James Dumas, OSB No. 771671 LINDSAY ... - Zofran Legal...

– NOTICE OF REMOVAL{01056737; 1}

LINDSAY HART, LLP1300 SW FIFTH AVENUE, SUITE 3400

PORTLAND, OREGON 97201-5640PHONE: 503-226-7677 FAX: 503-226-7697

James Dumas, OSB No. [email protected] J. Estok, OSB No. [email protected] HART, LLP1300 SW Fifth Avenue, Suite 3400Portland, Oregon 97201-5640Phone: 503-226-7677Fax: 503-226-7697

Attorneys for Defendant GlaxoSmithKline, LLC

UNITED STATES DISTRICT COURT

DISTRICT OF OREGON

PORTLAND DIVISION

THOMAS BROWN and MARIA DEL CARMENESPINDOLA GOMEZ, individually and as parentsand natural guardians of M.B., a minor,

Plaintiffs,

v.

GLAXOSMITHKLINE, LLC; and PROVIDENCEHEALTH SYSTEM- OREGON d/b/aPROVIDENCE NEWBERG MEDICAL CENTERf/k/a PROVIDENCE NEWBURG HOSPITAL,

Defendants.

Case No________________.

NOTICE OF REMOVAL

[Removal from Circuit Court of the State ofOregon, Multnomah County Case No. 15-cv-

23066]

PLEASE TAKE NOTICE that Defendant GlaxoSmithKline LLC (“GSK”) removes the

state court action entitled Brown, et al. v. GlaxoSmithKline LLC, et al., No. 15-cv-23066, filed in

the Circuit Court of Multnomah County, Oregon, to the United States District Court for the

District of Oregon, Portland Division, pursuant to 28 U.S.C. §§ 1331, 1332, 1441 and 1446.

In support of removal, Defendant GSK states:

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Case 3:15-cv-01918-HZ Document 1 Filed 10/09/15 Page 1 of 12

mailto:[email protected]





1. The United States District Court for the District of Oregon has original subject

matter jurisdiction of this civil action pursuant to 28 U.S.C. § 1332(a) because there is complete

diversity among all properly joined and served parties and the amount in controversy exceeds

$75,0000, exclusive of interest and costs. Under 28 U.S.C. § 1441(b), no party properly joined

and served as a Defendant in this action is a citizen of Oregon, the state in which this action was

filed. As explained below, the citizenship of Defendant Providence Health Systems – Oregon

d/b/a Providence Newberg Medical Center f/k/a Providence Newberg Hospital (the “Healthcare

Defendant”) should be disregarded in applying § 1441 because it was fraudulently joined.

2. On August 28, 2015, Plaintiffs Thomas Brown and Maria Del Carmen Espindola

Gomez filed a Complaint in the Multnomah County Circuit Court, Multnomah County, Oregon,

bearing civil action number 15-cv-23066. Pursuant to 28 U.S.C. § 1446(a), a true and correct

copy of all process, pleadings and orders is attached as Exhibit A, and those materials are

incorporated herein by reference. Plaintiffs’ Complaint alleges that their child, M.B., was born

with multiple congenital heart defects. Plaintiffs contend that Ms. Espindola ingested Zofran®

during her pregnancy. Plaintiffs bring three claims against the Healthcare Defendant: strict

products liability, negligent misrepresentation, and loss of child’s consortium. Against GSK,

Plaintiffs bring claims for strict products liability, negligence, negligent misrepresentation,

fraudulent misrepresentation, and loss of consortium. Plaintiffs seek compensatory damages,

including $25,000,000 in economic and non-economic damages, attorney’s fees and costs, and

any pre- or post-judgment interest recoverable at law. In addition, Plaintiffs intend to seek

punitive damages by asking the court to allow amendment for punitive damages by a separate

request to amend their Complaint as required under Oregon law.

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I. THE NOTICE OF REMOVAL IS TIMELY.

3. This removal is timely. GSK files this Notice of Removal within 30 days of

September 11, 2015, the date of service of the Summons and Complaint upon GSK, as required

by 28 U.S.C. § 1446(b). A copy of this Notice of Removal is being filed this day with the Clerk

of the Multnomah County Circuit Court, Multnomah County, Oregon, and has been served upon

Plaintiffs by mail, as indicated on the Certificate of Service.

4. No previous application has been made for the relief requested herein.

II. VENUE IS PROPER IN THE DISTRICT OF OREGON, PORTLAND DIVISION.

5. The United States District Court for the District of Oregon, Portland Division is

the proper venue for removal under 28 U.S.C. § 1441(a). The Multnomah County Circuit Court,

Multnomah County, Oregon is located within the Portland Division, pursuant to 28 U.S.C. § 117.

Therefore, the District of Oregon, Portland Division, is the “district and division embracing the

place where such action is pending.” 28 U.S.C. § 1441(a).

III. CO-DEFENDANT’S CONSENT TO THE FILING OF THIS NOTICE OFREMOVAL.

6. Because the Healthcare Defendant is fraudulently joined, for the reasons set forth

below, its consent to removal is not required. See 28 U.S.C. § 1446(b)(2).

IV. MULTIDISTRICT LITIGATION

7. On July 6, 2015, GSK moved the U.S. Judicial Panel on Multidistrict Litigation to

transfer all similar federal cases involving Zofran® to the United States District Court for the

Eastern District of Pennsylvania for coordinated and consolidated pretrial proceedings. See In

Re Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657. Not a single Plaintiff

has opposed coordination of the actions. On October 1, 2015, the Judicial Panel on Multidistrict





Litigation (“JPML”) heard oral argument from both GSK and plaintiffs regarding GSK’s Motion

for Transfer. A decision on the Motion for Transfer is expected any day.

V. REMOVAL IS PROPER BECAUSE THIS COURT HAS SUBJECT MATTERJURISDICTION UNDER 28 U.S.C. §§ 1332 AND 1441.

8. This Court has diversity jurisdiction pursuant to 28 U.S.C. § 1332(a) because (1)

the amount in controversy exceeds $75,000, exclusive of interests and costs, and (2) there is

complete diversity between Plaintiffs and Defendant GSK.

A. The Amount-in-Controversy Requirement Is Satisfied.

9. Removal is proper if the court finds, by a preponderance of the evidence, that the

amount in controversy exceeds $75,000, exclusive of interest and costs. See 28 U.S.C. §

1446(c)(2)(B). Where, as here, the Complaint alleges a specific amount of damages, “the sum

demanded in good faith in the initial pleading shall be deemed to be the amount in controversy.”

28 U.S.C. § 1446(c)(2).

10. The Complaint seeks damages not to exceed $25,000,000, including $8,000,000

in economic damages and $17,000,000 in non-economic damages, in addition to attorney fees

and costs, and pre- and post-judgment interest. See Compl., Prayer for Relief.

11. It is thus facially apparent from the Complaint that Plaintiffs’ claims exceed

$75,000.

12. Moreover, because Plaintiff has alleged very serious medical injuries, including

severe and permanent physical, emotional, and psychological injuries, see Compl. ¶¶ 1, 28, 31,

93-94, this Court can and should use its “judicial experience and common sense” in determining

that it is facially apparent from the Complaint that Plaintiff’s claims exceed $75,000. See Roe v.

Michelin North America, Inc., 613 F.3d 1058, 1062 (11th Cir. 2010) (“a district court need not





‘suspend reality or shelve common sense in determining whether the face of a complaint . . .

establishes the jurisdictional amount.’”).

13. Jury verdicts in other cases involving allegations of congenital defects further

demonstrate that the amount in controversy exceeds the jurisdictional minimum. In such cases,

juries routinely have awarded plaintiffs in excess of $75,000 in damages. See e.g., Tobin v. Astra

Pharm., Inc., No. 88-0350-L(CS), 1 Exp. Wit. 22873 (W.D. Ky. March 8, 1991) (awarding $4.5

million to compensate plaintiff for congestive heart failure and heart transplant allegedly caused

by use of defendant’s prescription medication during pregnancy); see also White v. Behlke, 24

Nat. J.V.R.A. 7:C1, 1000 WL 177472 (Pa. Com. Pl. Nov. 17, 2008) (awarding $20.5 million in

damages for birth defects caused by defendant doctor’s malpractice); Estrada v. Univ. of S. Fla.

Bd. of Trustees, 22 Nat. J.V.R.A. 10:C3, 2007 WL 7952305 (Fla. Cir. Ct. July 23, 2007)

(awarding $23.55 million in damages as a result of a doctor’s malpractice that resulted in

plaintiff’s child being born with birth defects). Indeed, numerous cases now pending against

GSK in federal courts across the country assert nearly identical claims as those alleged by

Plaintiffs and seek damages in excess of $75,000.1

1 Allen, et al. v. GlaxoSmithKline LLC, No. 1:15-cv-22563-RNS (S.D. Fla.); Coughlin, et al. v.GlaxoSmithKline LLC, No. 6:15-cv-01815 (W.D. La.); M. Green, et al. v. GlaxoSmithKline LLC,et al., No. 4:15-cv-03130-DMR (N.D. Cal.); Gruhn, et al. v. GlaxoSmithKline LLC, No. 1:15-cv-01436-PAG (N.D. Ohio); Hunter, et al. v. GlaxoSmithKline PLC, et al., No. 2:15-cv-00544-JEO(N.D. Ala.); T. Hogan, et al. v. GlaxoSmithKline LLC, No. 5:15-cv-01182-HGD (N.D. Ala.);Mandoyan, et al. v. GlaxoSmithKline LLC, et al., No. 2:15-cv-04536-JLL-JAD (D. N.J.);Marlenee, et al. v. GlaxoSmithKline LLC, No. 1:150cv-00026-SPW-CSO (D. Mont. July 16,2015; Ragland, et al. v. GlaxoSmithKline LLC, No. 2:15-cv-01053-VEH (N.D. Ala.); Regan, etal. v. GlaxoSmithKline LLC, No. 3:15-cv-01166-JGC (N.D. Ohio); K. Roberts et al. v.GlaxoSmithKline LLC, No. 5:15-cv-01411-JRA (N.D. Ohio); V. Roberts, et al. v.GlaxoSmithKline LLC, No. 1:15-cv-00320-WS-C (S.D. Ala.); Trivisonno, et al. v.GlaxoSmithKline LLC, No. 1:15-cv-01435-JG (N.D. Ohio); Turnage, et al. v. GlaxoSmithKlineLLC, No. 5:15-cv-00070-DCV-MTP (S.D. Miss.); but see Bircher, et al. v. GlaxoSmithKlineLLC, No. 3:15-cv-00787-SMY-DGW (S.D. Ill.); LeClair, et al. v. GlaxoSmithKline LLC, No.1:15-cv-10429-FDS (D. Mass.).





14. Because Plaintiffs’ Complaint alleges explicitly that the amount in controversy is

greater than $75,000 and given the nature of the alleged injuries and claims, it is apparent from

the face of the Complaint that Plaintiffs seek recovery in excess of $75,000, exclusive of interest

and costs. The amount in controversy therefore exceeds the threshold for purposes of diversity

jurisdiction under 28 U.S.C. § 1332(a).

B. Complete Diversity of Citizenship Exists Between Plaintiffs and GSK.

15. Upon information and belief, and based on the allegations in the Complaint,

Plaintiffs were at the time of the commencement of this action, and at all times thereafter through

and including the present time, citizens of Oregon. See Compl. ¶ 2.

