“Abandon hope all ye who enter here” appears at the entrance to Hell in Dante’s Divine Comedy. It could also appear at the court house door to warn those who sue global drug enterprises. When I review the following chronology of interlocutory citations from common law Canada, I recall the lyrics to the song at the end of the first Rambo movie:
The Road is long, yeah
Each step is only the beginning
No breaks just heartaches
Oh man is anybody winning?
It’s a long road
And it’s hard as hell
Tell me what do you do to survive
When they draw first blood
That’s just the start of it
Day and night you gotta fight
To keep alive
It’s a long road
Graham v Hoffman-La Roche Ltd.
Kohler v Apotex Inc.
Kutlu v Laboratorios Leon Farma S.A.
Lloyd / Waheed v GlaxoSmithKline Inc.
Sweetland v Glaxosmithkline Inc.
Wall Estate v GlaxoSmithKline Inc.
Bouchanskaia v Bayer Inc.
Lamb v Bayer Inc.
Walls v Bayer Inc.
Coleman v Bayer Inc.
Pardy v Bayer Inc.
5. Bextra and Celebrex
Perrotta / Voutour / Waheed v Pfizer Canada Inc.
6. Champix (Chantix)
Parker v Pfizer Canada Inc.
MacMillan v. Merck Frosst Canada & Co.
Charlton v Abbott Laboratories, Ltd.
Turon v Abbott Laboratories Ltd.
Schick v Boehringer Ingelheim (Canada) Ltd.
Englund v Pfizer Canada Inc.
Sollen v Pfizer Canada Inc.
Goodridge v Pfizer Canada Inc.
Bellefontaine v Purdue Frederick Inc.
Miller v Purdue Pharma, Inc.
Bartram v Glaxosmithkline Inc.
Duzan v GlaxoSmithKline, Inc.
White / Field v GlaxoSmithKline Inc.
Harris v GlaxoSmithKline Inc.
Banerjee v Shire Biochem Inc.
15. Ponderal, Redux, Pondimin
Armstrong v Servier Canada Inc.
Knowles v Wyeth-Ayerst Canada Inc.
Matthews v Servier Canada Inc.
Wilson v Servier Canada Inc.
Batten v Boehringer Ingelheim (Canada) Ltd.
17. Premarin (+ progestin) / Premplus
Stanway v Wyeth Canada Inc.
Boulanger v Johnson & Johnson Corporation
19. Propecia / Proscar
Miller v Merck Frosst Canada Ltd.
Brown v Janssen Inc.
Buelow v Morrissey
Martin v AstraZeneca Pharmaceuticals PLC
Tesluk v Boots Pharmaceutical PLC
Norman v Thunder Bay Regional Health Sciences Centre
Baumung v Bayer Inc.
Tluchak Estate v Bayer Inc.
Low v Pfizer Canada Inc.
Nelson v Merck Frosst Canada Ltd.
Wuttunee v Merck Frosst Canada Ltd.
Bear v Merck Frosst Canada & Co.
Grasby v Merck Frosst Canada Ltd.
Setterington / Tiboni / Mignacca v Merck Frosst Canada Ltd.
27. Yasmin / YAZ
Dembrowski v. Bayer Inc.
Schwoob v. Bayer Inc.
Buelow v. Morrissey
Heward v Eli Lilly & Co.
This log of citations contains numerous leading authorities on the admissibility of affidavits at certification, “carriage motions”, the “national” class and other private international law issues, precertification discovery, sequencing of pre-certification motions, the “some basis in fact” standard, medical records production, and waiver of tort.
To date, where contested, Canadian courts have certified respecting 12 prescription pharmaceuticals. Against manufacturers, certification was denied three times, respecting Meridia, Seroquel, and Taxotere. (I have not accounted for Quebec in this analysis, and there was an appellate denial of certification in a Vioxx action in Saskatchewan).
The defence bar has sought to introduce an impermissible, merits-based approach to certification under each stage of the certification analysis: the cause of action is “incapable of proof”; there’s individuals in the class who have no claim; there’s “no basis in fact” for the claim itself or the proposed common issues; and the representative plaintiff’s personal claim must fail.
