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BETWEEN: ONTARIO SUPERIOR COURT OF JUSTICE JENNIFER PRICE, INDIVIDUALLY, AND MATTHEW JANZIC, A ClllLD, BY illS 1 . NATURAL MOTHER AND LIDGATION GUARDIAN, JENNIFER PRICE ,(b "?· 1.) ,A· 4?' G;§i1 ] . Plaintiffs ."::> 'f,f:. .=:'*" "" - and - {J) () o · rn g. N 1.4! H. LUNDBECK A/S, and LUNDBECK CANADA INC. 'f.;(_ .!:) · '<tn·, t • r}l Defendants v,.o < "" / Proceedingunderthe Class Proceedings Act, 1992 STATEMENT OF CLAIM TO THE DEFENDANTS A LEGAL PROCEEDING HAS BEEN COMMENCED AGAINST YOU by the plaintiff. The claim made against you is set out in the following pages. IF YOU WISH TO DEFEND TillS PROCEEDING, you or an Ontario lawyer acting for you must prepare a statement of defence in Form 18A prescribed by the Rules of Civil Procedure, serve it on the plaintiff's lawyer or, where the plaintiff does not have a lawyer, serve it on the plaintiff, and file it, with proof of service, in this court office, WITHIN TWENTY DAYS after this statement of claim is served on you, if you are served in Ontario. If you are served in another province or territory of Canada or in the United States of America, the period for serving and filing your statement of defence is forty days. If you are served outside Canada and the United States of America, the period is sixty days. Instead of serving and filing a statement of defence, you may serve and file a notice of intent to defend in Form 18B prescribed by the Rules of Civil Procedure. This will entitle you to ten more days within which to serve and file your statement of defence. IF YOU FAIL TO DEFEND TillS PROCEEDING, ruDGMENT MAY BE GNEN AGAINST YOU IN YOUR ABSENCE AND WITHOUT FURTHER NOTICE TO YOU. IF YOU WISH TO DEFEND TillS PROCEEDING BUT ARE UNABLE TO PAY LEGAL FEES, LEGAL AID MAY BE AV AJLABLE TO YOU BY CONTACTING A LOCAL :?? OFFICE. Date: December 2d_, 2014 Issued by: Local Registrar 393 University A venue, 1Oth Floor Toronto, Ontario M5G 1E6

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BETWEEN:

ONTARIO

CourtFileNo. ~V-ll\--'51 ~ (oCf~ ooc~

SUPERIOR COURT OF JUSTICE

JENNIFER PRICE, INDIVIDUALLY, AND MATTHEW JANZIC, A ClllLD, BY illS

~oCR 1 . NATURAL MOTHER AND LIDGATION GUARDIAN, JENNIFER PRICE ,(b "?· 1.) ,A· •

4?' G;§i1 ] v<.:~~ . Plaintiffs • ."::> 'f,f:. .=:'*" "" - and -{J) ~~~;~:," ()

o · ,j',~- rn g. N ~- 1.4! H. LUNDBECK A/S, and LUNDBECK CANADA INC. ~ 'f.;(_ .::;_.~./:: .!:) · ~ '<tn·, t • r}l Defendants

v,.o < "" / ~-::..,~~>"/ Proceedingunderthe Class Proceedings Act, 1992

STATEMENT OF CLAIM

TO THE DEFENDANTS

A LEGAL PROCEEDING HAS BEEN COMMENCED AGAINST YOU by the plaintiff. The claim made against you is set out in the following pages.

IF YOU WISH TO DEFEND TillS PROCEEDING, you or an Ontario lawyer acting for you must prepare a statement of defence in Form 18A prescribed by the Rules of Civil Procedure, serve it on the plaintiff's lawyer or, where the plaintiff does not have a lawyer, serve it on the plaintiff, and file it, with proof of service, in this court office, WITHIN TWENTY DAYS after this statement of claim is served on you, if you are served in Ontario. If you are served in another province or territory of Canada or in the United States of America, the period for serving and filing your statement of defence is forty days. If you are served outside Canada and the United States of America, the period is sixty days.

