COURT FILE NO.: CV-14-518698

DATE: 20180716

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

Jennifer Price, Individually, and Matthew Janzic, a Child, by his Natural Mother and Litigation Guardian, Jennifer Price

Plaintiffs

– and –

H. Lundbeck A/S and Lundbeck Canada Inc.

Defendants

Casey R. Churko, Anthony Tibbs, and Venessa Vuia for the Plaintiffs

Frank J. McLaughlin, Brandon Kain, and Jacqueline Cole for the Defendants

HEARD: May 28-31, 2018

PERELL, J.

REASONS FOR DECISION

A. Introduction

[1] Approximately three and a half years ago, pursuant to the Class Proceedings Act, 1992,[^1] Matthew Janzic and his mother Jennifer Price in her personal capacity and in her capacity as litigation guardian for Matthew commenced a proposed class action against H. Lundbeck A/S and Lundbeck Canada Inc. (collectively “Lundbeck”), which are pharmaceutical companies that manufacture the drug “citalopram,” under the brand name Celexa®.

[2] Citalopram is an SSRI (selective serotonin reuptake inhibitor) indicated for the treatment of depression, and the thrust of Ms. Price’s proposed class action is that Lundbeck failed to warn women that Celexa® may be a “teratogen,” which is any agent that can disturb the development of an embryo or fetus and thereby cause congenital malformations, which, in turn, can cause the pregnancy to spontaneously abort or the child to be born with birth defects.

[3] This is a motion for certification of the action. The motion was fiercely and rudely contested.[^2] The parties asserted the routine arguments about the certification criteria, but they asserted them ad nauseum, and they asserted innumerable straw man arguments (knocking down an argument their opponent had not made) and innumerable ad hominem, mean, and taunting arguments. They distorted and misapplied the “some basis in fact” or the “no basis in fact” tests that are applied to four of the five certification motion, and they took much of the evidence and argument outside the boundaries of what is appropriate for a certification motion.

[4] Only the oral argument in court of the motion was polite. It proceeded over four days. I reserved judgment.

[5] I have now decided that Ms. Price’s action satisfies only two of the five criteria for certification; therefore, her motion for certification should be dismissed without costs.[^3]

B. Evidentiary Background

[6] Ms. Price supported her certification motion with the following evidence:

• Paul Battaglia of Toronto, Ontario swore an affidavit dated February 12, 2018. Mr. Battaglia is the President of Trilogy Class Action Services, a class action administration, advertising, and notice plan firm located in Toronto.

• Dr. Anick Bérard, PhD of Montreal, Québec swore an affidavit dated June 6, 2017. She was cross-examined. Dr. Bérard is a pharma-epidemiologist who is a professor at the Faculty of Pharmacy of the Université de Montréal. She has a doctorate in epidemiology and biostatics from McGill University. She did post-doctoral work at the Harvard School of Medicine. She is a member of the Teratology Society and of the Organization of Teratology Information Services. She has supervised nearly 70 graduate students in teratology. Her published papers include studies of antidepressants, including SSRIs, and congenital malformations. She has worked with Health Canada and the FDA (U.S. Food and Drug Administration). She has been an expert witness in proceedings in the U.S. and Canada.

• Pamela Bews of Abbotsford, British Columbia swore an affidavit dated July 6, 2017. While pregnant, Ms. Bews was prescribed Celexa® and her daughter was born with disfigured teeth and severe Ebstein’s Anomaly, a serious heart condition.

• Dr. Robert M. Cabrera, PhD, of Houston, Texas, USA, swore an affidavit dated December 5, 2017. He was cross-examined. Dr. Cabrera is a professor in the Department of Cellular and Molecular Biology at Baylor College of Medicine in Texas. He completed his graduate studies at Texas A&M University Health Center and the Institute of Biosciences and Technology. He is a teratologist and a member of the Teratology Society. He has conducted in vitro animal studies about SSRIs and presented his research at the Teratology Society. His research projects included a citalopram in vitro animal study.

• Deanna Gardner of Peterborough, Ontario swore an affidavit dated July 6, 2017. While pregnant she was prescribed Celexa®, and her daughter was born with a cleft foot.

• Dr. David Healy, MD swore affidavits dated July 5, 2017 and December 15, 2017. He was cross-examined. Dr. Healy is a professor of psychiatry at Bangor University, affiliated with the University of Wales. He has a doctorate from the University College Dublin. He is a Fellow of the Royal College of Psychiatrists. He has expertise in psychopharmacology and experience in epidemiology. He has a clinical practice. He has been a consultant for pharmaceutical companies, including Lundbeck. His publications include articles about the teratogenic effects of SSRIs, and he has been an expert witness and a consultant on birth defects cases, including cases involving SSRI’s, including escitalopram, paroxetine, sertraline, and citalopram.

• Lori Lovett of Ottawa, Ontario swore an affidavit dated July 5, 2017. While pregnant, Ms. Lovett was prescribed Celexa®. An ultrasound revealed that her unborn child could be suffering from Tetralogy of Fallot and esophageal atresia. After a caesarean section birth, the child was born and then died 13 hours after delivery.

• Dr. Derelie Mangin, MBChB of Hamilton, Ontario swore an affidavit dated December 30, 2017. She was cross-examined. Dr. Mangin is a graduate of the Otago Medical School and holds the Nancy Gordon Chair in family medicine and Associate Chair, Research at McMaster University in Hamilton. She has a clinical practice affiliated with the University’s medical centre. She is the Director of the Primary Care Research Unit at Christchurch School of Medicine, University of Otago. She has researched and published papers about antidepressants for primary care patients.

• Noble K. McIntyre, JD swore an affidavit dated December 5, 2017. Mr. McIntyre is an American personal injury attorney practising in Oklahoma, U.S. with a speciality in mass torts litigation in pharmaceutical and medical device cases. He graduated from the University of Oklahoma College of Law and began his law practice in 1995.

• Jennifer Price of Stoney Creek, Ontario swore an affidavit dated July 6, 2017. She was cross-examined. While pregnant she was prescribed Celexa,® and her son Matthew was born with several severe birth defects including ventricular septal defect, pulmonary valve stenosis, and absent fifth distal phalanx.

• Katherine Stymiest of Prince George, British Columbia swore an affidavit dated July 4, 2017. While pregnant she was prescribed Celexa®. An ultrasound showed that her unborn child had a small recessed jaw. The unborn child was subsequently diagnosed to have Treacher Collins Syndrome, a congenital disorder characterized by craniofacial deformities involving the ears, eyes, cheekbones, and jawbone. The child was born with severe micrognathia (undersized jaw), no ears, malformed or under-formed cheek bones, a severe cleft palate, and a hole between his throat and esophagus. The child died three hours after birth.

• Venessa Vuia of Toronto, Ontario swore an affidavit dated January 26, 2018. She is a lawyer with Merchant Law Group LLP, counsel for the Plaintiffs. She was cross-examined.

[7] Lundbeck resisted the certification motion with the following evidence:

• Dr. Michael Brunskill Bracken, PhD, of New Haven, Connecticut, swore an affidavit dated November 9, 2017. He was cross-examined. Dr. Bracken is an epidemiologist who specializes in perinatal epidemiology. He has a doctorate in epidemiology from Yale University. He is the Susan Dwight Bliss Professor Emeritus of Epidemiology, a Senior Research Scientist and a former Professor of Obstetrics and Gynecology, Reproductive Science and Neurology at Yale University. He is the founding Director of the Yale Perinatal Epidemiology Unit and Co-Director of its successor, the Yale Centre for Perinatal, Pediatric and Environmental Epidemiology.

• Dr. Jeffrey Brent, MD, PhD, of Denver, Colorado swore an affidavit dated November 9, 2017. He was cross-examined. Dr. Brent is a medical toxicologist. He has a doctorate in biochemistry from Mt. Sinai School of Medicine, New York. He is a practicing physician at the University of Colorado Hospital and The Children’s Hospital of Colorado and is the Distinguished Clinical Professor of Medicine in the Division of Clinical Pharmacology and Toxicology of the Department of Medicine at the University of Colorado School of Medicine and Hospital. He also holds secondary appointments in the Department of Emergency Medicine and the Colorado School of Public Health.

• Dr. Donna Stewart, MD, OC, of Toronto, Ontario, swore affidavits dated November 7, 2017 and January 31, 2018. She was cross-examined. Dr. Stewart is a medical doctor licensed to practice in Ontario and a certified specialist in Psychiatry by the Royal College of Physicians and Surgeons of Canada. She is the Head of Research and Academic Development at University Health Network Centre for Mental Health in Toronto and a Senior Scientist at Toronto General Hospital Research Institute. She established North America’s first perinatal psychiatry service for pregnant and postpartum women. Dr. Stewart reviewed the medical records of Mesdames Bews, Gardner, Lovett, Price, and Stymiest.

• Katherine Stubits of Toronto, Ontario, swore an affidavit dated April 30, 2018. Ms. Stubits is a law clerk at McCarthy, Tétrault LLP, lawyer of record for Lundbeck.

C. Procedural Background

[8] On December 22, 2014, Ms. Price commenced a proposed class action against Lundbeck.

[9] Ms. Price brings her action on behalf of the following class:

(i) Women who were prescribed Celexa® in Canada and subsequently aborted, delivered, or miscarried children with congenital malformations after ingesting citalopram while pregnant,

(ii) family members who may make claims under Family Compensation Legislation following the death of, or injury to, such children, [^4]

(iii) such children born to such women, and

(iv) provincial and territorial governments who paid health care costs on their behalf.

[10] On March 23, 2018, Ms. Price filed a “Certification Statement of Claim” as an appendix to her factum. In her Certification Statement of Claim, Ms. Price asserts four causes of action; namely: (a) failure to warn; (b) failure to contraindicate; (c) strict liability to fetuses who die in utero; and (d) statutory derivative claims, i.e., dependant’s relief claims and subrogated claims on behalf of provincial health insurers. For the purposes of the certification motion, she predominately relied on the failure to warn cause of action.

[11] Ms. Price’s cause of action in negligence is pleaded in paragraphs 10 to 17 of her Certification Statement of Claim, as follows:

A. Negligence

(1) Duty

10. Celexa® is or may be a Teratogen.

11. Before and after Lundbeck marketed Celexa® in Canada, Lundback knew or ought to have known that Celexa® is or may be a Teratogen.

(a) Scientific literature indicated that citalopram’s biological mechanism of action could cause Congenital Malformations.

(i) The human body naturally regulates serotonin, a vasoconstrictor and neurotransmitter that can be teratogenic.

(ii) SSRIs affect the body’s natural regulation of serotonin in a way that increases the risk of Congenital Malformations.

(b) Dog, rabbit, rat, and other animal studies indicated that Celexa® is developmentally toxic.

(c) Lundbeck received adverse event reports of Congenital Malformations in children born to women who ingested Celexa® during pregnancy.

(d) Epidemiological studies published in medical and scientific journals identified a causal association between Celexa® and Congenital Malformations.

12. Lundbeck owed the Plaintiffs duties of care.

(a) Lundbeck owed the Mother a duty of care to inform her prescribing physician that Celexa® is or may be a Teratogen.

(b) Lundbeck owed the Mother a duty of care to warn her that Celexa® is or may be a Teratogen.

(c) Lundbeck is strictly liable, or alternatively owed a duty of care to the Child for his Congenital Malformations.

(i) The Child could not give informed consent to accept or reject Celexa®.

(ii) Lundbeck did not intend the Child to benefit from Celexa®. The Child did not benefit from Celexa®.

(2) Breach

13. From 1999, Lundbeck breached a duty of care to warn that citalopram is or may be a Teratogen.

14. Lundbeck did not establish the efficacy of citalopram as an anti-depressant during pregnancy.

(a) Depression is an ordinary emotion during pregnancy.

(b) Depression naturally remits without pharmaceutical intervention.

(c) Depression relapses after discontinuation. Discontinuation can cause withdrawal syndrome.

(d) Treatment for depression can be deferred until after pregnancy.

15. From when and after it marketed Celexa®, Lundbeck failed to provide patients or their physicians with a clear, complete, and current warning in any product monograph that Celexa® is or may be a Teratogen. Particulars include the following:

(a) No product monograph included any statement about the established or suspected risk of birth defects during pregnancy.

(b) The “consumer” information section of the monographs told patients to tell their doctor or pharmacist if they are or intend to become pregnant.

