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UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

Paula Deaton and Donald Shaft, Plaintiffs, vs. Pfizer, Inc.; Pharmacia Corporation; and G.D. Searle LLC, (FKA F.D. Searle & Co.), Defendants.

Court File No. 07-2800 RHK/AJB

ANSWER AND DEFENSES OF DEFENDANTS PFIZER INC., PHARMACIA CORPORATION, AND G.D. SEARLE LLC TO PLAINTIFFS' COMPLAINT

Defendants Pfizer Inc., improperly captioned " Pfizer, Inc."(hereinafter " Pfizer" ), Pharmacia Corporation (hereinafter " Pharmacia" and G.D. Searle LLC (hereinafter ), " Searle" collectively " ), Defendants,"hereby answer Plaintiffs'Complaint in this action as follows: Defendants' Answer And Affirmative Defenses To Plaintiffs' Complaint 1. Answering paragraph 1, Defendants state that the allegations contained therein

assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants deny the allegations contained therein and specifically deny that Celebrex® is or was defective of unreasonably dangerous. 2. Answering paragraph 2, Defendants state that the allegations contained therein

assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that these actions will be subject to transfer and consolidation for pretrial proceedings. Except as otherwise admitted herein, Defendants deny the allegations of this paragraph.

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3.

Answering paragraph 3, Defendants have insufficient information or

knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. 4. Answering paragraph 4, Defendants have insufficient information or

knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. 5. Answering paragraph 5, Defendants have insufficient information or

knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. 6. Answering paragraph 6, Defendants state that the allegations contained therein

assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that it Pfizer a Delaware corporation with its principal place of business in New York, and that it acquired Pharmacia Corporation on April 16, 2003. Defendants further admit that, at times, they marketed and co-promoted Celecoxib under the name Celebrex® throughout the United States, including Minnesota. Except as admitted herein, Defendants deny the remaining allegations of this paragraph. 7. Answering paragraph 7, Defendants admit that Searle is a wholly-owned

subsidiary of Pharmacia, which is in turn a wholly-owned subsidiary of Pfizer. Searle is a Delaware limited liability company with its principal place of business in Illinois. Defendants admit that, during certain periods of time, Celebrex® was manufactured and packaged for Searle, which developed, tested, marketed, and distributed Celebrex® in the United States to be prescribed by health care providers who are authorized by law to

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prescribe drugs in accordance with their approval by the FDA. Except as admitted herein, Defendants deny the allegations of this paragraph. 8. Answering paragraph 8, Defendants admit that Pharmacia is a corporation

existing under the laws of the State of Delaware with its principal place of business in New Jersey. Defendants further admit that Pharmacia & Upjohn Company LLS merged with Monsanto Co. in April 2000 to form Pharmacia. Defendants also admit that Pharmacia is a wholly-owned subsidiary of Pfizer. Defendants admit that, during certain periods of time, Pharmacia marketed the prescription drug Celebrex® in the United States for the indications set forth in the FDA-approved package inserts, as permitted by law. Except as admitted herein, Defendants deny the allegations of this paragraph. 9. Answering paragraph 9, Defendants admit that Celebrex® was developed by

Searle and admit that on December 31, 1998 the FDA granted approval of an NDA submitted by Searle on June 29, 1998. Defendants also admit that, during certain periods of time, Searle and Pfizer marketed Celebrex®. Defendants admit that in April 2003, Pfizer acquired Pharmacia. Except as admitted herein, Defendants deny the allegations of this paragraph. 10. Answering paragraph 10, Defendants admit that Pfizer, at certain times,

marketed and co-promoted Celebrex®, that Pharmacia, at certain times, marketed Celebrex®, and that Searle, at certain times, marketed and distributed Celebrex®. Defendants deny making any misrepresentations or omissions regarding the safety and effectiveness of Celebrex®, deny any wrongdoing, and state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Answering further, Defendants state that Celebrex® is and was safe and effective when used
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in accordance with its FDA-approved prescribing information. Except as stated herein, Defendants deny the allegations of this paragraph. 11. Answering paragraph 11, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants deny the allegations contained therein. 12. Answering paragraph 12, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that this Court has jurisdiction pursuant to 28 U.S.C. § 1332 (diversity jurisdiction) in that Plaintiffs allege that the amount in controversy exceeds $75,000.00 and that they are citizens of a different state than Defendants. 13. Answering paragraph 13, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants state that referenced case law speaks for itself, and Defendants deny any attempt by Plaintiffs to characterize it. 14. Answering paragraph 14, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants state that referenced case law speaks for itself, and Defendants deny any attempt by Plaintiffs to characterize it. 15. Answering paragraph 15, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants deny the allegations contained in this paragraph and Defendants further allege that if Plaintiffs are citizens and resident of the States of Tennessee and Kansas, this action is subject to change of venue pursuant to 28 U.S.C. § 1404.
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16.

