Norman C. Kleinberg 

Theodore V. H. Mayer 

William J. Beausoleil 

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 & CO.,

v. Merck & Co., Inc. : INC. TO FIRST AMENDED

 : COMPLAINT; 

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 those allegations of Plaintiff’s First Amended Complaint. Merck 

repleads it responses to Plaintiff’s original Complaint as if fully set forth herein, and by 

this reference hereby incorporates the same herein. Merck denies all allegations set forth 

in the First Amended Complaint except to the extent such allegations are specifically 

admitted below: 

 108. The allegations of Paragraph 108 do not require a response. 

 109. The allegations contained in Paragraph 109 are legal conclusions as to 

which no responsive pleading is required. Should a response be deemed required, Merck 

denies each and every allegation contained in Paragraph 109, and respectfully refers the 

Court to the cited statutory provision for its actual language and full text. 

Case 1:07-cv-03248-JFK Document 28 Filed 01/30/2008 Page 1 of 11
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 110. The allegations of Paragraph 110 do not require a response. 

COUNT X: WRONGFUL DEATH

 111. Merck repleads its answers to Paragraphs 1 through and including 110 of 

Plaintiff’s original Complaint and First Amended Complaint, 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. 

 112. Merck denies each and every allegation of Paragraph 112. 

 113. Merck denies each and every allegation of Paragraph 113. 

 114. Merck denies each and every allegation of Paragraph 114. 

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. 

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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 caused 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. 

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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, 

subsequent medical conditions or natural courses of conditions for which this Defendant 

is not responsible. 

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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. 

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. 

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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®. 

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. 

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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 

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

York 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 

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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. 

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. 

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THIRTY-SIXTH AFFIRMATIVE DEFENSE

 Plaintiff’s claims 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

 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 

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 

 January 30, 2008 

Respectfully submitted, 

HUGHES HUBBARD & REED LLP 

By: /s/ 

Norman C. Kleinberg 

Theodore V. H. Mayer 

William J. Beausoleil 

One Battery Park Plaza 

New York, New York 10004-1482 

(212) 837-6000 

beausole@hugheshubbard.com 

Attorneys for Defendant Merck & Co., Inc. 

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