IN THE SUPREME COURT OF THE STATE OF MISSISSIPPINO. 2004-UA-02524-SCT

AMERICAN HOME PRODUCTS CORPORATION;WYTH-A YERST LABORATORIS COMPANa Division of American Home Products Corporation;A. H. ROBINS COMPANY, INCORPORATED APPELLANTS-DEFENDANS

VS.

MY SUMLIN APPELLEE-PLAITIFF

BRIEF OF APPELLANT WYTH

Appeal of Interlocutory Orders of Honorable Robert G. Evans, Circuit JudgeCircuit Cour of Smith County, Mississippi

ORA ARGUMENT REQUESTED

Kenneth W. Baron (M #2093)William M. Gage (M #8691)LeAn W. Nealey (M #8497)BUTLER, SNOW, O'

STEVENS & CANADA, PLLC17th Floor, AmSouth PlazaPost Office Box 22567Jackson, Mississippi 39225-2567(601) 948-5711

Robert D. Gholson (M #4811)BUR & FORM LLPPost Office Box 6523Laurel, Mississippi 39441-6523(601) 425-0400

ATTORNYS FOR APPELLAN WYTH

IN TH SUPREME COURT OF THE STATE OF MISSISSIPPINO. 2004-UA-02524-SCT

AMRICAN HOME PRODUCTS CORPORATION;WYTH-AYERST LABORATORIS COMPANYa Division of American Home Products Corporation;A. H. ROBINS COMPAN, INCORPORATED

VS.

APPELLANS-DEFENDANS

:.-

MY SUMIN APPELLEE-PLAITIFF

CERTIF1CATE OF INTERESTED PERSONS

The undersigned counsel of record certfies that the following listed persons have an

interest in the outcome of ths case. These representations are made in order that the Justices

of the Supreme Cour and/or the Judges of the Cour of Appeals may evaluate possible

disqualification or recusa1:

Myra Sumin - Appellee/Plaitiff

William R. Couch - Counsel for Appellee

Richard J. Lajuane - Counsel for Appellee

Deake-Couch Law Firm - Counsel for Appellee

Subria L. Cooper- Counsel for Appellee

Thomas Q. Brame, Jr. - Counsel for Appellee

Wyeth and AH Subsidiar Holding Corporation (hereinafer "Wyeth") - Appellants

Dr. Steve Morrs - Defendant

Robert D. Gholson - Counsel for Wyeth

Daniel D. Wallace - Counsel for Wyeth

Bur & Forman, LLP - Counsel for Wyeth

-Wiliam M. Gage - Counsel for Wyeth

LeAn W. Nealey - Counsel for Wyeth

Kenneth W. Baron - Counsel for Wyeth

Butler, Snow, O'Mara, Stevens & Canada, PLLC - Counel for Wyeth

Mark K. Tullos - Counsel for Wyeth

The Tullos Law Fir - Counsel for Wyeth

J. Robert Ramsay - Counsel for Wyeth

Amanda Clearan Waddell- Counsel for Wyeth

Ramsay & Hamond, PLLC - Counsel for Wyeth

Anand Agneshwar - Counsel for Wyeth

Arold & Porter LLP - Counsel for Wyeth

Fred L. Bans, Jr. - Counsel for Wyeth

James Shelson - Counsel for Wyeth

Phelps Dunbar - Counsel for Wyeth

On August 3, 1998 , A.B. Robins Company, Incorporated was merged into American HomeProducts Corporation ("AHC") and ceased to exist as a separate entity. On March 11 , 2002, AHCchanged its name to Wyeth. Additionally, on June 30, 2001 , Wyeth-Ayerst Laboratories Company wasmerged into AH Subsidiar Holding Corporation and ceased to exist as a separate entity. Thoughoutths brief, these Wyeth defendants will collectively be refered to as "Wyeth"

Mark S. Howard - Counsel for Steve Morrs III

Wil1 1:1

TABLE OF CONTENTS

Page

CERTIFICATE OF INERESTED PERSONS ........................................................................... i

TABLE OF CONTENTS ................ ............................... .........

"""'"'''''''' .................... ..

;... ......... iv

TABLE OF AUTHORITIES.... ....... .............. ......... .......... ............ .......... ....... ............. .......... ...... vi

STATEMENT REGARING ORA ARGUMNT

....................................................... ............

PREbIMARY STATEMENT .....

..... ........... """'" ... ... """""""" ..... """""'" ... ....... .....,.. ....... ...

STATEMENT OF ISSUES.... .............

."'"'''''''' "'''''''''''' ............. ""'"'''' ....................... '"'''''''' ...

STATEMENT OF THE CASE..... ..................

.................... ....... .............. .............. ............ ...........

A. Wyeth's Motion to Dismiss Sum' s Lawsuit Based on Her Lack ofMedical Eligibility. ............................................................. .............................................. ...

The Diet Drg Litigation and the Class Action Settlement .......................................

Medical Eligibilty Under the CAS.....

............. ........ ........... ....... ........... ......................

Wyeth' s Right to Challenge Medical Eligibility Under the CAS. ..............................

The Basis for Sum' s Lack of Medical Eligibility .................................................

Course of Proceedigs and Disposition Below Relating to Wyeth' Motion to Dismiss. .................... .............................................. ........

...... .... ........ ...... ..

B. Wyeth' s Motion to Transfer Venue............................................................. ............. .........

C. Wyeth's Petition to ths Cour for Interlocutory Appeal and for Stay ofTrial Cour Proceedigs

.... ......... ......................... ............ .................... ........ ""'"'''''''''''' ....

SUMY OF TH ARGUM

............. ..... ..... ........ ""'" ....... .......... "'"'' .......... ........... .... ..

ARGUMNT AN AUTHORIIES.......... ..........

.......... ....... ........ ......... """"""'"'' '"'''''' ....... ..

A. Standard Of Review................ ......................

"""'"'''''' "'"'''''''' "'"'''''''''''''' .... ......... .........

B. The Trial Cour Should Have Dismissed Sumin' s Case For Lack OfEligibilty To Sue Under The CAS.. .......... ...... ......... ................ ....... ...........

'''''' .... ...........

.19

The CAS Establishes Wyeth' s Right to Challenge -- and the TrialCour' s Responsibilty to Decide -- whether a Class Member IsEligible............................ .............................................. ""'..................................,.. ..

The Trial Cour Improperly Strpped Wyeth ofIts Right underthe CAS to Challenge Eligibility. ...

................ .............. .."""'''.''''''.'' .... .........

The Trial Cour Improperly Refused to Make EvidentiarDeterminations Regarding Sumlin s Standing ...............................................

The Trial Cour Improperly Delegated its GatekeepingFunction Under Daubert

................ ................ ....................................... ....... ..

Applyig Either a Standing or a Daubert Standard , Sumlin s ClaisShould Be Dismissed. ............. ""..............

.""""'''''''' .......... .................... ......... ...... ..

C. - - The Trial Court Should Have TransfelTed Ths Case To Wayne County- Because Venue In Smith County Is Improper ...............................................................

:...

CONCLUSION .......................................................................................................................... .3 5

CERTIFICATE OF SERVICE .............

............. ....... ....... .......... ... ... ... "'"'' ........ ................. .......

.3 6

CERTIFICATE OF FILING ........................ ......

.... ..... ............................................. ..................

.3 7

TABLE OF AUTHORITIES

State Cases

3M Co. v. Johnson 895 So. 2d 151 (Miss. 2005)......................................................................... .19

Baptist Memorial Hospital-Desoto Inc. v. Bailey, 2005 WL 1385129 (Miss. , June, 2005) .................................................................................................................. .. , 18 , 33 , 34

Caldwell, et al. v. Am. Home Prods. Corp. , et al. No. 2002- 113 (Jones Cty. , June, 4(03)

" ........ ... ..... "'''''''' ................... . "'" ""'" "'"'''' """""""'" """ ........ """'"'''''' '" ""'" ......

Capital City Ins. Co. v. B. "Boots " Smith Corporation 889 So. 2d 505 (Mss.2004) ........................ .......................................................................... ......... ... , 16, 18 , 19, 33 , 34

Desoto Inc. v. Bailey, 2005 WL 1385129 (Miss. , June 2 2005) .................................................. .34

East Ford, Inc. v. Taylor 826 So. 2d 709 (Miss. 2002) ................................................................

Facilities, Inc. v. Rogers- Usry Chevolet, Inc. 908 So. 2d 107 (Miss. 2005)..............................

Fairley v. George County, 800 So. 2d 1159 (Miss. 2001).............................................................

In re Consolo Diet Drug. Litg. (Fenfluramine-Dexfenfuramine-Phentermine),No. Misc. #PHF-OOI(Tex. First Adm. Jud. Reg. , ApI. 25 , 2003) ..........................................

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty., N. , Dec. 14 2004) ............................

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , N. , Sept. 23 , 2004).... , 12, 13

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , N. , Dec. 9 2004) ....... , 12, 13

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , N. , July 22 2004) ........... , 12

In re Diet Drug Litig., No. BER- 13379 (Bergen Cty. , N.J. , June 1 2005) .................. .10, 30, 32

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , N. , May 6 , 2005) ............. , 12, 13

In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , NJ, Februar 24 2005) .................. , 13

In re Diet Drug Litig. No. BER- 7718-03 (Bergen Cty. , N. , Apr. 13 2004) ........ , 28, 30

In re Ph en-Fen Litigation Revised Case Management Order No. 15 (phila. Cty.Pa. June 1 , 2005)...................................................................................................................... ..

Jones v. State 2005 WL 1712995 (Miss. 2005) ............................................................................

McClendon v. State 539 So. 2d 1375 (Miss. 1989) .....................................................................

Mississippi Transp. Com 'n v. McLemore 863 So. 2d 31 (Miss. 2003) ...................................

Namihira v Bailey, 891 So. 2d 831 (Miss. 2005)........................................................... ....... ... , 33

Poole ex rei. Wrongful Death Beneficiaries of Poole v. Avara 908 So. 2d716 (Miss. 2005)

"'"'''''' ....... ................... ........ .................. ............... ............,... .......... '"'''''''' .....

Progressive Cas. Ins. v. All Care, Inc. 2005 WL 1384232 (Miss. App. 2005) ............................

Quitman County v. State 910 So. 2d 1032 (Miss. 2005).............................................................. .19

, ,.

Snyder v. Logan 905 So. 2d 531 (Mss. 2005) ....................................................................... .18 , 33

Walters v. Walters 519 So. 2d 427 (Miss. 1988) .........................................................................

Wiliams v. Stevens 390 So. 2d 1012 (Miss. 1980)............................................................

;..........