Answering paragraph 16, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants state that they lacks sufficient knowledge and information to form a belief as to the meaning of " times relevant herein,"but admit that, at times, Pfizer all marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex® throughout the United States, including Minnesota. Defendants deny that they made material misrepresentations and breaches of warranty. Except as otherwise admitted herein, Defendants deny the allegations of this paragraph. 17. Answering paragraph 17, Defendants admit that Celebrex® is among a class

of medications called nonsteroidal anti-inflammatory drugs (" NSAIDs" Except as ). otherwise admitted herein, Defendants are without sufficient information or knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. 18. Answering paragraph 18, Defendants state that the allegations are not directed

to Defendants, and therefore, no response is required. To the extent a response is deemed required, Defendants state that as stated in the package insert approved by the FDA, Defendants admit that Celebrex® is approved by the FDA for the following indications: (1) (2) (3) (4) (5) Relief of the signs and symptoms of osteoarthritis; Relief of the signs and symptoms of rheumatoid arthritis; The management of acute pain in adults; Treatment of primary dysmenorrhea; To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) as an adjunct to usual care (e.g., endoscopic surveillance surgery); and Relief of signs and symptoms of ankylosing spondylitis.
5

(6)

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Defendants further admit that, as stated in the FDA-approved labeling for Celebrex®, " [t]he mechanism of action of Celebrex® is believed to be due to the inhibition of prostaglandin synthesis, primarily in inhibition of cyclooxygenase-2 (Cox-2), and at therapeutic concentrations in humans, Celebrex® does not inhibit the cyclooxygenase-1 (Cox-1) isoenzyme." Except as admitted herein, Defendants deny the allegations of this paragraph. 19. Answering paragraph 19, the allegations are not directed to Defendants, and

therefore, no response is required. To the extent a response is deemed required, Defendants incorporate their answer to paragraph 18 as if fully restated herein. Except as admitted herein, Defendants deny the allegations of this paragraph. 20. Answering paragraph 20, the allegations are not directed to Defendants, and

therefore, no response is required. To the extent a response is deemed required, Defendants incorporate their answer to paragraph 18 as if fully restated herein. Except as admitted herein, Defendants deny the allegations of this paragraph. 21. Answering paragraph 21, the allegations are not directed to Defendants, and

therefore, no response is required. To the extent a response is deemed required, Defendants incorporate their answer to paragraph 18 as if fully restated herein. Except as admitted herein, Defendants deny the allegations of this paragraph. 22. Answering paragraph 22, Defendants deny any wrongdoing and deny the

allegations contained therein. 23. Answering paragraph 23, Defendants admit that on December 31, 1998, the

FDA granted approval of an NDA submitted by Searle on June 29, 1998. Defendants further state that as stated in the package insert approved by the FDA, Defendants admit that Celebrex® is approved by the FDA for the following indications:
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(1) (2) (3) (4) (5)

Relief of the signs and symptoms of osteoarthritis; Relief of the signs and symptoms of rheumatoid arthritis; The management of acute pain in adults; Treatment of primary dysmenorrhea; To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) as an adjunct to usual care (e.g., endoscopic surveillance surgery); and Relief of signs and symptoms of ankylosing spondylitis.

(6)

Defendants further admit that, as stated in the FDA-approved labeling for Celebrex®, " [t]he mechanism of action of Celebrex® is believed to be due to the inhibition of prostaglandin synthesis, primarily in inhibition of cyclooxygenase-2 (Cox-2), and at therapeutic concentrations in humans, Celebrex® does not inhibit the cyclooxygenase-1 (Cox-1) isoenzyme." Except as admitted herein, Defendants deny the allegations of paragraph 27. 24. Answering paragraph 24, Defendants admit that, at times, they marketed and

co-promoted Celebrex® throughout the United States. Answering further, Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDAapproved prescribing information and that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny that they made any misrepresentations regarding the safety and effectiveness of Celebrex® and deny any wrongdoing. Except as otherwise admitted herein, Defendants deny the allegations of this paragraph.

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25.

Answering paragraph 25, Defendants refer to Dr. Eric Topol' August 22, s

2001 article in the Journal of the American Medical Association, which speaks for itself, and any attempt to characterize it is denied. Defendants state that the potential side effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law, and that Celebrex® is and was safe and effective when used in accordance with its FDAapproved prescribing information. Defendants deny the remaining allegations contained in this paragraph. 26. Answering paragraph 26, Defendants refer to Dr. Garrett Fitzgerald' October s

