On October 23, 2018 a
Answer
was filed
involving a dispute between
County Of Nueces,
Nueces County Hospital District,
and
Abbvie Inc,
Actavis Inc,
Actavis Laboratories Ut Inc,
Actavis Llc,
Actavis Pharma Inc,
Actavis Plc,
Advanced Pharma Inc,
Allergan Finance Llc (F K A Actavis Inc F K A Watson Pharmaceuticals,
Allergan Plc,
Allergan Sales Llc,
Allergan Usa Inc,
Amerisourcebergen Corporation,
Amerisourcebergen Drug Corporation,
Assertio Therapeutics, Inc., F K A Depomed Inc.,
Avella Of Houston,
Cardinal Health 105 Inc,
Cardinal Health 108 Llc,
Cardinal Health 110 Llc,
Cardinal Health 112 Llc,
Cardinal Health 200 Llc,
Cardinal Health 414 Llc,
Cardinal Health Inc,
Cephalon Inc,
Depomed Inc,
Endo Health Solutions Inc,
Endo Pharmaceuticals Inc,
Insys Manufacturing Llc,
Insys Therapeutics Inc,
Janssen Pharmaceutica Inc,
Janssen Pharmaceuticals Inc (F K A Ortho-Mcneil-Janssen,
Johnson & Johnson,
Knoll Pharmaceutical Company,
Mallinckrodt Llc,
Mallinckrodt Plc,
Mckesson Corporation,
Mckesson Medical-Surgical Inc,
Mission Pharmacal Company,
Mylan Bertek Pharmaceuticals Inc,
Mylan Inc,
Mylan Institutional Inc,
Mylan Pharmaceuticals Inc,
Mylan Specialty L P,
Noramco Inc,
Ortho-Mcneil-Janssen Pharmaceuticals Inc,
Purdue Pharmaceuticals L P,
Purdue Pharma Inc,
Purdue Pharma L P,
Purdue Pharma Manufacturing L P,
Teva Pharmaceutical Industries Ltd,
Teva Pharmaceuticals Usa Inc,
The Purdue Frederick Company,
The Purdue Frederick Company Inc,
Watson Laboratories Inc,
Watson Pharmaceuticals Inc,
Watson Pharma Inc,
for MDL - Opioid Litigation
in the District Court of Harris County.
Preview
MDL PRETRIAL CAUSE NO. -77083
COUNTY OF NUECES and IN THE COUNTY COURT
NUECES COUNTY HOSPITAL DISTRICT
Plaintiff
LAW
PURDUE PHARMA, L.P. et al.,
Defendants. NUECES COUNTY, TEXAS
MASTER FILE NO. 2018
IN THE DISTRICT COURT
IN RE: TEXAS OPIOID LITIGATION JUDICIAL DISTRICT
HARRIS COUNTY, TEXAS
DEFENDANTS JANSSEN PHARMACEUTICALS, INC. AND
JOHNSON & JOHNSON’S ANSWER TO PLAINTIFFS’ ORIGINAL PETITION
Janssen Pharmaceuticals, Inc., its predecessor companies Ortho-McNeil-Janssen
Pharmaceuticals, Inc. and Janssen Pharmaceutica, Inc. (collectively “Janssen”), and its parent
company Johnson & Johnson (“J&J”) hereby file their Original Answer to Plaintiffs Original
Petition and Jury Demand (“Petition”).
General Denial
Pursuant to Rule 92 of the Texas Rules of Civil Procedure, J&J and Janssen
generally deny each and every, all and singular the allegations set forth in Plaintiffs’ Petition
and demand strict proof thereof.
Specific Denial
Pursuant to Rule 54 of the Texas Rules of Civil Procedure, J&J and Janssen
specifically deny that Plaintiffs have properly pled that all conditions precedent to Plaintiffs
claims have been performed or have occurred, and deny that such conditions precedent have
been met in their entirety.
