Norman C. Kleinberg (NK 2735) 

Theodore V. H. Mayer (TM 9748) 

William J. Beausoleil (WB 5296) 

HUGHES HUBBARD & REED LLP 

One Battery Park Plaza 

New York, New York 10004-1482 

(212) 837-6000 

Attorneys for Defendant Merck & Co., Inc. 

UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF NEW YORK 

-----------------------------------------------------x 

IN RE: : 

Fosamax Products Liability Litigation : 1:06-md-1789 (JFK) 

 : 

-----------------------------------------------------x 

This Document Relates to: : ANSWER AND AFFIRMATIVE

Bronnie Lee : DEFENSES OF MERCK

v. Merck & Co., Inc. : & CO., INC.;

Case No: 1: 07-cv-3248-JFK : DEMAND FOR JURY TRIAL 

 : 

-----------------------------------------------------x 

 Defendant, Merck Co., Inc. (“Merck”), by and through its undersigned attorneys, 

hereby answers the Complaint. Merck denies all allegations directed against it set forth 

in the Complaint except to the extent such allegations are specifically admitted below: 

I. PARTIES

1. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 1. 

2. Merck admits that it is a corporation organized under the laws of the State 

of New Jersey with its principal place of business in Whitehouse Station, New Jersey. 

Except as expressly admitted herein, Merck denies the remaining allegations of 

Paragraph 2. 

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3. Merck admits that it is registered to do business in the State of North 

Carolina, but is without knowledge as to what is meant by the phrase “regularly 

transacted,” so the remaining allegations in Paragraph 3 are denied. 

4. Merck denies each and every allegation of Paragraph 4, except that it 

admits that Merck manufactured, marketed, and distributed the prescription medicine 

FOSAMAX® in accordance with its approved prescribing information. Merck denies 

any allegations in Paragraph 4 inconsistent with that prescribing information and 

respectfully refers the Court to the Physician's Desk Reference ("PDR") for 

FOSAMAX® for its actual language and full text. 

5. Merck admits only that it distributed FOSAMAX® for prescription in 

accordance with its approved prescribing information and denies any allegations in 

Paragraph 5 inconsistent with that prescribing information. Merck respectfully refers the 

Court to the PDR for FOSAMAX® for its actual language and full text. Except as 

expressly admitted herein, Merck denies the remaining allegations of Paragraph 5. 

6. Merck is without knowledge as to what is meant by the phrase “substantial 

revenue,” so the allegations in Paragraph 6 are denied. 

7. Merck is without knowledge as to what is meant by “consequences,” so 

the allegations in Paragraph 7 are denied. 

8. Merck admits only that it distributed FOSAMAX® for prescription in 

accordance with its approved prescribing information. Merck denies the remaining 

allegations of Paragraph 8. 

9. Merck denies each and every allegation of Paragraph 9, except that it 

admits that Merck manufactured, marketed, and distributed the prescription medicine 

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FOSAMAX® for prescription in accordance with its approved prescribing information 

and denies any allegations in Paragraph 9 inconsistent with that prescribing information. 

Merck respectfully refers the Court to the PDR for FOSAMAX® for its actual language 

and full text. 

10. Merck denies each and every allegation of Paragraph 10. 

11. Merck denies each and every allegation of Paragraph 11. 

12. Merck denies each and every allegation of Paragraph 12. 

13. Merck denies each and every allegation of Paragraph 13. 

II. JURISDICTION AND VENUE

 14. The allegations of Paragraph 14 are conclusions of law to which no 

response is required. To the extent that a response is required, Merck denies each and 

every allegation of Paragraph 14. 

 15. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 15. 

 16. Merck admits the allegations of the first sentence of Paragraph 16. Merck 

is without knowledge as to the allegations of the second sentence of Paragraph 16, but for 

jurisdictional purposes only, admits that the Plaintiff seeks in excess of $75,000. 

17. The allegations of Paragraph 17 are conclusions of law to which no 

response is required. To the extent that a response is required, Merck respectfully refers 

the Court to the relevant Case Management Order for its actual language and full text. 

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III. FACTUAL BACKGROUND

18. Merck denies each and every allegation of Paragraph 18, except that it 

admits that Merck manufactured, marketed, and distributed the prescription medicine 

FOSAMAX® for prescription in accordance with its approved prescribing information. 

