Wagner, Kathleen v. Pfizer, Inc. and Greenstone, Ltd. et al

Filing 113

Transmission of Notice of Appeal, Amended Notice of Appeal, Docketing Statement, Amended Docketing Statement, Order, Judgment and Docket Sheet to Seventh Circuit Court of Appeals re: 111 Notice of Appeal, 112 Amended Notice of Appeal by Plaintiff Kathleen Wagner. (Attachments: # 1 Amended Notice of Appeal, # 2 Docketing Statement, # 3 Amended Docketing Statement, # 4 Order of July 11, 2014, # 5 Judgment entered on June 2, 2015, # 6 Docket Sheet) (arw)

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IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WISCONSIN KATHLEEN A. WAGNER, ] ] UNITED STATES COURT Plaintiff, ] OF APPEALS FOR THE v. ] SEVENTH CIRCUIT ] AMENDED PFIZER INC., TEVA PHARMACEUTICAL ] DOCKETING STATEMENT INDUSTRIES, LTD., WYETH LLC, GREENSTONE LLC, ] AND JURISDICTIONAL PHARMACIA LLC, WYETH PHARMACEUTICALS INC., ] MEMORANDUM ESI LEDERLE, DURAMED PHARMACEUTICALS, INC., ] Case No. 13-cv-497-jdp PHARMACIA AND UPJOHN LLC, ] PHARMACIA AND UPJOHN COMPANY LLC, ] TEVA PHARMACEUTICALS USA. INC., ] BARR PHARMACEUTICALS, LLC and ] BARR LABORATORIES, INC., ] ] Defendants. ] AMENDED DOCKETING STATEMENT 1. Trial Court: U.S. District Court Western District of Wisconsin (Madison) Case #: 3:13-cv-00497-jdp 2. Trial Court Judge: Hon. James D. Peterson, presiding 3. Lead Counsel for Plaintiff Party: Appellant Kathleen A. Wagner Wagner Law Offices, S. C. 4513 Vernon Blvd. Suite 10 Madison, WI 53705-4964 608-256-6000 Fax: 608-238-1500 Email: attorney@execpc.com 1 4. Lead Counsel for Defendant: Teva Pharmaceuticals USA, Inc. Party: Appelle Matthew Victor Brammer 600 Vine St. Suite 2800 Cincinnati, OH 45202 513-698-5024 Fax: 513-698-5025 Email: mbrammer@ulmer.com Bruce A. Schultz Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 608-255-8592 Email: bschult@cnsbb.com Vincent J. Scipior Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 605-255-8592 Email: vscipior@cnsbb.com 5. Lead Counsel for Defendant: Barr Laboratories, Inc. Party: Appelle Gina Marie Saelinger Ulmer & Berne LLP 600 Vine Street Suite 2800 Cincinnati, OH 45202 513-698-5114 Fax: 513-698-5115 Email: gsaelinger@ulmer.com Matthew Victor Brammer Ulmer & Berne LLP 600 Vine St. Suite 2800 Cincinnati, OH 45202 2 513-698-5024 Fax: 513-698-5025 Email: mbrammer@ulmer.com Bruce A. Schultz Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 608-255-8592 Email: bschult@cnsbb.com Vincent J. Scipior Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 605-255-8592 Email: vscipior@cnsbb.com 6. Lead Counsel for Defendant: Barr Pharmaceuticals, LLC Formerly known as Barr Pharmaceuticals, Inc. Party: Appelle Gina Marie Saelinger Ulmer & Berne LLP 600 Vine Street Suite 2800 Cincinnati, OH 45202 513-698-5114 Fax: 513-698-5115 Email: gsaelinger@ulmer.com Matthew Victor Brammer Ulmer & Berne LLP 600 Vine St. Suite 2800 Cincinnati, OH 45202 513-698-5024 Fax: 513-698-5025 Email: mbrammer@ulmer.com 3 Bruce A. Schultz Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 608-255-8592 Email: bschult@cnsbb.com Vincent J. Scipior Coyne, Schultz, Becker & Bauer, S.C. 150 E. Gilman St., Suite 1000 Madison, WI 53703 608-255-1388 Fax: 605-255-8592 Email: vscipior@cnsbb.com 7. Date Notice of Appeal Filed: June 13,2015 8. File Date of Judgment in a Civil Case: June 2, 2015. 9. Date docket record shows notice of final order mailed by clerk: June 2, 2015 10. Appeal Involves: Judgment on Pleadings 11. Is Transcript of Proceedings to be filed? N/A. 12. Oral Argument Requested: Yes. 13. Nature of Case: General Civil Appeal of Products Liability/Personal Injury (365); 14. Other Activity: Stay request being filed with this court? No. Have the parties to this appeal been parties to a previous appeal? No. Do you know of another case(s) pending before this court or recently decided by this Court which raise the same issue? No, not in the Seventh Circuit Court of Appeals but multiple other U.S. Courts of Appeal, the California Supreme Court, cert. denied. U.S. Supreme Court (Jan., 2015) and other state Supreme Courts. 15. Summary Probable Issues for Review: a. Is a generic drug Defendant entitled to preemption if said Defendant didn’t have an identical warning label as the brand name drug and the failure to include the language was an approximate cause of Plaintiff’s injuries? i.e. Bold Black Box warning upfront, including a reference to the Women’s Health Initiative Study (WHI) findings, cancer concerns and long-term usage. 