Preview
7/29/2019 9:04 AM
Marilyn Burgess - District Clerk Harris County
Envelope No. 35489926
By: KATINA WILLIAMS
Filed: 7/29/2019 9:04 AM
CAUSE NO. CC-19-71
§
COUNTY OF JIM HOGG
§ IN THE DISTRICT COURT
Plaintiffs, §
§
vs. §
OF JIM HOGG COUNTY
§
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PURDUE PHARMA L.P., et. al. §
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Defendants. § 229th JUDICIAL DISTRICT
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MDL PRETRIAL CAUSE NO. 2019-49060
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COUNTY OF JIM HOGG IN THE DISTRICT COURT
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Plaintiffs, § Bu
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vs. § 152ND JUDICIAL DISTRICT
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PURDUE PHARMA L.P., et. al. §
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Defendants. § HARRIS COUNTY, TEXAS
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MCKESSON CORPORATION’S ORIGINAL
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ANSWER TO PLAINTIFF’S ORIGINAL PETITION
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Defendant McKesson Corporation (“Defendant” or “McKesson”) files its Original
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Answer and Defenses to Plaintiff’s Original Petition and in support shows the following:
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I.
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General Denial
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Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendant asserts a general
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denial, denies each and every allegation made by Plaintiff County of Jim Hogg, and demands
strict proof thereof.
880752.1
II.
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.
1. Plaintiff lacks standing to assert some or all of its claims.
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2. Plaintiff has no authority or right to bring such claims on behalf of itself or the
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citizens of Jim Hogg County.
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3. Plaintiff has no capacity, authority, or right to assert some or all of its claims,
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including claims brought indirectly on behalf of its citizens or claims brought as parens patriae.
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4. McKesson asserts that it is not liable in the capacity in which it has been sued.
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Plaintiff’s claims are barred because Plaintiff is not the real party in interest.
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6. Defendant further pleads, if such be necessary, and pleading in the alternative,
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that Plaintiff’s claims are barred by the doctrine of in pari delicto.
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7. Plaintiff’s claims are subject to all the defenses that could be asserted if Plaintiff’s
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claims were properly made by individuals on whose behalf or for whose alleged damages
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Plaintiff seeks to recover.
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8. The derivative injury rule and the remoteness doctrines bar Plaintiff from
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recovering payments that Plaintiff allegedly made on behalf of residents to reimburse any
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expenses for health care, pharmaceutical care, and other public services.
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9. The alleged injuries asserted by Plaintiff are too remote from the alleged conduct
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of Defendant to provide a basis for liability as a matter of law and due process.
10. Plaintiff’s damages and claims against Defendant 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 state county.
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880752.1
11. Plaintiff’s petition 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.
12. Plaintiff’s claims are preempted, in whole or in part, by federal law, including
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without limitation the federal Controlled Substances Act and the Food, Drug, and Cosmetic Act.
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13. Plaintiff’s claims are barred, in whole or in part, by conflict preemption, as set
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forth in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharm. Co. v. Bartlett, 133
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S. Ct. 2466 (2013).
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14. Plaintiff’s claims are preempted insofar as they conflict with Congress’s purposes
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and objectives in enacting relevant federal legislation and authorizing regulations, including the
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Hatch-Waxman amendments to the FDCA and implementing regulations. See Geier v. Am.
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Honda Co., 529 U.S. 861 (2000).
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15. Plaintiff’s claims are barred in whole or in part by the Dormant Commerce Clause
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of the United States Constitution.
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16. Plaintiff’s claims are barred, in whole or in part, by the deference that common
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law accords discretionary actions by the FDA under the FDCA and discretionary actions by the
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DEA under the Controlled Substances Act.
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17. Plaintiff’s claims are barred, in whole or in part, for failure to exhaust
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administrative remedies.
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18. Plaintiff’s claims are barred in whole or in part to the extent that they violate the
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Due Process Clause of the United States and Texas Constitutions.
19. 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.
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880752.1
20. Plaintiff cannot obtain relief on their claims based on actions undertaken by
Defendant of which Defendant provided notice of all reasonable facts.
21. Defendant did not owe or breach any duty to Plaintiff.
22. Defendant appropriately, completely, and fully discharged any and all obligations
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and legal duties arising out of the matters alleged in the Petition.
