Free Answer to Complaint - District Court of California - California

Case 3:08-cv-00838-CRB

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AMY W. SCHULMAN DLA PIPER LLP 1251 Avenue of the Americas New York, NY 10020 Telephone: (212) 335-4500 Facsimile: (212) 335-4501 [email protected] STUART M. GORDON (SBN: 037477) GORDON & REES LLP Embarcadero Center West 275 Battery Street, Suite 2000 San Francisco, CA 94111 Telephone: (415) 986-5900 Facsimile: (415) 986-8054 [email protected] MICHAEL C. ZELLERS (SBN: 146904) TUCKER ELLIS & WEST LLP 515 South Flower Street, Suite 4200 Los Angeles, CA 90071-2223 Telephone: (213) 430-3400 Facsimile: (213) 430-3409 [email protected] Attorneys for Defendants PFIZER INC., PHARMACIA CORPORATION, AND G.D. SEARLE LLC UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION IN RE CELEBREX AND BEXTRA MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION This document relates to JAMES SIMMONS as heir at law of decedent JOANN PAULA SIMMONS, Plaintiff, vs. PFIZER, INC., PHARMACIA CORPORATION, and G.D. SEARLE LLC, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) MDL Docket No. 1699 CASE NO. 3:08-cv-0838-CRB PFIZER INC., PHARMACIA CORPORATION, AND G.D. SEARLE LLC'S ANSWER TO COMPLAINT JURY DEMAND ENDORSED HEREIN

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NOW COME Defendants Pfizer Inc. (improperly captioned in Plaintiff's Complaint as "Pfizer, Inc.") ("Pfizer"), Pharmacia Corporation ("Pharmacia"), and G.D. Searle LLC ("Searle") (collectively "Defendants"), and file this 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 Decedent was prescribed or used Bextra® (valdecoxib) ("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 Decedent was prescribed and used Bextra®. II. ANSWER Response to Allegations Regarding Parties 1. Defendants admit that Plaintiff brought this civil action seeking monetary damages, but

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deny that Plaintiff is entitled to any relief or damages. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed and co-promoted Bextra® 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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 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 conduct, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 2. Defendants are without knowledge or information sufficient to form a belief as to the
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truth of the allegations regarding Plaintiff's and Decedent's age, citizenship, and marital status, and, therefore, deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 3. Defendants admit that Pfizer is a Delaware corporation with its principal place of

business in New York. Defendants admit that Pharmacia acquired Searle in 2000 and that, as the result of a merger in April 2003, Searle and Pharmacia became subsidiaries of Pfizer. Defendants admit that, during certain periods of time, Pfizer marketed and co-promoted Bextra® in the United States, including Arkansas and Washington, 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 Plaintiff's allegations regarding "predecessors 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 deny the remaining allegations in this paragraph of the Complaint. 4. Defendants admit that Searle is a Delaware limited liability company with its principal

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place of business in Illinois. Defendants admit that, during certain periods of time, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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. 5. Defendants admit that Pharmacia is a Delaware corporation with its principal place of

business in New Jersey. Defendants admit that, during certain periods of time, Pharmacia marketed and co-promoted Bextra® in the United States, including California, 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 Plaintiff's allegations regarding "predecessors 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 deny the remaining allegations in this Paragraph of the Complaint.

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Response to Allegations Regarding Jurisdiction and Venue 6. Defendants are without knowledge or information to form a belief as to the truth of the

allegations in this paragraph of the Complaint regarding the amount in controversy, and, therefore, deny that the same. However, Defendants admit that Plaintiff claims that the amount in controversy exceeds $75,000, exclusive of interests and costs. 7. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations in this paragraph of the Complaint regarding Plaintiff's citizenship and the amount in controversy, and, therefore, deny the same. However, Defendants admit that Plaintiff claims that the parties are diverse and that the amount in controversy exceeds $75,000, exclusive of interest and costs. Defendants deny the remaining allegations in this paragraph of the Complaint. 8. Defendants are without knowledge or information sufficient to form a belief as to the