(c) The physician information section of the monographs:

(i) did not contraindicate the use of citalopram in pregnancy for the treatment of mild and moderate depression;

(ii) did not provided any “Warning” that citalopram was a known or suspected Teratogen;

(iii) provided an unclear “Precaution” about nonexistent “expected” benefits of citalopram, but not the foreseeable teratogenic risks;

(iv) did not provide or reference in any manner adverse reaction reports of Congenital Malformations when used during pregnancy; and

(v) provided unclear, uncurrent [sic, out-of-date] and incomplete summaries of animal studies in the Toxicology section.

(3) Causation

16. As a result of Lundbeck’s breach of its duties to warn the Mother and her prescribing physician that Celexa® is a Teratogen, the Mother’s physician prescribed Celexa® to the Mother for use in pregnancy, the Mother took Celexa® while pregnant, and the Child developed Congenital Malformations.

17. Lundbeck’s breaches of its duties of care were a factual and legally proximate cause of the Child’s Congenital Malformations and the legally compensable loss and expense consequent thereon.

[12] A parallel Celexa® proceeding against Lundbeck, Bergeron v Lundbeck Canada Inc., No. 500-06-000734-168 (Montreal), was stayed pending the outcome of this certification motion.

[13] On July 7, 2015, Ms. Price delivered the first tranche of her certification motion record including affidavits from Drs. Bérard and Healy and from Mesdames Bews, Gardner, Lovett, Price, and Stymiest.

[14] On November 9, 2017, Lundbeck responded by filing affidavits from Drs. Bracken, Brent, and Stewart.

[15] In December 2017, Ms. Price delivered reply affidavits from Drs. Cabrera, Healy, and Mangin and from Mr. McIntyre.

[16] On January 31, 2018, Lundbeck delivered a further affidavit from Dr. Stewart.

[17] Cross-examinations took place in Canada, the United States, and the United Kingdom between February 2 and March 9, 2018.

D. The Representative Plaintiffs and the Putative Class Members’ Histories

[18] For the present purposes of this certification motion, it is not necessary to say more about the circumstances of Ms. Price and of her putative Class Member witnesses other than they were women who were prescribed Celexa® during pregnancies and that their children were born with birth defects and sadly some of the newborns died shortly after birth.

E. Estimate of Class Size

[19] Lundbeck did not provide information that would assist the court in determining the class size.

[20] The Plaintiffs estimate that the class will consist of approximately 8,600 mothers who were prescribed citalopram (those who ingested Celexa® or generic versions of citalopram), plus the children born with birth defects, plus the family claimants, plus the governments who paid health care costs on behalf of the mothers and children.

[21] The Plaintiffs’ estimate was based on 6.8 million births during the 18 years that Celexa® has been available in Canada. The assumptions then of the estimate were that: 12.5% of the birth mothers were exposed to SSRIs; 25.1% of those exposed to SSRI’s were prescribed Celexa®; and there was a 4% incidence of birth defects.

F. Background Science

1. Depression and its Treatment

[22] Depression is a psychiatric disorder identified through diagnostic criteria established by the World Health Organization and American Psychiatric Association. Depression is often co-morbid with other common psychiatric disorders, such as: anxiety, posttraumatic stress disorder, obsessive compulsive disorder, and eating disorders. Depression is also a major component of bipolar disorder. Major depression affects approximately 7-12% of the population. It is the leading cause of disability for women aged 15-44 and a major contributor to overall disease. Approximately 35% of pregnant women present with depressive symptoms and at least 10% are depressed.

[23] The harm caused to pregnant women by depression includes: emotional suffering, difficulty performing usual activities, family conflict, inadequate diet, the use of tobacco, alcohol, and other harmful substances, the potential for self-harm and suicide, the failure to seek prenatal care, and poor weight gain during pregnancy. Risks to the baby from the mother’s depression include: preterm birth, low birth weight, neonatal intensive care unit admissions, impairment in mother-infant bonding, infant sleep difficulties, cognitive, behavioural and emotional problems, and developmental delay.

[24] Major depression is a common and treatable mental disorder, and several therapies exist. Potential options include: (a) evidence-based psychotherapy (cognitive behavioural therapy or interpersonal therapy); (b) electroconvulsive therapy; and (c) antidepressant medications, including: (i) serotonin norepinephrine reuptake inhibitors (“SNRIs”); (ii) tricyclic antidepressants (“TCAs”); (iii) monoamine oxidase inhibitors (“MAOIs”), which, however, are inappropriate for pregnant women; and (iv) selective serotonin norepinephrine reuptake inhibitors (“SSRIs”).

[25] Before 1989, when SSRIs were introduced in Canada, most depression (including during pregnancy) was treated with electroconvulsive therapy or TCAs. The introduction of the first SSRI in 1989 – fluoxetine (Prozac®) – changed the treatment of depression because it was as effective as the TCAs but had fewer side effects and was safer in cases of overdose.

[26] During the early 1990s, additional SSRIs came to Canada, including fluvoxamine (Luvox®), paroxetine (Paxil®) and sertraline (Zoloft®).

[27] By the time citalopram arrived in Canada, SSRIs were well-established as a first-line treatment of depression. Today, the SSRIs are the most commonly prescribed antidepressants during pregnancy. The consensus in clinical guidelines is that it is appropriate to use SSRIs, including citalopram, to treat pregnant women who suffer from depression.

2. Teratogens

[28] A teratogen is any agent that can disturb the development of an embryo or fetus and thereby cause congenital malformations, which, in turn, can cause the pregnancy to spontaneously abort or the child to be born with birth defects.

[29] Teratogens can be diseases, parasites, medications, illegal drugs, tobacco, alcohol, or environmental exposures. Everything is potentially teratogenic. An example of a disease causing serious birth defects is the zika virus.

[30] Some teratogens cause one congenital malformation, others cause more than one.

[31] Several chemical substances are known to cause congenital malformations; e.g., alcohol, retinoic acid (vitamin A), methyl mercury, and cigarette smoke (nicotine), but there are currently very few drugs that have been identified as teratogens; e.g., thalidomide, some anti-epileptic drugs and isotretinoin.

3. Congenital Malformations

[32] Congenital malformations, also known as congenital anomalies, congenital abnormalities or birth defects, are structural or functional anomalies that occur during intrauterine life. Any organ or part of an organ in the developing embryo can be disrupted and altered during embryological development, resulting in a malformation. Congenital malformations can be identified prenatally, at birth, or later in infancy. Some of the errors in embryogenesis are lethal and can result in an early spontaneous abortion, often before the pregnancy has been recognized.

[33] Every pregnancy has a baseline risk of congenital malformations. Approximately 3-5% of newborns are born with a major congenital malformation and approximately 10% have minor malformations that are diagnosed later in the first year of life. Major malformations interfere with normal functions and can even threaten life. Minor malformations are important from a cosmetic standpoint, but do not interfere with life functions.

[34] The vast majority of congenital malformations are either due to single or multiple gene absences or abnormalities or are idiopathic, which is to say that they are a disease or condition that arises spontaneously or for which the cause is unknown.

[35] Only a very small percentage of congenital malformations, estimated at 1-3%, are known to have been caused by teratogens and many of these include non-chemical factors; e.g., excessive heat, radiation, surgery, amniocentesis, intracytoplasmic sperm injection, maternal health conditions such as diabetes, phenylketonuria, and periods of hypotension, and intrauterine infections such as chicken pox or rubella.

[36] For the purposes of this certification motion, is shall be important to note that illnesses - and depression is an illness - can be a cause of birth defects. Thus, depression, the underlying condition for which citalopram is prescribed, is associated with an increased risk of congenital malformations.

[37] There are a multitude of different types of malformations. Congenital malformations include: anencephaly; cardiac defects; clubfoot; craniosynostosis; Ebstein’s anomaly; gastroschisis; hypospadias; neural tube defects; omphalocele; pulmonary valve stenosis; right-ventricular outflow obstruction; Tetralogy of Fallot; Treacher-Collins syndrome; ventricular septal deficit; and anomalies of the bowel, ears, esophagus, eyes, fingers, hands, lower limb (including pelvic girdle), kidney, lungs, musculoskeletal, neck, palate, pancreas, ribs, spleen, teeth, trachea, toes, and vertebrae.

[38] There are no common etiological factors, which is to say that there is no common explanation for the cause or causes of the multitude of congenital malformations, and, thus each malformation has its own etiology, its own risk factors, its own criteria for screening and diagnosis, and each occurs at different baseline rates. For examples:

• Clubfoot is a malformation in which one or both feet are turned inward. Most cases are isolated defects and are idiopathic, although clubfoot can occur as part of some congenital syndromic complexes (e.g., 1/3rd of cases of spina bifida include clubfoot). A number of genetic factors are important in some cases. The incidence of clubfoot varies with both ethnicity and gender. Clubfoot occurs twice as often in males as in females.

• Craniosynostosis is an anomaly in which the spaces between the bones of the cranium close prematurely; it is thought to be caused by maternal thyroid disease, certain hematological syndromes, vitamin deficiency, beta-glucuronidase deficiency, Hurler Syndrome, Morquio syndrome, mucolipidosis, and environmental exposure during pregnancy to aminopterin, diphenylhydantoin, clomiphene oxymetazoline, isotretinoin, or valproic acid.

• Gastroschisis is a defect in the interior abdominal wall exposing digestive organs that may be lying uncovered outside the body on the fetal or neonatal abdomen; it is associated with and perhaps caused by alcohol or tobacco use in pregnancy.

• Hypospadias is a disorder in males in which the urethral orifice is located at a site other than the penile head. It usually occurs as an isolated anomaly, but can be part of a larger syndromic complex. Although most cases are idiopathic, genetic factors have been implicated in the causation of hypospadias because it tends to run in families. Caucasians are at an increased risk of hypospadias, particularly in families of Italian or Jewish origin. Hormonal factors (for example, insufficient testicular testosterone production or a defect in the gene producing the enzyme 5-alpha reductase, which activates testosterone), are also associated with hypospadias. Synthetic chemicals that interact with hormone receptors, and in vitro fertilization (due to the progesterone that is administered to women after IVF) is associated with hypospadias.

• Neural Tube Defects are a group of anomalies resulting from failure of the neural tubes to fuse during neurulation, with the two major types being anencephaly and spina bifida. These defects may occur in association with several genetic syndromes, and have been associated with folic acid, vitamin B12, specific genetic mutations, maternal diabetes or obesity, alcohol use, radiation exposure, methotrexate use, hyperthermia, maternal exposure to cigarette smoke, arsenic, large amounts of caffeine, a low calorie diet (including dieting or fasting), or decreased consumption of fruits and vegetables.

• Omphalocele is an umbilical defect in the anterior abdominal wall that allows abdominal contents (most typically the stomach, bowel and liver) to protrude through the defect covered by a membrane. It may occur as an isolated defect, but often as part of a genetic syndrome (most commonly the Beckwith-Wiedermann syndrome), and trisomy (an extra copy of a chromosome) is present in almost half of the cases.

• Right-ventricular outflow obstruction is a heart abnormality in which the normal flow of blood out to the right ventricle and into the pulmonary artery is impeded. Right-ventricular outflow obstruction is a heart abnormality that is be caused by at least 10 separate genetic abnormalities and by other factors including smoking.

G. Citalopram (Celexa®)

[39] Citalopram (Celexa®) is an SSRI. It was introduced in Canada in 1999. A s-enantiomer of citalopram called escitalopram (Cipralex®) was introduced in Canada in 2005 and is known as Lexapro® in the United States.

[40] Physicians prescribe citalopram for the following non-approved or “off-label” uses: (a) anxiety; (b) post-traumatic stress disorder; (c) obsessive compulsive disorder; and (d) eating disorders.

[41] The usual range of dose for citalopram is 20 to 40 mg. The dose will depend upon the illness type and severity and other individual factors, including the patient’s past treatment, other drugs the patient may be taking, and the presence of drug side effects.

[42] Citalopram has been approved around the world for the treatment of depression. This includes Health Canada, which required Lundbeck to undergo an extensive review process before obtaining approval to market citalopram under the brand Celexa®.

[43] Although it is Ms. Price’s purpose in this proposed class action to prove differently, at present, there is no proven causal association between citalopram (Celexa®) with congenital malformations, and citalopram is not at present considered to be a teratogen. To date, no regulatory agency, medical group, or teratology organization has declared citalopram unsafe to use in reproductive-aged or pregnant women.