19. Merck denies each and every allegation of Paragraph 19, except that 

Merck admits that it sought and, in 1995, first obtained FDA approval to manufacture and 

market FOSAMAX® 10 mg and FOSAMAX® 40 mg tablets, a prescription medication 

approved by the FDA for prescription in accordance with its approved prescribing 

information. Merck denies any allegations in Paragraph 19 inconsistent with that 

prescribing information and respectfully refers the Court to the PDR for FOSAMAX® 

for its actual language and full text. 

20. Merck admits only that FOSAMAX® is a prescription medication 

approved by the FDA for prescription in accordance with its approved prescribing 

information and denies any allegations in Paragraph 20 inconsistent with that prescribing 

information. Merck respectfully refers the Court to the PDR for FOSAMAX® for its 

actual language and full text. Merck also refers the Court to the prescribing information 

for Aredia and Zometa, and denies any allegations in Paragraph 20 with respect to Aredia 

and Zometa inconsistent with that prescribing information. 

21. Merck admits only that some bisphosphonates contain nitrogen and some 

do not and that FOSAMAX® is a prescription medication approved by the FDA for 

prescription in accordance with its approved prescribing information. Merck respectfully 

refers to the Court to the PDR for FOSAMAX® for its actual language and full text. 

Merck also refers the Court to the prescribing information for Aredia, Bondronat, 

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Didronel, Bonefos, Loron, and Skelid, and denies any allegations in Paragraph 21 with 

respect to Aredia, Bondronat, Didronel, Bonefos, Loron, and Skelid inconsistent with that 

prescribing information. Merck denies the remaining allegations of Paragraph 21. 

22. Merck denies each and every allegation of Paragraph 22. 

23. Merck denies each and every allegation of Paragraph 23. 

24. Merck denies each and every allegation of Paragraph 24. 

25. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 25. 

26. Merck denies each and every allegation of Paragraph 26. 

27. Merck denies each and every allegation of Paragraph 27. 

28. Merck denies each and every allegation of Paragraph 28. 

29. Merck denies each and every allegation of Paragraph 29. 

30. Merck denies each and every allegation of Paragraph 30, except that 

Merck admits that the FDA drafted an "ODS Postmarketing Safety Review," but 

respectfully refers the Court to said document for its actual language and full text. 

31. Merck denies each and every allegation of Paragraph 31. 

32. Merck denies each and every allegation of Paragraph 32. 

33. Merck denies each and every allegation of Paragraph 33. 

34. Merck denies each and every allegation of Paragraph 34, except that 

Merck admits that Fosamax product sales in 2005 amounted to approximately $3.19 

billion. 

35. Merck denies each and every allegation of Paragraph 35. 

36. Merck denies each and every allegation of Paragraph 36. 

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37. Merck is without knowledge as to whether Plaintiff was prescribed 

FOSAMAX®. Merck denies the remaining allegations in Paragraph 37. 

38. Merck denies each and every allegation of Paragraph 38. 

39. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 39. 

40. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 40. 

41. Merck denies each and every allegation of Paragraph 41. 

42. Merck denies each and every allegation of Paragraph 42. 

43. Merck is without knowledge or information sufficient to form a belief as 

to the allegations of Paragraph 43. 

44. Merck denies each and every allegation of Paragraph 44. 

45. Merck denies each and every allegation of Paragraph 45. 

46. Merck denies each and every allegation of Paragraph 46. 

COUNTS

COUNT I: NEGLIGENCE

 47. Merck repleads its answers to Paragraphs 1 through and including 46, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

 48. The allegations in Paragraph 48 are conclusions of law to which no 

response is required; to the extent that a response is deemed necessary, Merck 

respectfully refers the Court to the relevant legal standard, including any conflict of law 

rules. 

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 49. Merck denies each and every allegation of Paragraph 49, including each 

and every allegation contained in subparts (a) through (f). 

 50. Merck denies each and every allegation of Paragraph 50. 

 51. Merck denies each and every allegation of Paragraph 51. 

COUNT II: STRICT LIABILITY

 52. Merck repleads its answers to Paragraphs 1 through and including 51, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

 53. Merck denies each and every allegation of Paragraph 53, except that it 

admits that Merck manufactured, marketed and distributed the prescription medicine 

FOSAMAX® for prescription in accordance with its approved prescribing information.

 54. Merck denies each and every allegation of Paragraph 54, except that it 

admits that Merck manufactured, marketed and distributed the prescription medicine 

FOSAMAX® for prescription in accordance with its approved prescribing information 

and states that it is without knowledge as to the condition of the FOSAMAX® Plaintiff 

alleges she consumed. 

