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)
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
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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.
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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?
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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
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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
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