Free Case Transferred In - District Transfer - District Court of California - California

Case 3:07-cv-03448-CRB

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1 Anthony G. Brazil (State Bar No. 84297)
2 Kanika D. Corley (State Bar No. 223607)

MORRS POLICH & PURDY LLP 3 1055 West Seventh Street, Suite 2400

4 Los Angeles, CA 90017 Telephone: (213) 891-9100

5 Facsimile: (213) 488-1178
6

Attorneys for Defendant

7 AMRISOURCEBERGEN DRUG CORPORATION
8

UNITED STATES DISTRICT COURT

9 10

EASTERN DISTRICT OF CALIFORNIA
Case No. 2:06-CV-02768-MCE-DAD

11 CAROL ANN DAVIES and HARRY

12 DAVIES
13

Plaintiffs,
vs.

14

MERCK & COMPANY, INC., a 15 Corporation; MCKESSON
16 CORPORATION; a Corporation; AMRISOURCEBERGEN DRUG

ANSWER AND AFFIRMATIVE DEFENSES OF DEFENDANT AMERISOURCEBERGEN DRUG CORPORATION TO PLAINTIFFS' COMPLAINT; DEMAND FOR JURY TRIAL

i 7 CORPORA TION?-CORPORATION; INC.; PHALIA a Coæoration; PFIZER
18 G. D. SEARE LLC, (FKA to 100; SEARE & CO.); DOES 1 G.D.

19 DOES 101 to 200; DISTRIBUTOR

PHACEUTICAL DEFENDANT

20 DEFENDANT DOES 201 to 300, inclusive,
21

Defendants.

22
23

Defendant AMRISOURCEBERGEN DRUG CORPORATION ("Defendant" or 24 "AMERISOURCEBERGEN") files the following Answer to the unverified Complaint
25

("Complaint") filed in the matter of CAROL ANN DAVIES, et al. v. MERCK &

26 COMP ANY, INC., et al. (The term "Plaintiffs" as used herein shall refer to CAROL

27 ANN DAVIES and HAY DAVIES.) Defendant responds to Plaintiffs' Complaint as
28

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ANSWER AND AFFIRTIV DEFENSES OF DEFENDANT AMERISOURCEBERGEN DRUG
CORPORATION TO PLAINTIFFS' COMPLAINT; DEMAND FOR JUY TRIL

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1 INTRODUCTION
2 AMRISOURCEBERGEN is a wholesale distributor of pharaceuticals, over3 the-counter and health and beauty products to chain, independent pharmacy customers

4 and hospitals. As a wholesale distributor, AMRISOURCEBERGEN distributes products

5 manufactured by others. As to VIOXX(ß, AMRISOURCEBERGEN does not

6 manufacture, produce, process, test, encapsulate, label, package or repackage these
7 products, nor does it make any representations or warranties as to the products' safety or

8 efficacy. AMRISOURCEBERGEN lacks information or knowledge sufficient to admit
9 or deny the remaining allegations contained in the introduction paragraph of the
10 Complaint and therefore denies such allegations.

11 GENERAL ALLEGATIONS
12 1. AMRISOURCEBERGEN is a wholesale distributor of pharmaceuticals,
13 over-the-counter and health and beauty products to chain, independent pharmacy

14 customers and hospitals. As a wholesale distributor, AMRISOURCEBERGEN

15 distributes products manufactured by others. As to VIOXX(ß,
16 AMERISOURCEBERGEN does not manufacture, produce, process, test, encapsulate,

17 label, package or repackage these products, nor does it make any representations or
18 warranties as to the products' safety or efficacy. AMRISOURCEBERGEN lacks
19 information or knowledge sufficient to admit or deny the remaining allegations contained
20 in Paragraph 1 of the Complaint, and its subparts and subparagraphs, and therefore denies
2 i such allegations.

22 2. AMRISOURCEBERGEN is without knowledge or information sufficient

23 to form a belief as to the truth or falsity of the allegations of Paragraph 2 of the
24 Complaint, and therefore denies such allegations.