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truth of the allegations in this paragraph of the Complaint regarding the judicial district in which the asserted claims allegedly arose, and, therefore, deny the same. Defendants deny committing a tort in the States of Oregon and California and deny the remaining allegations in this paragraph of the Complaint. 9. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed

and co-promoted Bextra® in the United States, including California, 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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 they provided FDA-approved prescribing information regarding Bextra®. Defendants admit that they do business in the State of California. Defendants state that

Plaintiff's allegations regarding "predecessors 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 deny any wrongful conduct and deny the
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remaining allegations in this paragraph of the Complaint. Response to Allegations Regarding Interdistrict Assignment 10. 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 this case should be transferred to In re: Bextra and Celebrex Marketing, Sales Prac. and Prods. Liab. Litig., MDL-1699, assigned to the Honorable Charles R. Breyer by the Judicial Panel on Multidistrict Litigation on September 6, 2005. Response to Factual Allegations 11. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, and, therefore, deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 12. Defendants state that Bextra® was and is safe and effective when used in accordance

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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 are without knowledge or information sufficient to form a belief as to the truth of the allegations regarding whether Decedent used Bextra®, and, and, therefore, deny the same. Defendants deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 13. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 14. Defendants admit that Bextra® was expected to reach consumers without substantial

change from the time of sale. Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny the remaining allegations this paragraph of the Complaint.
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15.

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 are without knowledge or information sufficient to form a belief as to the truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny remaining the allegations in this paragraph of the Complaint. 16. Defendants admit that Bextra® is in a class of drugs that is, at times, referred to as non-

steroidal anti-inflammatory drugs ("NSAIDS"). 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. paragraph of the Complaint. 17. The allegations in this paragraph of the Complaint are not directed toward Defendants To the extent a response is deemed required, Defendants deny the remaining allegations in this

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and, therefore, no response is 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. 18. The allegations in this paragraph of the Complaint are not directed toward Defendants To the extent a response is deemed required,

and, therefore, no response is 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 To the extent a response is deemed required,

and, therefore, no response is required.

Defendants state that Plaintiff fails to provide the proper context for the allegations in this
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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 To the extent a response is deemed required,

and, therefore, no response is 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. Plaintiff fails to provide the proper context for the allegations in this paragraph of the

Complaint. Defendants lack sufficient information or knowledge to form a belief as to the truth of such allegations and, therefore, deny the same. 22. Defendants state that Plaintiff's allegations regarding "predecessors in interest" are

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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 deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 23. Plaintiff does not allege that Decedent used Celebrex® in this Complaint. Nevertheless,

Defendants admit that Celebrex® was launched in the United States in February 1999. Defendants state that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed and co-promoted 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, copromoted 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. The allegations in this paragraph of the Complaint regarding Merck and Vioxx® are not directed toward Defendants and, therefore, no response is required. To the extent a response is deemed required, Defendants state that Plaintiff fails to provide the proper context for the allegations in this paragraph of the Complaint regarding Merck and Vioxx®. Defendants
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therefore 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. 24. Defendants admit that the New Drug Application for Bextra® was filed with the FDA

on January 15, 2001. Defendants admit, 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 state that Plaintiff's allegations regarding "predecessors 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 deny the remaining allegations in this paragraph of the Complaint. 25. Defendants admit, as indicated in the package insert approved by the FDA, that Bextra®

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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® was approved by the FDA on November 16, 2001. Defendants admit, 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 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 at all times was adequate and comported with applicable standards of care and law. Defendants deny the remaining allegations in this paragraph of the Complaint. 26. 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 at all times was adequate and comported with applicable standards of care and law. Defendants deny the allegations in this paragraph of the Complaint. 27. Defendants state that Bextra® was and is safe and effective when used in accordance
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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 at all times was adequate and comported with applicable standards of care and law. Defendants deny the allegations in this paragraph of the Complaint. 28. Defendants state that the referenced FDA Talk Paper for Bextra® speaks for itself and

respectfully refer the Court to the Talk Paper for its actual language and text. Any attempt to characterize the Talk Paper is denied. paragraph of the Complaint. 29. Plaintiff fails to provide the proper context for the allegations concerning the "post-drug Defendants deny the remaining allegations in this

approval meta-analysis study" in this paragraph of the Complaint. Defendants are without sufficient information to confirm or deny such allegations and, therefore, deny the same. 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. 30. The allegations in this paragraph of the Complaint are not directed towards Defendants