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23. Plaintiff’s claims are not ripe, and/or have been mooted.
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24. Defendant has no legal duty to protect Plaintiff from the intentional criminal acts
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of third persons. The criminal conduct of a third party is a superseding cause that extinguishes
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liability. Plaintiff’s alleged damages were caused by the intentional and criminal activities of
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unidentified persons over which Defendant had no right of control.
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25. Plaintiff is barred by the free public services/municipal cost recovery doctrine
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from recovering costs incurred in providing public services.
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26. Plaintiff’s claims are barred, in whole or in part, by the economic loss rule.
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27. Plaintiff’s claims are barred by all applicable statutes of limitation and repose.
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28. Plaintiff’s claims are barred in whole or in part by Plaintiff’s knowledge of
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alleged falsity and/or acquiescence.
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29. Plaintiff’s claims are barred in whole or in part by the doctrine of avoidable
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consequences.
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30. Plaintiff’s claims are barred by consent.
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31. Plaintiff’s claims are barred by ratification and/or condonation.
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32. The alleged injuries were not legally foreseeable.
33. 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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880752.1
34. Plaintiff’s claims are barred in whole or in part by the doctrines of acquiescence,
settlement and or release.
35. 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
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and for all sums of money received or available from or on behalf of any tortfeasor(s) for the
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same injuries alleged in the Petition. Defendant has a right under Chapters 32 and 33 of the
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Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found
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against them, based on the product, negligence, or other conduct of any settling tortfeasor and/or
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responsible third-party. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff is
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proportionately responsible for any damage it alleges to have suffered with respect to the claims
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asserted against McKesson. Therefore, Plaintiff’s claims are barred in whole or in part by their
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contributory fault.
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36. McKesson pleads for, and is entitled to, a comparative fault submission under
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Chapter 33 of the Texas Civil Practice and Remedies Code which will compare the fault of all
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Parties and responsible third parties.
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37. Any damages that Plaintiff may recover against Defendant must be reduced to the
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extent that Plaintiff is seeking damages for alleged injuries or expenses related to the same
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user(s) of the subject prescription medications, or damages recovered or recoverable by other
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actual or potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be
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reduced to the extent they unjustly enrich Plaintiff.
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38. Plaintiff’s claims are barred, in whole or in part, by res judicata and collateral
estoppel.
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880752.1
39. Plaintiff’s 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.
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40. Any verdict or judgment that might be recovered by Plaintiff must be reduced by
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those amounts that have already indemnified or with reasonable certainty will indemnify Plaintiff
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in whole or in part for any past or future claimed economic loss from any collateral source or any
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other applicable law.
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41. Plaintiff’s damages, if any, were proximately caused, in whole or in part, by
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independent, intervening, or superseding causes, events, factors, occurrences, or conditions,
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which were not reasonably foreseeable and not caused by Defendant and for which Defendant is
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not liable.
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42. Any and all damages alleged by Plaintiff were caused by misuse of the products
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involved, failure to use the products properly, and/or alteration of, or criminal misuse or abuse of
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the product by third parties over whom Defendant had no control and for whom Defendant is not
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responsible.
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43. Plaintiff suffered no injuries or damages as a result of any action by Defendant.
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44. No conduct of Defendant was misleading, unfair, or deceptive.
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45. Plaintiff’s claims are barred, in whole or in part, by its failures to mitigate its
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alleged damages.
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46. Any and all damages claimed by Plaintiff, whether actual, compensatory,
punitive, attorneys’ fees, or otherwise are subject to all applicable statutory and common law
exclusions, caps, and limitations.
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880752.1
47. Plaintiff’s claims for punitive or exemplary damages are barred because Plaintiff
cannot 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 Plaintiff to recover
punitive or exemplary damages.
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48. Plaintiff’s alleged damages are speculative, uncertain, and hypothetical.
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49. Plaintiff’s claims are barred and/or reduced by the assumption of risk, informed
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consent, contributory or comparative negligence, contributory or comparative fault, and
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proportionate responsibility. McKesson asserts its right of contribution under Texas law with
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respect to any settling person, responsible party or tortfeasor, and McKesson invokes all
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protections contained within Chapter 41 of the Texas Civil Practice and Remedies Code.
