Free Answer to Complaint - District Court of California - California

Case 3:08-cv-00797-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 ) ) ) ) ) MARTIN FISHER, Individually and as Executor of ) ) the Estate of OLGA FISHER, ) ) Plaintiff, ) ) 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-00797-CRB PFIZER INC.'S ANSWER TO COMPLAINT JURY DEMAND ENDORSED HEREIN

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NOW COMES Defendant Pfizer Inc. ("Defendant"), and files this Answer to Plaintiff's Complaint ("Complaint"), and would respectfully show the Court as follows: I. PRELIMINARY STATEMENT The Complaint does not state in sufficient detail when Decedent was prescribed or used 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 Decedent was prescribed and used Celebrex®. II. ANSWER Response to Allegations Regarding Parties, Jurisdiction, and Venue 1. 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 Decedent's citizenship and whether Decedent used Celebrex®, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 2. 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 is a Delaware corporation with its principal place of business in New York. Defendant admits that it is registered to do and does business in the State of Maryland. Defendant denies any wrongful conduct, denies having committed a tort in the State of Maryland, and denies the remaining allegations in this paragraph of the Complaint. 3. 4. Plaintiff's Complaint omits paragraph number 3. 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 is without knowledge or information sufficient to form a belief as to the truth of the allegations in this paragraph of the Complaint concerning Plaintiff's citizenship and the amount in controversy, and, therefore, denies the same. However, Defendant admits that Plaintiff claims that the parties are diverse and that the amount in controversy exceeds $75,000, exclusive of
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interests and costs. Complaint. 5.

Defendant denies the remaining allegations in this paragraph of the

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 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant admits that, during certain periods of time, it marketed and copromoted 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 Celebrex®. Defendant admits that it does business in the State of Maryland. Defendant denies any

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wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. Response to Factual Allegations 6. Defendant admits that, during certain periods of time, it marketed and co-promoted

Celebrex® in the United States, including Maryland and North Carolina, 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 Celebrex®. Defendant denies the remaining allegations in this paragraph of the Complaint. 7. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant denies that Celebrex® caused Plaintiff or Decedent injury or damage and denies the remaining allegations in this paragraph of the Complaint. 8. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® 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. 9. Defendant admits that, during certain periods of time, it marketed and co-promoted

Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant admits that it provided FDA-approved prescribing information regarding Celebrex®. denies the remaining allegations in this paragraph of the Complaint. 10. Defendant admits that Celebrex® is in a class of drugs that is, at times, referred to as Defendant states that Celebrex® is a Defendant

non-steroidal anti-inflammatory drugs ("NSAIDS").

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. 11. Defendant states that Celebrex® was and is safe and effective when used in accordance

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with its FDA-approved prescribing information. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 12. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 13. Defendant states that Celebrex® 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 Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant admits that it provided FDA-approved prescribing information regarding Celebrex®. Defendant denies the remaining allegations in this paragraph of the Complaint. 14. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 15. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or

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Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to First Cause of Action: Negligence 16. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 17. Defendant admits that, during certain periods of time, it marketed and co-promoted

Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant denies the remaining allegations in this paragraph of the Complaint. 18. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is unreasonably dangerous, and denies the remaining allegations in this paragraph of the Complaint. 19. Defendant states that this paragraph of the Complaint contains legal contentions to
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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 Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of

Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. 20. 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 Celebrex® 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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Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Answering the unnumbered paragraph following Paragraph 20 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Second Cause of Action: Strict Products Liability 21. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 22. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective or unreasonably
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dangerous, and denies the remaining allegations in this paragraph of the Complaint. 23. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint. 24. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint. 25. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint. 26. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint.
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27.