21, 2005 editorial in The New England Journal of Medicine, which speaks for itself, and any attempt to characterize it is denies. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations contained in this paragraph. 27. Answering paragraph 27, Defendants state that referenced agency document

speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 28. Answering paragraph 28, Defendants state that Plaintiffs fail to provide proper

context for the allegations concerning the referenced " studies" and therefore Defendants are , without sufficient information to confirm or deny the allegations contained in this paragraph, and Defendants therefore deny the same. Defendants specifically deny any wrongdoing and deny the remaining allegations contained in this paragraph. 29. Answering paragraph 29, Defendants state that Plaintiffs fail to provide proper

context for the allegations concerning the referenced " studies" and therefore Defendants are ,
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without sufficient information to confirm or deny the allegations contained in this paragraph, and Defendants therefore deny the same. Except as stated herein, Defendants deny any wrongdoing and deny the allegations contained in this paragraph. 30. Answering paragraph 30, Defendants admit that a Medical Officer Review

dated September 20, 2000 was completed by the FDA for the supplemental NDA submitted for Celebrex®. Defendants assert that the Medical Officer Review and the referenced CLASS study speak for themselves and any attempt to characterize them is denied. Except as admitted herein, Defendants deny the remaining allegations contained in this paragraph. 31. Answering paragraph 31, Defendants refer to Dr. F. Silverstein, et al.' s

September 13, 2000 article in the Journal of the American Medical Association, which speaks for itself, and any attempt to characterize it is denied. 32. Answering paragraph 32, Defendants state that the CLASS study speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny making any misrepresentations or omissions regarding Celebrex®, deny any wrongdoing, and deny the allegations contained in this paragraph. 33. Answering paragraph 33, Defendants state that referenced agency documents

and CLASS study speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants incorporate their answer to paragraph 32 as if fully stated herein. Defendants deny the remaining allegations of this paragraph. 34. Answering paragraph 34, Defendants state that referenced study speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph.

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35.

Answering paragraph 35, Defendants state that referenced study and articles

speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny the remaining allegations of this paragraph. 36. Answering paragraph 36, Defendants refer to the August 5, 2001 article in the

Washington Post, which speaks for itself and any attempt to characterize it is denied. Defendants specifically deny making any misrepresentations and deny the remaining allegations of this paragraph. 37. Answering paragraph 37, Defendants refer to the August 5, 2001 article in the

Washington Post, which speaks for itself and any attempt to characterize it is denied. Defendants specifically deny making any misrepresentations and deny the remaining allegations of this paragraph. 38. Answering paragraph 38, Defendants state that referenced studies and

publications speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny making any misrepresentations and deny the remaining allegations of this paragraph. 39. Answering paragraph 39, Defendants state that referenced agency document

speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 40. Answering paragraph 40, Plaintiffs fail to provide proper context for the

allegations concerning " Public Citizen"contained in paragraph 45, and therefore Defendants are without sufficient information or knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. Defendants deny the remaining allegations of this paragraph.
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41.

Answering paragraph 41, Defendants state that the referenced article speaks

for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 42. Answering paragraph 42, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. Defendants further state that Plaintiffs fail to provide proper context for the allegations concerning " Public Citizen" contained in this paragraph, and therefore Defendants are without sufficient information or knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. Defendants state that referenced CLASS study speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations contained in this paragraph. 43. Answering paragraph 43, Defendants state that referenced study speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. 44. Answering paragraph 44, Defendants state that referenced studies and article

speak for themselves and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 45. Answering paragraph 45, Defendants state that referenced study and article

speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny the remaining allegations of this paragraph. 46. Answering paragraph 46, Defendants state that referenced agency document

speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph.

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47.

Answering paragraph 47, Defendants state that referenced agency document

and study speak for themselves and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 48. Answering paragraph 48, Defendants state that referenced trial speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 49. Answering paragraph 49, Defendants state that referenced article speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants further answer that Plaintiffs fail to provide proper context for the allegations concerning " Public Citizen"contained in this paragraph, and therefore Defendants are without sufficient information or knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. Defendants deny the remaining allegations of this paragraph. 50. Answering paragraph 50, Defendants state that referenced studies speak for

themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny the remaining allegations of this paragraph. 51. Answering paragraph 51, Defendants state that referenced study and Medical

Officer Review speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny the remaining allegations of this paragraph. 52. Answering paragraph 52, Defendants state that referenced study speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph.

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53.

Answering paragraph 53, Defendants state that referenced study speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 54. Answering paragraph 54, Defendants state that the allegations related to

Merck are unrelated to Defendants and therefore no response is required. To the extent a response is deemed required, Defendants state that the referenced study and article speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny the remaining allegations of this paragraph. 55. 56. Answering paragraph 55, Defendants deny the allegations contained therein. Answering paragraph 56, Defendants state that referenced article speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 57. Answering paragraph 57, Defendants state that the referenced article speaks

for itself and Defendants deny any attempt by Plaintiffs to characterize it. Defendants deny the remaining allegations of this paragraph. 58. Answering paragraph 58, Defendants state that Plaintiffs'allegations,

including but not limited to the allegations regarding " scientific data,"" testing,"and " studies,"are vague and ambiguous and, as a result, Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations. Defendants deny the remaining allegations of this paragraph. 59. 60. Answering paragraph 59, Defendants deny the allegations contained therein. Answering paragraph 650, Defendants state that Celebrex® is and was safe

and effective when used in accordance with its FDA-approved prescribing information.
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Answering further, Defendants deny any wrongdoing and deny the allegations contained in this paragraph. 61. Answering paragraph 61, Defendants deny any wrongdoing and deny the

allegations contained therein. 62. Answering paragraph 62, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information and that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Answering further, Defendants admit that, at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Defendants deny any wrongdoing and except as admitted herein, deny the allegations contained in this paragraph. 63. Answering paragraph 63, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information. Answering further, Defendants deny that their actions were fraudulent or misleading and deny the allegations contained therein and specifically deny that Celebrex® is or was defective of unreasonably dangerous. Defendants deny the remaining allegations contained in this paragraph. 64. Answering paragraph 64, Defendants state that referenced agency documents

speak for themselves and Defendants deny any attempt by Plaintiffs to characterize them. Defendants deny that their actions were fraudulent and deny the remaining allegations of this paragraph.