16. Defendant GSK is, and at the time the Complaint was filed was, a citizen of the

State of Delaware for purposes of diversity jurisdiction. GSK LLC is a limited liability

company. For purposes of diversity jurisdiction, the citizenship of a limited liability company is

that of its members. Johnson v. Columbia Properties Anchorage, LP, 437 F.3d 894, 899 (9th

Cir. 2006). The sole member of GSK LLC is, and at the time the Complaint was filed was,

GlaxoSmithKline Holdings (Americas) Inc. (“GSK Holdings”). Because Delaware is both GSK

Holdings’ state of incorporation and the location of its nerve center, GSK Holdings is solely a

citizen of Delaware. Therefore, GSK LLC also is solely a Delaware citizen.

17. The citizenship of the Healthcare Defendant should be ignored for purposes of

determining diversity jurisdiction because the Healthcare Defendant was fraudulently joined.

The doctrine of fraudulent joinder constitutes an exception to the complete diversity requirement

and prevents plaintiffs from defeating federal diversity jurisdiction simply by naming non-

diverse defendants. Under the doctrine, a court must disregard the citizenship of non-diverse

defendants where “plaintiff fails to state a cause of action against a resident defendant, and the





failure is obvious according to the well-settled rules of the state[.]” United Computer Sys., Inc.

v. AT&T Corp., 298 F.3d 756, 761 (9th Cir. 2002) (citing Morris v. Princess Cruises, Inc., 236

F.3d 1061, 1067 (9th Cir. 2001)); DaCosta v. Novartis AG, 180 F. Supp. 2d 1178, 1180 (D. Or.

2001).

18. Plaintiffs fraudulently joined the Healthcare Defendant, a local Oregon hospital,

because their claims against the hospital fall within Oregon’s product liability statutory scheme,

and such claims are not viable because the hospital is not a product “seller” within the meaning

of Oregon’s product liability statute. See ORS 30.900 et seq.

19. Plaintiffs brought claims against the Healthcare Defendant of strict product

liability, negligent misrepresentation, and loss of consortium, arising from Plaintiff Espindola’s

alleged use of the prescription drug Zofran® manufactured by GSK. See Compl. ¶¶ 27-33, 54-

60, 69-76, 92-95.

20. Oregon’s product liability statute has been interpreted to apply to all claims

(including fraud) for damages caused by a product. See Marinelli v. Ford Motor Co., 72 Or.

App. 268, 273 (1985) (holding plain language of ORS 30.900 indicated that Legislature intended

statute to apply to “any” claim based on a product defect or failure to warn, including negligence

claims); Kambury v. Daimler Chrysler, 185 Or. App. 635, 639 (2003) (a product liability civil

action “embraces all theories a plaintiff can claim in an action based on product defect” which

includes negligence claims); Simonsen v. Ford Motor Co., 196 Or. App. 460, 466-67 (2004)

(Oregon’s product liability statute embraces all claims based on product defect “including, for

example, negligence, strict liability, breach of warranty, and fraudulent misrepresentation”). The

Ninth Circuit, construing Oregon’s product liability statutes, has reached a similar conclusion.

See Philpott v. A.H. Robins Co., Inc., 710 F.2d 1422 (9th Cir. 1983).





21. The Healthcare Defendant is not a product “seller” within the meaning of

Oregon’s product liability statute. ORS 30.900 et seq. Oregon’s product liability scheme applies

to one who sells or leases any product in a defective condition if, inter alia, “[t]he seller or lessor

is engaged in the business of selling or leasing such a product.” ORS 30.920; see also

McCathern v. Toyota Motor Corp., 332 Or. 59, 73 n. 15 (2001). Oregon courts have strictly

construed this element. See Lancaster v. WA Hartzell & Assoc., Inc., 54 Or. App. 886 (1981)

(cabinetmaker is not liable on a strict liability theory because it was not in the business of selling

wood stain despite providing wood stain to customer to match cabinetry); see also Cafazzo v.

Central Med. Health Servs., Inc., 542 Pa. 526 (1995); Hector v. Cedars-Sinai Med. Ctr., 180

Cal.App.3d 493 (1986) (the essence of the relationship between hospital and patient is the

provision of medical services necessary to effect the implantation of the pacemaker – the patient

does not enter the hospital merely to purchase a pacemaker but to obtain treatment).

22. The Oregon Legislature recently demonstrated its intent to limit the application of

Oregon’s product liability statutory scheme in the context of healthcare providers. ORS 30.902

expressly excludes licensed physicians from the product liability statute’s definition of product

manufacturers, distributors, and sellers where the product at issue was provided by the physician

to a patient as part of a medical procedure and the physician was not involved in the design and

manufacture of the product. See ORS 30.902.

23. The same can be said for the Healthcare Defendant hospital here. Even taking

Plaintiffs’ allegations at face value, there is no claim that the Healthcare Defendant did anything

other than act as a “routine seller” of Zofran®, providing the drug to patients such as Plaintiff

Espindola without having any role or involvement in the design or manufacture of the underlying

drug product. See Compl. ¶ 70; see also id. at 57 (Zofran® provided by Providence Health





reached Plaintiff “without substantial change in the condition in which it was sold”). Moreover,

a hospital such as the Healthcare Defendant necessarily acts through its agents, namely here the

licensed physicians who allegedly dispensed Zofran® to Plaintiff Espindola. Plaintiffs’ claims

against the Healthcare Defendant hospital arise at their core from the alleged conduct of the

physicians who purportedly prescribed Zofran® to Plaintiff Espindola. See, e.g., Compl. ¶ 75

(“Providence Health is directly liable for the negligent conduct of its actual and/or ostensible

employees . . . .”). Therefore, Plaintiffs cannot state a claim against the Healthcare Defendant

because it does not qualify as a product “seller” within the meaning of Oregon’s product liability

statutory scheme.2

VI. FILING OF REMOVAL PAPERS.

24. Pursuant to 28 U.S.C. § 1446(a), a copy of all process, pleadings, and orders in

receipt of GSK, including the Summons and Complaint, are attached as Exhibit A.

25. Pursuant to 28 U.S.C. § 1446(d), GSK will promptly file a copy of this Notice of

Removal with the Multnomah County Circuit Court, Multnomah County, Oregon, and will serve

a copy of the same upon counsel for Plaintiffs. By filing this Notice of Removal, GSK does not

waive any jurisdictional or other defenses that might be available to it. In addition, GSK

expressly reserves the right to move for dismissal of some or all of Plaintiffs’ claims pursuant to

2 While district courts in the past have concluded that there is a “possibility” that an Oregonappellate court might recognize product liability claims against certain healthcare providers (seeSnyder v. Davol, No. cv-07-1081-ST, 2008 U.S. Dist. LEXIS 1675 (D. Or. Jan. 7, 2008); Ryles v.I-Flow Corp., No. 10-1315-AA, slip op. (D. Or. Feb. 15, 2011)), in the intervening years, noOregon appellate court has recognized such a claim. In addition, Snyder pre-dated the OregonLegislature’s passage of ORS 30.902, exempting physicians from the definition of “sellers,” andthis statute was not addressed by the court in Ryles. Furthermore, the courts’ rationale was, inturn, based on an older case—Docken v. Ceba-Geigy, 86 Or. App. 277, 282 (1987)—that isreadily distinguishable because, inter alia, (1) it did not involve a hospital defendant and (2) thecourt did not reach the issue of whether such a claim was valid under Oregon law and certainlydid not hold that a plaintiff could bring a product liability claim against a healthcare provider.





Rule 12 of the Federal Rules of Civil Procedure. GSK reserves the right to amend or supplement

this Notice of Removal.

WHEREFORE, GSK hereby removes this action from the Multnomah County Circuit

Court, Multnomah County, Oregon, to the United States District Court for the District of Oregon,

Portland Division and requests that this Court retain jurisdiction for all further proceedings in

this matter. Should any question arise as to the removal of this matter, Defendant GSK

respectfully requests an opportunity to conduct appropriate discovery and/or to provide briefing

and oral argument as to why removal is proper.

DATED this 9th day of October, 2015.

LINDSAY HART, LLP

By: /s/ James DumasJames L. Dumas, OSB No. [email protected] J. Estok, OSB No. [email protected] for Defendants

Trial Attorney: James Dumas///

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DEMAND FOR JURY TRIAL

Defendant GlaxoSmithKline LLC hereby demands trial by jury in this action.


LINDSAY HART, LLP

By: /s/ James DumasJames L. Dumas, OSB No. [email protected] J. Estok, OSB No. [email protected] for Defendant GlaxoSmithKline, LLC







CERTIFICATE OF SERVICE

I hereby certify that on October 9, 2015 I served a copy of NOTICE OF REMOVAL on

the following person(s) in the manner indicated below at the following address(es):

Laura B. Kalur7157 SW Beveland Street, Suite 100Tigard, OR 97223

Todd R. FalzoneCatherine DarlsonKelley/Uustal, PLC700 SE Third Ave., Suite 300Ft. Lauderdale, FL 33304

Attorney for Plaintiff

by Electronic Mailby Facsimile Transmissionby First Class Mailby Hand Deliveryby Overnight Delivery

By: /s/ James DumasJames L. Dumas, OSB No. [email protected] J. Estok, OSB No. [email protected] for Defendants

Trial Attorney: James Dumas




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REGISTER OF ACTIONSCASE No. 15CV23066

Thomas Brown, Maria Del Carmen Espindola Gomez, MB vsGlaxoSmithKline, LLC, Providence Health System - Oregon

Location : All Locations Images Help

Case Type: Tort - Malpractice MedicalDate Filed: 08/28/2015Location: Multnomah

PARTY INFORMATION

Attorneys

Defendant GlaxoSmithKline, LLC

Defendant Providence Health System -Oregon Formerly Known As ProvidenceNewberg Hospital Doing BusinessAs Providence Newberg Medical Center

Plaintiff Brown, Thomas LAURA B KALURRetained

503 223-8285(W)

Plaintiff Gomez, Maria Del Carmen Espindola LAURA B KALURRetained503 223-8285(W)

Plaintiff MB LAURA B KALURRetained503223-8285(W)

EVENTS & ORDERS OF THE COURT

OTHER EVENTS AND HEARINGS

08/28/2015 ComplaintCreated: 08/28/2015 6:36 PM

08/28/2015 ServiceGlaxoSmithKline, LLC Served 09/11/2015

Returned 10/06/2015

Providence Health System - Oregon Served 09/11/2015Returned 10/06/2015

Created: 08/28/2015 6:36 PM10/06/2015 Proof - Service

Created: 10/06/2015 2:09 PM10/06/2015 Summons

Created: 10/06/2015 2:09 PM10/06/2015 Proof - Service

Created: 10/06/2015 2:15 PM10/06/2015 Summons

Created: 10/06/2015 2:15 PM10/06/2015 Motion

to Admit Todd R Falzone and Catherine C Darison Pro Hac ViceCreated: 10/07/2015 7:02 AM

10/06/2015 Declarationin Support of MotionCreated: 10/07/2015 7:02 AM

FINANCIAL INFORMATION

Plaintiff Brown, ThomasTotal Financial Assessment 1,056.00

Total Payments and Credits 1,056.00

Balance Due as of 10/08/2015 0.00

08/28/2015 Transaction Assessment 1,056.00

08/28/2015 xWeb Accessed eFile Receipt # 2015-1300978 Brown, Thomas (1,056.00)

https://publicaccess.courts.oregon.gov/PublicAccessLogin/CaseDetalaspx?CaseID=24252539 10/8/2015

Exhibit A Page 1 of 45

Case 3:15-cv-01918-HZ Document 1-1 Filed 10/09/15 Page 1 of 45

8/28/2015 4:24:19 PM15CV23066

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IN THE CIRCUIT COURT OF THE STATE OF OREGON

FOR THE COUNTY OF MULTNOMAH

THOMAS BROWN and MARIA DELCARMEN ESPINDOLA GOMEZ,individually and as parents and naturalguardians of M.B., a minor,

Plaintiffs,

v.

