Burke et al v. Johnson & Johnson et al

Filing 4

CONDITIONAL REMAND ORDER from USDC for the District of Minnesota (MDL No. 1943). The parties shall furnish the Clerk for the District of Minnesota with a stipulation or designation of the contents of the record to be remanded. Signed by Jeffery N. Luthi, Clerk of the Panel on November 21, 2014. (mll)

Case ARW/4:09-cv-04124 Document 4 Filed 11/21/14 Page 1 of 3

UNITED STATES JUDICIAL PANEL
on
MULTIDISTRICT LITIGATION

IN RE: LEVAQUIN PRODUCTS LIABILITY
LITIGATION

MDL No. 1943

(SEE ATTACHED SCHEDULE)

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

FOR THE PANEL:

Nov 21, 2014
Jeffery N. Lüthi
Clerk of the Panel

Case ARW/4:09-cv-04124 Document 4 Filed 11/21/14 Page 2 of 3

IN RE: LEVAQUIN PRODUCTS LIABILITY
LITIGATION

MDL No. 1943

SCHEDULE FOR CRO
TRANSFEREE
DIST DIV. C.A.NO.
MN 0 11−03719
MN 0 09−03642

TRANSFEROR
DIST DIV. C.A.NO.
ALN 7 11−04095
ARW 4 09−04124

MN

0

12−02735

AZ

2

12−02005

MN

0

09−02218

CAC

2

09−04897

MN

0

10−01906

CAC

2

10−01929

MN

0

11−01181

CAC

2

11−03333

MN

0

11−02085

CAC

2

11−05761

MN

0

12−00043

CAC

2

11−10498

MN

0

12−02736

CAC

2

12−08344

MN

0

12−02737

CAC

2

12−08352

MN

0

12−02738

CAC

8

12−01646

MN

0

12−02739

CAC

8

12−01657

MN
MN
MN
MN
MN
MN
MN

0
0
0
0
0
0
0

10−01915
10−03815
11−02937
11−03455
11−02997
12−01159
13−00148

CO
CO
CO
CO
CT
CT
CT

1
1
1
1
3
3
3

10−00315
10−00893
11−01703
11−02525
11−01476
12−00642
12−01268

MN

0

13−00564

FLN

1

13−00028

MN
MN
MN
MN
MN
MN

0
0
0
0
0
0

10−00471
10−03903
10−03051
11−03339
11−03065
13−01489

FLN
FLN
GAN
ILN
INN
KS

4
4
1
1
3
5

09−00463
10−00308
10−01415
11−07305
11−00313
13−04060

MN

0

11−02731

MA

3

11−30221

CASE CAPTION
Ellinghausen et al v. Johnson & Johnson et al
Burke et al v. Johnson & Johnson et al
Teague v. Ortho−McNeil−Janssen
Pharmaceuticals Incorporated et al
Lee Trask et al v. Johnson & Johnson et al
Mark Semos et al v. Ortho−McNeil Janssen
Pharmaceuticals, Inc. et al
Victor Person v. Ortho−McNeil Janssen
Pharmaceuticals, Inc. et al
Kristin Nicholas v. Janssen Pharmaceuticals
Inc et al
Arthur Dement v. Janssen Pharmaceuticals Inc
et al
Ruttenberg v. Ortho−McNeil Janssen
Pharmaceuticals, Inc et al
Handley v. Ortho−McNeil Janssen
Pharmaceuticals Inc et al
LLorente v. Ortho−McNeil Janssen
Pharmaceuticals Inc et al
West v. Ortho−McNeil Janssen
Pharmaceuticals Inc et al
Schriner v. Johnson & Johnson et al
Hedrick v. Johnson & Johnson et al
Urynowicz v. Johnson & Johnson et al
McCullough v. Johnson & Johnson et al
Greenfield v. Pricara et al
Lindsay et al v. Pricara et al
Wickerd v. Johnson & Johnson et al
Fagler et al v Johnson & Johnson
Pharmaceutical Research & Development,
LLC et al
Thaxton v Johnson & Johnson et al
Hurst v. Johnson & Johnson et al
Bailey v. Johnson & Johnson et al
Majetic v. Johnson & Johnson, et al.,
Hostetler et al v. Johnson & Johnson et al
Smith v. Johnson & Johnson et al
Campora v. Ortho−McNeil−Janssen
Pharmaceuticals, Inc.

Case ARW/4:09-cv-04124 Document 4 Filed 11/21/14 Page 3 of 3
MN
MN
MN
MN
MN
MN
MN

0
0
0
0
0
0
0

09−03643
09−03644
10−00475
10−03818
11−02179
11−02180
11−02181

MOE
MSN
MSS
MSS
MSS
MSS
MSS

4
4
3
3
3
3
3

09−01639
09−00104
10−00031
10−00385
11−00443
11−00444
11−00445

MN

0

10−04878

MT

2

10−00061

MN
MN
MN
MN
MN

0
0
0
0
0

10−04697
10−03909
10−03910
12−02276
10−04698

NE
NJ
NJ
NM
NV

4
3
3
2
2

10−03204
10−03514
10−03515
12−00785
10−01796

MN

0

09−03091

NYE

1

09−03075

MN

0

12−02740

NYE

1

12−04755

MN
MN

0
0

11−01715
11−02286

NYE
NYE

2
2

11−02236
11−03551

MN

0

12−02652

NYE

2

12−04752

MN

0

12−02653

NYE

2

12−04753

MN

0

12−02654

NYE

2

12−04754

MN

0

09−02887

NYS

1

09−07753

MN
MN
MN
MN
MN
MN

0
0
0
0
0
0

12−02741
10−00993
11−01644
10−04559
10−03821
10−00995

NYS
OKE
OKW
SC
TXE
TXE

1
6
5
8
1
4

12−07320
10−00051
11−00668
10−02650
10−00200
09−00564

MN

0

10−04043

TXN

3

10−01543

MN

0

08−04698

WAW

2

07−01876

Bennett v. Johnson & Johnson et al
Litton v. Johnson & Johnson et al
Johnston et al v. Johnson & Johnson et al
Gibson v. Johnson & Johnson et al
Sandifer v. Johnson & Johnson et al
Stanley et al v. Johnson & Johnson et al
Sandifer v. Johnson & Johnson et al
Larson et al v. Ortho−McNeil Pharmaceutical,
Inc.
Marlar v. Johnson & Johnson et al
Sussman et al v Johnson & Johnson et al
Randle v Johnson & Johnson et al
Dewey v. Johnson and Johnson, et al
Fredrich v. Johnson & Johnson et al
Sylvester v. Ortho−McNeil Pharmaceutical,
Inc. et al
Watsky v. Ortho−McNeil Janssen
Pharmaceutical, Inc. et al
Bouse et al v. Johnson & Johnson et al
Bouse et al v. Johnson & Johnson et al
Meyer v. Ortho−McNeil Janssen
Pharmaceuticals, Inc. et al
Frenger v. Ortho−McNeil Janssen
Pharmaceutical, Inc. et al
Edwards v. Ortho−McNeil Janssen
Pharmaceuticals, Inc. et al
Rosenberg v. Ortho−McNeil Janssen
Pharmaceuticals, Inc. et al
Semos et al v. Johnson & Johnson
Lankford v. Johnson & Johnson et al
Mills v. Johnson & Johnson Services Inc et al
Jackson v. Johnson & Johnson Inc et al
Presley v. Johnson & Johnson et al
Ramsey v. Johnson & Johnson et al
Kamp v. Ortho−McNeil−Janssen
Pharmaceutical, Inc. et al
Hammond v. Ortho−McNeil Pharmaceutical
Inc

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 1 of 32

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
IN RE: LEVAQUIN PRODUCTS
LIABILITY LITIGATION,
Case No.: MDL 08-1943 (JRT)
This document relates to:
ALL ACTIONS
FINAL PRETRIAL ORDER AND
SUGGESTION OF REMAND

Levofloxacin is a broad-spectrum anti-infective prescription medication sold under
the name Levaquin® in the United States. Levaquin is a member of a class of antiinfectives known as fluoroquinolones.