 55. Merck lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 55. 

 56. Merck denies each and every allegation of Paragraph 56. 

 57. Merck denies each and every allegation of Paragraph 57. 

 58. Merck denies each and every allegation of Paragraph 58. 

 59. Merck denies each and every allegation of Paragraph 59. 

 60. Merck denies each and every allegation of Paragraph 60. 

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 61. Merck denies each and every allegation of Paragraph 61. 

 62. Merck denies each and every allegation of Paragraph 62. 

 63. Merck denies each and every allegation of Paragraph 63. 

COUNT III: BREACH OF EXPRESS WARRANTY

 64. Merck repleads its answers to Paragraphs 1 through and including 63, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

65. Merck denies each and every allegation of Paragraph 65, and respectfully 

refers the Court to the FDA-approved prescribing information for any and all 

representations contained therein. Merck further avers that FOSAMAX® is a 

prescription medication approved by the FDA for prescription in accordance with its 

approved prescribing information. 

 66. Merck denies each and every allegation of Paragraph 66. 

 67. Merck denies each and every allegation of Paragraph 67. 

 68. Merck lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 68. 

 69. Merck denies each and every allegation of Paragraph 69. 

 70. Merck denies each and every allegation of Paragraph 70. 

COUNT IV: BREACH OF IMPLIED WARRANTY

 71. Merck repleads its answers to Paragraphs 1 through and including 70, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

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 72. Merck denies each and every allegation of Paragraph 72, except that 

Merck admits that it manufactured, marketed, and distributed the prescription medicine 

FOSAMAX® for prescription in accordance with its approved prescribing information.

 73. Merck denies each and every allegation of Paragraph 73, and respectfully 

refers the Court to the FDA-approved prescribing information for any and all 

representations contained therein. Merck further avers that FOSAMAX® is a 

prescription medication approved by the FDA for prescription in accordance with its 

approved prescribing information. 

 74. Merck denies each and every allegation of Paragraph 74. 

 75. Merck lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 75. 

 76. Merck denies each and every allegation of Paragraph 76. 

 77. Merck lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 77. 

 78. Merck lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 78. 

 79. Merck denies each and every allegation of Paragraph 79. 

 80. Merck denies each and every allegation of Paragraph 80. 

COUNT V: FRAUDULENT MISREPRESENTATION

 81. Merck repleads its answers to Paragraphs 1 through and including 80, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

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 82. Merck denies each and every allegation of Paragraph 82, including each 

and every allegation contained in subparts (a) through (b). 

 83. Merck denies each and every allegation of Paragraph 83. 

 84. Merck denies each and every allegation of Paragraph 84. 

 85. Merck denies each and every allegation of Paragraph 85. 

 86. Merck denies each and every allegation of Paragraph 86. 

 87. Merck denies each and every allegation of Paragraph 87. 

 88. Merck denies each and every allegation of Paragraph 88. 

 89. Merck denies each and every allegation of Paragraph 89. 

COUNT VI: FRAUDULENT CONCEALMENT

 90. Merck repleads its answers to Paragraphs 1 through and including 89, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

 91. Merck denies each and every allegation of Paragraph 91, including each 

and every allegation contained in subparts (a) through (b). 

 92. Merck denies each and every allegation of Paragraph 92. 

 93. Merck denies each and every allegation of Paragraph 93. 

 94. Merck denies each and every allegation of Paragraph 94. 

 95. Merck denies each and every allegation of Paragraph 95. 

 96. Merck denies each and every allegation of Paragraph 96. 

 97. Merck denies each and every allegation of Paragraph 97. 

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COUNT VII: PUNITIVE DAMAGES

 98. Merck repleads its answers to Paragraphs 1 through and including 97, and 

by this reference hereby incorporates the same herein in this paragraph, and makes the 

same a part hereof as though fully set forth verbatim. 

 99. Merck denies each and every allegation of Paragraph 99. 

 100. Merck denies each and every allegation of Paragraph 100, except that it 

admits that Merck scientists participated in the VIGOR study involving Vioxx®, 

published in the New England Journal of Medicine, and respectfully refers the Court to 

the referenced study for its actual conclusions and full text. 

 101. Merck denies each and every allegation of Paragraph 101, except that it 

admits that Merck received a letter from Thomas W. Abrams of DDMAC in September 

2001 and respectfully refers the Court to that letter for its actual language and full text. 