[44] In contrast to citalopram, in 2005, the regulators in both the United States and Canada required GlaxoSmithKline Inc. to add warnings to its product monograph for Paxil (paroxetine), which is a competing SSRI antidepressant. The warning was with respect to a twofold increased risk of major congenital malformations and several specific types of cardiovascular malformations - compared to other antidepressants. Health Canada issued a Safety Alert in 2005 for Paxil warning of a possible increased risks of birth defects. A class action relating to paroxetine was certified in British Columbia in 2012; i.e., Bartram v. GlaxoSmithKline Inc.[^5] Unlike the case at bar, the representative plaintiff in Bartram did not allege that the defendant’s drug was the cause of birth defects generally.

[45] In the United States, notwithstanding the change to the monograph for paroxetine, the FDA did not require the same change for citalopram. Health Canada did not apply the paroxetine findings to citalopram, and Health Canada has never issued any safety alert or required the addition of risk information to the Celexa® Product Monograph pertaining to the risks of congenital malformation.

H. Product Monograph for Celexa®

[46] The Product Monograph for Celexa® states that citalopram is indicated for the treatment of symptomatic relief of depressive illness. The indication encompasses: (a) major depressive disorder; (b) persistent depressive disorder; and (c) unspecified depressive disorder with the specifiers anxious distress, mixed features, melancholic features, atypical features, mood congruent psychotic features, peripartum onset, seasonal pattern or premenstrual dysphoric disorder.

[47] For present purposes, the following excerpts from the Product Monograph are pertinent:

Product Monograph

Celexa®

Citalopram Hydrobromide Tablets

10; 20 and 40 tpg. as citalopram tablets

Antidepressant

Lundback Canada Inc.

THERAPEUTIC CLASSIFICATION

Antidepressant

ACTION AND CLINICAL PHARMACOLOGY

Celexa® (citalopram hydrobromide) is a highly selective and potent serotonin (5-hydroxytryptamine 5-HT) reuptake inhibitor with minimal effects on the neuronal reuptake norepinephrine. (NE) and dopamine (DA). The ability of citalopram to potentiate serotonergic activity in the central nervous system via inhibition of the neuronal reuptake of serotonin is thought to be responsible for its antidepressant action. Tolerance to the inhibition of serotonin reuptake is not induced by long-term (14 days) treatment of rats with citalopram

INDICATIONS AND CLINICAL USE

Celexa® (citalopram hydrobromide) is indicated for the symptomatic relief of depressive illness. [….]

CONTRAINDICATIONS

Celexa® (citalopram hydrobromide) is contraindicated in patients with known hypersensitivity to citalopram hydrobromide or the excipients of the drug product.

SEROTONIN SYNDROME

Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly including: agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition.

PREGNANCY AND NURSING MOTHERS

The safety of Celexa® during pregnancy and lactation has not been established. Therefore, Celexa® should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the fetus.

Celexa® is excreted in human milk. Celexa® should not be administered to nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child.

INFORMATION FOR THE PATIENT

Please read this information before you start to take your medicine. Keep the leaflet while you are taking Celexa®; you may want to read it again. This leaflet does not contain all the information about this medicine. For further information or advice please see your doctor or pharmacist.

What you should tell your doctor before taking Celexa®

• All your medical conditions, including heart problems, history of seizures, liver or kidney disease, diabetes.

• Any medications (prescription or non-prescription) which you are taking or have taken within the last 14 days, especially a monoamine oxidase inhibitor (e.g., phenelzine, tranylcypromine, moclobemide or selegiline), or any other antidepressant, lithium, tryptophan or cimetidine.

• If you ever had an allergic reaction to any medication.

• If you are pregnant or thinking of becoming pregnant; or if you are breast feeding.

• Your habits of alcohol consumption.

When not to use Celexa®

• You should not be taking Celexa® if you are pregnant or breast feeding.

Do not take Celexa® if you are allergic to it; or to any of the components of its formulation (for list of components see the section on What Celexa® contains).

• Stop taking. Celexa® and contact your doctor immediately if you experience an allergic reaction or any severe side effect.

[48] The Toxicology section of the first product monograph contained a discussion of the reproductive studies in animals that noted that teratogenic effects were seen in rats, but only at toxic doses that far exceeded human therapeutic doses. The Toxicology section noted that no teratogenic effects were seen at the highest dose that could be assessed in rabbits.

[49] Lundbeck revised the warnings in the product monograph in 2004, in regard to the risk of poor neonatal adaptation syndrome in newborns of pregnant women who used citalopram in the third trimester.

[50] Lundbeck revised the warnings in 2011 to add warnings about the risk of persistent pulmonary hypertension of the newborn in babies of pregnant women who used citalopram during the second half of their pregnancy.

[51] In 2011, Lundbeck revised the product monograph to provide further information regarding the animal reproductive studies, including the following statement in the Warnings and Precautions section of the monograph:

In animal reproductive studies citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects when administered at doses greater than human therapeutic doses. There are no adequate and well controlled studies in pregnant women: therefore, citalopram should be used in pregnancy only if the potential benefit the patient justifies the potential risk to the fetus.

[52] The Toxicology section of the 2011 product monograph stated that all doses in which adverse teratogenic effects occurred in animals well exceeded the standard therapeutic human dose for humans in rats, and were not confirmed in a second rat study, nor in studies for rabbits.

I. Citalopram (Celexa®) and Congenital Defects

[53] Etiology is the study of cause or causes, and epidemiology is the branch of medical science that studies the etiology of diseases and that identifies risk factors for disease or medical conditions. Epidemiology focuses on “general causation;” i.e., whether or not an agent has the capacity to cause a disease or medical condition rather than on “specific causation;” i.e., whether or not an agent did cause a disease or medical condition to be suffered by a specific person.

[54] There are a different kinds of epidemiological studies that are employed to determine the positive or adverse effects of drugs. Epidemiological studies are designed to determine whether there is an “association,” which may or may not be causal, between an agent and a disease and medical condition. Association is a necessary but not sufficient precondition for a causal connect between an agent and a consequence or effect

[55] The highest level of epidemiological evidence is the randomized control trial often referred to as an RCT. It is, however, unethical to include pregnant women in an RCT, and thus the cause and effect data on SSRIs including citalopram comes from case reports, retrospective observational studies, and meta-analysis studies, lower levels of epidemiological evidence.

[56] Case reports and retrospective observational studies are in and of themselves inadequate to draw a conclusion about whether there is causal relationship between the drug and an effect The meta-analysis groups information from epidemiological studies and seeks to draw general conclusions, but is only as valid as the included studies and also may suffer from a variety of biases that must be accounted for in any epidemiological study or statistical analysis.

[57] Using a variety of different methodologies derived from the branches of mathematics that develop techniques for organizing and analyzing information, an epidemiological study determines whether there is an association between an agent and a condition, state or event including a disease or syndrome. An association between an agent and a condition exists when the agent and condition occur together more frequently than one would expect by chance. If an association is established, then information in the study is examined to determine whether or not the association can be explained as causal. To determine causation, the researcher uses a variety of statistical methodologies and analytical tools including professional judgment and his or her knowledge from other fields of science.

[58] In the immediate case, the Plaintiffs do not take the position that citalopram causes all congenital malformations. Rather, the Plaintiffs’ argument is that there is some basis in fact for concluding that citalopram causes some major congenital malformations; i.e., that citalopram is a teratogen and that there was a breach of a duty to warn that citalopram is a teratogen. The Plaintiffs’ argument that (Celexa®) is a teratogen is based on Dr. Carbrera’s opinion that there is a plausible biological explanation of how citalopram could disrupt the development of an embryo or fetus and Dr. Bérard’s epidemiological evidence that there was some basis in fact for a possible association between SSRIs and congenital malformations.

[59] Dr. Bérard, Ms. Price’s epidemiology expert, reviewed the science literature that examined whether there was an association between SSRIs and cardiac birth defects or an association between SSRIs and any (overall) birth defects, and she also considered the research literature on SSRIs regardless of whether the authors found an increased risk of SSRIs being a teratogen.

[60] Dr. Bérard’s opinion, which was based on both statistically significant and non-statistically significant data and which Lundbeck criticized as not being a proper systematic literature review was that there is some basis in fact that citalopram use during pregnancy increases the risk of spontaneous abortion and major congenital malformations and is therefore a teratogen. It was further her opinion that the Celexa® product monograph did not adequately warn of citalopram's teratogenicity.

[61] Dr. Bracken, Lundbeck’s epidemiology expert, conducted a systematic review of the scientific literature examining the potential for an association between citalopram and all specific congenital malformations in humans. He analyzed 25 observational studies involving the potential association between SSRIs and congenital malformations, and 18 observational studies involving the potential association between congenital malformations and citalopram specifically. The studies were published over 20 years and involved several million women.

[62] Dr. Bracken found there was no support in the literature for the proposition that maternal SSRI exposure including exposure to citalopram increases the risk of congenital malformations. He noted while there were occasional reports of statistically significant associations of citalopram (and its isomer escitalopram) with a malformation, the random nature of these associations was demonstrated by a lack of consistency in the type of malformation. He reported that there was no evidence of a signal congenital malformation being associated with citalopram. He said that this conclusion was supported by every independent reviewer of the data and by the authors of the 25 published SSRI papers in the literature, including Dr. Bérard’s paper.

[63] Dr. Bracken noted that when a multitude of possible associations are studied between many malformation types and several drug exposures in a broad range of populations, typically some associations are reported that meet nominal statistical significance; however, this was not observed for citalopram, and in his opinion, it was not seen for any SSRI when account was taken of the multiple comparisons being made.

[64] It was Dr. Bracken’s opinion that chance as the explanation for any associations was not eliminated. He concluded that there was no robust and replicable statistically significant association between citalopram and any specific congenital malformation – nor with malformations “overall” that is free from evident bias and confounding. He concluded that there was too much heterogeneity in the data to permit a valid meta-analysis of whether citalopram could or did cause congenital malformations.

[65] Dr. Bracken concluded that the absence of any association precluded the need for a detailed Bradford Hill causation analysis, but Dr. Bérard opined that a Bradford Hill full causation analysis would confirm the conclusion that no causal association between citalopram and any congenital malformation.

[66] Dr. Brent, Lundbeck’s medical toxicologist did an epidemiological analysis and concluded that there was no significant association between citalopram use and clubfoot, craniosynostosis, encephaly, gastroschisis, hypospadias, lower limb anomalies, musculoskeletal anomalies, neural tube defects, omphalocele, and right-ventricular outflow obstruction.

[67] Dr. Breck opined that the proposition that any pregnancy in which there was use of citalopram resulted in a congenital malformation because of the citalopram was neither credible nor plausible. In his assessment, the research data did not support an overall increase in the rate of congenital malformations associated with citalopram use in pregnancy. The great majority of pregnancies resulting in infants with congenital malformations did not involve citalopram use and the great majority of pregnancies in which the mother used citalopram did not result in congenital malformations.

[68] Dr. Brent concluded that there is no medical or scientific support for the allegation by Drs. Bérard and Healy that therapeutic use of citalopram during pregnancy can cause any and all birth defects. He said that a review of the relevant medical and scientific data indicated that citalopram use is not associated with a significantly increased rate of abortion and citalopram use in pregnancy is not significantly associated with any of the individual defects enumerated by Dr. Bérard.

[69] To date, no peer-reviewed academic paper, including a 2012 paper by Dr. Bérard, has identified citalopram as a teratogen.

J. Legal Background: Products Liability Claims and the Duty to Warn

[70] The elements of a claim in negligence are: (1) the defendant owes the plaintiff a duty of care; (2) the defendant's behaviour breached the standard of care; (3) the plaintiff suffered compensable damages; (4) the damages were caused in fact by the defendant's breach; and, (5) the damages are not too remote in law.[^6]

[71] Manufacturers have a duty of care to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge.[^7] The warnings must be reasonably communicated and detailed to give the consumer a full indication of each of the specific dangers that arise from the ordinary use of the product.[^8] If a product, although suitable for the purpose for which it is manufactured, is at the same time dangerous to use, the manufacturer of the product has a duty to warn of the attendant dangers in using the product.[^9]

[72] In the case of medical products, given their substantial risk of harm from improper use, the standard of care is correspondingly high and there will almost always be a heavy onus on the manufacturer to provide clear, complete and current information concerning the dangers inherent in the ordinary use of its product.[^10]

[73] There is a high standard of care. In Buchan v. Ortho Pharmaceutical (Can.) Ltd.,[^11] Justice Robins stated at para. 18:

18. Once a duty to warn is recognized, it is manifest that the warning must be adequate. It should be communicated clearly and understandably in a manner calculated to inform the user of the nature of the risk and the extent of the danger; it should be in terms commensurate with the gravity of the potential hazard; and it should not be neutralized or negated by collateral efforts on the part of the manufacturer. The nature and extent of any given warning will depend on what is reasonable having regard to all the facts and the circumstances relevant to the product in question.

