Preview
2/18/2019 5:34 PM
Marilyn Burgess - District Clerk Harris County
Envelope No. 31280330
By: KATINA WILLIAMS
Filed: 2/18/2019 5:34 PM
MDL PRETRIAL CAUSE NO. 2018-77111
COUNTY OF HOPKINS § IN THE DISTRICT COURT
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Plaintiff, §
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v. § 152ND JUDICIAL DISTRICT
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PURDUE PHARMA LP, et al. §
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Defendants. § HARRIS COUNTY, TEXAS
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MASTER FILE NO. 2018-63587
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§ IN THE DISTRICT COURT
IN RE: TEXAS OPIOID LITIGATION
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MDL NO. 18-0358 § 152ND JUDICIAL DISTRICT
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§ HARRIS COUNTY, TEXAS
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MCKESSON CORPORATION’S ORIGINAL ANSWER TO PLAINTIFF’S FOURTH
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AMENDED PETITION
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Defendant McKesson Corporation (“Defendant” or “McKesson”) files its Original
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Answer and Defenses to Plaintiff’s Fourth Amended Petition and in support shows the
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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 Hopkins, and demands
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strict proof thereof.
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II.
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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
citizens of Hopkins County.
3. Plaintiff has no capacity, authority, or right to assert some or all of its claims,
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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5. 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.
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10. Plaintiff’s damages and claims against Defendant are barred or limited, in whole
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or in part, by common law, statutory, and state constitutional constraints on the exercise of police
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powers by a state county.
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11. Plaintiff’s petition fails in whole or in part to state a claim upon which relief can
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be granted, fails to state sufficient facts sufficient to constitute a cause of action, and fails to
plead cognizable injury.
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12. 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.
13. 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
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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.
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19. Plaintiff’s claims are barred, in whole or in part, to the extent that they violate the
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Ex Post Facto clauses of the United States and Texas Constitutions.
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20. Plaintiff cannot obtain relief on its 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.
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22. Defendant appropriately, completely, and fully discharged any and all obligations
and legal duties arising out of the matters alleged in the Petition.
23. Plaintiff’s claims are not ripe, and/or have been mooted.
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.
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33. The claims raised by Plaintiff are barred by the doctrines of laches, waiver,
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ratification, estoppel, unclean hands, quasi-estoppel, and/or equitable estoppel.
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34. Plaintiff’s claims are barred in whole or in part by the doctrines of acquiescence,
settlement and or release.
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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
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
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Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found
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against it,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
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estoppel.
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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,
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failure to fulfill conditions precedent, failure to provide requisite notice, payment, accord and
satisfaction, and compromise and settlement.
40. Any verdict or judgment that might be recovered by Plaintiff must be reduced by
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,
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punitive, attorneys’ fees, or otherwise are subject to all applicable statutory and common law
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exclusions, caps, and limitations.
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
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McKesson has neither acted nor failed to act in a manner that entitled Plaintiff to recover
punitive or exemplary damages.
48. Plaintiff’s alleged damages are speculative, uncertain, and hypothetical.
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
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North America v. Gore, 116 S. Ct. 1589 (1996) and State Farm Mutual Insurance Co. v.
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Campbell, 538 U.S. 408 (2003), preclude an award of punitive or exemplary damages.
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.
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56. Plaintiff’s claims based on alleged violations of industry customs fail because
purported industry customs do not create legal duties on Defendant.
57. Defendant is not liable to Plaintiff because Defendant is a non-manufacturing
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.
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61. Defendant is not liable for any injury allegedly caused to Plaintiff by the products
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in question because all formulations, labeling, and design of the products complied with
mandatory safety standards or regulations adopted and promulgated by the federal government,
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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
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 are based on alleged misrepresentations made to
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the FDA, such claims are barred pursuant to Buckman Co. v. Plaintiff’s Legal Committee, 531
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U.S. 341 (2001).
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67. 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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68. 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
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 seq.
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69. 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.
70. 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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71. 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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72. 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 Hopkins County.
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73. 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 continue to have no control.
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74. 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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75. 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.
76. 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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77. 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.
78. Defendant is not liable for statements or omissions in the Manufacturer
Defendants’ branded or unbranded materials.
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79. Plaintiff has failed to plead any actionable misrepresentation or omission made by
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or attributable to Defendant.
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80. 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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81. 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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82. 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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83. 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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84. 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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85. 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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86. 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.
