IN RE ETHICON, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION

MDL No. 2327.

IN RE: ETHICON, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION

United States Judicial Panel on Multidistrict Litigation.


CONDITIONAL REMAND ORDER

The transferee court in this litigation has advised the Panel that coordinated or consolidated pretrial proceedings in the action(s) on this conditional remand order have been completed and that remand to the transferor court(s), as provided in 28 U.S.C. § 1407(a), is appropriate. IT IS THEREFORE ORDERED that the action(s) on this conditional remand order be remanded to its/their respective transferor court(s).

IT IS ALSO ORDERED that, pursuant to Rule 10.2 of the Rules of Procedure of the United States Judicial Panel on Multidistrict Litigation, the transmittal of this order to the transferee clerk for filing shall be stayed 7 days from the date of this order. If any party files a notice of opposition with the Clerk of the Panel within this 7-day period, the stay will be continued until further order of the Panel. This order does not become effective until it is filed in the office of the Clerk for the United States District Court for the Southern District of West Virginia.

IT IS FURTHER ORDERED that, pursuant to Rule 10.4(a), the parties shall furnish the Clerk for the Southern District of West Virginia with a stipulation or designation of the contents of the record to be remanded.

SCHEDULE FOR CRO

TRANSFEREE TRANSFEROR DIST DIV. C.A.NO. DIST DIV. C.A.NO. CASE CAPTION WVS 2 12-00443 CAN 5 11-06584 Jones et al v. Ethicon, Inc. et al WVS 2 12-00498 MN 0 12-00070 Johnson v. Ethicon, Inc. et al WVS 2 12-00956 NCW 1 12-00057 Justus v. Ethicon, Inc. et al WVS 2 12-00957 NCW 3 12-00184 Funderburke v. Ethicon, Inc. et al IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION JOYCE JUSTUS, Plaintiff, v. CIVIL ACTION NO. 2:12-cv-00956 ETHICON INC., et al., Defendants.

ORDER AND SUGGESTION OF REMAND

Pursuant to 28 U.S.C. § 1407 and the Rules for Multidistrict Litigation promulgated thereunder, specifically Rule 10.1(b), the court suggests that this action be remanded to the United States District Court for the Western District of North Carolina.

All pretrial proceedings, including discovery and dispositive, Daubert and in limine motion practice, are complete, and the case is ready for trial. I have attached a Suggestion of Remand Memorandum for the transferor court's reference.

Upon receipt of an order to remand from the Clerk of the Judicial Panel on Multidistrict Litigation ("MDL Panel") and any joint designation of the MDL 2327 record by counsel, the Clerk of this court is directed to transmit the following to the transferor court: (1) a copy of the member case docket sheet; (2) the entire file for the member case; (2) the docket sheet for MDL 2327, 2:12-md-2327; (3) all Pretrial Orders ("PTO") entered in 2:12-md-2327; and (4) any other filing from 2:12-md-2327 which the parties jointly designate. It is ORDERED that within seven (7) days of the MDL Panel's remand order, the parties shall file a joint designation of any non-PTO filings from 2:12-md-2327.

The court DIRECTS the Clerk to send a copy of this Order and Suggestion of Remand to the Clerk of the MDL Panel, counsel of record and any unrepresented party.

ENTER: December 21, 2016 __________________________ JOSEPH R. GOODWIN UNITED STATES DISTRICT JUDGE

SUGGESTION OF REMAND MEMORANDUM

December 21, 2016

TO: Transferor Judge FROM: Judge Joseph R. Goodwin, Presiding Judicial Officer, Ethicon MDL, MD 2327 RE: Ethicon MDL Pelvic Mesh Case(s) transferred to your court- Joyce Justus v. Ethicon, Inc., et al., No. 2:12-cv-00956

I. Status of this case.

This case has been remanded to the transferor court, the United States District Court for the Western District of North Carolina, from MDL 2327 in the Southern District of West Virginia.

All pretrial proceedings, including discovery and dispositive and Daubert motion practice, are complete, and the case is ready for trial. In fact, I respectfully and strongly urge the transferor court to set this case for trial as soon as possible. While the parties may insist that further discovery or motion practice is necessary, I assure you that it is not. If the transferor court will set a firm date and not allow further delay, it will aid my efforts in this MDL. In addition, I urge the transferor court to limit the number of trial days for this trial. I limited trial in these cases to six to nine days, and this has proven more than adequate.