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

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint. 28. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Answering the unnumbered paragraph following Paragraph 28 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Third Cause of Action: Fraud 29. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 30. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint.
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Answering the unnumbered paragraph following Paragraph 30 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Fourth Cause of Action: Negligent Misrepresentation 31. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 32. Defendant admits that, during certain periods of time, it marketed and co-promoted

Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint. 33. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint, including all subparts. 34. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or

Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint.
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Answering the unnumbered paragraph following Paragraph 34 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Fifth Cause of Action: Express Warranty for Goods 35. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

Complaint as if fully set forth herein. 36. 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 admits that, during certain periods of time, it marketed and co-promoted Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Answering the unnumbered paragraph following Paragraph 36 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Sixth Cause of Action: Implied Warranty A. Warranty of Merchantability 37. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant admits that, during certain periods of
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time, it marketed and co-promoted Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the

potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, and denies the remaining allegations in this paragraph of the Complaint. 39. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® is defective, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. B. Warranty of Fitness 40. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

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Complaint as if fully set forth herein. 41. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant admits that, during certain periods of time, it marketed and co-promoted Celebrex® in the United States to be prescribed by healthcare providers who are by law authorized to prescribe drugs in accordance with their approval by the FDA. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant states that the

potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct and denies the remaining
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allegations in this paragraph of the Complaint. 42. Defendant states that Celebrex® was and is safe and effective when used in accordance

with its FDA-approved prescribing information. Defendant states that the potential effects of Celebrex® were and are adequately described in its FDA-approved prescribing information, which was at all times adequate and comported with applicable standards of care and law. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Answering the unnumbered paragraph following Paragraph 42 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Seventh Cause of Action: Unjust Enrichment 43. Defendant incorporates by reference its responses to each paragraph of Plaintiff's

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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, and, therefore, denies the same. Defendant denies the remaining allegations in this paragraph of the Complaint. 45. 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant denies any wrongful conduct and 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 Decedent used Celebrex®, and, therefore, denies the same. Defendant states that Celebrex® was and is safe and effective when used in accordance with its FDA-approved prescribing information. Defendant denies any wrongful conduct and denies the remaining allegations in this paragraph of the Complaint.
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Answering the unnumbered paragraph following Paragraph 46 of the Complaint, Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Response to Eighth Cause of Action: Wrongful Death Answering the unnumbered paragraph of the Complaint headed "Count VIII: Wrongful Death," 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 incorporates by reference its responses to each paragraph of Plaintiff's Complaint as if fully set forth herein. 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 and Decedent's marital status, and, therefore, denies the same. Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. Answering the unnumbered paragraph following the unnumbered paragraph of the Complaint headed "Count VIII: Wrongful Death," Defendant denies any wrongful conduct, denies that Celebrex® caused Plaintiff or Decedent injury or damage, and denies the remaining allegations in this paragraph of the Complaint. III. GENERAL DENIAL Defendant denies all allegations and/or legal conclusions set forth in Plaintiff's 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 Plaintiff to the extent that such defenses are supported by information developed through discovery or evidence at trial. Defendant affirmatively shows that: First Defense 1. The Complaint fails to state a claim upon which relief can be granted.
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Second Defense 2. Celebrex® is a prescription medical product. The federal government has preempted the

field of law applicable to the labeling and warning of prescription medical products. Defendant's labeling and warning of Celebrex® was at all times in compliance with applicable federal law. Plaintiff's causes of action against Defendant, therefore, fail to state a claim upon which relief can be granted; such claims, if allowed, would conflict with applicable federal law and violate the Supremacy Clause of the United States Constitution. Third Defense 3. At all relevant times, Defendant provided proper warnings, information and instructions

for the drug 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

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

applicable Statute of Limitations, and same is pled in full bar of any liability as to Defendant. Sixth Defense Plaintiff's action is barred by the statute of repose. Seventh Defense Plaintiff's claims against Defendant are barred to the extent Plaintiff or Decedent were

contributorily negligent, actively negligent or otherwise failed to mitigate Plaintiff's damages, and any recovery by Plaintiff should be diminished accordingly. Eighth Defense The proximate cause of the loss complained of by Plaintiff 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
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any way. Ninth Defense 9. The acts and/or omissions of unrelated third parties as alleged constituted independent,

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

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 affirmatively denies that it violated any duty owed to Plaintiff or Decedent. Twelfth Defense 12. A manufacturer has no duty to warn patients or the general public of any risk,