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50. Plaintiff’s claims or damages are barred because users of the medications at issue
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used them after they knew, or should have known, of their alleged risks.
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51. Defendant denies all types of causation including without limitation cause in fact,
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proximate cause and producing cause, with respect to the claims asserted against Defendant.
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52. Plaintiff’s claims and alleged damages are barred under the learned intermediary
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doctrine because adequate warnings were given to learned intermediaries.
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53. Plaintiff’s damages, if any, were the direct result of circumstances over which
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Defendant had and continues to have no control.
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54. All of the limitations and requirements contained in Chapter 41 of the Texas Civil
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Practice and Remedies Code, and all federal and Texas constitutional limitations upon the
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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.
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55. Plaintiff’s 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.
56. Plaintiff’s claims based on alleged violations of industry customs fail because
purported industry customs do not create legal duties on Defendant.
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57. Defendant is not liable to Plaintiff because Defendant is a non-manufacturing
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seller under Texas Civil Practice & Remedies Code § 82.003.
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58. Pursuant to Texas Civil Practice & Remedies Code § 82.007, Defendant is not
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liable with respect to any allegations involving failure to provide adequate warning or
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information because all of the warning or information that accompanied the allegedly distributed
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products were approved by the United States Food & Drug Administration for a product
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approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as
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amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended, or the
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warnings and information provided were those stated in monographs developed by the United
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States Food & Drug Administration for pharmaceutical products that may be distributed without
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an approved new drug application.
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59. Plaintiff’s claims are barred or limited to the extent they have been abrogated by
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the Texas Products Liability Act, Texas Civil Practice & Remedies Code Chapter 82.
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60. The conduct of Defendant conformed with the FDCA and the requirements of the
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FDA, the Controlled Substances Act, and DEA regulations, and the activities of Defendant
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alleged in the Petition conformed with all state and federal statutes, regulations, and industry
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standards based on the state of knowledge at the relevant time(s) alleged in the Petition.
61. 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
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mandatory safety standards or regulations adopted and promulgated by the federal government,
or an agency of the federal government, applicable to the products at the time of manufacture
and that governed the product risk that allegedly caused the purported harm.
62. Plaintiff may not recover against Defendant because the methods, standards, or
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techniques of designing, manufacturing, labeling and distributing of the prescription medications
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at issue complied with and were in conformity with the generally recognized state of the art at
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the time the product was designed, manufactured, labeled, and distributed.
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63. Plaintiff would be unjustly enriched if allowed to recover on any of their claims.
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64. Plaintiff’s claims are barred, in whole or in part, by application of the doctrine of
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release.
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65. Plaintiff’s claims are barred, in whole or in part, because the First Amendment
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and/or Article I, Section 8 of the Texas Constitution protect Defendant’s commercial and
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political speech.
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66. To the extent Plaintiff’s claims depend solely on violations of federal law,
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including any claims of “fraud on the DEA” with respect to Defendant’s compliance with
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statutes or regulations administered and/or enforced by the DEA, such claims are barred and
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should be dismissed. See Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001).
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67. To the extent that Plaintiff relies on letters or other informal guidance from the
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DEA to establish Defendant’s regulatory duties, such informal guidance cannot enlarge
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Defendant’s regulatory duties in the absence of compliance by DEA with the requirements of the
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Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
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68. Plaintiff cannot state a claim against Defendant with regard to warnings and
labeling for products because the remedy sought by the County is subject to the exclusive
regulation of the FDA.
69. To the extent Plaintiff seeks punitive, exemplary, or aggravated damages, any
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such damages are barred because the product at issue, and its labeling were subject to and
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received pre-market approval by the FDA under 52 Stat. 1040, 21 U.S.C. § 301.
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70. Plaintiff’s claims are barred, in whole or in part, because federal agencies have
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exclusive or primary jurisdiction over the matters asserted in Plaintiff’s petition.
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71. Plaintiff has failed to join one or more necessary and indispensable parties,
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including without limitation healthcare providers, prescribers, patients, and other third parties
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whom the County alleges engaged in the unauthorized or illicit prescription, dispensing,
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diversion, or use of prescription opioid products in Ellis County.
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72. Plaintiff’s damages, if any, were the direct result of pre-existing medical
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conditions, and/or occurred by operation of nature or as a result of circumstances over which
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Defendant had and continues to have no control.