I refer the transferor court to my Daubert rulings in this case [ECF Nos. 157, 158, 159, 160, 161, 164, 165, 166,170, 171, 172], summary judgment rulings [ECF No. 169], and rulings on motions in limine [ECF Nos. 167, 168].

II. History of MDL 2327 and other MDLs assigned to me.

I have been assigned seven MDLs by the Judicial Panel on Multidistrict Litigation (the "MDL Panel"), including MDL 2327, In re Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation. In total, there are over 58,000 cases filed in the seven MDLs assigned to me, 28,000 of which reside in the Ethicon MDL. These cases allege injury related to the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and/or stress urinary incontinence ("SUI").

I originally tried two of five bellwether cases. Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-cv-4301 and Jo Huskey, et al. v. Ethicon, Inc., et al., No. 2:12-cv-05201. In Lewis,

I entered judgment as a matter of law pursuant to Rule 50(a) of the Federal Rules of Civil Procedure, plaintiffs appealed, and the United States Court of Appeals for the Fourth Circuit affirmed the decision. In Huskey, the jury returned a verdict in favor of plaintiffs in the amount of $3,270,000. Defendants appealed, and the appeal is pending before the Fourth Circuit. The other three bellwethers settled or were dismissed by the parties prior to trial. Tonya Edwards, et al. v. Ethicon, Inc., et al., No. 2:12-09972; Dianne M. Bellew v. Ethicon, Inc., et al., No. 2:13-cv-22473; Brenda Lehrer v. Ethicon, Inc., et al., No. 2:12-08157.

In addition to trying bellwethers, I entered orders setting hundreds of additional cases (involving plaintiffs from several districts across the United States) on an expedited track for individual discovery and motion practice so that those cases, known as Ethicon Waves 1, 2, 3 and 4, could be remanded or transferred if no success is had in settlement. The instant case is one of those cases from Ethicon Wave 1. Incipient settlements exist and discussions are ongoing in many more cases. While I have been extremely patient in this process and continue to encourage those settlement discussions, I find it necessary to begin the process of remanding. In addition to the cases in Waves 1 through 4, thousands of additional cases will be identified, worked up and remanded or transferred. I note that there are approximately three cases that were transferred from North Carolina, and there are likely hundreds more direct filed in the Southern District of West Virginia with proper venue in North Carolina. These cases also will be worked up and remanded in the near future absent settlement. Finally, I have scheduled a trial involving approximately 30 plaintiffs from West Virginia in March, 2017.

III. Noteworthy Ruling regarding the FDA 510(k) process.

I have consistently and repeatedly ruled in all cases in this MDL and the other MDLs assigned to me that plaintiffs' claims are not preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA"). The Medical Device Amendments ("MDA") to the FDCA contain an express preemption provision. The provision provides that, with respect to medical devices, state law may not impose any requirement "which is different from, or in addition to" the requirements of the FDCA, or any requirement "which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the FDCA]." 21 U.S.C. § 360k(a). The products involved in this MDL received clearance under the FDCA's 510(k) process, which, as the Supreme Court held, focuses on "equivalence, not safety." Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996). Thus, as explained in Lohr, the FDCA's preemption provision does not apply to state law product liability claims regarding medical devices that underwent 510(k) clearance rather than the premarket approval process. In addition, I further concluded that the modest probative value of such evidence is substantially outweighed by the risk of unfair prejudice, specifically, the risk of confusing and misleading the jury. See, e.g., Cisson v. C. R. Bard, Inc., 86 F.Supp.3d 510, 517 (S.D. W. Va. 2015), available at 2015 WL 566959; Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 754 (S.D. W. Va. 2014); Sanchez v. Boston Scientific Corp. (Sanchez I), No. 2:12-cv-05762, 2014 WL 4059214, at *15 (S.D. W. Va. Aug. 18, 2014).

The Fourth Circuit recently affirmed this court's determination that the probative value of evidence related to 510(k) clearance is substantially outweighed by its possible prejudicial impact and was properly excluded under Rule 403. In re C. R. Bard, 810 F.3d 913, 922 (4th Cir. 2016) (crediting the district court's concern that "subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety. In other words, having a `mini-trial' could easily inflate the perceived importance of compliance and distract the jury from the central question before it").