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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. Celebrex® is a prescription medical product, available only on the order of a licensed physician. Celebrex® provided an adequate warning to Decedent's treating and prescribing physicians. Thirteenth Defense 13. The product at issue was not in a defective condition or unreasonably dangerous at the

time it left the control of the manufacturer or seller. Fourteenth Defense 14. Celebrex® was at all times material to the Complaint reasonably safe and reasonably fit

for its intended use and the warnings and instructions accompanying Celebrex® at the time of the occurrence of the injuries alleged by Plaintiff was legally adequate for its approved usages. Fifteenth Defense 15. Plaintiff's causes of action are barred in whole or in part by the lack of a defect as the

Celebrex® allegedly ingested by Decedent was prepared in accordance with the applicable
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standard of care. Sixteenth Defense 16. Plaintiff's and Decedent's alleged injuries/damages, if any, were the result of misuse or

abnormal use of the product Celebrex® after the product left the control of Defendant and any liability of Defendant is therefore barred. Seventeenth Defense 17. Plaintiff's alleged damages were not caused by any failure to warn on the part of

Defendant. Eighteenth Defense 18. Plaintiff's and Decedent's alleged injuries/damages, if any, were the result of preexisting

or subsequent conditions unrelated to Celebrex®. Nineteenth Defense 19. Decedent knew or should have known of any risk associated with Celebrex®; therefore,

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the doctrine of assumption of the risk bars or diminishes any recovery. Twentieth Defense Plaintiff is barred from recovering against Defendant because Plaintiff's claims are

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

subject pharmaceutical product at issue was 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 The manufacture, distribution and sale of the pharmaceutical product referred to in

Plaintiff's Complaint were at all times in compliance with all federal regulations and statutes, and Plaintiff's causes of action are preempted. Twenty-third Defense Plaintiff's claims are barred in whole or in part by the deference given to the primary
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jurisdiction of the Food and Drug Administration over the subject pharmaceutical product at issue under applicable federal laws, regulations, and rules. Twenty-fourth Defense 24. Plaintiff's 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. Plaintiff's claims are barred in whole or in part because Defendant provided adequate

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

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Celebrex® is a prescription pharmaceutical drug and falls within the ambit of Restatement (Second) of Torts § 402A, Comment k. Twenty-seventh Defense 27. Plaintiff's claims are barred in whole or in part because the subject pharmaceutical

product at issue "provides net benefits for a class of patients" within the meaning of Comment f to § 6 of the Restatement (Third) of Torts: Products Liability. Twenty-eighth Defense 28. Plaintiff's claims are barred under § 4, et seq., of the Restatement (Third) of Torts:

Products Liability. Twenty-ninth Defense 29. To the extent that Plaintiff is seeking punitive damages, Plaintiff has failed to plead facts

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

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

of Maryland and 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 Constitution. Thirty-third Defense 33. Plaintiff's punitive 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. Plaintiff and Decedent failed to provide Defendant with timely notice of any alleged

nonconformance to any express representation. Thirty-sixth Defense 36. To the extent that Plaintiff's 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. Plaintiff's 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 Plaintiff seeks punitive damages for the conduct which allegedly

caused injuries asserted in the Complaint, punitive damages are barred or reduced by applicable
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law or statute or, in the alternative, are unconstitutional insofar as they violate the due process protections afforded by the United States Constitution, the excessive fines clause of the Eighth Amendment of the United States Constitution, the Commerce Clause of the United States Constitution, the Full Faith and Credit Clause of the United States Constitution, and applicable provisions of the Constitutions of the States of Maryland 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 Plaintiff or Decedent; (4) permits recovery of punitive damages in an amount that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiff and Decedent 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 constitutionally 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 Celebrex®, if any, used in this case, included adequate warnings and instructions with respect to the product's use in the package insert and other literature, and conformed to the generally recognized, reasonably available, and reliable state of the knowledge at the time the product was marketed.
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Fortieth Defense 40. The claims asserted in the Complaint are barred because Celebrex® was 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 Plaintiff or Decedent 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 Celebrex®

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was not unreasonably dangerous or defective, was suitable for the purpose for which it was intended, and was distributed with adequate and sufficient warnings. Forty-third Defense 43. Plaintiff's claims are barred, in whole or in part, by the equitable doctrines of laches,

waiver, and/or estoppel. Forty-fourth Defense 44. Plaintiff's claims are barred because Decedent'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 Decedent, 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 Celebrex®