Faced with judicial statements that merits can’t be considered at certification and that affidavits relating thereto are of no value, the defence bar has moved for summary judgment before or with certification, and at certification has proposed a modified version of the “some basis in fact” test to focus on “the claim itself” rather than on the “certification criteria”. The former, developed in contravention of, or (most generously) as an extension of the Hollick 25 standard, can be seen as a judicially created “air of reality” test, but one that is very easy to satisfy by adducing some evidence of a causal connection between the drug and the harm. Where certification was contested, “some basis in fact” has been found in the following sources:
The usual US Rule 23-inspired defence bar arguments against certification (typicality and predominance in particular) have been rejected in Canada. They are not part of Canadian legislation, but American defence lawyers instruct their Canadian defence counterparts to try to wedge them into the components of the much more liberal Canadian certification test. Canadian courts have indicated that pharmaceutical cases may be certified notwithstanding the presence of individual issues respecting:
There are statements both for and against a categorical approach to certification in the prescription pharmaceutical cases. Generally, cases where the same “faulty product may be sold to numerous consumers” are particularly suitable for certification: Dutton, ¶26. Prescription drug class actions are specifically suitable for certification. Owing to Part C, Division 1 (Formerly, Schedule “F” Drugs” and subsequently under the Prescription Drug List SOR/2013-122, s. 18) of the Food and Drug Regulations, CRC, c. 870, prescription drugs imported into Canada are tightly controlled. They are:
Prescription drug manufacturers are subjected to strict obligations that governments have not imposed on manufacturers of many other products. They must report adverse reactions to Health Canada within 15 days of learning about them, and keep detailed records thereof: [C.01.016-C.01.017]. Manufacturers and importers of prescription drugs who recall their product must immediately report the quantity of the drug manufactured, imported, and distributed in Canada and the reasons for initiating the recall [C.01.051].
When certification is contested, Canadian Courts usually certify class actions involving the purchase, prescription, or ingestion of a prescription drug. In chronological order as of date of initial certification, they are:
Appellate bodies usually refuse appeals and leave to appeal entire certification orders. Chronologically as to last appeal denied:
Certified class definitions have included those who were prescribed and ingested the drug, and more recently in Stanway and Parker have referenced the type of harm alleged to have been caused by the drug. In Schwoob, the class extended to users before a particular date when the product monograph was amended to include additional warnings. Typically certified common issues relate to general causation, breach of duty, waiver of tort, punitive damages, miscellaneous forms of relief (subrogated health care costs, etc.), and in British Columbia, statutory consumer protection. Issues respecting vicarious liability were also certified in Wilson, Boulanger, and Tiboni. A unique feature of common issues respecting subrogated health care costs and punitive damages is that there is an initial common issues trial followed by individual issues resolution procedures, and then a second common issues trial.
What follows is a brief factual summary of prescription pharmaceutical cases where certification was contested in whole or in part.
Between March 2, 1998 and August 8, 2001, Baycol (cerivastatin sodium), a cholesterol reducing statin, was available in Canada in 0.2, 0.3, 0.4, and 0.8 mg doses. Baycol caused rhabdomyolysis, a form of myopathy, and which could result in a loss of kidney function or death. There were four different product monographs and two Dear Healthcare Professional letters. Plaintiffs sued Bayer Inc. in British Columbia, Saskatchewan, Manitoba, Ontario, and Newfoundland Labrador. Certification was decided on a contested basis in three provinces.
In Parker, on behalf of individuals who had ingested CHAMPIX® within a specified period of time and who had experienced any of a list of neuropsychiatric events or psychiatric symptoms while ingesting CHAMPIX®, Kenneth Parker sued Pfizer entities for general, aggravated, and punitive damages in negligence and waiver of tort. From April 2007, Pfizer sold CHAMPIX® (varenicline) in Canada in 0.5 and 1.0 mg doses to treat nicotine addiction. The first three product monographs between 2007 and 2010 failed to warn of serious side effects of neuropsychiatric adverse events, including suicidal and homicidal ideation.
In Charlton, on behalf of Canadians who were prescribed and ingested Meridia or Apo-Sibutramine and those entitled to make derivative claims under dependent’s relief legislation in respect of death or personal injury, Terry and Mayra Charlton, Angela Leone, Paula Smith-Turner, Carl Turner, and Mark Mandell sued Abbott Laboratories Ltd., Abbott Laboratories, and Apotex Inc. for damages, disgorgement, and punitive damages in negligence, waiver of tort, and for breach of the Business Practices and Consumer Protection Act, SBC 2008, c. 2 and the Competition Act, RSC 1985, c. C-34 (s. 52). From 2000, Abbott Laboratories Ltd. or its predecessor marketed Meridia (subutramine), a weight loss drug in Canada, and from March 16, 2010, Apotex Inc. marketed a generic version that caused or contributed to heart attacks, strokes, and arrhythmia.