IV. Resources available for transferor courts on the MDL 2327 website.

There is extensive information available on the court's website at www.wvsd.uscourts.gov related to the Ethicon MDL. Specifically, all Pretrial Orders in MDL 2327 can be found at http://www.wvsd.uscourts.gov/MDL/ethicon/orders.html.

V. Contact information for the MDL 2327 court.

Our court is ready, willing and able to assist you with any matters relating to this case or any substantive or procedural issues that may arise. Please do not hesitate to contact me or my law clerk, Kate Fife at 304-347-3199 or kate_fife@wvsd.uscourts.gov. Also, you may contact the Clerk's Office at 304-347-3000 for further assistance.

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION

IN RE: ETHICON, INC. PELVIC Master File No. 2:12-MD-02327 REPAIR SYSTEM PRODUCTS MDL No. 2327 LIABILITY LITIGATION __________________________________ THIS DOCUMENT RELATES TO: JOSEPH R. GOODWIN U.S. DISTRICT JUDGE Joyce Justus v. Ethicon, Inc., et al. Case No. 2:12-cv-00956

JOINT DESIGNATION OF NON-PTO FILINGS

Ethicon, Inc. and Johnson & Johnson (collectively, "Ethicon") and Plaintiff Joyce Justus ("Plaintiff"), by and through their respective counsel, pursuant to this Court's December 21, 2016 Order [ECF No. 173], hereby jointly designate the following non-Pretrial Order filings from MDL No. 2327, 2:12-md-2327, to transmit and remand to the United States District Court for the Western District of North Carolina:

