Free Answer to Complaint - District Court of California - California

Case 3:08-cv-03051-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 Defendant PFIZER INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION ) ) ) ) ) BETTY SUNDHAUSEN and JES SUNDHAUSEN, ) ) ) Plaintiffs, ) ) vs. ) ) PFIZER, INC., ) ) Defendant. ) IN RE BEXTRA AND CELEBREX MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION This document relates to MDL Docket No. 1699 CASE NO 3:08-cv-03051-CRB PFIZER INC.'S ANSWER TO COMPLAINT JURY DEMAND ENDORSED HEREIN

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NOW COMES Defendant Pfizer Inc. (improperly captioned in Plaintiffs' Complaint as "Pfizer, Inc.") ("Pfizer" or "Defendant") and files this Answer to Plaintiffs' Complaint ("Complaint"), and would respectfully show the Court as follows:
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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. Defendant may seek leave to amend this Answer when discovery reveals the specific time periods in which Plaintiff was prescribed and used Bextra®. II. ORIGINAL ANSWER Response to Allegations Regarding Jurisdiction 1. Defendant is without knowledge or information sufficient to form a belief as to the truth

of the allegations in this paragraph of the Complaint regarding Plaintiffs' citizenship and the amount in controversy, and, therefore, denies the same. However, Defendant admits that Plaintiffs claim that the parties are diverse and that the amount in controversy exceeds $75,000, exclusive of interests and costs. Response to Allegations Regarding the Nature of the Case 2. Defendant admits that, during certain periods of time, it marketed and co-promoted

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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. Defendant admits, as indicated in the package insert approved by the FDA, that Bextra® is indicated for use in the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as for the treatment of primary dysmenorrhea. Defendant denies the remaining allegations in this paragraph of the Complaint. 3. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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
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standards of care and law. Defendant denies any wrongful conduct, denies that Bextra® is defective, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 4. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 5. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 6. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 7. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint.

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Response to Allegations Regarding Parties 8. Defendant is without knowledge or information sufficient to form a belief as to the truth

of the allegations in this paragraph of the Complaint regarding Plaintiffs' age and citizenship, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 9. Defendant is 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, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 10. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies that Bextra® caused Plaintiffs injury or damages and denies the remaining allegations in this paragraph of the Complaint. 11. Defendant admits that it is a Delaware corporation with its principal place of business in

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New York. Defendant denies the remaining allegations in this paragraph of the Complaint. 12. Defendant admits that it is a Delaware corporation with its principal place of business in

New York. Defendant admits that it does business in New York. Defendant denies the remaining allegations in this paragraph of the Complaint. 13. Defendant admits that it does business in New York. Defendant denies the remaining

allegations in this paragraph of the Complaint. 14. Defendant admits that it does business in New York. Defendant denies the remaining

allegations in this paragraph of the Complaint. 15. Defendant admits that it does business in New York. Defendant denies the remaining

allegations in this paragraph of the Complaint.
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16.

Defendant admits that it does business in the United States, including New York.

Defendant denies the remaining allegations in this paragraph of the Complaint. 17. Defendant admits that, during certain periods of time, it 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 18. Defendant admits that it is registered to do and does business in New York. Defendant

is without knowledge or information sufficient to form a belief as to the judicial district in which the asserted claims allegedly arose, and, therefore, denies the same. Defendant denies any wrongful conduct, denies committing a tort in the States of New York or California, and denies the remaining allegations in this paragraph of the Complaint. Response to Factual Allegations 19. Defendant admits that Bextra® was approved by the FDA, on November 16, 2001.

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Defendant admits, as indicated in the package insert approved by the FDA, that Bextra® is indicated for use in the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as for the treatment of primary dysmenorrhea. Defendant denies the remaining allegations in this paragraph of the Complaint. 20. Defendant admits that Bextra® is in a class of drugs that is, at times, referred to as non-

steroidal anti-inflammatory drugs ("NSAIDs"). Defendant states that the remaining allegations in this paragraph of the Complaint are not directed toward Defendant, and, therefore, no response is required. To the extent that a response is deemed required, Defendant states that Plaintiffs fail to provide the context for the remaining allegations in this paragraph of the Complaint. Defendant is therefore without knowledge or information sufficient to form a belief as to the truth of such allegations, and, therefore, denies the same. 21. Defendant states that, as stated in the FDA-approved labeling for Bextra®, "[t]he

mechanism of action is believed to be due to inhibition of prostaglandin synthesis primarily through inhibition of cyclooxygenase-2 (COX-2). At therapeutic plasma concentrations in humans valdecoxib does not inhibit cyclooxygenase-1 (COX-1)." Defendant states that the
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remaining allegations in this paragraph of the Complaint are not directed toward Defendant, and, therefore, no response is required. To the extent that a response is deemed required, Defendant states that Plaintiffs fail to provide the context for the remaining allegations in this paragraph of the Complaint. Defendant is therefore without knowledge or information

sufficient to form a belief as to the truth of such allegations, and, therefore, denies the same. 22. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 23. Defendant states that the referenced media statement speaks for itself and respectfully

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refers the Court to the media statement for its actual language and full text. Any attempt to characterize the media statement is denied. Defendant denies the remaining allegations in this paragraph of the Complaint. 24. Defendant admits that the sale of Bextra® was voluntarily suspended in the U.S.

market as of April 7, 2005. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 25. Defendant admits that, during certain periods of time, it 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. Defendant admits, 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. allegations in this paragraph of the Complaint. 26. Defendant is without knowledge or information sufficient to form a belief as to the truth Defendant denies the remaining

of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective
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when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 27. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 28. Defendant is without knowledge or information sufficient to form a belief as to the truth

