LNITED STATES DISTRICT COURT

IN THE EASTERN DISTRICT OF MICHIGAN

SOUTHERN DIVISION

NICOLE KINSEY and SOPHIA BERNAL. a minor.

by her Next Friend, FERNANDO BERNAL.

Hon. District.Tudge Judith E. Levy Plaintifls, Magistrate.Tudge Elizabeth A. Stafford

Civil Action No. 15-cv-1 1752

SANDOZ. INC. and MEI.IER. INC..

Defendants.

ROBERT C. DOMOL Pl2854 JILL M. WHEATON P49921

ALAN WITTENBERG P49788 ALISON CARRUTHERS P77745

Attorneys for Plaintiffs Attorney's for Def-endants

3000 Tor.r,n center. suite 1250 2723 South State Street #400

Southfield. MI48075 Ann Arbor. MI 48104

(248) 353-1000 (731)214-7660

PLAINTIFFS' ANSWER TO DEFENDANT SANDOZ'S

MOTION TO DISMISS

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PLAINTIFFS' ANSWER TO DEFENDANT SANDOZ'S

MOTION TO DISMISS

NOW COME the plaintiffs herein. NICOLE KINSEY and SOPHIA BERNAL" a minor

by her Next Friend. FERNANDO BERNAL. b,v and through their attorneys. and in answer to

defendant's Motion to Dismiss. state as follou,s:

1. The plaintiffs admit that this is an action brought b1' the plaintiffs. Nicole Kinse-v--

(Kinsey) and Sophia Bernal. by her Next Friend. Fernando Bernal (SB) (collectively plaintiffs).

against the defendant Sandoz. Inc. and Meijer. Inc. (collectively defendants). The plaintiffs'

allegations are contained in the Complaint. which include negligence and gross negligence: and

breach of express and implied warranties.

2. Plaintiff denies and further states that claims for "wrongful conception" are not

prohibited by'Michigan lan. (See C'icfterlic': r' Sulesin.306 Mich App 14 (2014)). Funher.

claims for "wrongful life'' and ''w'rongful bir-th" are not prohibited b1 Michigan lar"'if the

plaintifl's can prove that the defendants u'ere grossll negligent. C'ichex,icz. supro. Furlher.

plaintiffs have properll'pled claims for breach of express and implied vn'arranties. Therefore. the

reasons set forth herein. the defendant Sandoz's request that this court dismiss all claims asserted

against Sandoz in the plaintiff Complaint should be denied.

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ISSUES PRESENTED

l. Does Michigan law recognize an ordinar,v negligence claim for "wrongful

conception"?

ANSWER: Yes.

2. Does Michigan law recognize a clairn for "r.l'rongful litb" and "wrongful birth" if

the defendant is grossly negligent?

ANSWER: Yes.

3. Have the plaintiff's adequatell'pled claims against Sandoz for breach of warranty?

ANSWER: YES

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CONTROLLING AUTHORITY

Plaintiffs herein rel1, upon Federal Rules of Ciyil Procedure 8.9 and 12(bX6) and the

authorities and case law cited herein.

lll

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TABLE OF CONTENTS

Page

PLAINTIFFS' ANSWER TO DEFENDANT SANDOZ. NC'S

MOTION TO DISMISS ... ......,..i

PLAINTIFFS' BRIEF IN SUPPORT OF PLAINTIFFS'ANSWER

TO DEFENDANT'S MOTION TO DISMISS ... ........1

I. TNTRODUCTION ....... I

II. FACTUAL BACKGROUND ..........1

IIL LEGALSTANDARD.. ........s

IV. LEGALARGUMENT.. .,...5

V. AMENDINGTHECOMPLAINT ...........13

vi. coNCLUSToN ........14

EXHIBITS

A) Complaint:

B) Press Release from Defendant Sandoz:

C) Case Lau,.