25 3. AMRISOURCEBERGEN is a wholesale distributor of pharmaceuticals,
26 over-the-counter and health and beauty products to chain, independent pharmacy

27 customers and hospitals. As a wholesale distributor, AMRISOURCEBERGEN

28 distributes products manufactured by others. As to VIOXX(ß,

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i AMRISOURCEBERGEN does not manufacture, produce, process, test, encapsulate,
2 label, package or repackage these products, nor does it make any representations or

3 warranties as to the products' safety or efficacy. AMRISOURCEBERGEN lacks
4 information or knowledge sufficient to admit or deny the remaining allegations contained
5 in Paragraph 3 of the Complaint and therefore denies such allegations.

6 4. AMRISOURCEBERGEN is without knowledge or information sufficient

7 to form a belief as to the truth or falsity of the allegations of Paragraph 4 of the
8 Complaint and its subparts and subparagraphs, and therefore denies such allegations.

9 5. AMRISOURCEBERGEN is without knowledge or information sufficient

10 to form a belief as to the truth or falsity of the allegations of Paragraph 5 of the
11 Complaint, and therefore denies such allegations.

12 6. AMRISOURCEBERGEN is a wholesale distributor of pharmaceuticals,
13 over-the-counter and health and beauty products to chain, independent pharmacy

14 customers and hospitals. As a wholesale distributor, AMRISOURCEBERGEN

i 5 distributes products manufactured by others. As to VIOXX(ß,
16 AMRISOURCEBERGEN does not manufacture, produce, process, test, encapsulate,

17 label, package or repackage these products, nor does it make any representations or
18 warranties as to the products' safety or efficacy. AMRISOURCEBERGEN lacks
i 9 information or knowledge sufficient to admit or deny the remaining allegations contained

20 in Paragraph 6 of the Complaint and its subparts and subparagraphs and therefore denies

21 such allegations.

22 7. AMRISOURCEBERGEN is a wholesale distributor of pharmaceuticals,
23 over-the-counter and health and beauty products to chain, independent pharmacy

24 customers and hospitals. As a wholesale distributor, AMRISOURCEBERGEN

25 distributes products manufactured by others. As to VIOXX(ß,
26 AMRISOURCEBERGEN does not manufacture, produce, process, test, encapsulate,

27 label, package or repackage these products, nor does it make any representations or
28 warranties as to the products' safety or efficacy. AMRISOURCEBERGEN lacks

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1 information or knowledge sufficient to admit or deny the remaining allegations contained
2 in Paragraph 7 of the Complaint and its subparts and subparagraphs, and therefore denies

3 such allegations.

4 AFFIRMATIVE DEFENSES
5 FIRST AFFIRMATIVE DEFENSE
6 8. The Complaint and all causes of action asserted against Defendant fail to

7 state facts sufficient to constitute a cause of action.

8 SECOND AFFIRMATIVE DEFENSE
9 9. Federal

law preempts Plaintiffs' claims. Plaintiffs have asserted claims for

10 relief which, if granted, would constitute an impermissible burden by this Court on

i 1 Federal laws, regulations, and policies relating to the development and marketing of
i 2 products, in violation of the Supremacy Clause, Aricle VI of the Constitution of the
i 3 United States.

14 THIRD AFFIRMATIVE DEFENSE
15 10. The causes of action alleged in the Complaint are barred by the applicable
16 statutes of limitations and/or statutes of repose, including but not limited to California
17 Code of

Civil Procedure §§ 335.1 and 338 and forrer § 340(3), California Business and

18 Professions Code § 17208, and California Civil Code § 1783. .
19 FOURTH AFFIRMATIVE

DEFENSE

20 i 1. During the time periods alleged in the Complaint, Plaintiffs failed to

2 i exercise ordinary care on Plaintiffs' own behalf for Plaintiffs' safety. Plaintiffs'
22 recklessness, carelessness and/or negligence caused any injury and damage that Plaintiff
23 may have sustained. Plaintiffs' right to recover should be diminished by Plaintiffs'
24 proportional share of fault.

25 FIFTH AFFIRMATIVE DEFENSE
26 12. Plaintiffs failed to mitigate any damage that Plaintiffs may have sustained.

27 Plaintiffs failed to exercise reasonable care to avoid the consequences of harm, if any.
28 Among other things, Plaintiffs failed to use reasonable diligence in caring for any injury,

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1 use reasonable means to prevent aggravation of any InJury, and/or take reasonable
2 precautions to reduce any injury and damage.