Affirmative and Other Defenses
3. Plaintiffs’ Petition fails to state a claim upon which relief may be granted, fails to
state facts sufficient to constitute a cause of action, and fails to plead a legally cognizable injury.
4. Plaintiffs’ claims are barred in whole or in part for lack of standing.
5. Plaintiffs’ claims are barred in whole or in part because Plaintiffs have no parens
patriae or other authority to bring the claims alleged.
6. Plaintiffs’ claims are barred in whole or in part by the learned intermediary
doctrine.
7. Plaintiffs’ claims are barred in whole or in part by the doctrine of laches.
8. Plaintiffs’ claims are barred in whole or in part by applicable limitations periods
and/or statutes of repose.
9. Plaintiffs’ claims are barred in whole or in part by Plaintiffs’ failure to mitigate its
alleged damages. The damages, if any, recoverable by Plaintiffs must be reduced by the amount
of damages caused by Plaintiffs’ failure to mitigate such damages.
10. Plaintiffs’ claims are barred in whole or in part by the economic loss rule.
11. Plaintiffs’ claims are barred in whole or in part by the municipal cost recovery
rule.
12. Plaintiffs’ alleged damages and other requested forms of relief are too speculative
and remote to serve as a legal basis for any recovery.
2
13. Plaintiffs’ claims are barred in whole or in part by the free public services
doctrine insofar as Plaintiffs seek to recover, inter alia, the cost of opioids disbursed or paid for
by Plaintiffs.
14. Plaintiffs’ claims are barred in whole or in part because the injuries alleged
resulted from one or more criminal acts by third parties.
15. Plaintiffs’ claims are barred in whole or in part because Plaintiffs fail to plead any
duty owed to Plaintiffs by J&J and/or Janssen.
16. If Plaintiffs have sustained any injuries or damages, such were the result of
intervening or superseding events, factors, occurrences, or conditions, which were not reasonably
foreseeable and in no way caused by J&J or Janssen and for which J&J and Janssen are not
liable.
17. Plaintiffs were negligent, careless, and/or at fault and contributed substantially to
any alleged risks, injuries, and damages. Such negligence, carelessness, and fault bar, in whole
or in part, the damages Plaintiffs seek in this case. Plaintiffs also failed to exercise ordinary care,
caution, or prudence to avoid its alleged injuries or damages; thus, Plaintiffs’ alleged injuries or
damages were caused by its own acts or omissions. For all of these reasons, any damages
awarded to Plaintiffs should be barred or limited under the contribution and proportionate-
responsibility provisions in Chapter 33 of the Texas Civil Practice and Remedies Code.
18. To the extent Plaintiffs sustained any injuries or incurred any expenses as alleged
in the Complaint, responsibility for 51% or more of those injuries or expenses lie with Plaintiffs
and/or parties or entities other than J&J or Janssen over whom J&J and Janssen have no
supervision or control and for whose actions and omissions J&J and Janssen have no
3
responsibility. As such, at most, J&J and Janssen may only be severally liable for Plaintiffs’
injuries or expenses.
19. Any damages Plaintiffs may have suffered were caused in whole or in part by the
negligence, carelessness, and/or other wrongful conduct of other persons or entities over which
J&J and Janssen had no control and for whose conduct J&J and Janssen are not responsible or
liable.
20. Any imposition of liability, damages, penalties, or other relief against J&J or
Janssen for the negligent, intentional, malicious, criminal, and/or other acts or omissions of
parties or third parties not subject to J&J and/or Janssen’s control or authority would violate J&J
and Janssen’s procedural and substantive due process rights under the Fourteenth Amendment to
the United States Constitution and Article I, Section 19 of the Texas Constitution.
21. To the extent Plaintiffs seek relief for conduct not actionable at the time it
occurred, Plaintiffs’ claims are barred because they violate J&J and Janssen’s procedural and
substantive due process rights under the Fourteenth Amendment to the United States
Constitution and Article I, Section 19 of the Texas Constitution, and by J&J and Janssen’s right
to be free from retroactive or ex post facto laws as guaranteed by Article I, Section 10 of the
United States Constitution and Article I, Section 16 of the Texas Constitution.