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

Decedent 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 product 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 Decedent would have taken Celebrex® even if the

product labeling contained the information that Plaintiff contends should have been provided. Forty-ninth Defense 49. The claims asserted in the Complaint are barred because the utility of Celebrex®

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outweighed its risks. Fiftieth Defense 50. Plaintiff's damages, if any, are barred or limited by the payments received from collateral

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

responsibility of all persons who caused or contributed toward Plaintiff's alleged damages, if any, are determined. Defendant seeks an adjudication of the percentage of fault of Plaintiff, Decedent, and each and every other person whose fault could have contributed to the alleged injuries and damages, if any, of Plaintiff or Decedent. Fifty-second Defense 52. Plaintiff's 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 Celebrex®

is comprehensively regulated by the FDA pursuant to the Federal Food, Drug & Cosmetic Act
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("FDCA"), 21 U.S.C. §§ 301 et seq., and regulations promulgated thereunder, and Plaintiff's 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 Celebrex®. Accordingly, Plaintiff's claims are preempted by the

Supremacy Clause of the United States Constitution, Art. VI, cl. 2, and the laws of the United States. Fifty-fourth Defense 54. Plaintiff's 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 action contained therein is barred by the statutes of limitations contained in California Code of Civil Procedure §§ 335.1 and 338 and former § 340(3), such other statutes of limitation as may apply. Fifty-sixth Defense 56. Defendant states on information and belief that any injuries, losses, or damages suffered

by Plaintiff or Decedent were proximately caused, in whole or in part, by the negligence or other actionable conduct of persons or entities other than Defendant. Therefore, Plaintiff's recovery against Defendant, if any, should be reduced pursuant to California Civil Code § 1431.2. Fifty-seventh Defense 57. To the extent that Plaintiff seeks 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 58. Defendant reserves the right to supplement its assertion of defenses as it continues with
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its factual investigation of Plaintiff's claims. V. JURY DEMAND Defendant hereby demands a trial by jury of all the facts and issue in this case pursuant to Federal Rule of Civil Procedure 38(b). VI. PRAYER WHEREFORE, Defendant prays for judgment as follows: 1. 2. 3. 4. That Plaintiff takes 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 Plaintiff's and Decedent's alleged injuries, losses or damages is attributable to each person; 5. That any judgment for damages against Defendant in favor of Plaintiff be no greater than an amount which equals Plaintiff's proportionate share, if any, of the total fault or other liability which proximately caused Plaintiff's and Decedent's injuries and damages; and 6. That Defendant has such other and further relief as the Court deems appropriate.

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March 7, 2008

GORDON & REES LLP

By: :_________/s/____________ Stuart M. Gordon [email protected] Embarcadero Center West 275 Battery Street, 20th Floor San Francisco, CA 94111 Telephone: (415) 986-5900 Fax: (415) 986-8054 March 7, 2008 TUCKER ELLIS & WEST LLP

By: :_________/s/____________ Michael C. Zellers [email protected] 515 South Flower Street, Suite 4200 Los Angeles, CA 90071-2223 Telephone: (213) 430-3400 Fax: (213) 430-3409 Attorneys for Defendant PFIZER INC.

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JURY DEMAND Defendant Pfizer Inc. hereby demands a trial by jury of all the facts and issues in this case pursuant to 38(b) of the Federal Rules of Civil Procedure. March 7, 2008 GORDON & REES LLP

By: :_________/s/____________ Stuart M. Gordon [email protected] Embarcadero Center West 275 Battery Street, 20th Floor San Francisco, CA 94111 Telephone: (415) 986-5900 Fax: (415) 986-8054 March 7, 2008 TUCKER ELLIS & WEST LLP

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By: :_________/s/____________ Michael C. Zellers [email protected] 515 South Flower Street, Suite 4200 Los Angeles, CA 90071-2223 Telephone: (213) 430-3400 Fax: (213) 430-3409 Attorneys for Defendant PFIZER INC.

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