Instead of serving and filing a statement of defence, you may serve and file a notice of intent to defend in Form 18B prescribed by the Rules of Civil Procedure. This will entitle you to ten more days within which to serve and file your statement of defence.

IF YOU FAIL TO DEFEND TillS PROCEEDING, ruDGMENT MAY BE GNEN AGAINST YOU IN YOUR ABSENCE AND WITHOUT FURTHER NOTICE TO YOU. IF YOU WISH TO DEFEND TillS PROCEEDING BUT ARE UNABLE TO PAY LEGAL FEES, LEGAL AID MAY BE AV AJLABLE TO YOU BY CONTACTING A LOCAL:?? OFFICE.

Date: December 2d_, 2014 Issued by: ~J;,......,.~ Local Registrar 393 University A venue, 1Oth Floor Toronto, Ontario M5G 1E6

..

TO: H. LUND BECK A/S Ottiliavej 9

AND TO:

2500 Valby, Denmark c

LUNDBECK CANADA INC. 1 000 rue de la Gauchetiere Ouest Bureau 500 Montreal, Quebec H3B4W5 Canada

2

CLAIM 1. The Plaintiffs, as representatives of the Class of persons resident or situated in

Ontario and throughout Canada, have suffered injury, economic loss, and

damages as a result of the Defendant's acts, omissions, wrongdoings, and

breaches of legal duties and obligations, included but not limited to deceit,

misrepresentation, negligence, misleading and misinforming their customers and

members of the public, failing to make proper public disclosure, and failing to

fulfill their statutory and common law duties and obligations to the Plaintiffs and

Class members.

2. The Plaintiffs therefore claim, on behalf of themselves and all Class members, for

the following relief against Lundbeck, on a joint and several basis:

(a) general damages in excess of $500,000,000, or such other amount as may be

proved in this Honourable Court;

(b) special damages in excess of $500,000,000, or such other amount as may be

proved in this Honourable Court;

(c) alternatively, an accounting and an order requiring the disgorgement of all

gross revenue or income from the sale received by the Defendants from the

sale of the Celexa;

(d) a declaration that the Defendants breached section 52 of the Competition Act

and an award of damages pursuant to section 36;

(e) punitive damages in the amount of$100,000,000;

(f) pre-judgment interest pursuant to the Courts of Justice Act, R.S.O. 1990,

c.C.43, as amended;

(g) costs of this action on a substantial indemnity basis and GST thereon;

(h) the costs of notice and of administrating the plan of distribution of the

recovery in this action, plus applicable tax, pursuant to s. 26(9) of the CPA;

and,

(i) such further and other relief as this Honourable Court deems just.

3

I. PARTIES

The Plaintiffs

3. At all material times, the Plaintiffs were residents of Stoney Creek, Ontario.

4. Jennifer Price ("Ms. Price"), was prescribed Celexa to treat depression in

December of2001.

5. Ms. Price, still residing in Stoney Creek, became pregnant with, the Plaintiff

Matthew Janzic ("Matthew"), in April of2005.

6. Matthew is a minor, and sues by his litigation representative Ms. Price.

7. Matthew was born in Stoney Creek in July 2006 with severe birth defects after his

mother was prescribed and ingested Celexa during pregnancy.

8. Matthew's birth defects were caused by Celexa.

The Proposed Class

9. The Plaintiff, Ms. Price brings this action on behalf of herself, her child, and

others similarly affected, as members to the proposed class, defined as follows:

"any person in Canada, born with defects, to women who ingested

Celexa while pregnant, and the mothers of those persons." (the

"Class" or "Class members")

The Defendants

10. The Defendant, H. Lundbeck A/S, is a Danish international corporation with its

headquarters located at Ottiliavej 9, 2500, Valby, Denmark.

11. H. Lundbeck A/S, originally founded in 1915, is a pharmaceutical company

primarily concerned with the treatment of disord0rs in the central nervous system.

4

For this purpose, it is engaged in the research and development, production,

marketing, and sale of pharmaceuticals across the world, including Celexa.

12. H. Lundbeck A/S employs approximately 6,000 people worldwide, with affiliates

and sales offices in 57 different countries. Its products are registered in more than

100 countries, and it generated revenue of approximately €2.04 billion in 2013.

