# The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee v. Momenta Pharmaceuticals, Inc.

> District Court, M.D. Tennessee · September 20, 2019

URL: https://www.frixlaw.com/law-library/cases/10436052

## Case

- **Court:** District Court, M.D. Tennessee
- **Decided:** September 20, 2019
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10436052

## How later opinions describe it (automated extraction)

- holding that denial of a motion as the result of a failure to comply with local rules is well within a district court’s discretion
- explaining that a court’s rigorous analysis will frequently entail “some overlap” with the merits of plaintiffs’ underlying claim
- holding that named plaintiffs had standing to assert claims under various state laws

## Opinion text

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF TENNESSEE
NASHVILLE DIVISION

THE HOSPITAL AUTHORTIY OF )
METOPOLITAN GOVERNMENT OF )
NASHVILLE AND DAVIDSON )
COUNTY, TENNESSEE, d/b/a )
NASHVILLE GENERAL HOSPITAL ) No. 3:15-cv-01100
and AMERICAN FEDERATION OF )
STATE, COUNTY AND MUNICPAL )
EMPLOYEES DISTRICT COUNCIL 37 )
HEALTH & SECURITY PLAN, )
)
Plaintiffs, )
)
v. )
)
MOMENTA PHARMACEUTICALS, )
INC. and SANDOZ INC., )
)
Defendants. )

MEMORANDUM OPINION

Pending before the Court is Nashville General Hospital (“NGH”) and American Federation
of State, County and Municipal Employees District Council 37 Health & Security Plan’s (“DC
37”) (collectively “Plaintiffs”) Renewed Motion for Class Certification and Appointment of Class
Counsel. (Doc. No. 349.) Momenta Pharmaceuticals, Inc. (“Momenta”) and Sandoz Inc.
(“Sandoz”) (collectively “Defendants”) have responded in opposition (Doc. No. 361) and also filed
a Motion to Exclude the Report and Opinions of Plaintiffs’ Expert Dr. Russell L. Lamb (Doc. No.
360). Plaintiffs filed both a reply in support of their renewed class certification motion (Doc. No.
369) and a response to Defendants’ Motion to Exclude (Doc. No. 367). The Court held an
evidentiary hearing on these motions on July 12, 2019. After the evidentiary hearing, the Court
requested post-hearing briefs from the parties, which have been filed. (Doc. Nos. 384, 387.) At the
Court’s count, there have been no fewer than seven briefs regarding class certification, one aborted
evidentiary hearing, amendment of the class definition, and one full evidentiary hearing. Needless
to say, these issues are ripe and ready to be decided. For the reasons that follow, the Court will
deny Defendants’ Motion to Exclude the Report and Opinions of Plaintiffs Expert Dr. Russell L.

Lamb and grant Plaintiffs’ Renewed Motion for Class Certification.
A. Procedural Background1
On October 14, 2015, NGH filed its initial complaint against the Defendants, alleging four
separate counts under the Sherman Antitrust Act (“Sherman Act”). (Doc. No. 1.) NGH sought
damages, as well as declaratory and injunctive relief. (Id. at 27.) NGH brought its claims on behalf
of itself and a nationwide class of persons and entities, pursuant to the Class Action Fairness Act
of 2005 (“CAFA”) and Fed. R. Civ. P. 23(a) and (b). (Id. at 6, 21.) As explained in more detail in
Section B infra, the alleged Sherman Act violations centered on the role that Defendants played in
a conspiracy to monopolize the production and distribution of enoxaparin, a generic version of the
drug Lovenox®. (Id. at 4-23.)

In response to the complaint, Defendants filed a motion to transfer the case to the District
of Massachusetts and a Motion to Dismiss. (Doc. Nos. 65, 68.) Momenta additionally filed a
separate Motion to Dismiss or Transfer for Improper Venue. (Doc. No. 62.) On September 29,
2016, Magistrate Judge Barbara Holmes entered a Report and Recommendation recommending
that the motions be denied. (Doc. No. 114.) Defendants filed joint and separate objections to the
Report and Recommendation. (Doc. Nos. 117, 119.) On March 21, 2017, the Court issued a

1 The following procedural and factual background is largely drawn from the Court’s prior
Memorandum Opinion granting in part and denying in part Defendants’ Motions to Dismiss. (See
Doc. No. 253.) The Court reiterates this background information to properly contextualize the
parties’ class certification arguments.
Memorandum Opinion that adopted in part and declined to adopt in part the Report and
Recommendation. (Doc. No. 134.) The Court dismissed NGH’s Sherman Act claims on the ground
that NGH did not have standing to seek damages under the “indirect purchaser rule.” (Id. at 8-14.)
However, NGH’s Sherman Act claims were permitted to proceed on declaratory and injunctive

theories of relief. (Id. at 16.)
Thereafter, NGH filed a motion for leave to file an amended complaint. (Doc. No. 140.)
The amended complaint contained three primary changes: (1) the addition of DC 37 as a new
representative plaintiff; (2) the addition of various state antitrust and consumer protection claims;
and (3) the addition of new substantive allegations pertaining to Defendants’ alleged
anticompetitive conduct. (Doc. No. 141 at 5.) Defendants filed a response in opposition. (Doc.
No. 148.) Ultimately, Magistrate Judge Holmes granted Plaintiffs’ motion for leave to file an
amended complaint, and Plaintiffs filed their amended complaint on December 21, 2017. (Doc.
No. 191.) Defendants then filed three Motions to Dismiss under Federal Rules of Civil Procedure
12(b)(1), 12(b)(2), and (12)(b)(6). (Doc. Nos. 193, 195, 197.) The Court granted Defendants’ Rule

12(b)(1) motion, denied the Rule 12(b)(2) motion, and granted in part and denied in part the
12(b)(6) motion. (See Doc. No. 253.) The net result of these rulings was that Plaintiffs’ federal
Sherman Act claims were dismissed but the majority of their state law antitrust claims were
allowed to proceed. (See Doc. No. 254 at 1-2.) Defendants filed two Motions for Reconsideration
of the Court’s Rule 12(b)(2) ruling, both of which were denied. (See Doc. Nos 257, 258, 275, 276.)
The parties then proceeded to the class certification phase. After Plaintiffs’ initial Motion
for Class Certification (Doc. No. 243) was fully briefed, the Court determined that an evidentiary
hearing was necessary and set the hearing for May 13, 2019. (See Doc. No. 283.) At the conclusion
of the first day of the evidentiary hearing, the Court inquired into the Plaintiffs’ objective criteria
for identifying members of the class. (See Doc. No. 329 at 172.) In response to this line of inquiry,
Plaintiffs returned the next day with an amended class definition that contained substantial
changes. (Doc. No. 330 at 12.) In light of this development, the Court continued the evidentiary
hearing, denied Plaintiffs’ initial Motion for Class Certification (Doc. No. 243) as moot, and

allowed Plaintiffs leave to file a Motion to Amend the Class Definition (Doc. No. 318). Plaintiffs
filed their Motion to Amend the Class Definition (Doc. No. 321), which the Court granted. (Doc.
No. 340.) The parties then briefed the new class definition, the Court held another evidentiary
hearing, and the matter is now ripe for disposition.
B. Factual Background
NGH is a metropolitan charity hospital that purchases certain drugs it administers,
including the generic anticoagulant enoxaparin. (Doc. No. 191 at 6-7.) DC 37 is a non-profit health
and welfare benefit plan covering public sector employees, retirees and their families. (Id.)
Plaintiffs allege that they have, and will continue to, indirectly purchase or provide reimbursement
for Lovenox® and enoxaparin. (Id. at 7-8.)

The drug at issue, enoxaparin, is used in the prevention and treatment of deep vein
thrombosis and in the treatment of heart attacks. (Id. at 10.) Sanofi-Aventis (“Aventis”), a non-
party to this lawsuit, brought enoxaparin to market in the United States under the brand name
Lovenox® and held a patent on the drug, which was subsequently held to be unenforceable in
2007. (Id. at 10-11.)
However, Momenta is the assignee of a patent (the “886 Patent”) for a chemical process
used to test the quality of enoxaparin (“Method <207>”). (Id. at 13.) In 2003, Momenta entered
into a collaboration agreement (the “Collaboration Agreement”) with Sandoz, whereby Sandoz
eventually began manufacturing and selling generic enoxaparin. (Id. at 11-14.) The Collaboration
Agreement provided for profit-sharing between Momenta and Sandoz regarding Sandoz’s sales of
its generic enoxaparin, so long as Defendants remained the sole source of generic enoxaparin in
the United States. (Id. at 13.) Further, the Collaboration Agreement provided for Momenta to
receive “milestone payments” if Sandoz remained the sole supplier of generic enoxaparin. (Id.)

