Segal McCambridge Singer & Mahoney, Ltd Market Street, Suite 2600 Philadelphia, PA (215) Fax: (215) : : : : : : : : : :

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1 Theodore C. Flowers, Esquire Attorney Identification No Segal McCambridge Singer & Mahoney, Ltd Market Street, Suite 2600 Philadelphia, PA (215) Fax (215) Attorney for Defendants, Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC Ú»¼ ²¼ ß»»¼ ¾ ÐÎÑÌØÑÒÑÌßÎÇ ðè ÍÛÐ îðïï ðíæëï ³ Îò ÉÛ ÍÍ IN RE REGLAN/METOCLOPRAMIDE LITIGATION This document relates to all cases. COURT OF COMMON PLEAS PHILADELPHIA COUNTY JANUARY TERM, 2010 NO PRELIMINARY OBJECTIONS OF DEFENDANTS MORTON GROVE PHARMACEUTICALS, INC. AND WOCKHARDT USA, LLC Filing Date Response Date October 3, 2011 Case ID Control No

2 IN RE REGLAN/METOCLOPRAMIDE LITIGATION This document relates to all cases. COURT OF COMMON PLEAS PHILADELPHIA COUNTY JANUARY TERM, 2010 NO ORDER AND NOW, this day of, 2011, upon consideration of Defendants thereto, this Honorable Court hereby finds that Defendants Morton Grove Pharmaceuticals, Inc. SUSTAINED. It is ORDERED and DECREED that as to Morton Grove Pharmaceuticals Inc. and ster Long Form Complaint is DISMISSED WITH PREJUDICE. BY THE COURT Sandra Mazer Moss, J. Case ID Control No

3 VIA ELECTRONIC FILING The Honorable Sandra Mazer Moss Court of Common Pleas of Philadelphia County Complex Litigation Center City Hall, Room 622 Philadelphia, PA Attn Donna Candelora, Esq. Re In re Reglan/Metoclopramide Litigation January Term, 2010, No Stewart Eisenberg, Esq. Response Deadline October 3, 2011 Dear Judge Moss PRELIMINARY OBJECTIONS OF DEFENDANTS MORTON GROVE THIRD AMENDED MASTER LONG FORM COMPLAINT AND BRIEF IN SUPPORT THEREOF I. SUMMARY OF ARGUMENT Morton the Generic Defendants. All theories of liability asserted by Plaintiffs in their Third Amended Master Long Form Complaint 3d AMLFC Mensing. Plaintiffs have now repled their case in light of Mensing, but it remains what it has always been a failure-to-warn case. most recent theory of liability against Morton Grove as the Reference Mensing was clear and unequivocal generic drug manufacturers are not permitted to change their labeling except to mirror the label of the brand manufacturer. 2 Plaintiffs here have not cited to a single statutory or regulatory authority that imposes any new or additional responsibilities upon a generic and is a manufacturer of generic metoclopramide. Wockhardt USA, LLC did not become a subsidiary of Morton Grove until October 2008 and did not begin distributing metoclopramide manufactured by Morton Grove until April 1, The wellestablished responsibilities of brand and generic manufacturers with regard to labeling are clearly addressed in Mensing as well as in these Preliminary Objections. Case ID Control No

4 Page 2 manufacturer who is subsequently and unilaterally designated by FDA as an RLD 3. Therefore, there is no separate and distinct theory of liability against Morton Grove or Wockhardt, as asserted by Plaintiffs in the 3d AMLFC, and all claims are preempted by the United States Mensing there conceded this very point when arguing before the United States Supreme Court when, responding to a question about the refer II. BACKGROUND FACTS 3d AMLFC alleges against numerous Defendants, including Morton Grove and Wockhardt, claims of strict liability - failure to warn, strict liability - design defect, negligence, negligence per se, fraud and intentional misrepresentation, constructive fraud, breach of express and implied warranties, unfair deceptive trade practices act, unjust enrichment, negligent misrepresentation, civil conspiracy, wrongful death, and survival action arising out of injuries Plaintiffs allegedly sustained due to the ingestion of Reglan or its generic equivalent, metoclopramide. See 3d AMLFC, generally, Exhibit A. As to Morton Grove, Plaintiffs also assert Although Morton Grove Pharmaceuticals, Inc. is a holder of an ANDA for metoclopramide syrup, it is also assigned as the Reference Listed Drug holder of Reglan syrup. Pursuant to the 21 C.F.R and , a Referenced Listed drug means the listed drug identified by the United States Food & Drug Administration as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Defendant Morton Grove Pharmaceuticals, Inc., as the Reference Listed Drug holder, is responsible for bioequivalence and label standards for all abbreviated applications requesting approval for the generic form of Reglan syrup, otherwise known as metoclopramide. See 3d AMLFC, fn 2, Exhibit A. This assertion is incorrect as, for the reasons stated below, Morton Grove and Wockhardt are not, by virtue of being the RLD, responsible for and label responsibility of the brand manufacturer. See Mensing, slip op at 6. 3 FDA undertakes this action without any notice to, or contact with, the newly designated ANDA RLD holder. See 57 FR 17950, para. 25, attached as Exhibit B. Case ID Control No

