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MDL PRETRIAL CAUSE NO. 2018-77106
THE DISTRICT COURT
COUNTY OF FALLS
Plaintiff,
ND JUDICIAL DISTRICT
PURDUE PHARMA LP, etal.
Defendants. HARRIS COUNTY, TEXAS
MASTER FILE NO. 2018-63587
IN RE: TEXAS OPIOID LITIGATION THE DISTRICT COURT
MDL NO. 18-0358 ND JUDICIAL DISTRICT
HARRIS COUNTY, TEXAS
MCKESSON CORPORATION’S ORIGINAL ANSWER TO PLAINTIFF'S FIRST
AMENDED PETITION
Defend nt McKesson Corporation (“Defendant” or “McKesson”) files its Original
Answer and Defenses to Plaintiff’ s First Amended Petition and in support shows the following:
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 alls, and demands strict
proof thereof.
Affirmative & Other Defenses
Without accepting the burden of proof on any issue on which McKesson does not have
the burden as a matter of law, McKesson sets forth the following affirmative and other defenses.
Plaintiff lacks standing to assert some or all of its claims.
Plaintiff has no authority or right to bring such claims on behalf of itself or the
citizens of FallsCounty.
Plaintiff has no capacity, authority, or right to assert some or all of claims,
including claims brought indirectly on behalf of itscitizens or claims brought as parens patriae
McKesson asserts that it is not liable in the capacity in which it has been sued.
Plaintiff’
s claims are barred because Plaintiff is not the real party
in interest.
Defendant further pleads, if such be necessary, and pleading in the altemative,
that Plaintiff’ s claims are barred by the doctrine of in pari delicto
Plaintiff’s claims
are subject to all the 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.
The derivative injury nile and the remoteness doctrines bar Plaintiff from
recovering payments that Plaintiff allegedly made on behalf of residents to reimburse any
expenses for health care, pharmaceutical care, and other public services.
The alleged injuries asserted by Plaintiff are too remote from the alleged conduct
of Defendant
to provide a basis for liability as a matter of law and due process.
Plaintiff's damages and claims against Defendant are barred or limited, in whole
orin part, by common law, statutory, and state constitutional constraints on the exercise of police
powers
by a state county.
Plaintiff’s etition fails in whole or in part to state a claim upon which relief can
be granted, fails to state sufficient facts sufficient to constitute a cause of action, and fails
to
plead cognizable injury.
829072.1
Plaintiff's claims
are preempted, in whole
or in part, by federal law, including
without limitation the federal Controlled Substances Act and the Food, Drug, and Cosmetic Act.
Plaintiff's claims
are barred, in whole
or in part, by conflict preemption, as set
forth
in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharm Co. v. Bartlett 133
S. Ct. 2466 (2013).
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 amendments to the FDCA and implementing regulations. See Geier v. Am
Honda Co, 529 U.S. 861 (2000).
Plaintiff’ s claims are barred in whole or in part by the Donmant Commerce Clause
of the United States Constitution.
Plaintiffs
claims are barred, in whole
or in part, by the deference
that common
law accords discretionary actions by the FDA under the FDCA and discretionary actions by the
DEA under the Controlled Substances Act.
Plaintiff's claims are bared, in whole or in part, for failure to exhaust
administrative remedies.
Plaintiff’ s claims are barred in whole or in part to the extent that they violate the
Due Process Clause of the United States and Texas Constitutions.
Plaintiff’s claims
are barred, in whole
or in part, to the extent that they violate the
Ex Post Facto clauses of the United States and Texas Constitutions.
Plaintiff cannot obtain relief on their claims based on actions undertaken by
Defendant of which Defendant provided notice of all reasonable facts.
Defendant did not owe or breach any duty to Plaintiff.
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Defendant appropriately, completely, and fully discharged any and all obligations
and legal duties arising out of the matters alleged in the Petition.
Plaintiff’s claims are not ripe, and/or have been mooted.
Defendant
has no legal duty to protect Plaintiff
from the intentional criminal acts
of third persons.
The criminal conduct of a third party is a superseding cause that extinguishes
liability. Plaintiff's alleged damages were caused by the intentional and criminal activities of
unidentified persons over which Defendant had no right of control.
Plaintiff is barred by the free public services/municipal cost recovery doctrine
from recovering costs incurred in providing public services.
Plaintiff’s claims are barred, in whole or in part, by the economic loss rule.
Plaintiff’s claims are barred by all applicable statutes of limitation and repose.
Plaintiff's claims are barred in whole or in part by Plaintiff s knowledge of
alleged falsity and/or acquiescence.
Plaintiff's claims are barred
in whole or in part by the doctrine of avoidable
consequences.
Plaintiff’
s claims are barred
by consent.
Plaintiff s claims are barred by ratification and/or condonation.
The alleged injuries were not legally foreseeable.
The claims raised by Plaintiff are barred by the doctrines of laches, waiver,
ratification, estoppel, unclean hands, quasi estoppel, and/or equitable estoppel.
Plaintiff’ s claims are barred in whole or in part by the doctrines of acquiescence
settlement
and or release.
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If Defendant is found liable to Plaintiff in any amount, Defendant is entitled to a
credit or set off for any and all sums Plaintiff has received in the way of any and all settlements
and for all sums of money received or available from or on behalf of any tortfeasor(s) for the
same injuries alleged in the Petition. Defendant
has a right under Chapters 32 and
33 of the
Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found
against it, based
on the product, negligence, or other conduct of any settling tortfeasor and/or
responsible third party. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff is
proportionately responsible for any damage it alleges to have suffered with respect to the claims
asserted against McKesson. Therefore, Plaintiff’s claims are barred in whole or in part by their
contributory fault.