Essentially, the Collaboration Agreement provided Momenta with a powerful incentive to use
whatever rights it had to prevent other parties from entering the generic enoxaparin market.
By 2007, Aventis had requested that the United States Pharmacopeial Convention (“USP”)
adopt criteria for enoxaparin that included a standardized test to assure that enoxaparin produced
by drug companies in the United States met chemical criteria approved by the FDA.2 (Id. at 16.)
Aventis’s proposed method for testing enoxaparin was Method <207>. (Id.) At that time, Aventis
had a pending patent application for Method <207>. (Id. at 17.) Defendants, who participated in
the relevant USP review panel, objected to Aventis having a patent that covered a standardized
USP test, contending that the test, once adopted, should be free for anyone to use. (Id.) After
discussions with USP, Aventis agreed to abandon its patent application. (Id. at 18.) However,

unbeknownst to the USP panel, Momenta had its own patent application pending—the 886
Patent—that, when granted, would give Momenta patent rights that could be asserted against third
parties that used Method <207>. (Id. at 18-19.) In December 2009, the USP approved and adopted
Method <207> as the standardized test to assure enoxaparin quality, and the 886 Patent was issued
shortly thereafter. (Id. at 13, 19.) Plaintiffs allege that, had Defendants disclosed their own
application for the 886 Patent, the USP would have either required Momenta to abandon its patent

2 The USP is a scientific nonprofit organization that sets standards for identity, strength,
quality, and purity of medicines, food ingredients, and dietary supplements that are manufactured,
distributed, and consumed worldwide, and the USP standards are enforceable as binding by the
United States Food and Drug Administration (“FDA”). 21 U.S.C. § 351(b).
rights, as it did with Aventis, or chosen an alternative test that would not have been subject to
patent protection. (Id. at 19.)
Defendants became the first entities authorized by the FDA to produce generic enoxaparin.
(Id. at 20.) Thereafter, Amphastar Pharmaceuticals, Inc. (“Amphastar”), a non-party to this case,

received FDA approval to sell generic enoxaparin on September 19, 2011. (Id. at 21.) Upon
approval, the FDA instructed Amphastar to use the USP compendium for enoxaparin, including
Method <207>. (Id.) Two days later, Defendants sued Amphastar in the District of Massachusetts,
contending that it was essentially illegal for Amphastar use Method <207> and produce generic
enoxaparin because it could not do so without infringing on the 886 Patent. (Id.) After filing their
complaint, Defendants obtained a temporary restraining order and preliminary injunction
preventing Amphastar from selling enoxaparin. (Id. at 22.) However, the U.S. Court of Appeals
for the Federal Circuit stayed the preliminary injunction in January 2012 and vacated it in August
2012. (Id.)
Plaintiffs, in their Amended Complaint, assert that Defendants’ alleged anticompetitive

activity violates numerous states’ antitrust, consumer protection, and unjust enrichment laws.
(Doc. No. 193 at 35-73.) As explained above, Plaintiffs now seek class certification.
C. Plaintiffs’ Renewed Motion for Class Certification
Plaintiffs seek certification of the following class:
Hospitals, third-party payors, and people without insurance who indirectly
purchased, paid for, and/or reimbursed some or all of the purchase price for, generic
enoxaparin or Lovenox®, in Arizona, Arkansas, California, District of Columbia,
Florida, Hawaii, Illinois, Iowa, Kansas, Maine, Massachusetts, Michigan,
Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire,
New Mexico, New York, North Carolina, North Dakota, Oregon, South Dakota,
Tennessee, Utah, Vermont, West Virginia, and Wisconsin, from September 21,
2011, through September 30, 2015 (the “Damages Class Period”), for the purpose
of personal consumption by themselves, their families, or their members,
employees, insureds, participants, patients, beneficiaries or anyone else.
With respect to third-party payors and people without insurance, the Damages Class
only includes those, described above, who purchased, paid for, and/or reimbursed
some or all of the purchase price for, generic enoxaparin or Lovenox® from a
pharmacy.

Excluded from the proposed Damages class are:

a. Defendants, their officers, directors, management, employees, subsidiaries,
and affiliates;

b. Federal and state governmental agencies except for cities, towns,
municipalities, counties or other municipal government entities, if otherwise
qualified;

c. Payors that received 100% reimbursement on all transactions, such as fully
insured health plans (i.e., plans that purchased insurance covering 100% of
their reimbursement obligation to members); and

d. Judges assigned to this case and any members of their immediate families.

(Doc. No. 349 at 2-3.)
D. Daubert Motion
As a preliminary matter, Defendants argue that Dr. Lamb’s expert opinions should be
excluded from consideration, pursuant to Federal Rule of Evidence 702 and Daubert v. Merrell
Dow Pharmaceuticals., Inc., 509 U.S. 579 (1993), because: (1) he did not perform a reliable
empirical analysis; (2) the lack of empirical analysis led Dr. Lamb to rely on assumptions and
vague “economic literature”; and therefore; (3) his opinion is not based on sufficient facts or data.
(Doc. Nos. 360, 363 at 9-11, 387 at 21-22.)
Plaintiffs respond that the motion should be denied on the merits because Defendants have
not met the standard to exclude Dr. Lamb’s testimony under Fed. R. Evid. 702 and Daubert. (Doc.
No. 367 at 2.) Plaintiffs contend that Defendants’ arguments go to the weight of the evidence,
rather than its admissibility. (Id.) Further, Plaintiffs note that the statistical regression analysis
Defendants assert is missing is not necessary because the pharmaceutical industry is based on
formulaic markups not individualized pricing schemes. (Id.)
First, the Court notes that Defendants’ Daubert motion is subject to denial for non-
compliance with the Court’s Local Rules. The Court’s Local Rules provide that “every motion that

may require the resolution of an issue of law must be accompanied by a separately filed
memorandum of law citing supporting authorities and, where allegations of fact are relied upon,
affidavits, depositions, or other exhibits in support thereof.” LR 7.01(a)(2). Defendants have
included their Daubert motion arguments in their response to Plaintiffs’ class certification motion
(Doc. No. 363) and post-hearing brief (Doc. No. 401)—neither of which is a “separately filed
memorandum” in support of their Daubert motion. Id. (emphasis added). Accordingly,
Defendants’ Daubert motion may be denied based on its failure to comply with the Court’s Local
Rules. See Grove v. Wells Fargo Fin. California, Inc., 606 F.3d 577, 582 (9th Cir. 2010) (holding
that denial of a motion as the result of a failure to comply with local rules is well within a district
court’s discretion).

Nevertheless, Defendants’ Daubert motion also fails on the merits. Federal Rule of
Evidence 702 governs the admissibility of an expert witness’ testimony at trial. Daubert, 509 U.S.
at 589. Under Rule 702:
A witness who is qualified as an expert by knowledge, skill, experience, training,
or education may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific, technical, or other specialized knowledge will help the
trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the
case.
“[T]he trial judge has discretion in determining whether a proposed expert’s testimony is
admissible based on whether the testimony is both relevant and reliable.” Palatka v. Savage Arms,
Inc., 535 Fed. Appx. 448, 453 (6th Cir. 2013) (quotation omitted). The Court’s task is to assess
“whether the reasoning or methodology underlying the testimony is scientifically valid and . . .

whether that reasoning or methodology properly can be applied to the facts in issue.” Daubert, 509
U.S. at 592–93.
The district court acts as the “gatekeeper” on opinion evidence, Gen. Elec. Co. v. Joiner,
522 U.S. 136, 142 (1997), and must exercise its gatekeeping function “with heightened care.” U.S.
v. Cunningham, 679 F.3d 355, 380 (6th Cir. 2012) (quotation omitted). The Court will not exclude
expert testimony “merely because the factual bases for an expert’s opinion are weak.” Andler v.
Clear Channel Broad., Inc., 670 F.3d 717, 729 (6th Cir. 2012) (citations omitted). Indeed, rejection
of expert testimony is the exception rather than the rule—the gatekeeping function established by
Daubert was never “intended to serve as a replacement for the adversary system.” See Rose v.
Matrixx Initiatives, Inc., Case No. 07-2404-JPM/tmp, 2009 WL 902311, at *7 (W.D. Tenn. 2009)

