Defendants argue that McGuire’s test would create, in the mind of the jury, an
impermissible presumption of anti-competitive conduct wherever a brand-name manufacturer
executes a hard switch, which is not a proposition of law that has been adopted by any court or an
economic theory published in any economic journal. D. 431-1 at 12-14. Other courts have,
however, found that hard switches may be anti-competitive.
See, e.g., New York ex rel.
Schneiderman v. Actavis PLC (In re Namenda), 787 F.3d 638, 652 (2d Cir. 2015). McGuire’s
economic analysis provides an explanation for why a hard switch might generally be
anticompetitive, but there is no reason for the jury to conclude that such is the case here. The fact
that McGuire’s theory has not yet been published is not alone grounds for its exclusion at trial.
The reasons proffered by the Defendants for why not all hard switches are anticompetitive are all
appropriate grounds for cross-examination.
Seventh, the Defendants seek to exclude the portion of McGuire’s testimony that supports
his conclusion that the introduction of Delzicol did not lead to a drop in the price of Asacol HD.
D. 431-1 at 14. The Defendants contend that McGuire did not specify for them at his deposition
whether he used the invoice date, accrual date or pay date to calculate the relevant date to associate
with particular price data, and thus must be excluded. D. 431-1 at 15. But, the Court does not
conclude that this is a sufficient basis alone for the drastic measure of excluding this opinion and
declines to do so.
Eighth, the Defendants contend that McGuire erred by using price data that did not reflect
rebates given to third-party payors and did not include comparisons to relevant similar ulcerative
colitis drugs. D. 431-1 at 16-17. But McGuire did adjust the price data to reflect rebates from the
manufacturer, D. 431-7 at 64, and the Court does not conclude that such adjustment is insufficient.
McGuire’s analysis of price data was limited to the general proposition that prices for Asacol HD
trended up from December 2012 to August 2013, so his failure to analyze price trends in other
drugs is irrelevant – he does not purport to opine that Asacol HD prices moved in a way that was
different from other drugs. D. 431-7 at 65.
Finally, the Defendants contend that McGuire’s conclusions about the likelihood of generic
entry should be excluded because McGuire does not identify any particular generic manufacturer
that would have entered. The Court rejects this argument for McGuire as it did for Clark.
Motion to Exclude Testimony of Bruce Strombom
The Plaintiffs move to exclude the testimony of Dr. Bruce Strombom (“Strombom”), the
Defendants’ expert. D. 444. Strombom opines about the number of uninjured class members,
certain putative defects in Conti’s model and the aggregate damages calculation. D. 453-1 at 3-4.
The Plaintiffs contend that Strombom’s testimony about the number of uninjured consumers
should be excluded because Strombom classifies consumers as “uninjured” where the consumer
experienced an overcharge but later received recoupment for that overcharge, in contrast to legal
precedent, which holds that an antitrust injury occurs “the moment the purchaser incurs an
overcharge, whether or not that injury is later offset” by “savings attributable to the same or related
transaction.” In re Nexium Antitrust Litig., 777 F.3d 9, 27 (1st Cir. 2015). D. 453 at 2. For the
purposes of the class certification inquiry, the Court applies First Circuit law and does not rely on
this portion of Strombom’s analysis. For the purposes of the total damages calculation the jury
must perform, however, Strombom’s opinions regarding the likely impact of generic entry, the
importance of rebates and coupons in offsetting damages and price trends in a but-for world remain
of value, and therefore the Court does not exclude them. D. 453-1 at 4.
The Plaintiffs’ Proposed Class
The Plaintiffs seek to certify a class defined as follows:
All persons or entities in the United States and its territories who purchased and/or
paid for some or all of the purchase price for Delzicol or Asacol HD in Arizona,
California, Florida, Iowa, Maine, Massachusetts, Michigan, Minnesota,
Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico,
New York, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota,
Tennessee, Vermont, West Virginia, Wisconsin, and the District of Columbia for
consumption by themselves, their families, or their members, employees, insureds,
participants, or beneficiaries, during the period July 31, 2013 through and until the
anticompetitive effects of Defendants’ unlawful conduct cease and also purchased
and/or paid for some or all of the purchase price for Asacol 400mg prior to July 31,
The following groups are excluded from the Class:
a. Defendants and their officers, directors, management, employees, subsidiaries,
b. All persons or entities who purchased Asacol 400mg, Asacol HD, or Delzicol
only directly from Defendants or for resale;
c. All government entities, except for government-funded employee benefit plans;
d. Fully insured health plans (i.e., plans that purchased insurance from another
third party payor covering 100% of the plan’s reimbursement obligations to its
e. Pharmacy benefit managers;
f. All entities whose only post-July 31, 2013 purchases of Asacol HD and Delzicol
were in Massachusetts, Missouri, or Vermont;
g. “Flat co-pay” “Cadillac Plan” consumers who made purchases only via fixed
dollar co-payments that do not vary between brand and generic drugs;
h. Consumers who purchased Asacol HD prior to March 8, 2013 or who purchased
Asacol 400mg, Asacol HD, or Delzicol only through a Medicaid program; and
i. The judges in this case and any members of their immediate families.
D. 380 at 1-2.
The Defendants contend that the Plaintiffs lack standing to bring claims under the laws of
any state where one of the named Plaintiffs has not allegedly made a purchase. D. 400 at 7. Article
III imposes a “threshold requirement” that “those who seek to invoke the power of federal courts
must allege an actual case or controversy” by pleading “some threatened or actual injury resulting
from the putatively illegal action.” O’Shea v. Littleton, 414 U.S. 488, 493 (1974). “[I]f none of
the named plaintiffs purporting to represent a class establishes the requisite of a case or controversy
with the defendants, none may seek relief on behalf of himself or any other member of the class.”
Id. at 494. Additionally, “a plaintiff must demonstrate standing for each claim he seeks to press.”
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352 (2006).
The Court addresses the standing question before certifying the class. See Modell v. Eliot
Sav. Bank, 139 F.R.D. 17, 20 (D. Mass. 1991) (stating that “[w]hen the issue of standing is raised
by a party, this Court must resolve that issue before considering the class certification requirements
of Rule 23”); In re Evergreen Ultra Short Opportunities Sec. Litig., 275 F.R.D. 382, 387 (D. Mass.
2011) (“courts often decide standing at the class certification stage or earlier”); In re Eaton Vance
Corp. Sec. Litig., 219 F.R.D. 38, 40-41 (D. Mass. 2003) (“[t]he burden is on the party invoking
federal jurisdiction, here the named plaintiffs, to meet each of the standing requirements"). See
also O’Shea, 414 U.S. at 494-95.
Article III “requires that federal courts may only adjudicate an actual ‘case or
controversy.’” In re Prudential Ins. Co., 148 F.3d 283, 306 (3d Cir. 1998). For Article III standing,
a plaintiff must have suffered an “injury in fact” by the defendants’ conduct for which the plaintiff
seeks redress. Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 103 (1998). Similar to Nexium,
there is no dispute that each named plaintiff allegedly paid overcharges as a result of Defendants’
alleged success in suppressing generic competition to Asacol 400mg and the named plaintiffs seek
monetary relief for those injuries. Nexium, 777 F.3d at 32 (noting that it is “undisputed that the
named plaintiffs have shown that they were overcharged for at least one Nexium transaction during
the class period, establishing standing”); see In re Relafen Antitrust Litig., 221 F.R.D. 260, 26768 (D. Mass. 2004).
