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Case 8:07-cv-00897-SDM-MAP Document 7 Filed 07/18/2007 Page 1 ofof 63 Case 3:07-cv-03701-CRB Document 1-8 Filed 06/01/2007 Page 1 63

IN THE UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA TAMPA DIVISION ADALBERTO ACOSTA RIVERA, Plaintiff, vs. MERCK & CO., INC.; PFIZER, INC.; PHARMACIA CORPORATION, a whollyowned subsidiary of PFIZER, INC.; PHARMACIA & UPJOHN COMPANY, LLC, a wholly-owned subsidiary of PHARMACIA CORPORATION; G.D. SEARLE LLC (f/k/a G.D. SEARLE & CO.); and MONSANTO COMPANY, Defendants. ___________________________________/ DEFENDANTS PFIZER INC., PHARMACIA CORPORATION, PHARMACIA & UPJOHN COMPANY LLC, AND G.D. SEARLE LLC'S ANSWER AND DEFENSES AND JURY DEMAND Defendants Pfizer Inc. (incorrectly captioned as "Pfizer, Inc.") (hereinafter "Pfizer"), Pharmacia Corporation (f/k/a Monsanto Company1) (hereinafter "Pharmacia"), Pharmacia & Upjohn Company LLC (incorrectly captioned as "Pharmacia & Upjohn Company, LLC"), and CASE NO.: 8:07-cv-00897-SDM-MAP

Plaintiff's Complaint names "Monsanto Company" as a defendant. Defendants state that in 1933, an entity known as Monsanto Company ("1933 Monsanto") was incorporated under the laws of Delaware. On March 31, 2000, 1933 Monsanto changed its name to Pharmacia Corporation. On February 9, 2000, a separate company, Monsanto Ag Company, was incorporated under the laws of Delaware. On March 31, 2000, Monsanto Ag Company changed its name to Monsanto Company ("2000 Monsanto"). The 2000 Monsanto is engaged in the agricultural business and does not and has not ever designed, produced, manufactured, sold, resold or distributed Bextra® or Celebrex®. Given that Plaintiff alleges in her Complaint that Monsanto Company was involved in developing Bextra® or Celebrex®, see PLAINTIFF'S COMPLAINT at ¶ 14, 17, and 18, Defendants assume Plaintiff means to refer to 1933 Monsanto. As a result, Pharmacia will respond to the allegations directed at Monsanto Company.

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G.D. Searle LLC (hereinafter "Searle") (collectively referred to herein as "Defendants") respond to the complaint as follows: I. PRELIMINARY STATEMENT The Complaint does not state in sufficient detail when Plaintiff was prescribed or used Celebrex® or Bextra®. Accordingly, this Answer can only be drafted generally. Defendants may seek leave to amend this Answer when discovery reveals the specific time periods in which Plaintiff was prescribed and used Celebrex® or Bextra®. This preliminary statement is incorporated by reference in its entirety in response to each and every Paragraph of the Complaint. II. ORIGINAL ANSWER 1. Defendants admit that Plaintiff purports to bring this action and seeks damages

in excess of $15,000, but deny that there is any legal or factual basis for the purported causes of action and/or damages sought by Plaintiff as a result of Celebrex® and/or Bextra® use. 2. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations in this Paragraph of the Complaint except that Defendants are informed and believe that Plaintiff is a citizen of Florida. 3. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations of Plaintiff's medical condition or whether he took Celebrex® or Bextra®, and therefore deny the same. Defendants deny that Celebrex® or Bextra® caused Plaintiff injury or damages and deny the remaining allegations in this Paragraph of the Complaint.

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4.

