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Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 1 of 12 UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF PENNSYLVANIA

IN RE: ZOLOFT (SERTRALINE
HYDROCHLORIDE) PRODUCTS
MDL NO. 2342
LIABILITY LITIGATION
2:12-MD-2342
____________________________________
THIS DOCUMENT APPLIES TO:
HON. CYNTHIA M. RUFE
ALL ACTIONS
DEFENDANTS PFIZER INC., PFIZER INTERNATIONAL LLC, AND GREENSTONE
LLC’S MASTER SHORT-FORM ANSWER AND AFFIRMATIVE DEFENSES TO
COMPLAINTS PENDING IN, FILED IN, OR TRANSFERRED TO THE IN RE:
ZOLOFT (SERTRALINE HYDROCHLORIDE) PRODUCTS LIABILITY LITIGATION
Defendants Pfizer Inc. (“Pfizer”)1, Pfizer International LLC, and Greenstone LLC, formerly Greenstone LTD (“Greenstone”) (collectively, the “Pfizer and Greenstone Defendants”), by their undersigned counsel, hereby file this Master Short-Form Answer and Affirmative Defenses (“Master Short-Form Answer”), pursuant to Pretrial Order No. 16 allowing the filing by the Pfizer and Greenstone Defendants of a Master Short-Form Answer in response to all complaints pending in, filed in, or transferred to the above-referenced MDL. This Master Short-Form Answer is not intended to and shall not waive any applicable defenses available to the Pfizer and Greenstone Defendants, including any objections to service, jurisdiction, or venue, and the Pfizer and Greenstone Defendants hereby reserve the right to respond to any particular individual complaint by way of motions permissible under the Federal Rules of Civil Procedure. The Pfizer and Greenstone Defendants may also file counterclaims, cross-claims and/or third-party complaints, pursuant to Rules 13 and 14 of the Federal Rules of Civil Procedure, in connection with any particular individual action. To the extent the Pfizer and Greenstone Defendants desire to respond to any particular individual complaint for the purpose of motion practice, or for the purpose of pleading any additional affirmative defenses, counterclaims, cross-claims and/or third-party complaints, the Pfizer and Greenstone Defendants 1 “Pfizer” includes all current and former unincorporated divisions and business units, including, without Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 2 of 12 shall file any such motions or pleadings within forty-five (45) days of transfer of the action to the MDL or, for those actions currently pending in the MDL, within forty-five (45) days of the filing This Master Short-Form Answer need only be filed once and shall be deemed to respond to the allegations of all complaints pending in, filed in, or transferred to the above-captioned GENERAL DENIALS AND ADMISSIONS
The Pfizer and Greenstone Defendants deny each and every allegation contained in the complaints pending in, filed in, or transferred to the above-captioned MDL that relate to or are directed to the Pfizer and Greenstone Defendants, Zoloft, sertraline hydrochloride, or any of the Pfizer and Greenstone Defendants’ alleged agents, servants or employees, except the Pfizer and Greenstone Defendants admit that: (i) Pfizer Inc. is a corporation duly existing under and by virtue of the laws of the State of Delaware with its principal place of business in New York City, New York; (ii) Pfizer International LLC is a subsidiary of Pfizer Inc. and, since March 7, 2003, Pfizer International LLC has been a limited liability company existing under the laws of the State of New York with its principal place of business in New York, New York; and (iii) Greenstone is an indirectly wholly owned subsidiary of Pfizer Inc. and, since December 11, 2007, Greenstone has been a limited liability company existing under the laws of the State of Delaware with its principal place of business in Peapack, New Jersey. The Pfizer and Greenstone Defendants further admit that Pfizer Inc., directly or indirectly through its subsidiaries, manufactures, markets, and sells sertraline hydrochloride under the brand name Zoloft® and since 2007, Greenstone has been in the business of selling sertraline hydrochloride, but the Pfizer and Greenstone Defendants aver that starting in 2006, sertraline hydrochloride also was manufactured and sold in generic form by several entities other than Pfizer and Greenstone. The Pfizer and Greenstone Defendants further state that Pfizer and Greenstone sold Zoloft and sertraline hydrochloride respectively, in the United States for use only upon prescription by a licensed physician, in accordance with applicable laws and regulations, and for its approved Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 3 of 12 indications and with FDA-approved warnings regarding risks and benefits of the medication. The Pfizer and Greenstone Defendants deny that their conduct, Zoloft, or sertraline hydrochloride caused or contributed to any Plaintiff’s alleged injuries and deny that they are liable to any Plaintiff for damages or any other relief sought in any complaint pending in, filed in, or transferred to the above-captioned MDL. The Pfizer and Greenstone Defendants additionally deny that there is any theory in law or fact or any legal relationship under which any Plaintiff is entitled to damages in any amount from the Pfizer and Greenstone Defendants. AFFIRMATIVE DEFENSES