[74] In cases involving highly technical products intended to be used under the supervision of experts or where the nature of the product is such that the consumer will not realistically receive information directly from the manufacturer without the intervention of a learned intermediary, the duty of the manufacturer is discharged if the manufacturer provides the learned intermediary (for example, physicians or surgeons), rather than the consumers, with an adequate warning of the potential dangers associated with the use of its product.[^12]

[75] In the context of manufacturers of pharmaceuticals and medical devices the learned intermediary is the physician that prescribes the drug or medical device. The legal theory here is that where a consumer places primary reliance on the judgment of a learned intermediary, then the manufacturer will satisfy its duty to warn the consumer by adequately warning the learned intermediary of the risks inherent in the use of the product.[^13]

K. Citalopram (Celexa®) and the Duty to Warn

[76] As noted above, it was Dr. Bérard opinion the Celexa® product monograph did not adequately warn of citalopram's teratogenicity.

[77] Dr. Healy said that although there are differences in risks between patients owing to the presence of additional concurrent risk factors in some patients, it is possible to estimate overall increased risks of congenital malformations as a single outcome and of specific types of congenital malformations within that outcome, and to apply that population-wide estimate to every citalopram patient as a foundation for determining whether the Canadian product monographs adequately warned doctors and patients that Celexa® is teratogenic

[78] Dr. Healy’s evidence was that the risk of congenital malformations as a single outcome has been examined for SSRIs as a class of antidepressants with a common mechanism of action, and the data from citalopram can be further extracted from the SSRI class data. It was Dr. Healy’s opinion that SSRIs pose unacceptable risk-benefit ratios and that the data for problems on citalopram is strong. It was his opinion that Citalopram can cause birth defects in children born to mothers who take it during pregnancy. He said that Lundbeck knew about the risk of birth defects from citalopram from the point of first marketing in Denmark in 1984, and it was his opinion that Lundbeck inappropriately marketed citalopram to women of child-bearing age in a way that minimized its risks and overstated its utility.

[79] It was Dr. Mangin’s opinion that Lundbeck's failure in its product monograph to reference the evidence of teratogenicity in each stage of pregnancy adversely affected the process of shared decision making between each Canadian physician and patient who contemplated using Celexa®. She said that Canadian physicians have a duty to relay information about teratogenic risks, but they were unable to discharge that duty when prescribing Celexa® because Lundbeck did not disclose any of the data from the maternal studies that showed that Celexa® may be a teratogen. She said all patients must be informed of the potential teratogenic risks, regardless of the severity of their depression or the stage of their pregnancy. She said the absence of disclosure of any of the studies showing an association affected all Canadian physicians and patients.

L. Certification: General Principles

[80] The court has no discretion and is required to certify an action as a class proceeding when the following five-part test in s. 5 of the Class Proceedings Act, 1992 is met: (1) the pleadings disclose a cause of action; (2) there is an identifiable class of two or more persons that would be represented by the representative plaintiff; (3) the claims of the class members raise common issues; (4) a class proceeding would be the preferable procedure for the resolution of the common issues; and (5) there is a representative plaintiff who: (a) would fairly and adequately represent the interests of the class; (b) has produced a plan for the proceeding that sets out a workable method of advancing the proceeding on behalf of the class and of notifying class members of the proceeding, and (c) does not have, on the common issues for the class, an interest in conflict with the interests of other class members.

[81] For an action to be certified as a class proceeding, there must be a cause of action shared by an identifiable class from which common issues arise that can be resolved in a fair, efficient, and manageable way that will advance the proceeding and achieve access to justice, judicial economy, and the modification of behaviour of wrongdoers.[^14] On a certification motion, the question is not whether the plaintiff's claims are likely to succeed on the merits, but whether the claims can appropriately be prosecuted as a class proceeding.[^15] The test for certification is to be applied in a purposive and generous manner, to give effect to the goals of class actions; namely: (1) providing access to justice for litigants; (2) encouraging behaviour modification; and (3) promoting the efficient use of judicial resources.[^16]

[82] The purpose of a certification motion is to determine how the litigation is to proceed and not to address the merits of the plaintiff's claim; there is to be no preliminary review of the merits of the claim.[^17] However, the plaintiff must show “some basis in fact” for each of the certification criteria other than the requirement that the pleadings disclose a cause of action.[^18] In the context of the common issues criterion, the "some basis in fact" standard involves a two-step requirement that: (1) the proposed common issue actually exists; and (2) the proposed issue can be answered in common across the entire class.[^19]

[83] The “some basis in fact” test sets a low evidentiary standard for plaintiffs, and a court should not resolve conflicting facts and evidence at the certification stage or opine on the strengths of the plaintiff’s case.[^20] In particular, there must be a basis in the evidence to establish the existence of common issues.[^21] To establish commonality, evidence that the alleged misconduct actually occurred is not required; rather, the necessary evidence goes only to establishing whether the questions are common to all the class members.[^22]

[84] The representative plaintiff must come forward with sufficient evidence to support certification, and the opposing party may respond with evidence of its own to challenge certification.[^23] Certification will be denied if there is an insufficient evidentiary basis for the facts on which the claims of the class members depend.[^24]

[85] On a certification motion, evidence directed at the merits may be admissible if it also bears on the requirements for certification but, in such cases, the issues are not decided on the basis of a balance of probabilities, but rather on the much less stringent test of some basis in fact.[^25] The evidence on a motion for certification must meet the usual standards for admissibility.[^26] While evidence on a certification motion must meet the usual standards for admissibility, the weighing and testing of the evidence is not meant to be extensive, and if the expert evidence is admissible, the scrutiny of it is modest.[^27] In a class proceeding, the close scrutiny of the evidence of experts should be reserved for the trial judge.[^28]

M. Cause of Action Criterion

1. General Principles: Cause of Action Criterion

[86] The first criterion for certification is that the plaintiff's pleading discloses a cause of action. The "plain and obvious" test for disclosing a cause of action from Hunt v. Carey Canada,[^29] is used to determine whether a proposed class proceeding discloses a cause of action for the purposes of s. 5(1)(a) of the Class Proceedings Act, 1992. To satisfy the first criterion for certification, a claim will be satisfactory, unless it has a radical defect, or it is plain and obvious that it could not succeed.[^30]

[87] In a proposed class proceeding, in determining whether the pleading discloses a cause of action, no evidence is admissible, and the material facts pleaded are accepted as true, unless patently ridiculous or incapable of proof. The pleading is read generously, and it will be unsatisfactory only if it is plain, obvious, and beyond a reasonable doubt that the plaintiff cannot succeed.[^31]

2. Analysis: Cause of Action Criterion

[88] Lundbeck did not dispute that the Plaintiffs have pleaded a tenable duty to warn products liability cause of action.

[89] Lundbeck did challenge the Plaintiffs’ cause of action based on an alleged duty “to contraindicate the use of citalopram in pregnancy for the treatment of mild and moderate depression.” Practically speaking, this challenge is moot because it is either subsumed by the Plaintiffs’ duty to warn cause of action or the point need not be decided because, as I shall explain below, there are no common issues being advanced other than the duty to warn issue.

[90] Lundbeck also challenged the inclusion of H. Lundbeck A/S as a party defendant for want of properly pleading the basis of a claim against the parent corporation. Because I am dismissing the certification motion on other grounds, I need not decide whether as a matter of pleading H. Lundbeck A/S. is a proper party to the action, which is a remedial matter in any event.

[91] I conclude that the Plaintiffs’ action satisfies the cause of action criterion.

N. Identifiable Class Criterion

1. General Principles: Identifiable Class Criterion

[92] The second certification criterion is the identifiable class criterion. The definition of an identifiable class serves three purposes: (1) it identifies the persons who have a potential claim against the defendant; (2) it defines the parameters of the lawsuit so as to identify those persons bound by the result of the action; and (3) it describes who is entitled to notice.[^32]

[93] In Western Canadian Shopping Centres v. Dutton,[^33] the Supreme Court of Canada explained the importance of and rationale for the requirement that there be an identifiable class:

First, the class must be capable of clear definition. Class definition is critical because it identifies the individuals entitled to notice, entitled to relief (if relief is awarded), and bound by the judgment. It is essential, therefore, that the class be defined clearly at the outset of the litigation. The definition should state objective criteria by which members of the class can be identified. While the criteria should bear a rational relationship to the common issues asserted by all class members, the criteria should not depend on the outcome of the litigation. It is not necessary that every class member be named or known. It is necessary, however, that any particular person’s claim to membership in the class be determinable by stated, objective criteria.

[94] In identifying the persons who have a potential claim against the defendant, the definition cannot be merits-based.[^34] In Frohlinger v. Nortel Networks Corporation[^35] at para. 21, Justice Winkler, as he then was, explained why merits-based definitions are prohibited; he stated:

21. The underlying reason for each of these prohibitions is readily apparent. Merits-based class definitions require a determination of each class member's claim as a pre-condition of ascertaining class membership. Carrying that concept to its logical conclusion, it would mean that at the conclusion of a class proceeding only those individuals who were successful in their claims would be members of the class and, therefore, bound by the result. Theoretically, unsuccessful claimants would not be "class members" and would be free to commence further litigation because s. 27(3) of the CPA, which states in part:

A judgment on common issues of a class or subclass binds every class member who has not opted out of the class proceeding [....]

would not bind them or bar them from commencing further actions.

[95] In defining the persons who have a potential claim against the defendant, there must be a rational relationship between the class, the cause of action, and the common issues, and the class must not be unnecessarily broad or over-inclusive.[^36] An over-inclusive class definition binds persons who ought not to be bound by judgment or by settlement, be that judgment or settlement favourable or unfavourable.[^37] The rationale for avoiding over-inclusiveness is to ensure that litigation is confined to the parties joined by the claims and the common issues that arise.[^38] The class should not be defined wider than necessary, and where the class could be defined more narrowly, the court should either disallow certification or allow certification on condition that the definition of the class be amended.[^39]

[96] A proposed class definition, however, is not overbroad because it may include persons who ultimately will not have a claim against the defendants.[^40]

2. Analysis: Identifiable Class Criterion

[97] Lundbeck makes several objections to the proposed class definition. None of these objections undermine the satisfaction of the identifiable class criterion.

[98] Lundbeck objects to the class definition’s reference to “congenital malformations” as vague and overbroad. This objection, which has some traction, however, is better dealt with in the context of the commonality and preferable procedure criteria. This objection, however, does not undermine the satisfaction of the identifiable class criterion.

[99] Moving on to another objection, in Goodridge v. Pfizer Canada Inc.,[^41] I held that the inventor of a drug does not have a duty of care to consumers who use a generic version of the drug, and in the immediate case, Lundbeck objects that the proposed definition includes as Class Members persons who were prescribed Celexa® but ingested a generic version of citalopram. I agree with Lundbeck that persons who would have received the product monograph of the generic drug manufacture should not be Class Members. Lundbeck’s objection about generic drug consumers, however, is not fatal to the class definition. The problem in the definition can be remedied by changing the definition to read: “Women in Canada who were prescribed and ingested Celexa® while pregnant….”

[100] I disagree with Lundbeck’s objection that the proposed definition should be qualified so that Class Members are limited to persons who were prescribed Celexa® only for depression; i.e., Lundbeck submits that the class should not include persons who were prescribed Celexa® for an off-label use, for example, for the treatment of obsessive compulsive disorder. I disagree because it is not plain and obvious that these persons who were prescribed and ingested Celexa® and whose doctors relied on the product monograph in prescribing Celexa® for its off-label uses do not have a claim, especially in circumstances where Lundbeck is aware of the off-label uses being made of its drug.