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65.

Answering paragraph 65, Defendants state that referenced agency document

speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. 66. Answering paragraph 66, Defendants state that referenced article speaks for

itself and Defendants deny any attempt by Plaintiffs to characterize it. As to the remaining allegations, Defendants deny making any misrepresentations and deny the remaining allegations of this paragraph. 67. Answering paragraph 67, Defendants state that referenced agency document

speaks for itself and Defendants deny any attempt by Plaintiffs to characterize it. 68. Answering paragraph 68, Defendants lack sufficient knowledge and

information to form a belief as to the meaning of " times relevant herein,"but admit that, all at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Except as otherwise admitted herein, Defendants deny the allegation of this paragraph. 69. Answering paragraph 69, Defendants admit that, at times, Pfizer marketed and

co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex® throughout the United States. Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Answering further, Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny making any misrepresentations or omissions regarding the safety and effectiveness of Celebrex®. Except as otherwise admitted or stated herein, Defendants deny the allegation of this paragraph.
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70.

Answering paragraph 70, Defendants deny any wrongdoing and state that the

potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants further state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations of this paragraph. 71. Answering paragraph 71, Defendants admit that, at times, they Pfizer

marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Defendants deny the remaining allegations of this paragraph or are without sufficient information or knowledge to form a belief as to the truth of the allegations contained therein, and therefore deny the same. 72. Answering paragraph 72, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information. Except as stated herein, Defendants deny the allegations of this paragraph. 73. Answering paragraph 73, Defendants deny any wrongdoing and state that the

potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Answering further, Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Except as stated herein, Defendants deny the allegations of this paragraph. 74. Answering paragraph 74, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information and that the potential effects of Celebrex® were and are adequately described in its FDA-approved
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prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny making any misrepresentations or omissions regarding the safety and effectiveness of Celebrex®, and deny the remaining allegations of this paragraph. 75. Answering paragraph 75, Defendants admit that, at times, Pfizer marketed and

co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Except as admitted herein, Defendants deny the allegations of this paragraph. 76. Answering paragraph 76, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information and that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Except as stated herein, Defendants deny the allegations of this paragraph. 77. Answering paragraph 77, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants deny any wrongdoing and deny concealing or omitting material information. Defendants deny the remaining allegations of this paragraph. 78. 79. Answering paragraph 78, Defendants deny the allegations contained therein. Answering paragraph 79, Defendants deny any wrongdoing and state that

Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all
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times adequate and comported with applicable standards of care and law. Defendants specifically deny that Celebrex® is or was defective of unreasonably dangerous and deny the remaining allegations of this paragraph. 80. Answering paragraph 80, Defendants state that Celebrex® is and was safe and

effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and except as stated herein deny the remaining allegations of this paragraph. 81. Answering paragraph 81, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants further state that Celebrex® is and was safe and effective when used in accordance with its FDAapproved prescribing information. Except as stated herein, Defendants deny the allegations of this paragraph. 82. 83. Answering paragraph 82, Defendants deny the allegations contained therein. Answering paragraph 83, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that, at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Answering further, Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law, and that Celebrex® is
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and was safe and effective when used in accordance with its FDA-approved prescribing information. Except as stated herein, Defendants deny the allegations of this paragraph. 84. Answering paragraph 84, Defendants are without sufficient information or

knowledge to form a belief as to the truth of the allegations contained therein relating to Plaintiff Paula Deaton' prescription and consumption of Celebrex®. Defendants deny that s Plaintiffs were injured as a result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. 85. Answering paragraph 85, Defendants are without sufficient information or

knowledge to form a belief as to the truth of the allegations contained therein relating to Plaintiff Paula Deaton' prescription and consumption of Celebrex®. Defendants deny that s plaintiffs were injured as a result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. 86. Answering paragraph 86, Defendants deny that plaintiffs were injured as a

result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and deny the allegations contained therein. 87. Answering paragraph 87, Defendants are without sufficient information or

knowledge to form a belief as to the truth of the allegations contained therein relating to Plaintiff Donald Shaft' prescription and consumption of Celebrex®. Defendants deny that s
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Plaintiffs were injured as a result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. 88. Answering paragraph 88, Defendants are without sufficient information or