With respect to any individual Complaint pending in, filed in, or transferred to the above- referenced MDL, the Pfizer and Greenstone Defendants assert the following affirmative defenses. By asserting these affirmative defenses, the Pfizer and Greenstone Defendants do not allege or admit that they have the burden of proof or the burden of persuasion with respect to any FIRST DEFENSE
Plaintiffs’ Complaint fails to state a claim against the Pfizer and Greenstone Defendants SECOND DEFENSE
The United States District Court in which the action was originally filed, or removed to, may be an improper and/or inconvenient venue. THIRD DEFENSE
Plaintiffs’ claims may be barred by the doctrine(s) contained in Restatement (Second) of Torts § 402A, and comments thereto, including but not limited to comments j and k, and/or Restatement (Third) of Torts: Products Liability §§ 2, 4 and 6 and comments thereto. FOURTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by misuse or unintended use of Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 4 of 12 FIFTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by the “learned intermediary” or SIXTH DEFENSE
Plaintiffs’ claims may be barred because Plaintiffs’ injuries, if any, were actually or proximately caused, in whole or in part, by the intervening or superseding conduct of Plaintiffs, independent third parties, or events that were extraordinary under the circumstances, not foreseeable in the normal course of events, or independent of or far removed from the Pfizer and Greenstone Defendants’ conduct or control. SEVENTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by the doctrine of learned consent. EIGHTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, because Plaintiffs’ injuries were caused, in whole or in part, by negligence, fault, or wrongful conduct of the Mother Plaintiffs or by third parties, and Plaintiffs’ claims may be barred or limited by the doctrines of comparative NINTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, because the Mother Plaintiffs did not rely to their detriment upon any statement by the Pfizer and Greenstone Defendants in determining to use Zoloft or sertraline hydrochloride. TENTH DEFENSE
Plaintiffs’ fraud-based claims may be barred for failure to plead them with the requisite ELEVENTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by applicable statutes of limitations Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 5 of 12 TWELFTH DEFENSE
To the extent any Complaint asserts claims for breach of express or implied warranty, Plaintiffs lack the requisite privity with the Pfizer and Greenstone Defendants to sustain such THIRTEENTH DEFENSE
To the extent any Complaint asserts claims for breach of express or implied warranty, such claims are barred because Plaintiffs did not reasonably rely on any alleged express or implied warranty, and because Plaintiffs did not give the Pfizer and Greenstone Defendants adequate notice of any alleged breach of warranty, express or implied. FOURTEENTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by the doctrines of waiver, laches, or FIFTEENTH DEFENSE
Plaintiffs’ damages, if any, may be barred, limited, or offset in the amount of any reimbursement received by Plaintiffs as a result of any insurance or other health benefits plan, or any amounts paid by any insurance or other health benefits plan. SIXTEENTH DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, by the doctrine of assumption of SEVENTEENTH DEFENSE
Plaintiffs’ claims are barred because Zoloft and sertraline hydrochloride were designed, manufactured, and marketed in accordance with the state of the art and when Zoloft left the control of Pfizer and sertraline hydrochloride left the control of Greenstone, no practical and technically feasible alternative formulation was available that would have prevented the harm for which Plaintiffs seek to recover without substantially impairing the safety, efficacy, or usefulness Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 6 of 12 EIGHTEENTH DEFENSE
Plaintiffs’ damages, if any, may be limited, in whole or in part, by Plaintiffs’ failure to NINETEENTH DEFENSE
Plaintiffs’ claims are barred, in whole or in part, because Zoloft and sertraline hydrochloride are comprehensively regulated by the United States Food and Drug Administration (“FDA”) pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., and regulations promulgated thereunder, and Plaintiffs’ claims conflict with the FDCA, with the regulations promulgated by the FDA to implement the FDCA, with the purposes and objectives of the FDCA and the FDA’s implementing regulations, and with the specific determinations by the FDA specifying the language that should be used in the labeling accompanying Zoloft and sertraline hydrochloride. Accordingly, Plaintiffs’ claims are preempted by the Supremacy Clause of the United States Constitution, Article VI, clause 2, and TWENTIETH DEFENSE
Plaintiffs’ claims are barred, in whole or in part, by the deference that common law gives to discretionary actions by the FDA under the FDCA. TWENTY-FIRST DEFENSE