The same is shown here for the named plaintiffs’ standing to bring this class action, where
each named plaintiff has suffered the same injury in fact as a result of the Defendants’ conduct.
That is, to show standing, the named plaintiffs must assert an injury in fact – but they need not
assert the same claims as the putative class members that, here, arise under the laws of different
states.2 To require more for Article III standing from the named plaintiffs is to jump forward to a
Rule 23 certification analysis about whether the named plaintiffs’ claims are typical and common
of those of the class and whether the named plaintiffs are adequate representatives of the class.
Even in the Rule 23 analysis, however, there is no requirement that putative class members share
“identical claims.” Piazza v. Ebsco Indus., Inc., 273 F.3d 1341, 1351 (11th Cir. 2001).3
Because the named plaintiffs have standing to assert a claim based on the allegedly anticompetitive conduct of the
Defendants, they also have standing to represent a putative class of similarly injured parties. The issue of which
specific state laws govern the dispute at issue is a choice of law question, not a standing question. See In re
Buspirone Litig., 185 F. Supp. 2d 363, 377. The parties appear to be in agreement that the dispute will be governed
by the laws of the state in which the qualifying purchase was made.
The Court is mindful of the disagreement between courts about this issue where named plaintiffs, like the named
plaintiffs here, assert the same injury-in-fact but under the laws of some state laws in which they have not made a
qualifying purchase. Compare Blessing v. Sirius XM Radio, Inc., 756 F. Supp. 2d 445, 452 (S.D.N.Y. 2010) with In
Class Certification: Burden of Proof and Standard of Review
A class action may be certified only if “(1) the class is so numerous that joinder of all
members is impracticable; (2) there are questions of law or fact common to the class; (3) the claims
or defenses of the representative parties are typical of the claims or defenses of the class; and (4)
the representative parties will fairly and adequately protect the interests of the class.” Fed R. Civ.
P. 23(a). Where, as here, the Plaintiffs have moved to certify the class under Fed. R. Civ. P.
23(b)(3), the Court must also determine whether “questions of law or fact common to class
members predominate over any questions affecting only individual members, and that a class
action is superior to other available methods for fairly and efficiently adjudicating the
controversy.” Fed R. Civ. P. 23(b)(3). “[T]he district court must undertake a ‘rigorous analysis’
to determine whether plaintiffs me[e]t the four threshold requirements of Rule 23(a) (numerosity,
commonality, typicality, and adequacy of representation) and Rule 23(b)(3)’s two additional
prerequisites.” Nexium, 777 F.3d at 17-18 (quoting Comcast, 569 U.S. at 33).
Numerosity Is Satisfied Here
To certify a class action, “the class [must be] so numerous that joinder of all members is
impracticable.” Fed. R. Civ. P. 23(a)(1). “‘Impracticability’ does not mean ‘impossibility,’ but
only the difficulty or inconvenience of joining all members of the class.” Advert. Specialty Nat’l
Ass’n v. FTC, 238 F.2d 108, 119 (1st Cir. 1956). “No minimum number of plaintiffs is
required . . . but generally if the named plaintiff demonstrates that the potential number of
plaintiffs exceeds 40, the first prong of Rule 23(a) has been met.” García-Rubiera v. Calderón,
570 F.3d 443, 460 (1st Cir. 2009) (quoting Stewart v. Abraham, 275 F.3d 220, 226-27 (3d Cir.
2001)); see In re Relafen Antitrust Litig., 218 F.R.D. 337, 342 (D. Mass. 2003).
re Propranolol Antitrust Litig., 249 F. Supp. 3d 712, 727 (S.D.N.Y. 2017). But, even considering this disagreement,
the Court concludes that Article III standing is satisfied here based upon the analysis above.
The Plaintiffs contend that they have met their burden of showing numerosity because the
proposed class includes most individuals who filled a prescription for Asacol HD or Delzicol in
the Class states, D. 381 at 14, and in 2013, there were 318,000 prescriptions for Asacol HD and
128,000 prescriptions for Delzicol in those states. D. 384-1 at 32. The Defendants respond that
the number of prescriptions filled is not the same as the number of consumers who made purchases,
because a single consumer may have filled multiple prescriptions. D. 400 at 12. It is true that the
number of prescriptions is not the same as the number of consumers, however, it is reasonable to
use “common sense assumptions” to conclude that if there were over 446,000 relevant
prescriptions filled in one year, there were more than 40 individual consumers – even assuming
some attrition based on class exclusions. See In re Playmobil Antitrust Litig., 35 F. Supp. 2d 231,
239 (E.D.N.Y. 1998). The Court thus finds that the Plaintiffs have met their burden of proving
numerosity under Rule 23(a)(1).
The Plaintiffs must also demonstrate that “there are questions of law or fact common to the
class.” Fed. R. Civ. P. 23(a)(2). The Plaintiffs contend that the common questions of law or fact
include, inter alia, the relevant market definition, the existence of monopoly power on the part of
the Defendants, and the market effect of the Defendants’ decision to pull Asacol 400mg off the
market. The Defendants do not contest that the commonality requirement is met, but rather
contend that issues common to the class do not predominate over individual issues, as is required
by Rule 23(b)(3). D. 400 at 13. The Court finds that the commonality requirement is satisfied.
Rule 23(a)(3) requires that the “claims or defenses of the representative parties are typical
of the claims or defenses of the class.” Fed. R. Civ. P. 23(a)(3). “The representative plaintiff
satisfies the typicality requirement when its injuries arise from the same events or course of
conduct as do the injuries of the class and when plaintiffs’ claims and those of the class are based
on the same legal theory.” In re Credit Suisse–AOL Sec. Litig., 253 F.R.D. 17, 23 (D. Mass. 2008)
(citation omitted). The Plaintiffs contend that the named plaintiffs’ claims are typical of the class
because the named plaintiffs, like all class members, overpaid for Asacol HD and Delzicol as a
result of the Defendants’ decision to pull Asacol 400mg from the market. D. 381 at 15.
The Defendants contend that the named plaintiffs – all unions – are not sufficiently similar
to the individual consumers and health insurers included in the class. D. 400 at 13. Specifically,
they contend that the Laborers and Masons were able to pass on the putative overcharge to others
and so suffered no net injury, unlike other class members, and that the Laborers suffered no net
injury because it received rebates that fully compensated it for the putative overcharge. Id. An
antitrust injury, however, occurs “the moment the purchaser incurs an overcharge, whether or not
that injury is later offset” by “savings attributable to the same or related transaction.” Nexium,
777 F.3d 9 at 27. Even if the named plaintiffs did not suffer a net injury, the named plaintiffs still
experienced an injury – the putative overcharge – and seek to recover on that injury on the basis
of an antitrust claim, just like the other class members. The Court finds that the typicality
requirement is satisfied.