5:15-cv-11752-JEL-EAS Doc # 10 Filed 07/27/15 Pg 5 of 22 Pg ID 237
TABLE OF AUTHORIT'IES

Federal Cases Page(s)

A u I o rtt ot i,- e (l o mp o ne n t s H o I d in g:; t, Ko n ul E n gi n e e r i n g

(US District Coufi, Eastern Distrir;t. Michigan 2012) . ... ...12

Bell Atlantic Corp v Tv,ornbly. 550 US 544 at 570 .. .........5

Bennert t, MIS ()orp.,607 F.3'd 1076. 1091 (6tr'Cir.2010) ... .......5

Bishop v Lucent Techs, Inc'..5201,. i"j 516. 5l g ..... .........5

16tr'cir. 2008)

Cichev,icz v Salesin,306 Mich App 1 4 (2014). ......1.6

C.rav,lv'ell v L'erspeden.2012 Westlaw 3307383 (2012) ............8

Detru'dyChuriot Cuble Co..331 Mich 576(1951). .......12

D ov, C' o r ni n g C' o r p o r ct t i o n y W'e a t h e r.y hi e / d,\4u n u ltt c t u r i n g.

790 F. Supp. 2"d 604 (201 1) . . . . . . .12

Fontanv Davis.371 US 178. 182 (1982) ......13

Ickes v. \excare Health.!r.'s/ert.r. t.US District Court. Eastern District

Michigan. Southern Division.20l5) ...........13

Janikort,skit, Bendix Corp..823 F, 2"d 945.951 (6'h Cir. 1987) ............13

Jett.s v* Stev'art Building Clorporution.2l0 West Lavn' 2384931

(Michigan Courl of Appeals.201)1.). .....12

Krq/i v Dr. Leonard's Health C'or1lorution.646 F. Supp. 2''d 882. 890

(Eastern District Michigan 2009) ........10

Ot:erstreet t,N-orden Lctboratorie.s.669 F l'"i 186. 190 (6'1'Cir. 1982) . ..10

Pctck v Daman Corp." 434 F. 3'd 810. 8 14 16'r' Cir. 2014) . . . .12

Price Brothers t, Philadelphia Gear Corp..49 F 2"d 476.42216'r'Cir. 1991) ....10

Renard v. Biczak. 111 l,[W 2d 11 ] ( 1989) . . .......6

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Rouse v l4/esley,494 NW 2"0 7 (1992) .. ....,....7

Salztnan v Maldaver, 24 NW 2"d 16l (1946) . ...1 0

L'andenBusch v Bayer Healthcare Pharntucy, lnc..2014

US Dist. Lexis 48055. pgs. 45-47 ... ......1 l

MCLA 400.2313.... ..........10

MCLA 600.294s(D) .. ......s

MCLA 600.2971...... ..5,6.7

Vl

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PLAINTIFIIS' BRIEF IN SUPPORT OF ANSWER

TO DEFENDANT'S MOTION TO DISMISS

I. INTRODUCTION

This is a civil action that was originalll' brought in the Circuit Court of Wayne County.

Michigan, by the plaintiff Nicole Kinsel' (Kinsey') and Sophia Bernal by her Next Friend

Fernando Bernal (SB) (collectivell'plaintiffs). against the defendants Sandoz. Inc. (Sandoz) and

Meijer, Inc. (Meijer) (collectively defendants). This case was removed to this coufi pursuant to

Sandoz's Notice of Removal on I\4a1' 15.2015. The plaintiffs have asserted claims for

negligence and gross negligence and breach of r.l'arranty against all the defendants.

Michigan law is absolutell'clear that. pursuant to Michigan statute and case lau'. there is

a viable claim for wrongful conception under ordinarl'negligence theories. (See Cichewicz,

supru. MCL 600.2971.) Further. under Michigan statutor)'lau'and case law. there are viable

claims fbr "wrongful lif-e" and "u'rongful birth" against the def-endant if the defendant is grossll'

negligent. (See Cicheu'icz.) Further. under Michigan statutorl'and case la',v. if the defendant is

grossly negligent. it expands the amount of damages allor,''able for a rvrongful conception claim.

(See Chichov'icz and MCL 600.2971(3)(4).)

II. FACTUAL BACKGROUND

A. PLAINTIFF MOTHER BACKGROUND

In 2013. the plaintiff mother (Kinsel'). u,as 391'ears old and gainfullv employed as a

respiratory therapist at a local hospital near Grand Rapids. Nlichigan. The plaintiff Kinsel'

purchased oral contraceptives. namelr'. Introvale. nhich u'as manufactured and packaged b1'the

defendant Sandoz and distributed b1'the defendant NIeiier. The Introvale purchased by the

plaintiff Kinsey was supposed to be packaged in a 13 ri'eek blister package rvith weeks 1-12

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being the active tablets and week l3 was to contain inactive placebos. That unbeknownst to the

plaintiff mother, the Introvale paclcage she purchased in 2013 was not manufactured and

packaged properly. More specifically. the inactive placebo pills were wrongly placed in week 9

of the blister package. The packalring of the Introvale in this fashion was not FDA approved

when it left the defbndant Sandoz. who r,vas the manufacturer.