McKesson pleads for, and is entitled to, a comparative fault submission under
Chapter
33 of the Texas Civil Practice and Remedies Code which will compare
the fault of all
Parties and responsible third parties.
Any damages that Plaintiff may recover against Defendant must be reduced to the
extent that Plaintiff is seeking damages for alleged injuries or expenses related to the same
user(s) of the subject prescription medications, or damages recovered or recoverable by other
actual or potential plaintiffs. Any damages that Plaintiff may recover against Defendant
must be
reduced to the extent they unjustly enrich Plaintiff.
Plaintiff's claims
are barred, in whole or in part, by res judicata
and collateral
estoppel
Plaintiffs claims are barred or limited by the terms and effect of any applicable
Consent Judgment, including
by operation of the doctrines of res judicata and collateral estoppel,
829072.1
failure to fulfill conditions precedent, failure to provide requisite notice, payment, accord and
satisfaction, and compromise and settlement.
Any verdict or judgment that might be recovered by Plaintiff must be reduced by
those amounts that have already indenmified or with reasonable certainty will indemnify Plaintiff
in whole or in part for any past or future claimed economic loss from any collateral source or any
other applicable law.
Plaintiff's damages, if any, were proximately caused, in whole or in part, by
independent, intervening, or superseding causes, events, factors, occurrences, or conditions,
which were not reasonably foreseeable and not caused by Defendant and for which Defendant is
not liable.
Any and all damages alleged by Plaintiff were caused by misuse of the products
involved, failure to use the products properly, and/or alteration of, or criminal misuse or abuse of
the product
by third parties over whom Defendant
had no control and for whom Defendant
is not
responsible.
Plaintiff suffered
no injuries or damages as a result of any action
by Defendant.
No conduct of Defendant was misleading, unfair, or deceptive.
Plaintiff's claims are barred, in whole
or in part, by its failures to mitigate its
alleged damages.
Any and all damages claimed by Plaintiff, whether actual, compensatory,
punitive, attomeys’ fees, or otherwise are subject to all applicable statutory and common law
exclusions, caps, and limitations.
Plaintiff’ s claims for punitive or exemplary damages are barred because Plaintiff
camnot prove by clear and convincing evidence that McKesson was grossly negligent and
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McKesson has neither acted nor failed to act in a manner that entitled Plaintiff to recover
punitive or exemplary damages.
Plaintiff’ s alleged damages are speculative, uncertain, and hypothetical.
Plaintiffs claims are barred and/or reduced by the assumption of risk, informed
consent, contributory or comparative negligence, contributory or comparative fault, and
proportionate responsibility. McKesson asserts its right of contribution under Texas law with
respect to any settling person, responsible party or tortfeasor, and McKesson invokes all
protections contained within Chapter 41 of the Texas Civil Practice and Remedies Code.
Plaintiff’ s claims or damages are barred because users of the medications at issue
used them after they knew, orshould have known, of their alleged risks.
Defendant denies all types of causation including without limitation cause in fact,
proximate
cause and producing cause, with respect to the claims asserted against Defendant.
Plaintiff's claims and alleged damages are barred under the leamed intermediary
doctrine because adequate wamings were given to leamed intermediaries.
Plaintiff s damages, if any, were the direct result of circumstances over which
Defendant
had and continues to have no control.
All of the limitations and requirements contained
in Chapter
41 of the Texas Civil
Practice and Remedies Code, and all federal and Texas constitutional limitations upon the
assessment of punitive or exemplary damages, including those stated in the decisions of BMW of
North America v. Gore, 116 S. Ct. 1589 (1996) and State Farm Mutual Insurance Co. v.
Campbell, 538 U.S. 408 (2003), preclude an award of punitive or exemplary damages.
Plaintiffs claims fail to the extent they are based on a theory of market share
bility, which is not a recognized means for recovering damages under Texas law.
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Plaintiff's claims based on alleged violations of industry customs fail because
purported industry customs
do not create legal duties
on Defendant.
Defendant is not liable to Plaintiff because Defendant is a non manufacturing
seller under Texas Civil Practice & Remedies Code § 82.003.
Pursuant to Texas Civil Practice & Remedies Code § 82.007, Defendant is not
liable with respect to any allegations involving failure to provide adequate waming or
information because all of the waming or information that accompanied the allegedly distributed
products were approved by the United States Food & Drug Administration for a product
approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as
amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended, or the
wamings and information provided were those stated in monographs developed by the United
States Food & Drug Administration for pharmaceutical products that may be distributed without
an approved new drug application.
Plaintiff s claims are barred or limited to the extent they have been abrogated by
the Texas Products Liability Act, Texas Civil Practice & Remedies Code Chapter
The conduct
of Defendant conformed with the FDCA and the requirements
of the
FDA, the Controlled Substances Act, and DEA regulations, and the activities of Defendant
alleged in the Petition conformed with all state and federal statutes, regulations, and industry
standards based on the state of knowledge at the relevant time(s) alleged
in the Petition.
Defendant is not liable for any injury allegedly caused to Plaintiff
by the products
in question because all formulations, labeling, and design of the products complied with
mandatory safety standards or regulations adopted and promulgated by the federal govemment,
829072.1
or an agency
of the federal govemment, applicable to the products at the time of manufacture
and that govemed the product risk that allegedly caused the purported harm.