Wilson, et al. v. Wyeth, et al. No. 2002-88 (Holmes Cty., Aug. 19 2002).................................. .24

Federal Cases

Daubert v. Merrell Dow Pharmaceuticals 509 U.S. 579 (1993)......... , 18 , 19

In re Diet Drug Litig. IvL 1203 (B. Pa. Nov. 14 2002) .............................................. , 29, 31

In re Diet Drugs Prods. Liab. Ling. No. 002859 275 F.3d 34 (3d Cir. 2001)(table) ......................................................... ....................... .......................................... ........

......... 6

In re Diet Drugs Prods. Liab. Ling. No. 1203 990 F.Supp. 834 (B.D. Pa. Jan. 61998) ........................................................................................................ ....................................

In re Diet Drugs Prods. Liab. Ling. No. 1203 , PTO 2654 (B.D. Pa, Nov. 252002) ... ...................

........................................... ........ ................................................... .....

..... 8 . 22

In re Diet Drugs Prods. Liab. Ling. No. 1203 , PTO 2662 (B.D. Pa. Nov. 262002) ..................................................... ............................. ...................................................... ..

In re Diet Drugs Prods. Liab. Ling. Nos. 1203 and 99-20593 , PTO 1 415 2000WL 1222042 (E.D. Pa. Aug. 28 2000) ............................................................................ , 8

In re Silca Prods. Liab. Litig. MDL No. 1553 2005 WL 1593936 (S.D. Tex.June 30, 2005)..............................................................................................................................

Kumho Tire Co. v. Carmichael 526 U.S. 137 (1999) ...................................................................

Statutes and Rules

Miss. Code An. 9 11-11- 11..............................................................................................

Vll

Miss. Code. An. 11- 11-3.................................................................................................... .33

Miss. R. App. P. 34...... ..........

........... ................... """""""'." ............. .""""."'''''''' ............... "...... ...

Miss. R. Evid. 104..... .................................................

....... ..... .............................. ........ ..... ..... ..... .....

Miss. R. Evid. 702........... .......

............. ........................... ..... ......... ............. ....... .............. ........ ....

, 26

Other Authorities

83 AM. J. CARDIOLOGY 897 (1999)..... .......................... ....

'"'''' .'."'''''''''' ......... ....... ............. ............

Arur . Weyman Priciples and Practice ofEchocardiography (2d ed. 1994) ............... , 11

Harey Feigenbaum Echocardiography (5th ed. 1994) ..................................................................

P. Singh, et al. Prevalence of Clincal Determants of Mitral. Tricuspid andAortc Regugitation (The Framngham Hear Study)

...... ...... ....... ............................ ........ ..........

Zoghbi, Willam A., Enrquez-Sarano , Maurce, et aI. Recommendations forEvaluation of the Severity of Native Valvular Regurgitation with Two-dimensional and Doppler Echocardiography, Joural of the American Societyof Echo cardiography. Vol. 16 (July 2003) ...................................................... ......................... .12

-_._.._._-------------..._._ .-

viii

IN THE SUPREME COURT OF THE STATE OF MISSISSIPPINO. 2004-UA-02524-SCT

AMRICAN HOME PRODUCTS CORPORATION;WYTH-AYERST LABORATORIS COMPANa Division of American Home Products Corporation;A. H. ROBINS COMPAN, INCORPORATED APPELLANS-DEFENDANTS

VS.

MY SUMLIN APPELLEE-PLAITIFF

STATEMENT REGARING ORA ARGUMNT

Pusuant to Mississippi Rule of Appellate Procedure 34, Wyeth respectively submits that

oral arguent would assist the Cour. Ths appeal presents for the first tie a signficant and

theshold question of plaitiffs medical eligibility to sue under the Diet Drug Nationwide Class

Action Settlement which will recur in potentially dozens of diet drg lawsuits pending in

Mississippi state and federal cours, as well as other issues confrontig tral cours in Mississippi

where these diet drg cases will be tred.

IN THE SUPREME COURT OF THE STATE OF MISSISSIPPINO. 2004-UA-02524-SCT

AMRICAN HOME PRODUCTS CORPORATION;WYTH-A YERST LABORATORIS COMPANa Division of American Home Products Corporation;A. H. ROBJNS COMPAN, INCORPORATED

VS.

APPELLANTS-DEFENDANTS

MY SUMJN APPELLEE-PLAITIFF

PRELThNARY STATEMENT

In ths pharaceutical product liability case, Plaitiff Myra Sumlin asserts a medicaly

and legally unupportable clai of hear valve regugitation purortedly caused by Redux, a diet

drg formerly marketed by Wyeth. Under a Nationwide Class Action Settlement Agreement

CAS"

),

Sum was requied to meet specific medical criteria in order to be "eligible" to sue

Wyeth. However, the Honorable Robert G. Evans, Circuit Judge in Smith County, Mississippi

failed to conduct an assessment of Sumin' s eligibility as required by the CAS and by

Mississippi law. In ths respect, the tral cour commtted reversible error.

-...,.. . -----_....-.-

The CAS is central to ths appeaI. The right of ths plaitiff -- who did not fully opt out

of the settlement -- to pursue her tort action against Wyeth is governed exclusively by its tenns.

As bargaied-for consideration for ths and other rights, as well as for Wyeth' s agreement to pay

up to $3.75 bilion into an independent settlement trst, the CAS grants Wyeth the right to

challenge whether plaintiffs who attempt a so-caled "downstream" opt-out are medically

eligible" to sue. Ths theshold question tus on whether a plaitiff has been diagnosed with a

prescribed level of hear valve regugitation based on an echocardiogram in accordance with a

delineated methodology.

In ths case, Wyeth proffered detailed expert evidence, though affidavit and live

testimony, demonstrating unequivocally that Sumlin s echocardiogram suffered from techncal

deficiencies renderig any attempt to quantify regurgitation medically uneasonable, as well as

that her diagnosis failed to satisfy a host of interpretative criteria generally accepted with the

medical community and mandated by the CAS. The plaintiff, by contrast, proffered a cursory

expert affdavit that asserted only a diagnosis without scientific support that failed to address the

litany -of echocardiographic and diagnostic inrmities identified by Wyeth. Confronted with

these extraordiarly lopsided presentations, however, the tral court made neither the requisite

theshold determination of Sumin s eligibility nor an evidentiary assessment of relevance and

reliability under standards governg the admssibility of scientific testimony. Rather, the cour

improperly delegated its responsibilities in ths regard to the jur by applyig a Rule 56 sumarjudgment standard and declarg the presence of unspecified disputed facts.

The tral cour's analysis of Sumin s eligibility under a sumar judgment framework

deprived Wyeth of its bargaied-for substantive pre-tral medical review of her clai, in essence

allowing a class member to sue Wyeth so long as her expert says she is medically eligible. Its

ruling directly contravenes Wyeth' s rights under the express languag qfthe CAS , and invites a

flood of litigation based on jun science of the tye both the CAS and this Cour' s evidentiar

rules are designed to prevent. It also stands in stark contrast to the rulings of other cours around

the countr, and is ireconcilable with the tral cour's own rUing in a prior diet drg case that

the CAS eligibilty inquiry is ak to one of standing or subject matter jursdiction.

The tral cour below, moreover, compounded its eror by permtting Sumin to assert her

medically unsupportable claim agaist Wyeth in an improper venue. This Cour's established

precedent regardig the venue statute operative here holds that, where one defendant in a multi-

defendant case resides in Mississippi, the in-state defendant' s county of residence provides the

only proper venue. In this case the lone in-state defendant resided in Wayne County at the time

suit was filed. Moreover, the plaintiff filled her Redux prescriptions in Wayne County and lived

in that county at the time she took the drug. Nevertheless, the tral cour denied Wyeth' s motion

to transfer venue without explanation and improperly allowed the plaintiff to pursue her lawsuit

in Smith County.

Having granted Wyeth' s Petition for Interlocutory Appeal, ths Cour now should reverse

these rulIngs ofthe trial cour.

STATEMENT OF ISSUES

Whether the tral cour violated Wyeth's right under the CAS to have Sumli'eligibility determned by the Cour as a theshold matter.

Whether the tral court improperly delegated to the jur its gatekeeping fuctionunder Daubert and Miss. R. Evid. 104 and 702.

Whether the trial cour erred in denyig a change of venue in light of the clearprecedent of Capital City Ins. Co. v. B. "Boots Smith Corporation and itsprogeny.

STATEMENT OF TH CASE

Wyeth' s Motion to Dismiss Sumln s Lawsuit Based on Her Lack of MedicalEligibilty.

The Diet Drug Litigation and the Class Action Settlement.

The clais at issue in the diet drug mass tort litigation generally -- and in this case in

parcular -- involve left-sided hear valve regugitation allegedly resulting ITom the ingestion of

Redux and/or Pondimin two appetite suppressants that were prescribed over the years by

thousands of physicians to treat the serious health problem of obesity. Hear valve regugitation

often referred to as a hear murur, is the backward flow of blood though the mitral or aortc

hear valves. Whle lesser levels of hear valve regugitation are common and insignficant

greater levels are less common in the general population. The undisputed record evidence in ths

case, for example, reflects that approximately 75% of the population, and up to 90% of those in

Plaintiff Myra Sumlin' s gender and age group, have minor amounts of mitral regurgitation -- the

tye alleged by Plaitiff Myra Sumlin. Tr. 12- 13. Hear valve regurgitation can be diagnosed

through a non-invasive ultrasound of the hear called an echocardiogram.

More precisely, the hear chambers are connected by valves that open to allow blood to

pass through and then close to prevent leakage in the opposite direction, or regugitation. Ths

litigation focuses on the left side of the hear and the following components: the mitral valve

which separates the two left chambers (the left atrli from the left ventricle); and the aortic

valve, which separates the left ventrcle from the aorta. R.E. 39; R 471. The left atrum and left

ventrcle continuously fill and empty in a two-phase cardiac cycle comprised of diastole (durg

which the hear muscle relaxes and chambers fill) and systole (durg which the hear muscle

contracts). Id. ; see also RE. 632; R 478 (hear diagrams). In diastole, the mitral valve is open

to permt the flow of blood from the left atrum into the left ventrcle and the aortc valve is

closed to prevent reverse flow (regugitation) of blood from the aorta into the left ventrcle. Id.

In systole, by contrast, the left ventrcle contracts and pumps blood though the open aortic valve

into the aorta, and the mitral valve closes to prevent regugitation of blood from the left ventrcle

into the left atrum. Id. Mitral regugitation, therefore, occurs only durg systole and aortc

""------.. --

regugitation only occurs in diastole. True regugitation lasts thoughout the relevant phase of

the cardiac cycle, that is, mitral regurgitation lasts throughout systole and aortc regugitation

throughout diastole. The degree of valvular regugitation is assessed as none, trace, mild

moderate or severe.

