Preview
2/18/2019 2:13 PM
Marilyn Burgess - District Clerk Harris County
Envelope No. 31271543
By: KATINA WILLIAMS
Filed: 2/18/2019 2:13 PM
MDL PRETRIAL CAUSE NO. 2018-76970-7
COUNTY OF EL PASO, § IN THE DISTRICT COURT
§
Plaintiff, §
§
VS. § 346TH JUDICIAL DISTRICT
§
k
ler
PURDUE PHARMA L.P., ET AL., §
§
tC
Defendants. § EL PASO COUNTY, TEXAS
ric
***************************************************************************
ist
sD
******
es
MASTER FILE NO. 2018-63587
rg
§ IN THE DISTRICT COURT
§ Bu
IN RE: TEXAS OPIOID § 152ND JUDICIAL DISTRICT
n
LITIGATION §
ily
§ HARRIS COUNTY, TEXAS
ar
M
DEFENDANT CARDINAL HEALTH, INC.’S
of
ORIGINAL ANSWER AND AFFIRMATIVE DEFENSES TO
e
PLAINTIFF’S ORIGINAL PETITION
ffic
O
TO THE HONORABLE JUDGE OF SAID COURT:
y
COMES NOW, Defendant Cardinal Health, Inc. (“Defendant”) and files its Original
op
C
Answer and Affirmative Defenses to Plaintiff’s Original Petition1 and in support shows the
ial
following:
fic
of
Un
1
As of this filing, the proceedings in this litigation have been stayed with limited exceptions that include the filing of
answers by defendants that have been served with process. On January 28, 2019, this Court entered an Order lifting
the stay as to Rule 91a motions and responses only in five Selected Cases. Proceedings and deadlines related to Rule
91a motions to dismiss in non-Selected Cases, and related to special exceptions in all cases, remain stayed pending
further order by this Court.In light of the stay, Defendant has not filed a Rule 91a motion to dismiss in this case.
I.
GENERAL DENIAL
Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendant asserts a general
denial, denies each and every allegation made by Plaintiff County of El Paso (“Plaintiff” or “the
County”), and demands strict proof thereof.
k
ler
II.
tC
SPECIAL DENIAL
ric
Pursuant to Rule 54 of the Texas Rules of Civil Procedure, Defendant specifically denies
ist
sD
that Plaintiff properly pled that all conditions precedent to Plaintiff’s claims have been performed
es
or have occurred, and denies that such conditions precedent have been met in their entirety.
rg
III.
AFFIRMATIVE DEFENSES Bu
n
Defendant asserts the following defenses to Plaintiff’s Original Petition (the “Petition”).
ily
ar
Defendant does not admit or acknowledge that it bears the burden of proof and/or burden of
M
persuasion with respect to any such defense. All of the following defenses are pled in the
of
e
alternative and none constitutes an admission that Defendant is liable to Plaintiff, that Plaintiff has
ffic
or will be injured or damaged in any way, or that Plaintiff is entitled to any relief whatsoever.
O
Defendant reserves the right to (i) rely upon any other applicable defenses set forth in any Answer
y
op
of any other defendant in this Action, (ii) rely upon any other defenses that may become apparent
C
ial
during fact or expert discovery in this matter, and (iii) to amend this Answer to assert any such
fic
defenses.
of
Un
1. Defendant further pleads, if such be necessary, and pleading in the alternative, that
the Petition fails to state facts sufficient to constitute a claim upon which an award of actual
damages, compensatory damages, restitutionary damages, punitive damages, or other relief may
be granted.
2
2. Defendant further pleads, if such be necessary, and pleading in the alternative, that
the Petition, and each alleged claim therein, is barred, in whole or in part, by the applicable statute
of limitations.
3. Defendant further pleads, if such be necessary, and pleading in the alternative, that
k
ler
the Petition, and each alleged claim therein, is barred, in whole or in part, by the applicable statute
tC
of repose.
ric
4. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ist
sD
Plaintiff’s claims for relief are barred by the doctrines of laches.
es
5. Defendant further pleads, if such be necessary, and pleading in the alternative, that
rg
venue may be improper and/or inconvenient in this Court.
Bu
6. Defendant further pleads, if such be necessary, and pleading in the alternative, that
n
ily
Plaintiff’s claims are barred or limited for lack of standing.
ar
M
7. Defendant further pleads, if such be necessary, and pleading in the alternative, that
of
Plaintiff lacks capacity to bring its claims, including claims indirectly maintained on behalf of its
e
ffic
citizens and claims brought as parens patriae.
