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Case 3:07-cv-02970-CRB

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Howard Ross Cabot, Bar No. 006669 Christopher S. Coleman, Bar No. 018287 PERKINS COIE BROWN & BAIN P.A. 2901 North Central Avenue, Suite 2000 Post Office Box 400 Phoenix, Arizona 85001-0400 Telephone: 602.351.8000 Facsimile: 602.648.7000 [email protected] [email protected] Attorneys for Defendants UNITED STATES DISTRICT COURT DISTRICT OF ARIZONA Edward Finck, a single man, Plaintiff, ANSWER v. (Jury Trial Requested) Pfizer, Inc., a Delaware corporation with its principal place of business in New York; Pharmacia Corporation, a Delaware corporation with its principal place of business in New Jersey; Monsanto Co., a subsidiary of Pharmacia and a Delaware corporation with its principal place of business in Missouri; G.D. Searle & Company, a Delaware corporation with its principal place of business in Illinois, Defendants. TO THE HONORABLE JUDGE OF SAID COURT: NOW COME Defendants Pfizer Inc. (incorrectly captioned in Plaintiff's Complaint as "Pfizer, Inc.") ("Pfizer"), Pharmacia Corporation (f/k/a "Monsanto No. CV 06-3017-PHX-JAT

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Company"1 ) ("Pharmacia"), and G.D. Searle LLC (improperly captioned in Plaintiff's Complaint as "G.D. Searle & Company") ("Searle"), collectively "Defendants," and file this their Original Answer to Plaintiff's Complaint ("Complaint"), and would respectfully show the Court as follows: I. PRELIMINARY STATEMENT The Complaint does not state in sufficient detail when Plaintiff was prescribed or used Celebrex®. 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®. II. ORIGINAL ANSWER Response to Introduction Defendants admit that, during certain periods of time, Pfizer and Pharmacia copromoted 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 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
1

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 Celebrex®. Given that Plaintiff alleges in his Complaint that Monsanto Company was involved in developing Celebrex®, see PLAINTIFF' S COMPLAINT at ¶ 4, 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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who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants state that Celebrex® is and was safe and effective when used in accordance with its FDA-approved prescribing information. As for the allegations in this paragraph of the Complaint regarding the NCI study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. Defendants deny that

Celebrex® is defective and deny the remaining allegations in the first unnumbered paragraph of the Complaint. Response to Allegations Regarding Jurisdiction and Venue 1. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations concerning the Plaintiff's citizenship, and therefore deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 2. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, 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 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® 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 deny the remaining allegations contained in this paragraph of the Complaint. 3. Defendants admit that Pharmacia is a Delaware corporation with its

principal pace of business in the State of New Jersey, and that Pharmacia does business in Arizona. Defendants admit that, during certain periods of time, Pharmacia marketed and

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co-promoted Celebrex® throughout the United States to be prescribed by healthcare providers who are authorized by law to prescribe drugs in accordance with their approval by the FDA. Defendants deny the remaining allegations contained in this paragraph of the Complaint. 4. 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, or distributed Celebrex®, Defendants therefore state that the 2000 Monsanto is not a proper party in this matter. Defendants deny the remaining allegations contained in this paragraph of the Complaint. Defendants state that the response to this paragraph of the Complaint regarding Monsanto is incorporated by reference in each and every paragraph of the Complaint referring to Monsanto and/or Defendants. 5. Defendants admit that Pfizer is a Delaware corporation with its principal

place of business in New York. Defendants admit that, during certain periods of time, Pfizer co-promoted and marketed the prescription drug Celebrex® in the United States, including Arizona, 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 as a result of a merger in April 2003, Pharmacia became a subsidiary of Pfizer. Defendants deny the remaining allegations contained in this paragraph of the Complaint.

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6.