Rule 23(a)(4) requires that “the representative parties will fairly and adequately protect the
interests of the class.” Fed. R. Civ. P. 23(a)(4). “[A] class representative must be part of the class
and ‘possess the same interest and suffer the same injury’ as the class members.” Amchem Prods.,
Inc. v. Windsor, 521 U.S. 591, 625–26 (1997) (quoting East Tex. Motor Freight Sys., Inc. v.
Rodriguez, 431 U.S. 395, 403 (1977) (alteration in original)). A putative representative must show
“first that the interests of the representative party will not conflict with the interests of any of the
class members, and second, that counsel chosen by the representative party is qualified,
experienced and able to vigorously conduct the proposed litigation.” Andrews v. Bechtel Power
Corp., 780 F.2d 124, 130 (1st Cir. 1985). “[P]erfect symmetry of interest is not required and not
every discrepancy among the interests of class members renders a putative class action untenable.”
Matamoros v. Starbucks Corp., 699 F.3d 129, 138 (1st Cir. 2012). “Only conflicts that are
fundamental to the suit and that go to the heart of the litigation prevent a plaintiff from meeting
the Rule 23(a)(4) adequacy requirement.” Id. (quoting 1 William B. Rubenstein, Newberg on
Class Actions § 3:58 (5th ed. 2012).
The Defendants contend that the named plaintiffs are not adequate representative parties
because, unlike the other class members, the named plaintiffs are third party payors who were able
to offset the alleged overcharge in the price of Asacol HD or Delzicol by recouping the overcharge
from the consumer through co-pays, from the manufacturer through rebates, or from employers
through contributions. D. 400 at 15. As described above, however, the antitrust injury occurs at
the moment of the overcharge and the presence of offsetting transactions does not change the fact
of injury. Thus, there is no reason to conclude that the presence of offsetting transactions would
make the named plaintiffs inadequate representatives.
The Defendants further contend that the Plaintiffs’ damages model created a “conflict”
because Conti’s model removed consumers who had not used Asacol 400mg prior to July 30, 2013,
but did not similarly exclude third-party payors who did not purchase Asacol 400mg prior to July
30, 2013. D. 400 at 15. The Defendants argue that this feature shows that the Plaintiffs “did not
ask Conti to make the same adjustment for their clients as they did for consumers,” demonstrating
the inadequacy of the class representatives. Id. But, as Conti explains, there is good reason for
making this exclusion for individual consumers but not for third-party payors. She opines that
“[u]nlike the consumer of an Asacol HD or Delzicol prescription who may be new to using the
franchise, a TPP is much more likely than not to have paid for an Asacol 400mg prescription as
well . . . since they cover so many consumers and pay for many prescription drug purchases.” D.
414 at 12. The Court concludes that there is no conflict created between the named plaintiffs and
members of the purported class on this basis and that the Plaintiffs have met their burden as to
Rule 23(b)(3) Predominance
Rule 23(b)(3) requires the Court to find that “the questions of law or fact common to class
members predominate over any questions affecting only individual members.” Fed. R. Civ. P.
23(b)(3). The focus of the predominance inquiry is “whether proposed classes are sufficiently
cohesive to warrant adjudication by representation.” Amchem, 521 U.S. at 623. When conducting
a Rule 23(b)(3) analysis, the Court must determine whether there is “reason to think that
[individualized] questions will overwhelm common ones and render class certification
inappropriate.” Halliburton Co. v. Erica P. John Fund Inc., 134 S. Ct. 2398, 2412 (2014). This
requires a district court to “formulate some prediction as to how specific issues will play out in
order to determine whether common or individual issues predominate in a given case.” Waste
Mgmt. Holdings, Inc. v. Mowbray, 208 F.3d 288, 298 (1st Cir. 2000). “To meet the predominance
requirement, the party seeking certification must show that ‘the fact of antitrust impact can be
established through common proof’ and that ‘any resulting damages would likewise be established
by sufficiently common proof.’” Nexium, 777 F.3d at 18 (quoting In re New Motor Vehicles
Canadian Exp. Antitrust Litig., 522 F.3d 6, 20 (1st Cir. 2008)) (emphasis and alteration in original).
“Predominance is not defeated by individual damages questions as long as liability is still subject
to common proof.” In re New Motor Vehicles, 522 F.3d at 28.
Rule 23(b)(3) carries an “implied” requirement that the class definition be sufficiently
definite such that the class members are “ascertainable.” See Nexium, 777 F.3d at 19; Matamoros,
699 F.3d at 139; see also In re Lidoderm Antitrust Litig., No. 14-md-02521, 2017 U.S. Dist. LEXIS
24097, at *105 (N.D. Cal. Feb. 21, 2017); Carrera v. Bayer Corp., 727 F.3d 300, 306 (3d Cir.
2013). The presence of sufficiently “objective criteria” in the class definition renders the class
sufficiently ascertainable. Nexium, 777 F.3d at 19; Matamoros, 699 F.3d at 139. Where the
proposed class may contain uninjured members, “[a]t the class certification stage, the court must
be satisfied that, prior to judgment, it will be possible to establish a mechanism for distinguishing
the injured from the uninjured class members” that is “administratively feasible” and “protective
of the defendants’ Seventh Amendment and due process rights.” Nexium, 777 F.3d at 19.
The Defendants argue that the Plaintiffs have failed to propose a definite class in which the
members of the class are ascertainable because the Plaintiffs have not proposed an administratively
feasible mechanism for distinguishing injured from uninjured class members at this stage of the
litigation. D. 400 at 10-11. The Plaintiffs, however, did propose such a mechanism. The Plaintiffs
proposed that “[i]n a Court-approved notice, Class members will be asked to submit a claim form,
along with data and documentation that may be deemed necessary for consideration. The Claims
Administrator will evaluate each claim pursuant to a formula proposed by Plaintiffs and approved
by the Court.” D. 381-3 at 8. In Nexium, the First Circuit held that where a class contained
uninjured members, a claims administration process where class members were required to submit
affidavits or other individual evidence to show that they were injured would be sufficiently feasible
and protective of the defendants’ Seventh Amendment and due process rights. Nexium, 777 F.3d
Rule 23(b)(3) also places a burden on the putative class to present a damages model that
establishes “that damages are capable of measurement on a classwide basis.” Behrand, 569 U.S.
at 34. This model must be “consistent with its liability case, particularly with respect to the alleged
anticompetitive effect of the violation,” id. at 35 (quoting ABA Section of Antitrust Law, Proving
Antitrust Damages: Legal and Economic Issues 57, 62 (2d ed. 2010)). “In other words, the
defendants cannot be held liable for damages beyond the injury they caused.” Nexium, 777 F.3d
at 18. Even if there are some disparities, “the need for some individualized determinations at the
liability and damages stage does not defeat class certification.” Id. at 21.