O
8. Defendant further pleads, if such be necessary, and pleading in the alternative, that
y
op
Plaintiff’s claims are barred because Plaintiff is not the real party in interest.
C
9. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ial
fic
Plaintiff’s claims are not ripe and/or have been mooted.
of
10. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Un
Plaintiff’s claims and damages are barred or limited, in whole or in part, by common law, statutory,
and state constitutional constraints on the exercise of police powers by a local government.
3
11. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Plaintiff’s claims are barred, in whole or in part, by the political question and separation of powers
doctrine and because its claims implicate issues of statewide importance that are reserved for state
regulation.
k
ler
12. Defendant further pleads, if such be necessary, and pleading in the alternative, that
tC
Plaintiff may be barred by the doctrine of unclean hands from all forms of relief sought in the
ric
Petition.
ist
sD
13. Defendant further pleads, if such be necessary, and pleading in the alternative, that
es
Plaintiff failed to exhaust administrative remedies.
rg
14. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Bu
Plaintiff may be barred by the doctrines of estoppel, quasi-estoppel, equitable estoppel, and/or
n
ily
waiver from all forms of relief sought in the Petition.
ar
M
15. Defendant further pleads, if such be necessary, and pleading in the alternative, that
of
Plaintiff’s claim may be barred by the doctrines of res judicata and collateral estoppel from all
e
ffic
forms of relief sought in the Petition.
O
16. Defendant further pleads, if such be necessary, and pleading in the alternative, that
y
op
Plaintiff’s claims are barred or limited by the terms and effect of any applicable Consent Judgment,
C
including by operation of the doctrines of res judicata and collateral estoppel, failure to fulfil
ial
fic
conditions precedent, failure to provide requisite notice, payment, accord and satisfaction, and
of
compromise and settlement.
Un
17. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Plaintiff has failed to join all necessary parties, including without limitation health care providers,
4
prescribers, patients, and other third parties whom Plaintiff alleges engaged in the unauthorized or
illicit prescription, dispensing, diversion, or use of prescription opioid products.
18. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Plaintiff’s claims against Defendant do not arise out of the same transaction or occurrences as its
k
ler
claims against other defendants, as required for joinder of parties.
tC
19. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ric
to the extent that Plaintiff’s claims relate to Defendant’s alleged advertising, public statements,
ist
sD
lobbying, or other activities protected by the First Amendment to the Constitution of the United
es
State or by the Constitution of the State of Texas or that of any other state whose laws may apply,
rg
such claims are barred.
Bu
20. Defendant further pleads, if such be necessary, and pleading in the alternative, that
n
ily
Plaintiff’s claims are barred to the extent that they violate the Due Process or Ex Post Facto clauses
ar
M
of the United States and Texas Constitutions.
of
21. Defendant further pleads, if such be necessary, and pleading in the alternative, that
e
ffic
Defendant’s right under the Due Process Clause of the United States Constitution and applicable
O
state Constitution or statute are violated by any financial or other arrangement that might distort a
y
op
government attorney’s duty to pursue justice rather than his or her personal interests, financial or
C
otherwise, in the context of a civil enforcement proceeding, including by Plaintiff’s use of a
ial
fic
contingency fee contract with private counsel.
of
22. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Un
Plaintiff’s claims are barred, in whole or in part, to the extent that they violate the Dormant
Commerce Clause of the United States Constitution.
5
23. Defendant further pleads, if such be necessary, and pleading in the alternative, that
it denies all types of causation including without limitation cause in fact, proximate cause, and
producing cause, with respect to the claims asserted against Defendant.
24. Defendant further pleads, if such be necessary, and pleading in the alternative, that
k
ler
the Petition, and each alleged claim contained therein, is barred, in whole or in part, because
tC
Defendant did not proximately cause the damages complained of, and because the acts of other
ric
persons (including individuals engaged in the illegal distribution or use of opioids without a proper
ist
sD
prescription) intervened between Defendant’s acts and Plaintiff’s harms. Defendant had no legal
es
duty to protect Plaintiff from the intentional criminal acts of third persons, which are superseding
rg
causes that extinguish any liability.
Bu
25. Defendant further pleads, if such be necessary, and pleading in the alternative, that
n
ily
the injuries and damages claimed by Plaintiff resulted from an intervening or superseding cause
ar
M
and/or causes, and any act or omission on the part of Defendant was not the proximate and/or
of
competent producing cause of such alleged injuries and damages.
e
ffic
26. Defendant further pleads, if such be necessary, and pleading in the alternative, that
O
Plaintiff’s injuries and damages, if any, were due to illicit use or abuse of the medications at issue
y
op
on the part of the medication users, for which Defendant is not liable.