13. The Defendant, Lundbeck Canada Inc, is a subsidiary of H. Lundbeck A/S, with

its head office located at 1000 rue de la Gauchetiere Ouest, Bureau 500, Montreal,

Quebec, Canada.

14. Lundbeck Canada Inc. has been active in the Canadian pharmaceutical industry

for almost two decades, marketing products for the treatment of depression,

anxiety, and other mental and physical ailments.

15. "Lundbeck" hereinafter refers to a partnership, joint venture, or other common

enterprise carrying on business in Canada and throughout the world, between H.

Lundbeck A/S, Lundbeck Canada Inc., and any of their other affiliates or

subsidiaries.

II. PARTICULARS OF THE CLAIM

Nature of the Class Action

16. Known pharmaceutically as Citalopram, Celexa is part of a class of

antidepressants called selective serotonin reuptake inhibitors (SSRis). These

medications work by increasing the amount of serotonin in the brain. Celexa is

prescribed most commonly to treat depression, anxiety, panic disorder, and

generalized anxiety disorders.

17. Originally created in 1989 by Lundbeck, the patent for the drug expired in 2003,

allowing other companies to produce a generic version of the drug. In recent

years, Lundbeck has resulted a slightly altered formulation of the drug marketed

as Cipralex or Lexapro, and acquired new patents.

5

18. Children in the proposed Class are, and have been, permanently disabled as a

result of defects in their in utero development caused by the use of Celexa by their

mothers when pregnant.

19. Class members are numerous and joinder in a single action is impractical.

However, each Class member will be readily identifiable from information in

their medical records.

20. Individual litigation of each Class member's claim would present the possibility

for varying, inconsistent, or contrary judgments and would magnify the delay and

expense to all parties resulting from multiple trials of the same factual issues. The

cost to pursue individual actions would effectively deny potential Class members'

access to justice.

21. There are common legal and factual issues which may be determined without

reference to the individual circumstances of Class members. These include, but

are not limited to:

a. Whether Celexa causes, contributes to, or increases the risk of birth

defects;

b. Where Lundbeck breached a duty of care in designing, developing,

testing, distributing, marketing, or selling Celexa;

c. Whether Lundbeck properly disclosed results of all testing and other

information in its knowledge or possession regarding the possibility that

Celexa can interfere with the proper development of an unborn fetus;

d. Whether Lundbeck knew or should have known that Celexa was a

substance that would be actively transported through the placenta during

pregnancy and could inhibit the health and development of a fetus, based

on available medical or scientific knowledge, or medical or scientific

knowledge of side effects associated with the class of drugs to which

Celexa belongs;

6

e. Whether Lundbeck negligently, carelessly, or otherwise unlawfully

represented to the public that Celexa was safe for use during pregnancy

when in fact Lundbeck knew or ought to have known that Celexa was

unsafe for this use;

f. Whether Lundbeck negligently and carelessly over-promoted Celexa to

such an extent that any warnings Lundbeck may have given regarding use

of Celexa for pregnant women were nullified;

g. Whether Lundbeck's marketing ofCelexa in Canada was negligent;

h. Whether Lundbeck breached common law, statutory, or equitable duties,

or acted otherwise unlawfully, with regard to the manufacturing,

production, distribution, marketing, and sale of Celexa;

1. Whether the Plaintiffs and Class members are entitled to damages or other

relief against Lundbeck as a result of these breaches and other unlawful

acts or omissions, and if so, in what amounts; and

J. Whether the Plaintiffs and Class members are entitled to aggravated,

punitive, or exemplary damages against Lundbeck, and if so, in what

amounts.

22. The only differences among Class members are the extent of damages suffered,

which damages can be aggregated and paid in categories on a Class-wide basis or

readily determined through individual assessment if needed, and ought not bar

certification of this action as a class proceeding.

23. Neither the Plaintiffs nor their counsel have interests which are conflicting with

those of Class members in respect of the common issues.

Efficacy of a Class Action

24. The Plaintiffs and Class members have in common that each has suffered injury

due to the ingestion of Celexa during or immediately prior to pregnancy, either by

themselves or through their mothers.

