Rocky Mountain Bank -v- Google, Inc.

Filing 353

Rocky Mountain Bank -v- Google, Inc.

Doc. 35

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Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

AMY W. SCHULMAN DLA PIPER LLP 1251 Avenue of the Americas New York, NY 10020 Telephone: [phone] Facsimile: [phone] [e-mail] m STUART M. GORDON (SBN: 037477) GORDON & REES LLP Embarcadero Center West 275 Battery Street, Suite 2000 San Francisco, CA 94111 Telephone: [phone] Facsimile: [phone] [e-mail] MICHAEL C. ZELLERS (SBN: 146904) TUCKER ELLIS & WEST LLP 515 South Flower Street, Suite 4200 Los Angeles, CA 90071-2223 Telephone: [phone] Facsimile: [phone] [e-mail] m Attorneys for Defendant PFIZER INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION IN RE BEXTRA AND CELEBREX MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION This document relates to TERESITA FALCON MATOS, et al., Plaint iffs, vs. ASTRA MERCK, INC., et al., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) MDL Docket No. 1699 CASE NO. 3:06-cv-2660-CRB PFIZER INC.'S ANSWER TO COMPLAINT JURY DEMAND ENDORSED HEREIN

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Dockets.Justia.com

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Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

NOW COMES Defendant Pfizer Inc. (improperly captioned in Plaintiffs' Complaint as Pfizer Corporation, Pfizer Pharmaceuticals, Inc., Pfizer Pharmaceuticals, LLC, Pfizer Disks, Inc., and Pfizer, Inc.") ("Pfizer" or "Defendant"), and files this Answer to Plaintiffs' Co mplaint ("Co mplaint"), 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®") and Celebrex® (celecoxib) ("Celebrex®"). 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® and Celebrex®. II. ANSWER Response to Allegations Regarding Jurisdiction Answering the first unnumbered paragraph preceding Paragraph 1 of the Complaint, Defendant states that, to the extent that the allegations in this paragraph of the Complaint are not directed toward Defendant, no response is required. Defendant states that Pfizer is a Delaware corporation with its principal place of business in New York. 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 the amount in controversy, and, therefore, denies the same. However, Defendant admits that Plaintiffs claim that the amount in controversy exceeds $75,000, exclusive of interests and costs. Defendant denies the remaining allegations in this paragraph of the Complaint. Answering the second unnumbered paragraph preceding Paragraph 1 of the Complaint, Defendant states that the allegations in this paragraph of the Complaint regarding Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 the judicial district in which the asserted claims allegedly
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arose and, therefore, denies the same.

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 Celebrex®, and, therefore, denies the same. Defendant admits that, during certain periods of time, it marketed and co-promoted Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. Response to Factual Allegations 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 Plaintiff's age, level of education, employment history, and citizenship, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 2. 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 Plaintiff's age, marital status, and citizenship, and, therefore, denies the same. 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 Plaintiffs' age, familial relationship, and citizenship, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 4. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 5. Defendant admits that, during certain periods of time, it marketed and co-promoted

Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant admits that it is registered to do and does business in Puerto Rico. Defendant denies the remaining allegations in this paragraph of the Complaint. 6. Defendant states that the allegations in this paragraph of the Complaint regarding
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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant admits that Bextra® and Celebrex® are in a class of drugs that are, at times, referred to as being non-steroidal anti-inflammatory drugs ("NSAIDs"). Defendant states that, as indicated in the package insert approved by the FDA, 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 states that Celebrex® is a prescription medication which is approved by the FDA for the following indications: (1) for relief of the signs and symptoms of osteoarthritis; (2) for relief of the signs and symptoms of rheumatoid arthritis in adults; (3) for the management of acute pain in adults; (4) for the treatment of primary dysmenorrhea; (5) to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) as an adjunct to usual care (e.g., endoscopic surveillance surgery); (6) for relief of signs and symptoms of ankylosing spondylitis; and (7) for relief of the signs and symptoms of juvenile rheumatoid arthritis in patients two years of age and older. Defendant denies the remaining allegations in this paragraph of the Complaint. 7. Defendant states that the allegations in this paragraph of the Complaint are not directed

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toward Defendant, and, therefore, no response is required. 8. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 9. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

and Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the

potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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. 10. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant
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states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 11. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

and Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant admits that, during certain periods of time, it marketed and co-promoted Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 12. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

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and Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 13. Defendant states that Bextra® and Celebrex® were and are safe and effective when
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used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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. 14. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 15. Defendant states that the allegations in this paragraph of the Complaint are not directed

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toward Defendant, and, therefore, no response is required. 16. 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 Celebrex®, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 17. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint.
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18.