C
27. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ial
fic
any injuries and/or damages sustained by Plaintiff may have been caused or contributed to by the
of
negligence or actual conduct of Plaintiff and/or other persons, firms, corporation, or entities over
Un
whom Defendant had no control or right to control and for whom it is not responsible.
28. Defendant further pleads, if such be necessary, and pleading in the alternative, that
any injuries or damages alleged in the Petition may have been caused by unforeseeable and
6
uncontrollable circumstances and/or other forces over which Defendant had no control and for
which Defendant is not responsible, including pre-existing medical conditions.
29. Defendant further pleads, if such be necessary, and pleading in the alternative, that
any and all damages alleged by Plaintiff were caused by misuse of the products involved, failure
k
ler
to use the products properly, and/or alteration of, or criminal misuse or abuse of the product by
tC
third parties over whom Defendant had no control and for whom Defendant is not responsible.
ric
30. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ist
sD
Plaintiff’s claims are barred to the extent they are based on alleged criminal acts of third parties,
es
which Defendant has no duty to control or prevent and which operate as superseding causes which
rg
extinguish any liability.
Bu
31. Defendant further pleads, if such be necessary, and pleading in the alternative, that
n
ily
Plaintiff suffered no injuries or damage as a result of any action by Defendant.
ar
M
32. Defendant further pleads, if such be necessary, and pleading in the alternative, that
of
the derivative injury rule and the remoteness doctrine bar Plaintiff from recovering payments that
e
ffic
Plaintiff allegedly made on behalf of residents to reimburse any expenses for health care,
O
pharmaceutical care, and other public services.
y
op
33. Defendant further pleads, if such be necessary, and pleading in the alternative, that
C
Plaintiff’s claims are barred to the extent that Defendant has valid defenses that bar recovery by
ial
fic
those persons on whose behalf Plaintiff purportedly seeks recovery.
of
34. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Un
Plaintiff’s claims are subject to all defenses that could be asserted if Plaintiff’s claims were
properly made by individuals on whose behalf or for whose alleged damages Plaintiff seeks to
recover.
7
35. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Plaintiff has failed to comply with the requirement that it must identify each patient in whose
claim(s) it has a subrogation interest and on whose behalf it has incurred costs.
36. Defendant further pleads, if such be necessary, and pleading in the alternative, that
k
ler
Plaintiff has failed to plead that it reimbursed any prescriptions for any opioid distributed by
tC
Defendant that harmed patients and should not have been written, or that Defendant’s allegedly
ric
improper conduct caused any health care provider to write any ineffective or harmful opioid
ist
sD
prescriptions.
es
37. Defendant further pleads, if such be necessary, and pleading in the alternative, that
rg
Plaintiff’s alleged damages are speculative, uncertain, and hypothetical.
Bu
38. Defendant further pleads, if such be necessary, and pleading in the alternative, that
n
ily
any recovery by Plaintiff may be barred or reduced, in whole or in part, by the principles of
ar
M
comparative or contributory fault and proportionate responsibility, pursuant to Chapters 32 and 33
of
of the Texas Civil Practices & Remedies Code and at common law.
e
ffic
39. Defendant further pleads, if such be necessary, and pleading in the alternative, that
O
any recovery against Defendant is barred or limited under the principles of assumption of the risk
y
op
and informed consent.
C
40. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ial
fic
Plaintiff’s damages, if any, were caused by the active, direct, and proximate negligence or actual
of
conduct of entities or persons other than Defendant, and in the event that Defendant is found to be
Un
liable to Plaintiff, Defendant will be entitled to indemnification, contribution, and/or
apportionment.
8
41. Defendant further asserts, if such be necessary, and pleading in the alternative, their
right to a proportionate reduction of any damages found against them, based on the product,
negligence, or other conduct of any settling tortfeasor and/or responsible third party and/or
Plaintiff.
k
ler
42. Defendant further pleads, if such be necessary, and pleading in the alternative, that
tC
a specific percentage of the tortious conduct that proximately caused the injury or loss to person
ric
or property is attributable to (i) Plaintiff, (ii) other parties from whom Plaintiff seeks recovery, and
ist
sD
(iii) persons from whom Plaintiff does not seek recovery in this action, including, but not limited
es
to, prescribing practitioners, non-party pharmacies and pharmacists, individuals and entities
rg
involved in diversion and distribution of prescription opioids, individuals and entities involved in
Bu
distribution and sale of illegal opioids, individuals involved in procuring diverted prescription
n
ily
opioids and/or illegal drugs, delivery services, federal, state, and local government entities, and
ar
M
health insurers and pharmacy benefit managers.
