case 1:14-cv-13234-wgy document 27 filed 11/19/15 page 1 of 12€¦ · 14-cv-13234-wgy boehringer...

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSACHUSETTS

LI LIU and DR. EMILY LIU, ASCO-ADMINISTRATORS OF THE ESTATE OF

DR. ZHENSHENG LIU and PERSONAL

REPRESENTATIVES OF THE HEIRS AT LAWOF DR. LIU,

Plaintiffs,

vs.

CIVIL ACTION NO.

14-CV-13234- WGY

BOEHRINGER INGELHEIM

PHARMACEUTICALS, INC., BOEHRINGERINGELHEIM CORPORATION, BOEHRINGERINGELHEIM USA CORPORATION, andBOEHRINGER INGELHEIM INTERNATIONAL

GMBH

So ordered as the case .xanagementscheduling order, ^

Defendants.

Discovery due,

Disposicive Kotior.b due

JOINT LOCAL RULE 16.1

SCHEDULING CONFERENCE STATEMENT

IT- ^ ^

Pursuant to Local Rule 16.1 of this District, the parties to the above captionedaction, by

their counsel, file their Joint Scheduling Conference Statement as follows;

I. SUMMARY OF CLAIMS

This is a wrongful death action under M.G.L. c. 229 § 2 et seq. Plaintiffs filed their

Complaint on August 5, 2014. Plaintiff served the Complaint upon Boehringer Ingelheim

Corporation, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim USA

Case 1:14-cv-13234-WGY Document 27 Filed 11/19/15 of 12

Corporation ("Boehringer Ingelheim" or "The Defendants") on August 7, 2014. On August 18,

2014, the United States Judicial Panel on Multi-District Litigation ("MDL") ordered this case

transferred to the United States District Court for the Southern District of Illinois as part of In

Re: Pradaxa (Dabigatran Etexilate) Product Liability Litigation, MDL No. 2385. On September

11, 2015, the case was remanded to this Court from the United States District Court for the

Southern District of Illinois as the MDL moved towards conclusion.

The Estate ofDr. Zhensheng Liu wrongful death case is the first case in the national MDL to

be remanded to its original forum for trial following a Six Hundred and Fifty Million

($650,000,000) Dollar settlement that was announced by Boehringer Ingelheim Pharmaceuticals,

Inc. and Boehringer Ingelheim International GmbH on May 28, 2014 following the completion

of fact discovery and implemented thereafter.

On October 14,2015 this case was rc-opcned in this Court.

A) Plaintiffs* Factual Position: Plaintiffco-administrators' claims are based on the wrongful

death suffered in November 2015 by their father. Dr. Zhensheng Liu ("Dr. Liu"), which occurred

while Dr. Liu's was a patient on Defendant's atrial fibrillation blood thinning medicine

PRADAXA. Whileentering his automobile on the afternoon ofThanksgiving Day, November

25,2012, Dr. Liu suffered a modest fall and head injury. Dr. Liu was emergently and initially

treated at Lawrence General Hospital for that injury and thereafter air-lifted to Massachusetts

General Hospital ("MGH") in Boston.

Dr. Liu's head injury, and associated cranial internal bleeding, proximately led to Dr.

Liu's "brain death" at Massachusetts General Hospital in the early morning hours ofNovember


26,2012. Dr. Liuwason life support machinery for four (4) days thereafter but died on

November 29, 2012.

Plaintiff co-administrators will prove that their father's death was and is attributed to the

uncontrollable internal cranial bleedingsuffered by Dr. Liu due to the blood thinner PRADAXA

in his system for which there was then no reversal agent. They will show that but for the

negligently marketed and designed PRADAXA, Dr. Liu would havereceived appropriate neuro-

surgical intervention at MGH and easily survived his injuries.

Based onthe above facts, the Complaint asserts claimsfor (1) wrongful death-negligent

failure to warn; (2) wrongful death-negligent designdefect; (3) wrongful death-negligence; and

(4) wrongful death-punitive damages.

Theheir-at-law of Dr. Liu is hiswife of sixty (60) years. Dr. Julia Song.