The allegations contained in this Paragraph of the Complaint are not directed

toward the Defendants and, therefore, no response is required. 5. The allegations contained this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. 6. Defendants admit that Pfizer is a Delaware corporation with its principal place

of business in New York. Defendants deny the remaining allegations in this Paragraph of the Complaint. 7. Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrase "[a]t all times material hereto" and therefore deny the same, but admit that Pfizer is authorized to do business in Florida. Defendants deny the remaining allegations in this Paragraph of the Complaint. 8. Defendants admit that Pharmacia is a Delaware corporation with its principal

place of business in New Jersey. 9. Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrase "[a]t all times material hereto" and therefore deny the same, but admit that Pharmacia is a wholly-owned subsidiary of Pfizer. 10. Defendants deny that Defendant Pharmacia & Upjohn Company LLC ever

designed, produced, manufactured, marketed, sold, resold or distributed Celebrex® or Bextra®, and deny that it is a proper party in this suit. Defendants deny all remaining allegations in this Paragraph of the Complaint. The response to this Paragraph of the Complaint regarding

Pharmacia & Upjohn is incorporated by reference in response to each and every Paragraph of the Complaint referring to Pharmacia & Upjohn and/or Bextra Defendants.

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11.

Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrase "[a]t all times material hereto" and therefore deny the same. Defendants deny that Defendant Pharmacia & Upjohn Company LLC ever designed, produced, manufactured, marketed, sold, resold or distributed Celebrex® or Bextra®, and deny that it is a proper party in this suit. Defendants deny the remaining allegations in this Paragraph of the Complaint. 12. Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrase "[a]t all times material hereto" and therefore deny the same. Defendants deny that Defendant Pharmacia & Upjohn Company LLC ever designed, produced, manufactured, marketed, sold, resold or distributed Celebrex® or Bextra®, and deny that it is a proper party in this suit. Defendants deny all remaining allegations in this Paragraph of the Complaint. 13. Defendants admit that Searle is a Delaware limited liability company with its

principal place of business in Illinois and that it is presently a wholly-owned third tier subsidiary of Pharmacia Corporation, which in turn is a wholly-owned subsidiary of Pfizer Inc. Defendants deny the remaining allegations in this Paragraph of the Complaint. 14. Defendants admit that, in 1933, an entity known as Monsanto Company ("1933

Monsanto") was incorporated under the laws of Delaware. On March 31, 2000, a subsidiary of 1933 Monsanto merged with Pharmacia & Upjohn, Inc, and 1933 Monsanto changed its name to Pharmacia Corporation. On February 9, 2000, a separate company, Monsanto Ag Company, was incorporated under the laws of Delaware. On March 31, 2000, Monsanto Ag Company changed its name to Monsanto Company ("2000 Monsanto"). The 2000 Monsanto is a

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corporation existing under the laws of Delaware. The 2000 Monsanto is engaged in the agricultural business and does not and has not ever designed, produced, manufactured, sold, resold or distributed Celebrex® or Bextra®. The 2000 Monsanto is not and has never been the parent of either Searle or Pharmacia. As the 2000 Monsanto does not and has not ever designed, produced, manufactured, sold, resold, marketed, or distributed Celebrex® or Bextra®, the 2000 Monsanto is not a proper party in this matter. Defendants deny all

remaining allegations in this Paragraph of the Complaint. The response to this Paragraph of the Complaint regarding Monsanto is incorporated by reference in response to each and every Paragraph of the Complaint referring to Monsanto and/or Celebrex Defendants. 15. The allegations in this Paragraph of the Complaint assert a legal conclusion to

which no response is required. To the extent a response is required, Defendants deny that Defendant Pharmacia & Upjohn Company LLC ever designed, produced, manufactured, marketed, sold, resold or distributed Celebrex® or Bextra®, and deny that it is a proper party in this suit. Defendants deny the remaining allegations in this Paragraph of the Complaint. 16. Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrase "[a]t all times material" and therefore deny the same. Defendants admit that during certain periods of time Pfizer and Pharmacia co-promoted and marketed Bextra® throughout the United States, including Florida, to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. . Defendants deny the remaining allegations in this Paragraph of the Complaint. 17. The allegations in this Paragraph of the Complaint assert a legal conclusion and

therefore no response is required. To the extent a response is required, Defendants state that