GLAXOSMITHKLINE, LLC;

and

PROVIDENCE HEALTH SYSTEM -OREGON d/b/a PROVIDENCE NEWBERGMEDICAL CENTER f/k/a PROVIDENCENEWBERG HOSPITAL

Plaintiffs allege:

Case No.

COMPLAINT AND DEMAND FORJURY TRIAL — Personal Injury;Negligence; and Products Liability

CLAIM NOT SUBJECT TOMANDATORY ARBITRATION(Pursuant to UTCR 13.060)

PRAYER AMOUNT: $25,000,000.00.Filing Fee Pursuant to ORS 21.160(1)(d).

1.

Plaintiffs bring this action to recover all damages allowable by law for the severe and

permanent injuries suffered as a result of M.B.'s prenatal exposure to the Defendant,

GlaxoSmithKline, LLC ("GSK")'s pharmaceutical product, Zofran (ondansetron

hydrochloride) Injection ("Zofran").

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COMPLAINT-- Page 1KELLEY/UUSTAL, PLC

700 SE Third Ave. Suite 300Fort Lauderdale, Florida 33304

(954) 522-6601

KALUR LAW OFFICE, P.C.7157 SW Beveland St, Suie 100

Tigard, Oregon 97223(503) 223-8285



THE PARTIES, JURISDICTION, AND VENUE

2.

Plaintiffs are natural persons and at all material times were and are citizens and

residents of the State of Oregon.

3.

Defendant GSK is a Delaware limited liability company with its principal place of

business in Philadelphia, Pennsylvania. GSK's sole member is GlaxoSmithKline Holdings,

Inc., a Delaware corporation which has identified its principal place of business in

Wilmington, Delaware. GSK is a subsidiary of GlaxoSmithKline plc, a company

incorporated under the laws of England.

4.

GSK is the successor in interest to Glaxo, Inc., and Glaxo Wellcome, Inc. Glaxo, Inc.

was the sponsor of the original New Drug Application ("NDA") for Zofran. Glaxo, Inc.,

through its division Cerenex Pharmaceuticals, authored the original package insert and

labeling for Zofran, including warnings and precautions attendant to its use. Glaxo

Wellcome, Inc. sponsored additional NDAs for Zofran, monitored and evaluated post-market

adverse event reports arising from Zofran and authored product labeling for Zofran. As used

herein, the terms "GSK" and "Defendant" refer to GlaxoSmithKline, LLC and all of its

predecessors and/or affiliates that were involved at any material time in the designing,

testing, researching, developing, manufacturing, labeling, marketing, distributing, promoting,

or selling of Zofran.

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COMPLAINT- Page 2KELLEY/UUSTAL, PLC


(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



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5.

At all material times, GSK conducted regular and sustained business in Multnomah

County, Oregon by marketing, promoting, distributing, providing and selling its products,

including Zofran, in Multnomah County, Oregon.

6.

Defendant Providence Health System - Oregon d/b/a Providence Newberg Medical

Center f/k/a Providence Newberg Hospital ("Providence Health") is an Oregon domestic

Limited Liability Company duly authorized to do business and doing business in the State of

Oregon. Providence Health is, and at all times herein mentioned was, engaged in the

business of Selling and/or distributing and/or supplying and/or administering medical

services and products, including Zofran, to patients in Multnomah County and throughout the

State of Oregon.

7.

Plaintiffs did not discover M.B.'s injury, the causal relationship between her injury

and the unreasonably dangerous and defective drug, and the causal relationship between her

injury and the conduct of Defendants, until within two years of the filing of his lawsuit.

8.

At all material times, Defendants Providence Health and GSK conducted regular and

sustained business in Multnomah County, Oregon.

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(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



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FACTS COMMON TO ALL CLAIMS

9.

Zofran is a potent prescription drug known as a 5-HT3 receptor-antagonist. It is a

powerful anti-emetic and is FDA-approved solely to alleviate cancer-treatment

(chemotherapy; radiotherapy) induced and post-operative nausea and vomiting.

10.

Zofran is not and never has been proven to be safe and effective nor FDA-approved

for use during pregnancy, to treat morning sickness or otherwise. The FDA-approved drug

label for Zofran instead states:

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction

studies have been performed in pregnant rats and rabbits at daily oral doses up

to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of

impaired fertility or harm to the fetus due to ondansetron. There are, however,

no adequate and well-controlled studies in pregnant women. Because animal

reproduction studies are not always predictive of human response, this drug

should be used during pregnancy only if clearly needed.

11.

Drugs characterized as "Pregnancy Category A" by the FDA are those for which

"[a]dequate and well-controlled studies have failed to demonstrate a risk to the fetus in the

first trimester of pregnancy (and there is no evidence of risk in later trimesters)." Thus, in

order to obtain "Pregnancy Category A" status, a drug must be evaluated in well-controlled

human trials, which in turn must not show risk to the mother or developing fetus. Zofran has

never been evaluated in such a trial.

A. Only one drug, Diclegis° (doxylamine succinate and pyridoxine

hydrochloride), is both Pregnancy Category A and indicated to treat nausea

and vomiting of pregnancy.

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(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



B. Diclegisil is a fixed-dose combination of an antihistamine and a vitamin B6

analog. As such, it is a drug of an altogether different class and type than

Zofran.

12.

From animal tests of Zofran conducted before the drug was approved or marketed for

human consumption, GSK learned that when Zofran is given to a pregnant mother, the drug

can and does traverse the placental barrier, affecting the fetus. A 2006 study in humans

confirmed the presence of Zofran in samples of coelomic fluid, amniotic fluid, and fetal

tissue collected after pregnant women had been administered the drug. That study noted that

a "significant" amount of the drug was present in "all embryonic compartments," and that the

"developmental significance of such exposure "requires further investigation."' GSK never

conducted any such investigation.

A. GSK in fact knew that even the primary drug-safety study upon which

Zofran's New Drug Application was based evaluated a population that was

only 29% women, none of whom were reportedly pregnant. When only the

childbearing-age group is examined, (defined as individuals aged 15-49), the

female population in the study drops to 19%.2

B. GSK further included in its New Drug Application the same information that

eventually ended up in the "Pregnancy" section of the drug's label: that

reproductive studies in animals showed no signs of harm to mammalian

fetuses. This was despite the fact that not one but two 1992 animal

Sui, et al. Placental transfer of ondansetron during early human pregnancy. Clin. Pharmacokinet.

2006;45(4):419-23.2 Kessler, David. Notice: Guidelines for the Study and Evaluation of Gender Differences in the Clinical

Evaluation of Drugs. July 19, 1993. FR Doc. 93-17411. Available at:

http://archive.hhs.gov/ohrp/humansubjects/guidance/58fr39406.htm.



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reproductive studies in fact revealed toxicity in fetuses at doses as low as 4

mg/kg,' intrauterine death, delayed or incomplete bone growth, and premature

birth.2 GSK never informed the public of this information, which was

published in Japanese, or included it in Zofran's product label or marketing

materials.

13.

One 1996 medical case report, addresses Zofran use in a pregnant woman and notes:

The paucity of data on the use of ondansetron in pregnancy make it difficult to

be certain of the safety of the drug in pregnancy. This report describes the

longest published duration of use of ondansetron from the second trimester

through to the third without any adverse clinical effects. The possibility of a

late adverse effect upon foetal and infant development cannot be ruled out at

this time, and it is not possible to make any comment as to the safety of the

drug if used early in the first trimester during organogenesis.3

14.

GSK began receiving reports associating Zofran with human birth defects as early as

1992. As of the present time, GSK has knowledge of over 200 such reports, which indicate

an array of associated harm, including heart, musculoskeletal, and kidney malformation;

stillbirth; miscarriage; fetal growth restriction; limb defects; and others.

15.

Despite GSK's knowledge of birth-defect reports and other data relating to Zofran's

effects on developing fetuses, GSK never warned the public, or conducted a study to evaluate

the extent of the effects Zofran® has on pregnant women or their unborn children.

Seeker, et al Reproduction study (Seg. III) of ondansetron hydrochloride in rats by intravenous route. Yakuri

to Chity5 1992;20(Suppl 4):207-19 [English abstract].

Ezaki, et al. Reproduction study (Seg II) of ondansetron hydrochloride in rabbits by oral route. Yakuri to

Chiry5 1992:s1187-s1196, 1992 [English abstract].

3 Tincello, DG and MJ Johnstone. Treatment of hyperemesis gravidarum with the 5-HT3 antagonist

ondansetron (Zofran). Postgrad Med J. 1996 Nov; 72(853):688-689.



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ZOFRAN'S EFFECTS IN THE BODY

16.

GSK does not know the precise mode of action by which Zofran controls nausea and

vomiting. 5-HT3 receptor-antagonists such as Zofran block the effects of the critical

neurotransmitter serotonin (5-HT) in the brain. This has the effect of altering levels of

serotonin in the brain and elsewhere in the body.

A. Serotonin is necessary for proper nerve cell and brain function. It is released in

the brain and gut in response to resource availability, such as the discovery of

food, and is a key mediator of central-nervous system function, vascular function,

and gastrointestinal motility. Serotonin levels have an impact on, among other

things, insulin secretion, heart rate and rhythm, digestion, and organ and limb

development.

B. Zofran may act on other serotonin receptors than 5-HT3, such as 5-HTI, 5-HT2,

and 5-HTa receptors.' These receptors are located in and affect various parts and

organs within the human body, including the heart and gut.

C. A wealth of scientific data supports the conclusion that serotonin is a regulator of

early embryogenesis and morphogenesis that "regulates basic developmental

processes, including cell proliferation, migration, differentiation, and

morphogenesis" in early embryos.2

///

///

I Ye, et al. Ondansetron: A Selective 5-HT3 Receptor Antagonist and Its Applications in CNS-Related

Disorders. CNS Drug Reviews, 2001;72(2)199-213.

2 See, e.g., Buznikov, et aI. Serotonin and serotonin-like substances as regulators of early embryogenesis and

morphogenesis.Cell Tissue Res. 2001 Aug;305(2):177-86.



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17.

On September 15, 2011, the FDA issued a Safety Announcement regarding an

ongoing safety review of Zofran, and warned that Zofran can affect electrical activity in the

heart, which in turn can lead to an abnormal and potentially fatal heart rhythm. The FDA

noted in this communication that it had previously warned of cardiovascular safety concerns

due to Zofran's potential to cause QT-interval (a term referring to the Q and T waves of the

electrocardio cycle) prolongation, which can result in potentially fatal abnormal heart

rhythm. The FDA required GSK to conduct a thorough QT study to assess the potential for

Zofran to prolong the QT interval.

18.

In early 2013, the FDA published New Safety Information Identified by the FDA

Adverse Event Reporting System. This bulletin identified serotonin syndrome as a serious

potential risk associated with Zofran.

A. Serotonin syndrome is a potentially fatal drug reaction caused by too much

serotonin production and/or lack of its absorption in the brain.

B. Reports showed an even greater risk for serotonin syndrome among patients who

were co-administered Zofran with a selective serotonin reuptake inhibitor (SSRI).

SSRIs are independently associated with serotonin-syndrome risk.

C. Like Zofran, SSRIs have the effect of altering levels of serotonin in the brain and

elsewhere in the body.