In late May of 2013" the plaintiff mother began taking the subject Introvale medication

that was manufactured and packaged by'the defendant Sandoz and distributed by the defendant

Meijer. The plaintifftook the medication per the directions contained in the Introvale package.

Specifically. the plaintiff was directed by'the defendant Sandoz to take 1 pill a day from weeks I

- 13. in the specific order that the pills rvere placed within the blister pack.

'Ihe plaintiff mother received a letter in August of 2013 from the defendant Meijer. r'r'ho

distributed the def-ectivell'packagr:d lntrovale. h.r the letter it indicated that there w'as a "Class I

drug recall of this rnedication'' (Introvaie) and due to the def-ect. it ma1'' cause an unintended

pregnancy. The plaintiff mother u,nfofiunatelv became pregnant u'hile taking the wrongll,placed

placebo before receiving the letter.

It should be noted that the plaintiff mother n.as 39 l'ears old'ul'hen she became pregnant.

Plaintiff mother was divorced. In her previous marriage. she had 4 children. B,v choice. plaintitf

mother had not been pregnant for over 12 1'ears. All 4 of her prer ious pregnancies involved

serious cornplications and plaintiff mother nas deemed a high risk patient. As a result. the

plaintiff mother wanted no rnore pregnancies fbr her safetl'and the safety of the child. The risk

w.as simply too high that life altenng complications could result. The plaintiff r-nother $'as not

tr,ving to conceive a child. Insteacl. the plaintitf r.nother relied upon the oral contraceptives that

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were manufactured and packaged by the det-endant Sandoz and distributed by the defendant

Meijer.

That upon learning that the plaintiff mother was pregnant. after the recall by the

defendant. the plaintiff mother began treating w'ith her OB/GYN. That despite all reasonable

effbrts by her OB/GYN to supervise and maintain the plaintiff mother's health while she was

pregnant. there were serious comprlications. During a visit to her OBiGYN's office in January of

2014. her doctor immediately,' hosritalized the plaintiff mother because her blood pressure was

too high and her OB/G\N and thc other specialists were concerned that the plaintiff mother ma.v

have either a seizure. stroke or heart attack. and the1, n'anted the bab1" delivered as quicklv as

possible. as the health of the mother and child n'ere at risk.

On January 21.2014. babl' Sophia u''as born at approximalely 24 weeks by emergency csection at Helen DeVoss Children's Hospital in Grand Rapids. Bab1,' Sophia weighed onll' 1

pound 5 ounces. The plaintiff mother had a long staf in the hospital u,hile she recovered from

the emergency surgery and the ph'vsical and emotional trauma of having delivered a bab1,' under

such dire circumstances.

The plaintiff babl'Sophia continues to have numerous medical problems due to her

premature birth. The plaintiff bat,) Sophia \\'as in the Neonatal Intensive Care Unit for nearll' 6

months. Following her discharge fiom the hospital. the plaintiff babl' Sophia has had numerous

hospitalizations due to medical problerns which are being addressed by the appropriate

specialists at University of Michigan Hospital and other institutions throughout the State of

Michigan.

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B. SECOND RECALI, WITHIN 1 YEAR FOR SAME EXACT DEFECT

The defendant Sandoz recalled the same exact medication (lntrovale) one year prior

because of the same defective packaging. More specifically" one vear before this incident. the

defendant Sandoz issued a national recall indicating that the medication Introvale was improperll,

packaged with placebo tablets mis;takenh'placed in the 9tl' ron,at opposed to the 13tl' row. This

is the exact same mistake that Sandoz made in the instant case. Further. in its first recall in

2012- Sandoz issued a national recall because of the wrongl.v placed placebo tablets. With that

first national recall. Sandoz alerte,d the media and teler,ision. The internet and newspapers

published this national recall. However. during the second recall in 2013. Sandoz did not alerr

the rnedia and. as such. there \\'as no media attention placed on this same exact recall. Clearl.v.