Color doppler echo cardiography is the technique most commonly used to assess valvular

regugitation. RE. 70; R 504. Color Flow Doppler is the principal Doppler modalty utilized

and is the technque requied by the CAS. RE. 39; R. 471. Durg Color Flow Dopplerecho cardiography, Doppler ultrasound technology is used to detenne the velocity and diection

of the movement of blood though the hear and hear valves. The machine assigns different

colors to blood cells based upon the velocity and direction in which the blood cells are moving.

RE. 39-40; R 471-72. Regugitant blood is high-velocity and tubulent in nature, resulting in a

multi-colored or mosaic pattern on the echocardiogram. RE. 40; R 472.

The primar claim in diet drg cases is that the long-term ingestion of diet drgs can

cause individuals to develop mitral or aortic regugitation that is detectable and quantifiable by

echocardiography.

In December 1997, all federal diet drg actions against Wyeth were transferred to the

United States Distrct Cour for the Eastern Distrct of Pennsylvana for coordinated pretral

proceedings. In re Diet Drugs Prods. Liab. Litig. No. 1203 , 990F.Supp. 834 (E.D. Pa. Jan. 6

1998) (ADD 212-214). Two years later, a tentative $3.75 billion settlement of a nationwide class

was reached. Followig one of the most extensive notice campaigns in history, as well as a

lengty fairness hearg, the settlement class was certfied and the CAS received distrct cour

approval on August 28, 2000. In re Diet Drugs Prods. Liab. Litig. Nos. 1203 and 99-20593

PTO 1415 , 2000WL 1222042 (E.D. Pa. Aug. 28 , 2000) (R.E. 447-503). Final judicial approval

was reached on Januar 3 , 2002, after all appeaIs were exhausted. In re Diet Drugs Prods. Liab.

Litig. No. 002859 275 F.3d 34 (3d Cir. 2001) (table) (ADD 215).

Medical Eligibilty Under the CAS.

The CAS gave class members a choice of initialy optig out or remaining in the class.

Sumin, who clais to have mitral hear valve regugitation, chose to remain in the class and

remain bound by its terms. In an unprecedented benefit in the history of class actions, the CAS

granted to class members "Intermediate Opt-Out" or "Back-End Opt-Out" rights to sue Wyeth in

the state or federal cour system. . To exercise these so-called "downstream opt-out" rights, class

members must be medically eligible under specific parameters set fort in the CAS. RE. 26-31;

R. 149-54 (CAS 99 IV. , IV.DA). Among other thngs, they must have been "diagnosed by a

Qualified Physician as FDA Positive by an Echocardiogram." RE. 26 58; R 149 , 151 (CAS 99

IV. , IV.DA.a).

The CAS defines "FDA Positive" by specifying both the quantitative and qualitative

standards for evaluatig the echocardiogram used to diagnose regurgitation. First, quantitatively,

class members claiing mitral regugitation are eligible only if diagnosed with moderate or

greateimitral regugitation based on specified echocardiographic views. RE. 16; R. 139. (CAS

9 I.22.b). The requisite level of mitral regugitation is defied under the CAS in accordance with

the Singh2 scale as:

Mitral Valve -- Moderate or greater regugitation, defied asregugitant jet area in any apicaI view equal to or greater thantwenty percent (20%) of the left atral area (RA/AA).

!d.

Second, qualitatively, the CAS mandates that the echocardiogram upon which a plaitiffrelies to demonstrate FDA Positive regugitation must be performed and evaluated by "qualified

medical personnel" in accordance with specific protocols found in leading texts on

echocardiography authored by Harey Feigenbaum, M. and Arhur Weyman, M. RE. 15;

138 (CAS 9 I.22.b (citations omitted)). These texts authoritatively establish the accepted

. . -

. _A. .

scientific methodology for performg echocardiograms -- includig such matters as identifyg

the correct settgs on the echocardiogram equipment and descrbing how to appropriately

measure regugitant jets.

2 J.P. Singh, et aI. Prevalence of Clincal Determants of Mitral. Tricuspid and Aortc

Regugitation (The Framingham Hear Studv), 83 AM. 1. CARIOLOGY 897 (1999) ( Singh ). The Singhcritera are incorporated into the CAS by reference and defie different levels of valve leakge from theaortc and mitral valves. R.E. 108; Tr. 11.

Harey Feigenbaum Echocardiography (5th ed. 1994) ("Feigenbaum

Arur E. Weyman Prciples and Practice of Echo cardiography (2d ed. 1994) (' 'Weyman

Under a federal injunction issued by the diet drg MDL cour, class members who do not

timely and properly" exercise downtream opt outs in accordance with these CAS requiements

are bared from filing suit agaist Wyeth. In re Diet Drugs Prods. Liab. Litig. Nos. 1203 and

99-20593 , PTO 1415 2000 WL 1222042 (E.D. Pa. Aug. 28 , 2000) (R.E. 447-503).

Wyeth 's Right to Challenge Medical Eligibilty Under the CAS.

To safeguard Wyeth' s agreement to be sued only by "eligible" class members, the CAS

grants to. Wyeth the right to chalenge eligibility:

, at any time after a Class Member exercises (a downstream opt-out) right, the Class Member initiates a lawsuit seekig to pursue aSettled Clai agaist (Wyeth) or any other Released Par, theReleased Par shall have the right to challenge, in such lawsuitonly, whether the opt-out was timely and proper. includingwhether the Class Member was eligible to exercise such an opt-outright.

RE. 27- , 59-60; R 150- , 153-54 (CAS 99 IV.D.3. , IV.D.4.c) (emphasis added).

Although the United States Distrct Cour for the Eastern Distrct of Pennsylvana retais

exclusive jursdiction to interpret and enorce the CAS , the CAS specifically vests in traI cours

authority to adjudicate challenges to eligibility. In re Diet Drugs Prods. Liab. Litig. No. 1203

PTO 2654 (E.D. Pa. Nov. 25, 2002) (ADD 258 - 263).

Thus, in assessing eligibility, a tral cour must determe whether the plaitiff received a

proper, reliable diagnosis of FDA Positive hear valve regugitation in accordance with CAS

procedures. The importance of enforcing the CAS' s eligibility requiements canot be over-

emphasized, as the diet drg litigation has been plagued by an unortate history of dubiousclaims, jun science and questionable arangements between plaintifs lawyers

echocardiogram techncian and reviewig cardiologists. Memorandum and Pre-Trial Order

2640, In re Diet Drug Litig., :ML 1203 (E. Pa. Nov. 14 2002) (R.E. 594-631). Regrettably,

such abuses have become al too common in diagnosis-drven mass tort litigation, as fuer

evidenced by a recent, watershed opinion from the U.S. Distrct Cour for the Southern Distrct

of Texas exposing thousands of unfounded diagnoses of the lung disease silicosis. See In re

Silca Prods. Liab. Litig. MDL No. 1553 2005 WL 1593936, at *60 (S.D. Tex. , June 30 2005)

The word ' litigation ' implies (or should imply) the search for truth and the quest for justice.

But it is apparent that trth and justice had very little to do with these diagnoses otherwse

more effort would have been devoted to ensurg they were accurate.

- "

il diet drg litigation, ths confluence of factors has spawned a multitude of lawsuits

based on" inappropriate and indefensible science. Indeed, the importance of meangful

eligibility review is parcularly well-ilustrated by the strng conclusions of a New Jersey state

cour over the past eighteen months. Thousands of diet drg claiants fied suit against Wyeth

in New Jersey pursuant to the CAS's downstream opt out provisions. With the aid of

independent court-appointed experts, the New Jersey cour in charge of that state s diet drg

litigation has held six evidentiar heargs regarding the eligibility of numerous plaitiffs. The

independent experts have found that the vast majority of plaintiffs do not have medically

reasonable diagnoses under the CAS and hence are ineligible to pursue their downstream opt out

clais, As the New Jersey court noted in December 2004 when it denied varous plaitiffs

motion to stay the process that cour had implemented to hear and decide challenges to

eligibility:

Durg the eligibility heargs (held to date), the experts appointedby the Cour advised it that in over 43% of the 49 cases underreview, the echocardiograms were found to be so techncallydeficient that no meangfu medical conclusion could be drawnfrom them. These same experts opined in an astonishing 89.8% ofthese cases that the plaitiffs' expert reached medicallyuneasonable conclusions.

In re Diet Drug Litig. No. BER- 13379 at 25 (Bergen Cty. , N.J. , Dec. 14, 2004) (R.E. 243;

App. XI accompanying Wyeth' s Petition for Interlocutory Appeal ("Petition

)).

Indeed, the New Jersey cour repeatedly has found through its eligibility hearngs that

(t)he initial reports of (plaitiffs' expert) physicians with respect to virtally all these

challenged echocardiograms signficantly overstate the pathology observed. In re Diet Drug

Litg. No. BER- 13379 at 16- 18 (Bergen Cty. , N.J., Dec. 9, 2004) (R.E. 272-74; App. XII

accompanyig Wyeth's Petition).6 To date, Wyeth has challenged eligibility in approximately

. ,

660 New Jersey cases. Plaintiffs chose not even to oppose Wyeth' s challenges in 414 of those --

an implicit admssion that that their cases were based on patently unsound diagnoses. What'

more, of the approxiately 240 eligibility challenges left for the tral cour to evaluate, the court

dismissed more than 205. In other words, the New Jersey cour' s eligibility review to date has

resulted in the voluntar or cour-ordered dismssal of an astounding 94% of the several hundred

cases in which Wyeth thus far has had the opportty to chalenge eligibility. Absent that

cour' s meangfl eligibility assessments, Wyeth would have been forced to litigate, and the

cour would have been forced to entertai, each of those meritless claims though discovery, tral

and beyond.

.... ---.--...-.- -.------- --- ---..-----

See a/so In re Diet Drug Ling. No. BER- 13379 at 17 (Bergen Cty., N. , Dec. 9, 2004) (RE.273; App. XI accompanying Wyeth' s Petition); In re Diet Drug Litig. No. BER- 13379 at 12 (BergenCty. , N. , Sept. 23 , 2004) (R.E. 393; R 285) (six of seven echocardiograms unacceptable); In re DietDrug Ling. No. BER- 13379 at 12 (Bergen Cty. , N. , July 22, 2004) (R.E. 427; R. 251) (six of tenechocardiograms unacceptable); see a/so In re Diet Drug Ling. No. BER- 13379 at 22 (Bergen Cty.

, May 6, 2005) (ADD 136) (72% of the regugitation deterations made by the plaintiffs expertwere not medically reasonable); In re Diet Drug Litig. No. BER- 13379 at 23 (Bergen Cty., N.J., June, 2005) (ADD 23) (78% of the regugitation detenations made by the plaintiffs ' expers were not

medically reasonable).