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73. Plaintiff’s injuries and damages, if any, were due to pre-existing conditions or
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idiosyncratic reaction to the medications on the part of the medication users, for which
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Defendant cannot be held responsible.
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74. Plaintiff’s claims are barred, in whole or in part, because neither users nor their
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prescribers relied to their detriment upon any statement by Defendant in determining to use
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medications at issue.
75. 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.
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76. Plaintiff’s claims are barred, in whole or in part, by the Restatement (Second) of
Torts § 402A, Comments j and k, and Restatement (Third) of Torts: Products Liability § 6.
77. Defendant is not liable for statements or omissions in the Manufacturer
Defendants’ branded or unbranded materials.
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78. Plaintiff has failed to plead any actionable misrepresentation or omission made by
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or attributable to Defendant.
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79. Plaintiff’s claims are barred in whole or in part because no statement or conduct
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of McKesson was misleading, unfair, or deceptive.
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80. Plaintiff’s claims are barred to the extent that they are based on alleged violations
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of industry customs because industry customs do not create legal duties on Defendant.
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81. Plaintiff’s claim for unjust enrichment is barred or limited because Defendant did
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not receive and retain any alleged benefit from Plaintiff.
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82. To the extent Plaintiff seeks relief for Defendant’s conduct occurring before
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enactment of applicable statutes or regulations, the claims fail because the statutes and
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regulations do not apply retroactively.
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83. McKesson’s rights under the Due Process Clause of the U.S. Constitution and
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applicable state Constitution or statute are violated by any financial or other arrangement that
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might distort a government attorney’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
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Plaintiff’s use of a contingency fee contract with private counsel.
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84. 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.
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85. 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.
86. The claims asserted against McKesson and other Defendants do not arise out of
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Preview
7/29/2019 9:04 AM Marilyn Burgess - District Clerk Harris County Envelope No. 35489926 By: KATINA WILLIAMS Filed: 7/29/2019 9:04 AM CAUSE NO. CC-19-71 § COUNTY OF JIM HOGG § IN THE DISTRICT COURT Plaintiffs, § § vs. § OF JIM HOGG COUNTY § k ler PURDUE PHARMA L.P., et. al. § § tC Defendants. § 229th JUDICIAL DISTRICT ric ist ************************************************************* sD MDL PRETRIAL CAUSE NO. 2019-49060 es § rg COUNTY OF JIM HOGG IN THE DISTRICT COURT § Plaintiffs, § Bu § n vs. § 152ND JUDICIAL DISTRICT ily § ar PURDUE PHARMA L.P., et. al. § M § Defendants. § HARRIS COUNTY, TEXAS of e MCKESSON CORPORATION’S ORIGINAL ffic ANSWER TO PLAINTIFF’S ORIGINAL PETITION O Defendant McKesson Corporation (“Defendant” or “McKesson”) files its Original y op Answer and Defenses to Plaintiff’s Original Petition and in support shows the following: C I. ial General Denial fic Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendant asserts a general of Un denial, denies each and every allegation made by Plaintiff County of Jim Hogg, and demands strict proof thereof. 880752.1 II. 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. 1. Plaintiff lacks standing to assert some or all of its claims. k ler 2. Plaintiff has no authority or right to bring such claims on behalf of itself or the tC ric citizens of Jim Hogg County. ist 3. Plaintiff has no capacity, authority, or right to assert some or all of its claims, sD including claims brought indirectly on behalf of its citizens or claims brought as parens patriae. es 4. McKesson asserts that it is not liable in the capacity in which it has been sued. rg 5. Bu Plaintiff’s claims are barred because Plaintiff is not the real party in interest. n 6. Defendant further pleads, if such be necessary, and pleading in the alternative, ily ar that Plaintiff’s claims are barred by the doctrine of in pari delicto. M 7. Plaintiff’s claims are subject to all the defenses that could be asserted if Plaintiff’s of e claims were properly made by individuals on whose behalf or for whose alleged damages ffic Plaintiff seeks to recover. yO 8. The derivative injury rule and the remoteness doctrines bar Plaintiff from op recovering payments that Plaintiff allegedly made on behalf of residents to reimburse any C ial expenses for health care, pharmaceutical care, and other public services. fic 9. The alleged injuries asserted by Plaintiff are too remote from the alleged conduct of Un of Defendant to provide a basis for liability as a matter of law and due process. 