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2000 Monsanto is engaged in the agricultural business and does not and has not ever designed, produced, manufactured, sold, resold or distributed Celebrex® or Bextra® and therefore deny that the 2000 Monsanto is a proper party to this suit. allegations in this Paragraph of the Complaint. 18. Defendants lack knowledge or information sufficient to form a belief as to the Defendants deny the remaining

meaning of the phrase "[a]t all times material" and therefore deny the same. Defendants admit that during certain periods of time Pfizer and Pharmacia co-promoted and marketed Celebrex® and Bextra® in the United States, including Florida, to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants admit that during certain periods of time Celebrex® and Bextra® were manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Celebrex® and Bextra® in the United States, to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with its approval by the FDA. Defendants state that the 2000 Monsanto is engaged in the agricultural business and does not and has not ever designed, produced, manufactured, sold, resold or distributed Celebrex® or Bextra®, and therefore deny that Monsanto is a proper party to this suit.. Defendants deny the remaining allegations in this Paragraph of the Complaint. 19. The allegations contained in this Paragraph concerning Vioxx, aspirin,

naproxen and ibuprofen are not directed toward the Defendants and, therefore, no response is required. Defendants admit that, as stated in the package inserts approved by the United States Food & Drug Administration ("FDA"), Celebrex® and Bextra® are in a class of drugs that is,

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at times, referred to as non-steroidal anti-inflammatory drugs ("NSAIDs"). the remaining allegations on this Paragraph of the Complaint. 20.

Defendants deny

The allegations contained in paragraph 20 are not directed towards Defendants

and, therefore, no response is required. Should a response be deemed required, Plaintiff fails to provide the proper context for the allegations in this Paragraph of the Complaint and Defendants therefore lack sufficient information or knowledge to form a belief as to the truth of the allegations and, therefore, deny the allegations in this Paragraph of the Complaint. 21. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Plaintiff fails to provide the proper context for the allegations in this Paragraph of the Complaint and Defendants therefore lack sufficient information or knowledge to form a belief as to the truth of the allegations and, therefore, deny the allegations in this Paragraph of the Complaint. 22. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Plaintiff fails to provide the proper context for the allegations in this Paragraph of the Complaint and Defendants therefore lack sufficient information or knowledge to form a belief as to the truth of the allegations and, therefore, deny the allegations in this Paragraph of the Complaint. 23. The allegations contained in this Paragraph of the Complaint concerning Merck

and "other pharmaceutical companies" are not directed toward Defendants and, therefore, no response is required. Defendants admit that, Celebrex® and Bextra® are in a class of drugs

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that is, at times, referred to as non-steroidal anti-inflammatory drugs ("NSAIDs"). In addition, Defendants admit that the mechanism of action for Celebrex® and Bextra® is believed to be due to the inhibition of prostaglandin synthesis, primarily through inhibition of cyclooxygenase-2 or COX-2. Defendants deny the remaining allegations in this Paragraph of the Complaint. 24. The allegations contained in this Paragraph of the Complaint concerning Merck

are not directed toward the Defendants and, therefore, no response is required. Defendants deny any wrongdoing and deny the allegations in this Paragraph of the Complaint. A. Response to Factual Background Relating to Defendant MERCK & CO., INC. ("MERCK") and Vioxx 25-97. The allegations contained in Paragraphs 25-97 of the Complaint concerning Merck and Vioxx are not directed toward the Defendants and, therefore, no response is required. Should a response be deemed required, Defendants are without knowledge or

information sufficient to form a belief as to the truth of the allegations in these Paragraphs of the Complaint, and therefore deny the same. B. Response to Factual Background Relating to Bextra® Defendants 98. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 the allegations in this Paragraph of the Complaint. 99. Defendants deny that Bextra® is defective and deny the allegations in this

Paragraph of the Complaint.

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100.

Defendants admit that Bextra® is in a class of drugs that is, at times, referred to Except as admitted herein, the

as non-steroidal anti-inflammatory drugs ("NSAIDs").