22. Plaintiffs’ claims are barred in whole or in part because the application of Texas
law to conduct in other states or countries would violate the Dormant Commerce Clause of the
United States Constitution.
23. Plaintiffs’ claims are preempted by federal and state law and any regulations or
rules promulgated under such law, including, but not limited to, the federal Food, Drug, and
Cosmetic Act (“FDCA”), associated U.S. Food and Drug Administration (“FDA”) regulations,
4
the federal Controlled Substances Act, the Texas Food, Drug, and Cosmetic Act, and the Texas
Controlled Substances Act. See, e.g., 21 U.S.C. §§ 301 et seq.; 21 U.S.C. §§ 802 et seq.;
21 C.F.R. §§ 201.1 et seq., 202.1 et seq., 203.1 et seq.; Tex. Health & Safety Code §§ 431.001 et
seq.; Tex. Health & Safety Code §§ 481 et seq.
24. Plaintiffs’ claims are preempted, in whole or in part, by federal law, to the extent
that they are based on alleged misrepresentations made to the FDA, or otherwise assert that
incorrect, incomplete, or inaccurate information was provided to the FDA. See, e.g., Mutual
Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); Buckman Co. v. Pls.’ Legal Comm., 531 U.S. 341
(2001); Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015); Geier v. Am.
Honda Co., 529 U.S. 861 (2000).
25. Plaintiffs’ claims, if granted, would constitute an impermissible burden by this
Court on federal laws, regulations, and policy relating to the development and marketing of
prescription drugs in violation of the Supremacy Clause of the United States Constitution.
26. Plaintiffs’ claims are barred in whole or in part by the deference that federal and
state constitutional law and federal and state common law give to discretionary actions by the
FDA under the FDCA and regulations promulgated under the FDCA.
27. Plaintiffs’ claims regarding warnings and labeling are barred in whole or in part
by the doctrine of primary jurisdiction, in that the FDA is charged under the law with
determining the content of warnings and labeling for products.
28. Plaintiffs cannot state a claim with regard to warnings and labeling for products
because the remedy sought by Plaintiffs is subject to the exclusive regulation of the FDA.
29. Plaintiffs’ claims are barred in whole or in part because the warnings and
instructions provided were adequate and complete. Janssen’s products were neither defective
5
nor unreasonably dangerous when used according to the instructions for use. Indeed, the
warnings and information that accompanied Janssen’s products were approved by the FDA for a
product approved under the FDCA and/or otherwise meet the presumption requirements in
chapter 82 of the Texas Civil Practice and Remedies Code. See Tex. Civ. Prac. & Rem. Code
§§ 82.007–.008
30. Plaintiffs’ claims are barred in whole or in part because J&J and Janssen’s alleged
misrepresentations and prescription opioid medications were not the legal or proximate cause of
the purported nuisance or the alleged injuries or damages incurred by Plaintiffs. Absent such
causation, Plaintiffs’ claims cannot be sustained as a matter of law under the laws and common
law of Texas and would also violate J&J and Janssen’s due process and equal protection rights
guaranteed by the Fifth and Fourteenth Amendments to the United States Constitution and
Article I, Sections 3 and 19 of the Texas Constitution.
31. Plaintiffs’ claims are barred, in whole or in part, by the First Amendment to the
United States Constitution, Article I, Section 8 of the Texas Constitution, and the Noerr-
Pennington doctrine.
32. Plaintiffs’ request for exemplary/punitive damages is barred or limited in whole
or in part, including by the following provisions: (a) chapter 41 of the Texas Civil Practice and
Remedies Code, including the cap on exemplary damages set out in section 41.008 of that code;
(b) the limits of the Due Process Clause of the Fifth and Fourteenth Amendments to the United
States Constitution; (c) the excessive fines clause of the Eighth Amendment to the United States
Constitution; (d) the Full Faith and Credit Clause of the United States Constitution; (e) the limits
of the Double Jeopardy Clause of the Fifth Amendment to the United States Constitution and
Article I, Section 14 of the Texas Constitution; and (f) other applicable provisions of the Texas
6
Constitution, as those limits have been applied by state and federal courts to restrict
exemplary/punitive damages.