Sandoz was embarrassed b.v having to recall the same medication for the same exact reason at it

did the vear prior. or had lbund or,Lt that sale suf-fered as a result of the public notification in 2012.

Instead of finding out through the media. the plaintiff r,vas infbnned of the recall by a letter sent

b.v the defendant Meijer on August 13.2013 that carne too late. If the defendant Sandoz had

earlier announced to the media that there \\'as a recall for this medication or notified olaintifT

earlier by direct coutact. the plaintiff mother u,ould have knou'n about the defective packaging

earlier, which could have prer,'ented the pregnanc)'.

C. EARLY STAGES OF DISCOVERY

It must be noted that r,r'e are in the extreme earlv stages of discover)'. We currentl)'ha\,e

interrogatories out to the defendants asking such questions as w,hen did they realize that the

medication was defectively packa;3ed: horr did thel find out that the medication w,as deiectir,'elv

packaged; what system w'as in place as to alerting the public about this defective mediation: wh1

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\\'asn't there national media attention to this recall. as \vas made 1 1,ear prior to the exact same

defect; etc.?

Fufther, there have been n,l depositions taken. Plaintiff has asked the defendants to

prol'ide the deposition of the person(s) most knowledgeable about recalls. Plaintiff wants to find

out u'hy the medication was packaged incorrectll': what measures were taken after the first recall

to prevent this type of incident from occurring again: rvh.v the media w-asn't alerted after the

second recall. when the defendant knew or should have knou'n about the defective packaging.

III. LEGAL STANDARD

When evaluating the rnerits of a Motion to Dismiss under Rule 12(bX6) of the Federal

Rules of Civil Procedure. the coutt accepts the plaintiff s n'ell pleaded allegations as being true

and construes each of them in a 1i13ht that is most favorable to him. (See Bennett v MIS Corp..

607 F. 3'd 1076. 1091. (6th Cir.2010).) A complaint must contain direct or inferential allegations

respecting all material elements tc, sustain a recoverv under some viable legal theor,v. See Bishop

t,LucentT'ech.s, Inc.-520F.3'd516.51916'r'Cir.2008). Disrnissalisonlyappropriateifthe

plaintiff has failed to offer suff-rcicnt factual allegations to make the asserted claim plausible on

its face. See Bell Atlantic Corp. v Twombly at 550 US 544 ar 570.

IV. LEGAL ARGUMENT

Plaintiffs' claims for neslisence and sross nesliqence should not be dismissed. The

"wrongful life" and/or "*'rongful conception" claims are permissible under Michigan law.

The relevant Michigan statute. narnell,'MLCA Section 600.2971states as follows:

(l) A person sirall not bring a civil action on a wrongful binh claim.

that but for an act or omission of the defendant. a child or children would

not or should not have been born:

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(2) A person sliall not bring a civil action for damages on a wrongful life

claim that" but for the negligent act or omission of the defendant. the

person bringing the action rvould not or should not have been bor.n:

(3) A person shall not bring a civil action for damages for daily living,

medical. ec.ucational or other expenses necessary to raise a child to

the age of rnajority. on a \\,,rongful pregnancy or wrongful conception

claim that. but for an act or omission b-v the defendant. the child would not

or should not have been conceir.ed:

(4) The prohibition stated in sub-section (1). (2). or (3) applies regardless of

w'hether the child is born healthy' or with a birth defect, or other adr,erse

medical condition. The prohibition stated in (1). (2), or (3) does not apply'

to a civil acrtion for damages for an intentional or grossly negligent act or

omission. including. but not limited to. an act or omission that violates the

Michigan penal code . . .

See Michigan Contpiled Laws Section 600.2911: see also Cichev'icz v Salesin.

854 N.W. 2no 901 r.Michigan Courl of Appeals 2014).

In C'ichev,icz. s'upre. the plaintiff brought a medical malpractice case against the

defendant forwrongful birth and,,'nrongful conception. The Court of Appeals specificalll'stated:

Unlike w'rongful b^rtli and u'rongful life claims. u,rongful conception

claims have consistentll'been permitted in Michigan: hon'ever. the

types of damages recoverable in r.r'rongful conception cases have been

disputed. See Chichov'icz aI pg. 905. See also Renat'd v Biczak.44l

NW 2d 441 ( 1989).