(citing Fed. R. Evid. 702 advisory committee’s note).
Rule 702 does not “require anything approaching absolute certainty.” Tamaraz v. Lincoln
Elec. Co., 620 F.3d 665, 671–72 (6th Cir. 2010) (citing Daubert, 509 U.S. at 590). Under Daubert,
experts are “permitted wide latitude in their opinions, including those not based on firsthand
knowledge, so long as the expert’s opinion has a reliable basis in the knowledge and experience
of the discipline.” Dilts v. United Grp. Servs., LLC, 500 Fed. Appx. 440, 445 (6th Cir. 2012)
(quoting Daubert, 509 U.S. at 592) (internal quotation marks omitted). Expert testimony is reliable
if it (1) is based on sufficient facts or data, (2) is grounded in reliable principles and methods, and
(3) applies those principles and methods to the facts of the case in a reliable manner. Fed. R. Evid.
702. The Supreme Court in Daubert provided several non-exclusive factors for district courts to
consider when evaluating the reliability of an opinion witness’s testimony. 509 U.S. at 592–94.
However, not all Daubert factors apply in every case. Dilts, 500 Fed. Appx. at 445. In Kumho Tire
Co. v. Carmichael, the Supreme Court explained that “the law grants a district court the same broad

latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability
determination.” 526 U.S. 137, 141–42 (1999). When evaluating the reliability of non-scientific
expert testimony, the district court may forgo these factors and focus on the reliability of the
expert’s personal knowledge or experience. Thomas v. City of Chattanooga, 398 F.3d 426, 431–
32 (6th Cir. 2005). In this situation, the expert cannot ask a court simply to take his “word for it,”
but “‘must explain how that experience leads to the conclusion reached . . . and how that experience
is reliably applied to the facts.’” Thomas, 398 F.3d at 432 (quoting Fed. R. Evid. 702 adv. comm.
note).
Here, Dr. Lamb’s opinions, reports, and testimony are based on sufficient facts and data
such that his expert opinion meets the threshold standard established by Rule 702 and Daubert. Dr.

Lamb’s expert report: (1) summarized his qualifications, the allegations, and background
information on the pharmaceutical industry and enoxaparin; (2) performed a “back casting”
analysis that purported to show the overcharges putative class members incurred from Defendants’
alleged anticompetitive conduct and generic enoxaparin prices that would have manifested in a
“but for” world absent Defendants’ activity; (3) surveyed the economic literature concerning the
effects of inter-generic competition; and (4) measured potential class-wide damages. (Doc. No.
303-1 at 6-90.) Dr. Lamb relies on a host of materials in coming to his conclusions, including
wholesale pharmaceutical data, Defendant’s internal documents, and economic literature. (Id.) To
the extent that Defendants argue that Dr. Lamb’s analysis is insufficient in the absence of any
statistical analysis, that argument goes to the weight afforded to his opinion, not its admissibility
under Rule 702 and Daubert. Dr. Lamb’s expert testimony and report are reliable because: (1) it is
based on sufficient facts and data (wholesale pharmaceutical data, Defendants’ internal documents,
and the case record); (2) it is grounded in reliable principles and methods (back casting and

deference to economic literature); and (3) applied reasonably to the facts of the case. Fed. R. Evid.
702. Perhaps Dr. Lamb’s expert opinion would have been more convincing with a statistical
regression analysis, but the absence of one does not render the opinion inadmissible under Rule
702 and Daubert. Dr. Lamb’s qualifications as an expert, unchallenged by Defendants, are
impressive and his opinion here is sufficiently reliable to survive this threshold challenge.
Accordingly, Defendants’ Motion to Exclude the Report and Opinions of Plaintiffs Expert Dr.
Russell L. Lamb (Doc. No. 360) will be denied.
E. Applicable Law on Class Certification
To certify a class, the Court must be satisfied that Plaintiffs have met the requirements of
both Rule 23(a) and Rule 23(b) of the Federal Rules of Civil Procedure. “A class action will be

certified only if, after ‘rigorous analysis,’ the Court is satisfied that the prerequisites of Rule 23(a)
have been met and also that the action falls within one of the categories under Rule 23(b).” Castillo
v. Envoy Corp., 206 F.R.D. 464, 467-68 (M.D. Tenn. 2002) (citing Gen. Tel. Co. of Sw. v. Falcon,
457 U.S. 147, 161 (1982)). The Sixth Circuit has recognized that district courts have broad
discretion in deciding whether to certify a class, but that courts “must exercise that discretion
within the framework of Rule 23.” Coleman v. Gen. Motors Acceptance Corp., 296 F.3d 443, 446
(6th Cir. 2002); see also In re Am. Med. Sys., Inc., 75 F.3d 1069, 1079 (6th Cir. 1996).
The party seeking class certification bears the burden of showing that the requirements for
class certification are met. Bridging Communities Inc. v. Top Flite Fin. Inc., 843 F.3d 1119, 1124
(6th Cir. 2016). In evaluating whether class certification is appropriate, “it may be necessary for
the court to probe behind the pleadings,” as the issues concerning whether it is appropriate to
certify a class are often “enmeshed” within the legal and factual considerations raised by the
litigation. In re Am. Med. Sys., Inc., 75 F.3d at 1079; see also Wal-Mart Stores, Inc. v. Dukes, 564

U.S. 338, 350-52 (2011) (explaining that a court’s rigorous analysis will frequently entail “some
overlap” with the merits of plaintiffs’ underlying claim) (citing Falcon, 457 U.S. at 160). A party
seeking to maintain a class action thus must be prepared to establish that Rule 23(a)’s numerosity,
commonality, typicality and adequacy of representation requirements have been met. Comcast v.
Behrend, 569 U.S. 27, 33 (2013). In addition, the party must satisfy, through evidentiary proof, at
least one of Rule 23(b)’s provisions. Id. at 34. Plaintiffs rely on Rule 23(b)(3), which allows for
certification of a Rule 23(a)-compliant class if:
the court finds that the 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. The matters pertinent to these findings include:

(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 will start with an examination of the Rule 23(a) factors then examine the Rule
23(b) predominance factor in terms of both the non-retail/hospital chain and the retail chain. The
Court then turns to an analysis of class-wide damages, Plaintiffs’ standing to pursue out of state
claims, and the superiority inquiry.
F. Rule 23(a)
1. Plaintiffs’ Arguments and Defendants’ Response

Plaintiffs assert that the class easily meets the requirements of Federal Rule Civil Procedure
23(a). (Id. at 8.) First, the proposed class consists of thousands of hospitals, insurers, and
uninsured, satisfying numerosity. (Id.) Plaintiffs also assert that there are common questions of
law and fact, namely the effect Defendants’ alleged antitrust activity had on members of the class
and the generic enoxaparin market. (Id. at 8-10.) Further, Plaintiffs’ claims are typical of the class
because they were injured in the same way as all members of the proposed class—they paid more
for enoxaparin than they would have absent Defendants’ alleged anticompetitive behavior. (Id. at
10.) Finally, Plaintiffs maintain that they are adequate class representatives because: (1) NGH and
DC 37 (as well as all members of the proposed class) were harmed by paying more for enoxaparin
than they otherwise would have absent Defendants’ conduct; and (2) there are no fundamental

intra-class conflicts sufficient to defeat certification. (Id. at 11-15.) Moreover, Plaintiffs contend
that they are adequate class representatives under the multiple state statutes because the statutes
are materially the same. (Id. at 15-16.)
Defendants have two primary arguments regarding Plaintiffs’ Rule 23(a) showing: (1)
Plaintiffs are not adequate class representatives because their interests conflict with putative class
members; and (2) Plaintiffs’ claims are not typical of other putative class members. (Id. at 24-26.)
Essentially, on the first point, Defendants argue that commercial insurers and hospitals have
divergent economic interests in this class action, as hospitals have every incentive to claim that
they absorbed enoxaparin overcharges, while commercial insurers (who pay some portion of the
final hospital bill) have an incentive to claim the overcharge was passed on to them. (Id. at 25-26.)
Defendants contend that this is a “quintessential class conflict” precluding certification. (Id. at 26.)
On the second point, Defendants argue that NGH and DC 37’s claims are not typical of other
putative class members’ claims because: (1) the proposed class includes commercial insurers and

hospitals, leading to a conflict of economic interests; and (2) individualized differences between
hospitals—billing differences, GPO suppliers, reimbursement policies—prevents any claim from
being typical. (Id.)
2. Numerosity
The class must be so numerous that joinder of all members is impractical. Fed. R. Civ. P.
23(a)(1). According to Plaintiffs, this requirement is met because the proposed class contains
thousands of members. Generally, the number of members of the proposed class, if more than
several hundred, easily satisfies the requirements of Rule 23(a)(1). Bacon v. Honda of Am. Mfg.,
Inc., 370 F.3d 565, 570 (6th Cir. 2004); see also Bittinger v. Tecumseh Prods. Co., 123 F.3d 877,
884 n. 1 (6th Cir. 1997) (joinder of parties impracticable for class with over 1100 members and

“[t]o reach this conclusion is to state the obvious”). Defendants do not appear to contest plaintiffs’
position on numerosity. Given the vast number of hospitals, pharmacies, and uninsured patients
that make up the class, joinder is impracticable and the requirements of Rule 23(a)(1) are met.
3. Commonality
Rule 23(a)(2) provides that “[o]ne or more members of a class may sue or be sued as
representative parties on behalf of all members only if . . . there are questions of law or fact
common to the class,” Fed. R. Civ. P. 23(a)(2), and commonality requires the plaintiffs to
demonstrate that the class members ‘have suffered the same injury.’” Dukes, 131 S.Ct. at 2551
(quoting Falcon, 457 U.S. at 157). “[P]laintiffs must show that their claims ‘depend upon a
common contention’ that is ‘of such a nature that it is capable of classwide resolution—which
means that determination of its truth or falsity will resolve an issue that is central to the validity of
each one of the claims in one stroke.’” Dukes, 131 S.Ct. at 2551. One common question is
sufficient. Powers v. Hamilton County Pub. Defender Com’n, 501 F.3d 592, 619 (6th Cir. 2007).

