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MDL PRETRIAL CAUSE NO. 2018-77083
COUNTY OF NUECES and THE DISTRICT COURT
NUECES COUNTY HOSPITAL
DISTRICT
Plaintiffs, ND JUDICIAL DISTRICT
PURDUE PHARMA LP,etal.
Defendants. HARRIS COUNTY, TEXAS
MASTER FILE NO. 2018-63587
THE DISTRICT COURT
IN RE: TEXAS OPIOID LITIGATION
MDL NO. 18-0358 ND JUDICIAL DISTRICT
HARRIS COUNTY, TEXAS
MCKESSON CORPORATIONMCKESSON MEDICAL SURGICAL, INC.’S
ORIGINAL ANSWER TO PLAINTIFFS’ ORIGINAL PETITION
Defendants McKesson Corporation and McKesson Medical Surgical, Inc. (collectively
“McKesson” or “Defendants”) file their Original Answer and Defenses to Plaintiffs’ Original
Petition and in support show the following:
General Denial
Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendants
assert a general
denial, denies each and every allegation made by Plaintiffs County of Nueces and Nueces
County Hospital District, 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.
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Plaintiff lack standing
to assert some or all of its claims.
PlaintiffNueces County has no authority or right to bring such claims on behalf of
itself or the citizens of NuecesCounty.
PlaintiffNueces County has no capacity, authority, or right to assert some or all of
their claims, including claims brought indirectly on behalf of their citizens or claims brought as
parens patriae
McKesson asserts that it is not liable in the capacity in which it has been sued.
Plaintiff claims are barred because Plaintiff are not the real parties 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
Plaintiffs claims
are subject to all the defenses that could be asserted if Plaintiffs
claims were properly made by individuals on whose behalf or for whose alleged damages
Plaintiff seeks to recover.
The derivative injury rule and the remoteness doctrines bar Plaintiff Nueces
County from recovering payments that Plaintiff Nueces County 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.
Plaintiffs 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.
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Plaintiffs etition fails in whole or in part to state a claim upon which relief ca
be granted, fails to state sufficient facts sufficient to constitute a cause of action, and fails to
Plead cognizable injury.
Plaintiffs 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.
Plaintiffs 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).
Plaintiffs’ 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).
Plaintiffs claims are barred in whole or in part by the Dormant 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.
Plaintiffs claims are bared, in whole or in part, for failure to exhaust
administrative remedies.
Plaintiffs 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.
Plaintiffs 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 Constitution
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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
Defendant appropriately, completely, and fully discharged any and all
obligations and legal duties arising out of the matters alleged in the Petition.
Plaintiffs claims are not ripe, and/or have been mooted.
Defendant 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. Plaintiffs alleged damages were caused by the intentional and criminal
activities of unidentified persons over which Defendant had no right of cont rol.
Plaintiff are barred
by the free public services/municipal cost recovery doctrine
from recovering costs incurred in providing public services.
Plaintiffs claims are barred, in whole or in part, by the economic loss nule.
Plaintiffs claims are barred by all applicable statutes of limitation and repose.
Plaintiffs claims are barred in whole or in part by Plaintiffs’ knowledge of
alleged falsity and/or acquiescence.
Plaintiffs claims are barred in whole or in part by the doctrine of avoidable
consequences.
Plaintiffs claims are barred by consent.
Plaintiffs’ 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.
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Plaintiffs claims are barred in whole or in part by the doctrines of acquiescence
settlement
and or release.
If Defendant are found liable to Plaintiff in any amount, Defendant entitled
to a credit or set off for any and all sums Plaintiff 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 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 rty. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff
are proportionately responsible for any damage they allege to have suffered with respect to the
claims asserted against McKesson. Therefore, Plaintiffs 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 are 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 Plaintiffs may recover against Defendant must
be reduced to the extent they unjustly enrich Plaintiff
Plaintiffs claims are barred, in whole or in part, by res judicata and collateral
estoppel
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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,
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
Plaintiffs in whole or in part for any past or future claimed economic loss from any collateral
source or any other applicable law.
Plaintiffs 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
arenot 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 are
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.
Plaintiffs 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.
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Plaintiffs claims for punitive or exemplary damages are barred because Plaintiffs
camnot prove by clear and convincing evidence that McKesson was grossly negligent and
McKesson has neither acted nor failed to act in a manner that entitled Plaintiffs to recover
punitive or exemplary damages.
Plaintiffs 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.
Plaintiffs claims or damages are barred because users of the medications at issue
used them after they knew, or should
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
Plaintiffs claims and alleged damages are barred under the leamed intermediary
doctrine because adequate wamings were given to leamed intermediaries.
Plaintiffs’ damages, if any, were the direct result of circumstances over which
Defendant had and continues
to have nocontrol.
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
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North Anerica 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
liability, which is not a recognized means for recovering damages under Texas law.
Plaintiffs claims based on alleged violations of industry customs fail because
purported industry customs
do not create legal duties
on Defendant
Defendant are not liable to Plaintiff because Defendant are manufacturing
seller under Texas Civil Practice & Remedies Code§ 82.003.