D. Drugs in the SSRI category include widely-used anti-depressants such as Paxil,

Zoloft, and Lexapro, the use of which during pregnancy has also been linked to



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birth defects, including cardiac malformation.'

E. Also like Zofran, SSRIs are known to increase risk of potentially fatal abnormal

heart rhythm.

ZOFRAN'S EFFECTS ON FETAL DEVELOPMENT

19.

In January 2012, a study of 9,000 pregnant women by the Center for Birth Defects

Research and Prevention identified a twofold increased risk (adjusted odds ratio: 2.37 with a

95% confidence interval) for cleft palate and other non-cardiac birth defects in children that

was associated with Zofran exposure during the first trimester of pregnancy.2

20.

Three recent epidemiological studies have examined the association between prenatal

exposure to Zofran and the risk of congenital heart defects in babies. These studies include:

(1) Pasternak, et al., Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes, New

England Journal of Medicine (Feb. 28, 2013) (the "Pasternak Study"); (2) Andersen, et al.,

Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations— A

Register Based Nationwide Control Study, presented as International Society of Pharmaco-

epidemiology, Montreal, Canada (2013) (the "Andersen Study"); and (3) Danielsson, et al.,

Ondansetron During Pregnancy and Congenital Malformations in the Infant (Oct. 31, 2014)

(the "Danielsson Study").

///

///

SSRI antidepressants and birth defects. Prescrire Int. 2006 Dec;15(86):222-3. Abstract available at:

littp://www.nebi.illm.nill.2ov/pubinedil 7 I 67929.

Anderka, et al. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth

defects. Birth Defects Res A Clin Mol Teratol. 2012 Jan;94(1):22-30.



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21.

Each of these studies includes methodological characteristics tending to bias its

results toward under-reporting the true risk of having a child with a birth defect.

Notwithstanding these characteristics biasing the results toward the null hypothesis, all three

studies show elevated risk ratios for cardiac malformations, including risk ratios greater than

2.0. In other words, the studies report that a mother exposed to Zofran had more than a

doubled risk of having a baby with a congenital heart defect as compared to a mother who

did not ingest Zofran during pregnancy.

22.

The Pasternak Study included data from the Danish National Birth Registry and

examined the use of Zofran during pregnancy and risk of adverse fetal outcomes. Adverse

fetal outcomes were defined as: spontaneous abortion, stillbirth, any major birth defect, pre-

term delivery, low birth weight, and small size for gestational age. There were 608,385

pregnancies between January 2004 and March 31, 2011 examined. The unexposed group

was defined as women who did not fill a prescription for ondansetron during the exposure

time window. The exposure time window was defined as the first 12 week gestational

period. Notably, the median fetal age at first exposure to Zofran was ten weeks, meaning

that half of the cases were first exposed to Zofran after organogenesis (organ formation).

This characteristic of the study led to an under-reporting of the actual risk of prenatal Zofran

exposure. The study's supplemental materials indicated that women taking Zofran during the

first trimester, compared to women who did not take Zofran, were 22% more likely to have

offspring with a septal defect, 41% more likely to have offspring with a ventricular septal

defect and greater than four-times more likely to have offspring with atrioventricular septal

defect.



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23.

The Andersen Study was also based on data collected from the Danish Medical Birth

Registry and the National Hospital Register, the same data examined in the Pasternak Study.

The Andersen study examined the relationship between Zofran use during the first trimester

and subgroups of congenital malformations. Data from all women giving birth in Denmark

between 1997 and 2010 were included in the study. A total of 903,207 births were identified

in the study period with 1,368 women filling prescriptions for Zofran during the first trimester.

The Andersen Study therefore used a larger data set (thirteen years) compared to the Pasternak

Study (seven years). Exposure to the drug was also defined as filling a prescription during the

first trimester, and prescription data were obtained from the National Prescription Registry.

The Andersen study reported that mothers who ingested Zofran during their first-trimester of

pregnancy were more likely than mothers who did not to have a child with a congenital heart

defect, and had a two- to four-fold greater risk of having a baby with a septal cardiac defect.

24.

The Danielsson Study investigated risks associated with Zofran use during pregnancy

and risk of cardiac congenital malformations from data available through the Swedish

Medical Birth Registry. The Swedish Medical Birth Registry was combined with the

Swedish Register of Prescribed Drugs to identify 1,349 infants born to women who had taken

Zofran in early pregnancy from 1998-2012. The total number of births in the study was

1,501,434 infants, and 43,658 had malformations classified as major (2.9%). Among the

major malformations, 14,872 had cardiovascular defects (34%) and 10,491 had a cardiac

septum defect (24%). The Danielsson study reported a statistically significantly elevated risk

for cardiovascular defects for mothers taking Zofran versus those who did not.

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The results reported that the mothers who took Zofran during early pregnancy had a 62%

increased risk of having a baby with a cardiovascular defect. Further, mothers who took

Zofran during pregnancy had a greater than two-fold increased risk of having a baby with a

septal cardiac defect, compared to mothers who did not take Zofran during pregnancy.

25.

In summary, since at least 1992, GSK has had mounting evidence showing that

Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during

pregnancy. GSK has been aware that Zofran readily crosses human placental barriers during

pregnancy. GSK has also been aware that the animal studies of Zofran cannot reliably

support an assertion that Zofran can be used safely or effectively in pregnant women. Since

1992, GSK has received hundreds of reports of major birth defects associated with prenatal

Zofran exposure. GSK also has had actual and/or constructive knowledge of the

epidemiological studies reporting that prenatal Zofran exposure can more than double the

risk of developing congenital heart defects. As alleged below, GSK not only concealed this

knowledge from healthcare providers and consumers in the United States, and failed to warn

of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to

physicians and patients specifically for the treatment of morning sickness in pregnancy

women.

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GSK'S OFF-LABEL MARKETING OF ZOFRAN TO PREGNANT WOMENAND THEIR PHYSICIANS

26.

GSK marketed Zofran aggressively and deceptively to both physicians and expectant

mothers throughout the 1990's and 2000's. GSK undertook these efforts with the specific

goal in mind of inducing prescribing of Zofran to treat morning sickness in pregnant women,

a condition that is at its most common and most severe during the first several weeks of

pregnancy — which is also the 'window of risk' for birth defects due to the fact that this is

when the embryo's major systems and structures begin to develop and its cells begin to

differentiate.

A. GSK's illegal off-label marketing of Zofran to expectant mothers and their

physicians, as well as GSK's payment of kickbacks to some physicians to

induce them to prescribe the drug, were subjects of a False Claims Act lawsuit

filed against GSK.

B. The False Claims Act suit settled in 2012 upon GSK's payment of penalties

and damages to the government for prescriptions that resulted from GSK's

illegal conduct. GSK also entered into a written settlement agreement; the

allegations resolved by the agreement that relate to Zofran are as follows:

1) On January 4, 1991, Zofran (ondansetron hydrochloride) was approved by

the FDA for the prevention of nausea and vomiting induced by

chemotherapy and radiation therapy as well as the prevention of post-

operative nausea and vomiting. Since its initial approval as an injectable,

Zofran® has received subsequent approvals on January 24, 1997 for an

oral solution and on January 27, 1999 for an orally disintegrating tablet.

2) On March 25, 2005, Zofran received FDA approval for use in children as

young as one (1) month of age to prevent nausea and vomiting associated

with general anesthesia, and for use in children as young as six (6) months

to prevent nausea and vomiting associated with chemotherapy.

3) Despite the limited indication, GSK attempted to expand dramatically the

off-label use of Zofran and has marketed the medication for the treatment



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of morning sickness in pregnant women, as well as nausea and vomitingassociated with influenza and gastrointestinal distress.

C. As to the above Zofran-marketing allegations, the written and executed

settlement agreement states that GSK:

1) [P]romoted the sale and use of Zofran for a variety of conditions otherthan those for which its use was approved as safe and effective by theFDA (including hyperemesis and pregnancy-related nausea);

2) [M]ade and/or disseminated unsubstantiated and false representations

about the safety and efficacy of Zofran concerning the uses described in

subsection (a) [hyperemesis and pregnancy-related nausea];

3) [0]ffered and paid illegal remuneration to health care professionals toinduce them to promote and prescribe Zofran.

PLAINTIFF MARIA DEL CARMEN ESPINDOLA GOMEZ

27.

On or about March 14, 2006, while she was seven weeks pregnant with M.B., Ms.

Espindola presented at Defendant Providence Health's emergency room, where she was

administered Zofran to treat symptoms of morning sickness. At that time, M.B. was an

embryo the size of a blueberry, and although growing quickly, she weighed less than an

aspirin. In the early stages of embryogenesis and morphogenesis, each of her essential

organs, including her heart, had only just begun to form. Her cells were rapidly developing,

dividing, and undergoing differentiation, a process whereby simple cell types, in response to

signaling from such substances as serotonin and neurotransmitters, become the specialized

cell types that go on to form, among other things, the structural tissues of the heart.

28.

Ms. Espindola did not know or have reason to know that use of Zofran during early

pregnancy was unsafe, or that it could result in birth defects such as cardiac malformation.

///



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29.

Ms. Espindola, had she known of the risk of harm to her unborn baby associated with

taking Zofran, would not have consented to administration of the drug.

30.

Apart from Zofran, Ms. Espindola took no drugs, prescription or otherwise, during

the course of her pregnancy.

31.

On October 17, 2006, Ms. Espindola gave birth to M.B. At birth, M.B. was diagnosed

with a number of heart defects, all congenital, including borderline hypoplastic left heart

syndrome; bicuspid aortic valve with hypoplastic annulus and adherent subaortic tissue; and

aortic coarctation.

32.

Neither Mr. Brown nor Ms. Espindola have family history of birth defects. Genetic

screening has revealed no genetic abnormalities.

33.

Plaintiffs file this suit within the applicable limitations period because Plaintiffs could

not; by the exercise of reasonable diligence, have discovered the cause of M.B.'s injuries at

an earlier time. Plaintiffs did not have reason to suspect the tortious nature of the conduct

causing M.B.'s injuries until a short time before the filing of this Complaint. Additionally,

Plaintiffs were foreclosed from discovering this information sooner because GSK's conduct

in misrepresenting to the public and to medical professionals throughout the country that

Zofran was safe for use during pregnancy. Further, GSK has fraudulently concealed facts and

information that could have led Plaintiffs to discover their potential causes of action. In any

event, the statute of limitations is tolled for claims arising from injuries to minors.



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GSK is and was subject to a continuing duty to disclose the true nature, character, and quality

of its products to the Plaintiffs and their healthcare providers. Because of GSK's concealment

of the true nature, character, and quality of Zofran, GSK is estopped from relying on any

statute of limitations defense.

FIRST CLAIM FOR RELIEF(STRICT PRODUCTS LIABILITY — DEFENDANT GSK)

34.

Plaintiffs re-allege each and every allegation contained in the prior paragraphs of this

Complaint.

35.

At all material times, GSK was responsible for designing, developing, processing,

manufacturing, testing, packaging, advertising, promoting, marketing, distributing, labeling,

and/or selling the Zofran that was administered to Plaintiff Maria Espindola during her

pregnancy.

36.

At all material times, Zofran was expected to reach, and did reach, consumers in the

State of Oregon, including Plaintiff Espindola, without substantial change in the condition in

which it was sold.

37.

GSK, as the manufacturer, seller, and distributor of Zofran, owed a duty to Plaintiff

Espindola and her physicians to design, develop, process, manufacture, test, package,

advertise, promote, market, distribute, sell, and/or label their product in a manner that is

reasonably safe, suitable, and which renders the product fit for its intended or reasonably



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foreseeable uses, and owed a duty to ensure that the product is accompanied by adequate

warnings and instructions for its use.