In Schick, on behalf of persons resident in Canada (other than in Québec) who were prescribed and ingested Mirapex® (pramipexole dihydrochloride) in Canada which was manufactured, marketed, and/or sold or otherwise placed into the stream of commerce in Canada by Boeghringer Ingelheim (Canada) Ltd., Boehringer Ingelheim Pharmaceutics Inc., and/or Pfizer Inc., Gerry Schick sued Boehringer Ingelheim (Canada) Ltd. in negligence. Mirapex (pramipexole dihydrochloride) was available in Canada, from 1998 to treat Parkinson’s disease, and from 2006 to treat restless leg syndrome (“RLS”), in 5 doses ranging from 0.125 mg to 1.5 mg. It caused impulse control disorders (“ICD’s”) including binge eating, compulsive gambling, hypersexuality, and compulsive shopping,
In Goodridge, on behalf of residents in Canada (excluding Quebec) who, before August 5th, 2004, were prescribed and ingested Neurontin or who by virtue of a personal relationship to such persons with a valid claim, have standing under s. 61(1) of the Family Law Act, RSO 1990, c. F.3 and similar provisions in other provinces, Rhonda Goodridge, Brian Davidson, and Jennifer Lauricella sued Pfizer entities for manufacturing and selling Neurontin (gabapentin), which was available in Canada from 1994 in generic form from 2001 for the treatment of epilepsy and later for neuropathic pain. Pfizer falsely and wrongfully promoted Neurontin for “off-label” uses when it was not fit and was harmful for those uses. Neurontin caused suicidal ideation and behaviours.
In Bartram, on behalf of Canadians born with cardiovascular defects to women who ingested the selective serotonin reuptake inhibitor (“SSRI”) antidepressant Paxil (paroxetine) while pregnant and the mothers of those persons, Meah Bartram (by her mother and litigation guardian, Faith Gibson) and Faith Gibson sued GSK entities in negligence and under the Business Practices and Consumer Protection Act, SBC 2004, c 2. From 1993, Paxil was approved for use in Canada for the treatment of major depressive disorder, panic disorder, social phobia/social anxiety disorder, obsessivecompulsive disorder, generalized anxiety disorder, and post-traumatic stress disorder. Paxil CR, a controlled release formulation of paroxetine, was available from 2003. On September 29th, 2005, GSK sent a Dear Healthcare Professional Letter that referred to preliminary results of an epidemiological study showing an increased incidence of VSD in babies born to women who had taken Paxil during the first trimester. The product monograph was amended in September and November of 2004 and February 2006. Paxil increased the likelihood of cardiovascular birth defects, particularly atrial and ventricular septal defects (ASD and VSD), and was unfit for use during pregnancy. GSK failed to warn of the true risk of cardiovascular birth defects caused by using Paxil.
In Wilson, on behalf of persons resident in Canada (excluding Quebec) who were prescribed and ingested the diet drugs marketed under the brand name Ponderal (generic name: fenfluramine) and/or Redux (generic name: dexfenfluramine), their executors, administrators, personal representatives, and spouses and relatives who had a derivative claim, Sheila Wilson initially sued Servier Canada Inc. and Biofarma, S.A., and later other defendants, in “negligence, failure to warn and breach of warranty”. Ponderal caused life threatening diseases, including PPH, valvular heart disease, and valvular regurgitation. On September 15th, 1997, Ponderal was withdrawn from the Canadian market. The defendants negligently misrepresented the safety of Ponderal and Redux (dexfenfluramine) to Health Canada and failed to advise that they should immediately be withdrawn after receiving information as to their potential to cause “serious health effects”.