In antitrust cases, the commonality requirement is often easily met. “Price-fixing
conspiracy cases by their very nature deal with common legal and factual questions about the
existence, scope, and extent of the alleged conspiracy.” In re Foundry Resins Antitrust Litig., 242
F.R.D. 393, 404–05 (S.D. Ohio 2007) (citing In re Workers'’Comp., 130 F.R.D. 99, 105 (D. Minn.
1990)). In this case, Plaintiffs argue that commonality is established because their claims are based
on Defendants’ allegedly anticompetitive conduct and its effects on the generic enoxaparin
marketplace. (Doc. No. 353 at 9.) Defendants do not appear to challenge Plaintiffs’ assertion that
the commonality requirement has been met, and the Court finds that the requirements of Rule
23(a)(2) are satisfied.
4. Typicality

Rule 23(a)(3) requires plaintiffs to show 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). Often, “[t]he
commonality and typicality requirements of Rule 23(a) tend to merge.” Dukes, 131 S.Ct. at 2551
n. 5. There are differences, however. Commonality traditionally refers to characteristics of the
class as a whole, while typicality “refers to the individual characteristics of the named plaintiff in
relation to the class.” Prado–Steiman, ex rel. Prado v. Bush, 221 F.3d 1266, 1279 (11th Cir. 2000).
“[A] plaintiff’s claim is typical if it arises from the same practice or course of conduct that gives
rise to the claims of other class members, and if his or her claims are based on the same legal
theory.” In re Am. Med. Sys., Inc., 75 F.3d at 1082. Typicality is ordinarily established in the
antitrust context when the named plaintiffs and all class members allege the same antitrust
violation by defendants. Thomas & Thomas Rodmakers, Inc. v. Newport Adhesives &
Composites, Inc., 209 F.R.D. 159, 164 (C.D.Cal. 2002); (citing In re Playmobil Antitrust Litig.,
35 F. Supp. 2d 231, 244 (E.D.N.Y.1998)).

As stated, Defendants muster two primary arguments regarding typicality: (1) the proposed
class includes commercial insurers and hospitals, setting up divergent economic incentives; and
(2) no “typical” claim exists among hospitals based on the individual differences in billing,
chargemasters, reimbursement, and GPO contracts. (Doc. No. 363 at 26.)
Defendant’s arguments miss the mark. The focus of the typicality inquiry is to resolve
whether the representatives claims arises from the same event or practice or course of conduct that
gives rise to the claims of other class members. In re Am. Med. Sys., 75 F.3d at 1082. Defendant’s
arguments are geared towards the predominance inquiry, which the Court will address below. As
to typicality, the Plaintiffs and putative class members have claims that arise from the same course
of conduct—the Defendants’ alleged anticompetitive conspiracy to reduce generic competition in

the enoxaparin market and reap the benefits of the resulting overcharges. These indirect purchasers
rely on the same course of conduct and their claims are cognizable under the various state antitrust,
consumer protection, and unjust enrichment laws. Accordingly, the typicality requirement, which
is “not onerous,” is satisfied. UAW v. Ford Motor Co., No. 06-cv-10311, 2006 WL 1984363, at
*19 (E.D. Mich. July 13, 2006); see also In re Packaged Ice Antitrust Litig., 322 F.R.D. 276, 285
(E.D. Mich. 2017) (finding the typicality requirement met in an indirect purchaser suit where the
putative members’ claims were based on defendants’ alleged anticompetitive conspiracy).
5. Adequacy
The final requirement of Rule 23(a) is that the representative parties must “fairly and
adequately represent the interests of the class.” Fed. R. Civ. P. 24(a)(4). “The two criteria for
determining whether class representatives are adequate are ‘(1) the representatives must have

common interests with unnamed members of the class, and (2) it must appear that the
representatives will vigorously prosecute the interests of the class through qualified counsel.’”
Ford Motor, 2006 WL 1984363, at *19 (quoting Senter v. General Motors Corp., 532 F.2d 511,
525 (6th Cir. 1976)).
Both NGH and DC 37’s interests are aligned with the putative class members because they
all possess the same interests and have suffered the same alleged injury i.e., they have each
allegedly paid more for generic enoxaparin than they would have paid absent the alleged
conspiracy. Essentially, Defendant’s argument on this point is that hospitals (such as NGH) and
commercial insurers (like BlueCross/BlueShield) will be pitted against each other because
hospitals will have every economic incentive to exclude those insurers from asserting claims based

on enoxaparin overcharge reimbursements those insurers may have absorbed in the hospital
setting. (Doc. No. 363 at 24-26.). First, based on Plaintiffs’ expert testimony from Dr. Lamb, the
Court finds that, based on hospital billing practices, hospitals absorbed the enoxaparin
overcharges, and, therefore, commercial insurers would not have these types of claims. Therefore,
Defendants’ argument asserts a merely speculative class conflict that is insufficient to challenge
adequacy. See In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., Case No. 14-md-
002503, 2017 WL 462177, at *13 (D. Mass Oct. 16, 2017) (holding that merely speculative or
hypothetical class conflicts are insufficient). Accordingly, the Court finds that: (1) NGH and DC
37 have common interests with unnamed class members because they have the same economic
interests and suffered the same alleged injury; and (2) DC 37 and NGH will vigorously prosecute
the interests of the class through qualified counsel.
With that, Rule 23(a)’s requirements are satisfied.
G. Rule 23(b)(3) Requirements: Predominance

Meeting the predominance requirement of Rule 23(b)(3) demands more than common
evidence that defendants colluded to raise prices for generic enoxaparin. Plaintiffs must also show
that they can prove, through common evidence, that all class members were in fact injured by the
alleged conspiracy. Amchem, 521 U.S. at 623–24. However, Plaintiffs are not required to
demonstrate through common evidence the precise amount of damages incurred by each class
member. See Dukes, 131 S.Ct. at 2558.
Rule 23(b)(3) tests “whether proposed classes are sufficiently cohesive to warrant
adjudication by representation,” Amchem, 521 U.S. at 623, but it is far more demanding than the
commonality, typicality, and adequacy inquiries of Rule 23(a). Comcast, 133 S.Ct. at 1432;
Amchem, 521 U.S. at 623–24. To satisfy Rule 23(b)(3), the questions in a class action that are

subject to generalized proof, and thus applicable to the class as a whole, must predominate over
questions that are subject only to individualized proof. Beattie, 511 F.3d at 560.
In conducting the predominance inquiry, courts must “take into account ‘the claims,
defenses, relevant facts, and applicable substantive law,’ to assess the degree to which resolution
of the class-wide issues will further each individual class member’s claim against the defendant.”
Klay v. Humana, Inc., 382 F.3d 1241, 1254 (11th Cir. 2004), abrogated on other grounds by Bridge
v. Phoenix Bond & Indem. Co., 553 U.S. 639 (2008) (quoting Castano v. Am. Tobacco Co., 84
F.3d 734, 744 (5th Cir. 1996)). “If proof of the essential elements of the cause of action requires
individual treatment, then class certification is unsuitable.” In re Hydrogen Peroxide Antitrust
Litig., 552 F.3d 305, 311 (3d Cir. 2008) (citing Newton v. Merrill Lynch, Pierce, Fenner & Smith,
Inc., 259 F.3d 154, 172 (3d Cir. 2001)). Although individual treatment of the essential elements of
a case precludes certification, it is not necessary that all questions of fact be common, but only that
some questions are common and that they predominate over individual questions. Id.