Defendants deny the allegations in this Paragraph of the Complaint. 101. Defendants admit, and as indicated in the package insert approved by the FDA,

that Bextra® is indicated for use in the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as for the treatment of primary dysmenorrhea. Defendants admit that Bextra® is in a class of drugs that is, at times, referred to as non-steroidal antiinflammatory drugs ("NSAIDs"). Except as admitted herein, Defendants deny the allegations in this Paragraph of the Complaint. 102. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Plaintiff fails to provide the proper context for the allegations in this Paragraph of the Complaint and Defendants therefore lack sufficient information or knowledge to form a belief as to the truth of the allegations and, therefore, deny the allegations in this Paragraph of the Complaint. 103. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Plaintiff fails to provide the proper context for the allegations in this Paragraph of the Complaint and Defendants therefore lack sufficient information or knowledge to form a belief as to the truth of the allegations and, therefore, deny the allegations in this Paragraph of the Complaint.

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104.

Defendants admit that during certain periods of time, Pfizer and Pharmacia co-

promoted and marketed Bextra®, but lack knowledge or information sufficient to form a belief as to the meaning of the phrase "a portion of the extremely lucrative consumer market," and thus deny the same. Defendants deny the remaining allegations in this Paragraph of the Complaint. 105. Defendants admit that Bextra® received FDA approval on November 16, 2001.

Defendants further admit, and as indicated in the package insert approved by the FDA, that Bextra® is indicated for use in the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as for the treatment of primary dysmenorrhea. Defendant Pfizer admits that, at certain times, it has co-promoted and marketed Bextra® and co-promoted and marketed Celebrex®. Defendants admit that Bextra® and Celebrex® are in a class of drugs that is, at times, referred to as non-steroidal anti-inflammatory drugs ("NSAIDs"). Except as admitted herein, the Defendants deny the allegations in this Paragraph of the Complaint. 106. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny the allegations in this Paragraph of the Complaint. 107. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny the allegations in this Paragraph of the Complaint. 108. Defendants state that the studies referred to in this Paragraph of the Complaint

speak for themselves and any attempt to characterize them is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint.

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109.

Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the studies referred to in this Paragraph of the Complaint speak for themselves and any attempt to characterize them is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint. 110. 111. Defendants deny the allegations in this Paragraph of the Complaint. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny that Bextra® caused Plaintiff injury or damages and deny the allegations in this Paragraph of the Complaint. 112. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny that Bextra® caused Plaintiff injury or damages and deny the allegations in this Paragraph of the Complaint. 113. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny any wrongdoing and deny the allegations in this Paragraph of the Complaint. 114. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether Plaintiff used Bextra®, and, therefore, deny the same. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care

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and law. Defendants deny that Bextra® caused Plaintiff injury or damages and deny the allegations in this paragraph of the Complaint. 115. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether Plaintiff used Bextra®, and, therefore, deny the same. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 Bextra® caused Plaintiff injury or damages and deny the allegations in this paragraph of the Complaint. 116. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 any wrongful act, deny that Bextra® caused Plaintiff injury or damages and deny the allegations in this paragraph of the Complaint. 117. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny the allegations in this paragraph of the Complaint. 118. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing

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information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny any wrongful act and deny the allegations in this paragraph of the Complaint. 119. Defendants admit that, at certain times, Pfizer and Pharmacia co-promoted and

marketed Bextra® in the United States for the indications set forth in the FDA-approved package inserts and as permitted by law. Defendants state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 the allegations in this Paragraph of the Complaint. 120. Defendants admit that, during certain periods of time, Pfizer and Pharmacia co-

promoted and marketed Bextra® in the United States for the indications set forth in the FDAapproved package inserts and as permitted by law. Defendants state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 admit that it provided FDA approved Defendants deny any misrepresentations or

prescribing information about Bextra®.

wrongdoing and deny the allegations in this paragraph of the Complaint. 121. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential

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effects of Bextra® 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 Bextra® is defective and deny the remaining allegations in this Paragraph of the Complaint. 122. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether Plaintiff used Bextra®, and, therefore, deny the same. Defendants admit that, during certain periods of time, Pfizer and Pharmacia copromoted and marketed Bextra® in the United States for the indications set forth in the FDAapproved package inserts and as permitted by law. Defendants state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 the allegations in this Paragraph of the Complaint. 123. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 124. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care