3 SIXTH AFFIRMATIVE DEFENSE
4 13. During the time periods alleged in the Complaint, Plaintiffs had full

5 knowledge of the risks and possible adverse effects pertaining to the use of the products.
6 Defendant alleges that part or all of the injuries, damages, or losses, if any, that Plaintiffs
7 claim to have sustained arose from or were caused by such risks. Plaintiffs were aware

8 of, accepted, and assumed the risks and possible adverse effects. Plaintiffs' recovery, if
9 any, should be diminished, reduced, offset, or barred by Plaintiffs' assumption of the
10 risks and informed consent.

11 SEVENTH AFFIRMATIVE DEFENSE
12 i 4. Defendant denies that Plaintiffs suffered injuries or incurred any damages, or

13 that any defendant is liable. If Plaintiffs did suffer any injuries or incur any damages, any

14 injuries or damages were caused, in whole or in part, by the acts or omissions of persons
15 or entities other than Defendant or superseding or intervening causes over which

16 Defendant had no control. If there is any negligence or liability by any defendant, it is the
i 7 sole and exclusive negligence and liability of others and not this answering Defendant.

18 EIGHTH AFFIRMATIVE DEFENSE
19 15. The intervening or superseding cause of any injury allegedly sustained by
20 the Plaintiffs may be conduct which is ilicit, criminal, or otherwise improper, and for

21 which conduct Defendant cannot be held responsible.

22 NINTH AFFIRMATIVE DEFENSE
23 16. Plaintiffs' alleged damages, injuries, or losses, if any, were not proximately
24 caused by any alleged act, omission, or breach of duty by Defendant but were caused in
25 whole or in part by the acts or omissions of Plaintiffs and/or others so that the principles
26 of contributory negligence, comparative fault and/or assumption of

the risk apply.

27 TENTH AFFIRMATIVE DEFENSE
28 17. Plaintiffs' claims are barred in whole or in part because they have been

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1

improperly joined in this action.

2
3

ELEVENTH AFFIRMATIVE DEFENSE
18. If any of the other parties are negligent, legally responsible, or otherwise at

4
5

fault for the damages alleged in the Master Complaint, and if there is a finding of any liability in favor of Plaintiffs or settlement or judgment against Defendant, Defendant

6 7
8

requests that the Court or Jury make an apportionment of fault among all parties as
permitted by Li v. Yellow Cab Co. and American Motorcycle Association v. Superior
Court. Defendant further requests a judgment and declaration of partial indemnification
and contribution against all other parties or persons in accordance with the apportionment
of fault.

9
10
11

TWELFTH AFFIRMATIVE DEFENSE
19. Plaintiffs' claims are barred in whole or in part because they have been filed

12
13

In an improper venue.

14
15

THIRTEENTH AFFIRMATIVE DEFENSE
20. Plaintiffs' alleged injuries were the direct and proximate result of an

16 17
18

idiosyncratic reaction which was not reasonably foreseeable, or was not the result of any
conduct or negligence on the part of

Defendant; and/or was not the result of any defect in

any product distributed or sold by Defendant.

19

FOURTEENTH AFFIRMATIVE DEFENSE

20
21

21. The hazards of foreseeable uses and misuses of the product are open and
obvious.

22
23

FIFTEENTH AFFIRMATIVE DEFENSE
22. After the products left the possession and control of

Defendant, ifin fact any

24
25

products were ever in the possession or control of Defendant, the products were

redesigned, modified, altered, or subjected to treatment that substantially changed their

26
27 28

character without Defendant's knowledge. Any alleged defect resulted, if at all, from the
redesign, modification, alteration, treatment or other change of the products after
Defendant relinquished possession of and control over any of the products.

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1 SIXTEENTH AFFIRMATIVE DEFENSE
2 23. The design, manufacture, and marketing of the products were in conformity
3 with the "state of the art" existing at the time of such design, manufacture, and marketing.

4 SEVENTEENTH AFFIRMATIVE DEFENSE
5 24. The learned intermediary doctrine bars Plaintiffs' recovery of any damages.

6 Any duty to warn Plaintiffs of the risks and hazards associated with the products was
7 discharged by providing adequate warning to physicians.