The Plaintiffs contend that Conti’s model matches the liability theory they have
presented – specifically, that the Defendants exercised monopoly power over the relevant market
by pulling Asacol 400mg from the market and thereby preventing generic competition. D. 381 at
24. Conti’s model estimates the damages to end-payors by simulating what the price and quantity
sold of Asacol 400mg would have been if the Defendants had not pulled Asacol 400mg from the
market, under several potential scenarios of generic entry, based on historical data from other
products regarding the effect of generic entry on the price and quantity sold of the brand-name
product. D. 384-1 at 21-24. Conti concludes that, under each of these scenarios of generic entry,
end-payors would have paid less for Asacol 400mg than they paid for Asacol HD and Delzicol.
D. 384-1 at 32-33.
The Defendants argue that Conti’s model does not match the liability theory presented by
the Plaintiffs because Conti’s model relied upon prescription-level data rather than patient-level
data. D. 400 at 16. Because of this flaw, they contend, Conti’s model is unable to calculate the
damages based on the class definition used by the Plaintiffs: a class definition that requires that a
member both purchased Asacol 400mg before July 31, 2013 and purchased Delzicol or Asacol HD
after July 31, 2013, and did not purchase Asacol HD before March 8, 2013. D. 400 at 17. Conti
did adjust her calculations to approximate the effect of excluding patients who did not take Asacol
400mg prior to July 31, 2013, based on the fraction of prescriptions for Asacol HD and Delzicol
that were new. D. 384-1 at 31. The Defendants contend that Conti’s model does not similarly
adjust for patients who purchased Asacol HD prior to March 8, 2013 (when Asacol 400mg was
still on the market). D. 400 at 17. But the Defendants present no reason to conclude that there is
a sizable population of patients who consumed Asacol 400mg prior to July 31, 2013, and consumed
Asacol HD prior to March 8, 2013 such that it would create the necessary divergence between the
Plaintiffs’ class definition and damages model.
That is, “[c]alculations need not be exact,” so
long as the model is “consistent with its liability case.” Comcast, 569 U.S. at 35 (citation omitted).
The Defendants also contend that Conti’s model diverges from the class definition by
failing to exclude third-party payors who did not purchase Asacol 400mg prior to July 31, 2013.
D. 400 at 17. But, as the Plaintiffs point out, a third-party payor makes purchases on behalf of
many patients, and Conti assessed that only a de minimus number of third-party payors had no
purchases whatsoever of Asacol 400mg, so no adjustment was needed to ensure conformity with
the dual-purchase aspect of the class definition for third-party payors. D. 411 at 10.
The Defendants next contend that Conti’s model fails to match the liability theory by
inappropriately assuming that, but for the purportedly unlawful conduct, the number of Asacol HD
consumers would stay static from February 2013 forward without any further switching from
Asacol 400mg to Asacol HD. D. 400 at 18. This argument, however, amounts to an argument
that the model’s assumptions are flawed, which the Defendants will have an opportunity to argue
before a factfinder.
The Defendants further contend that Conti’s model does not appropriately exclude thirdparty payors from the states for which the third-party claims have been dismissed. D. 400 at 18.
Conti has explained, however, that she did in fact exclude third-party claims from those states
using data on aggregate expenditures by state to estimate the relative proportion of sales from those
states, D. 384-1 at 31, even as Defendants’ expert, Strombom contests that such was an appropriate
Finally, the Defendants contend that Conti’s model does not correspond to the liability
theory because it does not account for the role of PBMs, who may reimburse third-party payors
for drug expenses that exceed contractually agreed-to limits. D. 400 at 19. But the fact that PBMs
may have reimbursed third-party payors for some portion of the antitrust injury does not mean that
Conti’s model should have included an adjustment for PBMs. Rather, because “antitrust injury
occurs the moment the purchaser incurs an overcharge,” Nexium, 777 F.3d at 27, the subsequent
reimbursement by PBMs does not have any bearing on the Plaintiffs’ liability theory.
Common Proof of Antitrust Impact
“To meet the predominance requirement, the party seeking certification must show that
‘the fact of antitrust impact can[ ] be established through common proof’” Id. at 18 (quoting New
Motor Vehicles, 522 F.3d at 20) (alternation in original). The Plaintiffs allege that the injury they
suffered came in the form of the excessively high prices they paid for Asacol HD and Delzicol, as
a result of the Defendants’ decision to pull Asacol 400mg from the market. D. 381 at 22. They
contend that Conti’s model establishes that a single model can provide common proof of antitrust
impact. D. 381 at 23.
The Defendants contend that Conti’s model cannot provide common proof of antitrust
impact for several reasons. They first argue that Conti’s model is unable to estimate damages for
injured and uninjured members of the class separately. D. 400 at 19. But, at the class certification
stage, it is not necessary to separate out injured and injured members; it is only necessary to
establish that “prior to judgment, it will be possible to establish a mechanism for distinguishing
the injured from the uninjured class members.” Id. at 19. As discussed above, it will be possible
to establish such a mechanism.
The Defendants next contend that Conti’s model inappropriately assumes that the effect of
generic entry into the market for Asacol 400mg would mirror historical patterns of other drugs;
that Conti’s model inappropriately assumes that generic entry would occur; and that Conti’s model
does not adequately account for the fact that generic versions of Asacol 400mg would still contain
DBP. D. 400 at 20-21. None of these arguments, however, challenge the Plaintiffs’ contention
that Conti’s model provides a common proof of antitrust impact. These challenges to the
assumptions underlying Conti’s model are susceptible to class-wide contestation and the
Defendants will have the opportunity to make these challenges before the factfinder.
Finally, the Defendants contend that individual issues predominate with respect to antitrust
impact because Conti’s model includes many uninjured members. D. 400 at 22. The Defendants
identify the following as uninjured class members: consumers with no co-pay; brand-loyal
consumers who would have switched to Asacol HD or Delzicol even in the presence of generic
Asacol 400mg; consumers who would have paid the same co-pay for brand-name and generic
products; third-party payors that are fully insured; consumers who used coupons; third-party
payors who received manufacturer rebates; third-party payors who had a risk-sharing arrangement
with a PBM or employer; and third-party payors who were able to recoup higher costs by passing
them on to employers. D. 400 at 22-24. As described above, several of these groups suffered the
antitrust injury of higher prices, and are, therefore, not uninjured (even if they were subsequently
reimbursed), such as third-party payors who received manufacturer rebates, third-party payors who
had a risk-sharing arrangement with a PBM or employer, third-party payors who are fully insured
and third-party payors who were able to recoup higher costs by passing them on to employers.
Some of these groups are explicitly excluded from the class, such as, for example, consumers with
flat co-pays. Thus, even if Conti has not explicitly excluded those prescriptions from her model,
the damages attributable to those consumers all accrue to the third-party payor – who is included
in Conti’s model. As for consumers who used coupons, Conti’s model adjusted for the aggregate
impact of those consumers, and the Defendants make no specific criticism of the way in which
Conti’s model adjusted for them. D. 384-1 at 30.
As for brand-loyal consumers, as the First Circuit explained in Nexium, “the need for some
individualized determinations at the liability and damages stage does not defeat class certification,”
at least so long as there is only a de minimis number of uninjured class members. Nexium, 777
F.3d at 21. The question is whether there is a de minimis number of brand-loyal consumers or not.