Pursuant to Texas Civil Practice & Remedies Code§ 82.007, Defendant are 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.
Plaintiffs’ claims are barred or limited to the extent they have been abrogated by
the Texas Products Liability Act, Texas Civil Practice& Remedies Code Chapter 82.
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.
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Defendant are 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,
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.
Plaintiffs claims are barred, in whole or in part, by application of the doctrine of
release.
Plaintiffs claims
are barred, in whole
or in part, because
the First Amendment
and/or Article I, Section 8 of the Texas Constitution protect Defendants commercial and
politicalspeech.
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 Defendants compliance with
statutes or regulations administered and/or enforced by the DEA, such claims are barred and
should be dismissed. See Buckman Co. v. Plaintiff s Legal Committee, 531 U.S. 341 (2001).
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To the extent that Plaintiff rel on letters or other informal guidance from the
DEA to establish Defendants regulatory duties, such informal guidance camnot enlarge
Defendants regulatory duties in the absence of compliance
by DEA with the requirements of the
Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
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.
To the extent Plaintiff seek 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.
Plaintiffs claims are barred, in whole or in part, because federal agencies have
exclusive or primary jurisdiction over the matters asserted in Plaintiffs etition.
Plaintiff 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 NuecesCounty.
Plaintiffs 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.
Plaintiffs injuries and damages, if any, were due to pre existing conditions or
idiosyncratic reaction to the medications on the part of the medication users, for which
Defendant cannot be held responsible.
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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.
Plaintiffs fraud based claims are barred, in whole or in part, because Plaintiffs
did not rely to theirdetriment upon any statement or omission by McKesson.
Plaintiffs 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 are not liable for statements or omissions in the Manufacturer
Defendants’ branded or unbranded materials.
Plaintiff 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.
Plaintiffs 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
Plaintiffs claim for unjust enrichment is barred or limited because Defendant did
not receive and retain any alleged benefit from Plaintiffs.
To the extent Plaintiffs seek relief for Defendants 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
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interests, financial or otherwise, in the context of a civil enforcement proceeding, including by
Plaintiffs’ use of a contingency fee contract with private counsel.
laintiffs claims are barred or limited by the political question and separation of
powers doctrines and because this claim implicates issues of statewide importance that are
reserved for state regulation.
Plaintiffs 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.
Defendants 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
Defendants allegedly improper conduct caused a health care provider
to write an ineffective or
hannful opioid prescription.
To the extent Plaintiffs attempt to seek equitable relief, Plaintiffs are not entitled
to such relief because Plaintiffs have an adequate remedy at law.
Plaintiffs have failed to comply with the requirement that they identify each
atient in whose claim(s) they have a subrogation interest.
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Plaintiffs’ 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.
Plaintiffs’ 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
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.
Plaintiffs 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 harm, to Plaintiffs;
(4) unconstitutionally may permit recovery of punitive damages or civil penalties in an amount
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that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiffs
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
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.
HalispU.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 deny that they made any representation to Plaintiff that Plaintiff
relied on and that was a cause of damages to Plaintiff
Defendant deny 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.
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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 lack the authority to file suit to collect penalties or
fines based on alleged violations of the Texas Controlled Substances Act.
Plaintiffs 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
Constitution because substantive due process forbids the retroactive imposition of changing and
unclear legal interpretations of the Texas Controlled Substances Act.
Plaintiffs claims
are barred, in whole or in part, because Defendant are not a
“practitioner” under Texas Health & Safety Code§ 481.071.
Defendant den that the TCSA is a statute designed to prevent the injury upon
which the Plaintiff’ s claim is based.
Defendant den that the TCSA is a safety statute that can form the basis of a
claim for negligence per se.
Defendant den that the TCSA was designed to prevent injury to the class of
persons or entities to which the Plaintiff belongs.
Defendant den that the TCSA creates a duty that Distributors owe to the
County/Plaintiff
Defendant den they entered any agreement or otherwise had a meeting of the
minds with any other person to accomplish an unlawful purpose or to accomplish
a lawful
purpose through unlawful means. Specifically, Defendant den they engaged in a civil
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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 den that they 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 den 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 request
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
relief, both general and special, at law and in equity, to which it may be justly entitled.
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Respectfully Submitted
MYSER APLAN ESELKA
By:/s/_ Craig Smyser
Craig Smyser
Attorney Charge
Texas Bar No. 18777575
David Isaak
xas Bar No. 24012887
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
2320 (fax)
csmyser@skv.com
disaak@skv.com.
tydoyle@skv.com
razvan@skv.com
kadler@skv.com
mstratton@skv.com.
crobles@skv.com
Counselfor McKesson Corporation and
McKesson Medical Surgical, Inc.
CERTIFICATE OF SERVI
I certify that on February 18, 2019 ‘true and conect copy of the above and
foregoing was forwarded to all counsel of record via electronic service.
:
Is.
Craig Smyser
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