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and law. Defendants deny any wrongdoing and deny the allegations in this Paragraph of the Complaint. 125. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether Plaintiff used Bextra®, and, therefore, deny the same. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 any wrongdoing or concealment, deny that Bextra® caused

Plaintiff injury or damages, and deny the allegations in this Paragraph of the Complaint. 126. Defendants state that the January 2005 letter from the FDA speaks for itself and

any attempt to characterize it is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint. 127. Defendants admit that the sale of Bextra® was voluntarily suspended in the

United States market as of April 7, 2005. Defendants further state that any statements made by the FDA speak for themselves and any attempt to characterize them is denied. Defendant denies the remaining allegations in this Paragraph of the Complaint. 128. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether Plaintiff used Bextra®, and, therefore, deny the same. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing

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information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny any wrongdoing or misrepresentation and deny the allegations in this Paragraph of the Complaint. 129. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 any wrongdoing or misrepresentation and deny the allegations in this Paragraph of the Complaint. 130. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 any wrongdoing or concealment and deny the allegations in this Paragraph of the Complaint. 131. Defendants state that Bextra® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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 any wrongful act and deny the allegations in this Paragraph of the Complaint. 132. Defendants deny the allegations in this Paragraph of the Complaint.

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133.

Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations whether Plaintiff used Bextra® and therefore deny the same. Defendants deny any wrongful act, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this Paragraph of the Complaint. 134. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations whether Plaintiff used Bextra® and therefore deny the same. Defendants deny the remaining allegations in this Paragraph of the Complaint. 135. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations whether Plaintiff used Bextra® and therefore deny the same. Defendant states that, in the ordinary case, Bextra® was expected to reach users and consumers without substantial change from the time of sale. Defendants deny the remaining allegations in this Paragraph of the Complaint. 136. Defendants state that the potential effects of Bextra® 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 the allegations in this Paragraph of the Complaint. 137. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations whether Plaintiff used Bextra® and therefore deny the same. Defendants state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants state that the potential effects of Bextra® 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

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that Bextra is defective, deny that Bextra caused Plaintiff injury or damages, and deny the remaining allegations of this paragraph of the Complaint. B. 138. Response to Factual Background Relating to Celebrex® Defendants Defendants state that Celebrex® was and is 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. Defendants deny the allegations in this Paragraph of the Complaint. 139. Defendants deny that Celebrex® is defective and deny the allegations in this

Paragraph of the Complaint. 140. Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrases "[a]t all times material hereto" and "predecessors in interest" and therefore deny the same. Defendants admit that during certain periods of time Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States, including Florida. Defendants deny the remaining allegations in this Paragraph of the Complaint. 141. The Answering Defendants lack knowledge or information sufficient to form a

belief as to the meaning of the phrase "[a]t all times material hereto" and therefore deny the same. 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, including Florida, to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with its approval by the FDA. Defendants deny all remaining allegations in this Paragraph of the Complaint.

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142.

Defendants lack knowledge or information sufficient to form a belief as to the

meaning of the phrases "[a]t all times material hereto" and "predecessors in interest" and therefore deny the same. Defendants admit that during certain periods of time, Pharmacia has co-promoted and marketed Celebrex® in the United States, including Florida to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny all remaining allegations in this Paragraph of the Complaint. 143. Defendants admit that, in 1933, an entity known as Monsanto Company ("1933