It was approved by the Food and Drug

Administration (“FDA”) at the end of 1996 and has been indicated for the treatment of a
variety of bacterial infections.
Beginning in late 2006, certain patients who had been prescribed Levaquin began
filing lawsuits against Ortho-McNeil-Janssen Pharmaceuticals, Inc. (“OMJPI” or
“Defendants”), 1 a wholly-owned subsidiary of Johnson & Johnson, that marketed
Levaquin pursuant to a licensing agreement between Daiichi Pharmaceutical Co., Ltd. of
Japan and Johnson & Johnson. The Plaintiffs primarily alleged that they were injured
after taking Levaquin and that Defendants failed to adequately warn physicians of the
risk of tendon disorders associated with Levaquin.
1

Levaquin was marketed by Ortho-McNeil Pharmaceuticals, Inc. (“OMP”) until
December 31, 2007, when the assets of OMP were transferred to OMJPI. Effective January 22,
2011, OMJPI changed its name to Janssen Pharmaceuticals, Inc. (“Janssen”).

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 2 of 32

In June 2008, the Judicial Panel on Multidistrict Litigation (“JPML”) transferred
fifteen actions, involving alleged tendon injuries resulting from the use of Levaquin, to
this Court for consolidated and coordinated pretrial proceedings. See In re Levaquin
Prods. Liability Litg., 560 F. Supp. 2d 1384 (J.P.M.L. 2008). The JPML found that the
actions “involve common questions of fact,” and that centralization in the District of
Minnesota “will serve the convenience of the parties and witnesses and promote the just
and efficient conduct of this litigation.” Id. at 1385.
Pursuant to Rule 7.6 of the Rules of Procedure of the Judicial Panel on
Multidistrict Litigation, and upon review of the files in the cases now pending in MDL
1943, the Court suggests to the JPML that the cases listed in Exhibit A are ready for
remand to their appropriate transferor jurisdictions. The Court finds that these cases will
no longer benefit from centralized proceedings; all common discovery and other
coordinated pretrial proceedings are complete, and the remaining case-specific issues are
best left to the transferor courts to decide. In addition, the Court enters this Final Pretrial
Order to summarize the coordinated proceedings thus far and to provide guidance to
transferor courts after remand.
BACKGROUND
A.

Defendants

Defendants named in the lawsuits filed in the District of Minnesota or transferred
to the MDL include: Johnson & Johnson, OMP, OMPJPI, Johnson & Johnson
Pharmaceutical Research & Development, LLC (“PRD”), and Janssen.
B.

Representative Counsel

2

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 3 of 32

By agreement, Plaintiffs proposed, and the Court approved, co-lead counsel:
Ronald S. Goldser, Zimmerman Reed, PLLP, Minneapolis, Minnesota and Lewis J. Saul,
Lewis Saul & Associates, Portland, Maine. Defendants were initially represented by lead
counsel William Robinson, LeClair Ryan, Alexandria, Virginia and John Dames,
Drinker, Biddle & Reath, Chicago, Illinois. Thereafter Defendants have been represented
by James B. Irwin, Irwin, Fritchie, Urquhart & Moore, LLC, New Orleans, Louisiana and
Tracy J. Van Steenburgh, Nilan Johnson Lewis PA, Minneapolis, Minnesota. In addition,
each side has been represented by a court-appointed liaison counsel: for Plaintiffs,
Ronald S. Goldser and for Defendants, Tracy J. Van Steenburgh.

The duties and

responsibilities of lead and liaison counsel are delineated in Amended Pretrial Order 1
Procedural Issues. (Docket No. 977.) 2 A Second Amended Pretrial Order 1 was issued
on February 23, 2011, to reflect the substitution of James Irwin, Irwin Fritchie Urquhart
& Moore LLC, as co-lead counsel for Defendants in place of William Robinson. (Docket
No. 2632.) A Third Amended Pretrial Order 2 was issued on May 7, 2014, to reflect the
substitution of Genevieve Zimmerman, Zimmerman Reed PLLP, as co-lead and liaison
counsel for Plaintiffs in place of Ronald S. Goldser. (Docket No. 6622.) Finally, a
Fourth Amended Pretrial Order 1 was issued on September 10, 2014, to reflect the
substitution of Charles S. Zimmerman, Zimmerman Reed PLLP, as co-lead and liaison
counsel for Plaintiffs in place of Genevieve M. Zimmerman.
C.

Plaintiffs’ Steering Committee

2

Unless otherwise noted Docket Numbers refer to docket entries in the main MDL case.
Case Number 08-1943.
3

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 4 of 32

Plaintiffs proposed and the Court agreed to the appointment of a Plaintiffs’
Steering Committee (“PSC”) to assist in the coordination of pretrial activities and trial
planning. (See Docket No. 977.) The PSC acts on behalf of, or in consultation with,
Plaintiffs’ Lead Counsel and Liaison Counsel in the management of litigation. Both
Plaintiffs’ Lead and Liaison Counsel are members of the PSC. 3
D.

Common Benefit Fund

Pretrial Order 3, filed on January 22, 2009, created guidelines for costs and
attorneys’ fees incurred by PSC members and other attorneys working for the common
benefit of Plaintiffs in MDL 1943. (Docket No. 105.) The Order directed Plaintiffs’
Liaison Counsel to establish a common benefit fund, provided direction regarding
assessments for the common benefit fund, provided the occasions on which
disbursements from the common benefit fund are to be made, and set guidelines and
deadlines for submission of time and expense costs by Plaintiffs’ Counsel.
E.

Status Conferences

The initial MDL pretrial conference was held on September 4, 2008. (Docket No.
31.) At the initial conference, the Court set the deadline for filing answers, entered a
stipulated confidentiality order, and established docketing and filing procedures. (Docket
No. 50.) All discovery disputes and issues during the course of the MDL were handled

3

The members of the PSC are: Yvonne Flaherty, Lockridge, Grindal Nauen, P.L.L.P,
Minneapolis, Minnesota; John P. Walsh, Seattle, Washington; Robert Binstock, Reich &
Binstock, Houston, Texas; W. Lewis Garrison, Heninger, Garrison & Davis, Birmingham,
Alabama; Troy Giatras, The Giatras Law Firm, Charleston, West Virginia; Brian J. McCormick,
Sheller, P.C., Philadelphia, Pennsylvania; and John J. Carey, Carey & Danis, L.L.C., St. Louis,
Missouri. (See Docket No. 977.)
4

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 5 of 32

primarily by the undersigned either through informal telephonic conferences or motion
hearings. Periodic status conferences were also held to address status and otherwise
time-sensitive issues that arose during the course of the proceedings.
F.