5 Page 3 III. LEGAL ANALYSIS Pennsylvania Rule of Civil Procedure Pa.R.C.P 1028(a)(4) allows for preliminary objections based on legal insufficiency of a pleading. When reviewing preliminary objections in -pleaded material, factual averments and all inferences fairly Tucker v. Philadelphia Daily News, 757 A.2d 938, (Pa.Super.Ct 2000). In reviewing preliminary objections in the nature of a demurrer, the Court must accept as true all well-pleaded facts, which are material and relevant, as well as any reasonable inferences deducible therefrom. Cohen v. City of Philadelphia, 806 A.2d 905 (Pa. 3d AMLFC must be dismissed as to Morton Grove and Wockhardt as all claims are preempted by the United States Mensing. A preliminary objection in the nature of a demurrer is Hess v. Fox Rothschild, LLP, 925 A.2d 798, 805 (Pa. Super. 2007); Pa. R. Civ. P. 1028(a)(4). IV. ARGUMENT Plaintiffs here are improperly, and without the support of any legal authority, attempting ANDA holder Morton Grove where no such responsibilities exist. An ANDA holder cannot step into the shoes of an NDA holder. Plaintiffs have not cited to a single statutory or regulatory authority that imposes any additional responsibilities upon a generic manufacturer who is subsequently and unilaterally designated an RLD by FDA. As a generic manufacturer of metoclopramide, Mensing makes clear that Morton Grove is not permitted to alter its label. On the contrary, its label must mirror the label of the brand manufacturer. In this case, it is undisputed that the brand manufacturer, AH Robins, no longer markets Reglan under NDA FDA unilaterally designated Morton Grove as the RLD so that subsequent ANDA applicants have a drug to reference for purposes of application submission and approval. See (a)(7). However, this unilateral designation does not alter the well-established regulatory framework for brand and generic drug manufacturers with regard to labeling by transforming Morton Grove, and ANDA holder, to an NDA holder. Such a position directly contradicts the current regulatory framework, well-established responsibilities Mensing. Case ID Control No

6 Page 4 Labeling Responsibilities of Drug Manufacturers The federal regulations are clear that the brand manufacturer the holder of an NDA is Under the 1962 Drug Amendments to the Federal Food, Drug, and Cosmetic Act, 76 Stat. 780, 21 U. S. C. 301 et seq., a manufacturer seeking federal approval to market a new drug must demonstrate that it is safe and effective and that the proposed label is accurate and adequate, and usually must conduct costly and extensive clinical testing to prove safety and efficacy of the drug. Mensing, slip op at 5. Under the Hatch-Waxman Amendments (the Drug Price Competition and Patent Term demonstrating bioequivalence to a reference listed drug that has already been approved by the FDA. 21 U. S. C. 355(j)(2)(A). The Mensing listed drug (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy. See, e.g., United States v. Generix Drug Corp., 460 U. S. 453, (1983); 21 Mensing, slip op at 5, fn 2. The generic manufacturer or ANDA applicant need not conduct clinical trials because the safety and efficacy of the drug have already been established. A generic drug applicant must show that the labeling proposed is the same as the labeling approved for the reference listed drug. (emphasis added) See 21 C.F.R (a)(8); 21 U. S. C. 355(j)(2)(A)(v); 21 U. S. C. 355(j)(4)(G). Therefore, concludes the Mensing Court, brand and generic drug manufacturers have different federal drug labeling duties -name manufacturer seeking new drug approval drug approval, on the other hand, is responsible for ensuring that its warning label is the same (emphasis added) See Mensing, slip op at 6. Mensing is clear that a of the brand manufacturer. Case ID Control No