38.

At all material times, Zofran was designed, developed, processed, manufactured,

tested, packaged, advertised, promoted, marketed, distributed, labeled, and/or sold in a

defective and unreasonably dangerous condition at the time it was placed in the stream of

commerce in ways which include, but are not limited to, one or more of the following

particulars:

A. At the time Zofran left the control of GSK, Zofran was defective as a

consequence of design flaws, manufacturing defects, and/or inadequate/deficient

warnings and/or instructions, which rendered the product unreasonably dangerous

for its foreseeable uses;

B. Zofran was not reasonably safe as designed, taking into account the foreseeable

risks involved in its use at the time the product left the possession of GSK, and

that such risks clearly outweighed the utility of the drug or its therapeutic

benefits;

C. At all material times, Zofran possessed a dangerous characteristic in that it could

cause cardiac and other birth defects, and it was not reasonably safe due to

defective warnings or instructions regarding this characteristic, which was known

or scientifically knowable at the time the product left the possession of GSK;

D. The labeling failed to disclose to patients and to the U.S. medical community that

injection of Zofran to women during their first trimester of pregnancy may cause

serious and permanent injury to the developing infant;

E. Zofran was and is dangerous to an extent beyond that which would be

contemplated and expected by the ordinary and foreseeable consumers of the drug

with the ordinary knowledge common to consumers, including Plaintiff

Espindola, and their physicians as to the characteristics of the drug.

///

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39.

Zofran was expected to, intended to, and did reach the Plaintiff without substantial

change from the condition in which it was manufactured, labeled, distributed and sold.

40.

It was foreseeable to, and expected and intended by GSK that Zofran would be

administered to pregnant women, such as Plaintiff Espindola, as treatment for first-trimester

morning sickness.

41.

The Zofran which was administered to Plaintiff Espindola was being used in the

manner in which GSK intended, without alteration or modification.

42.

As a result of the defective and unreasonably dangerous drug, M.B. suffers from a

permanent and life-threatening congenital heart defect, and Plaintiffs, Thomas Brown and

Maria Del Carmen Espindola Gomez, individually and as parents and natural guardians of

M.B., have been injured. The Plaintiffs and have suffered and will continue to suffer

economic damages in the form of past and future reasonable and necessary medical care and

expenses; past and future lost wages and impaired earning capacity; and the reasonable and

necessary expenses incurred for substitute domestic services and related medical services. To

date, Plaintiffs' economic damages are in a reasonable amount to be determined by a jury at

trial but not expected to exceed $8,000,000.

43.

As a further result of the defective and unreasonably dangerous product, Plaintiffs

have suffered non-economic damages including, but not limited to, past and future pain and

suffering; emotional and mental suffering caused by M.B.'s severe and permanent medical



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condition; and past and future interference with the functions of daily living. To date,

Plaintiffs' non-economic damages are in a reasonable amount to be determined by a jury at

trial but not expected to exceed $12,000,000.

SECOND CLAIM FOR RELIEF(NEGLIGENCE — DEFENDANT GSK)

44.

Plaintiffs re-allege each and every allegation contained in paragraphs 1 through 33

and 42 and 43 of this Complaint.

45.

At all material times, GSK was responsible for designing, developing, processing,

manufacturing, testing, packaging, advertising, promoting, marketing, distributing, labeling,

and/or selling the Zofran that was administered to Plaintiff Maria Espindola during her

pregnancy.

46.

GSK owed a duty to the Plaintiffs to exercise reasonable care, and comply with

existing standards of care, in the designing, researching, manufacturing, marketing,

supplying, promoting, packaging, sale, testing, and/or distribution of Zofran into the stream

of commerce, including a duty to ensure that the product would not cause users to suffer

unreasonable, dangerous side effects, and to adequately warn users of the potential risks.

47.

It was foreseeable that Zofran would be administered to Plaintiff Espindola and other

consumers like her as treatment for morning sickness during the first trimester of pregnancy,

and that these users, including Plaintiffs, would as a result be injured by the propensity for

Zofran to cause birth defects, and that Plaintiffs would incur damages as a result thereof.



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48.

GSK, its agents, servants, and/or employees, failed to exercise ordinary care and

failed to comply with existing standards of care in the designing, researching, manufacturing,

marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control,

and/or distribution of Zofran in the following acts and/or omissions:

A. Failing to conduct adequate testing, including pre-clinical and clinical testing and

post-marketing surveillance to determine the safety risks of Zofran for treating

pregnant women while promoting the use of Zofran and providing kickbacks and

financial incentives to health care professionals to convince health care

professionals to prescribe Zofran for pregnancy-related nausea;

B. Marketing Zofran for the treatment of morning sickness in pregnant women

without testing it determine whether or not Zofran was safe for this use;

C. Designing, manufacturing, producing, promoting, formulating, creating, and/or

designing Zofran without adequately and thoroughly testing it;

D. Selling Zofran without conducting sufficient tests to identify the dangers posed by

Zofran to pregnant women;

E. Failing to adequately and correctly warn the Plaintiff, the public, the medical and

healthcare profession, and the FDA of the dangers of Zofran for pregnant women;

F. Failing to evaluate available data and safety information concerning Zofran use in

pregnant women;

G. Advertising and recommending the use of Zofran without sufficient knowledge as

to its dangerous propensities to cause birth defects;

H. Representing that Zofran was safe for treating pregnant women, when, in fact, it

was and is unsafe;

I. Representing that Zofran was safe and efficacious for treating morning sickness

when GSK was aware that neither the safety nor efficacy for such treatment had

been established;

J. Representing that GSK's animal studies in rats and rabbits showed no harm to

fetuses, when the data in fact revealed signs of toxicity;

K. Failing to provide adequate instructions regarding birth defects including cleft

palate and cardiac malformations;

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L. Failing to accompany Zofran with proper and/or accurate warnings regarding allpossible adverse side effects associated with the use of Zofran;

M. Failing to include a black box warning concerning the birth defects associatedwith Zofran;

N. Failing to issue sufficiently strengthened warnings following the existence ofreasonable evidence associating Zofran use with the increased risk of birthdefects;

O. Failing to advise Plaintiff, her healthcare providers, FDA, and the medicalcommunity that neither the safety nor the efficacy of Zofran for treatingpregnancy-related nausea has been established and that the risks of the using thedrug for that condition outweigh any putative benefit;

P. Failing to advise Plaintiff Espindola, her healthcare providers, FDA, and the

medical community of clinically significant adverse reactions (birth defects)

associated with Zofran use during pregnancy; and

Q. Failing to correct its misrepresentations that the safety and efficacy of Zofran for

treating morning sickness had been established.

49.

Despite the fact that GSK knew or should have known that Zofran significantly

increased the risk of birth defects, GSK continued to negligently and misleadingly market,

manufacture, distribute and/or sell Zofran to consumers, including Plaintiff Espindola.

50.

GSK knew or should have known that consumers such as Plaintiffs would foreseeably

suffer injury as a result of GSK's failure to exercise ordinary care, as set forth above.

51.

The negligent acts and omissions alleged above were substantial contributing causes

of the injuries suffered by the Plaintiffs.

52.

GSK's negligence was the proximate cause of Plaintiffs' injuries, harm and economic

loss, which Plaintiff suffered and/or will continue to suffer.



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53.

As a foreseeable result of GSK's negligence, the Plaintiffs have been injured and

suffered damages as set forth in paragraphs 42 and 43 above.

THIRD CLAIM FOR RELIEF(STRICT PRODUCTS LIABILITY — DEFENDANT PROVIDENCE HEALTH)

54.

Plaintiffs re-allege each and every allegation contained in paragraphs 1 through 33


55.

At all material times, Providence Health was a distributor, seller, supplier, and vendor

of Zofran, engaged in the business of selling Zofran and products of the kind.

56.

Providence Health sold, distributed, vended, administered and/or supplied Zofran to

Plaintiff Espindola while she was pregnant with M.B.

57.

The Zofran that Providence Health sold, distributed, vended, administered, and

supplied to Plaintiff Espindola during her pregnancy was expected to and did reach Plaintiff

Espindola without substantial change in the condition in which it was sold.

58.

At all material times, the Zofran that Providence Health sold, distributed, vended,

administered and supplied to Plaintiff Espindola was unreasonably dangerous and defective

in ways which include, but are not limited to, one or more of the following particulars:

A. Zofran was defective as a consequence of design flaws, manufacturing defects, and/or

inadequate/deficient warnings and/or instructions, which rendered the product

unreasonably dangerous for its foreseeable uses;



(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



B. Zofran was not reasonably safe as designed, taking into account the foreseeable risksinvolved and that such risks clearly outweighed the utility of the drug or itstherapeutic benefits;

C. At all material times, Zofran possessed a dangerous characteristic in that it could

cause cardiac and other birth defects, and it was not reasonably safe due to defective

warnings or instructions regarding this characteristic, which was known or

scientifically knowable at the time the product left the possession of Providence

Health;

D. Zofran was and is dangerous to an extent beyond that which would be contemplated

and expected by the ordinary and foreseeable consumers of the drug with the ordinary

knowledge common to consumers, including Plaintiff Espindola, as to the

characteristics of the drug.

59.

The Zofran which was sold and administered to Plaintiff Espindola was being used in

its intended manner, without alteration or modification.

60.

As a result of the defective and unreasonably dangerous drug, the Plaintiffs have been

injured and suffered damages as set forth in paragraphs 42 and 43 above.

FOURTH CLAIM FOR RELIEF

(NEGLIGENT MISREPRESENTATION — DEFENDANT GSK)

6 1 .

Plaintiffs re-allege paragraphs 1 through 33 and 42 and 43 above.

62.

At all times material herein, GSK, as a manufacturer, designer, marketer, promoter,

distributor, supplier and/or vendor of Zofran, owed a duty to members of the public,

including Plaintiffs, to avoid causing injury through the use of its product; and to completely

and accurately disclose all known and reasonably foreseeable risks in the use of said product.



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Tigard, Oregon 97223(503) 223-8285



63.

GSK, in the course of business, negligently misrepresented and failed to disclose

material facts to Plaintiff Espindola, her physicians, and the general public concerning the

risks that Zofran posed to patients, in particular that using the product for during pregnancy

could cause congenital heart defects and other injuries and/or adverse side effects.

64.

At all material times, GSK knew, or in the exercise of reasonable care, should have

known, that its representations were false.

65.

The misrepresentations and concealments by GSK were made with the intent to

advertise, market and sell Zofran for off-label use to treat nausea and vomiting of pregnancy.

66.

As such, at all material times, GSK failed to exercise reasonable care of competence

in obtaining or communicating truthful and accurate information to Plaintiffs, their

physicians and the general public, and failed to comply with the existing standard of care.

67.

Further, GSK is directly liable for the negligent conduct of its actual and/or ostensible

employees, servants, and agents, including, but not limited to, its other sales representatives.

The negligent conduct of these employees, servants, and actual and/or ostensible agents,

jointly and severally, in not revealing the true risks of the drug, caused and/or increased the

risk of harm of, and the grievous injuries and damages sustained by Plaintiffs.

68.

Plaintiff and Plaintiffs physicians justifiably relied on the misrepresentations and

concealments, and as a direct and proximate result of such reliance, Plaintiffs have suffered



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Tigard, Oregon 97223(503) 223-8285



and will continue to suffer injuries, damages and losses as alleged and described in

paragraphs 42 and 43 above.