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 Plaintiff's medical condition, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 19. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 20. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 21. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care
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Gordon & Rees, LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111

and law. Defendant denies any wrongful conduct, denies that Bextra® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 22. Defendant denies any wrongful conduct, denies that Bextra® or Celebrex® caused

Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. 23. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. 24. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDA-approved prescribing information, which was at all t imes adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Bextra® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 25. Defendant states that the 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 proper context for the allegations in this paragraph of the Complaint. Defendant therefore lacks knowledge or

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informat ion sufficient to form a belief as to the truth of such allegations, and, therefore, denies the same. 26. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. Response to First Cause of Action: Breach of Implied Warranties 27. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

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Complaint as if fully set forth herein. 28. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 29. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 30. Defendant admits that, during certain periods of time, it marketed and co-promoted

Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant denies the remaining allegations in this paragraph of the Complaint. 31. Defendant admits that, during certain periods of time, it marketed and co-promoted

Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant admits that it provided FDA-approved prescribing information regarding Bextra® and Celebrex®. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their
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FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. paragraph of the Complaint. 32. Defendant states that the allegations in this paragraph of the Complaint regarding Defendant denies the remaining allegations in this

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Breach of Express Warranty 33. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

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Complaint as if fully set forth herein. 34. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 35. Defendant admits that, during certain periods of time, it marketed and co-promoted

Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant admits that it provided FDA-approved prescribing information regarding Bextra® and Celebrex®. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. paragraph of the Complaint. 36. Defendant states that the allegations in this paragraph of the Complaint are not directed Defendant denies the remaining allegations in this

toward Defendant, and, therefore, no response is required. 37. Defendant states that Bextra® and Celebrex® were and are safe and effective when

used in accordance with their FDA-approved prescribing information. Defendant states that the
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potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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. 38. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Strict Liability 39. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

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Complaint as if fully set forth herein. 40. Defendant states that the allegations in this paragraph of the Complaint are not directed

toward Defendant, and, therefore, no response is required. 41. Defendant admits that, during certain periods of time, it marketed and co-promoted

Bextra® and Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant denies the remaining allegations in this paragraph of the Complaint. 42. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

and Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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
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Celebrex®, and, therefore, denies the same.

Defendant states that, in the ordinary case,

Bextra® and Celebrex® were 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. 43. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® are defective or unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 44. Defendant states that the allegations in this paragraph o f the Complaint regarding Merck

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and Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the

potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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® or Celebrex® are defective or unreasonably dangerous, denies that Bextra® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 45. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

and Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex®
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were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® are defective or unreasonably dangerous, denies that Bextra® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. Response to Fourth Cause of Action: Negligence 46. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

Complaint as if fully set forth herein. 47. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 48. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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® and Celebrex® were and are safe and effective when used in accordance with their FDAapproved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 49. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 50. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 51. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care
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and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 52. Defendant states that Bextra® and Celebrex® were and are safe and effective when

used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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 the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Fraud 54. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

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Complaint as if fully set forth herein. 55. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care
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and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 56. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 57. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 58. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 59. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant
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states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 60. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Plaint iff used Bextra® and Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 61. Defendant states that the allegations in this paragraph of the Complaint regarding

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Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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. 62. 63. Defendant denies the allegations in this paragraph of the Complaint. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. Defendant is without knowledge or information sufficient to form a belief as to the truth of the allegations
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in this paragraph of the Complaint regarding whether Plaintiff used Bextra® and Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. 64. Defendant states that the allegations in this paragraph of the Complaint regarding

Vioxx® are not directed toward Defendant, and, therefore, no response is required. 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 Celebrex®, and, therefore, denies the same. Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the potential effects of Bextra® and Celebrex® were and are adequately described in their 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Sixth Cause of Action: Husband and Offspring Claims 65. Defendant incorporates by reference its responses to each paragraph of Plaintiffs'

