United States District Court, D. Massachusetts
MEMORANDUM AND ORDER
J. Casper United States District Judge.
a putative class action in which the Plaintiffs, members of a
putative class of end-payor purchasers of certain
pharmaceutical products,  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.
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.
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 ¶¶ 199-200; D. 510
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.
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.
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 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.
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.
29, 2008, the FDA approved a new NDA from P&G - this one
for a 800mg, long-acting 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
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.
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 ¶ 86.
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.
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.
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.
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.
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
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.
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
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.
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
Warner Chilcott Shifts to a Capsule Formulation of
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 ¶ 131.
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 ¶
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 100-mg
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.
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.
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 ¶¶
Warner Chilcott Launches Delzicol, Pulls Asacol, and
Shifts to a Patented Capsule for Delzicol
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
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.
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.
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.
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
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.
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
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.
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.
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.
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.
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 ¶¶
274-275; 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.
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 ¶¶ 316-17 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, 295-297; 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.
Delzicol launched, Mylan, Teva and Zydus filed ANDAs for
Delzicol with Paragraph IV certifications. D. 450 ¶ 328;
D. 510 ¶ 328.
Other Ulcerative Colitis Treatments
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.
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.
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 5-ASA:
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
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.
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.
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
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
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
Motion to Exclude Testimony of Todd Clark
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.
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.
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; ...