FIFTH CLAIM FOR RELIEF(NEGLIGENT MISREPRESENTATION — DEFENDANT PROVIDENCE HEALTH)

69.

Plaintiff re-alleges each and every allegation contained in paragraphs 1 through 33


70.

At all times material herein, as a routine seller, supplier, vendor, and dispenser of

Zofran, Providence Health had a duty to Plaintiff, Plaintiff's physicians and members of the

public, to avoid causing injury through the use of its products; and to completely and

accurately disclose all known and reasonably foreseeable risks in the use of said product.

71.

Providence Health, in the course of business, negligently misrepresented and failed to

disclose material facts to Plaintiff and the general public, concerning the risks that Zofran

posed to patients, particularly with respect to the safety of the drug's use to treat nausea and

vomiting of pregnancy, and with respect to the drug's propensity to cause severe and

permanent congenital birth defects.

72.

Providence Health knew, or in the exercise of reasonable care, should have known,

that those misrepresentations were false.

///

///

///



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Tigard, Oregon 97223(503) 223-8285



73.

Those misrepresentations and concealments by Providence Health were made with

the intent to sell, distribute, dispense and supply the drug to women suffering from nausea

and vomiting of pregnancy.

74.

As such, Providence Health failed to exercise reasonable care of competence in

obtaining or communicating truthful and accurate information to Plaintiffs and the general

public, and failed to comply with the existing standard of care.

75.

Further, Providence Health is directly liable for the negligent conduct of its actual

and/or ostensible employees, servants, and agents, including, but not limited to, the members

of its staff who treated Plaintiff Espindola. The negligent conduct of these employees,

servants, and actual and/or ostensible agents, jointly and severally, in not revealing the true

risks of Zofran to the Plaintiffs, caused and/or increased the risk of harm of, and the grievous

injuries and damages sustained by Plaintiffs.

76.

Plaintiffs justifiably relied on the misrepresentations and concealments, and as a

direct and proximate result of such reliance, Plaintiffs have suffered and will continue to

suffer injuries, damages and losses as alleged and described in paragraphs 42 and 43 above.

///

///

///

///



(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



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SIXTH CLAIM FOR RELIEF(FRAUDULENT MISREPRESENTATION — DEFENDANT GSK)

77.Plaintiffs re-allege each and every allegation contained in paragraphs 1-33 and 42 and

43 above.

78.

GSK committed actual and constructive fraud. GSK committed actual fraud by

misrepresenting material facts on which Plaintiff Espindola and her healthcare providers

acted. GSK committed constructive fraud by acting contrary to legal or equitable duties,

trust, or confidence upon which Plaintiff relied, and by failing to act, though it should have.

GSK's conduct constitutes constructive fraud because GSK breached legal and equitable

duties and violated its fiduciary relationships to patients and healthcare providers.

79.

At all material times, GSK had a duty to exercise reasonable care to consumers,

including Plaintiff Espindola, to whom it provided product information about Zofran, and to

all those relying on the information provided, including Plaintiff and her providers.

80.

In violations of existing standards and duties of care, GSK made misrepresentations

by means including, but not limited to, advertisements, labeling, marketing, marketing

persons, notices, product information and written and oral information provided to patients

and medical providers.

81.

In violations of existing standards and duties of care, GSK intentionally, knowingly,

falsely and fraudulently represented to the expectant mothers and the medical and healthcare

community, including Plaintiff Espindola and her providers, that:



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A. Zofran was safe and effective for treating pregnancy-related nausea;

B. Zofran had been adequately tested and studied in pregnant women;

C. Zofran use during pregnancy did not increase the risk of bearing children with birth

defects; and

D. Zofran's "Pregnancy Category B" designation established safety and efficacy of

Zofran for treating pregnancy-related nausea.

82.

The representations made by GSK were material, false and misleading.

83.

When GSK made these representations, it knew they were false.

84.

GSK made these representations with the intent of defrauding and deceiving the

public in general, and the medical and healthcare community in particular, including Plaintiff

Espindola and her providers, to recommend, prescribe, dispense and/or purchase Zofran to

treat pregnancy-related nausea.

85.

At the time these representations were made by GSK and, at the time Plaintiff used

Zofran, she was unaware of the falsity of said representations, had a right to believe they

were true, and reasonably believed them to be true.

86.

In reasonable reliance upon said representations, Plaintiffs prescribers were induced

to prescribe Zofran to her and recommend the drug as safe for treating pregnancy-related

nausea, and Plaintiff Espindola was induced to and did use Zofran to treat pregnancy-related

nausea. Had GSK not made the foregoing express and implied false statements about the

COMPLAINT- Page 28KELLEYIUUSTAL, PLC


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Tigard, Oregon 97223(503) 223-8285



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product, Plaintiff would not have used the product and her medical providers would not have

administered it and recommended it as safe.

87.

At all material times, GSK knew that Zofran had not been sufficiently tested for

pregnancy-related nausea and that it lacked adequate warnings.

88.

At all material times, GSK knew or should have known that Zofran increases

expectant mothers' risk of developing birth defects.

89.

As a result of the foregoing acts and omissions, M.B. was caused to suffer birth

defects that are permanent and lasting in nature, as well as physical pain and mental anguish,

including diminished enjoyment of life, as well as the need for lifelong medical treatment,

monitoring and/or medications.

90.

Plaintiffs Espindola and Brown also have sustained severe emotional distress and suffering as

a result GSK's wrongful conduct and the injuries to their child.

91.

Plaintiffs justifiably relied on the misrepresentations and concealments, and as a

direct and proximate result of such reliance, Plaintiffs have suffered and will continue to

suffer injuries, damages and losses as alleged and described in paragraphs 42 and 43 above.

///

///

///

///



(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



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SEVENTH CLAIM FOR RELIEF(LOSS OF CONSORTIUM — DEFENDANTS GSK AND PROVIDENCE HEALTH)

92.

Plaintiffs re-allege each and every allegation contained in the prior paragraphs of this

Complaint.

93.

As a further direct and proximate result of the Defendants' acts and omissions, the

Plaintiffs, Thomas Brown and Maria Del Carmen Espindola Gomez, have in the past suffered

and will in the future continue to suffer the loss of their daughter, M.B.'s care, comfort,

society, support, and attentions and have become indebted for her medical expenses in the

past and will continue to in the future.

94.

As a result of the above-described loss of consortium, Plaintiffs Brown and Espindola

have been damaged in a reasonable amount to be determined by a jury at trial, but not

expected to exceed $5,000,000.

95.

Plaintiffs hereby give notice to Defendants GSK and Providence Health that they will

ask the Court to allow amendment for punitive damages by a separate request to amend this

Complaint as provided by Oregon law.

PRAYER FOR RELIEF

WHEREFORE, Plaintiffs Thomas Brown and Maria Del Carmen Espindola Gomez,

individually and as parents and natural guardians of their child, M.B., a minor, pray for

judgment against the Defendants, and each of them, in a reasonable amount to be determined



(954) 522-6601


Tigard, Oregon 97223(503) 223-8285



by a jury at trial, but not to exceed $8,000,000 in economic damages and $17,000,000 in non-

economic damages, and any further relief as justice and equity may require.

Plaintiffs also seek their reasonable costs and disbursements incurred herein,

including any attorney fees incurred in prosecuting this action and recoverable at law; and

any pre- or post-judgment interest recoverable at law.

Dated this 28th day of August, 2015.

COMPLAINT- Page 31

KELLEY/UUSTAL, PLC

KALUR LAW OFFICE, P.C.

By:

Laura B. Kalur, Esq.OSB No. 023424

John J. Uustal, Esq.*Florida Bar No. 0073547ijua ku I aw.com

Todd R. Falzone, Esq.*Florida Bar No. 0975184trFdlulaw.com

Anthony H. Quackenbush, Esq.*Florida Bar No. [email protected]

Catherine C. Darlson, Esq.*Florida Bar No. 0112440ccdalculaw.com

Trial Attorneys for Plaintiffs

*Pro hac vice admission pending.

KELLEY/UUSTAL, PLC700 SE Third Ave. Suite 300Fort Lauderdale, Florida 33304

(954) 522-6601


Tigard, Oregon 97223(503)223-8285



10/6/2015 2:06:16 PM15CV23066


FOR THE COUNTY OF MULTNOIVIAH

THOMAS BROWN AND MARIA DELCARMEN,

Plaintiff/Petitioner,vs.

GLAXOSMITHKLINE, LLC ANDPROVIDENCE HEALTH SYSTEM - OREGOND/B/A PROVIDENCE NEWBERG MEDICALCENTER F/K/A PROVIDENCE NEWBERGHOSPITAL ,

Defendant/Respondent

Case No.: 15CV23066

DECLARATION OF SERVICE

I hereby declare that I made service of a/an Summons and Complaint upon the individuals and

other legal entities to be served, names below, by delivering or leaving true copies of said

Document(s) mentioned therein, certified to be such by the attorney for the Plaintiff, as follows:

Service on Corporations, Limited Partnerships or Unincorporated Associations

Subject to Suit Under a Common Name

Upon GlaxoSmithKline, LLC, by leaving such true copy with Sharon Walls, the person

who is apparently in charge of the office of Corporation Service Company, who is a/the

Registered Agent thereof. Service was made at 1127 Broadway St. NE #310, Salem, OR,

on Friday, September 11, 2015, at 1:43 PM.

I further declare that I am a competent person 18 years of age or older and a resident of the state

of service or the State of Oregon, and that I am not a party to nor an officer, director or employee

of, nor attorney for party, corporate or otherwise; that the person, firm or corporation served by

me is the identical person, firm or Corporation named in the action.

Dated September 12, 201

Signed

Page 1 of 1 — DECLARATION OF SERVICE

Amy McCaffieyMercuryPPO Box 22 4Portland, OR 97208503-247-8484



10/6/2015 2:06:16 PM15CV23066



THOMAS BROWN and MARIA DEL CARMENESPINDOLA GOMEZ, individually and as parents andnatural guardians of M.B., a minor,

Plaintiffs,

v.

GLAXOSMITI{KLINE, LLC, and, PROVIDENCEHEALTH SYSTEM - OREGON d/b/a PROVIDENCENEWBERG MEDICAL CENTER f/k/a PROVIDENCENEWBERG HOSPITAL

Defendants.

Case No. 15CV23066

SUMMONS

TO: CORPORATION SERVICE COMPANY, Registered Agent for GLAXOSMITBKLINE, LLC;

1127 Broadway Street NE, Suite 310Salem OR 97301

You are hereby required to appear and defend the complaint filed against you in the above entitled action

within thirty (30) days from the date of service of this summons upon you, and in case of your failure to do so, for

want thereof, plaintiff(s) will apply to the court for the relief demanded in the complaint.

NOTICE TO DEFENDANT: READ THESE PAPERS CAREFULLY!

You must "appear" in this case or the other side will winautomatically. To "appear you must file with the court a legal papercalled a "motion" or "answer." The "motion" or "answer must begiven to the court clerk or administrator within 30 days along withthe required filing fee. It must be in proper form and have proof ofservice on the plaintiffs attorney or, if the plaintiff does not have anattorney, proof of service on the plaintiffif you have any questions, you should see an attorney immediately. Ifyou need help in finding an attorney, you may contact the OregonState Bar's Lawyer Referral Service online atwww.oregonstatOar.org or by calling (503) 684-3763 in the Portlandmetropolitan area or toll free elsewhere in Oregon at (800) 452-7636.