87. The claims asserted against McKesson and other Defendants do not arise out of
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2/18/2019 5:34 PM Marilyn Burgess - District Clerk Harris County Envelope No. 31280330 By: KATINA WILLIAMS Filed: 2/18/2019 5:34 PM MDL PRETRIAL CAUSE NO. 2018-77111 COUNTY OF HOPKINS § IN THE DISTRICT COURT § Plaintiff, § § v. § 152ND JUDICIAL DISTRICT k § ler PURDUE PHARMA LP, et al. § § tC Defendants. § HARRIS COUNTY, TEXAS ric MASTER FILE NO. 2018-63587 ist sD § IN THE DISTRICT COURT IN RE: TEXAS OPIOID LITIGATION § es MDL NO. 18-0358 § 152ND JUDICIAL DISTRICT § rg § HARRIS COUNTY, TEXAS Bu n MCKESSON CORPORATION’S ORIGINAL ANSWER TO PLAINTIFF’S FOURTH ily AMENDED PETITION ar Defendant McKesson Corporation (“Defendant” or “McKesson”) files its Original M Answer and Defenses to Plaintiff’s Fourth Amended Petition and in support shows the of e following: ffic I. O General Denial y op Pursuant to Rule 92 of the Texas Rules of Civil Procedure, Defendant asserts a general C denial, denies each and every allegation made by Plaintiff County of Hopkins, and demands ial fic strict proof thereof. of II. Un 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. 829077.1 2. Plaintiff has no authority or right to bring such claims on behalf of itself or the citizens of Hopkins County. 3. Plaintiff has no capacity, authority, or right to assert some or all of its claims, including claims brought indirectly on behalf of its citizens or claims brought as parens patriae. k ler 4. McKesson asserts that it is not liable in the capacity in which it has been sued. tC 5. Plaintiff’s claims are barred because Plaintiff is not the real party in interest. ric 6. Defendant further pleads, if such be necessary, and pleading in the alternative, ist sD that Plaintiff’s claims are barred by the doctrine of in pari delicto. es 7. Plaintiff’s claims are subject to all the defenses that could be asserted if Plaintiff’s rg claims were properly made by individuals on whose behalf or for whose alleged damages Bu Plaintiff seeks to recover. n ily 8. The derivative injury rule and the remoteness doctrines bar Plaintiff from ar M recovering payments that Plaintiff allegedly made on behalf of residents to reimburse any of expenses for health care, pharmaceutical care, and other public services. e ffic 9. The alleged injuries asserted by Plaintiff are too remote from the alleged conduct O of Defendant to provide a basis for liability as a matter of law and due process. y op 10. Plaintiff’s damages and claims against Defendant are barred or limited, in whole C or in part, by common law, statutory, and state constitutional constraints on the exercise of police ial fic powers by a state county. of 11. Plaintiff’s petition fails in whole or in part to state a claim upon which relief can Un be granted, fails to state sufficient facts sufficient to constitute a cause of action, and fails to plead cognizable injury. 2 829077.1 12. 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. 13. 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 k ler S. Ct. 2466 (2013). tC 14. Plaintiff’s claims are preempted insofar as they conflict with Congress’s purposes ric and objectives in enacting relevant federal legislation and authorizing regulations, including the ist sD Hatch-Waxman amendments to the FDCA and implementing regulations. See Geier v. Am. es Honda Co., 529 U.S. 861 (2000). rg 15. Plaintiff’s claims are barred in whole or in part by the Dormant Commerce Clause Bu of the United States Constitution. n ily 16. Plaintiff’s claims are barred, in whole or in part, by the deference that common ar M law accords discretionary actions by the FDA under the FDCA and discretionary actions by the of DEA under the Controlled Substances Act. e ffic 17. Plaintiff’s claims are barred, in whole or in part, for failure to exhaust O administrative remedies. y op 18. Plaintiff’s claims are barred in whole or in part to the extent that they violate the C Due Process Clause of the United States and Texas Constitutions. ial fic 19. Plaintiff’s claims are barred, in whole or in part, to the extent that they violate the of Ex Post Facto clauses of the United States and Texas Constitutions. Un 20. Plaintiff cannot obtain relief on its 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. 3 829077.1 22. Defendant appropriately, completely, and fully discharged any and all obligations and legal duties arising out of the matters alleged in the Petition. 23. Plaintiff’s claims are not ripe, and/or have been mooted. 