of
43. Defendant further pleads, if such be necessary, and pleading in the alternative, that
e
ffic
any verdict or judgment that might be recovered by Plaintiff must be reduced by those amounts
O
that have already indemnified or with reasonable certainty will indemnify Plaintiff in whole or in
y
op
part for any past or future claimed economic loss from any collateral source or any other applicable
C
law.
ial
fic
44. Defendant further pleads, if such be necessary, and pleading in the alternative, that
of
if Defendant is found liable for Plaintiff’s alleged injuries and losses (which liability is specifically
Un
denied) and the percentage of responsibility attributed to Defendant with respect to a cause of
action is not greater than 50 percent, Defendant would be liable to Plaintiff only for the percentage
9
of the damages found by the trier of fact equal to Defendant’s percentage of responsibility with
respect to the economic loss or other harm for which damages are allowed.
45. Defendant further pleads, if such be necessary, and pleading in the alternative, that
any and all damages claimed by Plaintiff, whether actual, compensatory, punitive, attorneys’ fees,
k
ler
or otherwise are subject to all applicable statutory exclusions, caps, and limitations.
tC
46. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ric
any damages that Plaintiff may recover against Defendant must be reduced to the extent that
ist
sD
Plaintiff is seeking to recover damages for alleged injuries or expenses related to the same user(s)
es
of the subject prescription medications, or damages recovered or recoverable by other actual or
rg
potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be reduced
Bu
to the extent they unjustly enrich Plaintiff.
n
ily
47. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ar
M
Plaintiff’s claims fail to the extent they are based on a theory of market share liability, which is
of
not a recognized means for recovering damages under Texas law.
e
ffic
48. Defendant further pleads, if such be necessary, and pleading in the alternative, that
O
Plaintiff’s claims are barred or limited by the economic loss rule.
y
op
49. Defendant further pleads, if such be necessary, and pleading in the alternative, that
C
Plaintiff is barred, in whole or in part, from recovering costs incurred in providing public services
ial
fic
by the free public services and/or municipal cost recovery doctrine.
of
50. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Un
Plaintiff may have failed or refused to exercise reasonable care and diligence to avoid loss and
minimize damages and, therefore, may not recover for losses that could have been prevented by
10
reasonable efforts on its part, or by expenditures which might reasonably have been made.
Recovery, if any, should therefore be reduced by Plaintiff’s failure to mitigate damages, if any.
51. Defendant further pleads, if such be necessary, and pleading in the alternative, that
to the extent Plaintiff attempts to seek equitable relief, Plaintiff is not entitled to such relief because
k
ler
Plaintiff has an adequate remedy at law.
tC
52. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ric
the claims asserted in the Petition are barred, in whole or in part, because federal agencies have
ist
sD
exclusive or primary jurisdiction over the matters asserted in the Petition.
es
53. Defendant further pleads, if such be necessary, and pleading in the alternative, that
rg
Plaintiff’s claims are preempted by federal law, including (without limitation) the federal
Bu
Controlled Substances Act and the Food, Drug, and Cosmetic Act (“FDCA”).
n
ily
54. Defendant further pleads, if such be necessary, and pleading in the alternative, that
ar
M
the conduct of Defendant conformed with the FDCA and the requirements of the FDA, and the
of
activities of Defendant alleged in the Petition conformed with all state and federal statutes,
e
ffic
regulations, and industry standards based on the state of knowledge at the relevant time(s) alleged
O
in the Petition.
y
op
55. Defendant further pleads, if such be necessary, and pleading in the alternative, that
C
Plaintiff’s claims are barred, in whole or in part, by conflict preemption as set forth in the United
ial
fic
States Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual
of
Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).
Un
56. Defendant further pleads, if such be necessary, and pleading in the alternative, that
Plaintiff’s claims are preempted insofar as they conflict with Congress’s purposes and objectives
in enacting relevant federal legislation and authorizing regulations, including the Hatch-Waxman
11
Amendments to the FDCA and implementing regulations. See Geier v. Am. Honda Co., 529 U.S.
861 (2000).
57. Defendant further pleads, if such be necessary, and pleading in the alternative, that
to the extent Plaintiff claims that Defendant misled or defrauded FDA or any other federal agency
k
ler
with respect to the Manufacturer Defendants’ disclosure of information related to the safety of
tC
their medications at issue, such claims are preempted by federal law. See Buckman v. Plaintiffs’
ric
Legal Comm., 531 U.S. 341 (2001).