See a/so In re Diet Drug Ling. No. BER- 13379 at 11- 12 (Bergen Cty. , N. , Sept. 23 , 2004)(R.E. 392-93; R. 284-85); In re Diet Drug Ling., No. BER- 13379 at 12 (Bergen Cty. , N. , July 222004) (R.E. 427; R 251); In re Diet Drug Litig. No. BER- 13379 at 12 (Bergen Cty. , N. , July 222004); see a/so In re Diet Drug Ling. No. BER- 13379 at 15 (Bergen Cty., N. , May 6 2005) (ADD129); In re Diet Drug Litig. No. BER- 13379 at 17 (Bergen Cty., N. , June 1 2005) (ADD 17).

In the New Jersey litigation, Judge Charles Walsh, who presided over these cases

identified the same infIrmities that are present in ths case and found that they rendered the

echocardiograms methodologically deficient and medically uneasonable.

First, Judge Walsh dismissed the claims of dozens of plaitiffs whose echocardiograms

were performed with grossly deficient Nyquist settings. Every color Doppler echocardiogram

machie has varous settings that must be adjusted by the sonographer to permit a reliable

visualization of regugitant blood flow. One of those settings, called the Nyquist limt

establishes the velocity above which blood flow will be depicted on the echocardiogram screen

as a "mosaic " multi-colored pattern instead of as a solid or lamar color. When blood flow

appears as a multi-colored pattern, emanates backward from the valve and meets certin other

requiements, it is considered regugitation. RE. 40; R 472. If however, the Nyquist limt is

set inappropriately low, normal, low velocity blood flow will exceed the Nyquist velocity and

wil appear as regurgitation, even though it is actually flow that would not exceed a properly set

Nyquist limt. ld. Thus, the Nyquist limt must be set sufficiently high to permt accurate

visualization of regugitation with a mium of distorton.

Overwhelmng and generally accepted authority agrees that the Nyquist limit must be set

--- -.-

'-_"_0"_'". -.

. ----.

at least over 50 cm/sec, and preferably over 60 em/see, to permt a medically reasonable

diagnosis of FDA Positive valvular regurgitation. RE. 115- 17; Tr. 18-20; RE. 41- , R. 473-

74. The Weyman text, for example, provides that an appropriate Nyquist limit at which to image

regugitation is between 60-90 em/sec. RE. 47, R 481. Similarly, the American Society of

Echocardiography ("ASE") gudelines, which codify generally. accepted practices, allow for a

Nyquist of no less than 50 em/sec. RE. 69- , R. 503-28 (Zoghbi, Wiliam A., Enrquez-

Sarano, Maurce, et aI. Recommendations for Evaluation of the Severity of Native Valvular

Regurgitation with Two-dimensional and Doppler Echocardiography, Joural of the American

. "

Society of Echocardiography, Vol. 16:7 , 777-802 (July 2003) (statig that standard technque is

to have a minimum Nyquist limt of 50 em/sec. and that lower settings can introduce "substantial

error

In short, an inappropriately low Nyquist limit makes lower velocity, non-regugitant

blood flow appear as tubulent, high velocity regugitant flow, thereby exaggerating the

. -

appearance of any regugitation present and making it medically impossible to accurately

quantify regugitation. RE. 115- , Tr. 18-20; RE. 41- , R 473-74.

- -

Judge Walsh repeatedly rejected, under the CAS and New Jersey s version of Daubert

the plaintiffs ' arguents that Nyquist limts lower than 50 can pass muster. See, e. , In re Diet

Drug Litig. No. BER- 13379 at 17- 26-31 (Bergen Cty. , NJ, July 22 2004) (R.E. 432-

33; 437; 441-46; R 256-57; 261; 265-70); In re Diet Drug Litig. No. BER- 13379 at 12-

19-22 (Bergen Cty., NJ, Sept. 23 , 2004) (R.E. 393-95; 400-01; R 285-87; 292-93); In re Diet

Drug Litig. No. BER- 13379 at 24- , 29- , 33- , 76- , 101 (Bergen Cty. , NJ, Dec. 9

2004) (R.E. 280-81; 285-86; 289-94; 332-35; 357); In re Diet Drug Litig. No. BER-L-13379 at

68- , 101- 106, 137- 139, 153- 155 , 168-171 (Bergen Cty. , NJ, Februar 24 2005) (ADD 337-40;

370-75; 406-08;422-24; 437-40); In re Diet Drug Litig. No. BER"L-13379 at 27- 31- 33-

, 53- , 55- , 71- , 80- , 88-89 (Bergen Cty. , NJ, May 6, 2005) (ADD 141-42; 145-46;

147-49; 167-68; 169-70; 185-86; 194-95; 202-03).

Second Judge Walsh dismissed dozens of clais because the plaitiffs ' techncian had

characterized as "regurgitation" a fleeting jet lastig no more than a frame or two of the cardiac

cycle. As Judge Walsh and virtally every expert found, tbs "backfow" does not, under any

reasonable methodology, constitute tre regugitation. Rather, tre mitral regugitation must last

thoughout systole. See, e. , In re Diet Drug Litig. No. BER- 13379 at 12-14 (Bergen Cty.

, July 22 2004) (R.E. 427-29; R 251- 53); In re Diet Drug Litig. No. BER- 13379 at 19-

103 (Bergen Cty. , NJ, Dec. 9, 2004) (RE. 275-76; 359); In re Diet Drug Litig. No. BER-

13379 at 34, 41- , 45 , 47- , 128- 130, 133- 135 , 143- 145 , 164- 166, 176- 181 , 186- 187 , 194- 197

(Bergen Cty. , NJ Februar 24, 2005) (ADD 303; 310-11; 314; 316-19; 397-99; 402-04; 412- 14;

433-35; 445-50; 455-56; 463-66); In re Diet Drug Litig. No. BER- 13379 at 90-92 (Bergen

Cty. , NJ, May 6 , 2005) (ADD 204-06).

, ,.

Third and perhaps most egregiously, Judge Walsh found that in some cases plaitiffs

experts" measured regugitation in the wrong par of the cardiac cycle, a mistae so grave as tot ,.

be incomprehensible when coming from traied individuals. See, e.g In re Diet Drug Litig. No.

BER- 13379 at 66- , 89- , 108-109 (Bergen Cty. , NJ, Dec. 9, 2004) (R.E. 322-29; 345-47;

. .

364-65); In re Diet Drug Litig. No. BER- 13379 at 82-84 (Bergen Cty. , NJ, May 6, 2005)

. -

(ADD 196-98).

Fourth Judge Walsh found that on a number of occasions plaitiffs

' "

experts" traced

colors that under any reasonable methodology did not constitute actual regugitation and/or

. ;

vastly undertaced left atral areas. Of course, expanding the area of the regugitant jet or

decreasing the area of the left atrum wi arificially increase the amount of apparent1 ,;

regugitation. See, e. , In re Diet Drug Litig. No. BER- 13379 at 12- , 23-34 (Bergen Cty.

. i: , Sept. 23 2004) (R.E. 393-94; 404- 15; R. 285-86; 296-07); In re Diet Drug Litig. No. BER-

13379 at 50- 53 (Bergen Cty., NJ, Dec. 9, 2004) (R.E. 306-07; 309).

j. , ,

The Basis for Suml' s Lack of Medical Eligibilty.

The record in the instant case establishes that the FDA Positive diagnosis proffered by

Sumlin is equally baseless as a matter oflaw.

Sumlin sued Wyeth after purorting to exercise an Intermediate Opt-Out based on a

December 16, 2002, echocardiogfam which, she asserts, supports her claim of moderate mitr

regugitation; As set fort in fuer detail below, Sum' s echo cardiogram purorting to show.

FDA Positive regugitation is flawed under both the qualitative and quantitative requirements of

the CAS. First, the echo cardiogram is not techncally adequate to allow for any quantification of

. f,mitral regugitation because the Nyquist limit was inappropriately low. Second, even if the

echocardiogram had been techncally adequate, it does not support a medically reasonable

diagnosis of moderate mitral regugitation. To the contrar, Sum' s echocardiogram reveals no

phenomenon meeting accepted medical critera for FDA Positive mitral regugitation, and her

proffer d measurements of regugitant jet area ("RJA") and left atral area ("LAA") used to

quantify her regugitation were made in a medically uneasonable maner, resulting in a gross

over-assessment of the severity of any ' jet.

In support of her eligibility to sue, Sumli relies solely on the conc1usory affidavit of Jay

Libys, M. , in which he opines, in a few cursory sentences, that Sumlin has "Moderate Mitrl

Regugitation as that term is defied in the (CAS)." RE. 33-34; R. 539-40. By contrast, Wyeth

supported its challenge to Sum' s eligibility though the lengty and detailed afdavit and the

live testiony of Sanjiv Kaul, M. , a highy credentialed and recognzed cardiologist elected to

the two most prestigious societies in United States academic medicine: the American Society of

Clincal Investigation and the Association of Amercan Professors. RE. 36-38; R 468-70. Dr.

Kaul testified that Sumli' s echocardiogram is scientifically uneliable and does not meet the

requirements of the CAS because: (1) the study is not techncally adequate to allow for a

reasonable medical diagnosis of moderate mitral regugitation; and (2) the interpretation of the

study relied on by plaintif was not onducted in a medically reasonable maner. In parcular

Dr. Kaul showed the followig:

1. Sumin's echo cardiogram is techncally inadequate. Though the Nyquistlit is set at 54 em/sec. for most ofthe study, it drops to 45 em/sec. at the pointwhere the sonographer ' traces the RJAIAA ratio. RE. 43; R 475. Asexplaied above, a Nyquist lit of 45 ernsec. is inappropriately low -- falligwell under the standards required by the authoritative Weyman text and the ASEGuidelies -- and arficially makes the regugitant jet appear larger than it trly is

r ,.

by causing blood that is not tubulent to alias and appear in a mosaic pattern. RE.115- , Tr. 18-23; RE. 41 , R 473; 475; RE. 69- , R 503-28 (ASE Guidelines)(stating that standard technque is to have a Nyquist limit from 50 to 60 em/sec.

); ,

R.E. 47, R 481 (Weyman Text) (Nyquist limit at which to image regurgitation isbetween 60-90 em/sec.