Plaintiff may not recover against Defendant because the methods, standards, or
techniques of designing, manufacturing, labeling and distributing of the prescription medications
at issue complied with and were in conformity with the generally recognized state of the art at
the time the product
was designed, manufactured, labeled, and distributed.
Plaintiff would be unjustly enriched if allowed to recover
on any of their claims.
Plaintiff’
s claims are barred, in whole
or in part, by application
of the doctrine of
Telease.
Plaintiff's claims
are barred, in whole
or in part, because
the First Amendment
and/or Article I, Section 8 of the Texas Constitution protect Defendant’s commercial and
political speech.
To the extent Plaintiffs claims are based on alleged misrepresentations made to
the FDA, such claims are barred pursuant to Buckman Co. v. Plaintiffs
Legal Committee, 531
US. 341 (2001).
To the extent Plaintiffs claims depend solely on violations of federal law,
including any claims of “fraud on the DEA” with respect to Defendant's compliance with
statutes or regulations administered and/or enforced by the DEA, such claims are barred and
should be dismissed. See Buckman Co. v. PlaintifP s Legal Committee, 531 U.S. 341 (2001).
To the extent that Plaintiff relies on letters or other informal guidance from the
DEA to establish Defendant's regulatory duties, such informal guidance camnot enlarge
Defendant’
s regulatory duties in the absence of compliance
by DEA with the requirements of the
Administrative Procedure Act, 5 U.S.C. §§ 551 et seg.
829072.1
Plaintiff cannot state a claim against Defendant with regard to wamings and
labeling for products because the remedy sought by the County is subject to the exclusive
regulation of the FDA.
the extent Plaintiff seeks punitive, exemplary, or aggravated damages, any
such damages are barred because the product at issue, and its labeling were subject to and
received pre market approval by the FDA under 52 Stat. 1040, 21 U.S.C. § 301.
Plaintiff's
claims are barred, in whole
or in part, because federal agencies have
exclusive or primary jurisdiction over the matters asserted in Plaintiff’s etition.
Plaintiff has failed to join one or more necessary and indispensable parties,
including without limitation healthcare providers, prescribers, patients, and other third parties
whom the County alleges engaged in the unauthorized or illicit prescription, dispensing,
diversion, or use of prescription opioid products in FallsCounty.
Plaintiff's damages, if any, were the direct result of pre existing medical
conditions, and/or occurred by operation of nature or as a result of circumstances over which
Defendant
had and continue to have no control.
Plaintiff's injuries and damages, if any, were due to pre xisting conditions or
idiosyncratic reaction to the medications on the part of the medication users, for which
Defendant cannot be held responsible.
Plaintiffs claims
are barred, in whole
or in part, because neither
users nor their
prescribers relied to their detriment upon any statement by Defendant in determining to use
medications at issue.
Plaintiff’s fraud based claims are barred, in whole or in part, because Plaintiff did
not rely to its detriment upon any statement or omission by McKesson.
829072.1
Plaintiff's
claims are barred, in whole
or in part, by the Restatement (Second) of
Torts § 402A, Comments j andk, and Restatement (Third) of Torts: Products Liability § 6.
Defendant is not liable for statements or omissions in the Manufacturer
Defendants’ branded or unbranded materials.
Plaintiff has failed to plead any actionable misrepresentation or omission made by
or attributable to Defendant.
Plaintiffs claims are barred in whole or in part because no statement or conduct
of McKesson was misleading, unfair, or deceptive.
Plaintiff’ s claims are barred to the extent that they are based on alleged violations
of industry customs because industry customs do not create legal duties
on Defendant.
Plaintiff’s claim for unjust enrichment is barred or limited because Defendant did
not receive and retain any alleged benefit from Plaintiff
To the extent Plaintiff seeks relief for Defendant's conduct occurring before
enactment of applicable statutes or regulations, the claims fail because the statutes and
regulations do not apply retroactively.
McKesson’s rights under the Due Process Clause of the U.S. Constitution and
applicable state Constitution or statute are violated by any financial or other arrangement that
might distort a govemment attomey’s duty to pursue justice rather than his or her personal
interests, financial or otherwise, in the context of a civil enforcement proceeding, including by
Plaintiff s use of a contingency fee contract with private counsel.
Plaintiff’ s claims are barred or limited by the political question and separation of
powers doctrines and because this case implicates issues of statewide importance that are
reserved for state regulation.
829072.1
Plaintiff's claims or damages are barred because users of medications at issue
used them illegally and not after properly being prescribed the medication by a licensed health
care provider.
The claims asserted against McKesson and other Defendants do not arise out of
the same transactions or occurrences as required
for joinder of parties.
Defendant's liability, if any, will not result from its conduct, but is solely the
result of an obligation imposed by law, and thus McKesson is entitled to indemnity, express or
implied, by other parties.
Plaintiff failed to plead that they reimbursed any prescriptions for any opioid
distributed by Defendant that harmed patients and should not have been written or that
Defendant's allegedly improper conduct caused a health care provider to write an ineffective or
hannful opioid prescription.
To the extent Plaintiff attemp to seek equitable relief, Plaintiff not entitled t
such relief because Plaintiff an adequate remedy at law.
Plaintiff ha failed to comply with the requirement
that they identify each patient
in whose claim(s) they have a subrogation interest.
laintiff
s public nuisance claim is barred or limited to the extent that they lack
the statutory authority to bring a nuisance claim under Texas law or their own applicable county
or municipal codes or regulations.
