Suzanne Higley v. Bayer HealthCare Pharmaceuticals, Inc. et al
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ORDER TRANSFERRING CASE. To the United Stated District Court for the District of Minnesota. IN RE: FLOUROQUINOLONE PRODUCTS LIABILITY LITIGATION. MDL No. 2642. Signed by Sarah S. Vance, Chair of the Panel on 08/17/15. (aaa, COURT STAFF) (Filed on 8/18/2015)
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I,]NTTED STATES JUDICIAL PAI{EL
on
MULTIDISTRICT LITIGATION
IN RE: FLUOROQUINOLONE PRODUCTS
LIABILITY LITIGATION
MDLNo.2642
TRANST'ERORDER
Before the Panel: Plaintiffs in eight actions move under 28 U.S.C. $ 1407 to centralize
pretrial proceedings in this litigation in the Souttrem District of Illinois. This litigation current$
consists of 20 actions pending in 15 districts, as listed on Schedule A.' The actions allege that
fluoroquinolone antibiotics - principally, Levaquin, Avelox, and Cipro - cause or substantially
contribute to the development of irreversible peripheral neuropathy and that defendants' wamings
conceming the alleged risks were inadequate.2 The involved manufacturers and distributors are
Bayer (Cipro and Avelox), Janssen (kvaquin), and McKesson (a distributor). Since the filing of
the motiorl the parties have notified the Panel of 58 related actions pending in 23 additional
districts.3
Responding plaintiffs in six actions on the motion and 18 potential tag-along actions support
centralization, arguing in favor of either the Southem District of Illinois or the Distict of Minnesota.
Defendants oppose cenfi alizarion.
The primary arguments advanced against cenffalization are that
) centralization of actions
involving ditrerent manufacturers and different medications is inappropriate because ofthe different
factual issues involved in the composition, development, testing, and regulatory history of each
medicatioo; and (2) individualized facts conceming each plaintiffs case, zuch as medical history
the condition treated" the patient's overall risk-benefit profile, and diagnosis, will predominate over
common factual issues. There are undoubtedly individualized factual issues presented by these
actions, but after carefirl review ofthe record, we have determined that those considerations do not
outweigh the benefits of centralization.
(I
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There were 24 actions listed on plaintiffs' motion for centralization, but four actions have been
terminated since the filine of the motion.
?
The defendants are: Bayer HealthCare Pharmaceuticals, Inc., Bayer Corporation, Merck & Co.,
Inc., and Schering Corporation (collectively, Bayer); Johnson & Jobnson, Janssef, Research &
Development, LLC, Janssen Pharmaceuticals, Inc., and Ortho-McNeil-Janssen Pharmaceuticals, lnc.
(collectively, Janssen); and the McKesson Corporation.
I
These and any other related actions are potential tag-along
and,7 .2.
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-zOn August 15, 2013, the U.S. Food and Drug Administration announced that it had required
a revised label for the entire class of oral and injectable fluoroquinolone antibacterial drugs
concerning the risk ofirreversible peripheral neuropathy. The waming labels oflevaquin, Avelox,
and Cipro allegedly were revised to contain virnraily identical wamings with respect to that risk.
Plaintiffs' actions followed the FDA amouncement, relying on the same regulatory history and
scientific background to support the allegation that fluoroquinolone antibiotics, as a class, are
causally lhked to ttre development ofirreversible peripheral neuropathy. Thus, while we typically
are hesitant to centralize litigation on an indusfy-wide basis, here all fluoroquinolone actions,
regardless ofthe manufacturer, will share facnral questions regarding general causation (in parricular,
the biological mechanism of the alleged injury)" the background science, and courmon regulatory
issues.o
In these circumstances, the existence of individualized factual issues does not negate the
efficiencies gained by centralization. Almost all personal injury litigation involves questions of
causation that axe plaintiff-specific. Those differences are not an impediment to centralization when
common questions of fact are multiple and complex. See, e.g., In re: Xarelto (Rivaroxaban) Prods.
Liab. Litig.,65 F. Supp. 3d 1402, 1403 (J.P.M.L. 2014). Once discovery and other pretrial
proceedings related to the common issues have been completed the transferee judge may suggest
Section I 407 remand of actions to their transferor courts for more individual discoverv and trial, if
necessary. See In re: Darvocet, Darvon and Propoxl,phene Prods. Liab. Z;rrg., 78 0 F. S up p.2d,1379,
1381 (J.P.M.L.2011).