In Cichev,icz. the court intercreted MCL 600.2971 and stated:

Contrary to sub-ser:tion (1) and (2). r'r'hich prohibits ci'u'il actions

premised on wrongrful birth and wrongful life claims. sub-section

(3) does not prohiLrit civil actions prernised on r.vrongfirl pregnancy

or wrongful concelrtion claims. Rather. sub-section (3) prohibits

a wrongful pregnanc) or u'rongtul conception claim fbr

''damage for daily lir,'ing. rnedical. educational or other expenses

necessary to raise a child to the age of majoritl"'. But sub-section

(4) provides fbr an exception to that is applicable to each

prohibition statement sub-sections (1). (2). and (3). . . .

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Contrary to defendant's argument. MCL 600.2971 did not

'create' a cause of action for r.l'rongful conception. As discussed

earlier. claims for'*'rongful conception have long been

actionable in this state. although plaintiffs could not recover

as damages "the custornarv cost of raising and educating a

child".

See Roase v ll/e.sle.y.494 NW 2"d 7 1.19921.

The court went on to state that there are actionable claims for u,ronsful birth and

wronsful life:

We conclude that. through MCL 600.2971. the legislature

has spoken in no uncertain terms. and those terms state that

r.l,rongful birth and w.rongful life claims are actionable in

Michigan 'for damages for an intentional or grosslv negligent

act or omission'. llee MCL 600.2971(4). Further. nrongful

conception claims remain actionable in Michigan and damages

related to the cost of raising a child to the age of majority may

be recovered on th: sholl'ing of intentional or grossll' negligent

act or omission.

Clearly. Michigan courts tLave ackno*.ledged that urongful conception claims are viable

causes of action in Michigan. In the instant case. the plaintitThas properly pled numerous

breaches of dutl,as it relates to bcth Sandoz and Meijer. The plaintiff has alleged that the

defendant Sandoz had a dut-v to manufacturer and package the oral contraceptive. Introvale. in

such a manner that is reasonablr' :;afe for its intended users and nackaced in such a manner that

was appropnate

pharmaceuticals

for its use. Further. plaintiff has alleged that Sandoz had a duty to distribute

and/or prescription products such as Intror,ale. that u'ere manufactured and

packaged as approved b1'the Federal Drug Administralion. Furlher. plaintiff has allegedthat the

defendant Sandoz had a dutl'to noti11'the plaintiff that the supplied item w,as not fit to prevent

pregnancies as warranted. Further. plaintiff s Complaint clearll'sets forth numerous breaches in

these duties, which include the far:t that the def-endants failed to comply with packaging standards

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as approved by the FDA. namely. bl"placing inactive placebo pills in week 9 of the blister card.

as opposed to week l3 of the blister card: failed to use due care and caution fbr the safety and

protection of its foreseeable users b5,' packaging the oral contraceptive improperly; failed to

timely notify users, namely, the plaintiff mother. of the dangerous and improperly packaged

product. so as to prevent any harm or danger to the plaintiff mother: failed to notify perspective

users that the defendant had a history,'of not packaging its product in a fashion that wouid make

the product useful for its intended purpose: and failed to notifl'the plaintiff in as urgent as a

mannerpossible as to the uselessness of this svstem to pre\,ent unu'anted pregnancy and potential

compromised life. (See also plaintiff s Complaint).

Additionally, the plaintiff has alleged that the defendant's actions amount to gross

negligence. lnCrav,lv,ell v L'erspeden.2012 Westlau,3307383 (2012). the court noted that a

question of fact was raised by'the plaintiff concerning its claim for gross negligence. This case

involved a motor vehicle accident in a construction zone on I-94 expressw,av. The plaintiff

alleged that the construction zone where the accident occuned \\'as appropriately marked. signed

and appropriate warnings \\'ere posted. but that the det-endant failed to pa)'attention and lailed to

keep his vehicle under control. in spite of the rnan\ r'n'arnings ar-rd the knowledge. actual or

imputed that vehicles ahead of hirr n'ere slou'ing or stopped because of the construction zone.

The defendants argued that plaintiff did not piead sulficient facts to state a claim for gross

negligence or willful or $'anton misconduct.