The Pfizer and Greenstone Defendants are entitled to, and claim the benefit of, all defenses and presumptions set forth in or arising from any rule of law or statutes of any applicable states, or any other applicable law. TWENTY-SECOND DEFENSE
Plaintiffs’ claims may be barred, in whole or in part, under the doctrine of primary jurisdiction, in that the pertinent conduct of Pfizer and its activities with respect to Zoloft, and Greenstone and its activities with respect to sertraline hydrochloride, have been and are conducted under the supervision of the FDA. Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 7 of 12 TWENTY-THIRD DEFENSE
To the extent Plaintiffs seek recovery of punitive or exemplary damages against the Pfizer and Greenstone Defendants, unless the Pfizer and Greenstone Defendants’ liability for punitive damages and the appropriate amount of punitive damages is required to be established by clear and convincing evidence, any award of punitive damages would violate the Pfizer and Greenstone Defendants’ due process rights guaranteed by the Fourteenth Amendment to the United States Constitution and by any applicable state constitution, and would be improper under the common law and public policies of that state. TWENTY-FOURTH DEFENSE
To the extent Plaintiffs seek recovery of punitive or exemplary damages against the Pfizer and Greenstone Defendants, any such claim of Plaintiffs for punitive damages against the Pfizer and Greenstone Defendants cannot be maintained, because an award of punitive damages under applicable law would be unlawful and unauthorized, and would be void for vagueness, both facially and as applied, as a result of, among other deficiencies, the absence of adequate notice of what conduct is subject to punishment; the absence of adequate notice of what punishment may be imposed; and the absence of a predetermined limit, such as a maximum multiple of compensatory damages or a maximum amount, on the amount of punitive damages that a jury may impose, all in violation of the due process clause of the Fourteenth Amendment to the United States Constitution, the applicable state constitution, and the common law and TWENTY-FIFTH DEFENSE
To the extent Plaintiffs seek recovery of punitive or exemplary damages against the Pfizer and Greenstone Defendants, any such claim of Plaintiffs for punitive damages against the Pfizer and Greenstone Defendants cannot be maintained, because any award of punitive damages under applicable law would be by a jury that (1) is not provided standards of sufficient clarity for determining the appropriateness, and the appropriate size, of a punitive damages award, (2) is not adequately instructed on the limits on punitive damages imposed by the applicable principles of Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 8 of 12 deterrence and punishment, (3) is not expressly prohibited from awarding punitive damages, or determining the amount of an award of punitive damages, in whole or in part, on the basis of invidiously discriminatory characteristics, including the residence, wealth, and corporate status of the Pfizer and Greenstone Defendants, (4) is permitted to award punitive damages under a standard for determining liability for punitive damages that is vague and arbitrary and does not define with sufficient clarity the conduct or mental state that makes punitive damages permissible, (5) is permitted to award 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, if any, to Plaintiffs, (6) is permitted to award punitive damages in an amount that is not both reasonable and proportionate to the amount of harm, if any, to Plaintiffs and to the amount of compensatory damages, if any, and (7) is not subject to adequate trial court and appellate judicial review for reasonableness and furtherance of legitimate purposes on the basis of objective standards. Any such verdict would violate the Pfizer and Greenstone Defendants’ due process rights guaranteed by the Fourteenth Amendment to the United States Constitution and by the due process and equal protection provisions of any applicable state constitution, and would be improper under the common law and public policies of that state. TWENTY-SIXTH DEFENSE
To the extent Plaintiffs seek recovery of punitive or exemplary damages against the Pfizer and Greenstone Defendants, any award of punitive damages based on anything other than the Pfizer and Greenstone Defendants’ conduct in connection with the design, manufacture, and sale of the specific Zoloft and sertraline hydrochloride products that are the subject of these lawsuits would violate the due process clause of the Fourteenth Amendment to the United States Constitution and the due process provisions of the applicable state constitution, and would be improper under the common law and public policies of that state, because any other judgment for punitive damages in this case cannot protect the Pfizer and Greenstone Defendants against impermissible multiple punishment for the same wrong and against punishment for extraterritorial conduct, including especially conduct that is lawful in states other than the Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 9 of 12 applicable state. In addition, any such award would violate principles of comity under the laws TWENTY-SEVENTH DEFENSE