Defendants also argue that informal coordination among the involved courts and counsel is
preferable to creation of an MDL. But there are now 78 actions pending in 38 districts. Even
additional actions are not filed, the present number ofcases, districts, and involved counsel warrants
centralization, especially considering ttre complexity of the issues presented.
if
Additionally, defendants raise a number of arguments conceming the appropriateness of
centralization where the viability of plaintiffs' claims allegedly is in question. They argue, for
example, that plaintiffs are unlikely to prevail in light of tle products' 2004 waming labels on the
risk of peripheral neuropathy, that the majority of actions are "facially time-barred" and that
recovery agaiarst Janssen and Bayer is largely unavailable to users of the generic versions of the
medications which are in predominant use.s Those allegations do notjustiry a different outcome.
The Panel is not authorized to engage in an assessment ofthe merits ofthe acttons. See In.re: Maxim
a
Our decision here is in keeping with our past decisions in similar circumstances. We recently
centralized litigation involving multiple manufacturers of testosterone replacement therapies. .!ee
In re: Androgel Prods. Liab. Litig.,24F . Supp. 3d 1378 (J.P.M.L. 2014). We also have cenmlized
litigation involving multiple manufacturers of incretin-based diabetes dntgs. See In re: Incretin
Minetics Pro&. Liab. Litig.,968 F. Supp. 2d1345 (J.P.M.L.2013).
5 Defendants contend that, in the vast majority of states, a brand name manufacturer
cannot be
liable for injuries caused by the ingestion ofthe generic form ofa product" citlrng Guarino v. Wyah,
LLC,7L9 F.3d 1245,1252 (Itth C1r.2013). There is only one such action on the motion.
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-3Integrated Prods., Inc., Patent Litig., 867 F. Supp.2d 1333, 1335 (J.P.M.L. 2012) ("'[t]he frameff
of Section 1407 did not contemplate that the Panel would decide the merits ofthe actions before it
and neither the statute nor the implementing Rules of the Panel are drafted to allow for such
determinations"') (quoting In re: Kaufman Mut. Fund Actiow,337 F. Supp. 1337, 133940
(I.P .M.L.1972)). Moreover, placing those common issues before the transferee judge further serves
thejust and efficient conduct ofthis litigation, in contrast to allowing them to proceed separately in
dozens of different districts.
Nor are we pbnuaded by defendants' related argument that an MDL will generate the filing
of voluminous claims witlout due diligence by plaintiffs' cou:rsel, in an attempt to create prcssure
to settle. We have rejected essentially this same argument in the past, and do so again here. We
reiterate that if defense counsel has grounds to believe that frivolous claims are being filed, it is
incumbent upon them to raise that concern with the transferee judge, and to propose a process for
identifuing and disposing of those claims. See, e.g., In re: Cook Med., Inc., IVC Filters Mlag., Sales
Practices and Prods. Liab. Litig.,53 F. Supp. 3d 1379, l38l (J.P.M.L. 2014).
On the basis ofthe papers filed and the hearing session held, we find that the actions listed
on Schedule A involve common questions of fact and that centralization will serve the convenience
of the parties and witnesses and promote the just and efficient conduct of this litigation. These
actions share common factual questions arising out of allegations that oral and injectable
fluoroquinolone antibiotics cause or substantially confiibute to the development of irreversible
peripheral neuropathy and that the wamings provided by defendants conceming that risk were
inadequate. These actions, in particular, focus on kvaquin (levofloxacin), Avelox (moxifloxacin),
and Cipro (ciprofloxacin). Issues concerning general causation, the background science, regulatory
history, and labeling will be common to all actions. Centralization will reduce potentially costly
expert discovery facilitate the establishment of a uniform pretrial approach to tlese cases, reduce
the potential for inconsistent pretrial rulings, and conserve the resources ofthe pafties, their counsel,
and the judiciary. As with any MDL, the transferee judge may account, at his discretiorq for any
differences among the actions through the use ofappropriate pretrial devices, such as separate tracks
for discovery or motion practice for the various products. Sed, e.g., In re: Androgel Prods. Liab.
Lirig.,24 F. Supp. 3d at 1379-80.
The District ofMinnesota is an appropriate ransferee district for this litigation. This district
provides a geographically central and convenient forum for this nationwide litigation. Selection of
the District of M'innesota also enables us to assign this litigation to the Honorable John R. Tunheim.