Plaintiff Groups

The Court determined that bellwether trials would be useful. For purposes of
determining which cases that would be considered for bellwether trials and related case
specific discovery, the Court divided the cases into three groups:
Phase I: The first phase consisted of 15 specifically-identified cases for
which case-specific fact discovery was to begin for purposes of selecting
cases for bellwether trials. (Docket No. 132.) Subsequently, counsel for
the parties narrowed the list to six cases for purposes of selecting cases for
bellwether trials. (Docket No. 1036.)
Phase II: This group was comprised of thirty-four cases, including nine
cases initially included in the 15 Phase I cases and other cases assigned to
the MDL in which Defendants had appeared as of December 15, 2008.
(Docket Nos. 132, 1036.)
Phase III: This group was comprised of all cases filed in the District of
Minnesota or transferred to the MDL not otherwise identified in Phase I or
Phase II. (Docket Nos. 132, 1036.)
G.

Bellwether Trials

Of the six cases comprising the revised Phase I group, three cases have been tried
to verdict: Schedin v. Ortho-McNeil Pharmaceuticals, Inc. (Civil Case No. 08-5743);
Christensen v. Johnson & Johnson, et al. (Civil Case No. 07-3960); and Straka v.
Johnson & Johnson, et al. (Civil Case No. 08-5742).
1. Schedin v. Ortho-McNeil Pharmaceuticals, Inc.

5

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 6 of 32

The first bellwether trial, Schedin, was tried in November 2010, and resulted in a
jury verdict in favor of Plaintiff against OMJPI 4 in the amount of $700,000 in
compensatory damages, which was reduced to $630,000 as a result of the jury’s having
found Plaintiff 10% negligent. The jury awarded punitive damages in the amount of
$1,115,000. Defendant’s motion for post-trial relief was denied. Defendant appealed to
the Eighth Circuit, which issued a decision on November 30, 2012, affirming this Court’s
denial of Defendant’s motions for judgment as a matter of law or a new trial on Schedin’s
claim for compensatory damages, and reversing the denial of Defendant’s motion for
judgment as a matter of law on punitive damages. See In re Levaquin Prods. Liability
Litig., 700 F.3d 1161 (8th Cir. 2012). A related appeal was taken from the Court’s denial
of Defendant’s motion pursuant to Federal Rule of Civil Procedure 60 for relief from the
judgment. The Eighth Circuit affirmed the Court’s denial of Defendant’s Rule 60 motion
on January 7, 2014. See In re Levaquin Prods. Liability Litig., 739 F.3d 401 (8th Cir.
2014).
2. Christensen v. Johnson & Johnson, et al.
The second bellwether trial, Christensen, was tried in June 2011, and resulted in a
jury verdict in favor of Defendants Johnson & Johnson and OMJPI. 5 The Court denied
Plaintiff’s motions for post-trial relief. An appeal was taken, but later was voluntarily
dismissed by Plaintiff.

4

The other Defendants, Johnson & Johnson and PRD, were voluntarily dismissed prior to

5

Defendant PRD was voluntarily dismissed prior to trial.

trial.

6

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 7 of 32

3. Straka v. Johnson & Johnson, et al.
The third bellwether trial, Straka, was tried in January 2012, and resulted in a jury
verdict in favor of Defendants Johnson & Johnson and Janssen. 6 The Court denied
Plaintiff’s motions for post-trial relief and no appeal from the Court’s order was taken. 7
DISCOVERY
Pretrial Orders 2, 4 (as amended by Pretrial Order 6), and Pretrial Order 5 govern
the pretrial discovery in MDL 1943.
A.

Generic Fact Discovery
1. Document Discovery

Plaintiffs have conducted extensive fact discovery against Defendants. Prior to the
creation of the MDL, Plaintiffs had propounded initial document requests to Defendants
in the individual case Voss, et al. v. Johnson & Johnson, et al. (Civil Case No. 06-3728).
Defendants produced documents in response to Plaintiffs’ requests on a rolling basis.
On August 19, 2009, Plaintiffs served and filed and omnibus motion to compel
discovery.

On November 25, 2009, the Court granted in part and denied in part

Plaintiffs’ motion to compel, requiring Defendants to comply with their “continuing
obligation to produce documents as they are kept in the usual course of business,”
provide responses to certain interrogatories, and produce documents related to various

6

Defendant PRD was voluntarily dismissed prior to trial.

7

Two cases were also tried as part of consolidated state court proceedings in New Jersey
Superior Court, both of which resulted in jury verdicts in favor of Defendants Johnson &
Johnson and Janssen in October 2011.
7

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 8 of 32

subjects, including documents related to marketing, pricing, sales, revenue, profits and
costs, and Levaquin’s predecessor drug, Floxin. (Docket No. 732.)
Pursuant to the Federal Rules of Civil Procedure, Defendants prepared and served
a privilege log. Plaintiffs challenged certain entries on Defendants’ privilege log, and
after meeting and conferring with Defendants, Plaintiffs moved to compel production of
non-privileged documents. The documents were submitted for in camera review by the
Court, to Magistrate Judge Arthur J. Boylan, who issued an order on June 30, 2010
granting in part and denying in part Plaintiffs’ motion. (Docket No. 1511.)
2. Protective Order/Confidentiality
Prior to the creation of the MDL, the parties in the case of Voss, et al. v. Johnson
& Johnson, et al. (Civil Case No. 06-3728), had stipulated to the entry of a protective
order.

(Civil Case No. 06-3728, Docket Nos. 43-44.)

The Court incorporated the

September 7, 2007 Amended Stipulated Confidentiality Order by reference as part of
Pretrial Order 1. (Docket No. 50.)
3. Depositions of Generic Fact Witnesses
The guidelines governing the taking of depositions are outlined in Pretrial Order 2
(Docket No. 70), which includes, in part, a provision for cross-noticing depositions
between state court cases and this MDL, and provisions for attendance at depositions,
deposition scheduling, document production, and videotaping of depositions.
As part of generic discovery, Plaintiffs deposed approximately twenty-seven
current or former employees of Defendants, including Rule 30(b)(6) witnesses either as
part of the MDL or through depositions cross-noticed in the New Jersey state court

8

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 9 of 32

consolidated matter. 8 Third-party witnesses were also deposed, including John Seeger,
Alex Walker, Carla Canabarro, Drew Levy, and Wanju Dai.
B.

Case-Specific Fact Discovery
1. Plaintiff Fact Sheets

Pursuant to Pretrial Order 4, the Court directed that each Plaintiff complete a
Plaintiff Fact Sheet (“PFS”) and serve it on Defendants’ Liaison Counsel. The deadlines
for service of a PFS are as follows:
Phase I cases: February 15, 2009
Phase II cases: March 16, 2009
Phase III cases: No later than 90 days after Defendants had filed responsive
pleadings to the Complaint. 9 (Docket No. 132.)
The PFSs, agreed upon by the parties, included a request that a plaintiff provide
information, including but not limited to: the name of the plaintiff, the plaintiff’s alleged
injuries, the dates upon which Levaquin was prescribed, the warnings, written and verbal
instructions plaintiff received about Levaquin, and the plaintiff’s employment history,
educational history, and medical history. This sworn PFS required each plaintiff to verify

8

Those witnesses include: Cynthia Chianese, Carl DeStefanis, Daniel Fife, Tiziana Fox,
Lorie Gawreluk, Roger Graham, David Grewcock, John Johnson, Larry Johnson, James Kahn,
Sara Kennedy, Neil Minton, Gary Noel, Greg Panico, Kim Park, Janet Peterson, Phillip Pierce,
Katherine Rielly-Gauvin, Jeffrey Smith, Ira Solomon, Linda Stirano, Robyn Thomas, Teresa
Turano, Raymond Werts, Katania Vadana, David Wright, and Chuen Yee.
9

In Pretrial Order 6, the Court vacated Paragraphs 1 and 2 of Pretrial Order 4 with
respect to the cases listed in Phases I and II. Pretrial order 6 provides that the cases listed in
Pretrial Order 4 not included in Pretrial Order 6 were to be moved to Phase II. (Docket Nos.
132, 1036.)