Preview
2/18/2019 2:13 PM Marilyn Burgess - District Clerk Harris County Envelope No. 31271543 By: KATINA WILLIAMS Filed: 2/18/2019 2:13 PM MDL PRETRIAL CAUSE NO. 2018-76970-7 COUNTY OF EL PASO, § IN THE DISTRICT COURT § Plaintiff, § § VS. § 346TH JUDICIAL DISTRICT § k ler PURDUE PHARMA L.P., ET AL., § § tC Defendants. § EL PASO COUNTY, TEXAS ric *************************************************************************** ist sD ****** es MASTER FILE NO. 2018-63587 rg § IN THE DISTRICT COURT § Bu IN RE: TEXAS OPIOID § 152ND JUDICIAL DISTRICT n LITIGATION § ily § HARRIS COUNTY, TEXAS ar M DEFENDANT CARDINAL HEALTH, INC.’S of ORIGINAL ANSWER AND AFFIRMATIVE DEFENSES TO e PLAINTIFF’S ORIGINAL PETITION ffic O TO THE HONORABLE JUDGE OF SAID COURT: y COMES NOW, Defendant Cardinal Health, Inc. (“Defendant”) and files its Original op C Answer and Affirmative Defenses to Plaintiff’s Original Petition1 and in support shows the ial following: fic of Un 1 As of this filing, the proceedings in this litigation have been stayed with limited exceptions that include the filing of answers by defendants that have been served with process. On January 28, 2019, this Court entered an Order lifting the stay as to Rule 91a motions and responses only in five Selected Cases. Proceedings and deadlines related to Rule 91a motions to dismiss in non-Selected Cases, and related to special exceptions in all cases, remain stayed pending further order by this Court.In light of the stay, Defendant has not filed a Rule 91a motion to dismiss in this case. I. GENERAL DENIAL Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendant asserts a general denial, denies each and every allegation made by Plaintiff County of El Paso (“Plaintiff” or “the County”), and demands strict proof thereof. k ler II. tC SPECIAL DENIAL ric Pursuant to Rule 54 of the Texas Rules of Civil Procedure, Defendant specifically denies ist sD that Plaintiff properly pled that all conditions precedent to Plaintiff’s claims have been performed es or have occurred, and denies that such conditions precedent have been met in their entirety. rg III. AFFIRMATIVE DEFENSES Bu n Defendant asserts the following defenses to Plaintiff’s Original Petition (the “Petition”). ily ar Defendant does not admit or acknowledge that it bears the burden of proof and/or burden of M persuasion with respect to any such defense. All of the following defenses are pled in the of e alternative and none constitutes an admission that Defendant is liable to Plaintiff, that Plaintiff has ffic or will be injured or damaged in any way, or that Plaintiff is entitled to any relief whatsoever. O Defendant reserves the right to (i) rely upon any other applicable defenses set forth in any Answer y op of any other defendant in this Action, (ii) rely upon any other defenses that may become apparent C ial during fact or expert discovery in this matter, and (iii) to amend this Answer to assert any such fic defenses. of Un 1. Defendant further pleads, if such be necessary, and pleading in the alternative, that the Petition fails to state facts sufficient to constitute a claim upon which an award of actual damages, compensatory damages, restitutionary damages, punitive damages, or other relief may be granted. 2 2. Defendant further pleads, if such be necessary, and pleading in the alternative, that the Petition, and each alleged claim therein, is barred, in whole or in part, by the applicable statute of limitations. 3. Defendant further pleads, if such be necessary, and pleading in the alternative, that k ler the Petition, and each alleged claim therein, is barred, in whole or in part, by the applicable statute tC of repose. ric 4. Defendant further pleads, if such be necessary, and pleading in the alternative, that ist sD Plaintiff’s claims for relief are barred by the doctrines of laches. es 5. Defendant further pleads, if such be necessary, and pleading in the alternative, that rg venue may be improper and/or inconvenient in this Court. Bu 6. Defendant further pleads, if such be necessary, and pleading in the alternative, that n ily Plaintiff’s claims are barred or limited for lack of standing. ar M 7. Defendant further pleads, if such be necessary, and pleading in the alternative, that of Plaintiff lacks capacity to bring its claims, including claims indirectly maintained on behalf of its e ffic citizens and claims brought as parens patriae. O 8. Defendant further pleads, if such be necessary, and pleading in the alternative, that y op Plaintiff’s claims are barred because Plaintiff is not the real party in interest. C 9. Defendant further pleads, if such be necessary, and pleading in the alternative, that ial fic Plaintiff’s claims are not ripe and/or have been mooted. of 10. Defendant further pleads, if such be necessary, and pleading in the alternative, that Un Plaintiff’s claims and damages are barred or limited, in whole or in part, by common law, statutory, and state constitutional constraints on the exercise of police powers by a local government. 