A “close look” must be taken at whether common questions predominate over individual
ones and a “rigorous analysis” must be conducted that may “entail overlap with the merits of the
plaintiff's underlying claim.” Comcast, 133 S.Ct. at 1432 (internal quotations omitted). Free-
ranging merits inquires are not permitted at the certification stage, however. Amgen, 133 S.Ct. at
1194–95. “Merits questions may be considered to the extent—but only to the extent—that they are
relevant to determining whether the Rule 23 prerequisites for class certification are satisfied.” Id.
at 1195.
The predominance inquiry begins with the elements of the underlying cause of action. Erica
P. John Fund, Inc. v. Haliburton Co., 563 U.S. 804, 809 (2011). As set forth above, Plaintiffs have
alleged an overarching antitrust conspiracy that violates various states’ antitrust, unjust

enrichment, and consumer protection laws. To prevail on their antitrust claims based on allegations
of a conspiracy, plaintiffs must demonstrate (1) a violation of antitrust laws (i.e. the conspiracy),
(2) direct injury (or impact) from the violation, and (3) measurable damages. See Hydrogen
Peroxide, 552 F.3d at 311.
1. Plaintiffs’ Arguments and Defendants’ Response
Plaintiffs argue that common questions predominate, satisfying Rule 23(b)(3). (Id. at 16.)
Plaintiffs acknowledge that they must demonstrate that they can prove through common evidence
that all class members were in fact injured by the alleged antitrust conspiracy and assert that such
common proof of injury is available. (Id. at 18-19.) Specifically, they assert that Dr. Lamb’s expert
report and testimony at the evidentiary hearing establish this common proof. (Id. at 19.) Plaintiffs
explain that Dr. Lamb’s analysis establishes that after Amphastar’s actual entry into the enoxaparin
market, prices declined and class members paid less for generic enoxaparin than they did before a
second generic entered the market. (Id.) Plaintiffs argue that Dr. Lamb’s opinion is also confirmed

by Defendants’ own expert Dr. Pierre Cremieux, who opined that wholesalers, retail pharmacies,
and pharmacy benefit managers (PBMs) contract in such a way that overcharges for acquisitions
of drugs (like enoxaparin) are passed on to third-party payors (TPPs)/uninsured patients in the
retail channel and hospitals in the non-retail channel. (Id. at 19-20.) The Court finds that
Defendants’ arguments quibble with the data set relied by Dr. Lamb, rather than his ultimate
conclusions, which go to the weight of the evidence, not its suitability for use on a class-wide
basis. (Id. at 20-21.)
As to the non-retail/hospital component of predominance, Plaintiffs contend that individual
analysis of hospitals’ enoxaparin transactions is not necessary (and therefore does not defeat
predominance) because Dr. Lamb’s benchmark analysis demonstrates that hospitals paid more for

enoxaparin than they otherwise would have absent Defendants’ conduct. (Id. at 22.) Once the fact
of damages has been established, Defendants argument as to the quantum of damage cannot defeat
certification. (Id. at 22-23.) Further, Plaintiffs note that the differences between the claims in the
various states antitrust, consumer protection, and unjust enrichment laws does not require
individualized inquiry because those differences are immaterial and can be resolved using common
evidence on a class-wide basis. (Id. at 24-29.) Finally, Plaintiffs argue that the class mechanism is
superior to alternative methods, especially considering that individual class members would be
disincentivized from bringing suit because of the high cost of suit and small amount of available
monetary relief. (Id. at 29-30.) Plaintiffs then propose a notice plan and schedule to be instituted
after certification is granted. (Id. at 30-31.)
Defendants first contend that individualized questions regarding who was injured will
predominate over common questions, making class certification inappropriate. (Id. at 13.)

Defendants explain that indirect purchaser cases such as this one are complicated because Plaintiffs
bear the burden of proving not only that direct purchasers paid an inflated cost but that this inflated
cost was passed through to the indirect purchasers. (Id. at 13-14.) Further, for hospitals, Plaintiffs
must show that the hospital absorbed the inflated cost rather than passing it on to patients or
insurers. (Id. at 14.) Defendants maintain that Dr. Lamb has not empirically demonstrated either
of these propositions. (Id.) Instead, he simply assumes that hospitals never passed any of these
inflated costs on to insurers or patients (i.e., they always absorbed the inflated enoxaparin cost and
were injured), and, conversely, pharmacies always passed the inflated costs on to TPPs and
uninsured in the form of higher prescription prices. (Id.) However, Defendants maintain that a
rigorous analysis (as performed by their expert Dr. Cremieux) reveals that individualized inquiry

is required to demonstrate antitrust impact and exclude uninjured class members, making class
certification inappropriate. (Id. at 15-16.)
Defendants contend that, in the hospital channel, individualized inquiry is necessary to
determine whether any particular hospitals would have paid less for enoxaparin if Amphastar had
not been enjoined from entering the market. (Id. at 16.) In fact, given NGH’s contract with its
group purchasing organization (“GPO”), from whom it purchased enoxaparin, Defendants
maintain that NGH would not have paid less for enoxaparin in a but-for world, as it was already
receiving the benefit of a lower price based on a prior renegotiation. (Id. at 17.) Defendants argue
that these types of individualized inquiries are necessary for each hospital, which makes class
certification inappropriate. (Id. at 18.)
Similarly, Defendants assert that individualized inquiry is required to demonstrate antitrust
impact and to exclude uninjured class members in the retail pharmacy chain. (Id. at 20.) Defendants

explain that a “bottom level” analysis is necessary to demonstrate that pharmacies always passed
the overcharges to TPPs and uninsured purchasers, Dr. Lamb failed to conduct a “bottom level”
analysis showing this pass through, and, therefore, without individualized inquiry, many members
of the proposed class suffered no injury. (Id. at 20-22.) Defendants stress that these individualized
issues (both as to hospitals and the retail pharmacy channel) cannot be cured by adjusting aggregate
damages because there is no common method to identify and exclude uninjured class members or
to reduce Dr. Lamb’s damages model to account for the varying levels of pass through. (Id. at 22-
24.) Therefore, granting certification, even in light of an adjustment to the aggregate damages,
would deprive Defendants of their ability to fairly defend this litigation. (Id. at 24.)
2. Antitrust Conspiracy

“Predominance is a test readily met in certain cases alleging . . . violations of the antitrust
laws” and generally “proof of the conspiracy is a common question that is thought to predominate
over the other issues of the case . . . .” In re Scrap Metal Antitrust Litig., 527 F.3d 517, 532, 535
(6th Cir. 2008) (quoting Amchem, 521 U.S. at 625). Plaintiffs allege here that Defendants engaged
in a single, market wide conspiracy to reduce competition in the sale of generic enoxaparin, which
they will prove with evidence common to the class. “Courts have fairly consistently found . . . that
common issues regarding the existence and scope of the conspiracy predominate over other
questions affecting only individual members in antitrust price fixing cases.” In re Southeastern
Milk Antitrust Litig., Case No.l 2:08-MD-1000, 2010 WL 3521747, at *9 (E.D. Tenn. Sept. 7,
2010). That makes sense because determination of the conspiracy issue will focus on the conduct
of the Defendants, not the individual class members. See Merenda v. VHS of Mich., Inc., 296
F.R.D. 528, 548 (E.D. Mich. 2013). The existence of a conspiracy is central to the claims of all
putative class members and thus is appropriate for resolution generally on a class-wide basis. With

this in mind, the parties have focused on the second element, impact, as that element poses the
more serious impediment to certification, and, likewise, the Court focuses its attention there.
3. Impact
In recognition that Rule 23’s predominance requirement is “more stringent” than other
elements of the Rule, Amchem, 521 U.S. 591 at 609, the overwhelming focus of the briefing
discusses whether Plaintiffs can show that common questions of fact or law predominate over
those questions “affecting only individual members.” See Fed. R. Civ. P. 23(b)(3). To carry their
Rule 23(b)(3) burden, Plaintiffs offer the expert reports of Dr. Lamb. Defendants respond in kind,
offering the expert reports of Dr. Cremieux.
Contrary to Defendants’ protestations, at this stage of the litigation, Plaintiffs’ burden as it