9

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 10 of 32

the accuracy and completeness of information, and the verifications were given the same
legal significance as answers to interrogatories. 10
2. Defendant Fact Sheets
Pursuant to Pretrial Order 4, Defendants were required to complete and serve a
Defendant Fact Sheet (“DFS”) in each case as follows:
Phase I cases: 30 days following the receipt of a PFS in each Phase I case
Phase II: 60 days following receipt of a PFS in a Phase II case
Phase III: 90 days following receipt of a PFS in a Phase III case. (Docket Nos.
132, 1036.)
C.

Expert Discovery

The parties agreed, and the Court approved, a protocol for the exchange and
discovery of information regarding all generic expert witnesses identified in the MDL.
Pretrial Order 5 governs the discovery of drafts, communications, and other information
from experts; the content of reports; and the applicability of expert depositions to cases in
the MDL. (Docket No. 554.)
With respect to expert witnesses for bellwether cases selected for trial, disclosure
of the identity of each expert witness and full disclosures as required by Federal Rule of
Civil Procedure 26, accompanied by written reports, were to be made for all experts,
including generic experts.
GLOBAL ISSUES
10

A copy of the Plaintiff Fact Sheet form is available on the website for this MDL,
located
at
http://www.mnd.uscourts.gov/MDL-Levaquin/Forms/Levaquin-Plaintiff-FactSheet.pdf.
10

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 11 of 32

A.

Preemption

Defendants sought dismissal of Plaintiffs’ failure to warn claims on the grounds
they were preempted under federal law.

The Court denied Defendants’ motion,

ultimately determining that under Wyeth v. Levine, 555 U.S. 555 (2009), and Pliva v.
Mensing, 131 S. Ct. 2567 (2011), Defendants had not proffered evidence that the FDA
rejected an actual label change and thus Plaintiffs’ claims were not preempted. See In re
Levaquin Prods. Liability Litig., MDL No. 08-1943, Civ. No. 08-5742, 2011 WL
6826415, at *5 (D. Minn. Dec. 28, 2011).
B.

Punitive Damages

Pursuant to Minnesota law, each Plaintiff in each bellwether trial moved to amend
his/her complaint to add a claim for punitive damages. The Court granted each Plaintiff’s
motion for leave to amend in each case. The Court has not sought to determine the extent
to which, if at all, any other state’s law relative to punitive damages would apply to any
particular plaintiff’s claims.
C.

Daubert

Each side moved to exclude part or all of the testimony of the following generic
expert witnesses:

Cheryl Blume, Thomas Zizic, Martyn Smith, Gregory Bisson,

Martin Wells, 11 Joseph Rodricks, George Zhanel, Paul Waymack, George Holmes, John
Seeger, and Peter Layde. The Court issued rulings on these motions.
1. Defendants’ Motion to Exclude Dr. Blume – Denied (Docket No.
2277.)
11

Plaintiffs brought a motion in limine to exclude the expert testimony of Dr. Martin
Wells, but this motion was withdrawn without a ruling from the Court. (Docket No. 1874.)
11

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 12 of 32

Defendants sought to exclude Dr. Cheryl Blume’s expert testimony on several
grounds. First, Defendants argued that Blume lacks the required qualifications to be
considered an expert in the field because she is not a medical doctor and has never
prescribed Levaquin.

They also challenged the legitimacy of her methods and her

conclusions. Defendants claimed that the excessive recitation of the factual history of
Levaquin in her testimony is an effort to distort the facts, and that such matters should not
be the subject of expert testimony.
The Court found that Blume’s many years of experience working in the
pharmaceutical industry on label changes and interpreting adverse event data qualify her
to testify in these proceedings. In addition, the Court found that her methods are well
established and accepted, and that any other challenges to the credibility of her testimony
can be addressed in cross examination. Finally, the Court determined that Blume must
limit her testimony about facts in the case to those sufficient to provide context for the
jury. With this exception, the Court denied the motion to exclude Dr. Blume’s testimony.
2. Defendants’ Motion to Exclude Expert Testimony of Drs. Smith and
Zizic – Denied (Docket No. 2260.)
Defendants sought to exclude the expert testimony of Dr. Martyn Smith and Dr.
Tom Zizic. Defendants argued that Smith and Zizic’s conclusions about the comparative
tendon toxicity levels fail to meet the Daubert standard of reliable methods, because they
rely on extrapolations from animal studies. The Court denied the motion. The Court
found that there is no per se rule stating that animal studies are inadmissible as evidence.
Rather, this evidence is excluded in cases where there is sufficient reason to question the

12

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 13 of 32

legitimacy of extrapolations. Because those issues were not present in this case, the
Court found that any question of credibility in the conclusions could be addressed on
cross examination.
3. Defendants’ Motion to Exclude Expert Testimony on the Knowledge,
Motives, and Intent of the Defendants – Granted in part and Denied
in part (Docket No. 2267.)
Defendants moved to exclude testimony by several of Plaintiffs’ experts as to the
knowledge, motive, and intent of defendants in their participation in levofloxacin
studies. 12 Defendants argued that medical experts are not qualified to testify as to the
mental processes of the Defendants. Further, Defendants argued that the inferences as to
motivations and intentions are factual issues which should be left to the jury to determine.
Finally, Defendants contended that any such evidence that would otherwise be admissible
should be excluded because it is more prejudicial than probative. The Court granted the
motion with respect to statements made concerning particular biases of Defendants. The
Court denied the motion as to statements which were made about sources of potential
bias generally. 13 The Court found that the statements about particular motivation and
intentions of Defendants were unreliable, but that there was nothing objectionable about
experts offering general testimony as to possible sources of bias in scientific studies. The
Court noted that this type of testimony is routinely allowed by expert witnesses, and
admission would not be prejudicial or confusing to a jury.