7 Page 5 Applicable Regulations for Generic Drug Manufacturers the Duty of Sameness In support of their proposition, Plaintiffs cite to two regulations (relevant portions only cited below). Neither regulation supports the proposition that Morton Grove, by virtue of being and label See 3d AMLFC, fn 2, Exhibit A bioequavlence. But, these regulations do not state that an ANDA designated by FDA as the of a brand manufacturer. See Mensing, slip op at 6. The regulations cited by Plaintiffs are Sec Definitions 4 (b) The following definitions of terms apply to this part *** Reference listed drug means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Sec Content and format of an abbreviated application 5 *** (a)(3)basis for abbreviated new drug application submission. An abbreviated new drug application must refer to a listed drug. Ordinarily, that listed drug will be the drug product selected by the agency as the reference standard for conducting bioequivalence testing. The application shall contain *** (a) (7)Bioequivalence. (i) Information that shows that the drug product is bioequivalent to the reference listed drug upon which the applicant relies. A complete study report must be submitted for the bioequivalence study upon which the applicant relies for approval. For all other bioequivalence studies conducted on the same drug product formulation as defined in 320.1(g) of this chapter, the applicant must submit either a complete or summary 4 A complete copy of 21 C.F.R is attached as Exhibit C. 5 A complete copy of 21 C.F.R is attached as Exhibit D. Case ID Control No

8 Page 6 report. If a summary report of a bioequivalence study is submitted and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may require that the applicant submit a complete report of the bioequivalence study to FDA; or *** (a) (8)Labeling --(i)listed drug labeling. A copy of the currently approved labeling (including, if applicable, any Medication Guide required under part 208 of this chapter) for the listed drug referred to in the abbreviated new drug application, if the abbreviated new drug application relies on a reference listed drug. *** (iv)comparison of approved and proposed labeling. A side-by-side comparison of the applicant's proposed labeling including, if applicable, any Medication Guide required under part 208 of this chapter with the approved labeling for the reference listed drug with all differences annotated and explained. Labeling (including the container label, package insert, and, if applicable, Medication Guide) proposed for the drug product must be the same as the labeling approved for the reference listed drug, except for changes required because of differences approved under a petition filed under or because the drug product and the reference listed drug are produced or distributed by different manufacturers. Such differences between the applicant's proposed labeling and labeling approved for the reference listed drug may include differences in expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(4)(D) of the act. Case ID Control No

9 Page 7 The regulations cited by Plaintiffs do not impose on Morton Grove a Grove for the content of the label directly contradicts the current regulatory framework, welldecision in Mensing. The regulations cited by Plaintiffs in the 3d AMLFC are, in fact, consistent osition as both a generic manufacturer and RLD designee. Plaintiffs here have not cited to a single statutory or regulatory authority that places any additional responsibilities upon an ANDA applicant who is subsequently designated an RLD by FDA. In submitting an ANDA, an ANDA applicant must have approved labeling that of an RLD to refer to in order to achieve its responsibility the agency as the reference standard for conducting bioequavalency testing Mensing typically a brand- (emphasis added) Mensing, slip op at 5, fn 2. 6 However, in this case, the RLD (as of August 2006), was Morton Grove, a generic manufacturer. 7 The brand manufacturer, AH Robins, no longer markets Reglan syrup, and FDA designated Morton Grove as the RLD for the syrup formulation of metoclopramide. The clear purpose of this designation is so that a subsequent ANDA applicant can provide to FDA product designated by FDA as the RLD and that its label reflects the most current version approved by FDA. See 21 C.F.R (a)(3), (a)(7) and (a)(8). This unilateral designation does not in any way alter the well-established regulatory framework established for brand and ANDA into an NDA or somehow create new responsibilities for the ANDA holder. unequivocally, told the Supreme Court at oral argument Mensing, clearly and Mr. Bograd Somebody has been appointed to be the referencelisted drug. They have not been appointed to have obligations distinct from the other generic companies as far as updating label claims. Mensing Tr. at , Exhibit E. 6 The Mensing opinion appropriately refers to the brand drug as the RLD, because with respect to metoclopramide oral tablets at issue in Mensing, they were one and the same. But the true distinction the Mensing Court drew, and the material regulatory distinction, is between the NDA holder on the one hand and ANDA applicants on the other. 7 3d AMLFC. Case ID Control No