[101] Lundbeck objects to the inclusion of women who “aborted […] or miscarried children with congenital malformations.” The rationale for this objection is that there are many causes of spontaneous abortions and many aborted fetus are normal; i.e. without an apparent defect, and, thus, Lundbeck submits that many Class Members who were prescribed and ingested Celexa® will not be able to identify themselves as Class Members. I disagree with Lundbeck’s objection, which conflates identification of a claimant with the difficulty of that claimant proving her claim. If it were determined at a common issues trial or at an individual issues trial that Celexa® can cause spontaneous abortions (general causation), then it may be the case that a Class Member would have the difficulty of proving specific causation, but that is a problem of proving a claim not identifying oneself as person with a potential claim.

[102] Further, there may be Class Members who prior to the miscarriage had the unfortunate experience of an ultrasound that reveals a congenital malformation and who had a spontaneous abortion. These persons should not be excluded from class membership nor should persons who have the unfortunate experience of ingesting Celexa®, then having a spontaneous abortion or miscarriage of a deformed fetus that reveals a congenital malformation.

[103] In my opinion, with the revision noted above, Ms. Price’s action satisfies the identifiable class criterion.

O. Common Issues Criterion

1. General Principles: Common Issues

[104] The third criterion for certification is the common issues criterion. For an issue to be a common issue, it must be a substantial ingredient of each class member's claim and its resolution must be necessary to the resolution of each class member's claim.[^42] The underlying foundation of a common issue is whether its resolution will avoid duplication of fact-finding or legal analysis of an issue that is a substantial ingredient of each class member’s claim and thereby facilitate judicial economy and access to justice.[^43] In Pro-Sys Consultants Ltd. v. Microsoft Corporation,[^44] the Supreme Court of Canada describes the commonality requirement as the central notion of a class proceeding which is that individuals who have litigation concerns in common ought to be able to resolve those common concerns in one central proceeding rather than through an inefficient multitude of repetitive proceedings.

[105] All members of the class must benefit from the successful prosecution of the action, although not necessarily to the same extent. The answer to a question raised by a common issue for the plaintiff must be capable of extrapolation, in the same manner, to each member of the class.[^45]

[106] An issue is not a common issue if its resolution is dependent upon individual findings of fact that would have to be made for each class member.[^46] Common issues cannot be dependent upon findings which will have to be made at individual trials, nor can they be based on assumptions that circumvent the necessity for individual inquiries.[^47]

[107] Commonality is a substantive fact that exists on the evidentiary record or it does not, and commonality is not to be semantically manufactured by overgeneralizing; i.e., by framing the issue in general terms that will ultimately break down into issues to be resolved by individual inquiries for each class member.[^48] In Rumley v. British Columbia,[^49] Chief Justice McLachlin stated that an issue would not satisfy the common issues test if it was framed in overly broad terms; she stated:

[….] It would not serve the ends of either fairness or efficiency to certify an action on the basis of issues that are common only when stated in the most general terms. Inevitably such an action would ultimately break down into individual proceedings. That the suit had initially been certified as a class action could only make the proceeding less fair and less efficient.

[108] However, the commonality requirement does not mean that an identical answer is necessary for all the members of the class, or even that the answer must benefit each of them to the same extent; it is enough that the answer to the question does not give rise to conflicting interests among the members; success for one member must not result in failure for another.[^50]

[109] The common issue criterion presents a low bar.[^51] An issue can be a common issue even if it makes up a very limited aspect of the liability question and even though many individual issues remain to be decided after its resolution.[^52] Even a significant level of individuality does not preclude a finding of commonality.[^53]A common issue need not dispose of the litigation; it is sufficient if it is an issue of fact or law common to all claims and its resolution will advance the litigation.[^54]

[110] As already noted above, in the context of the common issues criterion, the some basis in fact standard involves a two-step requirement that: (1) the proposed common issue actually exists; and (2) the proposed issue can be answered in common across the entire class.

[111] Where questions relating to causation or damages are proposed as common issues, the plaintiff must demonstrate with supporting evidence that there is a workable methodology for determining such issues on a class-wide basis.[^55]

2. Common Issues: Discussion and Analysis

[112] Formerly, Ms. Price proposed the following common issues:

1. Is citalopram or may citalopram be teratogenic?

2. If so, did the Defendants breach a duty to warn Canadian physicians and patients that citalopram is or may be teratogenic? In particular:

(a) Did the Defendants owe and breach a duty to contraindicate citalopram for use during pregnancy?

(b) Did any Celexa® Product Monograph clearly, completely, or currently disclose that citalopram is or maybe teratogenic?

[113] In her reply certification factum, Ms. Price sought only the certification of the following common issue:

1. From 1999, did the Defendants breach of duty to warn Canadian physicians and patients that citalopram is or may be teratogenic?

[114] In my opinion, both parties had mistaken conceptions of the some basis in fact test for commonality and their own mistaken conceptions of how the some basis in fact test should be applied. The conceptual differences between the parties explain why there was 6,000 pages of legal authorities, brutish cross-examinations, and an almost 10,000-page evidentiary record for a motion that is ordained by the highest authorities to be procedural in nature and not a determination of the merits.

[115] The common issues debate in the immediate case was the litigation equivalent of Clostridium difficile (C. difficile), a bacterium that causes diarrhea and more serious intestinal conditions that are painful and may even be lethal. In plaguing one another, Ms. Price accused Lundbeck of attempting to have a certification motion that was hearing on the merits of the causes of action and to substitute the test for a summary judgment motion or the test for a criminal conviction instead of applying the some basis in fact test for the certification criteria, which criteria she asserted were obviously and overwhelmingly demonstrably satisfied. In plaguing one other, Lundbeck aggressively and rudely accused Ms. Price of having retained experts who were unqualified because of partisanship, incompetence, and irrelevance. Lundbeck accused Ms. Price of having a totally speculative case without a theory, without a methodology of proof, and without an air of reality.

[116] Lundbeck submitted that based on the evidence of her own experts, Ms. Price’s common issues did not satisfy the some basis in fact test because the Plaintiffs’ evidence demonstrated that there was no basis in fact for common issues regarding whether citalopram can cause congenital malformations or regarding whether Lundbeck failed to warn.

[117] In response, Ms. Price bitterly and sarcastically submitted that Lundbeck was in effect attempting to hijack the certification process and make a hearing on the merits.

[118] In my opinion, there was considerable merit to Ms. Price’s submission. It is one thing for a defendant to show that there are no facts that exist that would support the plaintiff’s case; i.e., that there is no basis in fact for the plaintiff’s case; however, but it is a far different thing for a defendant to show that the facts that do exist do not support the plaintiff’s case, which is what Lundbeck attempted to do in the immediate case. What Lundbeck attempted would be appropriate for a summary judgment motion or for a trial. It was not appropriate for a procedural motion.

[119] Lundbeck’s approach to the some basis in fact test was wrong. It submitted that its approach was the one that I adopted and that was affirmed by the Divisional Court in Batten v. Boehringer Ingelheim (Canada) Ltd.[^56] That submission was also wrong. In Batten, there was no evidence that the absence of an antidote was a hazard for which a warning was required. In the immediate case, nobody questions that congenital malformations are a hazard, and indeed Lundbeck gave some warning to pregnant women in its product monograph about using the drug during a pregnancy. The issue of something to warn about exists in the immediate case.

[120] The some basis in fact test simply means there must be some admissible evidence showing that the factual issue exists.[^57] Pleadings not being evidence will never satisfy the test, and depending on the circumstances of the particular case, it may or may not be necessary to have expert testimony to satisfy the test.

[121] In the immediate case, notwithstanding that Ms. Price retained four experts and notwithstanding that she delivered a humungous evidentiary record, she submitted that this mountain of evidence was superfluous because pharmaceutical class actions intrinsically satisfy the some basis in fact test. That particular submission was wrong, and if correct would belie the requirement that a plaintiff must support certification with some evidence, which Ms. Price was doing in any event. Ms. Price’s submission about the some basis in fact test was wrong, but on the duty to warn issue, she did provide admissible evidence from Drs. Dr. Bérard, Healy, and Mangin that there was a real issue about a breach of the duty to warn.

[122] While I was little helped by the competing arguments of the parties about the some basis in fact test and how it applies to the common issues criterion, hard upon the commencement of the hearing of the certification motion, Ms. Price made a strategic choice to seek certification based on only a duty to warn common issue. That choice did reduce the problems of dealing with the parties’ mutually exclusive wrong approaches to the same basis in fact test.

[123] Based on one common issue, Ms. Price sought certification for one action, an omnibus claim (involving approximately 130 congenital malformations) or she sought certification for more than one class action (each discrete action based on groupings of congenital malformations) focusing on the single proposed common issue about the duty to warn. This decision substantially reduced the still painful task of deciding whether her proposed action or actions satisfied the common issues and the preferable procedure criteria for certification for one or more class actions, but it eliminated the need to resolve many of the issues that had been hotly contested up until the commencement of the hearing of the certification motion.

[124] Ms. Price’s decision obviated the need to determine whether or not there existed a real issue about causation and about whether that issue was common across the class. Lundbeck’s argument based on its wrongheaded and dogged approach to some basis in fact was that there was no basis in fact for a general causation common issue, but it was no longer necessary for the court to determine whether there was a certifiable general causation issue at all. General causation is no longer a proposed common issue.

[125] From the commencement of the action on December 22, 2014 until the argument of the motion beginning on May 28, 2018, the focus of the parties was on the issue of whether there was some basis in fact that citalopram is a teratogen, which is to say the critical common issue for the certification motion was general causation; i.e., whether there was some basis in fact that citalopram could cause birth defects. However, Ms. Price’s strategic decision to focus on the duty to warn issue obviated the need to decide the original common issues based on causation; there is now only the need to decide the commonality of the duty to warn common issue.

[126] Ms. Price’s strategic decision leaves the identification issues, all the causation issues, and the damage assessment issues for individual issues trials. Since Ms. Price is no longer advancing the common issues that the parties plagued each other with for over three years, save insofar as their arguments are pertinent to determining the existence and the commonality of the duty to warn issue, I need not decide whether the originally proposed common issues satisfy the common issues criterion, and I need not decide whether the originally proposed common issues would satisfy the preferable procedure criterion.

[127] In the immediate case, in the determination of whether there is some basis in fact for the common issue, it is necessary to keep in mind that a common issue about general causation has been certified in a great many product’s liability class actions and other types of negligence class actions, but in the immediate case, Ms. Price is no longer proposing a general causation issue.

[128] In the immediate case, it is also necessary to keep in mind, as I held in Wise v. Abbott Laboratories Limited,[^58] which was a summary judgment and not a certification motion, that an association between a product and a dangerous condition may give rise to a duty to warn even if the association has not been demonstrated to be causal. Indeed, in Wise, I said that even something less than an association such as adverse event reports or other indications that something is amiss in the use of the drug may be enough to trigger a duty to warn including taking steps to change the warnings in a product monograph. In the Wise case, I decided that the defendant Abbott had a duty to warn, but I did not determine whether Abbott breached that duty because I concluded that the Wises had not proven general causation and hence their action should be summarily dismissed. A failure to warn that causes no harm is not culpable negligence; no harm, no foul.

[129] In the immediate case, there is some basis in fact for an issue that Lundbeck breached a duty to warn Canadian physicians and patients that citalopram is or may be teratogenic. That issue actually exists; i.e., notwithstanding Lundbeck’s arguments, there is an air of reality to the duty to warn issue. However, the duty to warn issue is not a common issue; it exists but it does not satisfy the test of commonality.

[130] From a public policy perspective and from a legal policy perspective, it makes sense that a duty to warn might be triggered before it was actually known whether or not the possibly dangerous thing is capable of causing harm. This is especially sensible with respect to drugs like an SSRI because it is unethical to prospectively test drugs in pregnant women and thus none of the randomized clinical trials for citalopram or the other SSRIs was able to test for congenital malformations. However, from a public policy perspective and from a legal policy perspective, it also makes sense that liability for a breach of a duty to warn still requires that the harm be caused by the threatening thing.

[131] Upon analysis, while Ms. Price’s proposed duty to warn issue exists, it has a fatal design flaw with respect to the commonality of the issue for her proposed class action, even accepting the truth of her expert witnesses’ opinions. Ms. Price’s strategic decision was too clever by half. The proposed duty to warn issue is a real issue, but it is not a common issue for two reasons.

[132] First, the duty to warn itself is not common across the class because commonality does not exist and cannot be semantically manufactured over such a broad range of dangers. Commonality does not exist in the case at bar because congenital malformations present a broad range of potential hazards ranging from the risk of minor human body imperfections of a cosmetic nature to major imperfections that destroy the quality of a person’s life or that destroy life itself.