(viii) premarin (+ progestin) / premplus
In Stanway, on behalf of women who were prescribed and ingested Premplus, or Premarin in combination with progestin, in Canada from January 1st, 1977 to December 1st, 2003 and were thereafter diagnosed with breast cancer, Dianna Louise Stanway sued Wyeth entities for damages and punitive damages in negligence and for “deceptive acts and practices” under the Business Practices and Consumer Protection Act. From 1977, the defendants marketed a conjugated estrogen called Premarin, which was typically prescribed with progestin (sold in the same packet as Premplus), that was used to treat menopause symptoms and was alleged to have caused breast cancer. Premarin was sold in 0.3, 0.625, 0.9, 1.25, and 2.5 mg doses.
In Boulanger, on behalf of all persons in Canada other than in Quebec who ingested Prepulsid and their estates and certain family members, Aline Boulanger sued Johnson & Johnson entities for damages and purchase price reimbursement in negligence. From January 1st, 1990 to August 7th, 2002, Prepulsid (cisapride) was available in Canadian pharmacies in 1 to 20 mg doses to treat gastroesophageal reflux disease and other gastrointestinal motility disorders. The defendants negligently developed, tested, manufactured, licensed, distributed, and marketed Prepulsid in Canada and failed to adequately warn Canadian doctors and patients of risks of “cardiac arrhythmia, including ventricular tachycardia, cardiac arrest, prolonged QT, torsades de pointes, ventricular fibrillation, sudden death and other heart disease”.
(x) propecia / proscar
In Miller, on behalf of men who were prescribed Propecia or Proscar (finasteride) for male pattern hair loss in British Columbia before November 18th, 2011, Michael Miller sued Merck for damages and disgorgement of profits or revenues in negligence and under the Business Practices and Consumer Protection Act, SBC 2008, c. 2. Merck marketed Proscar in Canada from December 1st, 1992 and Propecia from July 9th, 1998. They were prescribed as a cosmetic treatment for androgenic alopecia (male pattern baldness), and Proscar was also prescribed for the treatment of prostate problems. A generic version was available from February 1st, 2010. Merck failed to warn of the risk that Propecia and Proscar could cause permanent sexual dysfunction which persists after discontinuance. Propecia and Proscar both contained finasteride as the active ingredient, but they had different dosages (Propecia in 1 mg tablets; Proscar in 5 mg tablets), purposes, approval processes, testing, and product monographs. The Propecia product monographs included warnings respecting decreased libido, erectile dysfunction, and ejaculation disorder, but until November 18th, 2011, did not warn of the possibility that sexual dysfunction could persist after discontinuation.
In Martin, on behalf of all persons in Canada who were prescribed and consumed Seroquel and their family members, Don and Joanne Martin, Corrine Middleton, and Bernard VanKerrebroeck sued AstraZeneca entities for aggregate, special, aggravated, and punitive damages and an accounting and disgorgement of profits in negligence, failure to warn, and conspiracy. From 1997, Seroquel (quetiapine), a second generation anti-psychotic (same class as Zyprexa below), was available in 8 doses from 20 mg to 400 mg, and had at least 15 types of “off-label” uses. There were 25 product monographs. The plaintiffs initially alleged that Seroquel caused 20 “Health Risks” including liver, kidney, and pancreas damage, ketoacidosis, pancreatitis, diabetes mellitus, weight gain, impaired glucose regulation, hyperglycemia, blindness, cataracts, increased thirst, hypoglycemia, neuroleptic malignant syndome, tardive dyskinesia, heart disease, coma, seizures, and death. They later reduced it to “weight gain, diabetes and/or related metabolic disturbances as well as secondary injuries flowing therefrom”, which paralleled the general causation common issue in Heward.
In Norman v Thunder Bay Regional Health Sciences Centre, on behalf of at least 10 persons who received the drug Taxotere at the Thunder Bay Regional Health Sciences Centre between January 1, 2009 and December 31, 2010 and suffered respiratory illness, including pneumonitis, and their family members, Teresa and Warren Norman and Sarah Adams sued Thunder Bay Regional Health Sciences Centre, Dr. Dimitrios Vergidis, Dr. Dorie-Anna Dueck, Dr. Dolores Sicheri, Dr. Doe, Pharmacist Doe, Nurse Doe, Sanofi-Aventis Pharma Inc., and Sanofi-Aventis Canada Inc. for damages and punitive damages in breach of contract, breach of fiduciary duty, and negligence, and under the Family Law Act. Taxotere, a chemotherapy used to treat cancer, including breast cancer, caused lung toxicity, including respiratory illness and pneumonitis.