7

25. Individual members of the proposed class do not have a significant interest in

individually controlling the prosecution of their claim by way of separate actions,

and individualized litigation would also present the potential for varying,

inconsistent, and contrary judgments. Further, individual litigation would magnify

the delay and expense to all parties resulting from multiple proceedings on the

same issues. The cost to pursue individual actions concerning this claim would

effectively deny individual claimants' access to appropriate legal relief.

26. The Plaintiffs will fully and adequately protect the interests of the proposed Class,

and have retained counsel to represent the Class who are qualified to prosecute

complex class action litigation. Neither the Plaintiffs nor their solicitors have

interests which are contrary to, or conflicting with, the interests of the proposed

Class.

The Risks

27. Celexa has been associated with an increased risk of senous adverse

cardiovascular and other complications for newborns when taken by women

during or immediately before pregnancy.

28. A 2005 Danish study found that infants are 60 percent more likely to develop

heart problems if the mother took antidepressants during the first trimester.

29. A 2006 study published in the New England Journal of Medicine found that

infants born to mothers who took antidepressants after the 20th week of

pregnancy were 6 times more likely to have PPHN.

30. Another 2006 study published in Epidemiology found that Cymbalta birth defects

were three times more likely to occur in women who take Cymbalta while

pregnant.

31. A 2007 study published in the New England Journal of Medicine found SSRI

pregnancy use was linked to a higher risk of the brain and skull defects, as well as

8

birth defects in which the infant's intestine or other abdominal organs stick out of

the belly button.

32. A 2009 study published in the British Medical Journal found that using more than

one type of antidepressant during the first trimester resulted in a four-fold

increased risk of septal heart defects.

33. Nonetheless, Lundbeck marketed Celexa for use by women despite the fact that

Celexa is associated with an increased risk of birth defects as described above.

34. Even if the probability of injury is small or it may only affect a small group of

users, this must be balanced against considerations such as the nature of the drug,

the necessity for taking it, and the magnitude of the increased danger to the

individual consumer.

35. In this case, Lundbeck failed to adequately and clearly warn consumers of the

seriousness of Celexa's potential side effects, and denied the Plaintiff and Class

Members the ability to make an informed decision.

36. Additionally and in the alternative, Lundbeck downplayed the seriousness of

Celexa's potential side effects, and failed to make consumers adequately aware of

the seriousness ofCelexa's potential side effects.

3 7. There are numerous studies of which Celexa are or ought to be aware, that show

that men have experienced sexual dysfunction as a persistent side-effect during

and even after discontinuing use of Celexa, but nonetheless, Lundbeck have not

included an adequate warning of this risk on their product. Lundbeck are refusing

to do this because adding the warning to their product would affect the sales of

this product which is very profitable for Lundbeck. Lundbeck has placed the

profits oftheir conjoined companies ahead ofthe health of Canadian consumers.

9

38. Had the true facts been disclosed by Lundbeck, namely, that Celexa is associated

with an increased risk of birth defects when ingested by mothers during or

immediately before pregnancy, the Plaintiff and Class members in common

would not have used Celexa.

39. Lundbeck knew or ought to have known, that there was a significant risk of

serious adverse cardiovascular complications for newborns from pregnant

mothers ingesting Celexa. Lundbeck failed to apprise the Plaintiff, Ms. Price, or

her physician of that risk.

40. Lundbeck negligently or fraudulently failed to provide the medical community,

the Plaintiffs, the Class members, and the general public with sufficient, proper,

and adequate notice of the risks associated with Celexa use during or shortly

before pregnancy.

41. Lundbeck impliedly warranted to the public that Celexa was a drug of

merchantable quality and safe and fit for its intended and foreseeable purpose.

Lundbeck breached this implied warranty because Celexa was not, and is not, of

merchantable quality or safe for its implied use in that it poses an undue risk of

harm to developing fetuses when ingested by pregnant or soon-to-be pregnant

women.

Background

42. Upon becoming aware of her pregnancy, Ms. Price questioned her physician

regarding potential health effects that Celexa might have upon herself or her

unborn fetus. Based on Lundbeck's class-wide marketing, Ms. Price's was

assured that Celexa was safe for ingestion during pregnancy.