3 11. Defendant further pleads, if such be necessary, and pleading in the alternative, that Plaintiff’s claims are barred, in whole or in part, by the political question and separation of powers doctrine and because its claims implicate issues of statewide importance that are reserved for state regulation. k ler 12. Defendant further pleads, if such be necessary, and pleading in the alternative, that tC Plaintiff may be barred by the doctrine of unclean hands from all forms of relief sought in the ric Petition. ist sD 13. Defendant further pleads, if such be necessary, and pleading in the alternative, that es Plaintiff failed to exhaust administrative remedies. rg 14. Defendant further pleads, if such be necessary, and pleading in the alternative, that Bu Plaintiff may be barred by the doctrines of estoppel, quasi-estoppel, equitable estoppel, and/or n ily waiver from all forms of relief sought in the Petition. ar M 15. Defendant further pleads, if such be necessary, and pleading in the alternative, that of Plaintiff’s claim may be barred by the doctrines of res judicata and collateral estoppel from all e ffic forms of relief sought in the Petition. O 16. Defendant further pleads, if such be necessary, and pleading in the alternative, that y op Plaintiff’s claims are barred or limited by the terms and effect of any applicable Consent Judgment, C including by operation of the doctrines of res judicata and collateral estoppel, failure to fulfil ial fic conditions precedent, failure to provide requisite notice, payment, accord and satisfaction, and of compromise and settlement. Un 17. Defendant further pleads, if such be necessary, and pleading in the alternative, that Plaintiff has failed to join all necessary parties, including without limitation health care providers, 4 prescribers, patients, and other third parties whom Plaintiff alleges engaged in the unauthorized or illicit prescription, dispensing, diversion, or use of prescription opioid products. 18. Defendant further pleads, if such be necessary, and pleading in the alternative, that Plaintiff’s claims against Defendant do not arise out of the same transaction or occurrences as its k ler claims against other defendants, as required for joinder of parties. tC 19. Defendant further pleads, if such be necessary, and pleading in the alternative, that ric to the extent that Plaintiff’s claims relate to Defendant’s alleged advertising, public statements, ist sD lobbying, or other activities protected by the First Amendment to the Constitution of the United es State or by the Constitution of the State of Texas or that of any other state whose laws may apply, rg such claims are barred. Bu 20. Defendant further pleads, if such be necessary, and pleading in the alternative, that n ily Plaintiff’s claims are barred to the extent that they violate the Due Process or Ex Post Facto clauses ar M of the United States and Texas Constitutions. of 21. Defendant further pleads, if such be necessary, and pleading in the alternative, that e ffic Defendant’s right under the Due Process Clause of the United States Constitution and applicable O state Constitution or statute are violated by any financial or other arrangement that might distort a y op government attorney’s duty to pursue justice rather than his or her personal interests, financial or C otherwise, in the context of a civil enforcement proceeding, including by Plaintiff’s use of a ial fic contingency fee contract with private counsel. of 22. Defendant further pleads, if such be necessary, and pleading in the alternative, that Un Plaintiff’s claims are barred, in whole or in part, to the extent that they violate the Dormant Commerce Clause of the United States Constitution. 5 23. Defendant further pleads, if such be necessary, and pleading in the alternative, that it denies all types of causation including without limitation cause in fact, proximate cause, and producing cause, with respect to the claims asserted against Defendant. 24. Defendant further pleads, if such be necessary, and pleading in the alternative, that k ler the Petition, and each alleged claim contained therein, is barred, in whole or in part, because tC Defendant did not proximately cause the damages complained of, and because the acts of other ric persons (including individuals engaged in the illegal distribution or use of opioids without a proper ist sD prescription) intervened between Defendant’s acts and Plaintiff’s harms. Defendant had no legal es duty to protect Plaintiff from the intentional criminal acts of third persons, which are superseding rg causes that extinguish any liability. Bu 25. Defendant further pleads, if such be necessary, and pleading in the alternative, that n ily the injuries and damages claimed by Plaintiff resulted from an intervening or superseding cause ar M and/or causes, and any act or omission on the part of Defendant was not the proximate and/or of competent producing cause of such alleged injuries and damages. e ffic 26. Defendant further pleads, if such be necessary, and pleading in the alternative, that O Plaintiff’s injuries and damages, if any, were due to illicit use or abuse of the medications at issue y op on the part of the medication users, for which Defendant is not liable. C 27. Defendant further pleads, if such be necessary, and pleading in the alternative, that ial fic any injuries and/or damages sustained by Plaintiff may have been caused or contributed to by the of negligence or actual conduct of Plaintiff and/or other persons, firms, corporation, or entities over Un whom Defendant had no control or right to control and for whom it is not responsible. 