knowledge to form a belief as to the truth of the allegations contained therein relating to Plaintiff Donald Shaft' prescription and consumption of Celebrex®. Defendants deny that s plaintiffs were injured as a result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. 89. Answering paragraph 89, Defendants deny that plaintiffs were injured as a

result of using Celebrex®. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and deny the allegations contained therein. 90. Answering paragraph 90, Defendants incorporate by reference all previous

paragraphs as though fully set forth herein. 91. Answering paragraph 91, Defendants admit that, at times, Pfizer marketed and

co-promoted Celebrex®. Except as stated herein Defendants deny the allegations of this paragraph. 92. Answering paragraph 92, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants deny that Celebrex® is or was defective or unreasonably
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dangerous and state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations of this paragraph. 93. Answering paragraph 93, Defendants deny that Celebrex® is or was defective

or unreasonably dangerous and deny the remaining allegations of this paragraph. 94. Answering paragraph 94, Defendants state that in the ordinary case,

Celebrex® was expected to reach consumers without substantial change from the time of sale. However, Defendants are without sufficient information or knowledge to form a belief as to the truth of the allegations contained in this paragraph, and therefore deny the same. 95. Answering paragraph 95, Defendants deny that Plaintiffs were injured as a

result of using Celebrex® and deny the remaining allegations of this paragraph. 96. Answering paragraph 96, Defendants deny that Plaintiffs are entitled to the

relief sought therein. 97. Answering paragraph 97, Defendants incorporate by reference all previous

paragraphs as though fully set forth herein. 98. Answering paragraph 98, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that, at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. 99. Answering paragraph 99, Defendants deny that they made any statements or

representations to Plaintiffs or to others that might be implied by law as warranties regarding Celebrex®, and deny the allegations of this paragraph.

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100.

Answering paragraph 100, Defendants deny that they made any implied

warranties regarding Celebrex® and state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations of this paragraph. 101. 102. Answering paragraph 101, Defendants deny the allegations contained therein. Answering paragraph 102, Defendants deny that they made any implied

warranties regarding Celebrex®, deny that they breached any such warranty, deny that Plaintiffs were injured as a result of using Celebrex®, and deny the remaining allegations contained in this paragraph. 103. Answering paragraph 103, Defendants deny that Plaintiffs are entitled to the

relief sought therein. 104. Answering paragraph 104, Defendants incorporate by reference all previous

paragraphs as though fully set forth herein. 105. Answering paragraph 105, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required, Defendants admit that, at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Except as otherwise admitted herein, Defendants deny the allegations contained in this paragraph. 106. 107. Answering paragraph 106, Defendants deny the allegations contained therein. Answering paragraph 107, Defendants deny that they made any implied

warranties regarding Celebrex® and deny the allegations of this paragraph.

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108.

Answering paragraph 108, Defendants state that Celebrex® is and was safe

and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations of this paragraph, including all subpart. 109. Answering paragraph 109, Defendants state that Celebrex® is and was safe

and effective when used in accordance with its FDA-approved prescribing information. Answering further, Defendants deny that they made any implied warranties regarding Celebrex®, deny that they breached any such warranty, and deny the remaining allegations contained in this paragraph. 110. 111. Answering paragraph 110, Defendants deny the allegations contained therein. Answering paragraph 111, Defendants deny that they made any implied

warranties regarding Celebrex®, deny that they breached any such warranty, deny that Plaintiffs were injured as a result of using Celebrex®, and deny the remaining allegations contained in this paragraph. 112. Answering paragraph 112, Defendants deny that Plaintiffs are entitled to the

relief sought therein. 113. Answering paragraph 113, Defendants incorporate by reference all previous

paragraphs as though fully set forth herein. 114. Answering paragraph 114, Defendants deny that they made any express

warranties regarding Celebrex® and deny that they made any statements or representations to Plaintiffs or to others that might be implied by law as warranties regarding Celebrex®. Defendants further state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Celebrex® is and was safe and
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effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and deny the remaining allegations of this paragraph, including all subparts. 115. Answering paragraph 115, Defendants deny that Plaintiffs are entitled to the

relief sought therein. 116. Answering paragraph 116, Defendants incorporate by reference all previous

paragraphs as though fully set forth herein. 117. Answering paragraph 117, Defendants state that the allegations contained

therein assert legal conclusions to which no response is required. To the extent a response is deemed required Defendants admit that, at times, Pfizer marketed and co-promoted Celebrex®, Pharmacia marketed Celebrex®, and Searle marketed and distributed Celebrex®. Answering further, Defendants state that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and deny the remaining allegations of this paragraph, including all subparts. 118. Answering paragraph 118, Defendants deny that Plaintiffs were injured as a

result of using Celebrex® and deny the remaining allegations of this paragraph. 119. Answering paragraph 119, Defendants deny that Plaintiffs are entitled to the

relief sought therein. 120. Complaint.
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121.