[133] As noted above, the adequacy of a warning depends upon the nature and gravity of the potential hazard and the nature and extent of any given warning will depend on what is reasonable having regard to all the facts and the circumstances relevant to the product in question. In the case there may be commonality for one or even some combinations of the more hazardous congenital malformations, but there is no conceivable commonality in warning about birth defects generally as if they were all of the same gravity.

[134] Second, the duty to warn issue is not common because the resolution of it will not avoid duplication of fact-finding or legal analysis, because its resolution is not capable of meaningful extrapolation to assist each Class Member, and because even if the duty to warn issue was resolved favourably for the Class Members, its resolution will not form a substantial part of each Class Member’s case and very substantial individual inquiries will required for each Class Member claims. Put bluntly, the duty to warn issue does not connect the dots for a common issues trial that has any utility for a class proceeding that inevitably end with individual issues trials with very significant causation issues associated with the breach of the duty to warn.

[135] These points can be demonstrated by using the examples of the causes of action of Mesdames Bews, Gardner, Lovett, Price, and Stymiest. Each of their cases is built on the issue that Lundbeck breached a duty to warn that citalopram may cause congenital malformations. Notwithstanding Lundbeck’s arguments to the contrary, the issue of whether Lundbeck breached a duty to warn exists and has an air of reality to it, but the issue is not a common issue because the breach of the duty would be inconsequential across the Class and each individual Class Member would be unharmed by the breach of the duty to warn unless they were actually harmed as a consequence of their ingestion of citalopram.

[136] Take just Ms. Price as an example, assuming it was established at a common issues trial that Lundbeck did breach a duty to warn that Celexa® may cause congenital malformations, Ms. Price would then be entitled to compensation only if she proves at her inevitable individual issues trial that her ingesting citalopram could be (general causation) and was in her particular case (specific causation) the explanation as to why Matthew was born with septal defect, pulmonary valve stenosis, and absent fifth distal phalanx.

[137] As another example using Ms. Price’s and Ms. Gardner’s individual cases, assume again that it was proven at the common issues trial that Lundbeck did breach a duty to warn that citalopram may cause congenital malformations and assume further that Ms. Price was successful at her individual issues trial in proving that citalopram could and did cause Matthew’s pulmonary valve stenosis, the cause of action of Ms. Gardner would not gain anything from the issue estoppel and she would not be entitled to compensation for the breach of the duty to warn unless she proved that Celexa® could and did cause her daughter to be born with a club foot. A common issues trial just about a breach of a duty to warn does not take the individual Class Members pursuit of justice very far in the circumstances of the immediate case.

[138] After three-and-a-half years of litigation, Ms. Price apparently came to the strategic decision that there was some basis in fact for both the existence and the commonality of a duty to warn issue. That there may have also have be some basis in fact for an issue about whether citalopram is a teratogen was of no moment for the purposes of certification because this issue could be resolved at individual issues trials.

[139] Moreover, there was very serious problems with Ms. Price’s original proposal of causation issues about general causation. Based on Dr. Cabrera’s evidence, there no some basis in fact for concluding that there was a plausible biological means by which citalopram could cause each and every birth defect and there was some basis in fact in the epidemiological evidence for concluding that citalopram might be a cause of cardiac congenital malformations; however; that evidence does not provide some basis in fact for the proposition that citalopram is the cause of all congenital malformation and that evidence is not some basis in fact of a universal proposition that would be useful for a class proceeding. In other words, showing that there is some basis in fact for believing that citalopram is a teratogen only shows that some birth defects may be caused by citalopram and does not help in proving that the many and different congenital malformations in children born of mother’s who had ingested Celexa® were caused by citalopram.

[140] But as I have already said, all of the parties’ arguments about whether there is some basis in fact for a common issue based on general causation is of no moment because there is no such common issue being proposed. And while there is some basis in fact for an issue about a duty to warn, it is not a common issue for the reasons set out above.

[141] I conclude that the common issues criterion is not satisfied in the case at bar.

P. Preferable Procedure Criterion

1. General Principles: Preferable Procedure

[142] Under the Class Proceedings Act, 1992, the fourth criterion for certification is the preferable procedure criterion. Preferability captures the ideas of: (a) whether a class proceeding would be an appropriate method of advancing the claims of the class members; and (b) whether a class proceeding would be better than other methods such as joinder, test cases, consolidation, and any other means of resolving the dispute.[^59]

[143] In AIC Limited v. Fischer,[^60] the Supreme Court of Canada emphasized that the preferability analysis must be conducted through the lens of judicial economy, behaviour modification, and access to justice. Justice Cromwell for the court stated that access to justice has both a procedural and substantive dimension. The procedural aspect focuses on whether the claimants have a fair process to resolve their claims. The substantive aspect focuses on the results to be obtained and is concerned with whether the claimants will receive a just and effective remedy for their claims if established. Thus, for a class proceeding to be the preferable procedure for the resolution of the claims of a given class, it must represent a fair, efficient, and manageable procedure that is preferable to any alternative method of resolving the claims.[^61] Arguments that no litigation is preferable to a class proceeding cannot be given effect.[^62] Whether a class proceeding is the preferable procedure is judged by reference to the purposes of access to justice, behaviour modification, and judicial economy and by taking into account the importance of the common issues to the claims as a whole, including the individual issues.[^63]

[144] Relevant to the preferable procedure analysis are the factors listed in s. 6 of the Class Proceedings Act, 1992, which states:

6. The court shall not refuse to certify a proceeding as a class proceeding solely on any of the following grounds:

7. The relief claimed includes a claim for damages that would require individual assessment after determination of the common issues.

8. The relief claimed relates to separate contracts involving different Class Members.

9. Different remedies are sought for different Class Members.

10. The number of Class Members or the identity of each Class Member is not known.

11. The class includes a subclass whose members have claims or defences that raise common issues not shared by all Class Members.

[145] To satisfy the preferable procedure criterion, the proposed representative plaintiff must show some basis in fact that the proposed class action would: (a) be a fair, efficient and manageable method of advancing the claim; (b) be preferable to any other reasonably available means of resolving the class members' claims; and (c) facilitate the three principal goals of class proceedings; namely: judicial economy, behaviour modification, and access to justice.[^64]

[146] In considering the preferable procedure criterion, the court should consider: (a) the nature of the proposed common issue(s) and their importance in relation to the claim as a whole; (b) the individual issues which would remain after determination of the common issue(s); (c) the factors listed in the Act; (d) the complexity and manageability of the proposed action as a whole; (e)alternative procedures for dealing with the claims asserted; (f) the extent to which certification furthers the objectives underlying the Act; and (g) the rights of the plaintiff(s) and defendant(s).[^65]

[147] The court must identify alternatives to the proposed class proceeding.[^66] The proposed representative plaintiff bears the onus of showing that there is some basis in fact that a class proceeding would be preferable to any other reasonably available means of resolving the class members’ claims, but if the defendant relies on a specific non-litigation alternative, the defendant has the evidentiary burden of raising the non-litigation alternative.[^67] It is not enough for the plaintiff to establish that there is no other procedure which is preferable to a class proceeding; he or she must also satisfy the court that a class proceeding would be fair, efficient and manageable.[^68]

[148] In AIC Limited v. Fischer, Justice Cromwell pointed out that when the court is considering alternatives to a class action, the question is whether the alternative has potential to provide effective redress for the substance of the plaintiff’s claims and to do so in a manner that accords suitable procedural rights. He said that there are five questions to be answered when considering whether alternatives to a class action will achieve access to justice: (1) Are there economic, psychological, social, or procedural barriers to access to justice in the case? (2) What is the potential of the class proceeding to address those barriers? (3) What are the alternatives to class proceedings? (4) To what extent do the alternatives address the relevant barriers? and (5) How do the two proceedings compare?[^69]

[149] And in light of the Supreme Court of Canada’s directives in Hryniak v. Mauldin[^70] and Bruno Appliance and Furniture, Inc. v. Hryniak,[^71] one should now add to the preferable procedure factors the factor of the relationship between access to justice, which is the preeminent concern of class proceedings, and proportionality in civil procedures. The proportionality analysis, which addresses how much procedure a litigant actually needs to obtain access to justice, fits nicely with the focus on judicial economy and with the part of the preferable procedure analysis that considers manageability and whether the claimants will receive a just and effective remedy for their claims.

[150] In cases, particularly cases where the individual class members’ respective harm is nominal, or cases where an aggregate assessment of damages in whole or in part is possible, a class action may more readily satisfy the preferable procedure criterion because the common issues trial may be the only viable means for remedying the wrong and for calling the wrongdoer to account because individual litigation may be prohibitively expensive.[^72]

[151] In undertaking a preferable procedure analysis in a case in which individual issue trials are inevitable, it should be appreciated that the Class Proceedings Act, 1992 envisions the prospect of individual claims being litigated and it should be noted that sections 12 and 25 of the Act empower the court with tools to manage and achieve access to justice and judicial economy; thus the inevitability of individual issues trials is not an obstacle to certification. In the context of misrepresentation claims, numerous actions have been certified notwithstanding individual issues of reliance and damages.[^73]

[152] That said, in a given particular case, the inevitability of individual issues trials may obviate any advantages from the common issues trial and make the case unmanageable and thus the particular case will fail the preferable procedure criterion.[^74] Or, in a given case, the inevitability of individual issues may mean that while the action may be manageable, those individual issue trials are the preferable procedure and a class action is not the preferable procedure to achieve access to justice, behaviour modification, and judicial economy. A class action may not be fair, efficient and manageable having regard to the common issues in the context of the action as a whole and the individual issues that would remain after the common issues are resolved.[^75] A class action will not be preferable if, at the end of the day, claimants remain faced with the same economic and practical hurdles that they faced at the outset of the proposed class action.[^76]

2. Analysis: Preferable Procedure

[153] It is axiomatic that if the common issues criterion is not satisfied, the preferable procedure criterion is not satisfied.[^77] Therefore, in the immediate case, I can quickly conclude that the preferable procedure criterion is not satisfied.

[154] I, however, would have come to the same conclusion even if Ms. Price had established a common issue about the breach of the duty to warn. In considering the preferable procedure criterion, the court should consider the nature of the proposed common issue and its importance in relation to the claim as a whole and it should consider the individual issues which would remain after determination of the common issue. In the immediate case, the deferral of the general causation issue to individual issues trials meant that there was little utility to a common issues trial in making progress to access to justice, and thus the preferable procedure criterion is not satisfied.

[155] Moreover, I would have come to the same conclusion even if Ms. Price had not made her strategic decision and even if it were established that she satisfied the common issues criterion for her originally proposed common issues had satisfied the common issues criterion.

[156] As originally conceived, Ms. Price’s overly ambitious class action would not have been efficient and it would not have been manageable. The proposed general causation issue purporting to cover all of the numerous congenital malformations ranging from the minor to the life threatening had no methodology other than the idea that the congenital malformations could be connected to discrete groups of body parts or body systems. That methodology, however, would have not produced a common issues trial but rather a grouping of trials tried one after another while the Class Members waited for an individual determination of whether their child’s congenital malformation was caused by ingesting citalopram. A class proceeding would not be the preferable procedure in these circumstances.

[157] By these reasons for decision, I do not suggest that it is impossible to design a certifiable class action involving a drug alleged to be a teratogen. However, citalopram is not thalidomide and Ms. Price’s proposed class action is a quantum jump in diversity, complexity, and manageability than say Bartram v. GlaxoSmithKline Inc.[^78] which focused just on cardiac congenital malformations.

[158] I conclude that the preferable procedure criterion is not satisfied in the case at bar.