relates to predominance is “not to prove [ (for example) ] the element of antitrust impact.” In re
Hydrogen Peroxide, 552 F.3d at 311. Plaintiffs must instead show that the essential elements of
their claims are “capable of proof at trial through evidence that is common to the class rather than
individual to its members.” Id. at 311–12 (emphasis added). This inquiry necessarily requires this
Court to form “some prediction as to how specific issues will play out” in terms of trial proof,
particularly when a class certification decision is made on the basis of an incomplete discovery
record. In re New Motor Vehicles Canadian Exp. Antitrust Litig., 522 F.3d 6, 20, 27 (1st Cir.
2008). The predominance inquiry gauges whether a proposed class is cohesive enough to “warrant
adjudication by representation.” Beattie, 511 F.3d 554 at 564.
Plaintiffs’ approach to showing that impact is capable of proof using evidence common to
the class involves a two-step process. Because Plaintiffs are indirect purchasers (i.e., they
purchased enoxaparin from wholesalers who purchased it from Defendants) Plaintiffs must prove
that: (1) the conspiracy resulted in higher prices for Defendants’ customers (the wholesalers who

purchased directly from Defendants); and (2) this initial overcharge was passed through the non-
retail (hospital) and retail channels and was included in the final price they paid for the enoxaparin.
See In re Polyurethane Foam Antitrust Litig., 314 F.R.D. 226, 276 (N.D. Ohio 2014) (explaining
the impact burden plaintiffs have in indirect purchaser actions).
a. Non-Retail/Hospital Chain
In support of their assertion that Defendants’ antitrust conspiracy resulted in higher prices
for enoxaparin and these overcharges were passed down the supply chain, Plaintiffs primarily rely
on Dr. Lamb’s expert reports and testimony. To show that the alleged antitrust conspiracy resulted
in higher prices, Dr. Lamb uses a method known as “backcasting.” (Doc. No. 303-1 at 82-88.) Put
simply, Dr. Lamb starts with the “actual world” prices that existed for enoxaparin—taking into

account Defendants’ alleged anticompetitive activity in excluding Amphastar’s entry from the
generic enoxaparin marketplace. (Id. at 82.) Dr. Lamb then “backcasts” and shifts Amphastar’s
entry into the generic enoxaparin market four months earlier (from February 2012 to October
2011), which he asserts would have occurred absent Defendants’ alleged conduct. (Id. at 83-85.)
The difference between the actual world and but-for world price results in the “overcharge” that
wholesalers incurred and subsequently passed on to hospitals. (Id.) Dr. Lamb, in his original expert
report, estimated class-wide damages for indirect purchasers to be around $298 million, but, as a
result of Plaintiffs amended class definition, he reduced the damages estimate to approximately
$234 million. (Doc. No. 353-4 at 3.) Defendants do not take issue with Dr. Lamb’s backcasting
analysis or the proposition that the alleged antitrust activity resulted in higher generic enoxaparin
prices, rather, Defendants target the second part of the analysis—whether the initial overcharge
was passed through the retail and non-retail channels and whether these overcharges can be proven
through proof common to the class.

Defendants’ argument on this point can be summarized in two words: individualized
inquiry. (Doc. No. 363 at 16-22.) Relying on Dr. Cremieux’s expert reports and testimony,
Defendants contend that there is simply no way to calculate through common proof whether
putative class members suffered an overcharge in the first instance or suffered an overcharge and
passed it on downstream—either of which would exclude putative plaintiffs from the class. (Id.)
In his expert report, Dr. Cremieux criticizes Dr. Lamb for failing to perform a pass-through
analysis showing the overcharges incurred by putative class members. (Doc. No. 363-1 at 8.) Dr.
Cremieux opines that: (1) some hospitals pass on their acquisition costs to patients and insurance
companies and some do not; (2) Dr. Lamb has not identified a common method to determine which
hospitals pass on the overcharges and which ones absorb that cost; (3) this failure results in an

aggregate damages calculation that is unreliable and overstated; (4) conversely, Dr. Lamb, without
any statistical analysis, assumes that pharmacies act as resellers and pass 100% of any overcharge
on to downstream purchasers (uninsured and TPPs); and (5) individualized inquiry is required to
determine how and at what point in the process the overcharge was borne and by whom. (Id. at
11.) Defendants maximal focus on whether the overcharge was offset by the hospital passing on
the overcharge misses the point.
“[A]ntitrust injury occurs the moment the purchaser incurs an overcharge, whether or not
that injury is later offset.” In re Nexium Antitrust Litig., 777 F.3d 9, 27 (1st Cir. 2015) (citing
Adams v. Mills, 286 U.S. 397, 407 (1932); Hawaii v. Standard Oil Co. of Cal., 405 U.S. 251, 262
n. 14 (1972). “If a class member is overcharged, there is an injury, even if that class member suffers
no damages.” Id. Accordingly, in the hospital channel, the proper focus is on whether the hospital
incurred an overcharge in the first instance. Even if individualized inquiry is required to see if the
hospitals passed on that overcharge, as Defendants contend, such an inquiry is not necessary to

determine if the putative hospital claimant suffered actual antitrust impact, which is all that is
required in the predominance inquiry.
Thus, the Court must look to whether Plaintiffs, through Dr. Lamb, have demonstrated that
by common proof whether hospitals incurred overcharges in the first instance. In his expert report,
Dr. Lamb claims that the common proof showing hospitals bore these overcharges consists of: (1)
an extensive body of published research showing that direct and indirect purchasers realize
significant costs savings when generics enter the market; (2) Defendants’ documents, testimony,
and forecasts confirming that when generics enter the market there is a significant cost savings for
purchasers; and (3) IMS data on sales of generic enoxaparin that confirm that competition among
generic manufacturers would have led to significantly lower prices. (Doc. No. 353-1 at 60-61.)

Here, if a class member is overcharged, there is an injury, even if that class member suffers no
damages. Relying on economic literature, Dr. Lamb opines that:
[T[he price differential (generic versus the brand name drug) and the generic’s
share of unit sales increase over time following generic entry. Other studies show
that this price differential increases as additional generic manufacturers enter the
market, particularly with respect to the impact on generic price when a second
generic manufacturer (including an authorized generic) competes in a market
against a generic that otherwise would have been the only generic in that market.

(Id. at 61.) Similarly, Dr. Lamb cites to Defendants’ own internal documents and materials, all of
which are common to the class, demonstrating that Defendants realized that additional generic
entry would result in significant price erosion. (Id. at 63.) These internal memoranda show that
Defendants acutely understood the significant profits that could be realized by capturing an
extended exclusivity period for generic enoxaparin during which time consumers would be willing
to pay an anticompetitive price because the drug had no alternatives. (Id. at 65-67.) Finally, using
the IMS data, Dr. Lamb concludes that:
Sandoz began selling generic Enoxaparin in July 2010 and Amphastar and
Winthrop (Sanofi’s authorized generic) entered in October 2011. As shown, in the
retail channel, Sandoz’s share of the market relative to the other generics decreased
from 100 percent in September 2011 to approximately 49 percent in September
2012. In the non-retail channel, Sandoz’s share of the market relative to the other
generics decreased from 100 percent in September 2011 to approximately 66
percent in September 2012.

The substitution of Sandoz’s generic Enoxaparin for the generic Enoxaparin sold
by other manufacturers is evidence, common to the proposed Class as a whole, that
if another generic manufacturer had entered the market earlier, proposed Class
members would have purchased generic Enoxaparin at a lower price.

Thus, data on sales of Lovenox and A-rated generic Enoxaparin demonstrate that
competition among generic manufacturers in the actual world resulted in lower
prices for generic Enoxaparin following Amphastar’s entry into the market. That
is, in preventing a second or third generic manufacturer from entering the market,
Defendants’ alleged misconduct caused purchasers to be overcharged because the
prices for both Lovenox and A-rated generic Enoxaparin were higher than they
would have been had there been no impediment to entry by a second or third generic
manufacturer. In other words, the price-based competition between generic
manufacturers that would have occurred absent Defendants’ alleged misconduct
would have allowed all or nearly all proposed Class members to pay less for
Lovenox and A-rated generic Enoxaparin than they actually did.

(Id. at 67-71.)
The Court finds that Dr. Lamb’s analysis and examination of this evidence sufficiently
demonstrates that there is common evidence capable of demonstrating the fact of antitrust impact.
Defendants’ individual inquiry arguments are a red herring, as, in reality, the real issue is their
concern that the Court’s certification of the class will include persons who have not been injured
by the alleged anticompetitive conduct. However, the Defendants’ speculative concern will not
defeat certification. As the Seventh Circuit has explained:
[A] class will often include persons who have not been injured by the defendant’s
conduct. Such a possibility or indeed inevitability does not preclude class
certification, despite statements in some cases that it must be reasonably clear at
the outset that all class members were injured by the defendant’s conduct.