8 EIGHTEENTH AFFIRMATIVE DEFENSE
9 25. To the extent that Plaintiffs allege a failure to warn by Defendant, Defendant

10 alleges that the manufacturers, physician, and other health care providers associated with
11 the products knew, or should have been aware, of any risk and hazard that Plaintiffs

12 and/or Plaintiffs' decedent alleges rendered the products defective and that allegedly
13 caused Plaintiffs' and/or Plaintiffs' decedent's injuries and damages, if any. To the
14 extent that such manufacturers, physician, and other health care providers failed to

15 advise, inform, or warn Plaintiffs of such risks and hazards, such failure is imputed to
16 Plaintiffs under agency principles and Plaintiffs and/or Plaintiffs' decedent knowingly
17 and voluntarily assumed the risk of any injury as a result of the consumption of,
18 administration of, or exposure to the product.

19 NINETEENTH AFFIRMATIVE DEFENSE
20 26. The Complaint is barred due to the lack of privity, or a "transaction,"
21 between Plaintiffs and Defendant.

22 TWENTIETH AFFIRMATIVE DEFENSE
23 27. This Court lacks personal jurisdiction over this answering Defendant.

24 TWENTY-FIRST AFFIRMATIVE DEFENSE
25 28. Plaintiffs' claims are barred in whole or in part by the doctrines of accord
26 and satisfaction, good faith, consent, res judicata, payment and release, waiver, collateral

27 estoppel, judicial estoppel, equitable estoppel, unclean hands, laches, and/or statutory and
28 regulatory compliance.

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1 TWENTY-SECOND AFFIRMATIVE DEFENSE
2 29. The products were not used in the manner in which they were intended to be

3 used. The products were used in a manner that was abnormal and not reasonably

4 foreseeable by Defendant. Such misuse of the products proximately caused or
5 contributed to Plaintiffs' alleged damages, injuries, and losses, if any.

6 TWENTY-THIRD AFFIRMATIVE DEFENSE
7 30. The imposition of punitive or exemplary damages against Defendant or that

8 are in any way imputed against the interests of Defendant would violate the ruling in
9 State Farm Mut. Automobile Ins. Co. v. Campbell (2003) 538 U.S. 408, and Defendant's

10 constitutional rights under: the Due Process clauses in the Fifth and Fourteenth
11 Amendments to the Constitution of the United States; the Sixth Amendment to the
12 Constitution of

the United States; the Double Jeopardy clause in the Fifth Amendment to

13 the Constitution of the United States; comparable provisions contained within the

14 California Constitution; the common law and public policies of California; and applicable
15 statutes and court rules, including but not limited to, imposition of punitive damages and

16 determination of such an award:

17 (a) by a jury when the jury is: (i) not given standards of sufficient clarity for

18 determining the appropriateness, and the appropriate size, of a punitive 19 damages award; (ii) not adequately and clearly instructed on the limits on 20 punitive damages imposed by the principles of deterrence and punishment;

21 (iii) not expressly prohibited from awarding punitive damages, or
22 determining the amount of such an award, in whole or in part, on the basis of

23 invidiously discriminatory characteristics, including the corporate status, 24 wealth, or state of residence of Defendant; (iv) permitted to award punitive 25 damages under a standard for determining liability for such damages which 26 is vague and arbitrary and does not define with sufficient clarity the conduct 27 or mental state which makes punitive damages permissible; and (v) not
28

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1 subject to trial court and appellate judicial review for reasonableness, the
2 furtherance of legitimate purpose, and the basis of objective standards;
3 (b) where applicable law is impermissibly vague, imprecise, or inconsistent;

4 (c) subject to no predetermined limit, such as a maximum multiple of

5 compensatory damages or a maximum amount; and
6 ( d) based upon anything other than Defendant's conduct in connection with the

7 sale of the products alleged in this litigation, or in any other way subj ecting
8 Defendant to impermissible multiple punishment for the same alleged

9 wrong.
10 TWENTY-FOURTH AFFIRMATIVE DEFENSE
11 31. While continuing to deny any and all liability, Defendant states that if the
12 court determines that Plaintiffs are entitled to assert a claim for punitive damages, such
13 claim cannot be permitted to go forward until the trier of fact determines that punitive
14 damages should be considered, and, ultimately all issues regarding punitive damages
15 should be bifurcated at triaL. Any award for punitive or exemplary damage absent

16 bifurcating trial as to issues of compensatory and exemplary damages would be in
17 violation of Defendant's rights to due process under the Unites States Constitution and
18 the correlative provisions of California law.