Judge Tunheim is an experienced transferee judge familiar with the scientific and regulatory
background oflevaquin in his capacity as transfereejudge for a separate lrvaquin MDL conceming
tendon rupture iqjuries. See MDL No. 1943, ln re: Levaquin Products Liability Litigation. ln our
view, Judge Tunheim's experience in overseeing MDL No. 1943 will benefit the parties and
facilitate the iust and efficient conduct of this litisation.
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-aIT IS THEREFORE ORDERED that ihe actions listed on Schedule A and pending outside
the District of Minnesota are transferred to the District of Minnesota and with the consent of that
court, assigned to the Honorable Jobn R. Tunheim for coordinated or consolidated pretrial
proceedings.
PANEL ON MULTIDISTRICT LITIGATION
Sarah S. Vance
Chair
Ma{orie O. Rendell
Lewis A. Kaplan
R. David Proctor
o
Charles R. Breyer
Ellen Segal Huvelle
Catherine D. Perry
CASE 0:15-md-02642-JRT Document 1-L Filed 08/17115 Paoe 1 of 2
IN RE: FLUOROQUINOLOIIE PRODUCTS
LIABILITY LITIGATION
MDLNo.2642
SCMDULEA
District of Arizona
STREET v. JOHNSoN & JoIINSON, ET
AI., C.A. No.3:15-08065 15-
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Central District of Califomia
LOMBARD v. BAyER FTEALTHCARE PHARMACET.]-IrCAIS, rNC., ET AL.,
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C.A. No.2:15-03120
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Northem District of California
KELLERMAN v. BAYER }IEALTHCARE P}IARMACEUTICAIS, INC., ET AL., IE . JLT)TJAJ
C.A. No. 3:14-03680
LAMPARD, ETAL. v. JOHNSON &JOHNSON, ET AI., C.A. No. 3:14-04983i5 ' ,L$bT'Qf
HIGLEY v. BAYERHEALTHCARE PHARMACEUTICALS,INC., Er AL.,15 - ,LbbJ-Q5
C.A. No. 3:A-45254
DESALVO v. BAYER IIEALTHCARE PHARMACEUTICAIS, INC., ET AL, t5 4Lq0
C.A. No.3:14-05670
-I{l.lREIMAN v. JOIINSON & JoHNSON, ET Al." C.A. No. 3:1s-01610 t< 'LLq I
JIA
District of District of Columbia
HELLER v. BAYER HEAITHCARE PIIARMACEUTICAIS, INC., C.A. No. I : I 4-0 1 953 15
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Northem District of GeorEia
PRESLEY v. JOHNSON & JOHNSON, Er AL., C.A. No. l:15-01293
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Soutlem District of Illinois
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BULLARD v. BAYER HEALTHCARE PIIARMACEUTICALS, INC., ET AL.,\L; C.A. No. 3:15-00038
BUSH v. JANSSEN R-ESEARCH & DEVELOPMENT, LLC, ET Al., C.A. No. 3 : 1 5-004 52
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Western District of Kentucky
BALM v. JOHNSON & JOHNSON, ET AL., C.A. No. 3:154A2%
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District of Marvland
GRoSSMAN v. JoHNSoN & JOHNSON, ET AL., C.A. No. l:15-01082
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District of Minnesota
SMITH v. JOHNSON & JOHNSON, ET
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Al.,
C.A. No. 0:14-05021
District of Nebraska
BLACI(MoN v. BAYER HEALTHCARE PIIARMACEUTICAIS, INc., ET N',15
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C.A. No.4:15-03020
Southern District of New York
SPIEGEL v. JoHNSoN & JoFINSoN, ET
Ar., C.A. No.
1:15-03021
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Westem District of North Carolina
KING v. BAYER CORPORATION, ET At., C.A. No.
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Middle District of Pennsvlvania
IIEFFELFINGER, ET AL. v. BAYER SEALTHCARE PHARMACEUTICALS, INC.,l5
ET AL., C.A. No. l:15-00479
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District of South Carolina
MORRIS v. BAYER HEALTHCARE PIIARMACEUTICALS, INc., Er
C.A. No. 4:15-O1322
Westem District of Washington
BAUGHN v. JOHNSON & JOHNSON, Er AL., c.A. No.
3:
15-05283
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