Plaintiffs’ claims may be barred because of Plaintiffs’ failure to join necessary and TWENTY-EIGHTH DEFENSE
The claims asserted in the Complaint are barred because the risks, if any, associated with the use of Zoloft and sertraline hydrochloride are outweighed by the medication’s utility. TWENTY-NINTH DEFENSE
To the extent Plaintiffs’ claims relate to the Pfizer and Greenstone Defendants’ advertising, public statements, lobbying, or other activities protected by the First Amendment to the Constitution of the United States or by the Constitutions of any applicable state, such claims THIRTIETH DEFENSE
To the extent Plaintiffs assert claims that depend solely on violations of federal law, including any claims of a “fraud on the FDA” with respect to the Pfizer and Greenstone Defendants’ disclosure of information related to the safety of Zoloft and sertraline hydrochloride, such claims are barred and should be dismissed. See Buckman Co. v. Plaintiffs’ Legal Comm., THIRTY-FIRST DEFENSE
The Pfizer and Greenstone Defendants specifically deny all allegations of duty, breach, negligence, defect, causation, and all forms of damages and demands strict proof thereof. THIRTY-SECOND DEFENSE
The claims set forth in the Complaint are barred because the alleged injuries and damages, if any, were caused by medical conditions, disease, illness, or processes (whether pre- existing or contemporaneous) unrelated to Zoloft or sertraline hydrochloride. Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 10 of 12 THIRTY-THIRD DEFENSE
To the extent applicable, the Pfizer and Greenstone Defendants are entitled to contribution from any person and/or entity whose negligence or other fault contributed to Plaintiffs’ alleged injuries and damages. THIRTY-FOURTH DEFENSE
Should the Pfizer and Greenstone Defendants be held liable to Plaintiffs, which liability is specifically denied, the Pfizer and Greenstone Defendants would be entitled to a set-off for all sums of money received or available from or on behalf of any tortfeasors for the same injuries THIRTY-FIFTH DEFENSE
The conduct of the Pfizer and Greenstone Defendants, as well as Zoloft and sertraline hydrochloride, conformed with the FDCA and the requirements of the FDA. Moreover, the activities of the Pfizer and Greenstone Defendants alleged in the Complaint conformed with all state and federal statutes, regulations, and industry standards based upon the state of knowledge existing at the relevant time(s) alleged in the Complaint. THIRTY-SIXTH DEFENSE
The Pfizer and Greenstone Defendants at all times discharged any duty to warn through appropriate and adequate warnings in accordance with federal statutes and regulations with the then-existing states of medical and scientific knowledge. THIRTY-SEVENTH DEFENSE
Upon information and belief, some or all of the injuries alleged in Plaintiffs’ Complaint were caused by preexisting medical conditions, subsequent medical conditions, and the natural course of those conditions of Plaintiffs, by an idiosyncratic reaction, operation of nature, or act of God for which the Pfizer and Greenstone Defendants are not responsible. THIRTY-EIGHTH DEFENSE
The Pfizer and Greenstone Defendants incorporate all available defenses in the common law, statutes, regulations or other sources of law within the applicable state relating to any claims Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 11 of 12 set forth in Plaintiffs’ Complaint, including, but not limited to, claims based on allegations of violations of consumer protection laws and allegations of fraud. THIRTY-NINTH DEFENSE
This court or the United States District Court in which the action was originally filed, or removed to, may lack personal jurisdiction over Pfizer International LLC. WHEREFORE, the Pfizer and Greenstone Defendants request that any Complaint pending in, filed in, or transferred to the above-referenced MDL be dismissed in its entirety with prejudice, that judgment be entered in favor of the Pfizer and Greenstone Defendants, that the Pfizer and Greenstone Defendants be awarded costs and, to the extent provided by law, attorneys’ fees, and any such other relief as the Court may deem proper. Mark S. Cheffo Skadden, Arps, Slate, Meagher & Flom LLP Four Times Square New York, NY 10036-6522 [email protected] Telephone: (212) 735-3000 Facsimile: (212) 735-2000 Attorneys for Defendants Pfizer Inc., Pfizer International LLC, and Greenstone LLC Case 2:12-md-02342-CMR Document 307 Filed 01/02/13 Page 12 of 12 CERTIFICATE OF SERVICE
I hereby certify that, on January 2, 2013, I served the foregoing DEFENDANTS
PFIZER INC., PFIZER INTERNATIONAL LLC, AND GREENSTONE LLC’S MASTER
SHORT-FORM ANSWER AND AFFIRMATIVE DEFENSES TO COMPLAINTS
PENDING IN, FILED IN, OR TRANSFERRED TO THE IN RE: ZOLOFT
(SERTRALINE HYDROCHLORIDE) PRODUCTS LIABILITY LITIGATION on the
(Co-Lead Counsel and Executive Committee) [email protected] (Co-Lead Counsel and Executive Committee) Stephen A. Corr, Esquire Stark & Stark 777 Township Line Road, Suite 120 Yardley, PA 19067-5559 [email protected] (Plaintiffs’ Liaison Counsel) January 2, 2013 /s/ Mark S. Cheffo Mark S. Cheffo

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