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Complaint as if fully set forth herein. 66. Defendant denies any wrongful conduct, denies that Bextra® or Celebrex® caused

Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Allegations Regarding Obstinate and Temerarious Denial 67. Defendant states that the allegations in this paragraph of the Complaint regarding Merck

and Vioxx® are not directed toward Defendant, and, therefore, no response is required.
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Defendant states that Bextra® and Celebrex® were and are safe and effective when used in accordance with their FDA-approved prescribing information. Defendant states that the

potential effects of Bextra® and Celebrex® were and are adequately described in their FDAapproved 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® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint. Response to Demand for Relief Answering the unnumbered paragraph of the Complaint headed "Demand for Relief," Defendant denies any wrongful conduct, denies that Bextra® or Celebrex® caused Plaintiffs injury or damages, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. III. GENERAL DENIAL Defendant denies all allegations and/or legal conclusions set forth in Plaintiffs' Complaint that have not been previously admitted, denied, or explained. IV. AFFIRMATIVE DEFENSES Defendant reserves the right to rely upon any of the following or additional defenses to claims asserted by Plaintiffs to the extent that such defenses are supported by informat ion developed through discovery or evidence at trial. Defendant affirmat ively shows that: First Defense 1. The Complaint fails to state a claim upon which relief can be granted. Second Defense 2. Bextra® and Celebrex® are prescription medical products. The federal government has

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preempted the field of law applicable to the labeling and warning of prescription medical products. Defendant's labeling and warning of Bextra® and Celebrex® was at all times in compliance with applicable federal law. Plaintiffs' causes of action against Defendant,

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therefore, fail to state a claim upon which relief can be granted; such claims, if allowed, would conflict with applicable federal law and violate the Supremacy Clause of the United States Const itution. Third Defense 3. At all relevant times, Defendant provided proper warnings, information and instructions

for the drugs in accordance with generally recognized and prevailing standards in existence at the time. Fourth Defense 4. At all relevant times, Defendant's warnings and instructions with respect to the use of

Bextra® and Celebrex® conformed to the generally recognized, reasonably available, and reliable state of knowledge at the time the drugs were manufactured, marketed and distributed. Fifth Defense 5. Plaint iffs' action is time-barred as it is filed outside of the time permitted by the

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applicable Statute of Limitations, and same is pleaded in full bar of any liability as to Defendant. Sixth Defense Plaint iffs' act ion is barred by the statute of repose. Seventh Defense Plaint iffs' claims against Defendant are barred to the extent Plaintiffs were

contributorily negligent, actively negligent, or otherwise failed to mitigate Plaintiffs' damages, and any recovery by Plaintiffs should be diminished accordingly. Eighth Defense The proximate cause of the loss complained of by Plaintiffs is not due to any acts or

omissions on the part of Defendant. Rather, said loss is due to the acts or omissions on the part of third parties unrelated to Defendant and for whose acts or omissions Defendant is not liable in any way. Ninth Defense The acts and/or omissions of unrelated third parties as alleged constituted independent,
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intervening causes for which Defendant cannot be liable. Tenth Defense 10. Any injuries or expenses incurred by Plaintiffs were not caused by Bextra® or

Celebrex®, but were proximately caused, in whole or in part, by an idiosyncratic reaction, operation of nature, or act of God. Eleventh Defense 11. Defendant affirmat ively denies that it violated any duty owed to Plaintiffs. Twelfth Defense 12. A manufacturer has no duty to warn patients or the general public of any risk,

contraindication, or adverse effect associated with the use of a prescription medical product. Rather, the law requires that all such warnings and appropriate information be given to the prescribing physician and the medical profession, which act as a "learned intermediary" in determining the use of the product. Bextra® and Celebrex® are prescription medical products, available only on the order of a licensed physician. Bextra® and Celebrex® provided adequate warnings to Plaintiff's treating and prescribing physicians. Thirteenth Defense 13. The products at issue were not in a defective condition or unreasonably dangerous at the

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time they left the control of the manufacturer or seller. Fourteenth Defense 14. Bextra® and Celebrex® were at all times material to the Complaint reasonably safe and

reasonably fit for their intended use and the warnings and instructions accompanying Bextra® and Celebrex® at the time of the occurrence of the injuries alleged by Plaintiffs were legally adequate for their approved usages. Fifteenth Defense 15. Plaint iffs' causes of action are barred in whole or in part by the lack of a defect as the

Bextra® and Celebrex® allegedly ingested by Plaintiff were prepared in accordance with the applicable standard of care.

