Free Answer to Amended Complaint - District Court of California - California

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 1 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

LOREN H. BROWN 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 TOMAS MADRO BANDARIES, Plaintiff, vs. PFIZER INC., PHARMACIA CORPORATION, and G.D. SEARLE, LLC, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) MDL Docket No. 1699 CASE NO. 3:08-cv-03641-CRB PFIZER INC., PHARMACIA CORPORATION, AND G.D. SEARLE LLC'S ANSWER TO COMPLAINT JURY DEMAND ENDORSED HEREIN

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

-1ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 2 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

NOW COME Defendants Pfizer Inc. ("Pfizer"), Pharmacia Corporation ("Pharmacia"), and G.D. Searle LLC ("Searle") (improperly captioned in Plaintiff's Complaint as "G.D. Searle, LLC") (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 Plaintiff 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 Plaintiff 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

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

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 injury or damages, 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
-2ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 3 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

truth of the allegations in this paragraph of the Complaint regarding Plaintiff's age, citizenship, and whether Plaintiff used Bextra®, and, therefore, deny them. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 3. Defendants admit that Pfizer is a Delaware corporation with its principal place of Defendants admit that, as the result of a merger in April 2003,

business in New York.

Pharmacia became a subsidiary of Pfizer. Defendants admit that, during certain periods of time, Pfizer marketed and co-promoted Bextra® in the United States, including California, Illinois, Mississippi, and Arizona, 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 them. 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

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

place of business in Illinois. 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, 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. allegations in this paragraph of the Complaint. 5. Defendants admit that Pharmacia is a Delaware corporation with its principal place of Defendants deny the remaining

business in New Jersey. Defendants admit that, during certain periods of time, Pharmacia marketed and co-promoted Bextra® in the United States, including California, Illinois, Mississippi, and Arizona, 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
-3ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 4 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

without knowledge or information to form a belief as to the truth of such allegations, and, therefore, deny them. Defendants deny the remaining allegations in this Paragraph of the Complaint. 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 them. 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 them. However, Defendants admit that Plaintiff claims that the parties are diverse and that the amount in controversy exceeds $75,000, exclusive of interests and costs. 8. Defendants are without knowledge or information sufficient to form a belief as to the

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

truth of the allegations in this paragraph of the Complaint regarding the judicial district in which the asserted claims allegedly arose, and, therefore, deny them. Defendants deny any wrongful conduct, deny committing a tort in the States of Mississippi or 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 Mississippi, 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 States of California and Mississippi. Defendants state that Plaintiff's allegations regarding "predecessors in interest" are vague and ambiguous.
-4ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 5 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. Response to Factual Allegations 10. 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 medical condition and whether Plaintiff used Bextra®, and, therefore, deny them. Defendants deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 11. 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 medical condition and whether Plaintiff used Bextra®, and, therefore, deny them. 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 any wrongful conduct, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 12. Defendants are without knowledge or information sufficient to form a belief as to the

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

truth of the allegations in this paragraph of the Complaint regarding Plaintiff's medical condition and whether Plaintiff used Bextra®, and, therefore, deny them. 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 any wrongful conduct, deny that Bextra® caused Plaintiff injury or damages, 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
-5ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 6 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

truth of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, deny them. Defendants admit that Bextra® was expected to reach consumers without substantial change from the time of sale. Defendants deny the remaining allegations in this paragraph of the Complaint. 14. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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. 15. Defendants admit that Bextra® is in a class of drugs that is, at times, referred to as nonDefendants deny the remaining allegations in this

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

steroidal anti-inflammatory drugs ("NSAIDS"). Defendants state that the allegations in this paragraph of the Complaint regarding aspirin and ibuprofen 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 regarding aspirin and ibuprofen. Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny the remaining allegations in this paragraph of the Complaint. 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 are therefore without knowledge or information

sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. 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
-6ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 7 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

paragraph of the Complaint.

Defendants are therefore without knowledge or information

sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. 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 are therefore without knowledge or information

sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. 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 are therefore without knowledge or information

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

sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. 20. Plaintiff fails to provide the proper context for the allegations in this paragraph of the

Complaint. Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. 21. Defendants state that Plaintiff's allegations regarding "predecessors in interest" are

vague and ambiguous. Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 22. Plaintiff does not allege having 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
-7ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 8 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 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 regarding Merck and Vioxx®. Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny the remaining allegations in this paragraph of the Complaint. 23. 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 sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny the remaining allegations in this paragraph of the Complaint. 24. Defendants admit that Bextra® was approved by the FDA on November 16, 2001.