12

Specifically, Defendants sought to exclude particular statements by Drs. Zizic, Bisson,
and Wells.
13

The Court excluded two statements by Dr. Wells and one statement by Dr. Bisson.
13

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 14 of 32

4. Plaintiffs’ Motion to Exclude Expert Testimony of Dr. Rodricks –
Denied (Docket No. 3243.)
Plaintiffs moved to exclude Dr. Joseph Rodricks’s expert testimony on several
specific issues on the grounds that during deposition he stated that he had no opinion on
these issues. 14 Additionally Plaintiffs moved to strike his rebuttal report under Federal
Rule of Civil Procedure 26(a)(2)(C)(ii), claiming that it offers new opinions not presented
in the original report. Plaintiffs further argued that the opinions in the rebuttal report fail
to meet the generally accepted standard of Daubert. The Court found that Plaintiffs’
characterization of Rodricks’s testimony and reports was contrary to the record and that
the rebuttal did not contain new opinions. The Court further found that Rodricks’s report
was not excludable under the Daubert. The Court denied the motion in its entirety,
noting that Plaintiffs could challenge Rodricks’ findings on cross-examination.
5. Plaintiffs’ Motions to Exclude Expert Testimony of Dr. Zhanel –
Denied (Docket No. 2253.)
Plaintiffs sought to exclude Dr. George Zhanel’s expert testimony on specific
issues because he stated that he had no opinion on those issues, or presented seemingly
contradictory opinions on these issues. 15 Upon review of the deposition, the Court found

14

The particular issues are: 1) any opinion offered in the field of epidemiology; 2) any
opinion on the comparative toxicity of ofloxacin and levofloxacin, in animals or humans; 3) Any
opinions on whether fluoroquinolones can cause tendon disorder in humans; 4) any opinions on
comparative tissue penetration of ofloxacin and levofloxacin, in animals or humans; 5) any
opinions on the comparative pharmacokinetics of ofloxacin and levofloxacin; 6) any opinions
that there is no reliable animal modeling for studying the comparative tendon toxicity of
fluoroquinolones.
15

The particular issues are: 1) the relative tendon toxicity of various floroquinolones; 2)
that a prospective, randomized, double blind clinical trial is the only evidence that can
demonstrate a comparative relationship among fluoroquinolones regarding tendon toxicity; 3)
14

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that Zhanel’s testimony was consistent, and that his supposed statements about not
having an opinion were taken out of context. Consistent with this finding, the Court
denied the motion.
6. Plaintiffs’ Motions to Exclude Expert Testimony of Dr. Waymack –
Granted in part and Denied in Part (Docket No. 3243.)
Plaintiffs sought to exclude Dr. Paul Waymack’s expert testimony. Plaintiffs
argued that Waymack’s testimony concerning FDA regulations is contrary to law, and
that coupled with his routine exclusion in previous litigation, his testimony is unreliable.
The Court found that much of Waymack’s testimony is contrary to the law interpreting
current regulations.

The Court noted that Waymack’s testimony regarding FDA

regulations is largely unaltered from previously offered testimony that has been excluded
in other cases. The Court also found that this testimony was likely to prejudice or
confuse the jury. Pursuant to these findings, the Court granted the motion in part.
Waymack was allowed to testify but was not allowed to offer testimony that was contrary
to the law as articulated in Wyeth and the Court’s order. Further, Waymack was not
allowed to testify about the specific regulatory history of Levaquin.
7. Plaintiffs’ Motions to Exclude Expert Testimony of Dr. Holmes –
Denied (Docket No. 3253.)
Plaintiffs sought to exclude the expert testimony of Dr. George Holmes on several
grounds. Plaintiffs pointed to several problems with Holmes’s testimony which they
suggest make his testimony inadmissible: that Holmes is unqualified to testify regarding
that levofloxacin and ofloxacin have different toxicological and pharmacological profiles; and 4)
that levofloxacin is superior to moxifloxacin for upper respiratory illnesses and that levofloxacin
is superior to ciprofloxacin for urinary tract infections.
15

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 16 of 32

tendon ruptures associated with floraquinolones because he has never prescribed or
previously conducted research on the topic; that Holmes’s opinions were developed
solely for use at this trial; and that Holmes failed to distinguish between the and a
contributing cause and his lack of experience with Levaquin, thereby making a legal
argument and not a medical diagnosis. The Court denied the motions, finding that
Holmes was well qualified as an expert on the subject. In addition, the Court found no
evidence to suggest that Holmes’s report or testimony was not properly prepared or that it
was inadmissible on the grounds that it was prepared specifically for the litigation.
Though the Court denied the motions, it ordered Defendants to advise Holmes that he
must use the language “a substantial contributing cause” instead of “the substantial
contributing cause” when testifying about potential causes of tendon rupture.
8. Plaintiffs’ Motion to Exclude Expert Testimony of Drs. Seeger &
Layde – Denied (Docket No. 3243.)
Plaintiffs sought to exclude the expert testimony of Dr. John Seeger and Dr. Peter
Layde on the grounds that their opinions both fail to meet the general acceptance standard
of Daubert, and are irrelevant because they offer general opinions on issues that are not
in dispute. Specifically, Plaintiffs pointed to evidence that the Ingenix study, in which
Seeger participated, was improperly conducted and calls into question the legitimacy of
the conclusions in his report. 16 Plaintiffs also argued that because Layde’s opinions on
the associations between injuries and use of medications suggest opinions which he does
not purport to have and cannot support with evidence, the testimony is more prejudicial
16

Defendants did not challenge Dr. Seeger’s appearance as a fact witness to discuss the
Ingenix study; rather they challenged his appearance solely as an expert.
16

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 17 of 32

than probative. The Court denied the motion in its entirety. The Court found that Seeger
is qualified to testify as an expert witness. The Court further found that Plaintiffs’
complaints about Seeger speak to credibility, not admissibility, and can therefore be
addressed on cross-examination. The Court also found that the Rules of Evidence allow
experts to testify as to general principles, and since the general principles in Layde’s
testimony addresses issues pertinent to the case, his testimony was relevant.
D.

Other Evidentiary Rulings

The Court also made a number of other general evidentiary rulings that it applied
to the bellwether cases as the law of the case.
1. Defendants’ Motion to Exclude Foreign Regulatory Actions – Denied
(Docket No. 2264.)
Defendants sought to exclude evidence of regulatory documents and proposed
regulatory actions for Levaquin from foreign countries.

Defendants asserted these

documents were not relevant to the claim and should therefore be excluded pursuant to
Federal Rule of Evidence 401. Specifically, Defendants argued that in order to get such
evidence admitted, the Plaintiffs bear the burden of showing that the treating physician
directly relied on the foreign regulations or accompanying documents in arriving at
his/her medical decisions. Alternatively, they argued that the evidence was inadmissible
as hearsay under Federal Rule of Evidence 803 and would place too onerous a task on the
Court in trying to interpret and research the foreign regulation sufficiently under Federal
Rule of Civil Procedure 44.1. Finally, Defendants contended that this evidence was
unduly prejudicial under Federal Rule of Evidence 403. The Court reasoned that the

17

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evidence was not final regulatory action to which a jury might defer out of confusion:
rather, the evidence was preliminary regulatory action and was probative of an intent to
limit the impact that regulatory action in Europe might have on the U.S. market. As a
result, the Court found the evidence was not hearsay and was admissible. To cure any
potential prejudice, the Court issued a limiting instruction. 17
2. Defendants’ Motions to Exclude FDA Petitions – Denied (Docket No.
2264.)
Defendants sought to exclude evidence of petitions sent to the Food and Drug
Administration (“FDA”) requesting that the FDA strengthen the warning label on
Levaquin. 18 Defendants claimed that the petitions were inadmissible hearsay because no
one who could testify as to their production would be called by the defendants. They
further argued that, since one of the petitions was drafted before the release of Levaquin
and the other was drafted after the Plaintiffs’ injuries, they were not relevant to the

17

The limiting instruction read:

You have heard evidence on various regulatory issues that occurred outside of the
United States. The legal standards used by foreign regulatory agencies may be
different from those used in the United States. Therefore, you should not use
regulatory actions by foreign regulatory agencies to determine whether or not
defendants abided by or violates any legal duty in the United States. However,
the evidence surrounding these foreign regulatory events may be considered by
you as a basis for understanding defendant’s actions in the United States,
defendant’s notice about issues that were relevant in the United States, and
defendant’s motives in responding to those issues which may have impact in the
United States.
(Civil Case No. 08-5743, Jury Instruction 14, Docket No. 176; Civil Case No. 07-3960, Jury
Instruction 14, Docket No. 237.)
18

The petitions recommended the strengthening of the label on all floraquinolones, not
just Levaquin.
18

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 19 of 32

specific injury claims.

