NY 1165133_1.DOC 

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

Maxine Sklute : DEFENSES OF MERCK 

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

 : DEMAND FOR JURY TRIAL

Case No: 1: 07-cv-3461-JFK : 

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

ANSWER AND AFFIRMATIVE DEFENSES OF MERCK & CO., INC.

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

hereby answers the Complaint. Merck denies all allegations set forth in the Complaint 

except to the extent such allegations are specifically admitted below: 

I. JURISDICTION AND VENUE

 1. The allegations of the first sentence of Paragraph 1 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 the first sentence of Paragraph 1. As to the allegations of the 

second sentence of Paragraph 1, Merck is without knowledge or information sufficient to 

form a belief as to these allegations, except that Merck admits that it is a corporation 

organized under the laws of the State of New Jersey with its principal place of business in 

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New Jersey. Merck is without knowledge as to the allegations in the third sentence of 

Paragraph 1, but for jurisdictional purposes only, admits that the Plaintiff seeks in excess 

of $75,000. 

 2. The allegations of the first sentence of Paragraph 2 are conclusions of law 

to which no response is required. To the extent a response is required, Merck denies the 

allegations of Paragraph 2, except that Merck admits that pursuant to Section 4 of Case 

Management Order No. 3 entered by Judge John F. Keenan on November 1, 2006, this 

action may be filed directly in the Southern District of New York. Merck reserves all 

rights under Section 4 of Case Management Order No. 3. 

II. PARTIES

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

to the allegations of Paragraph 3. 

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

of New Jersey with its principal place of business in New Jersey. Except as expressly 

admitted herein, Merck denies the remaining allegations of Paragraph 4. 

5. Merck admits that it is registered to do business in the States of Alabama 

and New York. 

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

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

7. Merck denies each and every allegation of Paragraph 7, 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 7 inconsistent with that prescribing information and 

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

FOSAMAX® for its actual language and full text. 

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

accordance with its approved prescribing information and denies any allegations in 

Paragraph 8 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 8. 

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

revenue,” so the allegations in Paragraph 9 are denied. 

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

the allegations in Paragraph 10 are denied. 

III. SUMMARY OF THE CASE

11. Merck denies each and every allegation of Paragraph 11, except that it 

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

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

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

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

14. Merck denies each and every allegation of Paragraph 14. 

15. Merck denies each and every allegation of Paragraph 15. 

IV. FACTUAL BACKGROUND

16. Merck denies each and every allegation of Paragraph 16, except that it 

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

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

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17. Merck denies each and every allegation of Paragraph 17, 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 17 inconsistent with that 

prescribing information. 

18. 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 18 inconsistent with that prescribing 

information. Merck also refers the Court to the prescribing information for Aredia and 

Zometa, and denies any allegations in Paragraph 18 with respect to Aredia and Zometa 

inconsistent with that prescribing information. 

19. 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 denies any 

allegations in Paragraph 19 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, Bondronat, 

Didronel, Bonefos, Loron, and Skelid, and denies any allegations in Paragraph 19 with 

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

prescribing information. Merck denies the remaining allegations of Paragraph 19. 

20. Merck denies each and every allegation of Paragraph 20. 

21. Merck denies each and every allegation of Paragraph 21. 

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

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

to the allegations of Paragraph 23. 

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

25. Merck denies each and every allegation 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, 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. 

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

30. Merck denies each and every allegation of Paragraph 30. 

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

32. Merck denies each and every allegation of Paragraph 32, except that 

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

billion. 

33. Merck is without knowledge as to whether Plaintiff used FOSAMAX®. 

Merck denies the remaining allegations in Paragraph 33. 

34. Merck denies each and every allegation of Paragraph 34. 

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

FOSAMAX®. Merck denies the remaining allegations in Paragraph 35. 

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

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

to the allegations of Paragraph 37. 

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

to the allegations of Paragraph 38. 

39. Merck denies each and every allegation of Paragraph 39. 

40. Merck denies each and every allegation of Paragraph 40. 

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

to the allegations of Paragraph 41. 

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

43. Merck denies each and every allegation of Paragraph 43. 

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

COUNTS

COUNT I: NEGLIGENCE

 45. Merck repleads its answers to Paragraphs 1 through and including 44, 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. 

 46. The allegations in Paragraph 46 are conclusions of law to which no 

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

denied and Merck respectfully refers the Court to the relevant legal standard, including 

any conflict of law rules. 

 47. Merck denies each and every allegation of Paragraph 47, including each 

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

 48. Merck denies each and every allegation of Paragraph 48. 

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

COUNT II: STRICT LIABILITY

 50. Merck repleads its answers to Paragraphs 1 through and including 49, 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. 

 51. Merck denies each and every allegation of Paragraph 51, except that it 

admits that Merck manufactured, marketed and distributed the prescription medicine 

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

 52. Merck denies each and every allegation of Paragraph 52, 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 he consumed. 

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

to the allegations of Paragraph 53. 