. c

The echocardiogram was not interpreted in a scientifically sound maner.

a. The purorted mitral regugitant jet measured on Sumin'echocardiogram does not last "thoughout most or al of systole " as the

Weyman text recognzes it must in order to support an FDA Positivediagnosis. RE. 43 , 51; R 475 , 485; Tr. 23- , 33. The fact that the "jet"does not persist thoughout systole is fuer evidence that it is less thanmild in degree. ld.

b. Indeed, the phenomenon traced by Sumin' s sonographer asmitral regugitation" occured durg diastole, the par of the cardiac

cycle in which the mitral valve is open and mitral regugitation canotoccur. Tr. 34 35.

c. The sonographer s tracings of RJA are unsupportable. "Thesonographer improperly includes large areas of low velocity, lamar blueflow and static black blood in the RJA tracing so that the tracing is twcethe size of the actual jet." RE. 43; R 475, Tr. 25-26.

c. The LAA was improperly underestimated because it was notmeasured at end systole (as is required by Weyman), and was measured ina foreshortened view. R.E. 43 , 67; R 475 , 501; Tr. 26-27.

Sum offered no rebuttal to Dr. Kaul' s opinons.

",.

Course of Proceedings and Disposition Below Relatig to Wyeth's Motion toDismiss.

. ;.

On October 26, 2004, Wyeth moved the tral court to dismss the case because Sumli'

echocardiogram was performed and interpreted in an unaccePtable maner in contravention of

l,. the CAS and generally accepted priciples of echocardiography. R 106-528. A hearg was

held on December 3 , 2004, at which Wyeth presented the above-described testiony of Dr.

Kaul. Plaitiff presented vially no evidence at the hearg, relyig instead on her expert'

conclusory affidavit that simply concludes, without explanation, that lithe Nyquist lit was at an

appropriate level" and that Sumlin has "Moderate Mitral Regugitation as that term is defied in

the (CAS)." RE. 33-35; R 539-40.

, -

The tral cour denied Wyeth's Motion in a letter ruing dated December 7, 2004. R.E.

180-81; R 557-58. Applyig a Rule 56 sumar judgment standard, the tral-court made no

substantive fiding other than that the "issue of the FDA positive echocardiogram is a fact issue

, ,

for the jurs determination." RE. 180; R. 557. Wyeth's motion to reconsider, for certification

and fora stay were denied by order dated December 17 2004. R.E. 182-83; R 612-13.

. ,

i i Wyeth' s Motion to Transfer Venue

Wyeth challenged not only Sumli' s echo cardiogram, but also her choice of venue.

,;"

Although Sumlin was a Smith County resident at the time she filed suit, she was a Wayne

County resident at the tie she filled her prescription for and ingested Redux. RE. 151; Tr. 54.

Defendant Morrs was at all relevant times a resident of Wayne County whose medical practice

was located in Wayne County. RE. 191, R 6; RE. 151 , 153 , Tr. 54, 56. Despite the fact that

Smith County has no connection to the case, Sumlin filed ths case in Smith County on the

ground that some of the defendants, including Wyeth, are foreign corporations. See Miss. Code;.2

An 11- 11-11. Although the state legislatue repealed Section 11 11- 11 effective Januar 1

2003 , the statute was in effect at the time Sumlin filed suit in October, 2002.rj1

On November 29 2004, Wyeth moved to transfer venue to Wayne County on the basis of

ths Cour's opinon in Capital City Ins. Co. v. G.B. "Boots " Smith Corporation 889 So. 2d 505

(Miss. 2004). Capital City, as well as the Cour' s more recent decision in Baptist Memorial

Hospital-Desoto Inc. v. Bailey, 2005 WL 1385129 (Mss., June 2, 2005) (decided while ths

matter has been pendig), both make it clear that the only proper venue for ths case is Wayne

County -- the county in which the only resident defendant, prescribing physician Steve Morrs

- M. , resided and practiced. Nonetheless, by order dated December 9 2004 (entered December

2004), the tral cour denied Wyeth' s motion to transfer venue without explanation, and also

denied Wyeth's requests for certification and for a stay pendig appeal. RE. 184-85; R 554-55.

Wyeth' s Petition to this Court for Interlocutory Appeal and for Stay of TrialCourt Proceedings.

On December 22 , 2004, Wyeth fied in this Cour its Petition for Interlocutory Appeal on

eligibility and venue issues, together with its Motion to Stay the tral court proceedings. Wyeth'

Petitio and Motion for Stay were granted by this Cour on Januar 13 2005.

SUMARY OF THE ARGUMENT

The tral court erred by denyig Wyeth's challenge to Sumin' s eligibility to sue. Plaitiff

is a member of a national settlement class who may sue for diet drg related injures only if she

meets specifc medical criteria. The CAS provides the medical criteria and methodology that

must be met before a plaintiff may sue and gives Wyeth the right to contest medical eligibility in

order to preclude litigation by plaintiffs who do not meet these standards. Wyeth moved to

dismiss Sumin' s claim under the CAS because her key piece of evidence--an echocardiogram of

her hear--was performed and interpreted using methodologies that are unacceptable under the

CAS and under generally accepted priciples of echocardiography. Under the CAS and ths

Cour' s own rules concerg the admssibility of scientific evidence, the tral cour was

obligated to decide whether Plaitiff is eligible to sue and whether her FDA Positive diagnosis

was reliable. Instead, the cour below, invokig the sumar judgment standard of Rule 56 and

without any analysis or explanation, improperly delegated its responsibilties to the jur.

Whether Sumin s echocardiogram was performed and interpreted in accordance with the

methods and procedures of science and the CAS is not a question of fact for the jur. It is atheshold question for the tral cour to decide under the CAS. Many cours--includig the Smith

County Circuit Cour in May 2003--have held that the CAS grants to Wyeth the right to make

threshold eligibility challenges lie the one here. Evaluatig eligibility under a sumar

judgment standard exclusively eviscerates that right. Moreover, even if the CAS did not require

tral cours to make this theshold eligibility determination, under this Cour' s rules the tral cour

neverteless was obliged to determe whether the medical evidence concerng eligibility was

scientifically relevant and reliable under Daubert v. Merrell Dow Pharmaceuticals 509 U.S. 579

(1993). The trial cour' s faiure to engage in either of these legal analyses was erroneous.

Additionally, the tral cour also erred when it denied Wyeth' s Motion to Transfer Venue.

In Capiial City Ins. Co. v. G.B. "Boots " Smith Corporation 889 So. 2d 505 , 513-17 (Miss.

2004) (the basis for Wyeth' s Motion), ths Cour declared that the right of a resident co-defendant

to be sued in his county of residence or where the cause of action occured trped the plaitiffsright to sue non-resident co-defendants in the plaitiffs county of residence. Durg the

pendency of ths matter, ths Cour has reiterated ths holding, again retroactively correctig a

situation in which a lawsuit was origially filed in an improper venue. Baptist Memorial

Hospital-Desoto Inc. v. Bailey, 2005 WL 1385129 at *2-3 (Mss. , June 2 , 2005); see also Snyder

v. Logan 905 So. 2d 531 533 (Miss. 2005); Namihira v Bailey, 891 So. 2d 831 , 832 (Mss.

2005). Defendant Steve Morrs, M. , was at all relevant times a resident of Wayne County

whose medical practice was located in Wayne County. RE. 191 R 6; RE. 151 , 153 , Tr. 54; 56.

Although Plaintiff resided in Smith County at the tie she filed suit, she visited Dr. Morrs in his

offces in Wayne County where she was prescribed Redux (R.E. 151; Tr. 54); she filled heri.!

prescriptions for Redux in Wayne County (R.E. 209; R. 47; RE. 151; Tr. 54); and was a Wayne

County resident at the time she ingested and filled her prescription for Redux. R.E. 151; Tr. 54.

Wayne County is the only proper venue--however, the tral cour inexplicably refused to follow

Capital City by transferrng the case to Wayne County.

Wyeth should not be forced to litigate clais that are medically ineligible under the CAS,

and certaiy should not be forced to do so in an improper venue. Ths Cour should reverse the

tral cour's ruling and dismiss Sumlin s claims in toto based on her lack of medical eligibility to

sue. In "the alternative, the Cour should remand the case with instrctions that it be transferred

to the proper venue (Wayne County), where the court should hold a new hearg to assess

Sumlin' s eligibility based on the standard set fort in the CAS and consistent with the tral

court' s gatekeeping responsibilities under Daubert.

ARGUMENT AN AUTHORITIES

Standard Of Review

Where the tral cour has misapplied "the correct legal standards, (ths Cour's) customar

deference to the tral cour is pretermtted. . . for the error has become one of law. 3M Co. v.

Johnson 895 So. 2d 151 , 160 (Miss. 2005). As such, a de novo standard of review applies here

in determg the propriety of the tral cour's application of the sumar judgment standard.

Quitman County v. State 910 So. 2d 1032, 1035 (Mss. 2005) ("(IJf the tral cour applies the

wrong legaI standard, the review of the ruling is de novo. "). Indeed

, "

where. . . the tral judge

has applied an erroneous legal standard, (ths Cour) should not hesitate to reverse. Quitman

910 So. 2d at 1035 (citing McClendon v. State 539 So. 2d 1375 , 1377 (Mss. 1989)).

With respect to Wyeth' s motion to transfer venue, an abuse of discretion standard applies.

See, e. , Capital City Ins. Co. v. B, "Boots " Smith Corp. 889 So. 2d 505 513 (Mss. 2004).

The Trial Court Should Have Dismissed Sumlin s Case For Lack Of Eligibilty ToSue Under The CAS

The CAS Establishes Wyeth's Right to Challenge -- and the TrialCourt' s Responsibilty to Decide whether a Class Member IsEligible

The tral cour, by incorrectly applyig a sumar judgment standard to deny Wyeth'

Motion to Dismiss based on Sumin' s ineligibility, effectively held that a plaitiff s eligibilty to

exercise a downstream opt-out may be based solely on her having received an FDA Positive

diagnosis from a qualified cardiologist -- regardless of the propriety of that diagnosis. The

cour' s approach is at odds with a plain reading of the negotiated CAS , the statements of the

paries to the CAS , the holdings of the federal diet drg MDL judge, the holdigs of other state

cour judges who have had occasion to interpret the eligibility provisions of the CAS, the tral

cour' s own holding in a prior diet drug case, common sense and public policy. It also would

open the door to countless cour-cloggig, exaggerated diagnoses that are medically

unsupportable and impermssible under the agreement' s plain terms. By ignorig the priacy of

the CAS in this litigation, the tral cour: (1) effectively strpped Wyeth of its express, bargaied-

for right under the CAS to challenge Sumlin' s eligibility to sue; (2) side-stepped its duty to

determe whether Sumli has standing to sue and hence whether the cour has jursdiction; and

(3) delegated to the jur its gatekeeping responsibility under Daubert v. Merrell Dow

Pharmaceuticals 509 U.S. 579 (1993). Applyig the proper standard, Sumin' s claims should

be dismissed because she in ineligible to pursue them.