19 TWENTY-FIFTH AFFIRMATIVE DEFENSE
20 32. At all times, any products distributed by Defendant were distributed in
21 compliance with all applicable federal, state and local laws and regulations, and rules
22 promulgated and enforced by the Food and Drug Administration. The products were

23 subject to and received pre-market approval by the Food and Drug Administration under

24 52 Stat. 1040, 21 U.S.C. § 301. Compliance with such laws, regulations, and rules

25 demonstrates that due care and reasonable prudence were exercised in the design,
26 manufacture, and promotion of the subject pharmaceutical product and that said product
27

was not defective in any way.

28 III

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1 TWENTY-SIXTH AFFIRMATIVE DEFENSE
2 33. Any damages, injuries and/or losses alleged to have been suffered by
3 Plaintiffs have been mitigated, in whole or in part, by reimbursement from collateral

4 sources and therefore, Plaintiffs' claims against Defendant are barred and/or reduced by

5 any applicable set off.

6 TWENTY-SEVENTH AFFIRMATIVE DEFENSE
7 34. At all times, Defendant's acts or omissions were privileged, justified, fair

8 and undertaken in the good faith exercise of a valid business purpose.

9 TWENTY-EIGHTH AFFIRMATIVE DEFENSE
10 35. Plaintiffs cannot demonstrate the necessary elements to support the request
11 for injunctive relief, including without limitation, a threat of imminent or immediate

12 harm.

13 TWENTY-NINTH AFFIRMATIVE DEFENSE
14 36. Any alleged act or omission by Defendant concerning the manufacture,
15 warning, labeling, advertising and sale of VIOXX(ß referred to in the Complaint, was at
16 all times, the duty of an entity other than Defendant. Defendant acted in good faith

17 concerning all services for which it had a duty to provide as referred to in the Complaint.

18 THIRTIETH AFFIRATIVE DEFENSE
19 37. Plaintiffs' claims for disgorgement or restitution are barred under the
20 decision in Kraus v. Trinity Management Services, Inc. (2000) 23 CalAth 116 and related

21 authority.

22 THIRTY-FIRST AFFIRMATIVE DEFENSE
23 38. Plaintiffs' alleged injuries or ilnesses preexisted or were sllffered after the
24 alleged use of the products, and Plaintiffs' alleged injuries or ilnesses were neither

25 caused nor exacerbated by said alleged use.

26 THIRTY-SECOND AFFIRMATIVE DEFENSE
27 39. Plaintiffs' injuries were caused or contributed to by their failure to follow
28 the directions and precautions provided by the product's manufacturer(s).

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1 THIRTY-THIRD AFFIRMATIVE DEFENSE
2 40. Plaintiffs' breach of warranty claims are barred because Plaintiffs failed to
3 give adequate and timely notice of his alleged claims against Defendant and/or because
4 the alleged warranties were disclaimed.

5 THIRTY-FOURTH AFFIRMATIVE DEFENSE
6 41. Defendant's alleged business practices with respect to the subject product

7 were lawful, fair, truthful, not misleading or deceptive, not fraudulent, and were justified
8 based on the state of medical and scientific knowledge available during the relevant time

9 and were in compliance with the applicable laws, regulations, and rules within the

10 meaning of either Business and Professions Code Section 17200, et seq. or Business and

11 Professions Code Section 17500, et seq.

12 THIRTY- FIFTH AFFIRMATIVE DEFENSE
13 42. Plaintiffs' claimed injuries and/or damages are so remote, speculative or
14 contingent that Plaintiffs' claims must be barred on public policy grounds.