In Crav,lv,e//. supra. the courl denied the defendant's motion and indicated that:

Taking plaintiff s allegations as true. it is plausible that (the defendants) actions

amount to gross neqligence or n'illful or wanton misconduct. Contrary to r,r'hat

defendants argue. the allegations amount to more than a moment of

inattentiveness. The plaintifTs allege (def-endant) lailed to pay attention to the

'rnany' warnings and failed to control his vehicle. despite knowirrg of stopped cars

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ahead of him. A reasonable juror might conclude. especially in light of the fact

that the (defendant) drove the vehicle at his job. that ignoring many construction

signs and stopped cars on a highn'a1'n'ould amount of a'substantial lack of

concern whether an iniurl'results'. See MCLA 600.2945(D) or'such indifference

to whether harm will result has to the equivalent of a willingness that it does'.

In the instant case. the def,:ndant Sandoz recalled the exact same drug for the exact same

problemjustoneyearbeforetherLextrecall in2013.w'hichisthesubjectofthislawsuit. Inthe

2012 recall" there was national media attention. If one searches the internet for Introvale recalls.

the 2012 recall will be shown in numerous ne\\'s media reporls. magazines and newspapers.

However the 2013 recall is extrenrely difficult to locate on anv internet search engines. The

defendant clearly did not notif,v the medial of this recall. The defendants obviously tried to keep

this quiet. Certainly not a show o I concern for alerring users that ma1,' be affected.

It is plaintiffs' position that the defendant's actions of recalling the same exact drug for

the same exact problem again vn'ithin one vear s time. amounts to gross negligence. In 2012. the

defendant recalled the same drug ior placing the placebo piils in u'eek 9 of the 1 3 lr,eek blister

pack. Clearly" the defendant didn't bother to comect this manufacturing/packaging defect that

occuned and allowed the sarne rnistake to happen again in 2013 and then deliberatel.v

vn'ithholding this fact from the merlia. The plaintiff rnother u'ho lr'as 39 1,'ears old and had a

history of difficult pregnancies. did not want to become pregnant because of the dangers it posed

to her and her baby. Hower''er. because of the defendant's conduct. plaintiff mother became

pregnant and she almost died. PlaintifTmother n'as forced to give birth to the plaintiff bab1,

Sophia at only 24 weeks and she rveighed onh.' 1 pound 5 ounces. The baby Sophia spent the

first 8 months of her life in the NICU at Helen DeVos Children's Hospital. The plaintiff baby'

Sophia is now home" but suffbrs nllmerous serious medical problems. The plaintiff maintains

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that the defendant's actions clearly amount to a substantial lack of concern for whether an iniurv

would result.

Further, plaintiff has alleged breach of express and implied warranties. The plaintiff s

Complaint clearly states that the def'endant expresslv r,varanted that their product was appropriate

and safe for its intended use which included. but not limited it to preventing unwanted

pregnancies.

The Michigan Supreme Cout't has long implicitll'recognized that an express warrantf is

no different than another other term of the contract. See Salzntan v Maltlat,er.24 NW 2''d 161

( 1946). Michigan Compiled Lalr's. Section 400.23 1 3 provides that express warranties are limited

to statements. descriptions. representations. samples and models that are made part of the basis of

the bargain. Neverlheless. the UCC does not require that express wananties be parl of a writter-r

agreement of the parties and express w'arranties ma!'be added by proof of oral wamanties. as long

as the w'riting itself is not a complete integration of the agreement. See Price Brother.s y

Philadetphia Gear Corp," 49 F 2nd 416. -+ll. 16'r' Cir. I 991 ). The trier of fact musr determine

u'hether circumstances necessaril-r'create an express uarrantv are present in anv given case. See

Ot,erstreett',YorclenLtthorutorie.s.66gFl''d186. 190 16'r'Cir. 1982). UnderMichigan'sversion

of the Uniform Commercial Code. advertiser-r-rents and promotional literature can be part of the

basis of the bargain and thus constitute express \\,arranq'*'hen they are prepared and furnished

b1' a seller to induce purchase of ir.s products and the bu1'er relies on the representations. See

Kra.fi v Dr. Leonard's Health Corporution.646 F. Supp.2''d 881.890 lEastern Dist. Michigan

2009).

10

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Fufther, express wananty claints do not require privity of contract. If a manufacturer

makes express warranty to the product's consumer. privit,v of contract is not necessary. See

VandenBusch v Bayer Healthcare Phannacl'. \nc..2014 U.S. Dist. Lexis 48055, pages 15-47.