As discussed above, between the two expert reports, it seems that, by the end of the relevant period,
somewhere around 10% of the class members would have opted for Asacol HD or Delzicol even
in the presence of generic Asacol 400mg. But, even so, the Defendants do not sufficiently show
that even 10% of the class constitutes more than a de minimis number sufficient to deny class
Rule 23(b)(3) Superiority
A putative class seeking certification under Rule 23(b)(3) also bears the burden of showing
that a class action “is superior to other available methods for fairly and efficiently adjudicating the
controversy,” Fed. R .Civ. P. 23(b)(3). Nexium, 777 F.3d at 18. The Court considers four factors
within the superiority inquiry:
(A) the class members’ interests in individually controlling the prosecution or
defense of separate actions; (B) the extent and nature of any litigation concerning
the controversy already begun by or against class members; (C) the desirability or
undesirability of concentrating the litigation of the claims in the particular forum;
and (D) the likely difficulties in managing a class action.
Fed. R. Civ. P. 23(b)(3). The Court here considers the alternatives to a class action, conscious that
“[t]he policy at the very core of the class action mechanism is to overcome the problem that small
recoveries do not provide the incentive for an individual to bring a solo action prosecuting his or
her rights.” Amchem, 521 U.S. at 617 (quoting Mace v. Van Ru Credit Corp., 109 F.3d 338, 344
(1997)) (internal quotation marks omitted). The superiority inquiry thus ensures that litigation by
class action will “achieve economies of time, effort, and expense, and promote . . . uniformity of
decision as to persons similarly situated, without sacrificing procedural fairness or bringing about
other undesirable results.” Id. (quoting Advisory Committee’s Notes on Fed. R. Civ. P. 23).
The Plaintiffs contend that a class action is superior to other methods of adjudication
because each individual plaintiff’s damages are relatively small and thus would not have sufficient
incentive to bring individual lawsuits. D. 381 at 25. They further contend that the case is
sufficiently administrable as a class action. D. 381 at 26-27. The Defendants contend that the
class is not administrable because, as they argued with respect to ascertainability, the Plaintiffs
have not proposed a mechanism to separate uninjured from injured class members. D. 400 at 25.
But, for the same reasons this Court rejected that argument in the ascertainability context, it rejects
that argument here.
The Defendants move for summary judgment on several grounds. D. 449. First, they
contend that the hard switch from Asacol 400mg to Delzicol was not exclusionary; second, they
contend that the state-law antitrust claims are precluded by federal food and drug law; third, they
contend that the Plaintiffs cannot prove antitrust standing because there would not have been any
generic entry even without the hard switch; fourth, they contend that they did not exercise any
monopoly power; and fifth, they contend that Delzicol had procompetitive benefits which
outweighed any anticompetitive effects of the hard-switch. D. 449 at 3-4.
Standard of Review
The Court will grant summary judgment when there is no genuine dispute on any material
fact and the undisputed facts show that the moving party is entitled to judgment as a matter of law.
Fed. R. Civ. P. 56(a). “An issue is genuine if ‘it may reasonably be resolved in favor of either
party’ at trial, and material if it ‘possess[es] the capacity to sway the outcome of the litigation
under the applicable law.’” Iverson v. City of Boston, 452 F.3d 94, 98 (1st Cir. 2006) (alteration
in original) (internal citations omitted). The movant “bears the burden of demonstrating the
absence of a genuine issue of material fact.” Rosciti v. Ins. Co. of Pa., 659 F.3d 92, 96 (1st Cir.
2011) (quoting Carmona v. Toledo, 215 F.3d 124, 132 (1st Cir. 2000)). If the moving party meets
this burden, then the non-movant must “with respect to each issue on which she would bear the
burden of proof at trial, demonstrate that a trier of fact could reasonably resolve that issue in her
favor.” Borges ex rel. S.M.B.W. v. Serrano-Isern, 605 F.3d 1, 5 (1st Cir. 2010). “The test is
whether, as to each essential element, there is sufficient evidence favoring the nonmoving party
for a jury to return a verdict for that party.” DeNovellis v. Shalala, 124 F.3d 298, 306 (1st Cir.
1997) (internal quotation mark and citation omitted). In deciding a summary judgment motion,
the Court views the record in the light most favorable to the non-moving party, drawing all
reasonable inferences in his favor. Noonan v. Staples, Inc., 556 F.3d 20, 25 (1st Cir. 2009).
Under the state-law antitrust claims brought by the Plaintiffs, which the parties agreed are
construed in parallel with the federal Sherman Act, the Plaintiffs must prove “(1) that the defendant
possesses ‘monopoly power in the relevant market,’ and (2) that the defendant has acquired or
maintained that power by improper means.” Town of Concord, Mass. v. Bos. Edison Co., 915
F.2d 17, 21 (1st Cir. 1990). “[I]mproper methods of acquiring or maintaining monopoly power”
are also referred to as “exclusionary conduct,” which is “conduct, other than competition on the
merits or restraints reasonably ‘necessary’ to competition on the merits, that reasonably appears
capable of making a significant contribution to creating or maintaining monopoly power.” Id.
(citation omitted). To show that conduct is exclusionary, the Plaintiff must show that the conduct
has an “anticompetitive effect,” that is “it must harm the competitive process and thereby harm
consumers. In contrast, harm to one or more competitors will not suffice.” United States v.
Microsoft Corp., 253 F.3d 34, 58 (D.C. Cir. 2001) (emphasis in original). If the Plaintiff has
successfully demonstrated anticompetitive effect, the Defendant has the burden of showing a procompetitive justification, that is, that “its conduct is indeed a form of competition on the merits
because it involves, for example, greater efficiency or enhanced consumer appeal.” Id. at 59. If
the Defendant does so, “then the burden shifts back to the plaintiff to rebut that claim.” Id. Finally,
the Plaintiffs must show that, as private parties, they have standing to bring the antitrust action,
which involves showing, among other things, that they were harmed by the Defendants’
Preemption by Federal Law
The Defendants contend that, regardless of the merits of the Plaintiffs’ antitrust claims, the
Defendants are entitled to summary judgment on the ground that the Plaintiffs’ state law causes of
action are preempted by federal food and drug law. Specifically, they contend that it was
“impossible” for them to comply both with the FDA’s mandate to stop selling of Asacol 400mg
with DBP and with the putative state law requirement that they continue selling Asacol 400mg
with DBP. D. 449 at 23.
This argument fails for two reasons. First, the record does not show that the FDA
prohibited the Defendants from selling Asacol 400mg with DBP. As discussed above, the FDA
provided a series of recommendations to the Defendants that they stop selling products with DBP,
but at no point did the FDA require the Defendants to stop selling Asacol 400mg with DBP.
Rather, the record shows that the Defendants continued to sell a different product with DBP,
Asacol HD, until 2016, and even then there was no indication that the FDA was about to prohibit
the Defendants from selling the product.