Name:Address:

Telephone:Trial Attorney:

a 13.alur, OSB #0234247157 SW Beveland St., Suite 100Tigard, OR 97223(503) 223-8285Laura B. Kalur, OSB #023424

STATE OF OREGON, County of Washington ) ss.I, the undersigned attorney of record for the plaintiff, certify that the foregoing is an exact and complete copy

of the original summons in the above entitled action.

Attorney of Record for Plaintiff

TO THE OFFICER OR OTHER PERSON SERVING THIS SUMMONS: You are hereby directed to serve a true copy

of this summons, together with a true copy of the complaint mentioned therein, upon the individual(s) or other legal

entity(ies) to whom or which this summons is directed, and to make your proof of service on the reverse hereof or

upon a separate similar document which you shall attach hereto.

Attorney for Plaintiff

SUMMONS- Page I



10/6/2015 2:08:54 PM15CV23066



THOMAS BROWN AND MARIA DELCARMEN,

Plaintiff/Petitioner,

vs.

GLAXOSMITHKLINE, LLC ANDPROVIDENCE HEALTH SYSTEM - OREGOND/B/A PROVIDENCE NEWBERG MEDICALCENTER F/K/A PROVIDENCE NEWBERGHOSPITAL ,

Defendant/Respondent

Case No.: 15CV23066

DECLARATION OF SERVICE

I hereby declare that I made service of a/an Summons and Complaint upon the individuals and

other legal entities to be served, names below, by delivering or leaving true copies of said

Document(s) mentioned therein, certified to be such by the attorney for the Plaintiff, as follows:

Service on Corporations, Limited Partnerships or Unincorporated Associations

Subject to Suit Under a Common Name

Upon Providence Health System, Oregon, by leaving such true copy with Denise Wipper,

the person who is apparently in charge of the office of Business Filings Incorporated, who

is a/the Registered Agent thereof. Service was made at 388 State St. #420, Salem, OR, on

Friday, September 11, 2015, at 1:59 PM.

I further declare that I am a competent person 18 years of age or older and a resident of the state

of service or the State of Oregon, and that I am not a party to nor an officer, director or employee

of, nor attorney for party, corporate or otherwise; that the person, firm or corporation served by

me is the identical person, firm or Corporation named in the action.

Dated September 12, 201

Signed nAmy Mc ffreyMercury XPO Box 2274Portland, OR 97208503-247-8484

Page 1 of 1 — DECLARATION OF SERVICE



10/6/2015 2:08:54 PM15CV23066



THOMAS BROWN and MARIA DEL CARMENESPINDOLA GOMEZ, individually and as parents andnatural guardians of M.B., a minor,

Plaintiffs,

v.

GLAXOSMITHKLINE, LLC, and, PROVIDENCEHEALTH SYSTEM - OREGON d/b/a PROVIDENCENEWBERG MEDICAL CENTER f/k/a PROVIDENCENEWBERG HOSPITAL

Defendants.

Case No. 15CV23066

SUMMONS

TO: BUSINESS t1LINGS INCORPORATED, Registered Agent for PROVIDENCE ulli',ALTH

SYSTEM, OREGON;388 State St., Suite 420Salem OR 97301

You are hereby required to appear and defend the complaint filed against you in the above entitled action

within thirty (30) days from the date of service of this summons upon you, and in case of your failure to do so, for

want thereof, plaintiff(s) will apply to the court for the relief demanded in the complaint.

NOTICE TO DEFENDANT: READ THESE PAPERS CAREFULLY!

You must "appear in this case or the other side will winautomatically. To "appear" you must file with the court a legal paper

called a "motion" or "answer." The "motion" or "answer" must begiven to the court clerk or administrator within 30 days along with

the required filing fee. It must be in proper form and have proof ofservice on the plaintiff's attomcy or, if the plaintiff does not have anattorney, proof of service on the plaintiff.If you have any questions, you should see an attomcy immediately. Ifyou need help in finding an attorney, you may contact the OregonState Bar's Lawyer Referral Service online atWV,Iv.oregonstatcbar.org or by calling (503) 684-3763 in the Portlandmetropolitan area or toll free elsewhere in Oregon at (800) 452-7636.

Name:Address:

Telephone:Trial Attorney:

ra alur, OSB #0234247157 SW Beveland St., Suite 100Tigard, OR 97223(503) 223-8285Laura B. Kalur, OSB #023424

STATE OF OREGON, County of Washington ) ss.I, the undersigned attorney of record for the plaintiff, certify that the foregoing is an exact and complete copy

of the original summons in the above entitled action.

Attorney of Record for Plaintiff

TO THE OFFICER OR OTHER PERSON SERVING THIS SUMMONS: You are hereby directed to serve a true copy

of this summons, together with a true copy of the complaint mentioned therein, upon the individual(s) or other legal

entity(ies) to whom or which this summons is directed, and to make your proof of service on the reverse hereof or

upon a separate similar document which you shall attach hereto.

SUMMONS- Page 1



10/6/2015 2:32:27 PM15CV23066

IN THE CIRCUIT COURT OF THE STA I E OF OREGON



Plaintiffs,

) Case No. 15CV23066

)) MOTION TO ADMIT) TODD R. FALZONE and CATHERINE

) C. DARLSON PRO HAC VICE

)v. )

)

GLAXOSMITHKLINE, LLC; ))

and ))

PROVIDENCE HEALTH SYSTEM - )OREGON d/b/a PROVIDENCE NEWBERG )MEDICAL CENTER f/k/a PROVIDENCE )NEWBERG HOSPITAL )

Pursuant to UTCR 3.170, the undersigned Laura B. Kalur, a member in good standing of

the Oregon State Bar, requests an order admitting Todd R. Falzone and Catherine C. Darlson for

the purpose of appearing and representing the plaintiffs in this matter.

This motion is supported by the attached Declaration of Laura B. Kalur.


MOTION TO ADMIT PRO HAC VICE

- Page 1

KALUR LAW OFFICE, P.C.

By:Laura B. Kalur, Esq., OSB No. 023424

KALUR LAW OFFICE, P.C.7157 SW Beveland St, Suite 100

Tigard, Oregon 97223

(503) 223-8285



10/6/2015 2:32:27 PM15CV23066




)))))))

)))))

PROVIDENCE HEALTH SYSTEM - )OREGON d/b/a PROVIDENCE NEWBERG )MEDICAL CENTER f/k/a PROVIDENCE )NEWBERG HOSPITAL )

Plaintiffs,

v.

GLAXOSMITHKLINE, LLC;

and

Case No. 15CV23066

DECLARATION OF LAURA B.KALUR IN SUPPORT OF MOTION &ORDER ADMITTING TODD R.FALZONE and CATHERINE C.DARLSON PRO HAC VICE

I, Laura B. Kalur, hereby declare as follows:

1. I am a sole practitioner of the law firm of Kalur Law, and am an active member

in good standing of the Oregon State Bar.

2. Attached as Exhibit 1 is a true and correct original of the Certificate of Compliance

for Pro Hac Vice admission, signed by Todd R. Falzone, receipt of which was acknowledged by

the Oregon State Bar on September 29, 2015.

3. Attached as Exhibit 2 is a true and correct original ofthe Certificate of Compliance

for Pro Hac Vice admission, signed by Catherine C. Darlson, receipt of which was acknowledged

by the Oregon State Bar on September 29, 2015.

///

DECLARATION IN SUPPORT OF MOTION AND ORDER TO ADMIT PRO HAC VICE

- Page 1KALUR LAW OFFICE, P.C.

7157 SW Beveland St, Suite 100Tigard, Oregon 97223

(503) 223-8285



I HEREBY DECLARE UNDER PENALTY OF PERJURY OF THE LAWS OF

THE STATE OF OREGON THAT THE FOREGOING IS TRUE AND CORRECT.

Executed at Portland, Oregon on the 6th day of October, 2015.

By: Laura B. Kalur, Esq., OSB No. 023424

DECLARATION IN SUPPORT OF MOTION AND ORDER TO ADMIT PRO HAC VICE

- Page 2KALUR LAW OFFICE, P.C.

7157 SW Beveland St, Suite 100Tigard, Oregon 97223

(503) 223-8285



In re: Todd R. Falzone, Esquire Certificate of Compliance

Name of Out-of-State Attorney For Pro Hac Vice Admission

1, Todd R. Falzone (print name), am an attorney in the State of Florida

and I intend to seek pro hac vice admission in accordance with ORS 9.241 and UTCR 3.170 in the following Oregon court action or

proceeding:

Case Name: Brown et al v. GlaxoKlineSmith LLC & Providence Health System - Oregon

Court: Multnomah County Circuit Court Case No.: 15CV23066

1 certify that (check all that apply):

2 1 am an attorney in good standing in the State of Florida , as evidenced by the attached good standing

certificate issued by the licensing authority in that state.

1 ain not subject to any pending disciplinary proceedings in any jurisdiction; or

I am subject to pending disciplinary proceedings in another jurisdiction, the nature and status of which are described in an

attachment to this certificate.1 intend to associate in the above-referenced action or proceeding with Laura B. Kalur , OSB No.023424 , an active member in good standing of the Oregon State Bar, who will participate meaningfully in the matter.

El I will comply with applicable statutes, laws, and procedural rules of the State of Oregon; be familiar with and comply with

disciplinary rules of the Oregon State Bar; and submit to the jurisdiction of the Oregon courts and Oregon State Bar with respect to

acts and omissions occurring during my pro hac vice admission.

My private law practice activities in Oregon are covered by professional liability insurance substantially equivalent to the Oregon

State Bar Professional Liability Fund plan, as evidenced by the attached certificate of insurance coverage.

I agree, as a continuing obligation of pro hac vice admission, to notify the trial court promptly of any changes in my insurance

coverage, or my admission or disciplinary status in any other jurisdiction.

1 will provide to the Oregon State Bar a copy of the order admitting me pro hac vice in the above-referenced matter when such an

order is granted. In the event pro hac vice admission is revoked for any reason, l will promptly notify the Oregon State Bar.

I submit 5500 to the Oregon State Bar as payment of the pro hac vice fee established by ORS 9.241 and the Hiles of the Oregon

Supreme Court. I acknowledge that this fcc is for a period of twelve months from the date of the Acknowledgment of Receipt issued

below, and that an additional fee of 5500 will be required in order for me to continue my pro hac vice admission in the matter for

every twelve-month period thereafter.

Dated this 18th day of ptember , 20 15 .

X (Applicant Sigria‘re

Mailing Address: 700 Southeast 6th Street

Suite 300

Fort Lauderdale, FL 33316

Florida Bar No,: 975184

(Home Jurisdiction)

Phone: 954-522-6601

FAX: 954-522-6608

[email protected]

Acknowledgment of Receipt

As Regulatory Services Counsel of the Oregon State Bar, I acknowledge receipt from the above-named out-of-state attorney of the

Certificate of Compliance for Pro I-lac Vice Admission and attachments, and the S500 fee for pro hac vice appearance in the above-referenced

Oregon action or proceeding. The fee is for a period of twelve months from the date of this acknowlcd ment.

Dated this

(p- SEE MATERIALS ATTACHED:Regulatory Services Coun el

One on State Bar Regulatory Services, PO Box 131935, Tigard, OR 97281-1935Note that the professional 1ia10111coverage deductible substantiallyexceeds that of the PLF.

EXHIBIT 1Page 1 of 3



JOHN F. HARKNESS, JR.