33. Plaintiffs’ common-law claims are barred, in whole or in part, by the doctrine of
estoppel.
34. Plaintiffs’ claims are barred, in whole or in part, by principles of equity.
Numerous facts would render the imposition of injunctive relief, civil penalties, or other
remedies inequitable here, including but not limited to J&J’s and Janssen’s good faith reliance on
and interpretation of clinical data and medical literature, the absence of any intentional unlawful
conduct, the course of Plaintiffs’ investigation and pursuit of these claims, and J&J and Janssen’s
good faith reliance on guidance for product communications published by the FDA.
35. Plaintiffs’ claims are barred, in whole or in part, by the doctrine of waiver.
36. Plaintiffs’ claims are barred, in whole or in part, by the doctrines of release and/or
res judicata.
37. Plaintiffs’ claims are barred in whole or in part by assumption of the risk.
38. Plaintiffs’ claims are barred in whole or in part by the sophisticated or
knowledgeable user doctrine.
39. Plaintiffs’ claims are barred in whole or in part by informed consent.
40. In the unlikely event that J&J or Janssen are found liable to Plaintiffs, J&J and
Janssen are entitled to a credit or offset for any and all sums that Plaintiffs have received, or may
hereafter receive, by way of any and all settlements arising from Plaintiffs’ claims and causes of
action.
41. Any verdict or judgment that might be recovered by Plaintiffs must be reduced by
those amounts that have already or will in the future, with reasonable certainty, indemnify
7
Plaintiffs in whole or in part for any past or future claimed economic loss from any collateral
source.
42. Plaintiffs’ claims and damages are barred, in whole or in part, by common law,
statutory, and state constitutional constraints on the exercise of police powers by a state county.
43. Plaintiffs’ claims are barred and/or limited, in whole or in part, pursuant to
applicable statutory and common law regarding limitations on awards, caps on recovery, and
setoffs.
44. Plaintiffs’ claims are barred because its alleged injuries or damages, if any, were
caused in whole or in part by Plaintiffs’ ratification of J&J’s and/or Janssen’s allegedly deceptive
or misleading conduct.
45. Plaintiffs’ claims are barred in whole or in part by the doctrine of unclean hands.
46. Plaintiffs’ claims, injuries, and damages, if any, are barred, in whole or in part, by
the alteration, modification, misuse, illicit use, or abuse of the prescribed medications by third
parties, for which J&J and Janssen are not liable and over whom J&J and Janssen have no
supervision or control and for whose actions and omissions J&J and Janssen have no
responsibility.
47. As a matter of Texas law, Plaintiffs are not entitled to a declaratory judgment,
injunction, or attorney’s fees for these or any other alleged claims.
48. J&J and Janssen may assert other defenses that become available or appear during
the course of additional investigation or discovery in this case and hereby reserve the right to
amend this answer to assert any such defense, consistent with the Texas Rules of Civil
Procedure.
8
Prayer
49. For the reasons stated above, J&J and Janssen respectfully request that
(1) Plaintiffs take nothing in this lawsuit, (2) all of Plaintiffs’ claims be dismissed with prejudice,
(3) J&J and Janssen recover any costs or attorney’s fees to which J&J and Janssen are entitled or
permitted by law, and (4) J&J and Janssen be granted such other and further relief, both at law
and in equity, to which they are entitled.