Q. Representative Plaintiff Criterion

1. General Principles: Representative Plaintiff Criterion

[159] The fifth and final criterion for certification as a class action is that there is a representative plaintiff who would adequately represent the interests of the class without conflict of interest and who has produced a workable litigation plan. The representative plaintiff must be a member of the class asserting claims against the defendant, which is to say that the representative plaintiff must have a claim that is a genuine representation of the claims of the members of the class to be represented or that the representative plaintiff must be capable of asserting a claim on behalf of all of the class members as against the defendant.[^79]

[160] Provided that the representative plaintiff has his or her own cause of action, the representative plaintiff can assert a cause of action against a defendant on behalf of other class members that he or she does not assert personally, provided that the causes of action all share a common issue of law or of fact.[^80]

[161] Whether the representative plaintiff can provide adequate representation depends on such factors as: his or her motivation to prosecute the claim; his or her ability to bear the costs of the litigation; and the competence of his or her counsel to prosecute the claim.[^81]

[162] While a litigation plan is a work in progress, it must correspond to the complexity of the particular case and provide enough detail to allow the court to assess whether a class action is: (a) the preferable procedure; and (b) manageable including the resolution of the common issues and any individual issues that remain after the common issues trial.[^82] The litigation plan will not be workable if it fails to address how the individual issues that remain after the determination of the common issues are to be addressed.[^83]

2. Analysis: Representative Plaintiff

[163] Because Ms. Price’s proposed class action does not satisfy the common issues and the preferable procedure criteria, it follows that the representative plaintiff criterion cannot be satisfied for the simple reason that if there is no certifiable common issue and a class action is not the preferable procedure for disposing of the Class Members’ claims, then Class Counsel cannot produce a workable litigation plan,

[164] Had the common issues and preferable procedure criteria been satisfied, them Ms. Price personally would have qualified to be a representative plaintiff. In those circumstances, all the criteria would have been satisfied and the defects in her litigation plan could have been remedied. However, those circumstances did not exist and therefore the representative plaintiff criterion was not satisfied in the case at bar.

R. Conclusion

[165] For the above reasons, the certification motion is dismissed. The parties have agreed that there shall be no order as to costs.[^84]

Perell, J.

Released: July 16, 2018

[^1]: S.O. 1992, c.6.

[^2]: Both sides can be commended for their energy and diligence to their cause. However, although reciprocally provoked and frustrated by their opponent, both sides were bullying, arrogant, obstinate, and sanctimonious. Ms. Price’s motion record comprised over 8,000 pages. Ms. Price’s Book of Authorities comprised 1,556 pages. Her factum was 255 pages. Her reply factum was 406 pages and included an 18-page single-spaced table entitled “Annoying and Meaningless Clichés and Phrases Employed by Lundbeck,” (defined to be unhelpful, officious, and claying phrases in Lundbeck’s factum with no measurable and quantifiable meaning or phrases that signal where the factum misstates the evidence). In her reply factum, Ms. Price described Lundbeck’s 276-page factum as actually being 300 pages with proper margins and spacing, and she said a factum of this length was “disgusting,” and she submitted that her own factum would have been over 600 pages if she had stooped to Lundbeck’s level of improper argument. Ms. Price’s reply factum also included a “Table of Dot Dot Dots,” where she complained about “Lundbeck’s abuse of ellipsis.” Lundbeck’s responding motion record comprised over 791 pages. Its factum was 276 pages and included a chart entitled “Table of Misleading Assertions in Plaintiffs’ Factum.” Lundbeck’s Books of Authorities totaled 4,589 pages. Lundbeck’s factum was riddled with peevishness and distain for Ms. Price, Class Counsel, and the Plaintiffs’ witnesses, sparing neither the lay witnesses nor the experts.

[^3]: The parties have agreed that there shall be no order as to costs. But, for that agreement, I would have, at least, considered making the very rare award of costs to the unsuccessful party. Lundbeck’s over-the-top resistance to certification, which disregarded the fact-finding boundaries of such motions, might have justified it having to pay costs notwithstanding its success or I might have made each party bear their own costs, which is what they agreed.

[^4]: Family Compensation Act, R.S.B.C. 1996, c. 126; Fatal Accidents Act, R.S.A. 2000, c. F-8; Fatal Accidents Act, R.S.S. 1978, c. F-11; Fatal Accidents Act, C.C.S.M. c. F50; Family Law Act, R.S.O. 1990, c. F. 3; Fatal Accidents Act, S.N.B. 2012, c. 104; Fatal Accidents Act, R.S.P.E.I. 1988, c. F-5; Fatal Accidents Act, R.S.N.L. 1990, c F-6; Fatal Accidents Act, R.S.Y. 2002, c. 86; Fatal Accidents Act, R.S.N.W.T. 1988, c. F-3; Fatal Accidents Act, R.S.N.W.T. (Nu.) 1988, c F-3.

[^5]: 2012 BCSC 1804, aff’d, 2013 BCCA 462.

[^6]: Mustapha v. Culligan of Canada Ltd., 2008 SCC 27 at para. 3.

[^7]: Bow Valley Husky (Bermuda) Ltd. v. Saint John Shipbuilding Ltd., 1997 CanLII 307 (SCC), [1997] 3 S.C.R. 1210; Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at para. 20; Lambert v. Lastoplex Chemicals Co., 1971 CanLII 27 (SCC), [1972] S.C.R. 569 at p. 574.

[^8]: Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at paras. 20-21; Lambert v. Lastoplex Chemicals Co., 1971 CanLII 27 (SCC), [1972] S.C.R. 569 at pp. 574-75.

[^9]: Lambert v. Lastoplex Chemicals Co., 1971 CanLII 27 (SCC), [1972] S.C.R. 569.

[^10]: Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at para. 23.

[^11]: (1986), 1986 CanLII 114 (ON CA), 54 O.R. (2d) 92 (C.A.).

[^12]: Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at paras. 28-29; Buchan v. Ortho Pharmaceutical (Canada) Ltd., (1986), 1986 CanLII 114 (ON CA), 54 O.R. (2d) 92 at paras. 23, 59 (C.A.).

[^13]: Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at para. 27.

[^14]: Sauer v. Canada (Attorney General), 2008 CanLII 43774 (ON SC), [2008] O.J. No. 3419 at para. 14 (S.C.J.), leave to appeal to Div. Ct. refused, 2009 CanLII 2924 (ON SCDC), [2009] O.J. No. 402 (Div. Ct.).

[^15]: Hollick v. Toronto (City), 2001 SCC 68 at para. 16.

[^16]: Hollick v. Toronto (City), 2001 SCC 68 at paras. 15 and 16; Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at paras. 26 to 29.

[^17]: Hollick v. Toronto (City), 2001 SCC 68 at paras. 28 and 29.

[^18]: Hollick v. Toronto (City), 2001 SCC 68 at paras. 16-26.

[^19]: Batten v. Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 53, aff'd, 2017 ONSC 6098 (Div. Ct.), leave to appeal refused (28 February 2018) (C.A.); Dine v. Biomet, 2015 ONSC 7050, aff'd 2016 ONSC 4039 (Div. Ct.); Good v. Toronto Police Services Board, 2014 ONSC 4583 (Div. Ct.); McCracken v. Canadian National Railway Company, 2012 ONCA 445; Fulawka v. Bank of Nova Scotia, 2012 ONCA 443; Martin v. Astrazeneca Pharmaceuticals PLC, 2012 ONSC 2744; Williams v. Canon Canada Inc., 2011 ONSC 6571, aff'd 2012 ONSC 3992 (Div. Ct.).

[^20]: Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57; McCracken v. CNR Co., 2012 ONCA 445.

[^21]: Singer v. Schering-Plough Canada Inc., 2010 ONSC 42 at para. 140; Fresco v. Canadian Imperial Bank of Commerce, 2009 CanLII 31177 (ON SC), [2009] O.J. No. 2531 at para. 21 (S.C.J.); Dumoulin v. Ontario, [2005] O.J. No. 3961 at para. 25 (S.C.J.).

[^22]: Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 at para. 110.

[^23]: Hollick v. Toronto (City), 2001 SCC 68 at para. 22.

[^24]: Williams v. Canon Canada Inc., 2011 ONSC 6571, aff’d 2012 ONSC 3992 (Div. Ct.); Ernewein v. General Motors of Canada Ltd., 2005 BCCA 540 (C.A.), leave to appeal to S.C.C. ref’d, [2005] S.C.C.A. No. 545; Chadha v. Bayer Inc.(2003), 2003 CanLII 35843 (ON CA), 63 O.R. (3d) 22 (C.A.), leave to appeal to S.C.C. ref’d [2003] S.C.C.A. No. 106; Taub v. Manufacturers Life Insurance Co., 1998 CanLII 14853 (ON SC), 40 O.R. (3d) 379 (Gen. Div.), aff’d (1999), 1999 CanLII 19922 (ON SC), 42 O.R. (3d) 576 (Div. Ct.).

[^25]: Cloud v. Canada (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 50 (C.A.), leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50, rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.); Hollick v. Toronto (City), 2001 SCC 68 at paras. 16-26.

[^26]: Martin v. Astrazeneca Pharmaceuticals PLC, 2012 ONSC 2744; Williams v. Canon Canada Inc., 2011 ONSC 6571, aff’d 2012 ONSC 3992 (Div. Ct.); Schick v. Boehringer Ingelheim (Canada) Ltd., 2011 ONSC 63 at para.13; Ernewein v. General Motors of Canada Ltd. 2005 BCCA 540 (C.A.), leave to appeal to S.C.C. ref’d, [2005] S.C.C.A. No. 545.

[^27]: Griffin v. Dell Canada Inc., 2009 CanLII 3557 (ON SC), [2009] O.J. No. 418 at para. 76 (S.C.J.).

[^28]: Stanway v. Wyeth Canada Inc., 2011 BCSC 1057, aff’d 2012 BCCA 260.

[^29]: 1990 CanLII 90 (SCC), [1990] 2 S.C.R. 959.

[^30]: 176560 Ontario Ltd. v. Great Atlantic & Pacific Co. of Canada Ltd. (2002), 2002 CanLII 6199 (ON SC), 62 O.R. (3d) 535 at para. 19 (S.C.J.), leave to appeal granted, 2003 CanLII 36393 (ON SCDC), 64 O.R. (3d) 42 (S.C.J.), aff'd (2004), 2004 CanLII 16620 (ON SCDC), 70 O.R. (3d) 182 (Div. Ct.); Anderson v. Wilson (1999), 1999 CanLII 3753 (ON CA), 44 O.R. (3d) 673 at p. 679 (C.A.), leave to appeal to S.C.C. ref'd, [1999] S.C.C.A. No. 476.

[^31]: Cloud v. Canada (Attorney General) (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 41 (C.A.), leave to appeal to the S.C.C. refused, [2005] S.C.C.A. No. 50, rev'g, (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.); Hollick v. Toronto (City), 2001 SCC 68 at para. 25; Abdool v. Anaheim Management Ltd. (1995), 1995 CanLII 5597 (ON SCDC), 21 O.R. (3d) 453 at p. 469 (Div. Ct.).

[^32]: Bywater v. Toronto Transit Commission, [1998] O.J. No. 4913 (Gen. Div.).

[^33]: 2001 SCC 46 at para. 38.

[^34]: Keatley Surveying Ltd. v. Teranet Inc., 2012 ONSC 7120 at paras. 159-167; Frohlinger v. Nortel Networks Corporation, 2007 CanLII 696 (ON SC), [2007] O.J. No. 148 at para. 21 (S.C.J.); Chadha v. Bayer Inc. (2003), 2003 CanLII 35843 (ON CA), 63 O.R. (3d) 22 (C.A.), leave to appeal to S.C.C. ref’d [2003] S.C.C.A. No. 106; Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at para. 38.

[^35]: 2007 CanLII 696 (ON SC), [2007] O.J. No. 148 (S.C.J.).

[^36]: Pearson v. Inco Ltd. (2006), 2006 CanLII 913 (ON CA), 78 O.R. (3d) 641 at para. 57 (C.A.), rev'g 2004 CanLII 34446 (ON SCDC), [2004] O.J. No. 317 (Div. Ct.), which had aff'd [2002] O.J. No. 2764 (S.C.J.).

[^37]: Robinson v. Medtronic Inc., 2009 CanLII 56746 (ON SC), [2009] O.J. No. 4366 at paras. 121-146 (S.C.J.).

[^38]: Frohlinger v. Nortel Networks Corporation, 2007 CanLII 696 (ON SC), [2007] O.J. No. 148 at para. 22 (S.C.J.).

[^39]: Fehringer v. Sun Media Corp., [2002] O.J. No. 4110 at paras. 12-13 (S.C.J.), aff’d [2003] O.J. No. 3918 (Div. Ct.); Hollick v. Toronto (City), 2001 SCC 68 at para. 21.