The Trial Court Improperly Stripped Wyeth of Its Right under theCAS to Challenge Eligibilty.

Pursuant to the CAS and the accompanyig federal injunction, Sumlin is bared and

enjoined ftom suing Wyeth unless she "timely and properly exercised" an opt-out right. See In

re Diet Drugs Prods. Liab. Litig. Nos. 1203 and 99-20593 , PTO, 2000 WL 1222042 (E.D. Pa.

Aug. 28 2000) (R.E. 447-503).

As delineated above, the CAS sets fort precise stan ards for determng which class

members are eligible to exercise downstream opt out rights, providing, inter alia that only Glass

members "who have been diagnosed by a Qualifed Physician as FDA Positive by an

Echocardiogram performed (between September 30, 1999 and Januar 3 , 2003 ) are eligible to

exercise a right to Intermediate Opt-Out." RE. 26; R 149 (CAS IV.D.3.a). The CAS fuerprovides that "(Wyeth) shall have the right to challenge. . . whether the opt-out was tiely and

proper, including whether the Class Member was eligible to exercise such an opt-out right."

RE. 27; R 150 (CAS 9 IV.D.3.c). It is unaginable that Wyeth, in negotiating a "right to

challenge... whether the Class Member was eligible to exercise... an opt-out " would have

agreed to permit any class member to sue it without the ability to meanngfully guard against

medically uneasonable claims though some mechansm short of tral by jur. Wyeth paid over

$3.75 bilion to fud the Settlement Trust and effectuate the CAS. Moreover, the CAS is

. ,.

virtally unprecedented in providig certain class members who did not intially opt-out of the

class a:'I1ght to sue Wyeth in the tort system for compensatory damages, subject only to certai

timig and medical eligibility criteria. If the "right to challenge eligibility" for which Wyeth

bargaied is to have any meanng at all, it must encompass an early and meangful

determation regarding whether a purorted FDA Positive diagnosis was proper based on the

standards set fort in the CAS and authoritative literatue.

Notably, ths view is consistent not only with Wyeth' s position but also with that of the

class counel who represented the plaintiffs in the CAS negotiations. In a pleadig fied in

federal cour, class counsel represented that the purpose of the challenge provision was to ensure

that the tral cour shut the door early on uneasonable claims by tossing out those founded on

jun science. Any other result, they said, would "render nugatory the intent of the Settlement"

An interpretation of the Agreement that would prevent Wyeth fromchallengig whether a given opt-out plaintiff actualy had FDAPositive valve disease as defined in the Agreement would gut theanating purose of the Agreement, render its implementigterms wholly ineffective and lead to an uneasonable result... Indeed, the absence of such an opportty would mean that Wyethand the legal system must suffer full blown adjudication of opt-outclais even where they are based on fraudulent or medically bogusphysician "certfications" of a tye that have become all toocommon in the Matrx claims process.

Class members may choose to seek benefits within the CAS by filing a "Green Form " whichincludes an attestation from a physician that the class member has the claimed medical condition. AMatr governs the benefits that a class member will be paid. In ni Diet Drugs Prods. Liab. Litig., No.1203 , PTO 2662 (B.D. Pa. Nov. 26, 2002) (ADD 243-257).

Class Counsel's Reply Memorandum in Support of Wyeth's Motion for Entr of an Order

Establishing a Procedure for Challenging the Eligibilty of Plaintif in MDL 1203 to Exercise

Intermediate or Back-End Opt-Out Rights MDL No. 1203 at 10 (B.D. Pa. May 15 , 2003) (ADD

216-242).

Given that " (t)he priar purpose of all contract constrction principles and methods is

to determe the intent of. . . the contracting pares (Facilties, Inc. v. Rogers- Usry Chevrolet

Inc. 908So. 2d 107, 110 (Miss. 2005)), the views expressed by Class Counsel are dispositive

here. The central ai of the CAS is to secure compensation for deservng class members, while

at the same time empowerig Wyeth to be free from excessive litigation by class members who

have no identifiable injur. See In re Diet Drug Litig. No. BER- 7718-03 at 19-20 (Bergen

Cty. , N. , Apr. 13 2004) (R.E. 522-23; R. 215-16). Thus, as the New Jersey cour charged with

oversight of diet drug cases fied in that state has held, an "early and meangful" eligibilty

assessment is necessar to protect Wyeth's bargained for rights under the CAS. Id. On ths

point, that cour' s analysis could not be more clear or more correct:

It is inconceivable that Wyeth would have insisted on the right tochallenge the IOOs . . . and at the same time would be satisfiedwjth the mechancal gatekeeping suggested by plaintiffs. Afer allsuch a mechancal test would effectively preclude Wyeth fromsuccessfully challengig even outrght fraudulent clais. . . . (Acontrar) interpretation of the CAS .

. .

(would) place(J a hugefiancial burden on Wyeth for apparently no gai. . . . In essencethe bargaied for challenge process . would be viallywortless. .

. .

Id.

The MDL cour has gone to great lengths to ensure that in the context of downstream opt-

out lawsuits such as these, state tral cours have wide latitude to create and implement eligibilty

challenge procedures In re Diet prugs Prods. Liab. Litig. No. 1203 , PTO 2654 at 5 (E.D. Pa.

Nov. 25 , 2002) (ADD 263) ("(I)t is for the opt-out cour to work out when and how

...

(eligibilty is) to be detenned and what tye of hearg, fact-fidig, or other procedure is

appropriate, consistent with faiess and local law. ). Never has the MDL cour expressed the

view -- adopted without explanation by the tral cour below -- that eligibility must be

determed by a jur. Nor is that result contemplated by the CAS' s plai language or the

professed intent of its drafters.

In short, by applyig a sumar judgment standard and allowing Sumlin to pursue her

claim merely by producing a single piece of conflicting evidence (no matter how unsupported)

the tral cour elimated the meangful eligibilty reView to which Wyeth is entitled under the

CAS. The standard applied by the tral cour here, in other words, renders Wyeth's right to

challenge eligibility ' 'virtaIly wortess.

The Trial Court Improperly Refused to Make EvidentiaryDetermiations Regarding Sumlin's Standing.

Because the CAS provides that ineligible claiants may not sue Wyeth, the eligibility

,"'

inquiry is really one of standing -- if the plaitiff is not eligible to sue, the cour does not have

jursdiction over the claim. Indeed, the MDL cour, which oversees and interprets the entie

CAS , has repeatedly explained that Wyeth' s right to challenge an opt-out is a "prelimnar or

theshold matter " and other cours have agreed. See, e. , In re Diet Drugs Prods. Liab. Litig.

No. 1203 , PTO 2654 at 4-5 (E.D. Pa. Nov. 25, 2002) (ADD 262-63). The only difference

between ths case and one of ordinar standing is that here, jursdiction is confered by a class

action settlement agreement rather than the laws of personal or subject matter jursdiction.

Under Mississippi law on standig, it is the tral cour' s duty to make all fmdings of.fact

necessar to determe whether it has jursdiction. Walters v. Walters 519 So. 2d 427, 429

(Miss. 1988) (reversing tral cour where it failed to make "the fidigs of fact necessar to

decide whether jursdiction existed.... ). Ths Cour has liewise held in a varety of analogous

circumstances that tral cours must make factul fidings necessary to determing whether

plaitiff has satisfied jurisdictional prerequisites. See Fairley v. George County, 800 So. 2d

1159, 1163 (Miss. 2001) (tral cour to determine whether plaitiff has substantially complied

with notice requirements before brigig action under Tort Clais Act); see also East Ford, Inc.

v. Taylor 826 So. 2d 709 716-17 (Miss. 2002) (recognzing that upon par' s motion to compel

arbitration, tral cour must make factual fidings concernng preliar issues such as

, .

enforceability of arbitration contract before allowing tral on merits).

. .

As such, the burden of proof is on the plaintif to prove the facts supporting jursdiction

by a preponderance of the evidence. See Wiliams v. Stevens 390 So. 2d 1012, 1014 (Miss.

1980) ("one of the fundamental principles in invoking a cour' s jursdiction is that the

plaitiff...must show a right in himself to invoke the jursdiction of the cour.

Indeed, the very tral cour that rejected Wyeth' s eligibilty challenge here recognzed in a

prior diet drg case that eligibility is an issue of standing that requires specific jursdictional

fidings to be made by the cour at the outset: In order for the court to obtain jurisdiction over

the subject matter the plaitiffs must meet certain eligibility requiements set out in the

Settlement Agreement." RE. 549; R. 310 (James Letter Rulig at 3) (emphasis added). There

Judge Evans held that the importance of Wyeth' s right to challenge eligibility in a prior diet drg

case when it held "eligibility is a theshold issl,e to be determed by. the CQur" though

evidentiar heargs on eligibility. Id. The tral cour' rug in ths case is all the more

puzzlig in light of its wholly inconsistent -- but entirely correct -- recogntion of the

requiements of the CAS in James.

Simlarly, at least two other Mississippi tral cours presiding over diet drg cases have

recognized that a plmntiffs eligibilty to sue requies the cour to make factual determations.

See Order Wilson, et al. v. Wyeth, et al. No. 2002-88 (Holmes Cty. , Aug. 19 2002) (R.E. 550-

51; App. IX accompanyig Wyeth' s Petition) ("(T)his Cour must determe whether the opt-out

,..

was tiely and proper, as well as, whether the Intermediate Opt-Out Plaitiffs are eligible

(medically) to pursue a lawsuit."

);

see also Order Caldwell, et al. v. Am. Home Prods. Corp. , et

al. No. 2002-113 (Jones Cty. , June 24, 2003) (RE. 552-53; App. X accompanying Wyeth'

Petition) ("The merits of the challenges to eligibility shall be detennined by the cour prior to

tral. "

. .

Other cours around the countr have reached consistent conclusions. In addition to New

, ,

Jersey, Pennsylvana and Texas state cours in charge of the diet drg lawsuits filed in thosejursdiCtions recognze Wyeth's right to a meaningfuIeligibiIity challenge. See In re Phen-Fen

. ;

Litigation Revised Case Management Order No. 15 (phila. Cty. , Pa. June 1 2005) (ADD 264-

.;:

69); Order In re Consolo Diet Drug. Litig. (Fenfluramine-Dexenfuramine-Phentermine), No.

Misc. #PHF-OOI at 22-27 (Tex. First Adm. Jud. Reg. , Apr. 25, 2003) (R.E. 575- , R. 407-

12)N. J.; see also In re Diet Drug Litig. No. BER- 13379 (Bergen Cty. , N. , April 13 , 2004)

(R.E. 506- , R 199-200; RE. 520- , R. 213-22).