In the instant case. it is un,Jisputed that Sandoz manufactured lntrovale as a oral

contraceptive. When Sandoz laurrched Introvale. it stated that Introvale is an oral contraceptive

indicated for use by woman to pre vent pregnancv. The u'hole pulpose of why the plaintiff

mother took Introvale was to prevent her from getting pregnant. The plaintiff mother. because of

her age and her long history of ha'ving very traumatic and difficult pregnancies, was taking

Introvale so that she would not become pregnant. r,r'hich would endanger her health and the

baby's health. Unforlunately. the defendant did not properll'package the Introvale. w-hich

directly caused the plaintiff s pree,nancy. In fact. the defendant has submitted under Exl-ribit A. a

printout from the National Health lnstitute daill'med rvebsite. rvhich the defendant indicates the

couft ma.ytake judicial notice of-. In the printout fbr Irrtrovale. it specifically \\,arns users of the

medication that "If you miss pills,,vou could get pregnant. This includes starting the pack

late. The more pills you miss, the more likell'\'ou are to get pregnant." Further. on page 25

of the inserl. it advises the patient if r,ou miss even ''2 pills in a rou,'. you could become pregnant

if you have sex in the 7 da,vs after,vou restafi 1'our pills. and another form of birth control should

be used."

In the case at bar. the plairLtiff mother took 7 placebo pills (neek 9) w'hen she thought

those pills were the "active" pills The defendant expresslv uarranted that Introvale would

prevent unn'anted pregnanc)' if tallen as directed. The defendant breached this express \\,arrant)

by the defective packaging of the pills.

11

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Furlher, the plaintiffhas alleged implied w'ananty. The purpose of the Doctrine of

Implied Warranty is to promote high standards in business and discourage sharp dealings. See

Dev'ade v Chariot Cable C'o.. 33 I Mich 57 6 (195 1). The existence of an implied wananty of

fltness for a particular purpose is ,;snlingent on t\\'o general facts. First, the seller must be au,are

of the particular put?ose for whic h the bu1'er intends to use the goods. and the buyer must rely on

the seller's skill or judgment to select or furnish goods suitable ibr that particular purpose. See

Dov, Corning Corporation v Weathershield Manufacturing. 790 F Supp. 2"d 604 (201 1).

Furlher. plaintiff directs this cour-t Io Jetts t, Stev,art Building Corporation, 210" West

Lan'2384931 (Michigan Coufi of'Appeals. 2010). ln Jets. the Michigan Court of Appeals

detern'rined that plaintiff could bring a claim fbr breach of implied warranty against a brick maker

elen though the bricks had passeclthrough the hands. nho used the bricks to make a structure for

the plaintiffs. The courl found that the fact that the plaintiffs lacked any privity of contract with

the brick maker is of no consequence since the claims involved a breached of implied \\arrant\'.

Similarly. in terms of express \\'arranties. said w,arranties are not limited to the direct sel.ler and

the Michigan Uniform Commercial Code does not indicate that a seller is limited to one rvho

directly'sells goods to the consumer. See Pctckt'Dantan Cot'p..,134 F.3'd 810.81416th Cir.

2014). Thus. there is no particular requirement that an e\press $'arrant)'be limited to a direct

buyer. See Autontotive Components Holding r Konul Engineet'hzg (US District Cour1. Eastern

District Michigan. 20 12).

In the instanl case. the defl:ndant clearll'n'arranted that the purpose of this prodtrct u;as to

prer.'ent pregnancy. The def-endant further w'arned that taking the pills out of order or missing

pills would increase the risk of the pregnanc\,and that other birth control should be used. The

defendant warranted that its product rvas safe for its intended and expected use. However. the

T2

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birth control pills were defective and unreasonabll'dangerous because of the defect in its

packaging. Due to the defect in the packaging. the plaintiff unknowingly took placebo tablets

which were placed in week 9 of the 13 week blister package. As such, she took inactive pills

instead of taking the active pills. ivhich did not prevent plaintiff from getting pregnant.