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Sixteenth Defense 16. Plaint iffs' alleged injuries/damages, if any, were the result of misuse or abnormal use of

the products Bextra® and Celebrex® after the products left the control of Defendant and any liability of Defendant is therefore barred. Seventeenth Defense 17. Plaint iffs' alleged damages were not caused by any failure to warn on the part of

Defendant. Eighteenth Defense 18. Plaint iffs' alleged injuries/damages, if any, were the result of preexisting or subsequent

conditions unrelated to Bextra® and Celebrex®. Nineteenth Defense 19. Plaint iff knew or should have known of any risk associated with Bextra® and

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Celebrex®; therefore, the doctrine of assumption of the risk bars or diminishes any recovery. Twentieth Defense 20. Plaint iffs are barred from recovering against Defendant because Plaintiffs' claims are

preempted in accordance with the Supremacy Clause of the United States Const itution and by the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 301 et. seq. Twenty-first Defense 21. Plaint iffs' claims are barred in whole or in part under the applicable state law because

the subject pharmaceutical products at issue were subject to and received pre-market approval by the Food and Drug Administration under 52 Stat. 1040, 21 U.S.C. § 301. Twenty-second Defense 22. The manufacture, distribution and sale of the pharmaceutical products referred to in

Plaintiffs' Complaint were at all times in compliance with all federal regulations and statutes, and Plaintiffs' causes of action are preempted. Twenty-third Defense 23. Plaint iffs' claims are barred in whole or in part by the deference given to the primary

jurisdiction of the Food and Drug Administration over the subject pharmaceutical products at
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issue under applicable federal laws, regulations, and rules. Twenty-fourth Defense 24. Plaint iffs' claims are barred in whole or in part because there is no private right of

action concerning matters regulated by the Food and Drug Administration under applicable federal laws, regulations, and rules. Twenty-fifth Defense 25. Plaint iffs' claims are barred in whole or in part because Defendant provided adequate

"direction or warnings" as to the use of the subject pharmaceutical products within the meaning of Comment j to Section 402A of the Restatement (Second) of Torts. Twenty-sixth Defense 26. Plaint iffs' claims are barred or limited to a product liability failure to warn claim

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because Bextra® and Celebrex® are prescription pharmaceutical drugs and fall within the ambit of Restatement (Second) of Torts § 402A, Comment k. Twenty-seventh Defense 27. Plaint iffs' claims are barred in whole or in part because the subject pharmaceutical

products at issue "provide[] net benefits for a class of patients" wit hin the meaning of Comment f to § 6 of the Restatement (Third) of Torts: Products Liability. Twenty-eighth Defense 28. Plaint iffs' claims are barred under § 4, et seq., of the Restatement (Third) of Torts:

Products Liability. Twenty-ninth Defense 29. To the extent that Plaintiffs are seeking punitive damages, Plaintiffs have failed to plead

facts sufficient under the law to justify an award of punitive damages. Thirtieth Defense 30. Defendant affirmatively avers that the imposit ion of punitive damages in this case

would violate Defendant's rights to procedural due process under the Fourteenth Amendment of the United States Constitution and the Constitutions of the Puerto Rico and California, and would additionally violate Defendant's rights to substantive due process under the Fourteenth
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Amendment of the United States Constitution. Thirty-first Defense 31. Plaint iffs' claims for punitive damages are barred, in whole or in part, by the Fifth and

Fourteenth Amendments to the United States Constitution. Thirty-second Defense 32. The imposition of punitive damages in this case would violate the First Amendment to

the United States Const itution. Thirty-third Defense 33. Plaint iffs' punit ive damage claims are preempted by federal law. Thirty-fourth Defense 34. In the event that reliance was placed upon Defendant's nonconformance to an express