43. Ms. Price took Celexa throughout her pregnancy from October 2003 to June 2004.

10

Medical Complications

44. Matthew suffers from several birth defects. These include ventricular septal

defect; a large hole in the heart. The hole occurs in the wall that separates the

heart's lower chambers, and allows blood to pass from the left to the right side of

the heart. The oxygen-rich blood then gets pumped back to the lungs instead of

out to the body, forcing the heart to work harder. At eleven months old, Matthew

was required to undergo surgery to patch this large hole.

45. Matthew was also born with several smaller holes in the apex of his heart. These

holes have required constant monitoring and on-going cardiac work-ups.

46. Matthew also suffers from valve stenosis, whereby the flap of a heart valve is

abnormally thickened, stiff, and fused together. As a result, the valve cannot fully

open. Again, this forces the heart to work harder to pump blood through the

thickened valve, and the body suffers from a reduced supply of oxygen.

4 7. Matthew was also born missing the tip of his left baby finger, and left baby toe.

48. Further, he suffered from several withdrawal symptoms at birth, such as low sugar

levels. As a result, doctors had to install a feeding tube shortly after Matthew was

born.

49. All of these birth defects were caused by Matthew's mother having been

prescribed and having ingested Celexa during pregnancy, and he has been forced

to live with the negative health consequences from which he has suffered.

50. Matthew's injuries have required ongoing and onerous burdens of time and effort

on his mother and family. Matthew has required routine appointments with

physicians and specialists. Ms. Price has missed work in order to take him to these

appointments.

11

51. Matthew's physical and mental suffering. as well as the caregiving and financial

burdens that his injuries have imposed upon his mother and family, are an

ongoing reality. The costs generated to ensure proper monitoring and subsequent

treatment, all of which have been and will continue to be, incurred as a result of

Ms. Price having ingested Celexa during pregnancy.

III. CAUSES OF ACTION

Negligence

52. As manufacturers and marketers of a prescription pharmaceutical, Lundbeck

owed Class Members duties:

a. to conduct proper design, development and testing of Celexa to ensure it is

reasonably safe and fit for its intended purposes, and to determine whether

and to what extent ingestion of Celexa posed serious health risks to

pregnant women, including the risk of serious adverse complications for

newborn children of mothers who ingest Celexa during pregnancy;

b. not to market an unreasonably dangerous drug; and

c. to warn of the risks of serious side effects.

53. The aforementioned duties include that Lundbeck:

a. monitor and analyze data regarding the safety, efficacy, proper prescribing

practices, and effects of Celexa;

b. stay abreast medical knowledge on the effects associated with the class of

drugs to which Celexa belonged;

c. continually receive reports from Lundbeck's own clinical trials, associated

practicing physicians, and regulatory authorities of adverse effects that

occurred as a result of taking Celexa; and

d. continuously informing doctors, regulatory agencies, the Plaintiffs, the

Class members, and the general public of relevant safety information

Lundbeck knew, or ought to have known, about Celexa once that

information became available, whether attained via Lundbeck's own

clinical trials or other sources;

12

54. Before marketing Celexa in Canada, Lundbeck:

a. conducted no studies on the effects of Celexa on undeveloped fetuses;

b. failed to stay abre~;~.st medical knowledge on the effects of SSRis on

undeveloped fetuses; and

c. hired no outside endocrinology experts.

55. Lundbeck knew or should have known that Celexa can cause, contribute to, or

increase the risk of permanent forms of birth defects, based on:

a. medical and scientific journals, studies, and trials;

b. post-marketing adverse drug reaction reports;

c. scientific knowledge of a biologically plausible mechanism associated

with the class of drugs to which Celexa belongs (SSRis);

d. scientific knowledge of side effects associated with the class of drugs to

which Celexa belongs (SSRis); and

e. other evidence to be presented at trial.

56. Because of Celexa's serious side effects, Lundbeck breached their duty of care by

negligently designing, developing, and testing Celexa, marketing Celexa in

Canada at all, and by failing to withdraw Celexa from the market in Canada.