Monsanto") was incorporated under the laws of Delaware. On March 31, 2000, a subsidiary of 1933 Monsanto merged with Pharmacia & Upjohn, Inc, and 1933 Monsanto changed its name to Pharmacia Corporation. On February 9, 2000, a separate company, Monsanto Ag Company, was incorporated under the laws of Delaware. On March 31, 2000, Monsanto Ag Company changed its name to Monsanto Company ("2000 Monsanto"). The 2000 Monsanto is engaged in the agricultural business and does not and has not ever designed, produced, manufactured, sold, resold or distributed Celebrex®. The 2000 Monsanto is not and has never been the parent of either Searle or Pharmacia. As the 2000 Monsanto does not and has not ever designed, produced, manufactured, sold, resold, marketed, or distributed Celebrex®, the 2000 Monsanto is not a proper party in this suit. Defendants deny all remaining allegations in this Paragraph of the Complaint. 144. Defendants admit that, on December 31, 1998, the FDA approved Celebrex®

for the treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis to be available by prescription only by healthcare providers who are by law authorized to prescribe

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drugs in accordance with their approval by the FDA. Defendants further admit that during certain periods of time Celebrex® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant further admits that Pharmacia acquired Searle in 2000 and that, as a result of a merger in April 2003, Searle and Pharmacia became subsidiaries of Pfizer. Defendants further admit that during certain periods of time, Pharmacia co-

promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer co-promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny all remaining allegations in this Paragraph of the Complaint. 145. Defendants state that Celebrex® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendant states 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 any misrepresentations or wrongful acts and deny the remaining allegations in this Paragraph of the Complaint. 146. Defendants state that Celebrex® was and is 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

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information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny the allegations in this Paragraph of the Complaint. 147. Defendants admit that, during certain periods of time, Celebrex® was

manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that during certain periods of time, Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny all remaining allegations in this Paragraph of the Complaint. 148. This paragraph contains legal contentions to which no response is required. To

the extent that a response is required, Defendants deny them. Defendants admit that, during certain periods of time, Celebrex® was manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States and Florida to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States and Florida to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny wrongful conduct or misrepresentations and deny the remaining allegations in this Paragraph of the Complaint.

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149. Defendants admit that the NDA for Celebrex was submitted to the FDA on June 29, 1988 by Searle. Defendants admit that on December 31, 1998, the FDA granted approval of the NDA for Celebrex. Defendants admit that, as stated in the FDA-approved labeling, Celebrex was approved for relief of the signs and symptoms of osteoarthritis and for relief of the signs and symptoms of rheumatoid arthritis in adults. Defendants admit that, on December 23, 1999, Celebrex® was approved by the FDA to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis ("FAP") as an adjunct to usual care (e.g. endoscopic surveillance surgery). Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 150. Defendants admit that, during certain periods of time, Celebrex® was

manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States and Florida to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia copromoted and marketed Celebrex® in the United States and Florida to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further state that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny any misrepresentation or wrongful acts, and deny the remaining allegations this Paragraph of the Complaint.

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151.

Defendants state that Celebrex® was and is safe and effective when used in

accordance with its FDA-approved prescribing information. Defendants deny the allegations in this Paragraph of the Complaint. 152. Defendants state that the allegations regarding "FDA updates" are vague and

ambiguous and, therefore, the Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations and therefore deny the same. Defendants state that any "FDA updates" speak for themselves and any attempt to characterize them is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint. 153. Defendants state that Celebrex® was and is 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. Defendants deny the allegations in this Paragraph of the Complaint. 154. 155. Defendants deny the allegations in this Paragraph of the Complaint. As to the allegations in this paragraph regarding the CLASS study, Defendants

state that the study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny all remaining allegations contained in this Paragraph of the Complaint. 156. As to the allegations in this paragraph regarding the CLASS study, Defendants

state that the study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny all remaining allegations contained in this Paragraph of the Complaint.

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157.