Second, the Plaintiffs do not contend that state antitrust law required the Defendants to
continue selling Asacol 400mg with DBP; rather, they contend that the Defendants could have
reformulated Asacol 400mg with DBS rather than DBP without switching to a new product under
a new NDA, which would have preserved the likelihood of generic entry. D. 508 at 20. There’s
no suggestion that this course of action would have been prohibited by the FDA. In fact, the record
shows that the Defendants pursued exactly this course of action for Asacol HD. D. 509 ¶ 125.
Monopoly Power in the Relevant Market
The Defendants contend that there is no genuine dispute of material fact regarding the
Plaintiffs’ contention that the Defendants wielded monopoly power in the relevant market.
“Market power can be shown through two types of proof,” either through “direct evidence of
market power,” such as “actual supracompetitive prices and restricted output,” or “circumstantial
evidence of market power.” Coastal Fuels of P.R., 79 F.3d at 196–97.
The Plaintiffs first contend that they have shown direct evidence of monopoly power by
pointing to the high gross margins of Asacol 400mg as proof of supracompetitive prices. D. 508
at 41. The Defendants contend that the Plaintiffs’ showing of high gross margins is not direct
evidence of monopoly power because such margins are standard for brand-name manufacturers of
a patented product and those manufacturers cannot be considered per se monopolists. D. 449 at
45. In support of this proposition, they cite to In re Remeron Direct Purchaser Antitrust Litig., 367
F. Supp. 2d 675, 683 (D.N.J. 2005). In that case, the court concluded that the plaintiffs’ evidence
that the brand-name manufacturer maintained significantly higher prices prior to generic entry
insufficient to create a genuine dispute of material fact regarding direct evidence of market power.
Id. It reasoned that the plaintiffs provided “no evidence of excessive price-cost margins or
restricted output,” and that the brand-name manufacturer had incurred “initial fixed costs,” such
as “research, development, and the cost of being the first to gain FDA drug approval.” Id. at 682.
The court concluded that “[i]f the direct evidence approach can ever supplant the market definition
approach in a § 2 context, it can only do so where a reasonable juror could find the evidence
conclusive as to why Defendants' prices were higher.” Id. at 683. Essentially, the court recited
two propositions in reaching its conclusion: first, that determining whether a price is
supracompetitive requires taking cost into account; and second, that both variable and fixed costs
should be taken into account. Only the first was necessary to its decision, because the plaintiffs
had not even presented evidence of marginal cost.
In contrast, the court in In re Nexium, 968 F. Supp. 2d 367, 389 (D. Mass. 2013), aff’d 842
F.3d 34 (1st Cir. 2016), ruled that the plaintiffs had established direct evidence of market power
by demonstrating that the prices charged were “well in excess of marginal costs,” and thus
explicitly did not consider the fixed costs involved.
The Court finds the approach taken in Remeron to be more applicable for products with
relatively high fixed costs compared to variable costs. In the market for a product with high fixed
costs, evidence that prices routinely exceed marginal costs may not necessarily be evidence that
prices are supracompetitive, because even competitive prices may exceed marginal cost. See
United States v. Eastman Kodak Co., 63 F.3d 95, 109 (2d Cir. 1995) (holding that “[c]ertain
deviations between marginal cost and price, such as those resulting from high fixed costs, are not
evidence of market power”). However, there does not appear to be evidence in the record
establishing what the fixed costs for creating Asacol 400mg were and whether those costs were
sufficient to justify the prices charged for Asacol 400mg. Thus, there remains a genuine dispute
of material fact as to whether the prices charged for Asacol 400mg are supracompetitive, because
it is at least permissible for the jury to draw an inference from the supracompetitive nature of the
prices charged from the gross margin, even if evidence about the fixed costs involved in creating
Asacol 400mg would undermine the strength of such inference.
The Plaintiffs also contend that they have provided direct evidence of market power based
on restricted output, in the form of a total decrease in sales of oral mesalamine products after the
Defendants pulled Asacol 400mg from the market. D. 508 at 42. The Plaintiffs interpret the
Defendants’ charts as showing that total volume of oral mesalamine prescriptions dropped around
the time that Asacol 400mg was pulled from the market. D. 509 at 73. The Defendants dispute
this interpretation. D. 449 at 45. This dispute in interpretation is one that should be reserved for
Circumstantial evidence of market power requires a “showing that the defendant has a
dominant share in a well-defined relevant market and that there are significant barriers to entry in
that market and that existing competitors lack the capacity to increase their output in the short
run.” Coastal Fuels of P.R. v. Caribbean Petroleum Corp., 79 F.3d at 197. “The definition of the
relevant market is ordinarily a question of fact, and the plaintiff bears the burden of adducing
enough evidence to permit a reasonable factfinder to define the relevant market.” Flovac, Inc. v.
Airvac, Inc., 817 F.3d 849, 853 (1st Cir. 2016). “The market is established by examining both the
substitutes that a consumer might employ and ‘the extent to which consumers will change their
consumption of one product in response to a price change in another, i.e., the cross-elasticity of
demand.’” Id. at 854 (quoting Eastman Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 469
The Plaintiffs contend that the “relevant market” to consider is the market for Asacol
400mg and the products that the FDA rated as AB-rated bioequivalents to Asacol 400mg. D. 508
at 44. The Defendants contend that the relevant market is the market of all oral 5-ASA treatments.
D. 449 at 37. In support of this contention, the Defendants point to the fact that there were multiple
FDA approved treatments for ulcerative colitis that the FDA, insurers, PBM, and
gastroenterologists considered therapeutically interchangeable with Asacol 400mg and its
bioequivalents; that the marketing documents from the Defendants and other manufacturers show
that the Defendants considered Asacol 400mg to compete with other 5-ASA products; and that
Asacol 400mg lost volume just as Lialda, a competing 5-ASA drug, gained volume. D. 449 at 3942.
The Defendants, relying upon various documents and statements, also argue that patients
would switch among 5-ASA drugs, sometimes based on formulary status, which were based on
the level of rebates that the manufacturer provided to the PBM. D. 449 at 43; D. 450 ¶ 239; D.
458-6 at 213; D. 458-6 at 215; D. 458-7 at 303-305. The Defendants further contend that other
courts, when faced with similar facts, have concluded that the relevant market includes multiple
products – not just one product and its bioequivalents. They cite first to Mylan Pharms., Inc. v.
Warner Chilcott Pub. Ltd. Co., No. 12-cv-3824, 2015 WL 1736957 (E.D. Pa. Apr. 16, 2015). In
that case, the district court cited to evidence that dermatologists (the relevant specialty) considered
the product at issue, Doryx, interchangeable with other products; that managed care organizations
have sought to “constrain patients to substitute Doryx with other, less costly tetracyclines to treat
acne,” that “internal marketing documents” from the defendants also confirm that the defendant
subjectively perceived Doryx as in competition with other products; and that the defendants
“produced evidence of cross-elasticity of demand between Doryx and other oral tetracyclines,” by
way of showing that sales of Doryx fluctuated in response to the generosity of Doryx’s coupon
program. Id. at *9-10. They next cite to United States v. CIBA GEIGY Corp., 508 F. Supp. 1118,
1154-55 (D.N.J. 1976), in which the court determined that a particular pharmaceutical product was
in the same market as other products because it was “reasonably interchangeable” with them and
the testimony of the various manufacturers that they considered themselves to be in competition
with one another. Finally, the Defendants cite to Bayer Schering Pharma AG v. Sandoz, Inc., 813
F. Supp. 2d 569, 576-78 (S.D.N.Y. 2011), in which the court found that a pharmaceutical product
was not a single-product market if there were combinations of other therapies that would achieve
the same therapeutic effect.