57. Additionally and alternatively, Lundbeck breached their duty of care by failing to

include an adequate warning in the Celexa product monograph that:

a. Celexa could cause birth defects; and

b. Celexa can interfere with the proper development of an unborn fetus.

58. The Celexa product monograph failed to provide a clear, complete, and current

warning that Celexa could cause birth defects or interfere with the proper

development of an unborn fetus.

59. As a direct and proximate result of Lundbeck's unlawful conduct, the Plaintiffs

and Class members suffered serious and irreparable harm and are entitled to

special and compensatory damages. 13

Vicarious Liability

60. H. Lundbeck A/Sis liable for the acts ofLundbeck Canada Inc. because:

a. each Lundbeck entity is affiliated with the other;

b. for the purposes of marketing Celexa throughout the world, including in

Canada, each was the agent of the other;

c. Lundbeck intended that its business be operated as a single, global

enterprise;

d. Lundbeck, acting in common in the pursuit of mutual profit, marketed

Celexa throughout the world, including in Canada;

e. Lundbeck's business activities in furtherance of their common enterprise,

including their collection of scientific and clinical information about

Celexa, and their submission thereof to, or their concealment thereof from,

government regulators around the world were inextricably interwoven. In

particular, at all material times:

(i) They conducted clinical studies and trials, and the results were

shared throughout the company.

(ii) Based on the results of those studies and trials they coordinated the

preparation of similar applications, materials, and submissions for

filing with government regulators. To Lundbeck's knowledge,

government regulators communicated with each other respecting

the regulatory submissions that each Lundbeck entity made to each

regulator.

Statutory Breaches

61. Lundbeck engaged in: unfair trade practices; deceptive acts or practices,

unconscionable acts or practices, unfair business practices, unfair consumer

practices, prohibited practices; false, misleading or deceptive representations,

knowingly or recklessly making a representation to the public that was false or

misleading in a material respect, as well as breached statutory, express, or implied

conditions or warranties, by marketing Celexa in Canada, and failing to include an

14

adequate warning in the Celexa product monograph about potentially serious side

effects such as birth defects.

62. Lundbeck deliberately withheld information from the public about the risk of

serious side effects associated with Celexa use.

63. Celexa was not of acceptable quality, state, or condition; particular standard,

quality, grade, style, model, origin, or method of manufacture; or merchantable

quality. The serious and life-threatening side effects of the drug Celexa outweigh

its benefits.

64. On behalf of class members, the Plaintiffs plead the consumer protection and

trade practice legislation in Canada, Ontario, and other provinces, including:

a. Business Practices and Consumer Protection Act, S.B.C. 2004, c.2, as

am., including ss. 4-5 & 8-1 0;

b. Fair Trading Act, R.S.A. 2000, c. F-2, as am., including ss. 6, 7 & 13;

c. The Consumer Protection Act, S.S. 1996, c. C-30.1, as am., including ss.

5-8, 14, 16, 48, 64 & 65;

d. The Business Practices Act, S.M. 1990-91, c. 6, as am., including ss. 2 &

23;

e. Consumer Protection Act, 2002, S.O. 2002, c. 30, Sched. A, as am.,

including ss. 8, 11 & 14;

f. Consumer Protection Act, R.S.Q. c. P-40.1, as am., including ss. 219 &

272;

g. Consumer Product Warranty and Liability Act, S.N.B. 1978, c. C-18.1,

including ss. 4, 10, 12, 15-18, 23 & 27;

h. Consumer Protection Act, R.S.N.S. 1989, c. 92, including ss. 26 & 28A;

i. Business Practices Act, R.S.P .E.I. 1988, c. B-7, as am., including ss. 2-4;

J. Consumer Protection and Business Practices Act, SNL 2009, c C-31.1,

including ss. 7, 8 & 10; and

k. The Competition Act, R.S.C. 1985, c. C-34, including ss. 36, 52 and 74.01.

15

Unjust Enrichment

65. Lundbeck, as a direct result of its unlawful acts and omission set forth above, has

been unjustly enriched at the expense of the Plaintiffs and Class members, and

must make restitution.

66. Lundbeck profited from the sale ofCelexa, one ofLundbeck's most popular drugs

and a substantial source of revenues since the drug was first introduced. Celexa's

outstanding yet unmerited sales success during the Class period contributed

significantly to Lundbeck's annual sales revenues.