28. Defendant further pleads, if such be necessary, and pleading in the alternative, that any injuries or damages alleged in the Petition may have been caused by unforeseeable and 6 uncontrollable circumstances and/or other forces over which Defendant had no control and for which Defendant is not responsible, including pre-existing medical conditions. 29. Defendant further pleads, if such be necessary, and pleading in the alternative, that any and all damages alleged by Plaintiff were caused by misuse of the products involved, failure k ler to use the products properly, and/or alteration of, or criminal misuse or abuse of the product by tC third parties over whom Defendant had no control and for whom Defendant is not responsible. ric 30. Defendant further pleads, if such be necessary, and pleading in the alternative, that ist sD Plaintiff’s claims are barred to the extent they are based on alleged criminal acts of third parties, es which Defendant has no duty to control or prevent and which operate as superseding causes which rg extinguish any liability. Bu 31. Defendant further pleads, if such be necessary, and pleading in the alternative, that n ily Plaintiff suffered no injuries or damage as a result of any action by Defendant. ar M 32. Defendant further pleads, if such be necessary, and pleading in the alternative, that of the derivative injury rule and the remoteness doctrine bar Plaintiff from recovering payments that e ffic Plaintiff allegedly made on behalf of residents to reimburse any expenses for health care, O pharmaceutical care, and other public services. y op 33. Defendant further pleads, if such be necessary, and pleading in the alternative, that C Plaintiff’s claims are barred to the extent that Defendant has valid defenses that bar recovery by ial fic those persons on whose behalf Plaintiff purportedly seeks recovery. of 34. Defendant further pleads, if such be necessary, and pleading in the alternative, that Un Plaintiff’s claims are subject to all defenses that could be asserted if Plaintiff’s claims were properly made by individuals on whose behalf or for whose alleged damages Plaintiff seeks to recover. 7 35. Defendant further pleads, if such be necessary, and pleading in the alternative, that Plaintiff has failed to comply with the requirement that it must identify each patient in whose claim(s) it has a subrogation interest and on whose behalf it has incurred costs. 36. Defendant further pleads, if such be necessary, and pleading in the alternative, that k ler Plaintiff has failed to plead that it reimbursed any prescriptions for any opioid distributed by tC Defendant that harmed patients and should not have been written, or that Defendant’s allegedly ric improper conduct caused any health care provider to write any ineffective or harmful opioid ist sD prescriptions. es 37. Defendant further pleads, if such be necessary, and pleading in the alternative, that rg Plaintiff’s alleged damages are speculative, uncertain, and hypothetical. Bu 38. Defendant further pleads, if such be necessary, and pleading in the alternative, that n ily any recovery by Plaintiff may be barred or reduced, in whole or in part, by the principles of ar M comparative or contributory fault and proportionate responsibility, pursuant to Chapters 32 and 33 of of the Texas Civil Practices & Remedies Code and at common law. e ffic 39. Defendant further pleads, if such be necessary, and pleading in the alternative, that O any recovery against Defendant is barred or limited under the principles of assumption of the risk y op and informed consent. C 40. Defendant further pleads, if such be necessary, and pleading in the alternative, that ial fic Plaintiff’s damages, if any, were caused by the active, direct, and proximate negligence or actual of conduct of entities or persons other than Defendant, and in the event that Defendant is found to be Un liable to Plaintiff, Defendant will be entitled to indemnification, contribution, and/or apportionment. 8 41. Defendant further asserts, if such be necessary, and pleading in the alternative, their right to a proportionate reduction of any damages found against them, based on the product, negligence, or other conduct of any settling tortfeasor and/or responsible third party and/or Plaintiff. k ler 42. Defendant further pleads, if such be necessary, and pleading in the alternative, that tC a specific percentage of the tortious conduct that proximately caused the injury or loss to person ric or property is attributable to (i) Plaintiff, (ii) other parties from whom Plaintiff seeks recovery, and ist sD (iii) persons from whom Plaintiff does not seek recovery in this action, including, but not limited es to, prescribing practitioners, non-party pharmacies and pharmacists, individuals and entities rg involved in diversion and distribution of prescription opioids, individuals and entities involved in Bu distribution and sale of illegal opioids, individuals involved in procuring diverted prescription n ily opioids and/or illegal drugs, delivery services, federal, state, and local government entities, and ar M health insurers and pharmacy benefit managers. of 43. Defendant further