Defendants state that the allegations contained in Plaintiffs'Demand for Jury

Trial assert legal conclusions to which no response is required. AFFIRMATIVE DEFENSES Discovery and investigation may reveal that one or more of the following defenses should be available to Defendants in this matter. Defendants therefore assert the following defenses in order to preserve the right to assert them. Upon completion of discovery, if the facts warrant, Defendants will withdraw any of these defenses as may be appropriate. First Defense 1. The Complaint fails to state a claim upon which relief can be granted. Second Defense 2. The claims asserted in the Complaint are barred, in whole or part, by the

applicable statue(s) of limitations and/or repose, or by the applicable doctrines of laches, waiver, and/or estoppel. Third Defense 3. The claims asserted in the Complaint are barred, in whole or part, because

Plaintiffs lack standing and/or capacity to bring such claims. Fourth Defense 4. The claim(s) for breach of warranty asserted in the Complaint is (are) barred

by Plaintiffs'failure to give timely notice. Fifth Defense 5. The claims asserted in the Complaint are barred, in whole or in part, because

Plaintiffs did not incur any ascertainable loss as a result of Defendants'conduct.

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Sixth Defense 6. The claims asserted in the Complaint are barred, in whole or in part, because

Plaintiffs have not suffered injuries or a significantly increased risk of contracting serious latent diseases or injuries as a result of Celebrex® use. Seventh Defense 7. The claims asserted in the Complaint are barred, in whole or in part, by

Plaintiffs'failure to exercise reasonable care and diligence to mitigate their damages, if any. Eighth Defense 8. Plaintiffs'losses, if any, are subject to an offset for benefits received by

Plaintiffs resulting from their alleged use of Celebrex®. Ninth Defense 9. If Plaintiffs sustained any damages as alleged, such damages arose from, and

were caused by, risks, hazards, and dangers knowingly assumed by Plaintiffs. Plaintiffs' recovery accordingly is barred or should be reduced by their assumption of the risk. Tenth Defense 10. Defendants are entitled to credit for any settlement of claims for alleged

injuries and damages made by Plaintiffs with any other defendant, person, or entity. Eleventh Defense 11. This Court should abstain from adjudicating Plaintiffs'claims relating to

warnings and labeling in deference to the interpretation of regulations relating to prescription drug labeling by the FDA.

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Twelfth Defense 12. The claims asserted in the Complaint are barred, in whole or in part, by the

doctrine of abstention, in that the common law gives deference to discretionary actions by the FDA under the Federal Food, Drug, and Cosmetic Act (" FDCA" 21 U.S.C. §§ 301 et ), seq. Thirteenth Defense 13. The claims asserted in the Complaint are barred, in whole or in part, by the

doctrines of primary jurisdiction and exhaustion of administrative remedies, because the FDA has exclusive or primary jurisdiction over the matters asserted in the Petition. Fourteenth Defense 14. The claims asserted in the Complaint are barred, in whole or in part, because

the products are comprehensively regulated by the FDA pursuant to the FDCA, and regulations promulgated thereunder, and Plaintiffs'claims conflict with the FDCA, with the regulations promulgated by the FDA to implement the FDCA, with the purposes and objectives of the FDCA and the FDA' implementing regulations, and with the specific s determinations by the FDA specifying the language that should be used in the labeling accompanying the products. Accordingly, Plaintiffs'claims are preempted by the Supremacy Clause of the Constitution of the United States, Article VI, clause 2, and the laws of the United States, including but not limited to the FDCA and the regulations promulgated thereunder. Alternatively Defendants are entitled to a presumption that Celebrex® is not defective or unreasonably dangerous.

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Fifteenth Defense 15. The prescription drug Celebrex® complied with the then-applicable product

safety regulations promulgated by the FDA. Sixteenth Defense 16. The claims asserted in the Complaint are barred, in whole or in part, because

the manufacturing, labeling, packaging, and any advertising of the product complied with the applicable codes, standards, and regulations established, adopted, promulgated, or approved by any applicable regulatory body, including but not limited to the United States, any state, and any agency thereof. Seventeenth Defense 17. To the extent the claims asserted in the Complaint are based on a theory

providing for liability without proof of causation, the claims violate Defendants'rights under the Constitution of the United States and analogous provisions of the applicable states' constitutions. Eighteenth Defense 18. The claims asserted in the Complaint are barred, in whole or in part, by the

learned intermediary doctrine. Nineteenth Defense 19. If Plaintiffs sustained any damages as alleged, said damages resulted from an

intervening or superseding cause and/or causes, and any act or omission on the part of Defendants was not the proximate and/or competent producing cause of such alleged damages.