9
Dated: February 18, 2019 Respectfully submitted,
By: /s/ Stephen E. McConnico
Stephen E. McConnico
State Bar No. 13450300
smcconnico@scottdoug.com
Asher B. Griffin
State Bar No. 24036684
agriffin@scottdoug.com
John W. Ellis
State Bar No. 24078473
jellis@scottdoug.com
SCOTT DOUGLASS & MCCONNICO LLP
303 Colorado Street, Suite 2400
Austin, Texas 78701
Telephone: 512-495-6300
Facsimile: 512-495-6399
Charles C. Lifland
Admitted Pro Hac Vice Pursuant to CMO No. 1
O’MELVENY & MYERS LLP
400 South Hope Street
Los Angeles, California 90071
Telephone: (213) 430-6000
Facsimile: (213) 430-6407
clifland@omm.com
Stephen D. Brody
Admitted Pro Hac Vice Pursuant to CMO No. 1
O’MELVENY & MYERS LLP
1625 Eye Street, NW
Washington, DC 20006
Telephone: (202) 383-5300
sbrody@omm.com
ATTORNEYS FOR DEFENDANTS JOHNSON &
JOHNSON, JANSSEN PHARMACEUTICALS,
INC., ORTHO-MCNEIL-JANSSEN
PHARMACEUTICALS, INC. N/K/A JANSSEN
PHARMACEUTICALS, INC., AND JANSSEN
PHARMACEUTICA, INC. N/K/A JANSSEN
PHARMACEUTICALS, INC.
10
CERTIFICATE OF SERVICE
I certify that I caused a true and correct copy of the foregoing document to be
electronically filed on February 18, 2019, which will transmit service electronically through the
court’s electronic filing manager to all counsel of record.
/s/ Stephen E. McConnico
Stephen E. McConnico
11
Preview
MDL PRETRIAL CAUSE NO. -77083 COUNTY OF NUECES and IN THE COUNTY COURT NUECES COUNTY HOSPITAL DISTRICT Plaintiff LAW PURDUE PHARMA, L.P. et al., Defendants. NUECES COUNTY, TEXAS MASTER FILE NO. 2018 IN THE DISTRICT COURT IN RE: TEXAS OPIOID LITIGATION JUDICIAL DISTRICT HARRIS COUNTY, TEXAS DEFENDANTS JANSSEN PHARMACEUTICALS, INC. AND JOHNSON & JOHNSON’S ANSWER TO PLAINTIFFS’ ORIGINAL PETITION Janssen Pharmaceuticals, Inc., its predecessor companies Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica, Inc. (collectively “Janssen”), and its parent company Johnson & Johnson (“J&J”) hereby file their Original Answer to Plaintiffs Original Petition and Jury Demand (“Petition”). General Denial Pursuant to Rule 92 of the Texas Rules of Civil Procedure, J&J and Janssen generally deny each and every, all and singular the allegations set forth in Plaintiffs’ Petition and demand strict proof thereof. Specific Denial Pursuant to Rule 54 of the Texas Rules of Civil Procedure, J&J and Janssen specifically deny that Plaintiffs have properly pled that all conditions precedent to Plaintiffs claims have been performed or have occurred, and deny that such conditions precedent have been met in their entirety. Affirmative and Other Defenses 3. Plaintiffs’ Petition fails to state a claim upon which relief may be granted, fails to state facts sufficient to constitute a cause of action, and fails to plead a legally cognizable injury. 4. Plaintiffs’ claims are barred in whole or in part for lack of standing. 5. Plaintiffs’ claims are barred in whole or in part because Plaintiffs have no parens patriae or other authority to bring the claims alleged. 6. Plaintiffs’ claims are barred in whole or in part by the learned intermediary doctrine. 7. Plaintiffs’ claims are barred in whole or in part by the doctrine of laches. 8. Plaintiffs’ claims are barred in whole or in part by applicable limitations periods and/or statutes of repose. 9. Plaintiffs’ claims are barred in whole or in part by Plaintiffs’ failure to mitigate its alleged damages. The damages, if any, recoverable by Plaintiffs must be reduced by the amount of damages caused by Plaintiffs’ failure to mitigate such damages. 10. Plaintiffs’ claims are barred in whole or in part by the economic loss rule. 11. Plaintiffs’ claims are barred in whole or in part by the municipal cost recovery rule. 12. Plaintiffs’ alleged damages and other requested forms of relief are too speculative and remote to serve as a legal basis for any recovery. 2 13. Plaintiffs’ claims are barred in whole or in part by the free public services doctrine insofar as Plaintiffs seek to recover, inter alia, the cost of opioids disbursed or paid for by Plaintiffs. 