Wheeler v. Johnson & Johnson et al
CONDITIONAL REMAND ORDER remanding case back to District Court. Signed by Jeffery N. Luthi, Clerk of the Panel on 2/14/17. (Attachments: # 1 Exhibit Order and Suggestion of Remand) (rel)
Case MDL No. 2327 Document 2664-1 Filed 02/14/17 Page 1 of 5
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
PAMELA GRAY-WHEELER, et al.,
CIVIL ACTION NO. 2:12-00455
JOHNSON & JOHNSON, et al.,
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
All pretrial proceedings, including discovery and dispositive and Daubert 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; (3) the docket sheet for MDL 2327, 2:12md-2327; (4) all Pretrial Orders (“PTO”) entered in 2:12-md-2327; and (5) any other filing from
2:12-md-2327 which the parties jointly designate. It is ORDERED that within seven (7) days of
Case MDL No. 2327 Document 2664-1 Filed 02/14/17 Page 2 of 5
the MDL Panel’s transmittal of the remand order to this court, 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: February 1, 2017
Case MDL No. 2327 Document 2664-1 Filed 02/14/17 Page 3 of 5
SUGGESTION OF REMAND MEMORANDUM
February 1, 2017
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 –
Pamela Gray-Wheeler, et al. v. Johnson & Johnson, et al., No. 2:12-00455
Status of this case.
This case has been transferred to the transferor court, the United States District Court for
the Northern District of Mississippi, 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. 122, 123, 124,
125, 127, 128, 129, 132, 134], summary judgment rulings [ECF No. 131], and rulings on motions
in limine [ECF No. 130].
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 61,000 cases filed in the seven MDLs assigned to me,
approximately 32,000 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
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.
Case MDL No. 2327 Document 2664-1 Filed 02/14/17 Page 4 of 5
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 nine cases that were transferred from
Mississippi, and there are likely many more direct filed in the Southern District of West Virginia
with proper venue in Mississippi. 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.
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
Case MDL No. 2327 Document 2664-1 Filed 02/14/17 Page 5 of 5
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
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 email@example.com. Also, you may contact the
Clerk’s Office at 304-347-3000 for further assistance.
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