Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_15-cv-01610/USCOURTS-cand-3_15-cv-01610-0/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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CASE 0:15-md-O2M2-JRT Document 1 Filed O8lt7lt5 Page 1of 4

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 ( I ) 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.

' 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. 20 l0

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 1 of 6
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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 if

additional actions are not filed, the present number ofcases, districts, and involved counsel warrants

centralization, especially considering ttre complexity of the issues presented.

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.

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 2 of 6
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-3-

Integrated 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.

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 3 of 6
CASE 0:15-md-02642-JRT Document 1 Filed OBlLTlts Page 4 of 4

-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

Charles R. Breyer

Ellen Segal Huvelle

Catherine D. Perry

o

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 4 of 6
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- tlbb

Central District of Califomia

Western District of Kentucky

BALM v. JOHNSON & JOHNSON, ET AL., C.A. No. 3:154A2% 15- SLqb

-Jpx

LOMBARD v. BAyER FTEALTHCARE PHARMACET.]-IrCAIS, rNC., ET AL., 15 -5L04TO1-

C.A. No.2:15-03120

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 JIA

C.A. No.3:14-05670

REIMAN v. JOIINSON & JoHNSON, ET Al." C.A. No. 3:1s-01610 t< 'LLq I -I{l.lDistrict of District of Columbia

HELLER v. BAYER HEAITHCARE PIIARMACEUTICAIS, INC., C.A. No. I : I 4-0 1 953 15 :

Northem District of GeorEia

PRESLEY v. JOHNSON & JOHNSON, Er AL., C.A. No. l:15-01293 ls- JL13 fv-,7

Soutlem District of Illinois

BULLARD v. BAYER HEALTHCARE PIIARMACEUTICALS, INC., ET AL.,\L; - tLq{ Sgf

C.A. No. 3:15-00038

BUSH v. JANSSEN R-ESEARCH & DEVELOPMENT, LLC, ET Al., C.A. No. 3 : 1 5-004 52 l* A J\

lzr

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 5 of 6
CASE 0:15-md-02642-JRT Document 1-1 Filed A8lL7lI5 Page 2 ot 2

District of Marvland

a" n 11

GRoSSMAN v. JoHNSoN & JOHNSON, ET AL., C.A. No. l:15-01082 It' 

'Lq'/ 

TP-TDistrict of Minnesota

SMITH v. JOHNSON & JOHNSON, ET Al., C.A. No. 0:14-05021

District of Nebraska

o

BLACI(MoN v. BAYER HEALTHCARE PIIARMACEUTICAIS, INc., ET N',15 - Jlqb 5Vf

C.A. No.4:15-03020

Southern District of New York

SPIEGEL v. JoHNSoN & JoFINSoN, ET Ar., C.A. No. 1:15-03021 15 ' bLql 50I

Westem District of North Carolina

KING v. BAYER CORPORATION, ET At., C.A. No. 3: I s-00 | 9a | !' bb\ |

Middle District of Pennsvlvania

IIEFFELFINGER, ET AL. v. BAYER SEALTHCARE PHARMACEUTICALS, INC.,l5 '?3OflW

ET AL., C.A. No. l:15-00479

District of South Carolina

MORRIS v. BAYER HEALTHCARE PIIARMACEUTICALS, INc., Er AI., | 5 -bb -lU-T

C.A. No. 4:15-O1322

Westem District of Washington

- . ^,1

BAUGHN v. JOHNSON & JOHNSON, Er AL., c.A. No. 3: 15-05283 15' frU\

Case 3:15-cv-01610-VC Document 34 Filed 08/18/15 Page 6 of 6