Defendants admit that Searle is a Delaware limited liability company with

its principal place of business in Illinois. Pfizer Defendants also 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, including Arizona, 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 Paragraph 6 of the Complaint. 7. Defendants are without knowledge or information sufficient to form a belief

as to the truth of the allegations concerning the amount in controversy, and therefore deny the same. However, Defendants admit that Plaintiff claims that the amount in controversy exceeds $75,000, exclusive of interests and costs. Defendants are without knowledge or information sufficient to form a belief as to the judicial district in which the asserted claims allegedly arose and therefore denies that venue is proper in this district pursuant to 28 U.S.C. § 1391. Defendants further deny committing a tort within the State of Arizona and deny the remaining allegations in this paragraph of the Complaint. Response to General Allegations 8. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, 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 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® 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 state that Celebrex® was and is safe and effective

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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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny any wrongful conduct, deny that Celebrex® caused Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 9. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 10. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. Defendants state that Plaintiff's allegations regarding "successor in

interest" are vague and ambiguous. Defendants are without knowledge or information to form a belief as to the truth of such allegations, 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 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® 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 deny the remaining allegations in this paragraph of the Complaint. 11. Defendants admit that Pfizer, Pharmacia, and Searle are registered to do

business in Arizona. Defendants deny the remaining allegations in this paragraph of the Complaint.

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12.

Defendants 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 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 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 any wrongful conduct, deny that Celebrex® caused Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 13. This paragraph of the Complaint contains legal conclusions to which no

response is required. To the extent that a response is deemed required, Defendants are without knowledge or information sufficient to form a basis as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 any wrongful conduct, deny that Celebrex® caused Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint.

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14.

Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex® and whether Plaintiff suffered a myocardial infarction on January 18, 2002, and therefore deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. Response to Factual Allegations 15. Defendants admit that Celebrex® is in a class of drugs that is, at times, The remaining

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

allegations in this paragraph of the Complaint are not directed toward Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the remaining allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 16. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 17. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same.

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18.

The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 19. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 20. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 21. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 22. The allegations in this paragraph of the Complaint are not directed toward

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

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deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 23. Defendants state that, as stated in the FDA-approved labeling for

Celebrex®, "[t]he mechanism of action of Celebrex is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, Celebrex does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme." 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 24. 25. 26. Defendants deny the allegations in this paragraph of the Complaint. Defendants deny the allegations in this paragraph of the Complaint. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 27. As for the allegations in this paragraph of the Complaint 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

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study is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 28. Defendants state that the referenced study speaks for itself and respectfully Any attempt to

refer the Court to the study for its actual language and full text. characterize the study is denied. paragraph of the Complaint. 29.

Defendants deny the remaining allegations in this

Defendants state that referenced the study speaks for itself and respectfully Any attempt to

refer the Court to the study for its actual language and full text. characterize the study is denied. paragraph of the Complaint. 30.

Defendants deny the remaining allegations in this

Defendants admit that the CLASS study results were provided to the FDA

ADA Committee and deny the remaining allegations in this paragraph of the Complaint. 31. As for the allegations in this paragraph of the Complaint regarding the

CLASS study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. As for the allegations in this complaint regarding the findings of the FDA Arthritis Drugs Advisory Committee, Defendants state that the transcripts of the FDA Arthritis Drugs Advisory Committee hearings speak for themselves and respectfully refer the Court to the transcripts for their actual language and text. Any attempt to characterize the transcripts is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 32. As for the allegations in this paragraph of the Complaint regarding the

CLASS study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. As for the allegations in this complaint regarding the findings of the FDA Arthritis Drugs Advisory Committee, Defendants state that the transcripts of the

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FDA Arthritis Drugs Advisory Committee hearings speaks for themselves and respectfully refer the Court to the transcripts for their actual language and text. Any attempt to characterize the transcripts is denied. allegations in this paragraph of the Complaint. 33. Defendants state that Celebrex® was and is safe and effective when used in Defendants deny the remaining

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 at all times was adequate and comported with applicable standards of care and law. Defendants deny the allegations in this paragraph of the Complaint. 34. Defendants 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 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 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 35. Defendants admit that Searle submitted a New Drug Application ("NDA")

for Celebrex® on June 29, 1998. Defendants admit that, on December 31, 1998, the FDA