As to the allegations in this paragraph regarding the CLASS study, Defendants

state that the study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny any misrepresentation or wrongful acts, and deny all remaining allegations contained in this Paragraph of the Complaint. 158. As to the allegations in this paragraph regarding the CLASS study, Defendants

state that the study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. As to the Medical Officer's Review of the CLASS Study, Defendants state that the Medical Officer's Review speaks for itself and specifically refer the Court to the Medical Officer's Review for its actual language and text. Any attempt to characterize the Medical Officer's Review is denied. Defendants deny any misrepresentation or wrongful acts, and deny all remaining allegations contained in this Paragraph of the Complaint. 159. The allegations contained in this Paragraph of the Complaint are not directed

toward the Defendants and, therefore, no response is required. Should a response be deemed required, Defendants state that the referenced report speaks for itself and respectfully refer the Court to the report for its actual language and full text. Any attempt to characterize the report is denied. Defendants deny all remaining allegations in this Paragraph of the Complaint. 160. As to the allegations in this paragraph regarding the CLASS study, Defendants

state that the study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. As to the allegations regarding the article, Defendants state that the article speaks for itself and respectfully refer the

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Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny any misrepresentation or wrongful acts, and deny all remaining allegations contained in this Paragraph of the Complaint. 161. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Defendants state that the articles speak for themselves and respectfully refer the Court to the articles for their actual language and full text. Any attempt to characterize the articles is denied. Defendants deny any misrepresentation or wrongful acts and deny the remaining allegations contained in this Paragraph of the Complaint. 162. The allegations contained in this Paragraph of the Complaint are not directed

toward the Defendants and are vague and ambiguous and assert legal conclusions, therefore, no response is required. Should a response be deemed required, Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny any misrepresentation or wrongful acts and deny the remaining allegations contained in this Paragraph of the Complaint. 163. Defendants state that the referenced study speaks for itself and respectfully refer

the Court to the study for its actual language and full text. Any attempt to characterize the study is denied Defendants deny all remaining allegations contained in this Paragraph of the Complaint. 164. The allegations contained in this Paragraph are not directed toward the

Defendants and are not a direct, concise averment of fact; therefore, no response is required.

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Should a response be deemed required, the Defendants state that the referenced articles and reports speak for themselves, and any attempt to characterize them is denied. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 165. Defendants state that the referenced report speaks for itself and respectfully

refer the Court to the report for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny any wrongful conduct and deny the remaining

allegations contained in this Paragraph of the Complaint. 166. Defendants state that the referenced study speaks for itself and respectfully refer

the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint. 167. Defendants state that the referenced study speaks for itself and respectfully

refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations in this Paragraph of the Complaint.. 168. The allegations contained in this Paragraph of the Complaint are not directed

toward the Defendants and, therefore, no response is required. Should a response be deemed required, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations contained in this Paragraph of the

Complaint. 169. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and are not direct, concise averments of fact to which Defendants can

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reasonably respond, therefore, no response is required. Should a response be deemed required, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. The Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 170. The allegations contained in this Paragraph of the Complaint are not directed Defendants state that the

toward Defendants and, therefore, no response is required.

referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 171. This Paragraph is not a direct, concise averment of fact to which the Defendants

can reasonably respond and, therefore, no response is required. To the extent a response is deemed necessary, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 172. Defendants state that the referenced study speaks for itself and respectfully refer

the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny all remaining allegations contained in this Paragraph of the Complaint. 173. The allegations contained in this Paragraph are not directed toward Defendants

and, therefore, no response is required. Should a response be deemed required, Defendants state that plaintiff fails to provide the proper context for the allegations set forth in this

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Paragraph and, therefore, Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations and therefore deny the same. Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 174. Defendants state that the referenced studies speak for themselves and

respectfully refer the Court to the studies for their actual language and full text. Any attempt to characterize the studies is denied. Defendants specifically state that the referenced studies involved Vioxx®, not Celebrex®. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 175. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, Defendants state that the referenced Medical Officer's Review speaks for itself and respectfully refer the Court to the Medical Officer's Review for its actual language and full text. Any attempt to characterize the Medical Officer's Review is denied. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 176. The allegations contained in this Paragraph of the Complaint are not directed

toward Defendants and, therefore, no response is required. Should a response be deemed required, the Answering Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants specifically state that the referenced study

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involved Vioxx®, not Celebrex®. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 177. Defendants state that the referenced study speaks for itself and respectfully refer

the Court to the study for its actual language and full text. Any attempt to characterize a study is denied. Defendants specifically state that the referenced study involved Vioxx®, not