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representation, this action is barred as there was no reliance upon representations, if any, of Defendant. Thirty-fifth Defense 35. Plaint iffs failed to provide Defendant with t imely notice of any alleged nonconformance

to any express representation. Thirty-sixth Defense 36. To the extent that Plaintiffs' claims are based on a theory providing for liability without

proof of causation, the claims violate Defendant's rights under the United States Constitution. Thirty-seventh Defense 37. Plaint iffs' claims are barred, in whole or in part, because the advertisements, if any, and

labeling with respect to the subject pharmaceutical products were not false or misleading and, therefore, constitute protected commercial speech under the applicable provisions of the United States Constitution. Thirty-eighth Defense 38. To the extent that Plaintiffs seek punitive damages for the conduct which allegedly

caused injuries asserted in the Complaint, punitive damages are barred or reduced by applicable law or statute or, in the alternative, are unconstitutional inso far as they violate the due process
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protections afforded by the United States Constitution, the excessive fines clause of the Eighth Amendment of the United States Const itution, the Commerce Clause of the United States Const itution, and the Full Faith and Credit Clause of the United States Constitution, and applicable provisions of the Constitutions o f Puerto Rico and California. Any law, statute, or other authority purporting to permit the recovery of punitive damages in this case is unconstitutional, facially and as applied, to the extent that, without limitation, it: (1) lacks constitutionally sufficient standards to guide and restrain the jury's discretion in determining whether to award punitive damages and/or the amount, if any; (2) is void for vagueness in that it failed to provide adequate advance notice as to what conduct will result in punitive damages; (3) permits recovery of punitive damages based on out-of-state conduct, conduct that complied with applicable law, or conduct that was not directed, or did not proximately cause harm, to Plaintiffs; (4) permits recovery of punitive damages in an amount that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiffs and to the amount of compensatory damages, if any; (5) permits jury consideration of net worth or other financial information relating to Defendant; (6) lacks constitut ionally sufficient standards to be applied by the trial court in post-verdict review of any punitive damages awards; (7) lacks constitutionally sufficient standards for appellate review of punitive damages awards; and (8) otherwise fails to satisfy Supreme Court precedent, including, without limitation, Pacific Mutual Life Ins. Co. v. Haslip, 499 U.S. 1 (1991), TXO Production Corp. v. Alliance Resources, Inc., 509 U.S. 443 (1993); BMW of North America, Inc. v. Gore, 519 U.S. 559 (1996); and State Farm Mut. Auto Ins. Co. v. Campbell, 538 U.S. 408 (2003). Thirty-ninth Defense 39. The methods, standards, and techniques utilized with respect to the manufacture, design,

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and marketing of Bextra® and Celebrex®, if any, used in this case, included adequate warnings and instructions with respect to the products' use in the package inserts and other literature, and conformed to the generally recognized, reasonably available, and reliable state of the knowledge at the time the products were marketed.

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Fortieth Defense 40. The claims asserted in the Complaint are barred because Bextra® and Celebrex® were

designed, tested, manufactured and labeled in accordance with the state-of-the-art industry standards existing at the time of the sale. Forty-first Defense 41. If Plaintiffs have sustained injuries or losses as alleged in the Complaint, upon

information and belief, such injuries and losses were caused by the actions of persons not having real or apparent authority to take said actions on behalf of Defendant and over whom Defendant had no control and for whom Defendant may not be held accountable. Forty-second Defense 42. The claims asserted in the Complaint are barred, in whole or in part, because Bextra®

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and Celebrex® were not unreasonably dangerous or defective, were suitable for the purpose for which they were intended, and were distributed with adequate and sufficient warnings. Forty-third Defense 43. Plaint iffs' claims are barred, in whole or in part, by the equitable doctrines of laches,

waiver, and/or estoppel. Forty-fourth Defense 44. Plaint iffs' claims are barred because Plaintiff's injuries, if any, were the result of the

pre-existing and/or unrelated medical, genetic and/or environmental conditions, diseases or illnesses, subsequent medical conditions or natural courses of conditions of Plaintiff, and were independent of or far removed from Defendant's conduct. Forty-fifth Defense 45. The claims asserted in the Complaint are barred, in whole or in part, because Bextra®

and Celebrex® did not proximately cause injuries or damages to Plaintiffs. Forty-sixth Defense 46. The claims asserted in the Complaint are barred, in whole or in part, because Plaintiffs

did not incur any ascertainable loss as a result of Defendant's conduct.