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

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. 25. 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. 26. 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
-8ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 9 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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. 27. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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 FDAapproved 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 state that Plaintiff's allegations regarding "predecessors in interest" are vague and ambiguous. Defendants are without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 28. Defendants state that the referenced article speaks for itself and respectfully refer the

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

Court to the article for its actual language and full text. Any attempt to characterize the article is denied. 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. 29. The allegations in this paragraph of the Complaint are not directed toward Defendants,
-9ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 10 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

and, therefore, no response is required. To the extent that a response is deemed required, Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 30. Defendants admit that the New Drug Application for Bextra® was filed with the FDA

on January 15, 2001. Defendants admit that Bextra® was approved by the FDA, on November 16, 2001. 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 the remaining allegations in this paragraph of the Complaint. 31. 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. 32.

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 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 full text. Any attempt to characterize the Talk Paper is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 33. Defendants state that the referenced article speaks for itself and respectfully refer the

Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 34. Plaintiff fails to provide the proper context for the allegations in this paragraph of the

Complaint regarding the "post-drug approval meta-analysis study." Defendants are therefore without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants state that the referenced study speaks for itself and respectfully refer the Court to the study for its actual language and full text. Any attempt to characterize the study is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 35. 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,
-10ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 11 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Defendants state that the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 36. 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 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 full text. Any attempt to characterize the testimony is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 37. Defendants state that Bextra® was and is safe and effective when used in accordance

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

with its FDA-approved prescribing information. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 38. 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 full text. Any attempt to characterize the Alert for Healthcare Professionals is denied. Defendants deny the remaining allegations in this paragraph of the Complaint. 39. 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 full text. Any attempt to characterize the Alert for Healthcare Professionals is denied. Defendants 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 Defendants deny the allegations in this

with its FDA-approved prescribing information. paragraph of the Complaint. 41.

Defendants state that the referenced article speaks for itself and respectfully refer the

Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint.
-11ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 12 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

42.

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 the referenced article speaks for itself and respectfully refer the Court to the article for its actual language and full text. Any attempt to characterize the article is denied. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 43. Defendants state that the referenced PDR entry speaks for itself and respectfully refer

the Court to the PDR entry for its actual language and full text. Any attempt to characterize the PDR entry is denied. 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. 44. Defendants state that Bextra® was and is safe and effective when used in accordance

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

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. 45. 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. 46. 47. Defendants deny the allegations in this paragraph of the Complaint. 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 whether Plaintiff used
-12ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 13 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Bextra®, and, therefore, deny them.

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 deny any wrongful conduct and deny the allegations in this paragraph of the Complaint. 48. 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. paragraph of the Complaint. 49. Defendants admit, as indicated in the package insert approved by the FDA, that Bextra® Defendants deny the remaining allegations in this

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

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 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. 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
-13ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 14 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 state that Plaintiff's allegations regarding "predecessors in interest" are vague and ambiguous. Defendants are without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny any wrongful

conduct, deny that Bextra® is defective, and deny the allegations in this paragraph of the Complaint. 51. 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 FDAapproved prescribing information, which was at all times adequate and comported with applicable standards of care and law. paragraph of the Complaint. 52. Defendants state that Bextra® was and is safe and effective when used in accordance Defendants deny the remaining allegations in this

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

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. 53. 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.
-14ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 15 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 54. 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. 55. 56. Defendants deny the allegations in this paragraph of the Complaint. Defendants admit that the sale of Bextra® was voluntarily suspended in the U.S. market

as of April 7, 2005. Defendants deny any wrongful conduct and deny the remaining allegations contained in this paragraph of the Complaint. 57. Defendants state that Bextra® was and is safe and effective when used in accordance

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

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. 58. 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. 59. Defendants deny any wrongful conduct and deny the remaining allegations in this

paragraph of the Complaint. 60. 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 whether Plaintiff used
-15ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 16 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Bextra®, and, therefore, deny them.