The Defendants also asserted that these petitions are highly

prejudicial because they portray the FDA as incapable of effectively regulating the
market. The Court denied the motion to exclude since the petitions were relevant and
qualified for exemption from the hearsay rules under the public records exception of FRE
803(8). The Court further found arguments that the petitions were overly prejudicial to
be without merit.
3. Defendants’ Motions to Exclude Adverse Event Reports – Denied
(Docket No. 2264.)
Defendants sought to exclude evidence of adverse event reports (“AERs”)
gathered from two databases. 19 Defendants argued these reports were inadmissible to
establish causation because it is widely recognized that AERs are an unreliable method
for establishing causation, and the FDA itself refuses to treat such reports as establishing
causation; therefore, AERs cannot constitute notice evidence.

Defendants further

asserted that AERs were irrelevant and hearsay. The Court found the AERs alone might
not be permissible as evidence, given their lack of reliability to show a causal link
between the plaintiffs’ injuries and Levaquin. However, they are commonly used by
experts in the field to determine causation in correlation with other evidence.
Additionally, even if AERs could not be admitted to prove causation, they constitute
notice evidence. The Court found no merit in the hearsay objection so long as the

19

The AERs at issue are primarily gathered from two databases: one is the FDA’s AER
database; the other is Sceptre, maintained by the Defendants.
19

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 20 of 32

Plaintiffs or Plaintiffs’ experts discuss AERs in this context. Therefore, the Court denied
the motions. To cure any potential prejudice, the Court issued a limiting instruction. 20
4. Defendants’ Motions to Exclude Evidence of Label Changes
Subsequent to Plaintiffs’ Injuries – Denied (Docket No. 2326, 3243.)
Defendants sought to exclude evidence of label changes for Levaquin that
occurred subsequent to the plaintiffs’ prescriptions. 21 Additionally, Defendants moved
the Court to exclude evidence of other potential label changes prior to the injury that
would have conflicted with current FDA regulations.

Defendants argued that label

changes after the injury are the product of information that was not available at the time
of the prescription and, therefore, were not admissible to show what defendants should
have known. Defendants also argued that evidence suggesting that label changes should
have been made sooner is inadmissible—particularly an earlier addition of a black box
warning—because they were preempted from making these changes by FDA regulations
at the time. Further, Defendants emphasized that only the FDA could (and can) mandate

20

The instruction reads in pertinent part:

This type of information alone should not be considered by you as evidence of a
causal relationship between use of the drug and the injury, but may be considered
along with other evidence to determine whether the drug is a substantial
contributing factor to the injury. These reports may be considered as one type of
evidence of a signal that there may be an association between a drug and the
adverse event. Likewise, this type of information or data alone should not be
considered by you as evidence of the incidence of the injury associated with the
drug, or evidence of making comparisons between drugs. Simply because one
drug may have more reports of a particular injury, is not evidence that it presents
more of a risk of that injury than other drugs.
(Civil Case No. 08-5743, Jury Instruction 12; Civil Case No. 07-3960, Jury Instruction 12.)
21

Schedin was prescribed Levaquin in 2005 and Christensen in 2006.
20

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 21 of 32

a black box warning, and thus they cannot be held liable for failing to do something they
were unable to do.
The Court denied the motion. Specifically, the Court found that even though the
decision to institute a black box label was not within the power of Defendants,
Defendants could have used other procedural mechanisms to revise and improve the
label. The Court also found that the evidence of post-injury label changes was relevant
insofar as it demonstrated what the Defendants knew or should have known about the
inadequacy of the label at the time of injury. To cure any potential prejudice, the Court
issued a limiting instruction. 22
5. Defendants’ Motions to Exclude Evidence of Ortho-McNeil
“Ghostwriting” Articles – Denied in part (Docket No. 2264.)
Defendants moved to exclude all evidence and argument that they have
“ghostwritten” medical and scientific articles on the appropriate clinical use of Levaquin.
While acknowledging the fact that Defendants have, on several occasions, paid thirdparty vendors to conduct studies and write articles, defendants maintained there is no
evidence that they in any way influenced or attempted to influence the outcome of those

22

The instruction reads in pertinent part:
You have heard evidence that the FDA approved Levaquin as safe and effective
for its intended uses, that the FDA approved Levaquin’s label or “package insert”
in place at the time of plaintiff’s prescription, and that the FDA required changes
to the label in 2008 after the time of plaintiff’s prescription. . . . . Neither the
FDA’s approval of the drug and its label, nor its requirement of label changes, is
necessarily conclusive or controlling on any issue you have been asked to decide.
You may give it as much or as little weight as you think it deserves, in light of all
the evidence, under the law as set forth in these instructions.

(Civil Case No. 08-5743, Jury Instruction 13; Civil Case No. 07-3960, Jury Instruction 13.)
21

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 22 of 32

studies.

On this basis, Defendants contended that the introduction of argument or

evidence intimating the contrary would be highly prejudicial. The Court denied these
motions, noting that such evidence is routinely admissible in these types of proceedings
and relevant in this case. In particular, the Court found that the prescribing physicians
relied on the opinions and advice of other experts in the medical community, often the
product of relevant medical studies, and they could have contributed to the prescribing
physicians’ decisions to use Levaquin. The Court therefore denied the motion subject to
the exception that Plaintiffs refrain from using the term “ghostwriting,” as it is potentially
inflammatory and prejudicial.
6. Defendants’ Motions to Exclude Evidence of Health & Medical
Conditions of Persons Other than Plaintiffs – Denied (Docket No.
2264.)
Defendants moved the Court to exclude evidence of injuries to persons other than
the Plaintiffs. The Court noted that while these motions may have merit, they were not
ripe for ruling without knowing the particulars of the injuries, whether they are
substantially similar circumstances, or whether they are relevant to an expert’s report.
The Court therefore denied the motion but left the issue open to appropriate objection
during specific proceedings if potentially irrelevant information regarding third parties is
raised.
7. Defendants’ Motions to Exclude Any Reference to Documents
Created by Other Pharmaceutical Companies Unrelated to
Levofloxacin – Granted (Docket No. 2264.)
Defendants sought to exclude evidence of various marketing materials and other
documents which are produced by other pharmaceutical companies and are not directly

22

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 23 of 32

related to Levofloxacin. The Court granted these motions, reasoning that any evidence of
this sort is likely to be irrelevant to the case at hand and could potentially mislead or
confuse a jury.
8. Cross Motions Regarding Evidence of Defendants’ Other
Pharmaceutical Products – Evidence Excluded (Docket Nos. 2261,
2264.)
Defendants moved to exclude, on the basis of irrelevance and prejudice, evidence
of other defective products which have been manufactured and sold by the Defendants.
Plaintiffs moved for permission from the Court to introduce the same type of evidence.
Plaintiffs argued that such evidence is relevant to counter evidence offered by Defendants
of their companies’ excellent reputations. The Court excluded the evidence. Taking into
account that Defendants had no intention of introducing general evidence of their
reputation, the Court determined that the other products failed to be substantially similar
to Levaquin and were therefore irrelevant. The Court further noted that allowing such
evidence at trial (particularly evidence of product recalls) would waste trial time and be
an unnecessary distraction.
9. Plaintiffs’ Motions to Exclude Evidence on the Rarity of Tendon
Rupture – Denied (Docket No. 2261.)
Plaintiffs moved to exclude evidence that tendon rupture is a “rare occurrence.”
The Court denied this motion, finding Defendants could introduce evidence of the
statistical rarity of the occurrence.
10. Plaintiffs’ Motions to Exclude All References to Plaintiff Counsels’
Conduct – Denied (Docket No. 2261.)