67. The Defendant's enrichment occurred at a corresponding cost to the Plaintiffs.

Lundbeck benefitted immensely from the sale of Celexa at a cost to consumers

who purchased the drug, private insurance companies, and the publicly funded

medical system in Canada. Insurers reimbursed or funded the purchase of the drug

by the Plaintiffs, and in doing so, incurred a substantial expense.

68. But-for Lundbeck's decision to mislead the Plaintiffs and Class members

regarding the inherent dangers of using Celexa during or shortly before

pregnancy, the Plaintiffs and Class members would not have purchased, acquired,

or consumed the unsafe drug.

69. The Plaintiffs and Class members were intentionally misled to believe that Celexa

was safe for consumption during or immediately prior to pregnancy, and that it

would not harm the unborn fetus. Lundbeck intentionally concealed material

information regarding the damage Celexa was known to cause to developing

fetuses in order to minimize negative potential commercial impact.

70. Lundbeck is required to make full restitution of all revenues, profits and other

benefits from the sale of Celexa, and to compensate the Plaintiffs and Class

members for all economic losses incurred as a result of purchasing, acquiring, and

ingesting Celexa.

16

71. Information regarding these exact amounts unjustly derived from the sale of

Celexa to the Plaintiffs and Class members is in the knowledge and possession of

Lundbeck, and such information would become readily available after

examination for discovery.

Waiver of Tort

72. Because Celexa was unsafe for use by women who were pregnant or would soon

become pregnant, Lundbeck owed and breached a duty of care to Class members

not to market Celexa to them.

73. In breach of its duty of care to Class members Lundbeck did not reasonably

communicate that Celexa was unfit, and should therefore not be used by women

who were pregnant or who might become pregnant. Lundbeck did not provide

warning that Celexa could cause birth defects.

74. By failing to provide government regulators in Canada with adequate information

regarding the effects of Celexa on unborn children, Lundbeck independently

breached the Competition Act, R.S.C. 1985, c. C-34, The Food and Drugs Act,

R.S.C. 1985, c. F-27, and the Consumer Protection Act, 2002, S.O. 2002, c. 30,

Sched. A., and other similar provincial legislation.

75. In order to obtain and keep authorization to market Celexa in Canada to women

who were pregnant or who might become pregnant, Lundbeck withheld material

information that demonstrated that Celexa was unfit for this purpose.

76. At all material times, Lundbeck's acts and omissions were deliberate, flagrant,

malicious, oppressive, reckless, willful, and wanton.

77. If Lundbeck had not breached its duties as described herein, it would not have

received the associated revenues and profits.

17

78. Therefore, the Plaintiffs claim a money judgment in an amount equal to all

revenues or profits which Lundbeck received, that can reasonably be attributed to

sales of Celexa in Canada to women who were pregnant or who might become

pregnant.

Subrogated Medical Claims

79. The Plaintiffs claim on behalf of the:

a. Minister of Health of Saskatchewan, for the cost of health services

received by class members under The Department of Health Act, SS 1978,

cD-17,s.19(5);

b. Minister of Health of British Columbia, for the cost of health services

received by class members pursuant to s. 2 of the Health Care Costs

Recovery Act, S.B.C. 2008, c. 27, including necessary operating and care

room facilities, diagnostic or therapeutic X-ray and laboratory procedures,

anesthetics, prescriptions and drugs;

c. Minister of Health of Alberta, for the cost of health services received by

class members pursuant to Part 5, Division 1, of the Hospital Act, R.S.A.