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granted approval of the NDA for Celebrex® submitted by Searle on June 29, 1998. Defendants deny the remaining allegations in this paragraph of the Complaint. 36. Defendants admit that Searle submitted an NDA for Celebrex® on June 29,

1998. Defendants admit that on December 31, 1998, the FDA approved Celebrex® for the following indications: (1) for relief of the signs and symptoms of osteoarthritis; and (2) for relief of the signs and symptoms of rheumatoid arthritis in adults. Defendants admit that Celebrex® was released for sale in the United States in February 1999. Defendants deny the remaining allegations in this paragraph of the Complaint. 37. Defendants 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 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 deny the remaining allegations in this paragraph of the Complaint. 38. 39. Defendants deny the allegations in this paragraph of the Complaint. As for the allegations in this paragraph of the Complaint regarding the

CLASS study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. As for the allegations in this Paragraph of the Complaint regarding an article published in the September 13, 2000 issue of JAMA, Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and text. Any attempt to characterize the article is denied. Defendants admit that, before approving a drug, the FDA must conclude that a drug is safe and

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effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations in this paragraph of the Complaint. 40. Defendants state that the referenced study speaks for itself and respectfully

refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 41. As for the allegations in this paragraph of the Complaint regarding the

CLASS study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. As for the allegations in this Paragraph of the Complaint regarding the JAMA article, Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and text. Any attempt to characterize the article is denied. Plaintiffs fail to provide the proper context for the allegations in this paragraph of the Complaint regarding "data on the FDA's website." Defendants lack sufficient information or knowledge to form a belief as to the truth of such allegations and therefore deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 42. Defendants state that the referenced submission speaks for itself and

respectfully refer the Court to the submission for its actual language and text. Any attempt to characterize the submission is denied. allegations in this paragraph of the Complaint. 43. As for the allegations in this Paragraph of the Complaint regarding the Defendants deny the remaining

Medical Officer's Review, Defendants state that the Medical Officer's Review speaks for itself and respectfully 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. As for the allegations in this Paragraph of the Complaint regarding the "JAMA article",

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Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 44. As for the allegations in this paragraph of the Complaint regarding the

CLASS study, Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. As for the allegations in this Paragraph of the Complaint regarding the "article published in JAMA", Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and text. Any attempt to characterize the article is denied. As for the allegations in this Paragraph of the Complaint regarding the Medical Officer's Review, Defendants state that the Medical Officer's Review speaks for itself and respectfully 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. Plaintiffs fail to provide the proper context for the allegations in this paragraph of the Complaint regarding "the FDA's files." Defendants lack

sufficient information or knowledge to form a belief as to the truth of such allegations and therefore deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 45. Defendants state that the referenced study speaks for itself and respectfully

refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 46. Defendants state that the referenced study speaks for itself and respectfully

refer the Court to the study for its actual language and text. Any attempt to characterize

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the study is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 47. Defendants admit that the FDA Division of Drug Marketing, Advertising

and Communications sent Searle a letter dated July 16, 1997. Defendants respectfully refer the Court to the letter for its actual language and full text. Any attempt to

characterize the letter is denied. Defendants respectfully refer the Court to the letters for their actual language and full text. Any attempt to characterize the letters is denied. Defendants admit that the FDA sent letters to Searle dated October 6, 1999, April 6, 2000 and November 14, 2000. Defendants respectfully refer the Court to the letters for their actual language and full text. Any attempt to characterize the letters is denied.

Defendants admit that the FDA sent a letter to Pharmacia dated February 1, 2001, and that the FDA sent a letter to Pfizer dated January 10, 2005. Defendants respectfully refer the Court to the letters for their actual language and full text. Any attempt to characterize the letters is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 48. Defendants state that the referenced letter speaks for itself, and respectfully

refer the Court to the letter for its actual language and text. Any attempt to characterize the letter is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 49. Defendants 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 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

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FDA. 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 remaining allegations in this paragraph of the Complaint. 50. 51. Defendants deny the allegations in this paragraph of the Complaint. Defendants 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 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 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 state that as indicated in the package insert

approved by the FDA, Celebrex® has been 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 the management of acute pain in adults; (4) for the treatment of primary dysmenorrhea; (5) to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) as an adjunct to usual care (e.g., endoscopic surveillance surgery); (6) for relief of signs and symptoms of ankylosing spondylitis; and (7) for relief of the signs and symptoms of juvenile

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rheumatoid arthritis in patients two years of age and older. remaining allegations in this paragraph of the Complaint. 52.