Plaintiff s claim of public nuisance is barred or limited because (i) no action of
McKesson involved interference with real property, (ii) illegal conduct perpetrated by third
parties involving use of an otherwise legal product does not involve a public right against the
distributor sufficient to state a claim for public nuisance, (iii) the alleged public nuisance would
829072.1
have impermissible extratemitorial reach, and (iv) the alleged conduct of Defendant is too remote
from the alleged injury as a matter of law and due process.
Plaintiff's claims for punitive or exemplary damages or other civil penalties are
barred or reduced by applicable law or statute, or, in the altemative, are unconstitutional insofar
as they violate the due process protections afforded by the United States Constitution, the
excessive fines clause of the Eighth Amendment of the United States Constitution, and
applicable provisions of the Constitution of this State. Any law, statute, or other authority
purporting to permit the recovery of punitive damages or civil penalties in this case is
unconstitutional, facially and as applied, to the extent that, without limitation, it: (1) lacks
constitutionally sufficient standards to guide and restrain the jury’s discretion in determining
whether to award punitive damages or civil penalties and/or the amount, if any; (2) is void for
vagueness in that it fails to provide adequate notice as to what conduct will result in punitive
damages or civil penalties; (3) unconstitutionally may permit recovery of punitive damages or
civil penalties based on harms to third parties, out — state conduct, conduct
that complied with
applicable law, or conduct that was not directed, or did not proximately cause ham, to Plaintiff;
(4) unconstitutionally may permit recovery of punitive damages or civil penalties in an amount
that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiff
and to the
amount of compensatory damages, if any; (5) unconstitutionally may permit jury consideration
of net worth or other financial information relating to McKesson; (6) lacks constitutionally
sufficient standards to be applied by the trial court in post verdict review of any award of
punitive damages or civil penalties; (7) lacks constitutionally sufficient standards for appellate
review of any award of punitive damages or civil penalties; (8) would unconstitutionally impose
a penalty, criminal in nature, without according to Defendant the same procedural protections
829072.1
that are accorded to criminal defendant under the constitutions of the United States, this State,
and any other state whose laws may apply; and (9) otherwise
fails to satisfy Supreme Court
precedent, including without limitation, Pacific Mut. Life Ins. Co. v. Halisp, 499 U.S. 1 (1991);
TXO Prod. Corp. v. Alliance Res. Inc., 509 U.S. 443 (1993); BMW of N. Am v. Gore, 517 U.S.
559 (1996); State Farm Ins. Co. v. Campbell, 533 U.S. 408 (2003); and Philip Morris USA v.
Williams, 549 U.S. 346 (2007).
Defendant denies that it made any representation to Plaintiff that Plaintiff relied
on and that was a cause of damages to Plaintiff.
Defendant denies all liability under the Texas Controlled Substances Act (the
“TCSA”)
Defendant did not knowingly divert controlled substances for the unlawful use or
benefit of another person.
Defendant did not knowingly distribute, deliver, administer, or dispense
controlled substances in violation of the Texas Controlled Substances Act or with no valid
medical purpose.
Defendant did not fail to report signs of any alleged abuse, diversion, and
inappropriate prescribing. Defendant reported all information related to opioid orders as
required under both state and federal law, as applicable.
There is no private of action in the Texas Controlled Substances Act or its
legislative rules against Defendant. Plaintiff lacks the authority to file suit to collect penalties or
fines based on alleged violations of the Texas Controlled Substances Act.
Plaintiff's claims are barred by the Due Process Clause of the Fifth and
Fourteenth Amendments to the United States Constitution and Article 1 § 19 of the Texas
829072.1
Constitution because substantive due process forbids the retroactive imposition of changing and
unclear legal interpretations of the Texas Controlled Substances Act.
Plaintiff's claims
are barred, in whole or in part, because Defendant is not a
“practitioner” under Texas Health & Safety Code§ 481.071.
Defendant denies it entered any agreement or otherwise had a meeting of the
minds with any other person to accomplish an unlawful purpose or to accomplish
a lawfu
purpose through unlawful means. Specifically, Defendant denies it engaged in a civil conspiracy
to commit fraud, misrepresentation, unlawful marketing, unlawful distribution of opioids, or to
fail to prevent diversion, fail to monitor for, fail to report, and fail to prevent suspicious orders of
opioids.
Defendant denies that it committed any overt act in furtherance of the alleged
conspiracy, including but not limited to alleged unlawful marketing of opioids, fraudulent
statements, misrepresentations, etc., and Defendant denies Plaintiff suffered any injury as a
proximate result of the alleged wrongful act.
Defendant may rely upon any other applicable affirmative defense(s) set forth in
any Answer of any other defendant in this action and reserves the right to amend this answer to
assert any further defenses.
Prayer
Defendant respectfully requests that Plaintiff take nothing by reason of this suit, that this
lawsuit
be discharged, and that Defendant be awarded costs of court and any other and further
elief, both general and special, at law and in equity, to which it may be justly entitled.
829072.1
Respectfully ubmitted,
MYSER APLAN ESELKA
By:/s/_ Craig Smyser
Craig Smyser
Attorney Charge
Texas Bar No. 18777575
David Isaak
Texas Bar No. 24
Tyler G. Doyle
Texas Bar No. 24072075
Razvan Ungureanu
Texas Bar No.
Kristin E. Adler
Texas Bar No. 793233
Michelle Stratton.