24. Defendant has no legal duty to protect Plaintiff from the intentional criminal acts k ler of third persons. The criminal conduct of a third party is a superseding cause that extinguishes tC liability. Plaintiff’s alleged damages were caused by the intentional and criminal activities of ric unidentified persons over which Defendant had no right of control. ist sD 25. Plaintiff is barred by the free public services/municipal cost recovery doctrine es from recovering costs incurred in providing public services. rg 26. Plaintiff’s claims are barred, in whole or in part, by the economic loss rule. Bu 27. Plaintiff’s claims are barred by all applicable statutes of limitation and repose. n ily 28. Plaintiff’s claims are barred in whole or in part by Plaintiff’s knowledge of ar M alleged falsity and/or acquiescence. of 29. Plaintiff’s claims are barred in whole or in part by the doctrine of avoidable e ffic consequences. O 30. Plaintiff’s claims are barred by consent. y op 31. Plaintiff’s claims are barred by ratification and/or condonation. C 32. The alleged injuries were not legally foreseeable. ial fic 33. The claims raised by Plaintiff are barred by the doctrines of laches, waiver, of ratification, estoppel, unclean hands, quasi-estoppel, and/or equitable estoppel. Un 34. Plaintiff’s claims are barred in whole or in part by the doctrines of acquiescence, settlement and or release. 4 829077.1 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 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 k ler Texas Civil Practice & Remedies Code to a proportionate reduction of any damages found tC against it,based on the product, negligence, or other conduct of any settling tortfeasor and/or ric responsible third-party. Under Texas Civil Practices and Remedies Code, Chapter 33, Plaintiff is ist sD proportionately responsible for any damage it alleges to have suffered with respect to the claims es asserted against McKesson. Therefore, Plaintiff’s claims are barred in whole or in part by their rg contributory fault. Bu 36. McKesson pleads for, and is entitled to, a comparative fault submission under n ily Chapter 33 of the Texas Civil Practice and Remedies Code which will compare the fault of all ar M Parties and responsible third parties. of 37. Any damages that Plaintiff may recover against Defendant must be reduced to the e ffic extent that Plaintiff is seeking damages for alleged injuries or expenses related to the same O user(s) of the subject prescription medications, or damages recovered or recoverable by other y op actual or potential plaintiffs. Any damages that Plaintiff may recover against Defendant must be C reduced to the extent they unjustly enrich Plaintiff. ial fic 38. Plaintiff’s claims are barred, in whole or in part, by res judicata and collateral of estoppel. Un 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, 5 829077.1 failure to fulfill conditions precedent, failure to provide requisite notice, payment, accord and satisfaction, and compromise and settlement. 40. Any verdict or judgment that might be recovered by Plaintiff must be reduced by those amounts that have already indemnified or with reasonable certainty will indemnify Plaintiff k ler in whole or in part for any past or future claimed economic loss from any collateral source or any tC other applicable law. ric 41. Plaintiff’s damages, if any, were proximately caused, in whole or in part, by ist sD independent, intervening, or superseding causes, events, factors, occurrences, or conditions, es which were not reasonably foreseeable and not caused by Defendant and for which Defendant is rg not liable. Bu 42. Any and all damages alleged by Plaintiff were caused by misuse of the products n ily involved, failure to use the products properly, and/or alteration of, or criminal misuse or abuse of ar M the product by third parties over whom Defendant had no control and for whom Defendant is not of responsible. e ffic 43. Plaintiff suffered no injuries or damages as a result of any action by Defendant. O 44. No conduct of Defendant was misleading, unfair, or deceptive. y op 45. Plaintiff’s claims are barred, in whole or in part, by its failures to mitigate its C alleged damages. ial fic 46. Any and all damages claimed by Plaintiff, whether actual, compensatory, of punitive, attorneys’ fees, or otherwise are subject to all applicable statutory and common law Un exclusions, caps, and limitations. 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 6 829077.1 McKesson has neither acted nor failed to act in a manner that entitled Plaintiff to recover punitive or exemplary damages. 48. Plaintiff’s alleged damages are speculative, uncertain, and hypothetical. 49. Plaintiff’s claims are barred and/or reduced by the assumption of risk, informed k ler consent, contributory or comparative negligence, contributory or comparative fault, and tC proportionate responsibility. McKesson asserts its right of contribution under Texas law with ric respect to any settling person, responsible party or tortfeasor, and McKesson invokes all ist sD protections contained within Chapter 41 of the Texas Civil Practice and Remedies Code. es 50. Plaintiff’s claims or damages are barred because users of the medications at issue rg used them after they knew, or should have known, of their alleged risks. Bu 51. Defendant denies all types of causation including without limitation cause in fact, n ily proximate cause and producing cause, with respect to the claims asserted against Defendant. ar M 52. Plaintiff’s claims and alleged damages are barred under the learned intermediary of doctrine because adequate warnings were given to learned intermediaries. e ffic 53. Plaintiff’s damages, if any, were the direct result of circumstances over which O Defendant had and continues to have no control. y op 54. All of the limitations and requirements contained in Chapter 41 of the Texas Civil C Practice and Remedies Code, and all federal and Texas constitutional limitations upon the ial fic assessment of punitive or exemplary damages, including those stated in the decisions of BMW of of North America v. Gore, 116 S. Ct. 1589 (1996) and State Farm Mutual Insurance Co. v. Un Campbell, 538 U.S. 408 (2003), preclude an award of punitive or exemplary damages. 