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and, therefore, no response is necessary. Should a response be deemed necessary, 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. 31. The allegations in this paragraph of the Complaint are not directed towards Defendants

and, therefore, no response is necessary. Should a response be deemed necessary, Defendants admit that a Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee was held on February 16-18, 2005. Defendants state that the referenced testimony speaks for itself and respectfully refer the Court to the testimony for its actual language and text. Any attempt to characterize the testimony is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 32. Defendants state that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendants deny any wrongful conduct and
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deny the remaining allegations in this paragraph of the Complaint. 33. Defendants state that the referenced Alert for Healthcare Professionals speaks for itself

and respectfully refer the Court to the Alert for Healthcare Professionals for its actual language and text. Any attempt to characterize the Alert for Healthcare Professionals is denied.

Defendants deny the remaining allegations in this paragraph of the Complaint. 34. Defendants state that the referenced Alert for Healthcare Professionals speaks for itself

and respectfully refer the Court to the Alert for Healthcare Professionals for its actual language and text. Any attempt to characterize the Alert for Healthcare Professionals is denied.

Defendants deny the remaining allegations in this paragraph of the Complaint. 35. Defendants state that Bextra® was and is safe and effective when used in accordance Defendants deny the allegations in this

with its FDA-approved prescribing information. paragraph of the Complaint. 36.

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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 any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 37. The allegations in this paragraph of the Complaint are not directed towards Defendants

and, therefore, no response is necessary. Should a response be deemed necessary, Defendants state that the referenced articles speak for themselves and respectfully refer the Court to the articles for their actual language and text. Any attempt to characterize the articles is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 38. 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. 39. 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
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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 conduct, deny that Bextra® is defective, and deny the remaining allegations in this paragraph of the Complaint. 40. 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 conduct and deny the remaining allegations in this paragraph of the Complaint. 41. 42. Defendants deny the allegations in this paragraph of the Complaint. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed

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and co-promoted Bextra® 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants are without knowledge or information

sufficient to form a belief as to the truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny the allegations in this paragraph of the Complaint. 43. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed

and co-promoted Bextra® 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
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admit that, during certain periods of time, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. paragraph of the Complaint. 44. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed Defendants deny the remaining allegations in this

and co-promoted Bextra® 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendants admit, 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 deny the remaining allegations in this paragraph of the Complaint. 45. Defendants state that Bextra® was and is safe and effective when used in accordance

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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 are without knowledge or information sufficient to form a belief as to the truth of
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the allegations regarding and whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct, deny that Bextra® is defective, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 46. 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 are without knowledge or information sufficient to form a belief as to the truth of the allegations regarding and whether Decedent used Bextra®, and, therefore, deny the same. Defendants state that Plaintiff's allegations regarding "predecessors 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 deny any wrongful conduct, deny that Bextra® is defective, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to First Cause of Action: Negligence 47. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 48. Defendants state that this paragraph of the Complaint contains legal contentions to To the extent a response is deemed required,

which no response is deemed required.

Defendants admit that they had duties as are imposed by law but deny having breached such duties. 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 state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations in this paragraph of the Complaint. 49. Defendants state that this paragraph of the Complaint contains legal contentions to To the extent a response is deemed required,

which no response is deemed required.