B) Defendants' Factual Position: PRADAXA is a prescription drug approved by the United

States Food and Drug Administration in October, 2010 to reduce the risk of stroke and systemic

embolism in patients with non-valvular atrial fibrillation. Atrial fibrillation is a heartarrhythmia

that can lead to the formation of blood clots and cause strokes. Anticoagulants like PRADAXA

help prevent those clots from forming. All anticoagulantscarry a well-recognizedrisk of

bleeding, and the PRADAXA labeling specifically warns about the risks of potentially fatal

bleeding and the absence of a reversal agent. At the timeof Plaintiffs use of andalleged injury

from PRADAXA, the labeling information for PRADAXA explicitly warned as follows:

5. WARNINGS AND PRECAUTIONS

5.1 Risk of Bleeding


PRADAXA increases the riskof bleeding andcan cause significant and,sometimes, fatal bleeding

A specific reversal agent fordabigatran [PRADAXA] is not available.

BIPI denies that it is liable to Plaintiffs. Boehringer Ingelheim USA Corporation and

Boehringer Ingelheim Corporation areseparate corporate entities thatwere not responsible for

the sale, distribution or marketing of Pradaxa, and they deny all liability. On October 19, 2015

defendantsfiled their answers to Plaintiffs complaint.

II. STATUS OF SERVICE/JOINDER

Defendants BIPI, Boehringer Ingelheim USA Corporation and Boehringer Ingelheim

Corporation have been served and filed their answers tothe Complaint. Defendant Boehringer

Ingelheim International OmbH ("BII") hasnot beenserved, but counsel for BIPIagrees to meet

and confer withPlaintiffs counsel on service of BII. Atpresent the parties arenot aware ofthe

identity ofany parties who should bejoinedin this action. Theparties reserve the right to add

additional parties should discovery indicate that suchjoinder would be appropriate.


III. AMENDEMENTS TO THE PLEADINGS

The parties are not presently aware ofany need to amend the operative pleadings atthis point

in this action, but reserve their right to seek leave ofCourt to do so should itbecome necessary in

the future or discovery indicates that amendment is necessary.

IV. CONTEMPLATED DISPOSITIVE MOTIONS/OTHER MOTIONS

A) Plaintiffs* Position: Plaintiffs do not presently anticipate filingdispositive motions under

Federal Rule of Civil Procedure 56 in thecase but reserve the right to bring suchmotions should

discovery reveal a basis for the same. Plaintiffs anticipate that other motions may benecessary

conceming both procedural, discovery-related and substantive matters prior to trial.

B)Defendants' Position: Defendants anticipate filing Motions for Summary Judgment.

Defendants may file othermotions priorto trial as they become necessary.

V. JOINT DISCOVERY PLAN

A) Plaintiffs* Position: Plaintiffs believe that the essential facts pertaining to the specific events

whichgiverise to theirclaims are known, and largely undisputed. There is no genuine dispute

that decedent was taking PRADAXA at the time of his fall; that he struck his head on the

doorway of his automobile and fell backwards to the ground; and that he developed an

inoperable subarachnoid hemorrhage in his brain as a result of the head injuries sustained in the

fall. There is no dispute that there was no reversal agent for PRADAXA at the time of Dr. Liu's

fall. (On October 16,2015, the Defendants announced that the United States Food and Drug


Administration ("FDA") had approved that day a PRADAXA "reversal agent" called

PRAXBIND.) •

Plaintiffsanticipate that this case will require all of the discovery devices and tools,

including interrogatories, document production, and depositions allowed under the Federal Rules

of Civil Procedure 30, 33 and 34 and the Local Rules of this Court. Plaintiff is not yet prepared

to commit to Defendant's proposal regarding fact discovery that originated in the MDL Court;

Plaintiffwill determine, based on the threshold productionof factual discovery and deposition

transcripts from Defendants whether Plaintiff will elect to conduct its own fact discovery and

depositions ofDefendant witnesses. Plaintiff anticipates that the case can be prepared for a

December, 2016 trial and ready for a final pretrial conference in late November 2016 as

indicated below.