15 THIRTY-SIXTH AFFIRMATIVE DEFENSE
16 43. The conduct alleged in the Complaint does not plead a "violation of law"
17 sufficient to provide the necessary predicate for an "unlawful" business practices claim,
18 or any other claim, under either Business and Professions Code Section 17200, et seq. or
19 Business and Professions Code Section 17500 et seq.

20 THIRTY-SEVENTH AFFIRMATIVE DEFENSE
21 44. Plaintiffs' claims under Business and Professions Code Section 17200, et

22 seq. or Business and Professions Code Section 17500 et seq. are barred in whole or in
23 part under principles of substantive and procedural due process.

24 THIRTY-EIGHTH AFFIRMATIVE DEFENSE
25 45. Plaintiffs' claims under Business and Professions Code Section 17200, et

26 seq. or Business and Professions Code Section 17500, et seq. are barred in whole or in
27 part because Plaintiffs do not qualify as private attorneys general, and for that reason,
28 among others, lack standing to prosecute a claim for injunctive or monetary relief.

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1 THIRTY-NINTH AFFIRMATIVE DEFENSE
2 46. Plaintiffs' claims under Business and Professions Code Section 17200, et
3 seq. or Business and Professions Code Section 17500, et seq. are barred in whole or in

4 part because there is no basis for injunctive relief in this action and Plaintiffs have an
5 adequate remedy at law.

6 FORTIETH AFFIRMATIVE DEFENSE
7 47. Plaintiffs' claims under Business and Professions Code Section 17200, et

8 seq. or Business and Professions Code Section 17500, et seq. are barred in whole or in
9 part by the doctrine of primary jurisdiction. The subject of pharmaceutical product and

10 any advertising regarding such product are regulated by the Food and Drug
1 1 Administration and as such, answering Defendant requests that this Court, sitting in
12 equity, abstain from hearing claims under Sections 17200, et seq. and 17500, et seq.,
13 which are accordingly preempted by Federal

law.

14 FORTY-FIRST A FFIRMATIVE DEFENSE
15 48. The Plaintiffs are barred from recovery against Defendant because of the

16 sophisticated user doctrine.

17 FORTY-SECOND AFFIRATIVE DEFENSE
18 49. Plaintiffs' strict liability claims are barred under the principles set forth in
19 Brown v. Superior Court (1988) 44 Ca1.3d 1088.

20 FORTY-THIRD AFFIRMATIVE DEFENSE
21 50. Plaintiffs' claim, if any, for loss of consortium is barred because it is
22 derivative of the injured Plaintiffs'/decedent's claim, which fails pursuant to the

23 affirmative defenses set forth herein.

24 FORTY-FOURTH AFFIRMATIVE DEFENSE
25 51. Defendant is a provider of services, not products, and thus is not strictly
26 liable under California law.

27 FORTY-FIFTH AFFIRMATIVE DEFENSE
28 52. Plaintiffs' Complaint fails to allege ultimate facts sufficient to state a cause

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1 of action predicated upon negligence, strict liability, breach of implied warranty, breach
2 of express warranty, failure to warn or deceit by concealment.

3 FORTY-SIXTH AFFIRMATIVE DEFENSE
4 53. Plaintiffs' claims of any non-economic damages are subject to California

5 Civil Code § 1431.2, which is applicable to the Complaint and each cause of action
6 therein.

7 FORTY-SEVENTH AFFIRMATIVE DEFENSE
8 54. The product at issue in this litigation is not defective or unreasonably
9 dangerous because it is a prescription pharmaceutical bearing adequate warnings, and is

10 subject to the comment j exception to strict liability as set forth in § 402A of the
11 Restatement (Second) of Torts (1965), and/or because it is a prescription pharmaceutical
12 that is unavoidably unsafe pursuant to comment k of § 402A of the Restatement (Second)
13 of Torts

(1965).

14 FORTY-EIGHT AFFIRMATIVE DEFENSE
15 55. Plaintiffs' claims are barred in whole or in part because the subject
16 pharmaceutical product "provides net benefits for a class of patients" within the meaning
17 of Comment fto Section 6 of the Restatement (Third) of

Torts: Products Liability.

18 FORTY-NINTH AFFIRMATIVE DEFENSE
19 56. Plaintiffs' claims are barred under Section 4, et seq., of the Restatement
20 (Third) of

Torts: Products Liability.