Thus, by failing to conduct an assessment of Sumin' s eligibility, the tral cour

.;'

eschewed, without explanation, what it and other cours have already acknowledged -- that the

CAS requies a theshold judicial determation of a diet drg plaintifs standig to sue.

Whe downtream opt out cases were filed across the countr, a large porton of those cases werefiled in New Jersey and Pensylvana because Wyeth has operations in those states.

The Trial Court Improperly Delegated its Gatekeeping FunctionUnder Daubert.

Furermore, even if the tral cour had not been empowered by the law of standing to

find facts regarding Sumlin s eligibilty -- and it was -- at a minimum it should have subjected

Sumlin s evidence to scrutiny under Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 U.S. 579

(1993). As recognized by this Court in Mississippi Transp. Com v. McLemore 863 So. 2d 31

35 (Miss. 2003), the admission of expert testimony is governed by Miss.R.Evid. 702 , as amended

on May 29 2003 , as follows:

If scientific, techncal or other specialized knowledge will assistthe trer of fact to understand or to determe a fact in issue, awitness qualified as an expert by knowledge, skill, experiencetraig, or education may testify thereto in the form of an opinonor otherwise, if (1) the testiony is based upon suffcient facts ordata, (2) the testimony is the product of reliable priciples andmethods, and (3) the witness has applied the priciples andmethods reliably to the facts of the case.

Miss.R.Evid. 702 (Rile 702, as amended, is identical to Rule 702 of the Federal Rules of

Evidence).

In applyig Mississippi' s modified Daubert standard, a tral cour must take seriously its

gatekeeping responsibility. McLemore 863 So. 2d at 38 ("The Daubert test has effectively

tightened, not loosened, the alowance of expert testiony.

).

Daubert imposes a speciaI

obligation upon a tral judge to ensure that any and all scientific testiony is not only relevant

but reliable. Kumho Tire Co. v. Cannichael 526 U.S. 137, 147 (1999) (quotation omitted); see

Poole ex rei. Wrongful Death Beneficiaries of Poole v. Avara 908 So. 2d 716, 723 (Miss. 2005)

(to meet the "reliabilty" prong under Daubert the expert's testiony must be "somethg more

than unsupported speculation or subjective belief that is grounded in methods and procedures of

science

In undertakg its gatekeeping responsibility, the tral cour "must make a 'preliminar

assessment of whether the testimony is scientifically vald and of whether that reasoning and

methodology properly can be applied to the facts in issue.

'"

Progressive Cas. Ins. v. All Care

Inc. 2005 WL 1384232, *24 (Miss.App. 2005), quoting McLemore 863 So. 2d at 37; see Jones

v. State 2005 WL 1712995, *7 (Mss. 2005) ("The gatekeeping fuction of the tral cour is

consistent with the underlyig goals of relevancy and reliability in the Rules.

Ii is the burden of the par advancing expert testiony to prove, and not the opposing

par' s job to disprove

, "

that the expert has based his testimony on the methods and procedures

of science, not merely his subjective beliefs or unsupported speculation. McElmore 863 So. 2d

at 36. To assist tral cours in makg this determation Daubert provides 'an ilustrative, but

not an exhaustive, list of factors ' that tral cours may use in assessing the reliability of expert

testiony. (citation omitted). Id. The focus of ths analysis "'must be solely on priciples and

methodology, not on the conclusions they generate.

'"

Id at 36-37. Thus, before accepting the

conclusory affidavit of Sumn s expert as sufcient to permt a jur to determe the issue of

eligibility, the tral cour should have fist applied the "ilustrative " list of factors under Daubert:

(1) whether the theory or technque can be and has been tested; (2)whether it has been subjected to peer review and publication; (3)whether, in respect to a parcular technque, there is a high knownor potential rate of error; (4) whether there are standardscontrollig the technque s operation; and (5) whether the theory ortechnque enjoys general acceptance with a relevant scientificcommunty.

Id. at 37. Ths the tral cour did not do.

It is precisely ths tye of gatekeeping role that the New Jersey cour overseeing all diet

drg litigation in that state has adopted as the mechansm though which it assesses eligibility to

sue. Specificaly, that cour concluded, in decidig to implement a procedure for detenngeligibility in all opt out cases before it, that:

(T)he CAS , read in light of federal and state cour evidence ruesalready in place to assess the reliability of scientific evidencepermts Wyeth to disqualify a (downtream opt out) if it establishesthat the perfonnance and/or evaluation of the echocardiogram wasmedically uneasonable as a matter of law. Stated another way,Wyeth can disqualify (a case) if it establishes that the expert'conclusions respecting the echocardiogram supporting the opt-outcould not "reliably flow from the facts known to the expert and themethodology used." (Citations omitted).

In re Diet Drug Litig., No. BER- 7718-03 at 31 (Bergen Cty. , NJ, Apr. 13 2004) (R.E. 534, R.

Q,7). As explaied in ths brief, the New Jersey cour' s subsequent opinions on Wyeth'

eligibility challenges demonstrate that cour's thorough analysis of eligibility issues, and

recogntion of its corresponding duty to dismiss cases in which plaitiffs canot present reliable

medical evidence in satisfaction of CAS eligibility requirements.

Even if the CAS permitted the submission to a jur of confctig expert testimony on

eligibility, under Mississippi law such jur determnations are allowed only if the plaintiff

proffered expert evidence passes muster under the relevance and reliability requirements of

Daubert. Like the standing analysis, the Daubert anaIysis, too, is nowhere to be found in the

tral cour' s decision below.

Applying Either a Standing or a Daubert Standard, Sumlin s Claims. ShouldBe Dismissed.

It is clear on the present record that flaws in the perfonnance of Sumin s echocardiogram

render that study techncally inadequate and wholly uneliable o support her proffered diagnosis

of moderate mitral regurgitation. Moreover, even aside from these flaws in the performanc

her echocardiogram, her expert' interpretation of that study likewise was medically

umeasonable. Simply put, Sumin' s purortedly quafying echocardiogram was not properly

performed in accordance with tJe methodology dictated by the CAS and accepted medical

practice and does not show the requisite levels of valvular regugitation specified in the CAS.

Regardless of whether reviewed as an issue for judicial fact fidig or one of expert

admissibility, ths Cour -- either itself or via direction to the trial cour -- should dismiss

Sumlin' s claims outrght.

The relevant portion of Sumin s echocardiogram was acquired using an impermssibly

low Nyquist setting of 45 em/sec. Wyeth put forth overwhelming evidence that such a low

Nyquist setting is medically uneliable for the detection and quantification of mitral

regugitation, and rendered Sumin' s purorted FDA Positive diagnosis uneasonable. R.E. 36-

, R. 468-77; RE. 108- 136, Tr. 11-39; RE. 146- , Tr. 49-52.

. ,

The authoritative texts "and relevant practice guidelines agree that a Nyquist lit in the40s uneasonably exaggerates the degree of regugitation present and renders any attempt to

quantify a regugitatant jet unreliable. Discussing acceptable Nyquist standads, Dr. Kaul

concured:

Q. . . . Is it medically reasonable in your opinon to perform anechocardiogram to assess mitral regugitation at an arficially lowNyquist limit?

, I thnk that it is -- I would refuse to interpret it.

Tr. 20. By reducing the Nyquist limt to such low settgs, Dr. Kaul explaied

, "

you can make

the regugitation look much, much larger " thereby "creat(ingJ an arficiaI situation where thgs

look much bigger than they realy are." Tr. 21 , 23. In this case, Dr. Kaul contiued, there was

no medical reason whatsoever for the sonographer who acquir d Sumin s echocardiogram to

lower the Nyquist lit into the 40s at the point where the meaSurement was made. Tr. 33.

Other cours, including the MDL cour and the diet drg cour in New Jersey, similarly

have recognzed that echocardiograms conducted using Nyquist limts in the 40s violate

generally accepted scientific priciples for reliable jet quantification. See Memorandum and

Pretral Order No. 2640 In re Diet Drugs MDL No. 1203 at 11-12 (E.D. Pa. Nov. 14, 2002)

(R.E. 604-05; R 169-70) (recogng that, "by adjusting even slightly the settgs on the

machine, a cardiologist or sonographer can infuence and even distort the quality of the image

that he or she sees " and rejecting diagnosis of mitral regurgitation based on echocardiograms

with Nyquist settings in the 40s and below); In re Diet Drug Litig. No. BER- 7719-03 at 17

(Bergen Cty. , N. , Dec. 9, 2004) ("Nyquist limits. . . below the Nyquist limits outlined in the

ASE Standards at 777-78 (50-60 em/see) and in the Weyman Text at 245 (60-90 em/see)"

constitute "obvious deviations from proper echocardiographic practice" and "inate any

observed regurgitant jet.... ) (R.E. 273; App. XII accompanyig Wyeth's Petition).

Dr. Kaul also detailed the numerous ways in which Sumlin's echocardiogram was not

interpreted in a scientifically sound maner. First the purorted mitral regurgitant jet measured

on Sumin' s echocardiogram does not persist "thoughout most or al of systole" RE. 43; R 475;

Tr. 23- , 33. Indeed, the sonographer measured a phenomenon occurg in diastole, when the

mitral valve is open and mitral regugitation canot possibly occur. Tr. 34, 35. These egregious

errors in assessing the timng and persistence of any phenomena were compounded by the

absence of an EKG tracing on the study. Tr. 25.

Second the sonographer s tracings of RJA are unproper because solid-colored or

lamnar, non-mosaic areas representig slow moving blood flow, and even black areas

representig non-moving, static blood, are included in the RJA measurement. R.E. 43; R 475.

Dr. Kaul explaied the concept oflamar flow as follows:

Q. Now, the phrase "lamar flow " what does that meanDoctor?

See also, e. , In re Diet Drug Litig. No. BER- 7719-03 at 13-14 (Bergen Cty. , N. , Apr. 132004) (R.E. 516-17; R. 209- 10); In re Diet Drug Litig. No. BER- 7719-03 at 6- , 17 , 22, 26-(Bergen Cty., N. , July 22 2004) (R.E. 421- , 432, 437 441-46; R. 245-46, 256, 261 , 265-270); In reDiet Drug Litig. No. BER- 7719-03 at 7, 12- , 19-21 (Bergen Cty. , N. , Sept. 23 , 2004) (R. 388393- 400-02; R 280, 285- , 292-94); In re Diet Drug Litig. No. BER- 13379 at 16; 18-20 (BergenCty. , N. , May 6 2005) (ADD 130; 132-34); In re Diet Drug Litig. No. BER- 13379 at 17-19; 21-(Bergen Cty. , N. , June 1 2005) (ADD 17-19; 21-23).