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. 7 829077.1 56. Plaintiff’s claims based on alleged violations of industry customs fail because purported industry customs do not create legal duties on Defendant. 57. Defendant is not liable to Plaintiff because Defendant is a non-manufacturing seller under Texas Civil Practice & Remedies Code § 82.003. k ler 58. Pursuant to Texas Civil Practice & Remedies Code § 82.007, Defendant is not tC liable with respect to any allegations involving failure to provide adequate warning or ric information because all of the warning or information that accompanied the allegedly distributed ist sD products were approved by the United States Food & Drug Administration for a product es approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as rg amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended, or the Bu warnings and information provided were those stated in monographs developed by the United n ily States Food & Drug Administration for pharmaceutical products that may be distributed without ar M an approved new drug application. of 59. Plaintiff’s claims are barred or limited to the extent they have been abrogated by e ffic the Texas Products Liability Act, Texas Civil Practice & Remedies Code Chapter 82. O 60. The conduct of Defendant conformed with the FDCA and the requirements of the y op FDA, the Controlled Substances Act, and DEA regulations, and the activities of Defendant C alleged in the Petition conformed with all state and federal statutes, regulations, and industry ial fic standards based on the state of knowledge at the relevant time(s) alleged in the Petition. of 61. Defendant is not liable for any injury allegedly caused to Plaintiff by the products Un in question because all formulations, labeling, and design of the products complied with mandatory safety standards or regulations adopted and promulgated by the federal government, 8 829077.1 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 techniques of designing, manufacturing, labeling and distributing of the prescription medications k ler at issue complied with and were in conformity with the generally recognized state of the art at tC the time the product was designed, manufactured, labeled, and distributed. ric 63. Plaintiff would be unjustly enriched if allowed to recover on any of their claims. ist sD 64. Plaintiff’s claims are barred, in whole or in part, by application of the doctrine of es release. rg 65. Plaintiff’s claims are barred, in whole or in part, because the First Amendment Bu and/or Article I, Section 8 of the Texas Constitution protect Defendant’s commercial and n ily political speech. ar M 66. To the extent Plaintiff’s claims are based on alleged misrepresentations made to of the FDA, such claims are barred pursuant to Buckman Co. v. Plaintiff’s Legal Committee, 531 e ffic U.S. 341 (2001). O 67. To the extent Plaintiff’s claims depend solely on violations of federal law, y op including any claims of “fraud on the DEA” with respect to Defendant’s compliance with C statutes or regulations administered and/or enforced by the DEA, such claims are barred and ial fic should be dismissed. See Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001). of 68. To the extent that Plaintiff relies on letters or other informal guidance from the Un DEA to establish Defendant’s regulatory duties, such informal guidance cannot 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 seq. 9 829077.1 69. 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. 70. 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 71. 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 72. 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 Hopkins County. ar M 73. 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 continue to have no control. O 74. 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 75. 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. 76. 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 829077.1 77. 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. 78. Defendant is not liable for statements or omissions in the Manufacturer Defendants’ branded or unbranded materials. k ler 79. Plaintiff has failed to plead any actionable misrepresentation or omission made by tC or attributable to Defendant. ric 80. 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 81. 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 82. 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 83. 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 84. 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 85. 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 829077.1 86. 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. 87. The claims asserted against McKesson and other Defendants do not arise out of k