The plaintiffs respectfully request that the Court enter a scheduling order consistent with

the following lime table:

Deadline

Joinder of Parties by February 8,2016

Completion of Written Fact Discovery

Service and Responses byMarch 14,2016

Completion of Fact Depositions by June 1,2016

Amendments to the Pleadings by July 1,2016

^Plaintiff shall conduct discovery and depositions ofDefendant witnesses as needed about thedevelopment and marketing of, and the successful application to the FDA and subsequentapproval of the PRADAXA "reversal agent" PRAXBIND which was announced by theDefendants on October 16,2015.


Plaintiffs Identification and Reports ofTrial Experts

July 29, 2016

Defendants Identification and Reports

of Trial ExpertsAugust 29, 2016

Completion of Expert Depositions October 24, 2016

Fed. R. Civ. P. 26(a)(3) Pretrial

Di.sclosuresNovember 4,2016

Dispositive Mdtkips Filed Nj^vimbet^, 2016

Settlemen\conference^^\^^ N^ember 14,20T6v^^Einal PretriaPConference Nov^ber28,2016Trial ^Deteml2^r5,2016

Plaintiffs understand that Defendants will not consent to trial by a Magistrate Judge, therefore

trial will be before this Court, Judge Young.

B) Defendants' Position: Discovery will be required from the Plaintiffs family members and

his treating and prescribing physicians. Plaintiffs production of medical records and written

discovery is largely complete based on information required to be produced by Plaintiff in the

MDL, but some supplementation may be required.

Fact discovery, including document production, was completed in the MDL prior to the

national settlement. This discovery included corporate witness depositions of 24 BIPI and 19

BII employees. Subject to the entry of a Confidentiality Order (proposed below) and reasonable

agreement from Plaintiffs that they will not take duplicative discovery, BIPI will produce the


deposition ti*aiiscripts of these witnesses to Plaintiffscounsel,^ excluding case-specifie witnesses

suchas sales representatives who gave depositions in the first group of bellwether trial eases.

Absent a showing ofspecific need based on new information, none of those individuals should

be subject to new depositions.

Written discovery anddocument production was exhaustive in the MDLand was completed

priorto the national settlement. Subjectto the entry of a Confidentiality Order and reasonable

agreement from Plaintiffs that they will not take duplicative discovery, BIPI will produce its

written discovery responses anddocument production. BIPI has prepared the MDL document

production to be available in a manageable and searchable electronic format that it will make

available to Plaintiffs counsel, excluding documents produced solely forcase-specific discovery

(such as the custodial files of sales representatives who met with a bellwether plaintiffs

prescribing doctor). Counsel for BIPI will also meet and confer with Plaintiffs counsel within

forty-five days to address the potential productionof certain database information not amenable

to production via a searchable, electronic production platform. Absenta showing of specific

need, no additional document production should be required.

The defendants respectfully request that the Court enter a scheduling order consistent

with the following time table:

Deadline

Rule 26 Initial Disclosures December II, 2016

Joinder of Parties by February 8, 2016

^Production of all BII material, including witness transcripts, is subject to an agreement onservice of process and data privacy restrictions.


Completion of Written Fact Discovery

ServiceApril 15, 2016

Completion of Fact Depositions by June 1, 2016

Amendments to the Pleadings by July 1,2016

Plaintiffs Identification and Reports ofTrial Experts (Rule 26 ExpertDisclosures)

July 29, 2016

Defendants Identification and Reportsof Trial Experts (Rule 26 ExpertDisclosures)

August 29, 2016

Completion of Expert Depositions(Plaintiffs experts depositions shall betaken before Defendant's experts)

October 24, 2016

Fed. R. Civ. P. 26(a)(3) PretrialDisclosures

November 4, 2016

DispositivedôtiorRisJ^d October 24^046^^Settlement Conference November 1^2016FiriaTpRidrialô^^rence &Trial To bTsefby^Qît

VI. DISCOVERY EVENTS

Plaintiffs' Position: Plaintiffs believe that the discovery in this matter may meet the discovery

limitations contained with the Federal Rules of Civil Procedure and the Local Rules of this Court

and reserve the right to seek leave of court to exceed those discovery limitations if necessary.