 54. Merck denies each and every allegation of Paragraph 54. 

 55. Merck denies each and every allegation 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. 

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

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COUNT III: BREACH OF EXPRESS WARRANTY

 62. Merck repleads its answers to Paragraphs 1 through and including 61, 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. 

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

 64. Merck denies each and every allegation of Paragraph 64. 

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

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

truth or falsity of the allegations of Paragraph 66. 

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

 68. Merck denies each and every allegation of Paragraph 68. 

COUNT IV: BREACH OF IMPLIED WARRANTY

 69. Merck repleads its answers to Paragraphs 1 through and including 68, 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. 

 70. Merck denies each and every allegation of Paragraph 70, except that 

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

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

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 71. Merck denies each and every allegation of Paragraph 71, 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. 

 72. Merck denies each and every allegation of Paragraph 72. 

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

truth or falsity of the allegations of Paragraph 73. 

 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 lacks knowledge or information sufficient to form a belief as to the 

truth or falsity of the allegations of Paragraph 76. 

 77. Merck denies each and every allegation of Paragraph 77. 

 78. Merck denies each and every allegation of Paragraph 78. 

COUNT V: FRAUDULENT MISREPRESENTATION

 79. Merck repleads its answers to Paragraphs 1 through and including 78, 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. 

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

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

 81. Merck denies each and every allegation of Paragraph 81. 

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

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 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. 

COUNT VI: FRAUDULENT CONCEALMENT

 88. Merck repleads its answers to Paragraphs 1 through and including 87, 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. 

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

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

 90. Merck denies each and every allegation of Paragraph 90. 

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

 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. 

GLOBAL PRAYER FOR RELIEF

 Merck denies that Plaintiff is entitled to any of the relief requested in her Global 

Prayer for Relief. 

 WHEREFORE, 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. 

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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. 

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. 

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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. 

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 and/or negligence. 

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. 

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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, 

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. 

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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. 

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. 

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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®. 

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. 

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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 

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

Alabama, and New York 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. 

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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. 

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). 

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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 of fraud are not pleaded with the required particularity. 

FORTY-FIRST AFFIRMATIVE DEFENSE

 Plaintiff cannot recover for the claims asserted because Plaintiff has failed to 

comply with the conditions precedent necessary to bring this action and/or each particular 

cause of action asserted by Plaintiff. 

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

 An asymptomatic plaintiff lacks standing because she has 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 

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

(January 24, 2006). 

FORTY-FIFTH AFFIRMATIVE DEFENSE

 The substantive law of Alabama applies to Plaintiff's claims. 

FORTY-SIXTH AFFIRMATIVE DEFENSE

 Merck affirmatively pleads that any punitive damages that the Plaintiff may 

recover in this case should be capped in keeping with Alabama Code Section 6-11-21, as 

amended in 1999 (Act. No. 99-358) and in the spirit of the Alabama Supreme Court’s 

decision in Oliver v. Towns, 738 So. 2d 798 (Ala. 1999). 

FORTY-SEVENTH AFFIRMATIVE DEFENSE

 The demand for punitive damages in the instant case is subject to the limitations 

established by the Alabama legislature and set forth in Ala. Code § 6-11-21 (1975). 

Merck adopts by reference the defenses, criteria, limitations, and standards mandated by 

this Alabama statute. The Alabama Supreme Court’s action in abolishing the 

legislatively created cap on punitive damages was unconstitutional and is without effect. 

Under the Constitutions of the United States and the State of Alabama, the Alabama 

Supreme Court cannot abolish the cap created by the legislature on punitive damages 

through this judicial decision. See Honda Motor Co., Ltd. v. Oberg, 512 U.S. 415, 114 S. 

Ct. 2331, 2340 n.9 (1994). 

FORTY-EIGHTH AFFIRMATIVE DEFENSE

 Merck avers that the punitive damage cap set out in Ala. Code § 6-11-21 (1975) 

applies to the instant case. See Horton Homes, Inc. v. Brooks, 832 So. 2d 44 (Ala. 2001). 

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FORTY-NINTH AFFIRMATIVE DEFENSE

 Merck avers that the method of imposing punitive damages violates Amendment 

328, Section 6.11 of the Constitution of Alabama, which prohibits the use of a procedural 

rule to abridge, enlarge, or modify the substantive right of any party. See Leonard v. 

Terminix Int’l Co., 854 So. 2d 529 (Ala. 2002). 

FIFTIETH AFFIRMATIVE DEFENSE

 The imposition of punitive damages is an act of policy making on the part of the 

judiciary, in violation of Article III, Section 43 of the Constitution of Alabama.

_____________________________ 

In so much 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. 

 WHEREFORE, 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. 

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JURY DEMAND

Merck demands a trial by jury as to all issues so triable. 

DATED: New York, New York 

 June 12, 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. 

Case 1:07-cv-03461-JFK Document 6 Filed 06/12/2007 Page 21 of 21