2000, c. H-12, as am., including in-patient and out-patient services,

transportation services, public health services, mental health services and

drug services;

d. Minister of Health ofManitoba, for the cost of health services received by

class members under s. 106(1) of The Health Services Insurance Act,

C.C.S.M. c. H35;

e. Ontario Health Insurance Plan, for the cost of insured services received by

class members pursuant to Health Insurance Act, R.S.O. 1990, c. H.6, as

am., s. 31(1), including, prescribed services of hospitals and health

facilities, prescribed medically necessary services rendered by physicians,

and prescribed health care services rendered by prescribed practitioners;

f. Minister of Health and Social Services of Quebec, for the cost of all

insured services furnished or to be furnished pursuant to the Hospital

Insurance Act, R.S.Q. c. A-28, s. 1 0;

g. Her Majesty the Queen in right of N0w Brunswick, for the cost of entitled 18

. . .

services received by class members pursuant to Health Services Act,

R.S.N.B. 1973, c. H-9, as am., s.lO, including accommodation and meals,

nursing services, laboratory, radiological and other diagnostic procedures,

drugs, use of operating rooms, case rooms and anesthetic facilities, and

routine surgical supplies;

h. Her Majesty the Queen in right of Nova Scotia, for the cost of insured

hospital services received by class members pursuant to the Health

Services and Insurance Act, R.S.N.S. 1989, c. 197, as am., s. 18, including

benefits under the Insured Prescription Drug Plan, ambulance services,

and insured professional services; and

1. Minister of Health of Newfoundland and Labrador, for the cost of insured

services received by class members pursuant to s. 5 of the Hospital

Insurance Agreement Act, R.S.N. 1990, c. H-7, s. 5, as am.

Aggravated, Punitive, and Exemplary Damages

80. As a result of Lundbeck's deceitful conduct, acts, omissions, wrongdoing, and

breaches of legal duties and obligations, the Plaintiffs and Class members have

suffered injury, economic loss, and damages.

81. Lundbeck has demonstrated and taken a cavalier and arbitrary approach with

respect to its obligations to the Plaintiffs and Class members.

82. At all material times, the conduct of Lundbeck as set forth above was malicious,

deliberate and oppressive towards the Plaintiffs, Class members, and general

public. Lundbeck conducted itself in a willful, wanton, and reckless manner.

83. Lundbeck's aforementioned acts, omissions, wrongdoings, and breaches of legal

duties and obligations constitute a wanton and outrageous disrespect for business

practices and dealings with the public. Lundbeck was well outside of accepted

industry practices in place at the material time.

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. .

84. In addition to failing to provide clear, complete and current information

concerning the dangers inherent in the use of Celexa, and rather than discharging

their duty to the ultimate consumer by fully informing physicians who it was

reasonably foreseeable would communicate directly to the consumers the risks

inherent in the use of Celexa, Lundbeck willfully, deliberately, flagrantly, and

wantonly took steps to withhold and manipulate information regarding the

adverse effects of taking Celexa during or shortly before pregnancy.

85. Accordingly, the Plaintiffs are entitled to punitive damages in an amount

sufficient to deter and denounce the behaviour of Lundbeck, and to discourage the

broader pharmaceutical industry from engaging in such conduct in the future.

Service Outside of Ontario

86. This claim may be served, without a court order, on Lundbeck outside Ontario on

the basis that:

a. the damage was sustained in Ontario (Ontario Rule 17.02(h);

b. the tort was committed in Ontario (Ontario Rule 17.02(g)); and

c. the Defendants carry on business in Ontario (Ontario Rule 17.02(p));

Place of Trial

87. The Plaintiffs propose that this action be tried at the City of Toronto, in the

Province of Ontario.

Date oflssue; D e.c eVV'.bcc d d ) ~ 0 l ~

Merchant Law Group Barristers and Solicitors 65 St. Clair East Suite 800 Toronto, Ontario M2N6Kl

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Roch Dupont (49002E) [email protected] Tel: 306-359-7777 Fax: 306-522-3299 Solicitors for the Plaintiffs

" Jt

\_\) -\ y --s 1 ~ (o 9 -6-<XX"P JENNIFER PRICE, & MA ITHEW JANZIC v. H. LUND BECK A/S, & LUND BECK CANADA INC. Court File No.

Plaintiffs Defendants

ONTARIO SUPERIOR COURT OF JUSTICE

Proceeding commenced at Toronto

STATEMENT OF CLAIM

MERCHANT LAW GROUP

800- 65 ST. CLAIR AVE. E TORONTO,ON M4T2Y3

ROCH DUPONT (49002E) Rdu [email protected]

Tel: 306-359-7777 Fax: 306-522-3299