Date Filed ECF No. Docket Entry MOTION by All Plaintiffs Define Permissible Scope of Wave 1 Defense Medical Exams 2/17/2016 1879 18797-1 Correspondence 1879-2 Committee Opinion REPLY by All Plaintiffs to [1912] EMERGENCY MOTION by Wave 1 Plaintiffs to Reconsider the Scope of Wave 1 Defense Medical Exams 3/11/2016 1922 1922-1 Exhibit 1 1922-2 Exhibit 2 1922-3 Exhibit 3 1922-5 Exhibit 4 1922-5 Exhibit 5 MOTION by Ethicon, Inc., Johnson & Johnson to Exceed Page Limitation for Defendants' Memoranda of Law 4/13/2016 1965 supporting their forthcoming motions to exclude the general expert opinions of Dr. Jerry Blaivas, Dr. Daniel Elliott, Dr. Suzanne Parisian, and Anne Wilson in Wave 1 Cases ORDER granting MOTION by Ethicon, Inc., Johnson & Johnson to Exceed Page Limitation for Defendants' memoranda of law supporting their forthcoming motions to 4/15/2016 1966 exclude the general expert opinions of Dr. Jerry Blaivas, Dr. Daniel Elliott, Dr. Suzanne Parisian, and Anne Wilson in Wave 1 Cases MOTION by Ethicon, Inc., Johnson & Johnson to Exceed Page Limitation for Defendants' Memoranda of Law in 4/19/2016 1975 Support of Motion to Exclude the General Expert Opinions of Dr. Vladimir Iakovlev in Wave 1 Cases ORDER granting MOTION by Ethicon, Inc., Johnson & Johnson to Exceed Page Limitation for Defendants' 4/20/2016 1976 Memoranda of Law in Support of Motion to Exclude the General Expert Opinions of Dr. Vladimir Iakovlev in Wave 1 Cases MOTION by Ethicon, Inc., Johnson & Johnson To Limit the 4/20/2016 1978 Testimony of Prof. Dr. Med. Uwe Klinge in Wave 1 Cases MEMORANDUM by Ethicon, Inc., Johnson & Johnson in support MOTION by Ethicon, Inc., Johnson & Johnson To 4/20/2016 1982 Limit the Testimony of Prof. Dr. Med. Uwe Klinge in Wave 1 Cases MOTION by Certain Wave 1 Plaintiffs to Exclude the 4/20/2016 1979 Opinions and Testimony of Thomas C. Wright, Jr., M.D. MEMORANDUM OF LAW by Certain Wave 1 Plaintiffs in 4/20/2016 1980 support of MOTION by Certain Wave 1 Plaintiffs to Exclude the Opinions and Testimony of Thomas C. Wright, Jr., M.D. AMENDED MOTION by Certain Plaintiffs in Wave 1 Cases 4/20/2016 1986 to Exclude the Opinions and Testimony of Thomas C. Wright, Jr., M.D. AMENDED MEMORANDUM OF LAW by Certain Plaintiffs in Wave 1 cases in support of AMENDED MOTION by 4/20/2016 1988 Certain Plaintiffs in Wave 1 Cases to Exclude the Opinions and Testimony of Thomas C. Wright, Jr., M.D. MOTION by Certain Plaintiffs in Wave 1 Cases to Exclude the 4/21/2016 2039 Opinions and Testimony of Shelby Thames MEMORANDUM by Certain Plaintiffs in Wave 1 Cases in 4/21/2016 2042 support of [2039] MOTION by Certain Plaintiffs in Wave 1 Cases to Exclude the Opinions and Testimony of Shelby Thames DAUBERT MOTION by Certain Plaintiffs in Wave 1 Cases to 4/21/2016 2005 Preclude or, in the Alternative, to Limit the Opinions and Testimony of Elizabeth Kavaler, M.D. MEMORANDUM OF LAW by Certain Plaintiffs in Wave 1 Cases in support of DAUBERT MOTION by Certain Plaintiffs 4/21/2016 2007 in Wave 1 Cases to Preclude or, in the Alternative, to Limit the Opinions and Testimony of Elizabeth Kavaler, M.D. MOTION by Ethicon, Inc., Johnson & Johnson to Exclude 4/21/2016 2082 Certain General Opinions of Daniel Elliott, M.D. in Wave 1 Cases MEMORANDUM by Ethicon, Inc., Johnson & Johnson in support of MOTION by Ethicon, Inc., Johnson & Johnson to 4/21/2016 2085 Exclude Certain General Opinions of Daniel Elliott, M.D. in Wave 1 Cases MOTION by Ethicon, Inc., Johnson & Johnson to Exclude the 4/21/2016 2066 Opinions and Testimony of Dr. Vladirmir Iakovlev MEMORANDUM OF LAW by Ethicon, Inc., Johnson & Johnson in support of MOTION by Ethicon, Inc., Johnson & 4/21/2016 2070 Johnson to Exclude the Opinions and Testimony of Dr. Vladirmir Iakovlev DAUBERT MOTION by Certain Plaintiffs in Wave 1 Cases to 4/21/2016 2016 Exclude Certain Opinions and Testimony of Defense Expert Rebecca M. Ryder, M.D. MEMORANDUM OF LAW by Certain Plaintiffs in Wave 1 Cases in support of DAUBERT MOTION by Certain Plaintiffs 4/21/2016 2021 in Wave 1 Cases to Exclude Certain Opinions and Testimony of Defense Expert Rebecca M. Ryder, M.D. DAUBERT MOTION by Certain Plaintiffs in Wave 1 Cases to 4/21/2016 2060 Exclude the Opinions of FDA Expert Timothy Ulatowski MEMORANDUM by All Plaintiffs in support of [2060] 4/21/2016 2065 MOTION by All Plaintiffs to Exclude the Opinions of FDA Expert Timothy Ulatowski RESPONSE by Ethicon, Inc., Johnson & Johnson in opposition to DAUBERT MOTION by Certain Plaintiffs in 5/7/2016 2134 Wave 1 Cases to Exclude the Opinions of FDA