Texas Bar No. 24085606
Crystal Robles
Texas Bar No. 24083754
700 Louisiana, Suite 2300
Houston, Texas 77002
2320 (fax)
csmyser@skv.com
disaak@skv.com.
tydoyle@skv.com
razvan@skv.com
kadler@skv.com
mstratton@skv.com.
crobles@skv.com
Counsel for McKesson Corporation
CERTIFICATE OF SERVI
I hereby certify that on February 18, 2019 true and comnect copy of the above and
foregoing was forwarded to all counsel of record via electronic service.
:
ISIC
Craig Smyser
829072.1
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MDL PRETRIAL CAUSE NO. 2018-77106 THE DISTRICT COURT COUNTY OF FALLS Plaintiff, ND JUDICIAL DISTRICT PURDUE PHARMA LP, etal. Defendants. HARRIS COUNTY, TEXAS MASTER FILE NO. 2018-63587 IN RE: TEXAS OPIOID LITIGATION THE DISTRICT COURT MDL NO. 18-0358 ND JUDICIAL DISTRICT HARRIS COUNTY, TEXAS MCKESSON CORPORATION’S ORIGINAL ANSWER TO PLAINTIFF'S FIRST AMENDED PETITION Defend nt McKesson Corporation (“Defendant” or “McKesson”) files its Original Answer and Defenses to Plaintiff’ s First Amended Petition and in support shows the following: 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 alls, and demands strict proof thereof. Affirmative & Other Defenses Without accepting the burden of proof on any issue on which McKesson does not have the burden as a matter of law, McKesson sets forth the following affirmative and other defenses. Plaintiff lacks standing to assert some or all of its claims. Plaintiff has no authority or right to bring such claims on behalf of itself or the citizens of FallsCounty. Plaintiff has no capacity, authority, or right to assert some or all of claims, including claims brought indirectly on behalf of itscitizens or claims brought as parens patriae McKesson asserts that it is not liable in the capacity in which it has been sued. Plaintiff’ s claims are barred because Plaintiff is not the real party in interest. Defendant further pleads, if such be necessary, and pleading in the altemative, that Plaintiff’ s claims are barred by the doctrine of in pari delicto Plaintiff’s claims are subject to all the 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. The derivative injury nile and the remoteness doctrines bar Plaintiff from recovering payments that Plaintiff allegedly made on behalf of residents to reimburse any expenses for health care, pharmaceutical care, and other public services. The alleged injuries asserted by Plaintiff are too remote from the alleged conduct of Defendant to provide a basis for liability as a matter of law and due process. Plaintiff's damages and claims against Defendant are barred or limited, in whole orin part, by common law, statutory, and state constitutional constraints on the exercise of police powers by a state county. Plaintiff’s etition fails in whole or in part to state a claim upon which relief can be granted, fails to state sufficient facts sufficient to constitute a cause of action, and fails to plead cognizable injury. 829072.1 Plaintiff's claims are preempted, in whole or in part, by federal law, including without limitation the federal Controlled Substances Act and the Food, Drug, and Cosmetic Act. Plaintiff's claims are barred, in whole or in part, by conflict preemption, as set forth in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharm Co. v. Bartlett 133 S. Ct. 2466 (2013). 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 amendments to the FDCA and implementing regulations. See Geier v. Am Honda Co, 529 U.S. 861 (2000). Plaintiff’ s claims are barred in whole or in part by the Donmant Commerce Clause of the United States Constitution. Plaintiffs claims are barred, in whole or in part, by the deference that common law accords discretionary actions by the FDA under the FDCA and discretionary actions by the DEA under the Controlled Substances Act. Plaintiff's claims are bared, in whole or in part, for failure to exhaust administrative remedies. Plaintiff’ s claims are barred in whole or in part to the extent that they violate the Due Process Clause of the United States and Texas Constitutions. Plaintiff’s claims are barred, in whole or in part, to the extent that they violate the Ex Post Facto clauses of the United States and Texas Constitutions. Plaintiff cannot obtain relief on their claims based on actions undertaken by Defendant of which Defendant provided notice of all reasonable facts. Defendant did not owe or breach any duty to Plaintiff. 829072.1 Defendant appropriately, completely, and fully discharged any and all obligations and legal duties arising out of the matters alleged in the Petition. Plaintiff’s claims are not ripe, and/or have been mooted. Defendant has no legal duty to protect Plaintiff from the intentional criminal acts of third persons. The criminal conduct of a third party is a superseding cause that extinguishes liability. Plaintiff's alleged damages were caused by the intentional and criminal activities of unidentified persons over which Defendant had no right of control. Plaintiff is barred by the free public services/municipal cost recovery doctrine from recovering costs incurred in providing public services. Plaintiff’s claims are barred, in whole or in part, by the economic loss rule. Plaintiff’s claims are barred by all applicable statutes of limitation and repose. Plaintiff's claims are barred in whole or in part by Plaintiff s knowledge of alleged falsity and/or acquiescence. Plaintiff's claims are barred in whole or in part by the doctrine of avoidable consequences. Plaintiff’ s claims are barred by consent. Plaintiff s claims are barred by ratification and/or condonation. The alleged injuries were not legally foreseeable. The claims raised by Plaintiff are barred by the doctrines of laches, waiver, ratification, estoppel, unclean hands, quasi estoppel, and/or equitable estoppel. Plaintiff’ s claims are barred in whole or in part by the doctrines of acquiescence settlement and or release. 829072.1 If Defendant is found liable to Plaintiff in any amount, Defendant is entitled to a credit or set off for any and all sums Plaintiff has received in the way of any and all settlements and for all sums of money received or available from or on behalf of any tortfeasor(s) for the same injuries alleged in the Petition. Defendant has a right under Chapters 32 and 33 of the Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found against it, based on the product, negligence, or other conduct of any settling tortfeasor and/or responsible third party. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff is proportionately responsible for any damage it alleges to have suffered with respect to the claims asserted against McKesson. Therefore, Plaintiff’s claims are barred in whole or in part by their contributory fault. McKesson pleads for, and is entitled to, a comparative fault submission under Chapter 33 of the Texas Civil Practice and Remedies Code which will compare the fault of all Parties and responsible third parties. Any damages that Plaintiff may recover against Defendant must be reduced to the extent that Plaintiff is seeking damages for alleged injuries or expenses related to the same user(s) of the subject prescription medications, or damages recovered or recoverable by other actual or potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be reduced to the extent they unjustly enrich Plaintiff. Plaintiff's claims are barred, in whole or in part, by res judicata and collateral estoppel Plaintiffs claims are barred or limited by the terms and effect of any applicable Consent Judgment, including by operation of the doctrines of res judicata and collateral estoppel, 829072.1 failure to fulfill conditions precedent, failure to provide requisite notice, payment, accord and satisfaction, and compromise and settlement. Any verdict or judgment that might be recovered by Plaintiff must be reduced by those amounts that have already indenmified or with reasonable certainty will indemnify Plaintiff in whole or in part for any past or future claimed economic loss from any collateral source or any other applicable law. Plaintiff's damages, if any, were proximately caused, in whole or in part, by independent, intervening, or superseding causes, events, factors, occurrences, or conditions, which were not reasonably foreseeable and not caused by Defendant and for which Defendant is not liable. Any and all damages alleged by Plaintiff were caused by misuse of the products involved, failure to use the products properly, and/or alteration of, or criminal misuse or abuse of the product by third parties over whom Defendant had no control and for whom Defendant is not responsible. Plaintiff suffered no injuries or damages as a result of any action by Defendant. No conduct of Defendant was misleading, unfair, or deceptive. Plaintiff's claims are barred, in whole or in part, by its failures to mitigate its alleged damages. Any and all damages claimed by Plaintiff, whether actual, compensatory, punitive, attomeys’ fees, or otherwise are subject to all applicable statutory and common law exclusions, caps, and limitations. Plaintiff’ s claims for punitive or exemplary damages are barred because Plaintiff camnot prove by clear and convincing evidence that McKesson was grossly negligent and 829072.1 McKesson has neither acted nor failed to act in a manner that entitled Plaintiff to recover punitive or exemplary damages. Plaintiff’ s alleged damages are speculative, uncertain, and hypothetical. Plaintiffs claims are barred and/or reduced by the assumption of risk, informed consent, contributory or comparative negligence, contributory or comparative fault, and proportionate responsibility. McKesson asserts its right of contribution under Texas law with respect to any settling person, responsible party or tortfeasor, and McKesson invokes all protections contained within Chapter 41 of the Texas Civil Practice and Remedies Code. Plaintiff’ s claims or damages are barred because users of the medications at issue used them after they knew, orshould have known, of their alleged risks. Defendant denies all types of causation including without limitation cause in fact, proximate cause and producing cause, with respect to the claims asserted against Defendant. Plaintiff's claims and alleged damages are barred under the leamed intermediary doctrine because adequate wamings were given to leamed intermediaries. Plaintiff s damages, if any, were the direct result of circumstances over which Defendant had and continues to have no control. All of the limitations and requirements contained in Chapter 41 of the Texas Civil Practice and Remedies Code, and all federal and Texas constitutional limitations upon the assessment of punitive or exemplary damages, including those stated in the decisions of BMW of North America v. Gore, 116 S. Ct. 1589 (1996) and State Farm Mutual Insurance Co. v. Campbell, 538 U.S. 408 (2003), preclude an award of punitive or exemplary damages. Plaintiffs claims fail to the extent they are based on a theory of market share bility, which is not a recognized means for recovering damages under Texas law. 829072.1 Plaintiff's claims based on alleged violations of industry customs fail because purported industry customs do not create legal duties on Defendant. Defendant is not liable to Plaintiff because Defendant is a non manufacturing seller under Texas Civil Practice & Remedies Code § 82.003. Pursuant to Texas Civil Practice & Remedies Code § 82.007, Defendant is not liable with respect to any allegations involving failure to provide adequate waming or information because all of the waming or information that accompanied the allegedly distributed products were approved by the United States Food & Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended, or the wamings and information provided were those stated in monographs developed by the United States Food & Drug Administration for pharmaceutical products that may be distributed without an approved new drug application. Plaintiff s claims are barred or limited to the extent they have been abrogated by the Texas Products Liability Act, Texas Civil Practice & Remedies Code Chapter The conduct of Defendant conformed with the FDCA and the requirements of the FDA, the Controlled Substances Act, and DEA regulations, and the activities of Defendant alleged in the Petition conformed with all state and federal statutes, regulations, and industry standards based on the state of knowledge at the relevant time(s) alleged in the Petition. Defendant is not liable for any injury allegedly caused to Plaintiff by the products in question because all formulations, labeling, and design of the products complied with mandatory safety standards or regulations adopted and promulgated by the federal govemment, 829072.1 or an agency of the federal govemment, applicable to the products at the time of