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of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 29. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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
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standards of care and law. Defendant denies any wrongful conduct, denies that Bextra® is defective, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to First Cause of Action: Negligence and Negligence Per Se 30. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 31. Defendant admits that it had duties as are imposed by law but denies having breached Defendant states that Bextra® was and is safe and effective when used in

such duties.

accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 32. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 33. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint, including all subparts. 34. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 35. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 36. Defendant is without knowledge or information sufficient to form a belief as to the truth

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of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 37. Defendant is 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, denies the same. Defendant admits that, during certain periods of time, it 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. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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.
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Defendant admits that the sale of Bextra® was voluntarily suspended in the U.S. market as of April 7, 2005. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 38. Defendant is 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, denies the same. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 39. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 40. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

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damages, and denies the remaining allegations in this paragraph of the Complaint. 41. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 42. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Strict Products Liability 43. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 44. Defendant is 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, denies the same. Defendant admits that, during certain periods of time, it 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 45. Defendant admits that, during certain periods of time, it 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. Defendant states
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that, in the ordinary case, Bextra® was expected to reach users and consumers without substantial change from the time of sale. Defendant denies the remaining allegations in this paragraph of the Complaint. 46. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 47. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 48. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 49. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint.
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50.

Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 51. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 52. Defendant is without knowledge or information sufficient to form a belief as to the truth

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of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 53. Defendant states that this paragraph of the Complaint contains legal contentions to

which no response is required. To the extent that a response is deemed required, Defendant admits that it had duties as are imposed by law but denies having breached such duties. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the
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remaining allegations in this paragraph of the Complaint. 54. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 55. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 56. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 57. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint.
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58.

Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 59. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 60. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 61. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 62. Defendant states that Bextra® was and is safe and effective when used in accordance
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with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 63. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 64. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 65. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

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damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Breach of Express Warranty 66. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 67. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 68. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 69. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or
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damages, and denies the remaining allegations in this paragraph of the Complaint. 70. Defendant admits that it provided FDA-approved prescribing information regarding

Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 71. Defendant admits that it provided FDA-approved prescribing information regarding

Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 72. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 73. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 74. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 75. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 76. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 77. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or
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damages, and denies the remaining allegations in this paragraph of the Complaint. 78. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Fourth Cause of Action: Breach of Implied Warranties 79. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 80. Defendant admits that, during certain periods of time, it 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 81. Defendant is without knowledge or information sufficient to form a belief as to the truth

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

of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing

information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 82. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 83. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information,
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which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 84. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing

information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 85. Defendant is without knowledge or information sufficient to form a belief as to the truth

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

of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant admits that it provided FDA-approved prescribing

information regarding Bextra®. Defendant denies the remaining allegations in this paragraph of the Complaint. 86. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant states that, in the ordinary case, Bextra® was expected to reach users and consumers without substantial change from the time of sale. Defendant denies any wrongful conduct, denies that Bextra® is defective or unreasonably dangerous, and denies remaining allegations in
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this paragraph of the Complaint. 87. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies remaining allegations in this paragraph of the Complaint. 88. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 89. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 90. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

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

damages, and denies the remaining allegations in this paragraph of the Complaint. 91. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Fraudulent Misrepresentation 92. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 93. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 94. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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.
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Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 95. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 96. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 97. Defendant is without knowledge or information sufficient to form a belief as to the truth

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

of the allegations in this paragraph of the Complaint regarding whether Plaintiff used Bextra®, and, therefore, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 98. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information,
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which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint. 99. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 100. Defendant admits that, during certain periods of time, it 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. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 101. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

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

damages, and denies the remaining allegations in this paragraph of the Complaint. 102. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 103. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Sixth Cause of Action: Fraudulent Concealment 104. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 105. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph
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of the Complaint. 106. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 107. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is defective, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. 108. Defendant states 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 required. To the extent that a response is deemed required, Defendant admits that it had duties as are imposed by law but denies having breached such duties. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 109. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is
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defective, denies that Bextra® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 110. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 111. Defendant states 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. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 112. Defendant is 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, denies the same. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 113. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 114. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint.
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115.

Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Seventh Cause of Action: Negligent Misrepresentation 116. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 117. Defendant states that this paragraph of the Complaint contains legal contentions to

which no response is required. To the extent that a response is deemed required, Defendant admits that it had duties as are imposed by law but denies having breached such duties. Defendant states that Bextra® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 118. Defendant states 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. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 119. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 120. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information,
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which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 121. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct, denies that Bextra® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 122. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. 123. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

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damages, and denies the remaining allegations in this paragraph of the Complaint. 124. Defendant denies any wrongful conduct, denies that Bextra® caused Plaintiffs injury or

damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Eighth Cause of Action: Fraud and Deceit 125. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 126. Defendant states that Plaintiffs fail to provide the proper context for the allegations in Defendant therefore lacks knowledge or information

this paragraph of the Complaint.

sufficient to form a belief as to the truth of such allegations and, therefore, denies the same. 127. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 128. Defendant denies any wrongful conduct and denies the remaining allegations in this
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paragraph of the Complaint. 129. Defendant states that this paragraph of the Complaint contains legal contentions to

which no response is required. To the extent that a response is deemed required, Defendant admits that it had duties as are imposed by law but denies having breached such duties. Defendant denies the remaining allegations in this paragraph of the Complaint. 130. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 131. Defendant states that Bextra® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant states 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. Defendant denies the remaining allegations in this paragraph of the Complaint. 132. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states 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. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 133. Defendant states that Bextra® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Bextra® were and are adequately described in its FDA-approved prescribing information,