Defendants deny the

To the extent that the allegations in this paragraph of the Complaint are not

directed at Defendants, no response is required. To the extent that a response is deemed required, Plaintiffs fail to provide the proper context for such allegations. Defendants lack sufficient information or knowledge to form a belief as to the truth of such allegations 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 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® 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 deny the remaining allegations in this paragraph of the Complaint. 53. The allegations in this paragraph of the Complaint regarding "other drug

companies" are not directed at Defendants, and, therefore, no response is required. To the extent that a response is deemed required, Plaintiffs fail to provide the proper context for the allegations in this paragraph of the Complaint regarding "other drug companies." Defendants lack sufficient information or knowledge to form a belief as to the truth of such allegations and therefore deny the same. Plaintiffs fail to provide the proper context for the allegations in this paragraph of the Complaint regarding "blockbuster drugs." Defendants lack sufficient information or knowledge to form a belief as to the truth of such allegations 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 to be prescribed by healthcare providers who are by law authorized to prescribe

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drugs in accordance with their approval by the FDA. 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 deny the remaining allegations in this paragraph of the Complaint. 54. Defendants deny any wrongful conduct and deny the remaining allegations

in this paragraph of the Complaint. 55. 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 any wrongful conduct and denies the

remaining allegations in this paragraph of the Complaint. 56. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 57. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same.

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58.

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 remaining allegations in this paragraph of the Complaint. 59. Defendants state that the referenced study speaks for itself and respectfully

refer the Court to the study for its actual language and text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 60. The allegations in this paragraph of the Complaint are not directed toward

Defendants and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint. Defendants therefore lack sufficient

information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 61. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 62. Defendants state that the referenced FDA documents speak for themselves

and respectfully refer the Court to the documents for their actual language and text. Any attempt to characterize the documents is denied. allegations this paragraph of the Complaint. Defendants deny the remaining

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63.

Defendants admit that the FDA sent a letter to Searle dated October 6, 1999.

Defendants respectfully refer the Court to the letter for its actual language and full text. Any attempt to characterize the letter is denied. allegations in this paragraph of the Complaint. 64. Defendants admit that the FDA sent a letter to Searle dated April 6, 2000. Defendants deny the remaining

Defendants respectfully refer the Court to the letter for its actual language and full text. Any attempt to characterize the letter is denied. allegations in this paragraph of the Complaint. 65. Defendants admit that the FDA sent a letter to Searle dated November 14, Defendants deny the remaining

2000. Defendants respectfully refer the Court to the letter for its actual language and full text. Any attempt to characterize the letter is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 66. Defendants admit that the FDA sent a letter to Pharmacia dated February 1,

2001. Defendants respectfully refer the Court to the letter for its actual language and full text. Any attempt to characterize the letter is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 67. 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 state that the referenced letter speaks for itself and respectfully refer the Court to referenced letter for its actual language and full text. Any attempt to characterize the letter is denied. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 68. Defendants state that Celebrex® was and is safe and effective when used in

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

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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 state that the referenced letter speaks for itself and respectfully refer the Court to referenced letter for its actual language and full text. Any attempt to characterize the letter is denied. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 69. As for the allegations in this paragraph of the Complaint regarding

advertising and packaging materials, Defendants state that the referenced advertising and packaging materials speaks for themselves and respectfully refer the Court to the advertising and packaging materials for their actual language and text. Any attempt to characterize the advertising and packaging materials is denied. 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 at all times was adequate and comported with applicable standards of care and law. Defendants 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 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 deny the remaining allegations in this paragraph of the Complaint. 70. Defendants state that the referenced advertising and packaging materials

speak for themselves and respectfully refer the Court to the advertising and packaging materials for their actual language and text. Any attempt to characterize the advertising