manufacture and that govemed the product risk that allegedly caused the purported harm. Plaintiff may not recover against Defendant because the methods, standards, or techniques of designing, manufacturing, labeling and distributing of the prescription medications at issue complied with and were in conformity with the generally recognized state of the art at the time the product was designed, manufactured, labeled, and distributed. Plaintiff would be unjustly enriched if allowed to recover on any of their claims. Plaintiff’ s claims are barred, in whole or in part, by application of the doctrine of Telease. Plaintiff's claims are barred, in whole or in part, because the First Amendment and/or Article I, Section 8 of the Texas Constitution protect Defendant’s commercial and political speech. To the extent Plaintiffs claims are based on alleged misrepresentations made to the FDA, such claims are barred pursuant to Buckman Co. v. Plaintiffs Legal Committee, 531 US. 341 (2001). To the extent Plaintiffs claims depend solely on violations of federal law, including any claims of “fraud on the DEA” with respect to Defendant's compliance with statutes or regulations administered and/or enforced by the DEA, such claims are barred and should be dismissed. See Buckman Co. v. PlaintifP s Legal Committee, 531 U.S. 341 (2001). To the extent that Plaintiff relies on letters or other informal guidance from the DEA to establish Defendant's regulatory duties, such informal guidance camnot enlarge Defendant’ s regulatory duties in the absence of compliance by DEA with the requirements of the Administrative Procedure Act, 5 U.S.C. §§ 551 et seg. 829072.1 Plaintiff cannot state a claim against Defendant with regard to wamings and labeling for products because the remedy sought by the County is subject to the exclusive regulation of the FDA. the extent Plaintiff seeks punitive, exemplary, or aggravated damages, any such damages are barred because the product at issue, and its labeling were subject to and received pre market approval by the FDA under 52 Stat. 1040, 21 U.S.C. § 301. Plaintiff's claims are barred, in whole or in part, because federal agencies have exclusive or primary jurisdiction over the matters asserted in Plaintiff’s etition. Plaintiff has failed to join one or more necessary and indispensable parties, including without limitation healthcare providers, prescribers, patients, and other third parties whom the County alleges engaged in the unauthorized or illicit prescription, dispensing, diversion, or use of prescription opioid products in FallsCounty. Plaintiff's damages, if any, were the direct result of pre existing medical conditions, and/or occurred by operation of nature or as a result of circumstances over which Defendant had and continue to have no control. Plaintiff's injuries and damages, if any, were due to pre xisting conditions or idiosyncratic reaction to the medications on the part of the medication users, for which Defendant cannot be held responsible. Plaintiffs claims are barred, in whole or in part, because neither users nor their prescribers relied to their detriment upon any statement by Defendant in determining to use medications at issue. Plaintiff’s fraud based claims are barred, in whole or in part, because Plaintiff did not rely to its detriment upon any statement or omission by McKesson. 829072.1 Plaintiff's claims are barred, in whole or in part, by the Restatement (Second) of Torts § 402A, Comments j andk, and Restatement (Third) of Torts: Products Liability § 6. Defendant is not liable for statements or omissions in the Manufacturer Defendants’ branded or unbranded materials. Plaintiff has failed to plead any actionable misrepresentation or omission made by or attributable to Defendant. Plaintiffs claims are barred in whole or in part because no statement or conduct of McKesson was misleading, unfair, or deceptive. Plaintiff’ s claims are barred to the extent that they are based on alleged violations of industry customs because industry customs do not create legal duties on Defendant. Plaintiff’s claim for unjust enrichment is barred or limited because Defendant did not receive and retain any alleged benefit from Plaintiff To the extent Plaintiff seeks relief for Defendant's conduct occurring before enactment of applicable statutes or regulations, the claims fail because the statutes and regulations do not apply retroactively. McKesson’s rights under the Due Process Clause of the U.S. Constitution and applicable state Constitution or statute are violated by any financial or other arrangement that might distort a govemment attomey’s duty to pursue justice rather than his or her personal interests, financial or otherwise, in the context of a civil enforcement proceeding, including by Plaintiff s use of a contingency fee contract with private counsel. Plaintiff’ s claims are barred or limited by the political question and separation of powers doctrines and because this case implicates issues of statewide importance that are reserved for state regulation. 829072.1 Plaintiff's claims or damages are barred because users of medications at issue used them illegally and not after properly being prescribed the medication by a licensed health care provider. The claims asserted against McKesson and other Defendants do not arise out of the same transactions or occurrences as required for joinder of parties. Defendant's liability, if any, will not result from its conduct, but is solely the result of an obligation imposed by law, and thus McKesson is entitled to indemnity, express or implied, by other parties. Plaintiff failed to plead that they reimbursed any prescriptions for any opioid distributed by Defendant that harmed patients and should not have been written or that Defendant's allegedly improper conduct caused a health care provider to write an ineffective or hannful opioid prescription. To the extent Plaintiff attemp to seek equitable relief, Plaintiff not entitled t such relief because Plaintiff an adequate remedy at law. Plaintiff ha failed to comply with the requirement that they identify each patient in whose claim(s) they have a subrogation interest. laintiff s public nuisance claim is barred or limited to the extent that they lack the statutory authority to bring a nuisance claim under Texas law or their own applicable county or municipal codes or regulations. Plaintiff s claim of public nuisance is