4 b. Does the failure to comply with the Food and Drug Administration Amendments Act of 2007 121 Stat. 823 for claims arising after said Act disqualify the generic Defendants from preemption because there is no longer “impossibility” between federal and state law? [In PLIVA, Inc. v. s 131 S. Ct. 2567 (2011 all claims were prior to the Act of 2007 Amendments)? Also see Fulgenzi v. PLIVA, Inc. 711 F.3d 575 (6th Cir. 2013). c. Are generic Defendants negligent or negligent pro se when they fail to provide a label identical to the brand drugs as mandated by the Drug Price Competition and Patent Term restoration Act of 1984 also known as the 1984 Hatch-Waxman Amendments 21 U.S.C. §355(j) (2)(A)(v) or fail to communicate the already strengthened warnings of a Reference Listed Drug (RLD)? See. Fisher v. Pelstring 2011 U.S. Dist 116162 (DSC 2011). Lyman v. Pfizer, Inc. 2012 WL 2970627 (D. Vermont, 2012). d. Does failure to comply with the Food and Drug Administration Amendments Act of 2007 standards render the drug misbranded per se under 21 U.S.C. §331(a) and do the changes in the Act of 2007 21 U.S.C. §355(o)(4) and 21. U.S.C. §255 (1)-(3) now shift the burden to a generic defendant to show that the FDA would not have approved a label change (the standard set forth in Wyeth v. Levine, 555 U.S. 555 (2009) post the Amendments? (See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) footnote 4.) e. Is a state by state analysis of a state’s defective design liability and negligence requirements necessary to determine whether a generic defendant is preempted per Restatement (second) of Torts § 402A as Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) did with New Hampshire’s law? And if so, would Wisconsin’s design defect laws that requires a showing of the existence of an alternative safe product defeat a generic defendant’s preemption? f. Does Wisconsin’s design defect legislation that requires a showing of the existence of an alternate safe product meet a negligent design defect claim when a generic defendant sells and markets a drug it knew was unreasonably dangerous or defective when it left the manufacturer’s hand’s and was expected to reach the consumer without change? See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) g. Does the modification of a natural molecule (human or plant progesterone) which contains an additional segment (synthetic progestin), in order to obtain a patent, that causes unintended consequences-- that is, a change to the natural molecular structure has the effect of blocking the apoptosis of breast cells and results in being the proximate cause of breast cancer, preclude a generic defendant’s preemption with respect to Restatement (second) of Torts § 402A because the drug is unreasonably dangerous to a group of individuals? 5 16. Does the appeal turn on an interpretation or application of a particular case(s) or statute(s)? Yes. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013); Huck v. Wyeth, Inc., 850 N.W.2d 353, 364 (Iowa 2014) Fulgenzi v. PLIVA, Inc. 711 F.3d 575 (6th Cir. 2013); In Re: Reglan Litigation, No. A2014-13T4, (N.J. Super., App. Div.); Lyman v. Pfizer, Inc. 2012 WL 2970627 (Vermont, 2012); Fisher v. Pelstring 2011 U.S. Dist 116162 (DSC 2011). Dow Pharmaceuticals, Inc. v. Thompson, et al, 478 .S. 804 (1986). Hassett v. Teva et al, 2013 Pa Super 214 (2011); 217 Cal. App. 4th 96 (2013), review denied (Sept. 25, 2013), cert. denied sub nom. Teva Pharm. USA, Inc. v. Superior Court of Cal., Orange Cnty., 2015 WL 231967, cert. denied, (U.S.Supreme Court, Jan. 20, 2015). Huck v. Wyeth, Inc., 850 N.W.2d 353, 364 (Iowa 2014) cert. denied (U.S. Supreme Court, March 30, 2015) CERTIFICATION I certify that the information provided on this docketing statement is accurate Dated: June 14, 2015 at Madison, Wisconsin /s/Kathleen A. Wagner Signature of counsel for Plaintiff/Appellant 6 AMENDED JURISDICTIONAL MEMORANDUM A. JURISDICTION OF THE DISTRICT COURT The district court had jurisdiction as a civil action arising under the laws of the United States pursuant to a removal action under 28 U.S.C. §1441 because this action could have originally been filed under 28 U.S.C. §1332. Specifically, the district court had subject matter jurisdiction because there was the requisite diversity of citizenship between plaintiff and each of the defendants and the amount in controversy exceeded $75,000, exclusive of interest and costs. B. JURISDICTION OF THE COURT OF APPEALS This appeal is taken from the final decision of the U.S. District Court for the Western District of Wisconsin entered on June 2, 2015 by the Honorable James D. Peterson. The United States Court of Appeals has jurisdiction to decide this case pursuant to 28 U.S.C. §1291. The Notice of Appeal was filed with the District Court on June 13, 2015. Dated at Madison, Wisconsin, this 13th day of 2015. /s/ Kathleen A. Wagner, Esq. Wagner Law Offices, S. C. Attorney for Plaintiff 4513 Vernon Blvd. Suite 10 Madison, WI 53705-4964 (608)256-6000 Fax: (608)238-1500 Email: attorney@execpc.com 7

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