Celebrex®. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 178. Defendants state that the referenced study speaks for itself and respectfully refer

the Court to the study for its actual language and full text. Any attempt to characterize a study is denied. Defendants specifically state that the referenced study involved Vioxx®, not

Celebrex®. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 179. 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® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the allegations contained in this Paragraph of the Complaint. 180. Defendants specifically deny that testing and studies were grossly inadequate

and deny the allegations contained in this Paragraph of the Complaint. 181. Defendants state that the potential effects of Celebrex® were and are

adequately described in its FDA-approved prescribing information, which was at all times

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adequate and comported with applicable standards of care and law. Defendants further state that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the allegations contained in this Paragraph of the Complaint. 182. Defendants specifically deny any "intentional[] suppress[ion]"and deny the

allegations contained in this Paragraph of the Complaint. 183. Defendants deny any wrongful conduct and deny the allegations contained in

this Paragraph of the Complaint. 184. 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® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongful conduct and deny the allegations contained in this Paragraph of the Complaint. 185. Defendants are without knowledge or information sufficient to form a belief as

to the truth of the allegations regarding whether plaintiff used Celebrex® and therefore deny the same. 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® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongful conduct and deny the allegations contained in this Paragraph of the Complaint.

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186.

Defendants state that the referenced letters speak for themselves and

respectfully refer the Court to the letters for their actual language and full text. Any attempt to characterize the letters is denied. Defendants deny any wrongful conduct and deny the remaining allegations contained in this Paragraph of the Complaint. 187. Defendants state that the referenced letter speaks for itself and respectfully refer

the Court to the letter for its actual language and full text. Any attempt to characterize the letter is denied. Defendants refer to the cited material for its contents. Any attempt to

characterize it is denied. Defendants deny any wrongful conduct and deny all remaining allegations contained in this Paragraph of the Complaint. 188. Defendants state that the cited material speaks for itself and respectfully refer

the Court to the material for its actual language and full text. Any attempt to characterize the material is denied. Defendants deny any wrongful conduct and deny the remaining allegations contained in this Paragraph of the Complaint. 189. Defendants state that Celebrex® was and is 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. Defendants admit that, during certain periods of time, Celebrex® was manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia co-promoted and

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marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 190. Defendants admit that, during certain periods of time, Celebrex® was

manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants state that Celebrex® was approved by the FDA for the following indications: (1) for relief of the signs and symptoms of osteoarthritis; (2) for relief of the signs and symptoms of rheumatoid arthritis in adults; (3) for relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older; (4) for the relief of the signs and symptoms of ankylosing spondylitis; (5) for the management of acute pain in adults; (6) for the treatment of primary dysmenorrhea; and (7) to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). Defendants further state that Celebrex® was and is 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

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standards of care and law. Defendants deny any wrongful conduct and deny the remaining allegations contained in this Paragraph of the Complaint. 191. 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® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny any wrongful conduct and deny the allegations contained in this Paragraph of the Complaint. 192. Defendants admit that, during certain periods of time, Celebrex® was

manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants state that Celebrex® was and is safe and effective when used in accordance with its FDAapproved 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. Defendants deny any wrongful conduct and deny all remaining allegations contained in this Paragraph of the Complaint.

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193.

Defendants admit that, during certain periods of time, Celebrex® was

manufactured and packaged for Searle which developed, tested, marketed, co-promoted and distributed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants further admit that, during certain periods of time, Pfizer and Pharmacia co-promoted and marketed Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants state that Celebrex® was and is safe and effective when used in accordance with its FDAapproved 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. Defendants deny the remaining allegations contained in this Paragraph of the Complaint. 194. 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® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny that Celebrex® was or is dangerous and deny the allegations contained in this Paragraph of the Complaint. 195. 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® was and is safe and effective when used in accordance with its FDA-approved

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prescribing information. Defendants deny any wrongful conduct and deny the allegations contained in this Paragraph of the Complaint. 196. Defendants la