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 deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 61. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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. 62. Defendants admit, as indicated in the package insert approved by the FDA, that Bextra®

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

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 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. 63. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants state that Bextra® was and is safe and

effective when used in accordance with its FDA-approved prescribing information. Defendants
-16ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 17 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 state that Plaintiff's allegations regarding "predecessors in interest" are vague and ambiguous. Defendants are without knowledge or information sufficient to form a belief as to the truth of these allegations, and, therefore, deny them. Defendants deny any wrongful conduct, deny that Bextra® is defective or unreasonably dangerous, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. Response to First Cause of Action: Negligence 64. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth here. 65. Defendants state that this paragraph of the Complaint contains legal contentions to

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

which no response is deemed 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 those 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. 66. Defendants state that this paragraph of the Complaint contains legal contentions to

which no response is deemed 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 those 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. 67. Defendants state that this paragraph of the Complaint contains legal contentions to
-17ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 18 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 those 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. 68. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants state that Bextra® was and is safe and

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

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 deny any wrongful conduct, deny that

Bextra® is unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint. 69. 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. 70. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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-18ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 19 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 71. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 72. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 73. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Strict Liability 74. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

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

Complaint as if fully set forth here. 75. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants admit that Bextra® was expected to reach consumers without substantial change in the condition from the time of sale. 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 the remaining allegations in this paragraph of the Complaint.
-19ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 20 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 77. 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. 78. Defendants state that Bextra® was and is safe and effective when used in accordance

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

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 unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint, including all subparts. 79. 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 unreasonably dangerous, and deny the remaining allegations in this paragraph of the Complaint. 80. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants state that Bextra® was and is safe and

effective when used in accordance with its FDA-approved prescribing information. Defendants
-20ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 21 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 deny any wrongful conduct, deny that

Bextra® is defective, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 81. 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, and deny the remaining allegations in this paragraph of the Complaint. 82. Defendants are without knowledge or information sufficient to form a belief as to the

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

truth of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, deny them. 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 deny any wrongful conduct, deny that

Bextra® is defective, deny that Bextra® caused Plaintiff injury or damages, and deny the remaining allegations in this paragraph of the Complaint. 83. 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. 84. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants state that Bextra® was and is safe and

-21ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 22 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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 deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 85. 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. 86. Defendants state that Bextra® was and is safe and effective when used in accordance

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

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. 87. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 88. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

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

damages, and deny the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Breach of Express Warranty 90. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth here. 91. 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 whether Plaintiff used
-22ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 23 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Bextra®, and, therefore, deny them.

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 that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint. 92. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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 that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint, including all subparts. 93. 94. Defendants deny the allegations in this paragraph of the Complaint. Defendants state that Bextra® was and is safe and effective when used in accordance

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

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 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.
-23ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 24 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

Defendants admit that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny any wrongful conduct and deny the remaining allegations in this paragraph of the Complaint. 96. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants admit that they provided FDA-approved prescribing information regarding Bextra®. Defendants deny the remaining allegations in this paragraph of the Complaint. 97. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 98. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

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

damages, and deny the remaining allegations in this paragraph of the Complaint. 99. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. Response to Fourth Cause of Action: Breach of Implied Warranty 100. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth here. 101. 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. 102. Defendants admit that they provided FDA-approved prescribing information regarding

Bextra®. 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
-24ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 25 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

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. 103. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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. 104. 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 whether Plaintiff used Bextra®, and, therefore, deny them. Defendants state that Bextra® was and is safe and

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

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. 105. Defendants are without knowledge or information sufficient to form a belief as to the Defendants deny the remaining allegations in this

truth of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, deny them. 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. 106. 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 whether Plaintiff used Bextra®, and, therefore, deny them. 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.
-25ANSWER TO COMPLAINT ­ 3:08-cv-03641-CRB

Case 3:08-cv-03641-CRB

Document 14

Filed 08/13/2008

Page 26 of 45

1 2 3 4 5 6 7 8 9 10 11
Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

107.

Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 108. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. 109. Defendants deny any wrongful conduct, deny that Bextra® caused Plaintiff injury or

damages, and deny the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Fraudulent Misrepresentation & Concealment 110. Defendants incorporate by reference their responses to each paragraph of Plaintiff's

Complaint as if fully set forth here. 111. Defendants state that this paragraph of the Complaint contains legal contentions to

which no response is deemed 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 those 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 informa