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Defendants admit that they had duties as are imposed by law but deny having breached such duties. 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 in this paragraph of the Complaint. 50. 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 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 conduct and deny the remaining allegations in this paragraph of the Complaint, including all subparts. 51. Defendants state that Bextra® was and is safe and effective when used in accordance

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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 are without knowledge or information sufficient to form a belief as to the truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 52. 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 conduct and deny the remaining allegations in this paragraph of the Complaint. 53. Defendants state that Bextra® was and is safe and effective when used in accordance
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with its FDA-approved prescribing information. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 54. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 55. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage and deny the remaining allegations in this paragraph of the Complaint. 56. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Strict Liability 57. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 58. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants admit that Bextra® was expected to reach consumers without substantial change in the condition from the time of sale. 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® is defective or

unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint. 59. 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. 60. 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
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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 or unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint. 61. 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 conduct, deny that Bextra® is defective, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 62. Defendants state that Bextra® was and is safe and effective when used in accordance

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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 conduct, deny that Bextra® is defective, and deny the remaining allegations in this paragraph of the Complaint. 63. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 admit that, during certain periods of time, Pfizer and Pharmacia marketed and copromoted Bextra® 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® in the United States to be
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prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendants deny any wrongful conduct, deny that Bextra® is defective, deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 64. 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 remaining allegations in this paragraph of the Complaint. 65. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 the remaining allegations in this paragraph of the Complaint. 66. Defendants state that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 67. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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® is defective and deny the remaining allegations in this paragraph of the Complaint. 68. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent
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injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 69. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 70. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Breach of Express Warranty 71. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 72. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 admit that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint. 73. Defendants are without knowledge or information sufficient to form a belief as to the

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truth of the allegations regarding whether Decedent 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 admit that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint, including all subparts. 74. 75. 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 state that the potential effects of
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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 they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint. 76. 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 they provided FDA-approved prescribing information regarding Bextra®. Defendants deny any wrongful conduct the remaining allegations in this paragraph of the Complaint. 77. Defendants are without knowledge or information sufficient to form a belief as to the

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truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants admit that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint. 78. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 79. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 80. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Fourth Cause of Action: Breach of Implied Warranty 81. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 82. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed

and co-promoted Bextra® 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, Bextra® was manufactured and packaged for Searle,
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which developed, tested, marketed, co-promoted and distributed Bextra® 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. 83. Defendants admit that they provided FDA-approved prescribing information regarding

Bextra®. Defendants admit, 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 state that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendants deny the remaining allegations in this paragraph of the Complaint. 84. Defendants are without knowledge or information sufficient to form a belief as to the

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truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants admit, 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 deny the remaining allegations in this paragraph of the Complaint. 85. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 deny the remaining allegations in this paragraph of the Complaint. 86. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants state that Bextra® was expected to reach consumers without substantial change in the condition from the time of sale. Defendants deny the remaining allegations in this paragraph of the Complaint. 87. Defendants are without knowledge or information sufficient to form a belief as to the
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truth of the allegations regarding whether Decedent 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 deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 88. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 89. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 90. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Fraudulent Misrepresentation & Concealment 91. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 92. Defendants state that this paragraph of the Complaint contains legal contentions to To the extent a response is deemed required,

which no response is deemed required.

Defendants admit that they had duties as are imposed by law but deny having breached such duties. 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 remaining allegations in this paragraph of the Complaint. 93. 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 conduct and deny the remaining allegations in this paragraph of the Complaint, including all subparts. 94. Defendants state that Bextra® was and is safe and effective when used in accordance
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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 conduct and deny the remaining allegations in this paragraph of the Complaint. 95. 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 conduct, deny that Bextra® is defective or unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint. 96. Defendants state that Bextra® was and is safe and effective when used in accordance

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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 conduct and deny the remaining allegations in this paragraph of the Complaint. 97. Defendants deny any wrongful conduct and deny the remaining allegations in this

paragraph of the Complaint. 98. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 99. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 100. Defendants are without knowledge or information sufficient to form a belief as to the
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truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 101. Defendants deny any wrongful conduct and deny the remaining allegations in this

paragraph of the Complaint. 102. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 103. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

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injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 104. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Sixth Cause of Action: Unjust Enrichment 105. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 106. Defendants admit that, during certain periods of time, Pfizer and Pharmacia marketed

and co-promoted Bextra® 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, Bextra® was manufactured and packaged for Searle, which developed, tested, marketed, co-promoted and distributed Bextra® 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.
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107.