The Plaintiffs contend that the key inquiry in market definition is whether, from the
“perspective of consumers,” the products were interchangeable such that there was significant
cross-elasticity of demand, such that an increase in the price of one product in the market would
lead to meaningful substitution to another product in the market. See Flovac, 817 F.3d at 855.
And, they contend, consumers did not behave as if different 5-ASA drugs were interchangeable.
In particular, Frank noted that internal Warner Chilcott documents indicated that the market for
ulcerative colitis drugs is relatively static, with only 3% of prescriptions in a given month
representing a shift from one ulcerative colitis drug to a different one. D. 428-3 at 22. Experts
testified that both patient and physicians had a strong tendency to stick with a given product if it
was working for the patient. D. 509 ¶¶ 347-348. According to the testimony of a Warner Chilcott
employee, the rebates offered by Warner Chilcott were, in some cases, significantly less generous
than the rebates offered by other manufacturers of 5-ASA products, D. 458 at 506, yet Warner
Chilcott was able to persist without lowering prices to match, because patients continue to purchase
Asacol 400mg. Additionally, Frank concluded that, if Warner Chilcott had raised the prices of its
Asacol products by 5%, it would not have appreciably reduced sales, showing a relatively low
cross-elasticity of demand between Asacol 400mg and other 5-ASA products. D. 428-3 at 70-71.
While Frank’s data did not account for the differential rebates provided by different manufacturers
because he deemed the rebates to be sufficiently similar between manufacturers, the Court
explained above that this goes to the weight rather than admissibility of his testimony.
Additionally, the Plaintiffs cite to In re Nexium, 968 F. Supp. 2d at 388, in which the court
found that the plaintiffs had created a genuine dispute of material fact regarding a market definition
consisting of a single product and its generic equivalents. Id. (collecting cases also finding such a
market). The court reasoned that “the reasonable interchangeability of brand Nexium with other
drugs [is] a factually intensive determination better left for resolution by a jury.” Id.
In Coastal Fuels of P.R., 79 F.3d at 198, the First Circuit explained that the “touchstone of
market definition is whether a hypothetical monopolist could raise prices,” citing the Ninth
Circuit’s decision in Rebel Oil Co., Inc. v. Atl. Richfield Co., 51 F.3d 1421, 1434 (9th Cir. 1995).
The Ninth Circuit has explained that one way of measurement of this touchstone is whether “a
monopolist in the proposed market could profitably impose a small but significant and
nontransitory price increase [SSNIP].” Theme Promotions, Inc. v. News Am. Mktg. FSI, 546 F.3d
991, 1002 (9th Cir. 2008). While this SSNIP test is used most often in the merger context, see,
e.g., Saint Alphonsus Med. Ctr.-Nampa Inc. v. St. Luke's Health Sys., Ltd., 778 F.3d 775, 784 (9th
Cir. 2015), courts have also used it outside that context. See, e.g., Ky. Speedway, LLC v. Nat'l
Ass'n of Stock Car Auto Racing, Inc., 588 F.3d 908, 918 (6th Cir. 2009); Theme Promotions, 546
F.3d at 1002; Golden Boy Promotions LLC v. Haymon, No. 15-cv-3378, 2017 WL 460736, at *11
(C.D. Cal. Jan. 26, 2017; IGT v. All. Gaming Corp., No. 2:04-CV-1676-RCJ-RJJ, 2008 WL
7071468, at *10 (D. Nev. Oct. 21, 2008). “Typically, the increase that is posted is five percent.”
In re Se. Milk Antitrust Litig., 739 F.3d 262, 277 (6th Cir. 2014).
There is a genuine dispute of fact regarding the Plaintiffs’ putative market definition of a
market that consisted of Asacol 400mg and its bioequivalent products. As the court found in
Nexium, this fact-intensive inquiry is best left for the jury.
The Defendants argue that there is no genuine dispute of material fact regarding the
exclusionary nature of the Defendants’ decision to pull Asacol 400mg from the market when it
launched Delzicol, for several reasons. D. 449 at 14. They contend first that the FDA requested
the removal of products containing DBP and second that Delzicol is a safer product than Asacol
400mg. D. 449 at 14-19.
It is undisputed that the FDA requested the removal of products containing DBP and that
the FDA considered the removal of DBP to have accompanying safety benefits. The question of
whether the safety risk of DBP was substantive enough to justify the Defendants’ conduct goes to
whether the Defendants’ conduct had sufficient procompetitive justification to outweigh the
anticompetitive effects. Additionally, the Plaintiffs contend that the Defendants could have
captured the safety benefits of removing DBP without switching to the capsule formulation that
deterred generic entry.
The Defendants respond that antitrust law does not impose upon them a “duty to
reformulate in a manner that will aid potential competitors.” D. 449 at 20. But the Plaintiffs do
not argue that the Defendants had the obligation to reformulate in the manner that would best
facilitate generic entry. Rather, according to the Plaintiffs’ narrative, the Defendants had already
reformulated Asacol 400mg to have a DBS coating instead of a DBP coating, and instead of
seeking FDA approval for that product, they needlessly included in the Asacol 400mg
reformulation a patented capsule that conferred no additional value. Thus, the “duty” that
Plaintiffs seek to impose on the Defendants is to refrain from reformulating in such a way that
adds features – like the capsule – that have minimal or no value beyond their anticompetitive
The Plaintiffs’ theory is in line with the Second Circuit’s decision in In re Namenda, 787
F.3d at 652. In that decision, the Second Circuit found a likelihood of success on the merits where
the plaintiffs alleged a similar hard switch between brand-name products. Id. at 647-48. It
reasoned that “neither product withdrawal nor product improvement alone is anticompetitive. But
. . . when a monopolist combines product withdrawal with some other conduct, the overall effect
is which to coerce consumers rather than persuade them on the merits, and to impede competition,
its actions are anticompetitive.”
Id. at 653-54.
It concluded that “antitrust law requires
[defendants] to allow generic competitors a fair opportunity to compete using state substitution
laws.” Id. at 658 (citation omitted).
Like the plaintiffs in Namenda, the Plaintiffs’ redesign theory here would require the
Defendants to engage in some conduct that they did not engage in: in Namenda, the conduct was
continuing to sell the prior version of Namenda, whereas here, the conduct would be selling a
version of Asacol 400mg with DBS instead of DBP, but no capsule. It is certainly relevant that
the Defendants did not, at any point, sell Asacol 400mg with DBS instead of DBP with no capsule
in the United States. But they did sell Asacol 400mg with DBS instead of DBP in the United
Kingdom and had planned to do so in the United States for some period of time before deciding to
switch to the capsule formulation.