 102. Merck denies each and every allegation of Paragraph 102. 

 103. Merck denies each and every allegation of Paragraph 103, except that it 

admits that on August 26, 2004, Merck issued a press release regarding the conclusions 

of a study presented at the 20th International Conference of Pharmacoepideminology & 

Therapeutic Risk Management and respectfully refers the Court to that press release for 

its actual language and full text. 

 104. Merck denies each and every allegation of Paragraph 104, except that it 

admits that the referenced study exists and respectfully refers the Court to said study for 

its actual language and full text. Merck further admits that on September 30, 2004, 

Merck announced that in a prospective, randomized, placebo-controlled clinical trial 

there was an increased relative risk for confirmed cardiovascular events beginning after 

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18 months of treatment in the patients taking Vioxx compared with those taking placebo, 

and that , given the availability of alternative therapies and questions raised by the data 

from that trial, Merck concluded that a voluntary withdrawal of Vioxx best served the 

interests of patients. 

 105. Merck denies each and every allegation of Paragraph 105. 

 106. Merck denies each and every allegation of Paragraph 106. 

COUNT VIII: PRAYER FOR RELIEF

 107. WHEREFORE, Merck denies that Plaintiff is entitled to any of the relief 

requested in the Prayer for Relief ,and Merck respectfully demands judgment dismissing 

Plaintiff's Complaint with prejudice and awarding Merck such other and further relief 

that the Court may deem just and proper. 

AFFIRMATIVE DEFENSES

 Discovery and investigation may reveal that any one or more of the following 

affirmative defenses should be available to Merck in this matter. Merck, therefore, 

asserts said affirmative defenses in order to preserve the right to assert them. Upon 

completion of discovery, and if the facts warrant, Merck may withdraw any of these 

affirmative defenses as may be appropriate. Further, Merck reserves the right to amend 

its Answer to assert additional defenses, cross-claims, counterclaims, and other claims 

and defenses as discovery proceeds. Further answering and by way of additional defense, 

Merck states as follows: 

FIRST AFFIRMATIVE DEFENSE

 Each and every claim asserted or raised in the Complaint is barred by the 

applicable statute of limitations and is otherwise untimely. 

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SECOND AFFIRMATIVE DEFENSE

 The Complaint fails to state a claim upon which relief can be granted. 

THIRD AFFIRMATIVE DEFENSE

 Each and every claim asserted or raised in the Complaint is barred by the 

doctrines of estoppel, waiver or statutory and regulatory compliance. 

FOURTH AFFIRMATIVE DEFENSE

 If Plaintiff has sustained injuries or losses as alleged in the Complaint, upon 

information and belief, such injuries or losses were caused in whole or in part through the 

operation of nature or other intervening cause or causes. 

FIFTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff asserts claims based on Merck’s adherence to and 

compliance with applicable state laws, regulations and rules, such claims are preempted 

by federal law under the Supremacy Clause of the United States Constitution. 

SIXTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff asserts claims based upon an alleged failure by Merck 

to warn Plaintiff directly of alleged dangers associated with the use of FOSAMAX®, 

such claims are barred under the learned intermediary doctrine because Merck has 

discharged its duty to warn in its warnings to the prescribing physician. 

SEVENTH AFFIRMATIVE DEFENSE

 If Plaintiff has sustained injuries or losses as alleged in the Complaint, such 

injuries or losses were cause in whole or in part by the contributory negligence of the 

allegedly injured Plaintiff. 

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EIGHTH AFFIRMATIVE DEFENSE

 Any liability that might otherwise be imposed upon this Defendant is subject to 

reduction by the application of the doctrine of comparative fault. 

NINTH AFFIRMATIVE DEFENSE

 If Plaintiff has sustained injuries or losses as alleged in the Complaint, such 

injuries or losses were only sustained after Plaintiff knowingly, voluntarily, and willfully 

assumed the risk of any injury as the result of the consumption of, administration of, or 

exposure to any medicine or pharmaceutical preparation manufactured or distributed by 

Merck or other manufacturer. 

TENTH AFFIRMATIVE DEFENSE

 If Plaintiff has 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 Merck and over whom 

Merck had no control and for whom Merck may not be held accountable. 