V. A.MENDING THE COMPLAINT

Finally. plaintiffs submits that their Complaint satisfies Federal Rule l2(b)(6). and

contains sufficient direct and inferential allegations respecting the elements that sustain a

recovery under viable legal theori,:s. Howel,er. if this Honorable Court does not believe that

plaintiff has satisfied Federal Rule 12(b)(6). the plaintiff respectfully requests this Honc,rable

Court allow them to amend their (lomplaint. The 6'h Circuit has emphasized "That the case lau,

in this circuit manifests liberalitf in allouing amendments to Complaints." See Janikou'sfri v

Bendix Corp.,823 F. 2"d 945.951 16'h Cir. 1987). This is because rhe thrusr of the provision is to

reinforce the principal that cases should be tried on their merits. rather than on the techrLicalities

of the pleadings. SeJanikott.ski. .supt'ct. See also lckes v,\'excure Health Systems. US lDistrict

Courl. Eastern District Michigan. Southern Division. 2015).

Further. even though its ri,ithin the discretion of the District Court. "in the absence of anl'

apparent or declared reason. such as undue delal'. bad faith . . . undue prejudice to the c,pposing

party by'virtue olallow'ance of the amendment. . . leave sought should. as the rule requires. be

freely given." See Foman v Davi:;.371 US i78, 182 (1982)

The instant case was recerLtly filed in April 201 5. Even before sen'ice of the Complaint.

the def-endants. on its ou'n doing. found out about the filed Complaint and immediately'removed

the case from State Cour-t to Federal Court. Even befbre filing an ans\\'er. the def-endant.

responded by filing its Motion to Dismiss. pursuant to Federal Rule 12 (bX6). While plaintiff

13

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has sent out initial discovery requests. no discoverl"has really'I'et begun in this case. As such, if

this court does not believe the Complaint satisfies Federal Rule 12(b)(6), the plaintiff should be

allowed to amend tlieir Complain.l to satisf' Rule 12(bX6). It would not cause any undue delay

or undue prejudice to the defendant. Further. at this earlv stage. the plaintiffs are clearly not

showins anv bad faith.

V. CONCLUSION

Therefore. plaintiff respectfulh'requests that this Honorable Court deny defendant's

Motion to Dismiss. pursuant to Ferderal Rule 12(bX6). However. if this Courl is so inclined. the

plaintiff respectfully asks that this Court allou'them to amend their Complaint at this early'stage

of litigation to more thoroughlv articulate its allegations of negligence. gross negligence. express

and implied warranty.

WHERFORE. for the abor e stated reasons herein. the plaintiff respectfr-rllv requests this

Honorable Court deny defendant's Motion to Dismiss: or. in the alternative. allou'plaintiffs to

amend their Complaint to more thoroughll arliculate its allegations against the defendant.

Res pectfi.rl l1' submitted.

LOPATIN & WITTENBERG

B1,:_ is/ Robert C. Dornol

ROBERT C. DOMOL P12854

ALAN WITTENBERG P49788

Attornel's for Plaintiffs

3000 Town Center. Suite 1250

Southf-reld. MI 18075

(248) 353-1000

Dated: Julv 27 .2015

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L]NITED STATES DISTRICT COURT

IN THE I]ASTERN DISTRICT OF MICHIGAN

SOUTHERN DIVISION

NICOLE KINSEY and SOPHIA IIERNAL. a minor.

by her Next Friend. FERNANDO BERNAI-.

Hon. District Judge Judith E. Levy Plaintiffs, Magistrate Judge Elizabeth A. Stafford

Cir.il Action No. 1 5-cv-11752

SANDOZ. INC. and MEIJER. INrl..

Defendants.

ROBERT C. DOMOL Pl2854 JIT,L M. WHEATON P49921

AI-AN WITTENBERG P49788 ALISON CARRU'|HERS P77745

Attorneys for Plaintiff-s Attornel's fbr Defendants

3000 Town center. suire 1250 2723 South State Street #400

Southfield. MI 48075 Ann Arbor. MI 48104

(248) 353-1000 

, 

(734)214_7660

PROOF OF SERVICE

I hereby cerrify that on Ju\t 27 .201 5. I electronicalll. filed the Plaintiffs' Answer to

Defendant Sandoz's Motion to Dirsmiss and Brief in Supporl. r,r'ith the Od,vssey E-File &. Serve

E-Filing System. which will send r;uch filing to all counsel of record.

's Sandra L. Donalc

Sandra L. Donald

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