23

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 24 of 32

Plaintiffs moved to exclude all reference to Plaintiff counsels’ conduct.
Specifically, Plaintiffs sought to prevent Defendants from referencing commercials
soliciting clients for Levaquin litigation or eliciting testimony suggesting that the
Plaintiffs were in any way influenced to sue Defendants by advertisements. Additionally,
Plaintiffs sought to exclude any evidence of fee structures or Plaintiff counsels’
compensation for the trials. Plaintiffs argued that allowing this type of evidence and
testimony would intrude on attorney-client privilege. The Court found that some of the
examples given by Plaintiffs’ counsel would be protected under attorney-client privilege,
but others would not, and denied the motion as overbroad.
11. Defendants’ Motions to Exclude Evidence of Marketing and
Communication for Levaquin to Non-Parties – Denied (Docket No.
2264.)
Defendants sought to exclude all evidence of marketing materials or
communications about Levaquin which allegedly misrepresented or failed to disclose the
risks associated with prescribing the drug. Defendants argued that because there was no
evidence that the prescribing physicians ever saw or relied on statements in these
marketing materials, they are irrelevant and inadmissible. The Court found that these
materials may have shaped the way that marketing and sales representatives represented
Levaquin to physicians in general, and thus may have indirectly influenced the
prescribing physicians. The Court denied this motion.
12. Plaintiffs’ Motions to Exclude Evidence that Plaintiffs’ Injuries May
Have Been the Result of Other Defective Products – Denied (Docket
No. 2261.)

24

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 25 of 32

Plaintiffs sought to exclude any mention, suggestion, or attempt to elicit testimony
that Plaintiffs’ injuries were caused by another defective product. Plaintiffs argued that
there is no expert designated to substantiate such a claim, and that this would amount to
an affirmative defense that Defendants waived.

Therefore, Plaintiffs argued, the

introduction of such evidence would be overly prejudicial, and likely to confuse or
mislead the jury.

Defendants maintained that they only waived the defense of

superseding cause, and never intended to waive a defense of alternative causation. The
Court denied the motion because the possibility of alternative causation is relevant.
ACTIONS COMPLETED BEFORE REMAND
The cases listed in Exhibit A are ripe for remand. They are cases in which
Plaintiffs have completed generic discovery of Defendants. The plaintiff in each case has
served a PFS, and Defendants have served a DFS. The cases have not been settled.
Furthermore, the Court has instituted procedures, through the use of various types of
orders to show cause, to ensure that the cases listed in Exhibit A are cases in which
Plaintiffs have recently indicated their desire to move forward with their cases.
These cases will require case-specific depositions of the plaintiff, treating
physician(s), case-specific expert designations, and pretrial motions, all of which can be
addressed by the transferor courts.

Certain other case-specific issues are addressed

below.
CASE-SPECIFIC ISSUES FOR RESOLUTION
A.

Damage Caps, Other Limitations on Recovery, and State Consumer
Fraud Statutes

25

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 26 of 32

Because all of the bellwether trials involved cases brought by Minnesota residents
and involved cases originally filed in the District of Minnesota, the Court has not sought
to determine, and has not addressed, whether and/or to what extent statutory damage caps
or other limitations on recovery existing under other state statutes may apply to any
particular plaintiff’s claims for those cases listed in Exhibit A.
Further, this Court has not sought to determine, and has not addressed, whether
and/or to what extent any claim of a violation of any other state’s statutory consumer
fraud laws by any plaintiff listed in Exhibit A has merit.
B.

Statutes of Limitations

Because case-specific discovery has been limited in the MDL, and because
variability exists among state laws as to when an applicable limitation period began to
run, issues as to whether a particular plaintiff’s claim in any of the cases listed in Exhibit
A are barred by an applicable statute of limitations have not been submitted to this Court
for determination. The Court anticipates that in certain cases, the transferor courts may
be required to evaluate whether a particular plaintiff has timely filed his/her claims.
C.

Daubert

In light of medical and legal causation challenges addressed by the Court in each
of the bellwether trial cases, this Court anticipates that transferor courts will likely need
to address Daubert challenges to case-specific medical experts. 23

23

In the consolidated state court proceedings in New Jersey, the court addressed the
adequacy of the Levaquin black box warning that was mandated by the FDA beginning in July
2008, holding that the warning was adequate as a matter of law. Hain et al. v. Johnson &
Johnson, et. al, Court File No. ATL-L-8568-11-MT (Higbee, J. June 13, 2013).
26

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 27 of 32

DOCUMENTS TO BE SENT TO TRANSFEROR COURTS
After receiving the Final Remand Order (“FRO”) from the JPML, the Clerk of
Court will issue a letter to the transferor courts, via email, setting out the process for
transferring the individual cases listed in the FRO. The letter and certified copy of the
FRO will be sent to the transferor court’s email address.
If a party believes that the Docket Sheet for a particular case to be remanded is not
correct, a party to that case may, with notice to all other parties in the case, file with the
transferor court a Designation Amending the Record. Upon receiving a Designation
Amending the Record, the transferor court may make any needed changes to the docket.
If the docket is revised to include additional documents, the parties should provide those
documents to the transferor court.
OBJECTIONS TO REMAND
If a plaintiff identified in Exhibit A believes his/her case should not be remanded,
he/she shall file a Notice of Objection to this Final Pretrial Order and Suggestion of
Remand within thirty (30) days of the entry of this Order, including in his or her Notice a
basis for objection.

DATED: September 10, 2014
at Minneapolis, Minnesota.