10. Plaintiff’s damages and claims against Defendant 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 state county. 2 880752.1 11. Plaintiff’s petition 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. 12. Plaintiff’s claims are preempted, in whole or in part, by federal law, including k ler without limitation the federal Controlled Substances Act and the Food, Drug, and Cosmetic Act. tC 13. Plaintiff’s claims are barred, in whole or in part, by conflict preemption, as set ric forth in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharm. Co. v. Bartlett, 133 ist sD S. Ct. 2466 (2013). es 14. Plaintiff’s claims are preempted insofar as they conflict with Congress’s purposes rg and objectives in enacting relevant federal legislation and authorizing regulations, including the Bu Hatch-Waxman amendments to the FDCA and implementing regulations. See Geier v. Am. n ily Honda Co., 529 U.S. 861 (2000). ar M 15. Plaintiff’s claims are barred in whole or in part by the Dormant Commerce Clause of of the United States Constitution. e ffic 16. Plaintiff’s claims are barred, in whole or in part, by the deference that common O law accords discretionary actions by the FDA under the FDCA and discretionary actions by the y op DEA under the Controlled Substances Act. C 17. Plaintiff’s claims are barred, in whole or in part, for failure to exhaust ial fic administrative remedies. of 18. Plaintiff’s claims are barred in whole or in part to the extent that they violate the Un Due Process Clause of the United States and Texas Constitutions. 19. 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. 3 880752.1 20. Plaintiff cannot obtain relief on their claims based on actions undertaken by Defendant of which Defendant provided notice of all reasonable facts. 21. Defendant did not owe or breach any duty to Plaintiff. 22. Defendant appropriately, completely, and fully discharged any and all obligations k ler and legal duties arising out of the matters alleged in the Petition. tC 23. Plaintiff’s claims are not ripe, and/or have been mooted. ric 24. Defendant has no legal duty to protect Plaintiff from the intentional criminal acts ist sD of third persons. The criminal conduct of a third party is a superseding cause that extinguishes es liability. Plaintiff’s alleged damages were caused by the intentional and criminal activities of rg unidentified persons over which Defendant had no right of control. Bu 25. Plaintiff is barred by the free public services/municipal cost recovery doctrine n ily from recovering costs incurred in providing public services. ar M 26. Plaintiff’s claims are barred, in whole or in part, by the economic loss rule. of 27. Plaintiff’s claims are barred by all applicable statutes of limitation and repose. e ffic 28. Plaintiff’s claims are barred in whole or in part by Plaintiff’s knowledge of O alleged falsity and/or acquiescence. y op 29. Plaintiff’s claims are barred in whole or in part by the doctrine of avoidable C consequences. ial fic 30. Plaintiff’s claims are barred by consent. of 31. Plaintiff’s claims are barred by ratification and/or condonation. Un 32. The alleged injuries were not legally foreseeable. 33. The claims raised by Plaintiff are barred by the doctrines of laches, waiver, ratification, estoppel, unclean hands, quasi-estoppel, and/or equitable estoppel. 4 880752.1 34. Plaintiff’s claims are barred in whole or in part by the doctrines of acquiescence, settlement and or release. 35. 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 k ler and for all sums of money received or available from or on behalf of any tortfeasor(s) for the tC same injuries alleged in the Petition. Defendant has a right under Chapters 32 and 33 of the ric Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found ist sD against them, based on the product, negligence, or other conduct of any settling tortfeasor and/or es responsible third-party. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff is rg proportionately responsible for any damage it alleges to have suffered with respect to the claims Bu asserted against McKesson. Therefore, Plaintiff’s claims are barred in whole or in part by their n ily contributory fault. ar M 36. McKesson pleads for, and is entitled to, a comparative fault submission under of Chapter 33 of the Texas Civil Practice and Remedies Code which will compare the fault of all e ffic Parties and responsible third parties. O 37. Any damages that Plaintiff may recover against Defendant must be reduced to the y op extent that Plaintiff is seeking damages for alleged injuries or expenses related to the same C user(s) of the subject prescription medications, or damages recovered or recoverable by other ial fic actual or potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be of reduced to the extent they unjustly enrich Plaintiff. Un 38. Plaintiff’s claims are barred, in whole or in part, by res judicata and collateral estoppel. 