21 FIFTIETH AFFIRMATIVE DEFENSE
22 57. Plaintiffs' claims, if any, related to negligence per se are barred, in whole or
23 in part, because there is no statute violated by this Defendant.

24 FIFTY-FIRST AFFIRMATIVE DEFENSE
25 58. Plaintiffs' claims are barred in whole or in part by the deference given to the
26 primary jurisdiction of the Food and Drug Administration over the subject

27 pharmaceutical product under applicable federal laws, regulations, and rules. These
28 claims are thus preempted by Federal

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1

FIFTY-SECOND AFFIRMATIVE DEFENSE

2 59. Plaintiffs' claims are barred in whole or in part because there is no private
3 right of action concerning matters regulated by the Food and Drug Administration under
4 applicable federal

laws, regulations, and rules.

5 FIFTY-THIRD AFFIRMATIVE DEFENSE
6 60. Plaintiffs' claims are barred in whole or in part because Plaintiffs lack
7 standing to bring such claims.

8 FIFTY-FOURTH AFFIRMATIVE DEFENSE
9 61. Plaintiffs' claims are barred in whole or in part because they fail to meet the

10 requirements of California Code of Civil Procedure §§ 377.30, et seq., and 377.60, et
11 seq., governing a decedent's cause of action and wrongful death actions.

12 FIFTY-FIFTH AFFIRMATIVE DEFENSE
13 62. Plaintiffs' claims are barred to the extent they are made by, or on behalf of,
14 out of state Plaintiffs or Plaintiffs' decedent, or arose from events occurring out of state,
15 are barred in whole or in part under principles of forum non conveniens and due process.

16 FIFTY-SIXTH AFFIRMATIVE DEFENSE
17 63. Plaintiffs' claims are barred in whole or in part because the Complaint fails
18 to join necessary and indispensable parties.

19 FIFTY-SEVENTH AFFIRMATIVE DEFENSE
20 64. Plaintiffs' Consumer Legal Remedies Act cause of action is barred because

21 it fails to meet the requirements of California Civil Code §§ 1750, et seq.

22 FIFTY-EIGHTH AFFIRMATIVE DEFENSE
23 65. Defendant did not design, manufacture, formulate, distribute, market, sell,
24 research, develop, test or supply the VIOXX(ß that was alleged to have been ingested by
25 Plaintiffs and/or any of

the ingredients contained therein.

26 FIFTY-NINTH AFFIRMATIVE DEFENSE
27 66. Plaintiffs failed to allege specific facts that Defendant distributed and/or
28 supplied the subject product that Plaintiffs allegedly ingested. Accordingly, Plaintiffs

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1 failed to plead facts sufficient to show an actual connection between Defendant's alleged

2 conduct and the Plaintiffs' purported injury and Defendant has, therefore, been
3 fraudulently joined.

4 SIXTIETH AFFIRMATIVE DEFENSE
5 67. Plaintiffs' vague allegations are legal conclusions directed at "defendants" in
6 general and fail to support any claims specific to Defendant.

7 SIXTY-FIRST AFFIRMATIVE DEFENSE
8 68. Plaintiffs' claims are barred by the applicable prescriptive periods or statutes
9 of limitations provided for such claims.

1 0 SIXTY-SECOND AFFIRMATIVE DEFENSE
11 69. Defendant denies that the products distributed by it caused or contributed to
12 the alleged injuries of Plaintiffs and further denies that it is liable to Plaintiffs for the
13 claims alleged or for any other claims whatsoever.

14 SIXTY-THIRD AFFIRMATIVE DEFENSE
15 70. Defendant did not make any material representation of fact regarding the

16 products it distributes which was not true, or if such representation was made, which
17 Defendant specifically denies, then AMRISOURCEBERGEN did not make such
18 representation with the intent to either deceive or to induce Plaintiffs to act in justifiable

19 reliance.

20 SIXTY-FOURTH AFFIRMATIVE DEFENSE
21 71. Plaintiffs did not justifiably rely, in any fashion whatsoever, upon any
22 statement, representation, advice or conduct of AMRISOURCEBERGEN, and did not
23 act upon any statement, representation advice or conduct to their detriment.