ELEVENTH AFFIRMATIVE DEFENSE

 If Plaintiff has sustained injuries or losses as alleged in the Complaint, upon 

information and belief, such injuries and losses were proximately caused by Plaintiff’s 

misuse or abuse of FOSAMAX®. 

TWELFTH AFFIRMATIVE DEFENSE

 If Plaintiff has sustained injuries or losses as alleged in the Complaint, such 

injuries or losses resulted from Plaintiff’s pre-existing and/or unrelated medical, genetic 

and/or environmental conditions, diseases, or illnesses, idiosyncratic reactions, 

Case 1:07-cv-03248-JFK Document 5 Filed 05/23/2007 Page 14 of 21
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subsequent medical conditions or natural courses of conditions for which this Defendant 

is not responsible. 

THIRTEENTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff relies upon any theory of breach of warranty, such 

claims are also barred for lack of timely notice of breach and/or lack of privity. 

FOURTEENTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part under the applicable state law 

because FOSAMAX® was subject to and received pre-market approval by the FDA 

under 52 Stat. 1040, 21 U.S.C. § 301. 

FIFTEENTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part because the product at issue was 

made in accordance with the state of the art at the time it was manufactured. 

SIXTEENTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff seeks punitive damages for the conduct which 

allegedly caused the injuries asserted in the Complaint, such an award would, if granted, 

violate Merck’s state and federal constitutional rights. 

SEVENTEENTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff seeks punitive damages for an alleged act or omission 

of Merck, no act or omission was malicious, willful, wanton, reckless or grossly 

negligent and, therefore, any award of punitive damages is barred. 

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EIGHTEENTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff seeks punitive damages, such claim is barred because 

FOSAMAX® and its labeling was subject to and received pre-market approval by the 

FDA under 52 Stat. 1040, 21 U.S.C. § 301. 

NINETEENTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part under comment k to Section 402A 

of the Restatement (Second) of Torts. 

TWENTIETH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part because Merck provided legally 

adequate “directions or warnings” as to the use of FOSAMAX® and any other medicine 

or pharmaceutical preparation Plaintiff alleges to have taken within the meaning of 

comment j to Section 402A of the Restatement (Second) of Torts. 

TWENTY-FIRST AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred under Section 4, et seq., of the Restatement (Third) of 

Torts: Products Liability. 

TWENTY-SECOND AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred under comment f to Section 6 of the Restatement 

(Third) of Torts: Products Liability. 

TWENTY-THIRD AFFIRMATIVE DEFENSE

 There is no practical or technically feasible alternative design that would have 

reduced the alleged risk without substantially impairing the reasonably anticipated and 

intended function of FOSAMAX®. 

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TWENTY-FOURTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part by failure to mitigate damages. 

TWENTY-FIFTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims are barred in whole or in part because Merck’s conduct 

conforms with medical knowledge. 

TWENTY-SIXTH AFFIRMATIVE DEFENSE

 With respect to each and every cause of action, Plaintiff is not entitled to recovery 

for strict liability because Plaintiff cannot state claims founded in strict liability because, 

among other things, comments j and k to Section 402A of the Restatement (Second) of 

Torts relegates Plaintiff’s claims to a negligence cause of action. 

TWENTY-SEVENTH AFFIRMATIVE DEFENSE

 All activities of Merck as alleged in the Complaint were expressly authorized 

and/or regulated by a government agency. Therefore, Plaintiff’s claims pertaining to 

unfair or deceptive practices are barred. 

TWENTY-EIGHTH AFFIRMATIVE DEFENSE

 With respect to each and every cause of action, Plaintiff is not entitled to recover 

because if the product involved was unsafe, which Merck denies, then it was unavoidably 

unsafe as defined in Restatement of Torts. The apparent benefits of the product exceeded 

any apparent risk given the scientific knowledge available when the product was 

marketed. 

TWENTY-NINTH AFFIRMATIVE DEFENSE

 Merck’s advertisements and labeling with respect to the products which are the 

subject matter of this action were not false or misleading and, therefore, constitute 

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protected commercial speech under the applicable provisions of the United States and 

North Carolina Constitutions. 

THIRTIETH AFFIRMATIVE DEFENSE

 The public interest in the benefit and availability of the product which is the 

subject matter of this action precludes liability for risks, if any, resulting from any 

activities undertaken by Defendant, which were unavoidable given the state of human 

knowledge at the time those activities were undertaken. With respect to Plaintiff’s 

claims, if it is determined there is a risk inherent in the product which is the subject 

matter of this action, then such risk, if any, is outweighed by the benefit of the product. 