10 Page 8 Furthermore, support for this proposition can be found in FDA guidance documents and Labeling Changes Implementation of Section 505(o)(4) of the Federal Food, Drug, and rocedures for required safety labeling changes once FDA has determined that new safety information is available and should be included in labeling. 8 In identifying the categories of manufacturers to whom notice will be given, FDA clearly delineates between the holders of a NDA, BLA and ANDA without a marketed NDA RLD. See Exhibit F, p. 5, section IV (emphasis added). In addition, FDA has stated that when an NDA designated as the RLD is discontinued for ed ANDAs that refer to the NDAs... are unaffected by the discontinued marketing of the products subject to those NDAs.... If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise AND See FDA, Notice, Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75 Fed. Reg. 48,352, 48,353 (Aug. 10, 2010) (emphasis added), attached as Exhibit F. 9 Indeed, this is precisely what FDA intended when the Agency rendered its decision that Reglan under NDA was not discontinued for safety or effectiveness reasons all approved ANDAs, including any ANDA that FDA unilaterally designates as the RLD, are unaffected by the Reglan withdrawal. See FDA, Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 74 Fed. Reg. 22,751, 22,752 (May 14, 2009), attached as Exhibit H Defendants request Safety Labeling Changes Exhibit E general knowledge; (2) it must be well and authoritatively settled; and (3) it must be known within the limits of the Cosom v. Marcotte 8 Standard Pennsylvania Practice 2d s4968 (1982)). FDA determinations have been held by Pennsylvania Courts as facts to which a court may take judicial notice. Id.; see also, Bacon v. The Upjohn Co., 2 Phila. 285, 296 (Phila. Cty. Rptr. LEXIS 24 March 7, 1979). 9 Defendants request (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or G. 10 Defendants request DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or G. Case ID Control No

11 Page 9 The intention of the regulations, and as confirmed by the cited guidance and Federal Register Notices, is to maintain as separate and distinct the responsibilities of brand and generic drug manufacturers as was intended by Congress in passing the Hatch-Waxman Amendments. This distinction has been made clear by the United States Supreme Court in Mensing. V. CONCLUSION For the foregoing reasons, Defendant Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC respectfully request that this Court sustain its Preliminary Objections and dismiss Pl with prejudice as to Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC. Defendants respectfully request leave to file a Reply Brief and for oral argument in this matter. Respectfully submitted, Segal McCambridge Singer & Mahoney, Ltd. By /s/ Theodore C. Flowers Theodore C. Flowers Segal McCambridge Singer & Mahoney, Ltd Market Street, Suite 2600 Philadelphia, PA Tel (215) Fax (215) tflowers@smsm.com and By /s/ Kimberly A. Kayiwa 233 S. Wacker Drive, Ste Chicago, IL Tel (312) Fax (312) romalley@smsm.com Counsel for Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC Case ID Control No

12 Theodore C. Flowers, Esquire Attorney Identification No Segal McCambridge Singer & Mahoney, Ltd Market Street, Suite 2600 Philadelphia, PA (215) Fax (215) Attorney for Defendants, Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC IN RE REGLAN/METOCLOPRAMIDE LITIGATION This document relates to all cases. COURT OF COMMON PLEAS PHILADELPHIA COUNTY JANUARY TERM, 2010 NO CERTIFICATION OF SERVICE I, Theodore C. Flowers, do hereby certify that on this 8 th day of September, 2011, I electronically filed a true and correct copy of the foregoing Preliminary Objections of Amended Master Long Form Complaint using The Philadelphia Courts Electronic Filing System, which will automatically send notification of such filing to all counsel of record registered with the Philadelphia Courts Electronic Filing System and thereby deemed served on all counsel of record pursuant to Rule 205.4(g) of the Pennsylvania Rules of Civil Procedure and Local Rule *205.4(f)(7). Segal McCambridge Singer & Mahoney, Ltd. By /s/ Theodore C. Flowers Theodore C. Flowers, Esquire Case ID Control No