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

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 108. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 109. Defendants are without knowledge or information sufficient to form a belief as to the

truth of the allegations regarding whether Decedent 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 deny the remaining allegations in this paragraph of the Complaint. 110. Defendants are without knowledge or information sufficient to form a belief as to the

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truth of the allegations regarding whether Decedent used Bextra®, and, therefore, deny the same. Defendants deny the remaining allegations in this paragraph of the Complaint. 111. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Seventh Cause of Action: Wrongful Death 112. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 113. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. 114. Defendants deny that Bextra® caused Plaintiff or Decedent injury or damage, and deny

the remaining allegations in this paragraph of the Complaint. 115. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent

injury or damage, and deny the remaining allegations in this paragraph of the Complaint. Response to Prayer for Relief Answering the unnumbered paragraph of the Complaint headed "Prayer for Relief," Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff or Decedent injury
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or damage, and deny the remaining allegations in this paragraph of the Complaint, including all subparts. III. GENERAL DENIAL Defendants deny all allegations and/or legal conclusions set forth in Plaintiff's Complaint that have not been previously admitted, denied, or explained. IV. AFFIRMATIVE DEFENSES Defendants reserve the right to rely upon any of the following or additional defenses to claims asserted by Plaintiff to the extent that such defenses are supported by information developed through discovery or evidence at trial. Defendants affirmatively show that: First Defense 1. The Complaint fails to state a claim upon which relief can be granted. Second Defense 2. Bextra® is a prescription medical product. The federal government has preempted the

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4. 3.

field of law applicable to the labeling and warning of prescription medical products. Defendants' labeling and warning of Bextra® was at all times in compliance with applicable federal law. Plaintiff's causes of action against Defendants, therefore, fail to state a claim upon which relief can be granted; such claims, if allowed, would conflict with applicable federal law and violate the Supremacy Clause of the United States Constitution. Third Defense At all relevant times, Defendants provided proper warnings, information and

instructions for the drug in accordance with generally recognized and prevailing standards in existence at the time. Fourth Defense At all relevant times, Defendants' warnings and instructions with respect to the use of

Bextra® conformed to the generally recognized, reasonably available, and reliable state of knowledge at the time the drug was manufactured, marketed and distributed.
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Fifth Defense 5. Plaintiff's action is time-barred as it is filed outside of the time permitted by the

applicable Statute of Limitations, and same is pled in full bar of any liability as to Defendants. Sixth Defense 6. Plaintiff's action is barred by the statute of repose. Seventh Defense 7. If Plaintiff or Decedent sustained any injuries or incurred any losses or damages as

alleged in the Complaint, the same were caused by the negligence or fault of the Plaintiff or Decedent and Plaintiff's damages, if any, are barred or reduced by the doctrines of comparative fault and contributory negligence and by the failure to mitigate damages. Eighth Defense 8. The proximate cause of the loss complained of by Plaintiff is not due to any acts or

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omissions on the part of Defendants. Rather, said loss is due to the acts or omissions on the part of third parties unrelated to Defendants and for whose acts or omissions Defendants are not liable in any way. Ninth Defense 9. The acts and/or omissions of unrelated third parties as alleged constituted independent,

intervening causes for which Defendants cannot be liable. Tenth Defense 10. Any injuries or expenses incurred by Plaintiff and Decedent were not caused by

Bextra®, but were proximately caused, in whole or in part, by an idiosyncratic reaction, operation of nature, or act of God. Eleventh Defense 11. Defendants affirmatively deny that they violated any duty owed to Plaintiff or Decedent. Twelfth Defense 12. A manufacturer has no duty to warn patients or the general public of any risk,

contraindication, or adverse effect associated with the use of a prescription medical product. Rather, the law requires that all such warnings and appropriate information be given to the
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prescribing physician and the medical profession, which act as a "learned intermediary" in determining the use of the product. Bextra® is a prescription medical product, available only on the order of a licensed physician. Bextra® provided an adequate warning to Decede