THIRTY-FIRST AFFIRMATIVE DEFENSE

 At all times relevant herein, any product which is the subject matter of this action 

manufactured and distributed by Merck in any state in the United States was 

manufactured and distributed in a reasonable and prudent manner based upon available 

medical and scientific knowledge and further was processed and distributed in 

accordance with and pursuant to all applicable regulations of the FDA. 

THIRTY-SECOND AFFIRMATIVE DEFENSE

 With respect to each and every purported cause of action, the acts of Merck were 

at all times done in good faith and without malice. 

THIRTY-THIRD AFFIRMATIVE DEFENSE

 To the extent there were any risks associated with the use of the product which is 

the subject matter of this action which Merck knew or should have known and which 

gave rise to a duty to warn, Merck at all times discharged such duty through appropriate 

and adequate warnings in accordance with federal and state law. 

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THIRTY-FOURTH AFFIRMATIVE DEFENSE

 Plaintiff has not sustained an ascertainable loss of property or money. 

THIRTY-FIFTH AFFIRMATIVE DEFENSE

 Plaintiff has not suffered any actual injury or damages. 

THIRTY-SIXTH AFFIRMATIVE DEFENSE

 Plaintiff’s claimed are barred under the doctrine of economic loss. 

THIRTY-SEVENTH AFFIRMATIVE DEFENSE

 This case is more appropriately brought in a different venue as defined in 28 

U.S.C. §1404(a). 

THIRTY-EIGHTH AFFIRMATIVE DEFENSE

 This case is subject to dismissal and/or transfer to another venue pursuant to 28 

U.S.C. §1406(a). 

THIRTY-NINTH AFFIRMATIVE DEFENSE

 This case is subject to dismissal or stay on the grounds of forum non conveniens. 

FORTIETH AFFIRMATIVE DEFENSE

Plaintiff’s claims which are based on allegations of fraud have not been plead 

with sufficient particularity. 

FORTY-FIRST AFFIRMATIVE DEFENSE

 To the extent Plaintiff makes a claim for punitive damages, Merck asserts that 

such Plaintiff has not complied with statutory requirements to recover punitive damages. 

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FORTY-SECOND AFFIRMATIVE DEFENSE

Plaintiff’s claims for breach of warranty are barred because Plaintiff did not rely 

on such warranties and the claims are otherwise barred for lack of timely notice, lack of 

privity and/or because the alleged warranties were disclaimed. 

FORTY-THIRD AFFIRMATIVE DEFENSE

 The asymptomatic plaintiffs lack standing because they have suffered no damages 

and no injury-in-fact. 

FORTY-FOURTH AFFIRMATIVE DEFENSE

 To the extent that Plaintiff asserts claims based on Merck’s adherence to and 

compliance with applicable state laws, regulations and rules, such claims are preempted 

by federal law under the Final Rule, Requirements on Content and Format of Labeling 

for Human Prescription Drug and Biologic Products, FDA Docket No. 2000N-1269 

(January 24, 2006). 

FORTY-FIFTH AFFIRMATIVE DEFENSE

 The substantive law of North Carolina applies to Plaintiff’s claims. 

__________________________________ 

 Inasmuch as the Complaint does not describe the alleged underlying claims with 

sufficient particularity to enable Merck to determine all of its legal, contractual and 

equitable rights, Merck reserves the right to amend and/or supplement the averments of 

its Answer to assert any and all pertinent liability defenses ascertained through further 

investigation and discovery. 

 Merck will rely on all defenses that may become available during discovery or 

trial. 

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 WHEREFORE, Merck respectfully demands judgment dismissing the Complaint 

with prejudice and awarding Merck its reasonable costs and disbursements, including 

reasonable attorneys’ fees as may be available by law, together with such and other and 

further relief that the Court may deem just and proper. 

JURY DEMAND.

 Defendant hereby demands a trial by jury. 

DATED: New York, New York 

 May 23, 2006 

Respectfully submitted, 

HUGHES HUBBARD & REED LLP 

By: /s/ 

Norman C. Kleinberg (NK 2735) 

Theodore V. H. Mayer (TM 9748) 

William J. Beausoleil (WB 5296) 

One Battery Park Plaza 

New York, New York 10004-1482 

(212) 837-6000 

Attorneys for Defendant Merck & Co., Inc. 

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