The Defendants next contend that, even if their challenged conduct was anticompetitive,
the anticompetitive effects had a procompetitive justification. Specifically, they argue that DBPfree Delzicol is safer than the DBP-containing Asacol 400mg; that Delzicol improved dissolution
stability and reduced the occurrence of “early openers;” and that Delzicol served as a bridge to the
novel, pediatric friendly 4 x 100mg Delzicol, which offers a lower-dose option. D. 449 at 50.
The first argument fails because, as discussed above, the Plaintiffs contend that the
Defendants could have produced a DBP-free version of Asacol 400mg without switching to a
capsule formulation, meaning that any safety benefits from removing DBP would have been
captured as well in the Plaintiff’s but-for scenario. The second argument fails because there is a
genuine dispute of material fact regarding whether Delzicol improved the dissolution stability and
reduced the occurrence of early openers. The record shows that the Defendants did not have any
validated experimental evidence of a benefit to either dissolution stability or early openers until
October 2012 – after the Defendants submitted the NDA for Delzicol to the FDA. D. 509 ¶¶ 209213; D. 450 ¶ 163; D. 510 ¶ 163. Additionally, the Plaintiffs dispute the quality of the October
2012 studies showing a stability benefit to the capsule formulation. D. 450 ¶ 163; D. 510 ¶ 163.
The third argument fails because the Defendants have presented no evidence that the Defendants
needed to produce a 1x400mg formulation in order to produce the later 4x100mg formulation.
Instead, the record shows that the Defendants started down the path of producing a 4x100mg
capsule formulation, but temporarily shifted away from that path to focus on a 1x400mg capsule
formulation that might be ready before the patents for Asacol 400mg expired.
Causation and Antitrust Standing
The Defendants contend that there is no genuine dispute of material fact regarding the issue
of antitrust standing. “The Supreme Court has set forth a six-factor test to determine whether a
plaintiff has standing to bring an antitrust action. These factors are: (1) the causal connection
between the alleged antitrust violation and harm to the plaintiff; (2) an improper motive; (3) the
nature of the plaintiff's alleged injury and whether the injury was of a type that Congress sought
to redress with the antitrust laws (“antitrust injury”); (4) the directness with which the alleged
market restraint caused the asserted injury; (5) the speculative nature of the damages; and (6) the
risk of duplicative recovery or complex apportionment of damages.” RSA Media, Inc. v. AK
Media Grp., Inc., 260 F.3d 10, 14 (1st Cir. 2001). “Although we technically balance the six factors
to determine if standing is appropriate, this Court has emphasized the causation requirements of
that test.” Id.
The Defendants contend that the Plaintiffs have not shown antitrust causation, that is, they
have not shown that the Defendants’ purportedly anticompetitive conduct caused the Plaintiffs
harm because they contend that the Plaintiffs have not shown that there would have been generic
versions of Asacol 400mg produced if not for the Defendants’ choice to pull Asacol 400mg from
the market. D. 449 at 25. The Defendants argue that the Plaintiffs have the burden of showing
that a generic manufacturer was “ready, willing, and able” to enter the Asacol 400mg market
during the relevant time period. D. 449 at 25; Indium Corp. of Am. v. Semi-Alloys, Inc., 781 F.2d
879, 882 (Fed. Cir. 1985). The Defendants’ argument is based on the undisputed fact that Zydus,
Lupin, Roxane, and Par all did not have ANDAs pending at the time Asacol 400mg was pulled
from the market, and that the Plaintiffs did not produce evidence that any other generic
manufacturer had an ANDA with a Paragraph III certification pending at the time Asacol 400mg
was pulled from the market. D. 449 at 28-31. The Defendants contend that the expert testimony
of Clark and McGuire are too speculative because both experts fail to identify the specific generic
manufacturer that would have entered but for the purportedly anticompetitive conduct. D. 449 at
Antitrust law, however, does not support the Defendants’ contention that the Plaintiffs’
causation theory is too speculative if it does not identify a specific entrant that had a pending
ANDA. In Microsoft, 253 F.3d at 54, the court stated that “[n]othing in § 2 of the Sherman Act
limits its prohibition to actions taken against threats that are already well-developed enough to
serve as present substitutes.” It held that, where the exclusionary conduct is aimed at “producers
of nascent competitive technologies,” the issue is “whether [competitors] reasonably constituted
nascent threats at the time [the defendant] engaged in the anticompetitive conduct at issue,” even
if those competitors were “unproven.” Id. at 79. Moreover, in antitrust suits, “juries are allowed
to act on probable and inferential as well as (upon) direct and positive proof.” Bigelow v. RKO
Radio Pictures, 327 U.S. 251, 264 (1946). Additionally, even if the Defendants were able to prove
that no ANDAs with a Paragraph III certification were pending at the time that the Defendants
pulled Asacol 400mg from the market, it is undisputed that the FDA had both the authority and
interest to fast-track ANDAs for Asacol 400mg, so an ANDA with a Paragraph III certification
submitted after July 31, 2013 might have been approved during the relevant period. D. 509 ¶ 317.
The Defendants next contend that the FDA’s bioequivalence standards prevented generic
manufacturers from producing a generic version of Asacol 400mg. D. 449 at 34. But, the record
reflects that the Defendants perceived the FDA’s shift from requiring clinical studies to focusing
on PK testing as lowering the bar for generic entry, D. 509 ¶ 289 and that another generic
manufacturer, Zydus, produced generic versions of both Asacol HD and another oral mesalamine
product that were approved by the FDA as bioequivalent in 2017; D. 509 at 318-320.
There is a genuine dispute of material fact as to the issue of causation. Drawing all disputed
facts in favor of the Plaintiffs, as this Court must in evaluating the Defendants’ motion for
summary judgment, the record shows that, according to the Defendants’ own documents, the
industry had identified Asacol 400mg as likely to face generic entry; D. 509 ¶ 241, that generic
manufacturers had significant incentives to be the first-mover to create a generic version of Asacol
400mg; D. 426-5 at 20; that generic manufacturers had the technological capability to develop a
generic versions of oral delayed release mesalamine products, D. 509 ¶ 296; and historical
experience in the pharmaceutical industry indicates that it was highly likely that a generic version
of Asacol 400mg would emerge. D. 509 ¶ 284. Drawing all inferences in favor of the Plaintiffs
as the non-movants, there is a genuine dispute of fact over whether a generic manufacturer would
have produced a generic version of Asacol 400mg within the relevant timeframe.
For the foregoing reasons, the Court DENIES the parties’ motions to exclude testimony,
D. 426; D. 427; D. 428; D. 429; D. 430; D. 431; D. 444, provides the reasons for ALLOWING the
Plaintiffs’ motion for class certification under Fed. R. Civ. P. 23(b)(3) in D. 559, D. 380, and
DENIES the Defendants’ motion for summary judgment, D. 445.
/s/ Denise J. Casper
United States District Judge
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