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Twentieth Defense 20. If Plaintiffs sustained any damages as alleged, said damages were solely

caused by the acts or omissions, abuse or misuse, negligence, or fault, of third persons or parties over whom Defendants had no control or right to control and whose actions are not, therefore, imputable to Defendants. Twenty-first Defense 21. If Plaintiffs sustained any damages as alleged, said damages were directly and

proximately caused by the negligence, carelessness, or fault of the Plaintiffs, whose comparative negligence or fault is sufficient to bar these claims, or to proportionately reduce Plaintiffs'recovery. Twenty-second Defense 22. The claims asserted in the Complaint are barred as a matter of law pursuant to

the Restatement (Third) of Torts: Product Liability §§ 6(c) and 6(d), as reasonable physicians knowing of the reasonably foreseeable risks and therapeutic benefits associated with Celebrex® would have prescribed and did prescribe Celebrex® to Plaintiffs, and Defendants provided reasonable instructions and/or warnings to prescribing physicians. Twenty-third Defense 23. If Plaintiffs sustained any damages as alleged, said damages were directly and

proximately caused by the negligence, carelessness, or fault of parties other than Defendants, whether named or unnamed in Plaintiffs'Complaint, over whom Defendants had no supervision or control, and for whose actions and omissions Defendants has no legal responsibility. Plaintiffs'recovery, if any, should therefore be apportioned in accordance with the applicable law.
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Twenty-fourth Defense 24. The claims asserted in the Complaint are barred, in whole or in part, because

Plaintiffs would have taken the product even if the product labeling contained the information Plaintiffs contends should have been provided. Twenty-fifth Defense 25. The claims asserted in the Complaint are barred, in whole or in part, because

the advertisements, if any, and labeling with respect to the product, was not false or misleading, and therefore constitute protected commercial speech under the applicable provisions of the Constitution of the United States. Twenty-sixth Defense 26. The claims asserted in the Complaint are barred, in whole or in part, because

Plaintiffs lack an adequate scientific basis to demonstrate any resulting harm or increased risk of future harm as a result of Plaintiffs'alleged Celebrex® use. Twenty-seventh Defense 27. The claims asserted in the Complaint are barred, in whole or in part, because

the product was not unreasonably dangerous or defective, was suitable for the purpose for which it was intended, and was marketed with adequate and sufficient warnings. Twenty-eighth Defense 28. The claims asserted in the Complaint are barred, in whole or in part, because

Celebrex® possesses no characteristic which renders it unreasonably dangerous in a reasonably anticipated use by an individual.

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Twenty-ninth Defense 29. The claims asserted in the Complaint are barred, in whole or in part, because

the utility of Celebrex® outweighs the alleged risk. Thirtieth Defense 30. The claims asserted in the Complaint are barred, in whole or in part, because

Celebrex® was designed, tested, manufactured, and labeled in accordance with state-of-theart and industry standards existing at the time of sale. Thirty-first Defense 31. The methods, standards, and techniques utilized with respect to the

manufacture, testing, design, and marketing of Celebrex®, if any, including adequate warnings and instructions with respect to the product' use included in the product' package s s insert and other literature, conformed to the generally recognized, reasonably available and reliable state of the knowledge at the time the product was designed, tested, manufactured, and marketed. Thirty-second Defense 32. Plaintiffs'injuries, if any, were due to an allergic, idiosyncratic, or idiopathic

reaction to Celebrex®, or by an unforeseeable illness, unavoidable acts, or preexisting condition without any negligence or culpable conduct by Defendants. Thirty-third Defense 33. The claims asserted in the Complaint are barred, in whole or in part, because

the products " provide net benefits for a class of patients"within the meaning of comment f to Section 6 of the Restatement (Third) of Torts: Products Liability.

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Thirty-fourth Defense 34. The claims asserted in the Complaint are barred as a matter of law pursuant to

the Restatement (Third) of Torts: Product Liability § 4, et seq., because Celebrex® complied with applicable product safety statutes and administrative regulations. Thirty-fifth Defense 35. The claims asserted in the Complaint are barred as a matter of law pursuant to

Restatement (Second) of Torts § 402A, comments j & k. Thirty-sixth Defense 36. Plaintiffs'fraud-based claims, if any, are not stated with particularity as

required by Rule 9 of the Federal Rules of Civil Procedure. Thirty-seventh Defense 37. Defendants assert the defense of improper venue pursuant to 28 U.S.C.

§§ 1404 and 1406. Thirty-eighth Defense 38. Plaintiffs are improperly joined within the under Rule 20 of the Federal Rules

of Civil Procedure. Thirty-ninth Defense 39. To the extent that Tennessee or Kansas law applies, Defendants plead all of

the above affirmative defenses as they exist under Tennessee or Kansas common law and the applicable sections of Tennessee or Kansas statutory law. DEFENDANTS' REQUEST FOR JURY TRIAL Defendants request a trial by jury on all issues triable.

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DEFENDANTS' PRAYER FOR RELIEF WHEREFORE, Defendants pray for relief from judgment from Plaintiffs as follows: 1. Plaintiffs take nothing by reason of their Complaint. 2. Defendants recover their costs and attorneys'fees incurred herein; 3. For a trial by jury on all issues so triable; and 4. For such further and other relief as the Court deems proper.