__________s/John R. Tunheim_________
JOHN R. TUNHEIM
United States District Judge

27

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 28 of 32

EXHIBIT A
Cases Subject to Order
Count

Plaintiff Name

Case Number

1

Bailey, Gwendolyn

MDL: 10-3051

Bennett, Bambi

Orig: N.D. Ga. 10-01415
MDL: 09-3643

Bouse, Donna and Frank

Orig: E.D. Mo. 09-01639
MDL: 11-1715

Soffey & Soffey

Orig: E.D.N.Y. 2:11- 02236
MDL: 11-2286

Soffey & Soffey

Orig: E.D.N.Y. 2:11- 03551
MDL: 09-3642

Provost Umphrey

Campora, Donna, for the
Estate of Mario Campora,
deceased
Dement, Arthur

Orig: W.D. Ark. 09-04124
MDL: 11-2731

Ross & Ross

Orig: D. Mass. 3:11- 30221
MDL: 12-0043

Girardi & Keese

Dewey, David

Orig: C.D. Cal. 11-10498
MDL: 12-2276

Edwards, Sharon

Orig: D.N.M. 12-00785
MDL: 12-2654

Girardi & Keese

Orig: E.D.N.Y. 2:12- 04754
MDL: 11-3719

Sheller, PC

2

3

4

5

6

7

8

9

10

11

12

Bouse, Wendy and
Cornell
Burke, Tess and Tommy

Ellinghausen, Lynn and
Dale
Fagler, Willard C. and
Rosemary
Fredrich, Laurie

Orig: N.D. Ala. 11-04095
MDL: 13-0564
Orig: N.D. Fla. 13-00028
MDL: 10-4698
Orig: D. Nev. 10-01796

Plaintiff’s
Counsel
Lanham &
McGehee
Gray Ritter &
Graham

Steve K. Sanders
& Associates

Fisher Butts
Sechrest &
Warner PA
Jones Vargas

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 29 of 32

Count

Plaintiff Name

Case Number

13

Frenger, Richard

MDL: 12-2653

14

Gibson, Charles E., III

Orig: E.D.N.Y. 2:12- 04753
MDL: 10-03818

15

Greenfield, Stewart

Orig: S.D. Miss. 3:10-00385
MDL: 11-2997

16

17

Hammond, Patricia as
personal representative of
Richard Hammond
deceased
Handley, Mark

Orig: D. Conn. 11-01476
MDL: 08-4698

Plaintiff’s
Counsel
Girardi & Keese

Hawkins,
Stracener &
Gibson
Stratton Faxon

Law Office of
John P. Walsh

Orig: W.D. Wash. 07-01876
MDL: 12-2737

Girardi & Keese

18

Hedrick, Heidi

Orig: C.D. Cal. 2:12- 08352
MDL: 10-3815

19

Henry-Samuel, Christelle

Orig: D. Colo. 10-00893
MDL: 12-2741

Hillyard,
Wahlberg, Kudla
& Sloane
Girardi & Keese

Hostetler, Max and Diane

Orig: S.D.N.Y. 1:12- 07320
MDL: 11-3065

Padove Law

21

Hurst, Harold Ray

Orig: N.D. Ind. 11-00313
MDL: 10-3903

22

Jackson, Sallie Tomlinson

Orig: N.D. Fla. 10-00308
MDL: 10-4559

20

23

Johnston, Paula and
Marty

Sidney L.
Matthew
The Allen Law
Firm

Orig: D.S.C. 10-02650
MDL: 10-0475

Gilmer Law Firm

The Schiller Firm

24

Kamp, Derek

Orig: S.D. Miss. 10-00031
MDL: 10-4043

25

Lankford, David

Orig: N.D. Tex. 10-1543
MDL: 10-0993
Orig: E.D. Okla. 10-00051

2

Edwards Law
Office

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 30 of 32

Count

Plaintiff Name

Case Number

26

Larson, Andrew and
Roxanne

MDL: 10-4878

Plaintiff’s
Counsel
Knight, Dahood,
Everett & Sievers

27

Lindsay, Lori

Orig: D. Mont. 10-00061
MDL: 12-1159

28

Litton, Earl

Orig: D. Conn. 12-00642
MDL: 09-3644

Kobs & Philley

Llorente, Kristen

Orig: N.D. Miss. 09-00104
MDL: 12-2738

Girardi & Keese

30

Majetic, Michael

Orig: C.D. Cal. 8:12- 01646
MDL: 11-3339

31

Marlar, Michael

Orig: N.D. Ill. 11-07305
MDL: 10-4697

29

Stratton Faxon

Romanucci &
Blandin

McCullough, Richard

MDL: 11-3455

Meyer, Janice

Orig: D. Colo. 11-02525
MDL: 12-2652

Knudsen
Berkheimer
Richardson &
Endacott
Hillyard,
Wahlberg, Kudla
& Sloane
Girardi & Keese

34

Mills, John

Orig: E.D.N.Y. 2:12- 04752
MDL: 11-1644

Delluomo & Crow

35

Nicholas, Kristin

Orig: W.D. Okla.
MDL: 11-2085

Person, Victor

Orig: C.D. Cal. 11-05761
MDL: 11-1181

Girardi & Keese

37

Presley, Lisa

Orig: C.D. Cal.
MDL: 10-3821

Provost Umphrey

38

Ramsey, Wilson “Bill” Jr.

Orig: E.D. Tex. 10-00200
MDL: 10-00995

Orig: D. Neb. 10-03204
32

33

36

Orig: E.D. Tex. 09-00564

3

Brian C. Gonzalez
Law Offices

Law Firm of
Barrett W. Stetson

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 31 of 32

Count

Plaintiff Name

Case Number

39

Randle, Carolyn L.

MDL: 10-3910

40

Rosenberg, Eric

Orig: D.N.J. 10-03515
MDL: 09-2887

41

Ruttenberg, Emil

Orig: S.D.N.Y. 1:09-07753
MDL: 12-2736

Law Office of
Joseph
Lichtenstein
Girardi & Keese

Sandifer, George

Orig: C.D. Cal. 10-01929
MDL: 11-2179

Gilmer Law Firm

43

Sandifer, Robert G.

Orig: S.D. Miss. 11-00443
MDL: 11-2181

Gilmer Law Firm

44

Schriner, Bonnie

Orig: S.D. Miss. 11-00445
MDL: 10-1915

Semos, Mark

Orig: D. Colo. 10-00315
MDL: 10-1906

Smith, Amanda

Orig: C.D. Cal. 10-01929
MDL: 13-1489

42

45

46

Plaintiff’s
Counsel
Sheller, PC

Hillyard,
Wahlberg, Kudla
& Sloane
Girardi & Keese

Law Office of
Dennis Hawver

Orig: D. Kan. 13-04060
47

Stanley, Debra C. and
Wrenn W.

MDL: 11-2180

Gilmer Law Firm

48

Sussman, Jerrold and
Eileen

Orig: S.D. Miss. 11-00444
MDL: 10-3909

Sheller, PC

Sylvester, Susan

Orig: D.N.J. 10-03514
MDL: 09-3091

Richard J. Jaegers

50

Teague, Joan

Orig: E.D.N.Y. 09-03075
MDL: 12-2735

Girardi & Keese

51

Thaxton, Michael

Orig: D of Az. 2:12- 02005
MDL: 10-0471

49

Orig: N.D. Fla. 09-00463

4

Sidney L.
Matthew

Case ARW/4:09-cv-04124 Document 4-1 Filed 11/21/14 Page 32 of 32

Count

Plaintiff Name

Case Number

52

Trask, Lee and Bergstein,
Scotty

MDL: 09-2218

Plaintiff’s
Counsel
Henderson
Humphrey

53

Urynowicz, Barbara

Orig: C.D. Cal. 09-04897
MDL: 11-2937

54

Watsky, Marvin

Orig: D. Colo. 11-01703
MDL: 12-2740

Hillyard,
Wahlberg, Kudla
& Sloane
Girardi & Keese

West, Kathrin Jeannie

Orig: E.D.N.Y. 1:12- 04755
MDL: 12-2739

Girardi & Keese

Wickerd, Mark

Orig: C.D. Cal. 8:12- 01657
MDL: 13-0148

55

56

Orig: D. Conn. 12-01268

5

Duggan &
Caccavaro