Kohen v. Pacific Inv. Mgmt. Co. LLC, 571 F.3d 672, 677 (7th Cir. 2009) (citations omitted). The
Court agrees with Kohen and with other courts that “have routinely observed that the inability to
show injury . . . does not defeat class certification where the plaintiffs can show widespread injury
to the class.” In re Cardizem CD Antitrust Litig., 200 F.R.D. 297, 320–21 (E.D. Mich. 2001) (citing
In re NASDAQ Market–Makers Antitrust Litig., 169 F.R.D. 493, 523 (S.D.N.Y. 1996)). As to the
non-retail/hospital channel, the Court is persuaded that Dr. Lamb’s analysis and testimony shows
that, based on Defendants’ alleged antitrust activity, the price for generic enoxaparin was sold to
non-retail putative class members (hospitals) at an anticompetitive price during the class period.
Although this finding is sufficient for Rule 23(b)(3) purposes, the Court separately examines
Defendants and Dr. Cremieux’s other arguments for completeness of the record.
Before considering Dr. Cremiuex’s reports and testimony in-depth, the Court pauses to
note that, in the discretion afforded by the Sixth Circuit, it ascribes little, if any, weight to these
reports and testimony. See Deal v. Hamilton Cty. Bd. of Educ., 392 F.3d 840, 851 (6th Cir. 2004)
(“Furthermore, this Court is not in the business of dictating to district courts the amount of weight
they must give certain expert opinions.”) The Court gives little weight to Dr. Cremieux’s opinions
because: (1) there were manifest contradictions between his original and supplemental expert
reports; and (2) he was forced to admit significant error in his supplemental report on cross-
examination during the certification hearing. The Court places particular emphasis on the latter
incident. In brief, Dr. Cremieux stated in his supplemental report that Sanofi and Medassets (a
GPO from whom NGH purchased enoxaparin) had an agreement to reduce the price of generic
enoxaparin as early as September 2011. (Doc. No. 363-1 at 16.) Dr. Cremieux links this
“agreement” with his ultimate opinion that this “agreement” would have resulted in a price decline
in generic enoxaparin even absent the Defendants’ alleged antitrust activity. (Id. at 17.) However,
on cross-examination, Dr. Cremieux was forced to admit that no such agreement existed in
September 2011, and, in fact, when MedAssets was considering Sanofi’s price reduction,

Defendants’ alleged anticompetitive activity (enjoining Amphastar from entering the generic
enoxaparin marketplace) was already occurring. (Doc. No. 396 at 260-62.) The Court also finds a
significant negative change in Dr. Cremieux’s demeanor at this point. This admission of error not
only substantially undermines Dr. Cremieux’s expert opinion on this particular issue, but also casts
serious doubt on his credibility and the remainder of his opinions. Accordingly, the Court ascribes
Dr. Cremieux’s testimony little, if any, weight because the Court does not find Dr. Cremieux
credible.
In Defendants’ brief, they argue that NGH itself was not injured by the alleged
anticompetitive activity based on the Sanofi-MedAssets September agreement. (See Doc. No. 363
at 17.) However, based on the Dr. Cremieux’s fatal admission in his testimony during cross-

examination, the evidentiary record before the Court does not support such an argument.
Defendants’ arguments that individualized inquiry is necessary to determine how the particular
hospitals set their charges, reimbursement, insurer contracts, and patient circumstances is also
incorrect. In the non-retail/hospital chain, the Court is concerned with the purchase by the hospitals
in the first instance. The insurer contracts, patient charges, and charge-setting practices have no
effect on the hospital’s initial purchase of generic enoxaparin, which is the only inquiry that matters
for antitrust impact.
At bottom, Plaintiffs’ evidence has shown, by a preponderance of the evidence, that the
vast majority of non-retail/hospital class members were most likely injured, based on how the
generic enoxaparin supply chain is structured. “Rigorous analysis” of the evidence does not show,
by a preponderance of the evidence, that the number of uninjured class members is more than de
minimis. This Court is well within its discretion to find that the Plaintiffs have presented a
sufficient showing of common antitrust impact to the putative non-retail/hosptial class.

Defendants’ speculation, built on the back of an unreliable expert opinion, cannot defeat the
Plaintiffs’ showing. See Messner v. Northshore Univ. HealthSystem, 669 F.3d 802, 825 (7th Cir.
2012) (once plaintiffs had shown broad antitrust impact, certification could not be denied just
because defendants pointed to a class of uninjured members but “[gave] no indication how many
such individuals actually exist”).
b. Retail/Pharmacy Chain
As to the retail class, Plaintiffs assert that common proof of injury is clearly available.
(Doc. No. 353 at 19.) Plaintiffs point to: (1) Dr. Lamb’s certification testimony that pharmacies
are resellers, and, therefore, the anticompetitive price they paid for generic enoxaparin was
automatically passed on to TPPs and uninsured consumers; and (2) the IMS data definitively shows

that pharmacies paid an anticompetitive price. (Id.) Plaintiffs acknowledge that Defendants take
issue with Dr. Lamb’s reliance on the IMS data, but argue that such an assertion goes to the weight
of the evidence, rather than its admissibility or its ability to satisfy the predominance inquiry. (Id.
at 21.)
Indeed, Defendants’ arguments as to the retail/pharmacy chain of the class definition
largely focus on the alleged deficiencies in the IMS data used by Dr. Lamb. (See Doc. No. 363 at
20-22.) Defendants argue that the IMS data only shows the prices paid by pharmacies and provides
no insight on what price the end-consumers (TPPs and uninsured patients) paid for generic
enoxaparin when they obtained it from said pharmacies. (Id. at 20-21.) Therefore, because Dr.
Lamb failed to use an approach that accounted for the price paid at the “final level,” Defendants
argue that there is no common proof available to show that the TPPs and uninsured patients were
injured. (Id.) Defendants also argue that the pass-through rate for pharmacies is less than 100%,
meaning it would require individualized inquiry to ascertain whether the TPP or uninsured patient

suffered antitrust impact by actually paying an inflated price. (Id. at 21-22.)
Again, it bears repeating, the Court places little, if any, weight on Dr. Cremieux’s report
or opinion testimony, given his blatant contradictory testimony at the certification hearing. In his
initial report, Dr. Lamb summarized how pharmaceuticals, including generic enoxaparin, are
distributed in the retail chain and how anticompetitive prices at the top-end of the chain affect
prices at the consumer level:
Manufacturers of prescription drugs, including brand-name drugs and generics, sell
directly to drug wholesalers, and in some circumstances, directly to retail pharmacy
chains, mail order and specialty pharmacies, hospital chains, and health plans. As
described in Momenta’s 2012 SEC Form 10-K, "[g]eneric pharmaceutical products
are sold through various channels, including retail, mail order . . . .

Drug manufacturers determine the Wholesale Acquisition Cost ("WAC"), which is
typically the ‘baseline price at which wholesale distributors purchase products.’
Drug wholesalers purchase prescription drugs from manufacturers and resell them
to retail pharmacies, mail-order pharmacies, hospitals, long-term care and other
medical facilities. In turn, retail pharmacies purchase prescription drugs from
wholesalers, and, in some cases, directly from the manufacturers, and ultimately
sell those drugs to their customers holding prescriptions. Some retailers also
purchase prescription drugs directly from the manufacturers.

(Doc. No. 353-1 at 18.) In his reply report, Dr. Lamb elaborates, stating that as a matter of
economics, pharmacies would pass through higher costs of generic enoxaparin to their customers,
including uninsured patients and TPPs. (Doc. No. 353-2 at 68-69.) Dr. Lamb notes that the retail
supply chain is simple—manufacturers sell to wholesalers who sell to pharmacies who sell to end
users (TPPs and uninsured patients)—such that any increase in the acquisition cost invariably must
be passed to the final level. (Id.) He also explains that economic literature supports his conclusion
that pass through in the retail chain occurs because in markets that suffer from monopoly
overcharges, a high degree of pass on almost always occurs and is likely to manifest rapidly. (Id.
at 69.) Dr. Lamb notes that, based on the back casting, showing that a higher price was paid by
wholesalers because of Defendants’ alleged activity, and principles of economics, which suggest

that some percentage of a price increase (overcharge) is invariably passed to end consumers,
common proof available to the class supports the finding that TPPs and uninsured patients suffered
antitrust impact. (Id. at 69-70.)
Admittedly, Dr. Lamb’s expert report, testimony, and supporting evidence for antitrust
impact in the retail channel is very thin. However, Plaintiffs’ burden is limited, even in the
predominance inquiry. “Antitrust plaintiffs have a limited burden with respect to showing that
individual damages issues do not predominate. Plaintiffs do not need to supply a precise damage
formula at the certification stage of an antitrust action. Instead, in assessing whether to certify a
class, the Court's inquiry is limited to whether or not the proposed methods are so insubstantial as
to amount to no method at all.” In re Potash Antitrust Litig., 159 F.R.D. 682, 697 (D. Minn. 1995).