The Florida Bar651 EAST JEFFERSON STREET

TALLAHASSEE, FLORIDA 32399-2300EXECUTIVE DIRECTOR www.FLOREDABAR.oRG

State of Florida

County of Leon

In Re: 975184Todd Robert FalzoneKelley Uustal, PLC700 S.E. 3rd Ave., Ste. 300Fort Lauderdale, FL

850/561-5600

I HEREBY CERTIFY that I am the duly appointed custodian of membership records of The

Florida Bar.

I FURTHER CERTIFY that the records in the office of the Clerk of the Supreme Court of

Florida indicate that said attorney was admitted to practice law in the State of Florida on May 7,

1993.

I FURTHER CERTIFY that the records in the office of The Florida Bar indicate that the above

attorney is an active member of The Florida Bar in good standing.

Dated this Imo`day of September, 2015.

Pam GerardMembership Records ManagerThe Florida Bar

PG/BJ:ksthl:R10




Declarations

Primary Lawyers Professional Liability Insurance Policy

NOTICE: THIS IS A CLAIMS-MADE POLICY. EXCEPT AS OTHERWISE PROVIDED HEREIN,

COVERAGE IS LIMITED TO LIABILITY FOR ONLY THOSE CLAIMS THAT ARE FIRST MADE AGAINST

THE INSURED DURING THE POLICY PERIOD OR EXTENDED REPORTING PERIOD AND REPORTED

TO THE COMPANY PURSUANT TO THE TERMS HEREIN.

Insured by the Stock Company below and hereinafter called the company.New York Marine and General Insurance Company

59 Maiden Lane27th Floor

New York, NY 10038-4647

POLICY NUMBER: PL2015LPL90053 RENEWAL OF POLICY NUMBER: PL2014LPL90053

Item 1. Named Insured and Address(Number, Street, Town or City, County, State, Zip Code)

Kelly Uustal, PLC700 Southeast Third Avenue, Suite 300

Ft. Lauderdale, Florida 33316

Producer NameProQuest, a division of Alliant Insurance Services, Inc.

ttem 2. Policy Perlod

Inception Date (i.vereMarch 20, 2015

Expiration Date (M/Dirt

March 20, 201612:01 A.M. StandardTime at the addressof the NamedInsured as Matedherein.

Item 3. Form of Named Insureds Business

Insured Is 0 Individual ❑Partnership DCorporatm

Other

Item 4. Limits of Liability

$5,000.000 Each Claim

55,000,000 Aggregate

23 a. Claim expenses are included within the limits of liability.

❑ b. Claim expenses are payable in addition to the limits of liability.

Item 5. Deductible$100,000 Per Aggregate

❑ a. The deductible amount specified above applies only to damages.

El b. The deductible amount specified above applies to both damages and claim expenses.

Item 6. Annual Premium

Item 7. Forms and Endorsements attached at Issue

Schedule of Forms and Endorsements PL 1000 0910

By acceptance of this policy the Insured agrees that the statements in the Declarations and the Application and any attachments

hereto are the Insureds agreements and representations and that this policy embodies all agreements existing between the Insured

and the Company o any of its representatives relating to this insurance.

Policy Holder Questions or Complaints-

1-800-774-2755

Countersigned (as required Countersign Date

Issue DateMarch 13. 2015

PL 1002 0910 EXHIBIT 1Page 3 of 3



In re: Catherine C. Darlson

Name of Out-of-State Attorney

Certificate of ComplianceFor Pro Hac Vice Admission

1, Catherine C. DarlsonFlorida(print name), am an attorney in the State of

and I intend to seek pro hac vice admission in accordance with ORS 9.241 and UTCR 3.170 in the following Oregon court action or

proceeding:

Case Name: Brown et al v. GlaxoKlineSmith LLC & Providence Health System - Oregon

Court: Multnomah County Circuit Court Case No.: 15CV23066

I certify that (check all that apply):

El 1 am an attorney in good standing in the State of Florida , as evidenced by the attached good standingc rtificate issued by the licensing authority in that state.

1 am not subject to any pending disciplinary proceedings in any jurisdiction; or

1 am subject to pending disciplinary proceedings in another jurisdiction, the nature and status of which arc described in an

attachment to this certificate.1 intend to associate in the above-referenced action or proceeding with Laura B. Kalur , OSB No.023424 , an active member in good standing of the Oregon State Bar, who will participate meaningfully in the matter.

1 will comply with applicable statutes, laws, and procedural rules of the State of Oregon; be familiar with and comply with

disciplinary rules of the Oregon State Bar; and submit to the jurisdiction of the Oregon courts and Oregon State Bar with respect to

acts and omissions occurring during my pro hoc vice admission.El My private law practice activities in Oregon are covered by professional liability insurance substantially equivalent to the Oregon

State. Bar Professional Liability Fund plan, as evidenced by the attached certificate of insurance coverage.

1 agree, as a continuing obligation of pro hac vice admission, to notify the trial court promptly of any changes in my insurance

coverage, or my admission or disciplinary status in any other jurisdiction,

El l will provide to the Oregon State Bar a copy of the order admitting me pro hac vice in the above-referenced matter when such an

order is granted. In the event pro hac vice admission is revoked for any reason, l will promptly notify the Oregon State Bar.

I submit $500 to the Oregon State Bar as payment of the pro hac vice fce established by ORS 9.241 and the rules of the Oregon

Supreme Court. 1 acknowledge that this fee is for a period of twelve months from the date of the Acknowledgment of Receipt issued

below, and that an additional fee of $500 will be required in order for me to continue my pro hac vice admission in the matter for

every twelve-month period thereafter.

Dated this 18th

x(Ap, nt Signature)

day of September

Mailing Address: 700 Southeast 6th Street

Third Floor

Fort Lauderdale, FL 33316

Florida Bar No.: 112440

(Home Jurisdiction)

Phone: 954-522-6601

FAX: 954-522-6608

Email: [email protected]

Acknowledgment of Receipt

As Regulatory Services Counsel of the Oregon State Bar, 1 acknowledge receipt from the above-named out-of-state attorney of theCertificate of Compliance for Pro Mc Vice Admission and attachments, and the 5500 fee for pro hac vice appearance in the above-referenced

Oregon action or proceeding. The fee is for a period of twelve months from the date of this acknowledgment.

144 , 20Dated this day of 1 /

Pi SEE MATERIALS ATTACHED:Regulatory Services ounscl

Note that the professional II Obirieifon State Bar Regulatory Services, PO Box 231935, Tigard, OR 97281-1935a ycoverage deductible substantiallyexceeds that of the PLF,




JOHN F. HARKNESS, JR.EXECUTIVE DIRECTOR

State of Florida

County of Leon

The Florida Bar651 EAST JEFFERSON STREET

TALLAHASSEE, FLORIDA 32399-2300

In Re:

850/561-5600www.FLORIDABAR.Oao

112440Catherine Claire DarlsonKelley Uustal700 S.E. 3rd Ave., Ste. 300Fort Lauderdale, FL

I HEREBY CERTIFY that I am the duly appointed custodian of membership records of The

Florida Bar.

I FURTHER CERTIFY that the records in the office of the Clerk of the Supreme Court of

Florida indicate that said attorney was admitted to practice law in the State of Florida on October

1, 2014.

I FURTHER CERTIFY that the records in the office of The Florida Bar indicate that the above

attorney is an active member of The Florida Bar in good standing.

Dated this 43-6 day of September, 2015.

Pam GerardMembership Records Manager

The Florida Bar

PG/BJ:ksthl:RIO




DeclarationsPrimary Lawyers Professional Liability Insurance Policy

NOTICE: THIS IS A CLAIMS-MADE POLICY. EXCEPT AS OTHERWISE PROVIDED HEREIN,

COVERAGE IS LIMITED TO LIABILITY FOR ONLY THOSE CLAIMS THAT ARE FIRST MADE AGAINST

THE INSURED DURING THE POLICY PERIOD OR EXTENDED REPORTING PERIOD AND REPORTED

TO THE COMPANY PURSUANT TO THE TERMS HEREIN.

Insured by the Stock Company below and hereinafter called the company.

New York Marine and General Insurance Company

59 Maiden Lane

27th Floor

New York, NY 10038-4647

POLICY NUMBER: PL2015LPL90053 RENEWAL OF POLICY NUMBER: PL2014LPL90053

Item 1. Named Insured and Address(Number. Street, Town or City, County, Slate, Zip Code)

Kelly Uustal, PLC700 Southeast Third Avenue, Suite 300

Ft. Lauderdale, Florida 33316

Producer NameProQuest, a division of Alliant Insurance Services, Inc.

Item 2. Policy Period

Inception Date (WON):

March 20, 2015Explraion Data (WON):

March 20, 201612:01 A.M. StandardTime et the addressof the NomadInsured as slatedherein.

Item 3. Form of Named Insured's BusinessInsured is ❑ Individual ❑Partnership ❑Corporation

IZI Other

Item 4. Limits of Liability

$5,000,000 Each Claim

$5,000,000 Aggregate

El a. Claim expenses are included within the limits of liability.

❑ b. Claim expenses are payable in addition to the limits of liability.

Item 5. Deductible$100,000 Per Aggregate

❑ a. The deductible amount specified above applies only to damages.

El b. The deductible amount specified above applies to both damages and claim expenses.

Item 6. Annual Premium

Item 7. Forms and Endorsements attached at issue

Schedule of Forms and Endorsements PL 1000 0910

By acceptance of this policy the Insured agrees that the statements in the Declarations and the Application and any attachments

hereto are the Insured's agreements and representations and that this policy embodies all agreements existing between the Insured

and the Company or any of its representatives relating to this insurance,

Policy Holder Questions or Complaints-

1-800-774-2755

Countersigned (as required) Countersign Date

Issue DateMarch 13, 2015

PL 1002 0910 EXHIBIT 2Page 3 of 3



CIVIL COVER SHEET

(SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)

I. (a) PLAINTIFFS DEFENDANTS

(b)

(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)

(c) (Firm Name, Address, and Telephone Number) (If Known)

II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff(For Diversity Cases Only) and One Box for Defendant)

PTF DEF PTF DEF

(U.S. Government Not a Party) or

and(Indicate Citizenship of Parties in Item III)

IV. NATURE OF SUIT (Place an “X” in One Box Only)

CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES

PERSONAL INJURY PERSONAL INJURY

PROPERTY RIGHTS

LABOR SOCIAL SECURITYPERSONAL PROPERTY

REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS FEDERAL TAX SUITS

Habeas Corpus:

IMMIGRATION

Other:

V. ORIGIN (Place an “X” in One Box Only)

(specify)

VI. CAUSE OF ACTION

(Do not cite jurisdictional statutes unless diversity)

VII. REQUESTED INCOMPLAINT:

CLASS ACTION DEMAND $

JURY DEMAND:

VIII. RELATED CASE(S)IF ANY (See instructions):

FOR OFFICE USE ONLY

Thomas Brown and Maria Del Carmen Espindola Gomez

Unknown

Laura B. Kalur, Kalur Law Office, P.C., 7157 SW Beveland St, Ste 100,

Tigard, OR 97223 and Todd R. Falzone and Catherine Darlson of Kelley/

Uustal, PLC, 700 SE Third Ave., Suite 300, Ft. Lauderdale, FL 33304

GlaxoSmithKline, LLC, et al.

James Dumas and Michael Estok of Lindsay Hart, LLP

1300 SW Fifth Ave., Suite 3400, Portland, OR 97201

503-226-7677

28 U.S.C. 1332, 1441, 1446

Removal of products liability action based on diversity

25,000,000.00

10/09/2015 s/ James L. Dumas


James Dumas, OSB No. 771671 LINDSAY ... - Zofran Legal...

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