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Forty-seventh Defense 47. The claims asserted in the Complaint are barred, in whole or in part, because the

manufacturing, labeling, packaging, and any advertising of the products complied with the applicable codes, standards and regulations established, adopted, promulgated or approved by any applicable regulatory body, including but not limited to the United States, any state, and any agency thereof. Forty-eighth Defense 48. The claims must be dismissed because Plaintiff would have taken Bextra® and

Celebrex® even if the product labeling contained the information that Plaintiffs contend should have been provided. Forty-ninth Defense 49. The claims asserted in the Complaint are barred because the utility of Bextra® and

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Celebrex® outweighed their risks. Fiftieth Defense 50. Plaint iffs' damages, if any, are barred or limited by the payments received from

collateral sources. Fifty-first Defense 51. Defendant's liabilit y, if any, can only be determined after the percentages of

responsibility of all persons who caused or contributed toward Plaintiffs' alleged damages, if any, are determined. Defendant seeks an adjudication of the percentage of fault of the

claimants and each and every other person whose fault could have contributed to the alleged injuries and damages, if any, of Plaintiffs. Fifty-second Defense 52. Plaint iffs' claims are barred, in whole or in part, by the doctrine of abstention in that the

common law gives deference to discretionary actions by the United States Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. Fifty-third Defense 53. The claims asserted in the Complaint are barred, in whole or in part, because Bextra®
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and Celebrex® are comprehensively regulated by the FDA pursuant to the Federal Food, Drug & Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., and regulations promulgated there under, and Plaintiffs' claims conflict with the FDCA, with the regulations promulgated by FDA to implement the FDCA, with the purposes and objectives of the FDCA and FDA's implementing regulations, and with the specific determinations by FDA specifying the language that should be used in the labeling accompanying Bextra® and Celebrex®. Accordingly, Plaintiffs' claims are preempted by the Supremacy Clause of the United States Constitution, Article VI, clause 2, and the laws of the United States. Fifty-fourth Defense 54. Plaint iffs' misrepresentation allegations are not stated with the degree of particularity

required by Federal Rule of Civil Procedure 9(b) and should be dismissed. Fifty-fifth Defense 55. Defendant states on information and belief that the Complaint and each purported cause

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of act ion contained therein is barred by the statutes of limitations contained in California Code of Civil Procedure §§ 335.1 and 338 and former § 340(3), and such other statutes of limitation as may apply. Fifty-sixth Defense Defendant states on information and belief that any injuries, losses, or damages suffered

by Plaintiffs were proximately caused, in whole or in part, by the negligence or other actionable conduct of persons or entities other than Defendant. Therefore, Plaintiffs' recovery against Defendant, if any, should be reduced pursuant to California Civil Code § 1431.2. Fifty-seventh Defense To the extent that Plaintiffs seek punitive damages for an alleged act or omission of

Defendant, no act or omission was oppressive, fraudulent, or malicious under California Civil Code § 3294, and, therefore, any award of punitive damages is barred. Any claim for punitive damages is also barred under California Civil Code § 3294(b). Fifty-eighth Defense Defendant reserves the right to supplement its assertion of defenses as it continues wit h
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its factual invest igation of Plaintiffs' claims. V. PRAYER WHEREFORE, Defendant prays for judgment as follows: 1. 2. 3. 4. That Plaintiffs take nothing from Defendant by reason of the Complaint; That the Complaint be dismissed; That Defendant be awarded its costs for this lawsuit; That the trier of fact determine what percentage of the combined fault or other liability of all persons whose fault or other liability proximately caused Plaintiffs' alleged injuries, losses or damages is attributable to each person; 5. That any judgment for damages against Defendant in favor of Plaintiffs be no greater than an amount which equals its proportionate share, if any, of the total fault or other liability which proximately caused Plaintiffs' injuries and damages; and 6. That Defendant has such other and further relief as the Court deems appropriate.

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