14. Plaintiffs’ claims are barred in whole or in part because the injuries alleged resulted from one or more criminal acts by third parties. 15. Plaintiffs’ claims are barred in whole or in part because Plaintiffs fail to plead any duty owed to Plaintiffs by J&J and/or Janssen. 16. If Plaintiffs have sustained any injuries or damages, such were the result of intervening or superseding events, factors, occurrences, or conditions, which were not reasonably foreseeable and in no way caused by J&J or Janssen and for which J&J and Janssen are not liable. 17. Plaintiffs were negligent, careless, and/or at fault and contributed substantially to any alleged risks, injuries, and damages. Such negligence, carelessness, and fault bar, in whole or in part, the damages Plaintiffs seek in this case. Plaintiffs also failed to exercise ordinary care, caution, or prudence to avoid its alleged injuries or damages; thus, Plaintiffs’ alleged injuries or damages were caused by its own acts or omissions. For all of these reasons, any damages awarded to Plaintiffs should be barred or limited under the contribution and proportionate- responsibility provisions in Chapter 33 of the Texas Civil Practice and Remedies Code. 18. To the extent Plaintiffs sustained any injuries or incurred any expenses as alleged in the Complaint, responsibility for 51% or more of those injuries or expenses lie with Plaintiffs and/or parties or entities other than J&J or Janssen over whom J&J and Janssen have no supervision or control and for whose actions and omissions J&J and Janssen have no 3 responsibility. As such, at most, J&J and Janssen may only be severally liable for Plaintiffs’ injuries or expenses. 19. Any damages Plaintiffs may have suffered were caused in whole or in part by the negligence, carelessness, and/or other wrongful conduct of other persons or entities over which J&J and Janssen had no control and for whose conduct J&J and Janssen are not responsible or liable. 20. Any imposition of liability, damages, penalties, or other relief against J&J or Janssen for the negligent, intentional, malicious, criminal, and/or other acts or omissions of parties or third parties not subject to J&J and/or Janssen’s control or authority would violate J&J and Janssen’s procedural and substantive due process rights under the Fourteenth Amendment to the United States Constitution and Article I, Section 19 of the Texas Constitution. 21. To the extent Plaintiffs seek relief for conduct not actionable at the time it occurred, Plaintiffs’ claims are barred because they violate J&J and Janssen’s procedural and substantive due process rights under the Fourteenth Amendment to the United States Constitution and Article I, Section 19 of the Texas Constitution, and by J&J and Janssen’s right to be free from retroactive or ex post facto laws as guaranteed by Article I, Section 10 of the United States Constitution and Article I, Section 16 of the Texas Constitution. 22. Plaintiffs’ claims are barred in whole or in part because the application of Texas law to conduct in other states or countries would violate the Dormant Commerce Clause of the United States Constitution. 23. Plaintiffs’ claims are preempted by federal and state law and any regulations or rules promulgated under such law, including, but not limited to, the federal Food, Drug, and Cosmetic Act (“FDCA”), associated U.S. Food and Drug Administration (“FDA”) regulations, 4 the federal Controlled Substances Act, the Texas Food, Drug, and Cosmetic Act, and the Texas Controlled Substances Act. See, e.g., 21 U.S.C. §§ 301 et seq.; 21 U.S.C. §§ 802 et seq.; 21 C.F.R. §§ 201.1 et seq., 202.1 et seq., 203.1 et seq.; Tex. Health & Safety Code §§ 431.001 et seq.; Tex. Health & Safety Code §§ 481 et seq. 24. Plaintiffs’ claims are preempted, in whole or in part, by federal law, to the extent that they are based on alleged misrepresentations made to the FDA, or otherwise assert that incorrect, incomplete, or inaccurate information was provided to the FDA. See, e.g., Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); Buckman Co. v. Pls.’ Legal Comm., 531 U.S. 341 (2001); Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015); Geier v. Am. Honda Co., 529 U.S. 861 (2000). 25. Plaintiffs’ claims, if granted, would constitute an impermissible burden by this Court on federal laws, regulations, and policy relating to the development and marketing of prescription drugs in violation of the Supremacy Clause of the United States Constitution. 26. Plaintiffs’ claims are barred in whole or in part by the deference that federal and state constitutional law and federal and state common law give to discretionary actions by the FDA under the FDCA and regulations promulgated under the FDCA. 27. Plaintiffs’ claims regarding warnings and labeling are barred in whole or in part by the doctrine of primary jurisdiction, in that the FDA is charged under the law with determining the content of warnings and labeling for products. 28. Plaintiffs cannot state a claim with regard to warnings and labeling for products because the remedy sought by Plaintiffs is subject to the exclusive regulation of the FDA. 29. Plaintiffs’ claims are barred in whole or in part because the warnings and instructions provided were adequate and complete. Janssen’s products were neither defective 5 nor unreasonably dangerous when used according to the instructions for use. Indeed, the warnings and information that accompanied Janssen’s products were approved by the FDA for a product approved under the FDCA and/or otherwise meet the presumption requirements in chapter 82 of the Texas Civil Practice and Remedies Code. See Tex. Civ. Prac. & Rem. Code §§ 82.007–.008 30. Plaintiffs’ claims are barred in whole or in part because J&J and Janssen’s alleged misrepresentations and prescription opioid medications were not the legal or proximate cause of the purported nuisance or the alleged injuries or damages incurred by Plaintiffs. Absent such causation, Plaintiffs’ claims cannot be sustained as a matter of law under the laws and common law of Texas and would also violate J&J and Janssen’s due process and equal protection rights guaranteed by the Fifth and Fourteenth Amendments to the United States Constitution and Article I, Sections 3 and 19 of the Texas Constitution. 31. Plaintiffs’ claims are barred, in whole or in part, by the First Amendment to the United States Constitution, Article I, Section 8 of the Texas Constitution, and the Noerr- Pennington doctrine. 32. Plaintiffs’ request for exemplary/punitive damages is barred or limited in whole or in part, including by the following provisions: (a) chapter 41 of the Texas Civil Practice and Remedies Code, including the cap on exemplary damages set out in section 41.008 of that code; (b) the limits of the Due Process Clause of the Fifth and Fourteenth Amendments to the United States Constitution; (c) the excessive fines clause of the Eighth Amendment to the United States Constitution; (d) the Full Faith and Credit Clause of the United States Constitution; (e) the limits of the Double Jeopardy Clause of the Fifth Amendment to the United States Constitution and Article I, Section 14 of the Texas Constitution; and (f) other applicable provisions of the Texas 6 Constitution, as those limits have been applied by state and federal courts to restrict exemplary/punitive damages. 33. Plaintiffs’ common-law claims are barred, in whole or in part, by the doctrine of estoppel. 34. Plaintiffs’ claims are barred, in whole or in part, by principles of equity. Numerous facts would render the imposition of injunctive relief, civil penalties, or other remedies inequitable here, including but not limited to J&J’s and Janssen’s good faith reliance on and interpretation of clinical data and medical literature, the absence of any intentional unlawful conduct, the course of Plaintiffs’ investigation and pursuit of these claims, and J&J and Janssen’s good faith reliance on guidance for product communications published by the FDA. 35. Plaintiffs’ claims are barred, in whole or in part, by the doctrine of waiver. 36. Plaintiffs’ claims are barred, in whole or in part, by the doctrines of release and/or res judicata. 