pleads, if such be necessary, and pleading in the alternative, that e ffic any verdict or judgment that might be recovered by Plaintiff must be reduced by those amounts O that have already indemnified or with reasonable certainty will indemnify Plaintiff in whole or in y op part for any past or future claimed economic loss from any collateral source or any other applicable C law. ial fic 44. Defendant further pleads, if such be necessary, and pleading in the alternative, that of if Defendant is found liable for Plaintiff’s alleged injuries and losses (which liability is specifically Un denied) and the percentage of responsibility attributed to Defendant with respect to a cause of action is not greater than 50 percent, Defendant would be liable to Plaintiff only for the percentage 9 of the damages found by the trier of fact equal to Defendant’s percentage of responsibility with respect to the economic loss or other harm for which damages are allowed. 45. Defendant further pleads, if such be necessary, and pleading in the alternative, that any and all damages claimed by Plaintiff, whether actual, compensatory, punitive, attorneys’ fees, k ler or otherwise are subject to all applicable statutory exclusions, caps, and limitations. tC 46. Defendant further pleads, if such be necessary, and pleading in the alternative, that ric any damages that Plaintiff may recover against Defendant must be reduced to the extent that ist sD Plaintiff is seeking to recover damages for alleged injuries or expenses related to the same user(s) es of the subject prescription medications, or damages recovered or recoverable by other actual or rg potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be reduced Bu to the extent they unjustly enrich Plaintiff. n ily 47. Defendant further pleads, if such be necessary, and pleading in the alternative, that ar M Plaintiff’s claims fail to the extent they are based on a theory of market share liability, which is of not a recognized means for recovering damages under Texas law. e ffic 48. Defendant further pleads, if such be necessary, and pleading in the alternative, that O Plaintiff’s claims are barred or limited by the economic loss rule. y op 49. Defendant further pleads, if such be necessary, and pleading in the alternative, that C Plaintiff is barred, in whole or in part, from recovering costs incurred in providing public services ial fic by the free public services and/or municipal cost recovery doctrine. of 50. Defendant further pleads, if such be necessary, and pleading in the alternative, that Un Plaintiff may have failed or refused to exercise reasonable care and diligence to avoid loss and minimize damages and, therefore, may not recover for losses that could have been prevented by 10 reasonable efforts on its part, or by expenditures which might reasonably have been made. Recovery, if any, should therefore be reduced by Plaintiff’s failure to mitigate damages, if any. 51. Defendant further pleads, if such be necessary, and pleading in the alternative, that to the extent Plaintiff attempts to seek equitable relief, Plaintiff is not entitled to such relief because k ler Plaintiff has an adequate remedy at law. tC 52. Defendant further pleads, if such be necessary, and pleading in the alternative, that ric the claims asserted in the Petition are barred, in whole or in part, because federal agencies have ist sD exclusive or primary jurisdiction over the matters asserted in the Petition. es 53. Defendant further pleads, if such be necessary, and pleading in the alternative, that rg Plaintiff’s claims are preempted by federal law, including (without limitation) the federal Bu Controlled Substances Act and the Food, Drug, and Cosmetic Act (“FDCA”). n ily 54. Defendant further pleads, if such be necessary, and pleading in the alternative, that ar M the conduct of Defendant conformed with the FDCA and the requirements of the FDA, and the of activities of Defendant alleged in the Petition conformed with all state and federal statutes, e ffic regulations, and industry standards based on the state of knowledge at the relevant time(s) alleged O in the Petition. y op 55. Defendant further pleads, if such be necessary, and pleading in the alternative, that C Plaintiff’s claims are barred, in whole or in part, by conflict preemption as set forth in the United ial fic States Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual of Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013). Un 56. Defendant further pleads, if such be necessary, and pleading in the alternative, that Plaintiff’s claims are preempted insofar as they conflict with Congress’s purposes and objectives in enacting relevant federal legislation and authorizing regulations, including the Hatch-Waxman 11 Amendments to the FDCA and implementing regulations. See Geier v. Am. Honda Co., 529 U.S. 861 (2000). 57. Defendant further pleads, if such be necessary, and pleading in the alternative, that to the extent Plaintiff claims that Defendant misled or defrauded FDA or any other federal agency k ler with respect to the Manufacturer Defendants’ disclosure of information related to the safety of tC their medications at issue, such claims are preempted by federal law. See Buckman v. Plaintiffs’ ric Legal Comm., 531 U.S. 341 (2001).