5 880752.1 39. Plaintiff’s 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. k ler 40. Any verdict or judgment that might be recovered by Plaintiff must be reduced by tC those amounts that have already indemnified or with reasonable certainty will indemnify Plaintiff ric in whole or in part for any past or future claimed economic loss from any collateral source or any ist sD other applicable law. es 41. Plaintiff’s damages, if any, were proximately caused, in whole or in part, by rg independent, intervening, or superseding causes, events, factors, occurrences, or conditions, Bu which were not reasonably foreseeable and not caused by Defendant and for which Defendant is n ily not liable. ar M 42. Any and all damages alleged by Plaintiff were caused by misuse of the products of involved, failure to use the products properly, and/or alteration of, or criminal misuse or abuse of e ffic the product by third parties over whom Defendant had no control and for whom Defendant is not O responsible. y op 43. Plaintiff suffered no injuries or damages as a result of any action by Defendant. C 44. No conduct of Defendant was misleading, unfair, or deceptive. ial fic 45. Plaintiff’s claims are barred, in whole or in part, by its failures to mitigate its of alleged damages. Un 46. Any and all damages claimed by Plaintiff, whether actual, compensatory, punitive, attorneys’ fees, or otherwise are subject to all applicable statutory and common law exclusions, caps, and limitations. 6 880752.1 47. Plaintiff’s claims for punitive or exemplary damages are barred because Plaintiff cannot 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 Plaintiff to recover punitive or exemplary damages. k ler 48. Plaintiff’s alleged damages are speculative, uncertain, and hypothetical. tC 49. Plaintiff’s claims are barred and/or reduced by the assumption of risk, informed ric consent, contributory or comparative negligence, contributory or comparative fault, and ist sD proportionate responsibility. McKesson asserts its right of contribution under Texas law with es respect to any settling person, responsible party or tortfeasor, and McKesson invokes all rg protections contained within Chapter 41 of the Texas Civil Practice and Remedies Code. Bu 50. Plaintiff’s claims or damages are barred because users of the medications at issue n ily used them after they knew, or should have known, of their alleged risks. ar M 51. Defendant denies all types of causation including without limitation cause in fact, of proximate cause and producing cause, with respect to the claims asserted against Defendant. e ffic 52. Plaintiff’s claims and alleged damages are barred under the learned intermediary O doctrine because adequate warnings were given to learned intermediaries. y op 53. Plaintiff’s damages, if any, were the direct result of circumstances over which C Defendant had and continues to have no control. ial fic 54. All of the limitations and requirements contained in Chapter 41 of the Texas Civil of Practice and Remedies Code, and all federal and Texas constitutional limitations upon the Un 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. 7 880752.1 55. Plaintiff’s 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. 56. Plaintiff’s claims based on alleged violations of industry customs fail because purported industry customs do not create legal duties on Defendant. k ler 57. Defendant is not liable to Plaintiff because Defendant is a non-manufacturing tC seller under Texas Civil Practice & Remedies Code § 82.003. ric 58. Pursuant to Texas Civil Practice & Remedies Code § 82.007, Defendant is not ist sD liable with respect to any allegations involving failure to provide adequate warning or es information because all of the warning or information that accompanied the allegedly distributed rg products were approved by the United States Food & Drug Administration for a product Bu approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as n ily amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended, or the ar M warnings and information provided were those stated in monographs developed by the United of States Food & Drug Administration for pharmaceutical products that may be distributed without e ffic an approved new drug application. O 59. Plaintiff’s claims are barred or limited to the extent they have been abrogated by y op the Texas Products Liability Act, Texas Civil Practice & Remedies Code Chapter 82. C 60. The conduct of Defendant conformed with the FDCA and the requirements of the ial fic FDA, the Controlled Substances Act, and DEA regulations, and the activities of Defendant of alleged in the Petition conformed with all state and federal statutes, regulations, and industry Un standards based on the state of knowledge at the relevant time(s) alleged in the Petition. 61. 