[^40]: Silver v. Imax Corp., 2009 CanLII 72334 (ON SC), [2009] O.J. No. 5585 at para. 103-107 (S.C.J.) at para. 103-107, leave to appeal to Div. Ct. refused 2011 ONSC 1035 (Div. Ct.); Boulanger v. Johnson & Johnson Corp., 2007 CanLII 735 (ON SC), [2007] O.J. No. 179 at para. 22 (S.C.J.), leave to appeal ref’d [2007] O.J. No. 1991 (Div. Ct.); Ragoonanan v. Imperial Tobacco Inc. (2005), 2005 CanLII 40373 (ON SC), 78 O.R. (3d) 98 (S.C.J.), leave to appeal ref’d 2008 CanLII 19242 (ON SCDC), [2008] O.J. No. 1644 (Div. Ct.); Bywater v. Toronto Transit Commission, [1998] O.J. No. 4913 at para. 10 (Gen. Div.) at para. 10.

[^41]: 2010 ONSC 1095.

[^42]: Hollick v. Toronto (City), 2001 SCC 68 at para. 18.

[^43]: Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at paras. 39 and 40.

[^44]: 2013 SCC 57 at para. 106.

[^45]: Batten v. Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 53, aff’d, 2017 ONSC 6098 (Div. Ct.), leave to appeal refused (28 February 2018) (C.A.); Amyotrophic Lateral Sclerosis Society of Essex County v. Windsor (City), 2015 ONCA 572 at para. 48; McCracken v. CNR, 2012 ONCA 445 at para. 183; Merck Frosst Canada Ltd. v. Wuttunee, 2009 SKCA 43 at paras. 145-46 and 160, leave to appeal to S.C.C. refused, [2008] S.C.C.A. No. 512; Ernewein v. General Motors of Canada Ltd., 2005 BCCA 540 (C.A.), leave to appeal to S.C.C. ref’d, [2005] S.C.C.A. No. 545; Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at para. 40.

[^46]: Fehringer v. Sun Media Corp., [2003] O.J. No. 3918 at paras. 3, 6 (Div. Ct.).

[^47]: McKenna v. Gammon Gold Inc., 2010 ONSC 1591, [2010] O.J. No. 1057 at para. 126 (S.C.J.), leave to appeal granted 2010 ONSC 4068, [2010] O.J. No. 3183 (Div. Ct.), var’d 2011 ONSC 3882 (Div. Ct.); Nadolny v. Peel (Region), [2009] O.J. No. 4006 at paras. 50-52 (S.C.J.); Collette v. Great Pacific Management Co., 2003 BCSC 332, [2003] B.C.J. No. 529 at para. 51 (B.C.S.C.), var’d on other grounds (2004) 2004 BCCA 110, 42 B.L.R. (3d) 161 (B.C.C.A.).

[^48]: McCracken v. Canadian National Railway Company, 2012 ONCA 445 at para. 132; Microcell Communications Inc. v. Frey, 2011 SKCA 136 at para. 48-50, leave to appeal refused, [2012] S.C.C.A. No. 42; 197; Merck Frosst Canada Ltd. v. Wuttunee, 2009 SKCA 43, leave to appeal refused, [2008] S.C.C.A. No. 512; Rumley v. British Columbia, 2001 SCC 69, [2001] 3 S.C.R. 184 at para. 29.

[^49]: 2001 SCC 69, [2001] 3 S.C.R. 184 at para. 29.

[^50]: Vivendi Canada Inc. v. Dell’Aniello, 2014 SCC 1 at paras. 44–46.

[^51]: 203874 Ontario Ltd. v. Quiznos Canada Restaurant Corp., 2009 CanLII 23374 (ON SCDC), [2009] O.J. No. 1874 (Div. Ct.), aff’d 2010 ONCA 466, [2010] O.J. No. 2683 (C.A.), leave to appeal to S.C.C. refused [2010] S.C.C.A. No. 348; Cloud v. Canada (Attorney General) (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 52 (C.A.), leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50, rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.); Carom v. Bre-X Minerals Ltd. (2000), 2000 CanLII 16886 (ON CA), 51 O.R. (3d) 236 at para. 42 (C.A.).

[^52]: Cloud v. Canada (Attorney General), (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 (C.A.), leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50, rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.).

[^53]: Hodge v. Neinstein, 2017 ONCA 494 at para. 114; Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 at para. 112; Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at para. 54.

[^54]: Harrington v. Dow Corning Corp., 2000 BCCA 605, [2000] B.C.J. No. 2237 (C.A.), leave to appeal to S.C.C. ref’d [2001] S.C.C.A. No. 21.

[^55]: Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 at paras. 114-119; Chadha v. Bayer Inc. (2003), 2003 CanLII 35843 (ON CA), 63 O.R. (3d) 22 (C.A.), leave to appeal to S.C.C. ref’d [2003] S.C.C.A. No. 106.

[^56]: 2017 ONSC 53, aff’d, 2017 ONSC 6098 (Div. Ct.), leave to appeal to C.A. refused (February, 28, 2018).

[^57]: Fehr v. Sun Life Assurance Company of Canada, 2016 ONSC 7659 at para. 52.

[^58]: 2016 ONSC 7275.

[^59]: Markson v. MBNA Canada Bank, 2007 ONCA 334 at para. 69, leave to appeal to SCC ref’d [2007] S.C.C.A. No. 346; Hollick v. Toronto (City), 2001 SCC 68.

[^60]: 2013 SCC 69 at paras. 24-38.

[^61]: Cloud v. Canada (Attorney General) (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 52 (C.A.), leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50, rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.).

[^62]: 1176560 Ontario Ltd. v. The Great Atlantic and Pacific Company of Canada Ltd. (2002), 2002 CanLII 6199 (ON SC), 62 O.R. (3d) 535 at para. 45 (S.C.J.), aff’d (2004), 2004 CanLII 16620 (ON SCDC), 70 O.R. (3d) 182 (Div. Ct.).

[^63]: Markson v. MBNA Canada Bank, 2007 ONCA 334; Hollick v. Toronto (City), 2001 SCC 68.

[^64]: Musicians’ Pension Fund of Canada (Trustee of) v. Kinross Gold Corp., 2014 ONCA 901; AIC Limited v. Fischer, 2013 SCC 69; Hollick v. Toronto (City), 2001 SCC 68.

[^65]: Cloud v. Canada (Attorney General) (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 52 (C.A.), leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50, rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.); Chadha v. Bayer Inc. (2003), 2003 CanLII 35843 (ON CA), 63 O.R. (3d) 22 (C.A.), leave to appeal to S.C.C. ref’d [2003] S.C.C.A. No. 106.

[^66]: AIC Limited v. Fischer, 2013 SCC 69 at para. 35; Hollick v. Toronto (City), 2001 SCC 68 at para. 28.

[^67]: AIC Limited v. Fischer, 2013 SCC 69 at paras. 48-49.

[^68]: Amyotrophic Lateral Sclerosis Society of Essex County v. Windsor (City), 2015 ONCA 572 at para. 62; Caputo v. Imperial Tobacco Ltd., 2004 CanLII 24753 (ON SC), [2004] O.J. No. 299 at para. 62-67 (S.C.J.).

[^69]: Musicians’ Pension Fund of Canada (Trustee of) v. Kinross Gold Corp., 2014 ONCA 901 at para. 125; AIC Limited v. Fischer, 2013 SCC 69 at paras. 27-38.

[^70]: 2014 SCC 7.

[^71]: 2014 SCC 8.

[^72]: Marcantonio v. TVI Pacific Inc., [2009] O.J. No. 3409 (S.C.J.) at para. 9; Silver v. IMAX Corp., 2009 CanLII 72334 (ON SC), [2009] O.J. No. 5585 at paras. 215-216 (S.C.J.), leave to appeal to Div. Ct. refused, 2011 ONSC 1035 (Div. Ct.); Markson v. MBNA Canada Bank, 2007 ONCA 334.

[^73]: Fantl v. Transamerica Life Canada, 2016 ONCA 633; OPA v. Ottawa Police Services Board, 2014 ONSC 1584 at para. 59 (Div. Ct.); Cannon v. Funds for Canada Foundation, 2012 ONSC 399 at paras. 340, 350-351, leave to appeal to Div. Ct. refused, 2012 ONSC 6101 (Div. Ct.); Ramdath v. George Brown College of Applied Arts & Technology, 2010 ONSC 2019 at para. 103; Silver v. Imax Corp., 2009 CanLII 72334 (ON SC), [2009] O.J. No. 5585 (S.C.J.), leave to appeal to Div. Ct. refused, 2011 ONSC 1035 (Div. Ct.); Hickey-Button v. Loyalist College of Applied Arts & Technology (2006), 2006 CanLII 20079 (ON CA), 267 D.L.R. (4th) 601 (Ont. C.A.); Murphy v. BDO Dunwoody LLP, 2006 CanLII 22809 (ON SC), [2006] O.J. No. 2729 (S.C.J.); Lewis v. Cantertrot Investments Ltd., [2005] O.J. No. 3535 at para. 20 (S.C.J.); Canadian Imperial Bank of Commerce v. Deloitte & Touche, 2003 CanLII 38170 (ON SCDC), [2003] O.J. No. 2069 at para. 35 (Div. Ct.); Carom v. Bre-X Minerals Ltd. (2000), 2000 CanLII 16886 (ON CA), 51 O.R. (3d) 236 at paras. 48-49 (C.A.), rev’g (1999), 1999 CanLII 14794 (ON SCDC), 44 O.R. (3d) 173 (S.C.J.), leave to appeal to S.C.C. refused, [2000] S.C.C.A. No. 660.

[^74]: Arabi v. Toronto-Dominion Bank, [2006] O.J. No. 2072 (S.C.J.), aff’d 2007 CanLII 56527 (ON SCDC), [2007] O.J. No. 5035 (Div. Ct.); Mouhteros v. DeVry Canada Inc. (1998), 1998 CanLII 14686 (ON SC), 41 O.R. (3d) 63 (Gen. Div.).

[^75]: Musicians’ Pension Fund of Canada (Trustee of) v. Kinross Gold Corp., 2014 ONCA 901.

[^76]: Fantl v. Transamerica Life Canada, 2016 ONCA 633 at para. 26.

[^77]: Batten v. Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 53 at para. 209, aff’d, 2017 ONSC 6098 (Div. Ct.), leave to appeal to C.A. refused (February 28, 2018); Vester v. Boston Scientific Ltd., 2015 ONSC 7950 at para. 140, additional reasons, 2017 ONSC 1095; O’Brien v. Bard Canada Inc., 2015 ONSC 2470 at para. 221.

[^78]: 2012 BCSC 1804, aff’d, 2013 BCCA 462.

[^79]: Drady v. Canada (Minister of Health), 2007 CanLII 27970 (ON SC), [2007] O.J. No. 2812 at paras. 36-45 (S.C.J.); Attis v. Canada (Minister of Health), [2003] O.J. No. 344 at para. 40 (S.C.J.), aff'd [2003] O.J. No. 4708 (C.A.).

[^80]: Voutour v. Pfizer Canada Inc., [2008] O.J. No. 3070 (S.C.J.); LeFrancois v. Guidant Corp., [2008] O.J. No. 1397 at para. 55 (S.C.J.); Matoni v. C.B.S. Interactive Multimedia Inc., 2008 CanLII 1539 (ON SC), [2008] O.J. No. 197 at paras. 71-77(S.C.J.); Boulanger v. Johnson & Johnson Corp., [2002] O.J. No. 1075 at para. 2 (S.C.J.), leave to appeal granted, [2002] O.J. No. 2135 (S.C.J.), varied (2003), 2003 CanLII 45096 (ON SCDC), 64 O.R. (3d) 208 (Div. Ct.), varied 2003 CanLII 52154 (ON CA), [2003] O.J. No. 2218 (C.A.).

[^81]: Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at para. 41.

[^82]: Carom v. Bre-X Minerals Ltd. (1999), 1999 CanLII 14794 (ON SCDC), 44 O.R. (3d) 173 (Div. Ct.), rev’d on other grounds (2000), 2000 CanLII 16886 (ON CA), 51 O.R. (3d) 236 (C.A.); Cloud v. Canada (Attorney General) (2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 at para. 95 (C.A.); Caputo v. Imperial Tobacco Ltd., 2004 CanLII 24753 (ON SC), [2004] O.J. No. 299 at para. 76 (S.C.J.); Griffin v. Dell Canada Inc., 2009 CanLII 3557 (ON SC), [2009] O.J. No. 418 at para. 100 (S.C.J.).

[^83]: Caputo v. Imperial Tobacco Ltd., 2004 CanLII 24753 (ON SC), [2004] O.J. No. 299 at paras. 62-67 (S.C.J.); Griffin v. Dell Canada Inc., 2009 CanLII 3557 (ON SC), [2009] O.J. No. 418 (S.C.J.).