A. Lamar flow is normal flow. . . . And on color Dopplerit(J look(s) as homogeneous color of flow. And if the flowbecomes tubulent, then you get a whole number of differentvelocities and so the -- it appears as a mosaic pattern on color.

Is laminar flow the same as regugitation?

A. Regugitation is ahnost -- is always tubulent because youhave -- it' s lie a nozzle with a garden hose. . .. (L Jet' s say thatthere s water flowig down a garden hose, and you re holdig thegarden hose in a garden, right? And if you are just flowigthough quietly, that's laminar flow , it will just come down. Butyou put your figer on the tip of it to create a jet or put a nozzle in, then the jet that is comig out is always tubulent. It is not

lamar.

Tr. 25-26. Reviewing the RJA measurement on Sumin' s echocardiogram, Dr. Kaul continued:

(T)his is not a regugitation. Ths is where they have drawn the so-called jet, and they haven t even drawn it accurately because thereis no mosaic color. Ths is pure blue, ths color here. It is notmosaic. There s no tubulence, so it's not a jet agai. And thenthey have drawn -- drwn not only on the color, but they have goneway outside the color to draw the size of ths so that they canproduce a number that is large.

Tr. 34.

Third the LAA measurement used in quantifying Sumin' s purorted regugitation was

improperly underestated because it was not measured at end systole, when the left atrum is

largest, in accordance with authoritative literatue and with accepted echocardiography. Tr. 26-

27. Moreover, Sumin' s LAA was measured using a foreshortened view of her left atrum

resulting in fuer underestimation of the RJNLAA ratio. R.E. 44; R. 476.

Agai, other cours are in accord that these tyes of errors render unsound any attempt to

quantify a jet as FDA Positive.

10 See, e. Memorandum and Pretral Order No. 2640 In re Diet Drugs :ML No. 1203 at 15-

(B.D. Pa. Nov. 14 2002) (R.E. 608-09; R. 173-74); In re Diet Drug Litig. No. BER- 7719-03 at 13-18- 19 (Bergen Cty. , N. , July 22 2004) (R.E. 428- , 433-34; R. 252- , 257-58); In re Diet Drug Litig.No. BER- 7719-03 at 14-15 (Bergen Cty. , N. , Sept. 23 , 2004) (RE. 395-96; R. 287-88); In re DietDrug Litig. No. BER- 7719-03 at 20 29- 38-40 53 (Bergen Cty. , N. , Dec. 9, 2004) (R.

What's more , Dr. Kaul testified that, notwithstanding the uneasonably low Nyquist limit

that rendered Sumin' s echocardiogram techncaly inadequate for jet quantification, oit was

apparent ITom the study that she did not have FDA Positive regurgitation:

If you have -. if I saw a regugitant jet, a real regugitation, at thatlow Nyquist I couldn' t tell you how much it was. But I see none orthe closing volume at (an) arificial-- arificially low Nyquist liit.

, I can be sue there is no mitral regugitation. ... If I had seena certai jet, I could not have said ths is the right size of jetbecause I know the jet is too large for that Nyquist lit.

. . .

But here we are sayig there is no jet, and even at the lowNyquist lit, all (that is) defied is a little whiff. So, I can make adiagnosis that ths patient has trace mitral regugitation.

Tr. 51. Dr. Kaul was careful to explai that ths was not a simple difference of opinon among

experts: (T)here s not a matter of opinion that ths is 2 percent or 3 percent. It' s a matter of

doing something totally wrong, and (Sumin' s sonographer and expert) did somethg wrong.

, there is not interreader varability. Ths is somethng else." Tr. 52.

In the face of ths detailed expert testimony fushed by Wyeth in both the afdavit of

Dr. Kaul and though his live testiony, Sum put fort only a conclusory affdavit ITom her

expert which simply stated (without supportg explanation) that "the Nyquist lit was at an

appropriate level" and that Sum has "Moderate Mitral Regugitation as that term is defied in

the (CAS)." RE. 33-34; R 539-40. Moreover, plaitiff conducted no cross-examation of Dr.

Kaul concerng the Nyquist limt or any other medical area at the hearg on Wyeth's Motion to

Dismiss.

At that point, the tral cour was obligated, at a minum, to exercise its gatekeeping

responsibility under Daubert and reject both the conclusory Libys affidavit and the

echocardiogram itself as medically uneliable. More properly, the tral cour should have made a

276 278, 285- , 294- , 297, 309; App. xn accompanyig Wyeth's Petition); In re Diet Drug Litig.No. BER- 13379 at 27, 29; 37 (Bergen Cty., N. , June 1 2005) (ADD 27; 29; 37).

fiding of fact that Sumlin did not satisfy the CAS' s eligibility requisites and that the cour

therefore lacked jursdiction over her clai. Either way, Sumli is not eligible to pursue her

downstream opt out lawsuit and the tral cour erred in denyig Wyeth's motion to dismiss.

The Trial Court Should Have Transferred This Case To Wayne County BecauseVenue In Smith County Is Improper

In denyig Wyeth' s motion to tranfer venue, the trial cour not only ignored ths Cour'

clear pr cedent set fort in Capital City Ins. Co. v. E. "Boots " Smith Corporation 889 So. 2d

505 , 513- 17 (Miss. 2004), but also ignored the unambiguous language of the applicable venue

statute, Miss. Code. An. 11- 11-3 (effective prior to Januar 1 , 2003). Indeed, durg the

L j; pendency of ths appeal, this Cour has reiterated the gudig priciple mandatig reversal of the

tral cour's venue decision:

, '

The venue statutes which control ths case were never designed toremove a resident defendant's right to be sued in his or her owncounty of residence. Moreover, the Legislatue never intended aninterpretation of the venue statutes that would allow a residentdefendant to be sued in the plaintiffs county of residence simplybecause a non-resident defendant, be it an individual or acorporation is joined in the same suit.

, -

Baptist Memorial Hospital-Desoto Inc. v. Bailey, 2005 WL 1385129 at *2-3 (Miss. , June 2

2005); see also Snyder v. Logan 905 So. 2d 531 533 (Mss. 2005); Namihira Bailey, 891 So.

2d 831 , 832 (Miss. 2005).

At ,the time Sumin' s lawsuit was commenced, the general venue statute, Miss. Code

An. 11- 11- , mandated that civil actions "shall be commenced in the county in which. the

defendant or any of them may be found or in the county where the cause of action may occur or

accrue." A permissive option was contaed in the non-resident venue statute, Miss. Code An.

11- 11-11 (now repealed), allowiJ?g that in cases agaist non-residents, a civi action "may be

commenced in the county in which the action accrued or where the plaitiff then resides or is

domiciled." Ths permssive option, however, is not available when a resident is also sued, as in

the case at hand. Capitol City, 889 So. 2d at 513-17.

As ths Cour explained in Capitol City, the mandatory language of Miss. Code An.

9 11-11-3 ("shall be commenced") takes priority over the permssive language of Miss. Code

An. 9 11-11- 11 ("may be commenced"). Accordingly, the "option of suig in the plaintiffs

I': home county is not available to a plaitiff when a resident defendat is sued" (id.

),

even when

non-resident defendants are also in the lawsuit. ll See 'Baptist Memorial Hospital-Desoto Inc.

- .

Bailey, 2005 WL 1385129 at *2-3 (Miss. , June 2 2005).

Because Sumin' s Complait names a Mississippi resident defendant, and there is no

evidence Sumin' clai occured or accrued in Smith County, the general venue statute applies.

As such, venue is only appropriate in the county of residence of Dr. Steve Morrs: Wayne

County. RE. 191; R. 6; R.E. 151 , 153; Tr. 54, 56. Under these circumstances, and in

accordance with Capitol City and its progeny, the mandatory language that was contained in 9

11- 11-3 takes precedence over the permssive language in 11-11-11 and venue is proper only

in Wayne County.

11 Although the facts in Capitol City dealt with the venue statute for a non-resident insurance

company (rather than Miss. Code An. 11-11-11), the Cour explicitly recognized that "the reasonigand logic is analogous" to the now repealed non-resident venue statute. Id. at 515.

, r

CONCLUSION

This Cour should reverse the tral cour's ruling and dismiss Sumlin s clais in totobased on her medical ineligibility, or remand ths case to the tral cour with instrctions to enter

such a dismissal. Alternatively only, if ths Cour fids that reconsideration under the proper

standards is necessar, then the case should be remanded to Smith County Circuit Cour, with

instrctions to transfer to the proper venue, Wayne County Circuit Cour, and with instrctions to

that coUr to determe Sumlin' s eligibility consistent With the proper standards. Wyeth prays for

such other general or specific relief as may be appropriate.

TilS , the 18th day of Januar, 2006.

Respectfully submitted

WYTH

By:Kenneth W. Baron (M 093)Wilam M. Gage (M 8691)LeAn W. Nealey (M #8497)

ITS ATTORNYS

tZi4 11

OF COUNSEL:

BUTL R, SNOW, O' MA STEVENS & CANADA, PLLC17th Floor, AmSouth PlazaPost Office Box 22567Jackson, Mississippi 39225-2567(601) 948-5711

Robert D. Gholson (M #4811)BUR & FORM, LLPPost Office Box 6523Laurel, MS 39441-6523((501) 425-0400

CERTIFICATE OF SERVICE

, William M. Gage, one of the attorneys for Wyeth, do hereby certify that I have ths day

, -

served a tre and correct copy of the above and foregoing document, by mailig same by United

States Mail with postage fully prepaid thereon to the following:

Honorable Robert G. EvansCircuit Cour of Smith CountyPost Office Box 545Raleigh, MS 39153

SMITH COUNY CIRCUIT COURT JUGE

William R CouchRichard L. LajauneDEAKE - COUCH LAW FIRPost Office Box 2072Hattiesburg, MS 39403

, ,

Subria L. Cooper

SUBRIA L. COOPER, P A500 Central Avenue, Suite 300Laurel, MS 39440

. ,

Thomas Q. Brame, Jr.Post Offce Box 301Bay Sprigs, MS 39422

- :;

ATTORNYS FOR PLAIIF

Mark S. Howard513 Cour StreetPost Offce Box 918Waynesboro, Mississippi 39367. 1

ATTORNY FOR STEVE MORRS, il, M.

SO CERTIFIED, ths the 18th day of Januar 2006.

. t WilLIA M. GAGE

CERTIFICATE OF FILING

Wiliam M. Gage, certify that I have had hand-delivered the origial and thee 'copies

of the BRIF OF APPELLANT WYTH and an electronic diskette containg same on Januar

, 2006, addressed to Ms. Bett W. Sephton, Clerk, Supreme Court of Mississippi , 450 High

Street, Jackson, Mississippi 39201.

IA M. GAGE