barred or limited because (i) no action of McKesson involved interference with real property, (ii) illegal conduct perpetrated by third parties involving use of an otherwise legal product does not involve a public right against the distributor sufficient to state a claim for public nuisance, (iii) the alleged public nuisance would 829072.1 have impermissible extratemitorial reach, and (iv) the alleged conduct of Defendant is too remote from the alleged injury as a matter of law and due process. Plaintiff's claims for punitive or exemplary damages or other civil penalties are barred or reduced by applicable law or statute, or, in the altemative, are unconstitutional insofar as they violate the due process protections afforded by the United States Constitution, the excessive fines clause of the Eighth Amendment of the United States Constitution, and applicable provisions of the Constitution of this State. Any law, statute, or other authority purporting to permit the recovery of punitive damages or civil penalties in this case is unconstitutional, facially and as applied, to the extent that, without limitation, it: (1) lacks constitutionally sufficient standards to guide and restrain the jury’s discretion in determining whether to award punitive damages or civil penalties and/or the amount, if any; (2) is void for vagueness in that it fails to provide adequate notice as to what conduct will result in punitive damages or civil penalties; (3) unconstitutionally may permit recovery of punitive damages or civil penalties based on harms to third parties, out — state conduct, conduct that complied with applicable law, or conduct that was not directed, or did not proximately cause ham, to Plaintiff; (4) unconstitutionally may permit recovery of punitive damages or civil penalties in an amount that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiff and to the amount of compensatory damages, if any; (5) unconstitutionally may permit jury consideration of net worth or other financial information relating to McKesson; (6) lacks constitutionally sufficient standards to be applied by the trial court in post verdict review of any award of punitive damages or civil penalties; (7) lacks constitutionally sufficient standards for appellate review of any award of punitive damages or civil penalties; (8) would unconstitutionally impose a penalty, criminal in nature, without according to Defendant the same procedural protections 829072.1 that are accorded to criminal defendant under the constitutions of the United States, this State, and any other state whose laws may apply; and (9) otherwise fails to satisfy Supreme Court precedent, including without limitation, Pacific Mut. Life Ins. Co. v. Halisp, 499 U.S. 1 (1991); TXO Prod. Corp. v. Alliance Res. Inc., 509 U.S. 443 (1993); BMW of N. Am v. Gore, 517 U.S. 559 (1996); State Farm Ins. Co. v. Campbell, 533 U.S. 408 (2003); and Philip Morris USA v. Williams, 549 U.S. 346 (2007). Defendant denies that it made any representation to Plaintiff that Plaintiff relied on and that was a cause of damages to Plaintiff. Defendant denies all liability under the Texas Controlled Substances Act (the “TCSA”) Defendant did not knowingly divert controlled substances for the unlawful use or benefit of another person. Defendant did not knowingly distribute, deliver, administer, or dispense controlled substances in violation of the Texas Controlled Substances Act or with no valid medical purpose. Defendant did not fail to report signs of any alleged abuse, diversion, and inappropriate prescribing. Defendant reported all information related to opioid orders as required under both state and federal law, as applicable. There is no private of action in the Texas Controlled Substances Act or its legislative rules against Defendant. Plaintiff lacks the authority to file suit to collect penalties or fines based on alleged violations of the Texas Controlled Substances Act. Plaintiff's claims are barred by the Due Process Clause of the Fifth and Fourteenth Amendments to the United States Constitution and Article 1 § 19 of the Texas 829072.1 Constitution because substantive due process forbids the retroactive imposition of changing and unclear legal interpretations of the Texas Controlled Substances Act. Plaintiff's claims are barred, in whole or in part, because Defendant is not a “practitioner” under Texas Health & Safety Code§ 481.071. Defendant denies it entered any agreement or otherwise had a meeting of the minds with any other person to accomplish an unlawful purpose or to accomplish a lawfu purpose through unlawful means. Specifically, Defendant denies it engaged in a civil conspiracy to commit fraud, misrepresentation, unlawful marketing, unlawful distribution of opioids, or to fail to prevent diversion, fail to monitor for, fail to report, and fail to prevent suspicious orders of opioids. Defendant denies that it committed any overt act in furtherance of the alleged conspiracy, including but not limited to alleged unlawful marketing of opioids, fraudulent statements, misrepresentations, etc., and Defendant denies Plaintiff suffered any injury as a proximate result of the alleged wrongful act. Defendant may rely upon any other applicable affirmative defense(s) set forth in any Answer of any other defendant in this action and reserves the right to amend this answer to assert any further defenses. Prayer Defendant respectfully requests that Plaintiff take nothing by reason of this suit, that this lawsuit be discharged, and that Defendant be awarded costs of court and any other and further elief, both general and special, at law and in equity, to which it may be justly entitled. 829072.1 Respectfully ubmitted, MYSER APLAN ESELKA By:/s/_ Craig Smyser Craig Smyser Attorney Charge Texas Bar No. 18777575 David Isaak Texas Bar No. 24 Tyler G. Doyle Texas Bar No. 24072075 Razvan Ungureanu Texas Bar No. Kristin E. Adler Texas Bar No. 793233 Michelle Stratton. Texas Bar No. 24085606 Crystal Robles Texas Bar No. 24083754 700 Louisiana, Suite 2300 Houston, Texas 77002 2320 (fax) csmyser@skv.com disaak@skv.com. tydoyle@skv.com razvan@skv.com kadler@skv.com mstratton@skv.com. crobles@skv.com Counsel for McKesson Corporation CERTIFICATE OF SERVI I hereby certify that on February 18, 2019 true and comnect copy of the above and foregoing was forwarded to all counsel of record via electronic service. : ISIC Craig Smyser 829072.1