In Tiboni, on behalf of all persons in Canada (including their estates but excluding residents of Quebec and Saskatchewan) who were prescribed and ingested Vioxx and their spouses, children, grandchildren, parents, grandparents, and siblings, Robert Tiboni, Benny Mignacca, and Elaine Mignacca sued Merck entities for a disgorgement and general and punitive damages in negligence and waiver of tort. On October 25th, 1999, Health Canada approved Vioxx (rofecoxib), a Cyclooxygenase-2 specific inhibitor non-steroidal anti-inflammatory, to treat the signs and symptoms of osteoarthritis, pain in adults, and menstrual pain. Merck failed to warn of the increased risk of cardiovascular events such as heart attacks and strokes associated with Vioxx.
(xiii) yasmin / YAZ
In Schwoob, on behalf of Ontario residents who were prescribed and used Yasmin or YAZ before November 30th, 2011 or who by virtue of a personal relationship to such users had a derivative claim for damages, Ann Schwoob (for herself and as litigation guardian for Cody Schwoob) and Christine Lovelace sued Bayer Inc. for damages and restitution in negligence (design, testing, failure to warn, marketing, distribution, sale), in waiver of tort, and under the Family Law Act, R.S.O. 1990, c. F. 3, ss. 61(1)-(2). Bayer manufactured and marketed Yasmin in Canada from December 10th, 2004, and YAZ from late 2008. Yasmin and YAZ were fourth generation combination oral contraceptives (“COC’s”) that contained an estrogen component (ethinyl estradiol) that was common to COC’s but also a progestin component (drospirenone) that was unique to Yasmin and YAZ. The plaintiffs asserted that Yasmin and YAZ caused or contributed to an increased risk of “pulmonary embolism, deep vein thrombosis, stroke, heart issues and/or gallbladder disease/removal” compared to other available oral contraceptives, that they were thereby defective or unfit for the purpose for which they were intended, and that Bayer knowingly, recklessly or negligently breached a duty to warn or materially misrepresented the risks of harm from using Yasmin and YAZ. On November 30th, 2011, Health Canada changed the product monographs of Yasmin and YAZ to include additional warnings of the possible risk of adverse effects.
In Buelow v Morrissey, on behalf of persons who were prescribed and administered Zyprexa or Seroquel, or both, after January 1st, 2006 when they were 55 years or older, were patients in a care facility, and had been diagnosed as having dementia or generalized loss of cognitive and intellectual functions as evidenced by memory impairment plus either deficits in attention or concentration, cognitive deficits of disturbances of aphasia, apraxia or agnosia, etc., while one of the defendant physicians was the attending physician for such persons or prescribed, recommended, or approved Zypreza or Seroquel, or both, for such persons as documented in the medical records, Jodi Buelow and Kim Bordignon, on their own behalf and as personal representatives of the estate of Carol Ann Pifko sued seven doctors, Alberta Health Services, and Capital Care Group Inc. for damages in negligence. The defendant doctors negligently prescribed Seroquel and Zyprexa, antipsychotic medications to elderly patients with dementia, despite clear warnings from Health Canada that the drugs are not approved for such use, and in circumstances where the drugs have no proven efficacy for treating elderly persons with dementia.
In Heward, on behalf of all persons resident in Canada (excluding British Columbia and Quebec) who were prescribed and ingested the Zyprexa (generic name: olanzapine), which was manufactured, marketed, and/or sold or otherwise placed into the stream of commerce in Canada by Eli Lilly & Company and/or Eli Lilly Canada Inc. and those who by virtue of a personal relationship to one or more of such persons have a Family Law Act (or equivalent in other provinces or territories) derivative claim for damages, Andrea Heward, Kelly Hutchins, and Daniel Wells and their spouses sued Eli Lilly entities for compensatory and punitive damages and recovery of revenue in negligence, unjust enrichment, waiver of tort, and pursuant to the Family Law Act, RSO 1990, c F.3, s 61. Zyprexa (olanzapine), a “second-generation” anti-psychotic prescription drug, was available from 1996 for schizophrenia, bipolar, and other mood disorders, and from 2003 and 2004, for bipolar disorders to control non-psychotic agitation, anxiety, aggression, and behavioural disturbance. Zyprexa was alleged to have caused a significantly increased risk of diabetes and hyperglycemia, pancreatitis, other blood sugar disorders, weight gain and, in elderly patients, strokes.