24 SIXTY-FIFTH AFFIRMATIVE DEFENSE
25 72. Defendant asserts that as of the relevant times alleged in the Complaint, it

26 did not know and, in light of the then existing reasonable available scientific and
27 technological knowledge, could not have known of: (1) the design characteristics, if any,

28 that allegedly caused the injuries and damages complained of in the Petition; (2) the

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1 alleged danger of any such design characteristics.

2 SIXTY-SIXTH AFFIRMATIVE DEFENSE
3 73. Plaintiffs' claims are barred, in whole or in part, to the extent Plaintiffs, or
4 any state entity acting on behalf of Plaintiffs, has released, settled, entered into an accord
5 and satisfaction or otherwise compromised Plaintiffs' claims.

6 SIXTY-SEVENTH AFFIRMATIVE DEFENSE
7 74. Defendant is entitled to set-off, should any damages be awarded against it, in

8 the amount of damages or settlement amounts recovered by Plaintiffs, or any state entity

9 acting on behalf of Plaintiffs, with respect to the same alleged injuries. Defendant is also

10 entitled to have any damages that may be awarded to Plaintiffs reduced by the value of
11 any benefit or payment to Plaintiffs, or any state entity acting on behalf of

Plaintiffs, from

12 any collateral source.

13 SIXTY-EIGHTH AFFIRMATIVE DEFENSE
14 75. Defendant asserts that it has complied with all applicable state and federal
15 laws relating to the distribution and/or sale of pharmaceuticals.

16 SIXTY-NINTH AFFIRMATIVE DEFENSE
17 76. To the extent Plaintiffs assert claims based upon an alleged failure by
18 Defendant to warn Plaintiffs directly of alleged dangers associated with the use of
19 VIOXX(ß, such claims are barred under the learned intermediar doctrine.

20 SEVENTIETH AFFIRMATIVE DEFENSE
21 77. Defendant reserves the right to rely upon other affirmative defenses as they

22 become reasonably available and apparent during the discovery proceedings in this case.

23 Defendant reserves the right to amend this Answer to assert any such defenses.

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1 WHEREFORE, AMRISOURCEBERGEN prays for relief as follows:
2 1. That Plaintiffs take nothing by this action;

3 2. That judgment be entered in favor of AMRISOURCEBERGEN and against

4 Plaintiffs;
5 3. That AMRISOURCEBERGEN be awarded costs of suit herein; and
6 4. F or such other and further relief as the Court may deem just and proper.

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8 Dated: December ~, 2006
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Respectfully Submitted,

MORRS POLICH & PURDY LLP
By: Isl Kanika D. Corley, Esq.
Anthony G. Brazil

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Kanika D. Corley Attorneys for Defendant
CORPORATION

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AMRISOURCEBERGEN DRUG

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1 DEMAND FOR JUY TRIAL
2 Defendant hereby demands trial by jury in this matter.
3

4 Dated: December~, 2006
5

Respectfully Submitted,

MORRS POLICH & PURDY LLP
By: Isl Kanika D. Corley Anthony G. Brazil Kanika D. Corley Attorneys for Defendant

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AMRISOURCEBERGEN DRUG
CORPORATION

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1

ELECTRONIC PROOF OF SERVICE
I am employed in the County of Los Angeles, State of Californa. I am over the age of eighteen (18) years and am not a party to the within action.

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On December 21,2006, pursuant to the Cour's Electronic Filing System, I
12 submitted an electronic version of the following document via file transfer protocol. t ECF (Electronic Case Filing)
o submitted a hard copy of the following document to ECF (Electronic Case Filing) by

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D facsimile

D

overnight delivery

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10 "ANSWER AND AFFIRMTIVE DEFENSES OF DEFENDANT MCKESSON
CORPORATION TO PLAINTIFF'S COMPLAINT; DEMAND FOR JURY TRIAL"
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D STATE I declare under penalty of perjur under the laws of the state of California, that the above i
true and correct.

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12 FEDERA I declare that I am employed in the offce of a member of the bar of ths cour at whos
direction the service was made
Executed on December 21, 2006, at Los Angeles, California.

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-1ELECTRONIC PROOF OF SERVICE