“This relaxed standard flows from the equitable notion that the wrongdoer should not be able to
profit by insistence on an unattainable standard of proof.” Id. (citation omitted). “Moreover, the
fact that the damages calculation may involve individualized analysis is not by itself sufficient to
preclude certification when liability can be determined on a class-wide basis.” Id.
Simply put, the Court believes that Dr. Lamb’s opinion and testimony, supported by
economic literature and the IMS data, provides enough evidence to demonstrate antitrust impact
in the retail channel. To be clear, the Court finds Dr. Lamb credible and Dr. Cremieux not credible.
Accordingly, Plaintiffs have established antitrust impact as to both the retail and non-retail
channels of their class definition, and, therefore, the Rule 23(b)(3) predominance requirement is
satisfied.
H. Class-Wide Damages
The Court also finds that, as to the issue of class-wide damages, Plaintiffs, through Dr.

Lamb, have presented a proper methodology to measure class-wide damages. Based on the above
analysis, the Court is satisfied that an injury-in-fact impacted the proposed class members. As with
all other issues in this case, the parties disagree as to the quantum of damages. However, at this
point, the Court need not provide any definitive answer to this issue. In re Loestrin 24 Fe Antitrust
Litig., Case No. 13-2472-WES-PAS, 2019 WL 3214257, at *5 (D. R. Isl. Jul. 2, 2019) (holding
that, on the issue of class-wide damages, “[w]hile Defendants fashion a colorable argument on this
score, the [Plaintiffs] have satisfied their burden to produce a ‘scientifically sound and
methodologically reliable’ opinion . . . [and] [i]t will be up to the jury to determine which party’s
theory wins the day.”). As discussed above, that Dr. Lamb’s damages model may include a
purchaser that was uninjured does not render his analysis unsound. It is for the jury to determine

whether the potential class members were injured, and if so, to what extent; or to determine that
they were not. Id. at *6. At bottom, Dr. Lamb has produced a viable, methodologically sound
opinion as to the calculation of damages, and, at this stage, that is all that is required.
I. State Law Differences and Standing
Plaintiffs argue that, to the extent there are differences between the 30 state laws they are
bringing claims under, those differences can be resolved using common evidence on a class-wide
or state-wide basis, and, in any event, most of the differences are immaterial. (Doc. No. 353 at 24.)
Defendants argue that Plaintiffs lack standing to bring claims on behalf of class members in the
majority of class states because they did not suffer injury in those states and the material state law
differences in those states’ statutes prevent certification. (Doc. No. 363 at 27-29.)
Threshold individual standing is a prerequisite for all actions, including class actions. See
O’Shea v. Littleton, 414 U.S. 488, 494 (1974). A potential class representative must demonstrate

individual standing vis-as-vis the defendant; he cannot acquire such standing merely by virtue of
bringing a class action. Fallick v. Nationwide Mut. Ins. Co., 162 F.3d 410, 423 (6th Cir. 1998)
(citing Brown v. Sibley, 650 F.2d 760, 770 (5th Cir. 1981)). As the Sixth Circuit has made clear,
however, “once an individual has alleged a distinct and palpable injury to himself he has standing
to challenge a practice even if the injury is of a sort shared by a large class of possible litigants.”
Id. (quoting Senter v. Gen. Motors Corp., 532 F.2d 511, 517 (6th Cir. 1976)). Once his standing
has been established, whether a plaintiff will be able to represent the putative class, including
absent class members, depends solely on whether he is able to meet the additional criteria
encompassed in Rule 23 of the Federal Rules of Civil Procedure. Id. (citing Cooper v. Univ. of
Texas at Dallas, 482 F. Supp. 187 (N.D. Tex. 1979); Herbert B. Newberg & Alba Conte, Newberg

on Class Actions § 2.05 (3d ed. 1992)). Here, the Court has previously determined that NGH and
DC 37 have standing to sue Defendants under the states in which they were harmed (i.e. where
they purchased enoxaparin)—Tennessee and New York, respectively. (See Doc. No. 253.)
However, the Court deferred deciding the issue of whether Plaintiffs had standing to pursue claims
based on other state laws and statutes. (Id. at 20.) The Sixth Circuit’s decision in Fallick suggests
that this standing inquiry turns on whether Plaintiffs have satisfied the Rule 23(a) factors. 162 F.3d
at 423-25. As demonstrated above, the Court finds that Plaintiffs have satisfied the Rule 23(a)
factors, and, therefore, under Fallick, Plaintiffs have standing to assert claims under the various
state statutes on behalf of absent class members.
Also, the Court looks to the First Circuit Court of Appeals’ decision in In re Asacol, 907
F.3d 42, 49 (1st Cir. 2018), for guidance. In Asacol, the First Circuit focused on the “basic Article
III requirement that a plaintiff possess ‘such a personal stake in the outcome of the controversy as
to assure . . . concrete adverseness.’” 907 F.3d at 49 (quoting Baker v. Carr, 369 U.S. 186, 204

(1962)). “So the question of standing is not: Are there differences between the claims of the class
members and those of the class representative? Rather, the pertinent question is: Are the
differences that do exist the type that leave the class representative with an insufficient personal
stake in the adjudication of the class members’ claims?” Id.
Here, as in Asacol, the Court likewise concludes that “success on the claim under one
state’s law will more or less dictate success under another state’s law.” Id. Although both Fallick
and Asacol approach the standing inquiry in differently, the end result is the same: does the nature
of Plaintiffs’ injury give it a sufficient incentive to adequately litigate claims that are similar, but
not identical, to those of absent class members? The answer to that inquiry is a yes. Under these
parallel laws, all plaintiffs who were forced to pay a higher price in the absence of generic

competition have a substantial and shared interest in proving that the higher price was the result
of unlawful monopolizing conduct that is redressable by an award of damages. “[T]he fact that
judgments for some class members will nevertheless enter under the laws of states other than the
states under which any of the class representative’ judgments will enter, where those laws are
materially the same, has no relevant bearing on the personal stake of the named plaintiffs in
litigating the case to secure such judgments.” Id. The Court has reviewed the differences in the
state statutes that Plaintiffs assert claims under, and, contrary to Defendants’ arguments, the
differences are not material. Moreover, in any event, the fundamental issues under these statutes
remains the same—proving that putative plaintiffs were forced to pay a higher price in the absence
of generic enoxaparin competition. Finding Article III standing otherwise satisfied in this case is
in accord with the decisions of other circuits that have considered similar issues. See Langan v.
Johnson & Johnson Consumer Cos., 897 F.3d 88, 92-96 (2d Cir. 2018) (holding that named
plaintiffs had standing to assert claims under various state laws). Accordingly, the Court finds that

Plaintiffs have standing to bring claims under the various state statutes in the jurisdictions
identified in the class definition.
J. Superiority
Finally, to earn certification, a putative class must establish that a class action is “superior
to other available methods for fairly and efficiently adjudicating the controversy.” Fed. R. Civ. P.
23(b)(3). In undertaking this analysis, the Court examines four factors:
(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.

Defendants do not dispute that superiority is met here. (See Doc. No. 363.) In the instant
case, three of the four factors weigh in favor of a certifying the case as a class action. First, the
relatively small amount of individual damages and the similarity of claims give class members
little interest in individually controlling separate actions. Second, concentration of these claims in
this Court is desirable, as it will streamline the resolution of the claims and conserve judicial and
litigation resources. Finally, the Court is aware of no particular difficulties associated with the
management of this class action, especially given the current stage of the litigation. Thus, for
purposes of Rule 23(b)(3), a class action is superior to other methods of adjudication in the instant
case. With that, the Plaintiffs have carried their burden in establishing that their proposed class
should be certified under Rule 23(a)(1) and (b)(3) under the Federal Rules of Civil Procedure.
K. Conclusion
For the reasons stated above, the Plaintiffs’ Renewed Motion for Class Certification and
Appointment of Class Counsel (Doc. No. 349) is GRANTED and Defendants’ Motion to Exclude
the Report and Opinions of Plaintiffs Expert Dr. Russell L. Lamb (Doc. No. 360) is DENIED. The
Court further APPOINTS NGH and DC 37 as class representatives. Additionally, after
considering the factors set out in Federal Rule of Civil Procedure 23(g)(1)(A), the Court
determines that Lieff Cabraser is qualified to represent the class and, therefore, APPOINTS Lieff
Cabraser as Class Counsel.
An appropriate order will enter.

Whubd. Qeshe
Ll > Cincy
CHIEF UNITED STATES DISTRICT JUDGE

37

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10436052. Public record. Not legal advice.