37. Plaintiffs’ claims are barred in whole or in part by assumption of the risk. 38. Plaintiffs’ claims are barred in whole or in part by the sophisticated or knowledgeable user doctrine. 39. Plaintiffs’ claims are barred in whole or in part by informed consent. 40. In the unlikely event that J&J or Janssen are found liable to Plaintiffs, J&J and Janssen are entitled to a credit or offset for any and all sums that Plaintiffs have received, or may hereafter receive, by way of any and all settlements arising from Plaintiffs’ claims and causes of action. 41. Any verdict or judgment that might be recovered by Plaintiffs must be reduced by those amounts that have already or will in the future, with reasonable certainty, indemnify 7 Plaintiffs in whole or in part for any past or future claimed economic loss from any collateral source. 42. Plaintiffs’ claims and damages are barred, in whole or in part, by common law, statutory, and state constitutional constraints on the exercise of police powers by a state county. 43. Plaintiffs’ claims are barred and/or limited, in whole or in part, pursuant to applicable statutory and common law regarding limitations on awards, caps on recovery, and setoffs. 44. Plaintiffs’ claims are barred because its alleged injuries or damages, if any, were caused in whole or in part by Plaintiffs’ ratification of J&J’s and/or Janssen’s allegedly deceptive or misleading conduct. 45. Plaintiffs’ claims are barred in whole or in part by the doctrine of unclean hands. 46. Plaintiffs’ claims, injuries, and damages, if any, are barred, in whole or in part, by the alteration, modification, misuse, illicit use, or abuse of the prescribed medications by third parties, for which J&J and Janssen are not liable and over whom J&J and Janssen have no supervision or control and for whose actions and omissions J&J and Janssen have no responsibility. 47. As a matter of Texas law, Plaintiffs are not entitled to a declaratory judgment, injunction, or attorney’s fees for these or any other alleged claims. 48. J&J and Janssen may assert other defenses that become available or appear during the course of additional investigation or discovery in this case and hereby reserve the right to amend this answer to assert any such defense, consistent with the Texas Rules of Civil Procedure. 8 Prayer 49. For the reasons stated above, J&J and Janssen respectfully request that (1) Plaintiffs take nothing in this lawsuit, (2) all of Plaintiffs’ claims be dismissed with prejudice, (3) J&J and Janssen recover any costs or attorney’s fees to which J&J and Janssen are entitled or permitted by law, and (4) J&J and Janssen be granted such other and further relief, both at law and in equity, to which they are entitled. 9 Dated: February 18, 2019 Respectfully submitted, By: /s/ Stephen E. McConnico Stephen E. McConnico State Bar No. 13450300 smcconnico@scottdoug.com Asher B. Griffin State Bar No. 24036684 agriffin@scottdoug.com John W. Ellis State Bar No. 24078473 jellis@scottdoug.com SCOTT DOUGLASS & MCCONNICO LLP 303 Colorado Street, Suite 2400 Austin, Texas 78701 Telephone: 512-495-6300 Facsimile: 512-495-6399 Charles C. Lifland Admitted Pro Hac Vice Pursuant to CMO No. 1 O’MELVENY & MYERS LLP 400 South Hope Street Los Angeles, California 90071 Telephone: (213) 430-6000 Facsimile: (213) 430-6407 clifland@omm.com Stephen D. Brody Admitted Pro Hac Vice Pursuant to CMO No. 1 O’MELVENY & MYERS LLP 1625 Eye Street, NW Washington, DC 20006 Telephone: (202) 383-5300 sbrody@omm.com ATTORNEYS FOR DEFENDANTS JOHNSON & JOHNSON, JANSSEN PHARMACEUTICALS, INC., ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC., AND JANSSEN PHARMACEUTICA, INC. N/K/A JANSSEN PHARMACEUTICALS, INC. 10 CERTIFICATE OF SERVICE I certify that I caused a true and correct copy of the foregoing document to be electronically filed on February 18, 2019, which will transmit service electronically through the court’s electronic filing manager to all counsel of record. /s/ Stephen E. McConnico Stephen E. McConnico 11