Expert Timothy Ulatowski RESPONSE by Ethicon, Inc., Johnson & Johnson in opposition to [2039] MOTION by Certain Plaintiffs in Wave 1 5/9/2016 2187 Cases to Exclude the Opinions and Testimony of Shelby Thames MEMORANDUM OF LAW by Ethicon, Inc., Johnson & Johnson in opposition to DAUBERT MOTION by Certain 5/9/2016 2165 Plaintiffs in Wave 1 Cases to Preclude or, in the Alternative, to Limit the Opinions and Testimony of Elizabeth Kavaler, M.D. MEMORANDUM by Certain Plaintiffs in Wave 1 Cases in opposition to MOTION by Ethicon, Inc., Johnson & Johnson 5/9/2016 2181 to Exclude Certain General Opinions of Daniel Elliott, M.D. in Wave 1 Cases MOTION by Certain Plaintiffs in Wave 1 Cases to Exceed Page Limitation for Response to Defendant Ethicon's Motion 5/9/2016 2146 to Exclude the Opinions and Testimony of Dr. Vladimir Iakovlev, M.D. ORDER granting MOTION by Certain Plaintiffs in Wave 1 Cases to Exceed Page Limitation for Response to Defendant 5/9/2016 2152 Ethicon's Motion to Exclude the Opinions and Testimony of Dr. Vladimir Iakovlev, M.D. RESPONSE by Certain Plaintiffs in Wave 1 Cases in opposition to MOTION by Ethicon, Inc., Johnson & Johnson 5/9/2016 2185 to Exclude the Opinions and Testimony of Dr. Vladirmir Iakovlev RESPONSE by Certain Plaintiffs in Wave 1 Cases in opposition to MOTION by Ethicon, Inc., Johnson & Johnson 5/9/2016 2188 To Limit the Testimony of Prof. Dr. Med. Uwe Klinge in Wave 1 Cases MEMORANDUM by Ethicon, Inc., Johnson & Johnson in opposition to DAUBERT MOTION by Certain Plaintiffs in 5/9/2016 2154 Wave 1 Cases to Exclude Certain Opinions and Testimony of Defense Expert Rebecca M. Ryder, M.D. RESPONSE by Ethicon, Inc., Johnson & Johnson in opposition to AMENDED MOTION by Certain Plaintiffs in 5/9/2016 2143 Wave 1 Cases to Exclude the Opinions and Testimony of Thomas C. Wright, Jr., M.D. AMENDED MEMORANDUM by Certain Plaintiffs in Wave 5/10/2016 2191 1 Cases in opposition to Defendants' Motion to Exclude Certain General Opinions of Daniel Elliott, M.D. REPLY by Ethicon Women's Health and Urology, Johnson & 5/13/2016 2200 Johnson to [2188] Response In Opposition (Klinge) REPLY by Ethicon Women's Health and Urology, Johnson & Johnson to [2082] MOTION by Ethicon, Inc., Johnson & 5/16/2016 2215 Johnson to Exclude Certain General Opinions of Daniel Elliott, M.D. REPLY by All Plaintiffs to [2134] Response In Opposition 5/16/2016 2232 (Ulatowski) REPLY by All Plaintiffs to [2187] Response In Opposition 5/16/2016 2247 (Thames) REPLY by Ethicon Women's Health and Urology, Johnson & 5/16/2016 2251 Johnson to [2185] Response In Opposition (Iakovlev) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/24/2016 2642 re: Prof. Dr. Med. Uwe Klinge) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/25/2016 2653 re: Rebecca M. Ryder, M.D.) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/25/2016 2649 re: Timothy Ulatowski) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/25/2016 2661 re: Thomas C. Wright Jr., M.D.) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/26/2016 2666 re: Daniel Elliott, M.D.) MEMORANDUM OPINION AND ORDER (Daubert Motion 8/31/2016 2704 re: Elizabeth Kavaler, M.D.) MEMORANDUM OPINION AND ORDER (Daubert Motion 9/1/2016 2710 re: Vladimir Iakovlev, M.D.) MEMORANDUM OPINION AND ORDER (Daubert Motion 9/2/2016 2723 re: Shelby Thames, Ph.D.) MOTION by Certain Plaintiffs in Wave 1 Cases to Strike Dr. Shelby Thames' Supplemental Reports or, in the Alternative, 10/6/2016 2880 for Leave to File a Daubert Motion Based on the Flawed Methodology Employed Therein RESPONSE by Ethicon, Inc., Johnson & Johnson in opposition to [2880] MOTION by Certain Plaintiffs in Wave 1 10/20/2016 3018 Cases to Strike Dr. Shelby Thames' Supplemental Reports or, in the Alternative, for Leave to File a Daubert Motion Based on the Flawed Methodology Employed Therein Submitted: January 4, 2017 /s/ Susan M. Robinson /s/ Kimberly Wilson White Susan M. Robinson (WVSB # 5169) Kimberly Wilson White Thomas Combs & Spann, PLLC NC Bar No. 30044 300 Summers Street, Suite 1380 Wilson Law, P.A. P.O. Box 3824 P.O. Box 10389 Charleston, WV 25338-3824 Raleigh, NC 27605 (304) 414-1800 (919) 890-0180 srobinson@tcspllc.com (919) 882-1758 facsimile Email: kim@wilsonlawpa.com Christy D. Jones Counsel for Plaintiff Joyce Justus Butler Snow LLP 1020 Highland Colony Parkway Suite 1400 (39157) P.O. Box 6010 Ridgeland, MS 39158-6010 (601) 985-4523 Christy.jones@butlersnow.com Attorneys for Defendants Ethicon, Inc. and Johnson & Johnson


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