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 8 880752.1 mandatory safety standards or regulations adopted and promulgated by the federal government, or an agency of the federal government, applicable to the products at the time of manufacture and that governed the product risk that allegedly caused the purported harm. 62. Plaintiff may not recover against Defendant because the methods, standards, or k ler techniques of designing, manufacturing, labeling and distributing of the prescription medications tC at issue complied with and were in conformity with the generally recognized state of the art at ric the time the product was designed, manufactured, labeled, and distributed. ist sD 63. Plaintiff would be unjustly enriched if allowed to recover on any of their claims. es 64. Plaintiff’s claims are barred, in whole or in part, by application of the doctrine of rg release. Bu 65. Plaintiff’s claims are barred, in whole or in part, because the First Amendment n ily and/or Article I, Section 8 of the Texas Constitution protect Defendant’s commercial and ar M political speech. of 66. To the extent Plaintiff’s claims depend solely on violations of federal law, e ffic including any claims of “fraud on the DEA” with respect to Defendant’s compliance with O statutes or regulations administered and/or enforced by the DEA, such claims are barred and y op should be dismissed. See Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001). C 67. To the extent that Plaintiff relies on letters or other informal guidance from the ial fic DEA to establish Defendant’s regulatory duties, such informal guidance cannot enlarge of Defendant’s regulatory duties in the absence of compliance by DEA with the requirements of the Un Administrative Procedure Act, 5 U.S.C. §§ 551 et seq. 9 880752.1 68. Plaintiff cannot state a claim against Defendant with regard to warnings and labeling for products because the remedy sought by the County is subject to the exclusive regulation of the FDA. 69. To the extent Plaintiff seeks punitive, exemplary, or aggravated damages, any k ler such damages are barred because the product at issue, and its labeling were subject to and tC received pre-market approval by the FDA under 52 Stat. 1040, 21 U.S.C. § 301. ric 70. Plaintiff’s claims are barred, in whole or in part, because federal agencies have ist sD exclusive or primary jurisdiction over the matters asserted in Plaintiff’s petition. es 71. Plaintiff has failed to join one or more necessary and indispensable parties, rg including without limitation healthcare providers, prescribers, patients, and other third parties Bu whom the County alleges engaged in the unauthorized or illicit prescription, dispensing, n ily diversion, or use of prescription opioid products in Ellis County. ar M 72. Plaintiff’s damages, if any, were the direct result of pre-existing medical of conditions, and/or occurred by operation of nature or as a result of circumstances over which e ffic Defendant had and continues to have no control. O 73. Plaintiff’s injuries and damages, if any, were due to pre-existing conditions or y op idiosyncratic reaction to the medications on the part of the medication users, for which C Defendant cannot be held responsible. ial fic 74. Plaintiff’s claims are barred, in whole or in part, because neither users nor their of prescribers relied to their detriment upon any statement by Defendant in determining to use Un medications at issue. 75. 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. 10 880752.1 76. Plaintiff’s claims are barred, in whole or in part, by the Restatement (Second) of Torts § 402A, Comments j and k, and Restatement (Third) of Torts: Products Liability § 6. 77. Defendant is not liable for statements or omissions in the Manufacturer Defendants’ branded or unbranded materials. k ler 78. Plaintiff has failed to plead any actionable misrepresentation or omission made by tC or attributable to Defendant. ric 79. Plaintiff’s claims are barred in whole or in part because no statement or conduct ist sD of McKesson was misleading, unfair, or deceptive. es 80. Plaintiff’s claims are barred to the extent that they are based on alleged violations rg of industry customs because industry customs do not create legal duties on Defendant. Bu 81. Plaintiff’s claim for unjust enrichment is barred or limited because Defendant did n ily not receive and retain any alleged benefit from Plaintiff. ar M 82. To the extent Plaintiff seeks relief for Defendant’s conduct occurring before of enactment of applicable statutes or regulations, the claims fail because the statutes and e ffic regulations do not apply retroactively. O 83. McKesson’s rights under the Due Process Clause of the U.S. Constitution and y op applicable state Constitution or statute are violated by any financial or other arrangement that C might distort a government attorney’s duty to pursue justice rather than his or her personal ial fic interests, financial or otherwise, in the context of a civil enforcement proceeding, including by of Plaintiff’s use of a contingency fee contract with private counsel. Un 84. 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. 11 880752.1 85. 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. 86. The claims asserted against McKesson and other Defendants do not arise out of k