Plaintiffs are not yet committed to use in this case discovery conducted in the MDL. But if


utilization ofsuch materials are made by Plaintiffs the Confidentiality Order proposed by the

Defendants from the MDL Court is acceptable.

Defendants* Position: As set forth above, BlPl and BII have already produced all relevant

corporate witnesses for deposition and completed exhaustive document production in the MDL.

Subject to reasonable agreement from Plaintiffs that they will not lake duplicative discovery,

BIPI will makethosematerials available here in a usable, manageable and cost-efficient manner

that should essentially eliminatethe need for additional document production or written

discovery.

CONFIDENTIALITY ORDER

Given the nature ofthis case and tofacilitate the production ofdiscovery materials already

taken inthe MDL subject toa Confidentiality Order, the Defendants request that this Court adopt

in this case the Confidentiality Order in place in the federal MDL from which this case was

remanded, styled IN RE PRADAXA (DABIGATRAN ETEXILATE) PRODUCT LIABILITY

LITIGATION MDL No. 2385 in the United States District Court for the Southem District of

Illinois ("MDL 2385'*). The Confidentiality Order is attached as "Exhibit A."

VII. PROSPECTS FOR SETTLEMENT

A) Plaintiffs* Position: Plaintiffs are amenable to participating in mediation. They have served

their Rule 16.1(C) written settlement demand on the Defendants.

B) Defendants* Position: BIPI has received and considered Plaintiffs settlement demand. Based

on that demand BIPI deems the prospect ofsettlement at this point unlikely. BIPI remains

willing to participate in mediation.


VIII. CEOTgglCATIONS REGARDING BUDGET AND ABR

A. WCj Al(?x MacDonald. Esq. and Pjaintiffs li Liu and Emily Liu, M.D., hereby

affinn that we have conferred with a view toestablisliing a budget for the costs ofconducting the

full coui'se, and various alternative courses of this litigation; and toconsider theresolution of the

litigation through the use of alternative dispute resolution programs.

Alex H. MacDonald, Esq. Li Liu Emily Liu, M.D.

B. We,Eric Hudson, Esq., and WendyHufford, Esq., the duly authorized

representative of Defendants Boehi'inger- Ingelheim Pharmaceuticals, Inc.,Boehringer Ingelheim

Corporation, and Boehi'inger Ingelheim USA Corporation hereby affirm that we have confen-ed

with a viewto establishing a budget for the costs ofconductingthe full course, and vai'ious

alternative courses of this litigation; and to considerthe resolution of the litigationtlii'ough the

use of alternative dispute resolution programs.

s/ Eric Hudson s/ Wendv Hufford

Eric Hudson, Esq. Wendy Hufford, Esq.

For Boehringer Ingelheim Pharmaceuticals, Inc.,Boehi'inger Ingelheim Corporation,and Boehi'ingerIngelheim USA Corporation

Counsel for PlaintiffsLi Liu and Emily Liu Counsel forDefendantsBoehi'inger IngelheimPhamiaceuticals, Inc.,

Boeliringer Ingelheim Corporation, andBoeliringer Ingelheim USA Cotporation


/s/Alex H. MacDonald

Alex H. MacDonald

[email protected] D. Lurie

[email protected] Robertson

[email protected] LAW GROUP LLC

OneBowdoin Square, 8*'' FloorBoston, MA 02114

(617)747-7550

Boehringer Ingelheim Corporation, andBoehringer Ingelheim USA Corporation

A'/ William Joseph FlanasanWilliam Joseph Flanagan

[email protected] Carpenter

ccarpenter@morrisonmahoney. comMORRISON MAHONEY LLP

250 Summer Street

Boston, MA 02110

(617)439-7500

Eric E. Hudson, admittedpro hac vice

BUTLER SNOW LLP

6075 Poplar Ave, Suite 500

Memphis, TN

(901)680-7309

[email protected]


case 1:14-cv-13234-wgy document 27 filed 11/19/15 page 1 of 12€¦ · 14-cv-13234-wgy boehringer...

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