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and packaging materials is denied. 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 at all times was adequate and comported with applicable standards of care and law. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 71. Defendants state that the referenced advertising and packaging materials

speaks for themselves and respectfully refer the Court to the advertising and packaging materials for their actual language and text. Any attempt to characterize the advertising and packaging materials is denied. 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 at all times was adequate and comported with applicable standards of care and law. As for the allegations in this paragraph of the Complaint regarding advertising and packaging materials, Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 72. Defendants state that the referenced print advertisements speak for

themselves and respectfully refer the Court to the print advertisements for their actual language and text. Any attempt to characterize the print advertisements is denied.

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 at all times was adequate and comported with applicable standards of care and law. Complaint. Defendants deny the remaining allegations in this paragraph of the

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73.

Defendants state that the referenced print advertisements speak for

themselves and respectfully refer the Court to the print advertisements for their actual language and text. Any attempt to characterize the print advertisements is denied.

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 at all times was adequate and comported with applicable standards of care and law. Complaint. 74. Defendants state that the referenced print advertisement speaks for itself and Defendants deny the remaining allegations in this paragraph of the

respectfully refer the Court to the print advertisement for its actual language and text. Any attempt to characterize the print advertisement is denied. 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 at all times was adequate and comported with applicable standards of care and law. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. Response to First Cause of Action: Strict Liability ­ Failure to Warn 75. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 76. 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

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standards of care and law. Defendants deny any wrongful conduct, deny that Celebrex® is defective, and deny the remaining allegations in this paragraph of the Complaint. 77. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 any wrongful conduct, deny that Celebrex® is defective, and deny the remaining allegations in this paragraph of the Complaint. 78. Defendants deny any wrongful conduct, deny that Celebrex® is defective,

deny that Celebrex® caused Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Negligence 79. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 80. Defendants state that this paragraph of the Complaint contains legal

contentions to which no response is required. To the extent that a response is deemed required, Defendants admit that they had duties as are imposed by law but deny having breached such duties. 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 remaining allegations in this paragraph of the Complaint.

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81.

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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 82. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 83. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Breach of Implied Warranty 84. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 85. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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

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standards of care and law.

Defendants admit that they provided FDA-approved

prescribing information regarding Celebrex®. Defendants deny the remaining allegations in this paragraph of the Complaint. 86. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. Complaint. 87. Defendants state that Celebrex® was and is safe and effective when used in Defendants deny the remaining allegations in this paragraph of the

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 remaining allegations in this paragraph of the Complaint. 88. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Fourth Cause of Action: Breach of Express Warranty 89. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 90. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 they provided FDA-approved

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prescribing information regarding Celebrex®. Defendants deny the remaining allegations in this paragraph of the Complaint. 91. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 they provided FDA-approved

prescribing information regarding Celebrex®. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 92. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Deceit by Concealment 93. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 94. Defendants state that this paragraph of the Complaint contains legal

contentions to which no response is required. To the extent that a response is deemed required, Defendants admit that they had duties as are imposed by law but deny having breached such duties. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint.

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95.

Defendants 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 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 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 any wrongful conduct, deny that Celebrex® caused Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 96. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 97. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint.

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Response to Sixth Cause of Action: Negligent Misrepresentation Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 99. Defendants 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 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 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 100. Defendants deny any wrongful conduct and deny the remaining allegations

in this paragraph of the Complaint. 101. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 102. Defendants deny any wrongful conduct and deny the remaining allegations

in this paragraph of the Complaint.

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103.

Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®, and therefore deny the same. 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 any wrongful conduct and deny the

remaining allegations in this paragraph of the Complaint. 104. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Punitive Damage Allegations (As to only the First, Second, Fifth, and Sixth Causes of Action) 105. Defendants incorporate by reference their responses to each paragraph of

Plaintiff's Complaint as if fully set forth herein. 106. Defendants deny any wrongful conduct, deny that Celebrex® caused

Plaintiff injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 107. Defendants are without knowledge or information sufficient to form a basis

as to the truth of the allegations regarding whether Plaintiff used Celebrex®,