Dated: July 10, 2007

FAEGRE & BENSON LLP

s/Joseph M. Price Joseph M. Price, # 88201 Davina ShaRik Carson, #0351726 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402-3901 (612) 766-7000 ATTORNEYS FOR PFIZER INC., PHARMACIA CORPORATION, AND G.D. SEARLE LLC
fb.us.2166233.01

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ATYADM, CLOSED, CV

U.S. District Court U.S.District Court Minnesota (DMN) CIVIL DOCKET FOR CASE #: 0:07-cv-02800-ADM-JSM

Deaton et al vs Pfizer et al DO NOT DOCKET. CASE HAS BEEN TRANSFERRED OUT. Assigned to: Judge Ann D. Montgomery Referred to: Magistrate Judge Janie S. Mayeron Cause: 28:1332-pip-Diversity-Personal Injury, Product Liability Plaintiff Paula Deaton

Date Filed: 06/13/2007 Jury Demand: Plaintiff Nature of Suit: 365 Personal Inj. Prod. Liability Jurisdiction: Diversity

represented by Elizabeth-NA L. Dudley Not Admitted LEAD ATTORNEY ATTORNEY TO BE NOTICED Mark-NA B. Hutton Not Admitted LEAD ATTORNEY ATTORNEY TO BE NOTICED Martha K Wivell Attorney at Law PO Box 339 Cook, MN 55723 218-666-0250 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED

Plaintiff Donald Shaft represented by Elizabeth-NA L. Dudley (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Mark-NA B. Hutton (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Martha K Wivell (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

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V. Defendant Pfizer Inc. represented by Davina ShaRik Carson Faegre & Benson LLP 90 S 7th St Ste 2200 Mpls, MN 55402-3901 612-766-7344 Fax: 612-766-1600 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED Joseph M Price Faegre & Benson LLP 90 S 7th St Ste 2200 Mpls, MN 55402-3901 612-766-7000 Fax: 612-766-1600 Email: [email protected] ATTORNEY TO BE NOTICED Defendant Pharmacia Corporation represented by Davina ShaRik Carson (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Defendant G. D. Searle LLC formerly known as G.D. Searle & Co. represented by Davina ShaRik Carson (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Joseph M Price (See above for address) ATTORNEY TO BE NOTICED

Date Filed 06/13/2007

#

Docket Text 1 COMPLAINT with Jury Demand against Pfizer, Inc., Pharmacia Corporation, and G. D. Searle LLC ( Filing fee $ 350 receipt number 400-13903.) assigned to Judge Richard H. Kyle per Master List and referred to Magistrate Judge Arthur J. Boylan, filed by Paula Deaton, and Donald Shaft. (Attachments: # 1 Civil Cover Sheet)(GJS) (Entered: 06/14/2007) Summons Issued as to Pfizer, Inc., Pharmacia Corporation, and G. D.

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Searle LLC. (GJS) (Entered: 06/14/2007) 06/15/2007 2 DISQUALIFICATION AND ORDER FOR REASSIGNMENT. Case reassigned to Judge Ann D. Montgomery for all further proceedings. Judge Richard H. Kyle no longer assigned to case. The new case number is 07cv2800 ADM/AJB. Signed by Judge Richard H. Kyle on 6/15/07. (JME) (Entered: 06/15/2007) 3 SUMMONS Returned Executed by Paula Deaton. Pfizer, Inc. served on 6/13/2007, answer due 7/3/2007. (Wivell, Martha) (Entered: 06/15/2007) 4 ORDER OF RECUSAL. Magistrate Judge Arthur J. Boylan recused. Case reassigned to Magistrate Judge Janie S. Mayeron for all further proceedings. The new case number is 07cv2800 ADM/JSM. Signed by Magistrate Judge Arthur J. Boylan on 6/18/07. (JME) (Entered: 06/19/2007) 5 SUMMONS Returned Executed by Paula Deaton, Donald Shaft. G. D. Searle LLC served on 6/14/2007, answer due 7/5/2007. (Wivell, Martha) (Entered: 06/22/2007) 6 SUMMONS Returned Executed by Paula Deaton, Donald Shaft. Pharmacia Corporation served on 6/14/2007, answer due 7/5/2007. (Wivell, Martha) (Entered: 06/22/2007) 7 ANSWER to Complaint with Jury Demand and DEFENSES by Pfizer, Inc., G. D. Searle LLC.(Price, Joseph) (Entered: 07/10/2007) 8 RULE 7.1 DISCLOSURE STATEMENT by Pfizer, Inc., Pharmacia Corporation, G. D. Searle LLC that there is no such parent or publicly held corporation to report. (Price, Joseph) (Entered: 07/10/2007) 9 CERTIFICATE OF SERVICE by Pfizer, Inc., Pharmacia Corporation, G. D. Searle LLC re 7 Answer to Complaint, 8 Rule 7.1 - Disclosure Statement (Price, Joseph) (Entered: 07/10/2007) 10 CERTIFIED COPY OF CONDITIONAL TRANSFER ORDER (CTO75), transferring case to the Northern District of California per MDL Panel for coordinated or consolidated pretrial proceedings. Case assigned to Judge Charles R Breyer. (kt) (Entered: 01/29/2008) NOTICE to Attorney: #07-2800 ADM/JSM has been transferred to the Northern District of California pursuant to CTO-75. (kt) (Entered: 01/29/2008)

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