CITATION: Palmer v. Teva Canada Ltd., 2022 ONSC 4690  
COURT FILE NO.: CV-18-00601555-00CP  
DATE: 20220812  
ONTARIO  
SUPERIOR COURT OF JUSTICE  
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BETWEEN:  
Theodore P. Charney, Caleb Edwards,  
Anthony Leoni, Rebecca Loeb, and Matthew  
Burtini for the Plaintiffs  
GLORIA PALMER, JO-ANNE WILLS,  
DIANE PEREHUDOFF, BRADLEY  
HALAYKA, DIANNE TIEDJE,  
MURRAY HALBERT, CHARLENE  
BOURDON, KENNETH AITCHISON,  
and MAY VENTURA  
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Plaintiffs  
- and –  
TEVA CANADA LIMITED, SANDOZ  
CANADA INC., PRO DOC LIMITÉE,  
SANIS HEALTH INC., and SIVEM  
PHARMACEUTICALS ULC  
Laura K. Fric, Robert Carson, Lauren  
Harper and Jessica Habib for the Defendant  
Teva Canada Limited  
Peter J. Pliszka, Zohaib I. Maladwala, and  
Aery Raajan for the Defendants Sandoz  
Canada Inc., Pro Doc Limitée, Sanis Health  
Inc. and Sivem Pharmaceuticals ULC  
Defendants  
Proceeding under the Class Proceedings  
) HEARD: June 27-29, 2022  
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Act, 1992  
PERELL, J.  
Contents  
A. Preamble ................................................................................................................................. 3  
B. Introduction and Overview ..................................................................................................... 3  
C. Parallel American Class Proceedings ..................................................................................... 5  
D. Procedural and Evidentiary Background ................................................................................ 5  
E. Class Size................................................................................................................................ 9  
F. Facts ........................................................................................................................................ 9  
1. The Defendants .................................................................................................................... 9  
2. The Manufacture and Distribution of valsartan................................................................. 10  
3. The Centerpiece Epidemiological Issues........................................................................... 11  
4. Nitrosamines, NDMA, and NDEA .................................................................................... 12  
5. Is There Some Basis in Fact that NDMA and NDEA are a Cause of Cancer in Humans?13  
6. Is There Some Basis in Fact that Exposure to NDMA or NDEA Increases the Risk of  
Being Diagnosed with Cancer?................................................................................................. 14  
7. The Recall and the Advice of Health Canada.................................................................... 18  
8. The Plaintiffs’ Testing of the valsartan.............................................................................. 26  
9. Physical Harm.................................................................................................................... 26  
10. Psychological Harm ....................................................................................................... 27  
G. Certification: General Principles........................................................................................... 29  
H. The Cause of Action, the Common Issues, and the Preferable Procedure Criteria Ensemble  
30  
1. General Principles: Cause of Action Criterion .................................................................. 30  
2. General Principles: Common Issues Criterion................................................................... 31  
3. General Principles – Preferable Procedure ........................................................................ 32  
4. Products Liability............................................................................................................... 33  
(a) Products Liability and the Claim for Psychological Harm......................................... 34  
(b) Negligence/product liability ....................................................................................... 40  
5. Strict Liability.................................................................................................................... 42  
6. Toxic Battery ..................................................................................................................... 43  
7. Breach of Consumer Protection Laws ............................................................................... 45  
8. Breach of the Competition Act........................................................................................... 49  
9. Breach of the Civil Code of Québec .................................................................................. 51  
10. Unjust enrichment .......................................................................................................... 52  
11. Punitive Damages........................................................................................................... 53  
I. Identifiable Class Criterion (s. 5 (1)(b)) ............................................................................... 53  
1. General Principles – Identifiable Class Criterion .............................................................. 53  
2. Analysis – Identifiable Class Criterion.............................................................................. 54  
J. Common Issues Criterion (s. 5 (1)(c)) Redux....................................................................... 55  
1. General Causation.............................................................................................................. 55  
2. Aggregated Damages......................................................................................................... 56  
3. Punitive Damages .............................................................................................................. 57  
K. Preferable Procedure Criterion (s. 5 (1)(d)) Redux .............................................................. 58  
1. Analysis – Preferable Procedure........................................................................................ 58  
L. Representative Plaintiff Criterion (s. 5 (1)(e))...................................................................... 60  
1. General Principles – Representative Plaintiff Criterion..................................................... 60  
2. Analysis – Representative Plaintiff Criterion .................................................................... 60  
M.  
Conclusion ......................................................................................................................... 61  
Schedule “A” – Proposed Common Issues................................................................................... 63  
REASONS FOR DECISION  
A. Preamble  
[1]  
This certification motion raises a “what if” legal question about the greatest tort case of all  
time.1 As every law student, law professor, lawyer, and judge in the common law world knows,  
on a summer evening in 1928, at an ice-cream parlor in Glasgow, Scotland, May Donoghue was  
served an ice-cream float of two scoops of ice-cream covered in ginger beer. After she had eaten  
one scoop, more ginger beer was poured from an opaque glass bottle. To May Donoghue’s dismay,  
out poured the remains of a decomposed snail. The “what if” legal question is: “What if the 29-  
year-old May Donoghue went to her doctor to be examined, would the manufacturer of the ginger-  
beer be liable to pay the doctor’s bill if the diagnosis was “May, as far as I know, you’re quite fine  
after that distressing incident; here’s my bill”?  
B. Introduction and Overview  
[2]  
In this proposed class action pursuant to the Class Proceedings Act, 1992,2 the proposed  
nine Representative Plaintiffs,3 Kenneth Aitchison, Charlene Bourdon, Bradley Halayka, Murray  
Halbert, Gloria Palmer, Marie-Eve Pellicelli,4 Diane Perehudoff, Dianne Tiedje, and Jo-Anne  
Wills sue the Defendants: (a) Teva Canada Limited, and (b) Sandoz Canada Inc., Pro Doc Limitée,  
Sanis Health Inc., and Sivem Pharmaceuticals ULC (collectively “Sandoz”).  
[3]  
The Defendants are respectively manufacturers of “valsartan”, a prescription drug  
indicated to treat high blood pressure.  
[4] In the summer and autumn of 2018, in Canada, the U.S., Europe, Australia, Japan,  
Singapore, and Brazil manufacturers of valsartan recalled some lots of their pharmaceutical  
product. The valsartan was recalled because to varying degrees, the lots of valsartan were  
1 Donoghue v. Stevenson, [1932] A.C. 562 (H.L.); A.C. Hutchinson, Is Eating People Wrong? Great Legal Cases  
and How They Shaped the World, (Cambridge University Press, New York, New York: 2011)  
2 S.O. 1992, c. 6.  
3 At the commencement of the certification hearing, May Ventura withdrew as a proposed Representative Plaintiff.  
She should be removed as a party plaintiff. Order accordingly.  
4 At the commencement of the certification hearing, Marie-Eve Pellicelli from Québec was added as party plaintiff  
without opposition from the Defendants. Order accordingly.  
   
contaminated with N-nitrosodimethylamine (“NDMA”) and N-nitrosodiethylamine (“NDEA”).  
The source of the contamination was Zhejiang Huahai Pharmaceuticals (“ZHP”) a Chinese  
manufacturer and a subcontractor supplier of valsartan.  
[5]  
The Plaintiffs and Class Members are persons who were prescribed valsartan by their  
physicians. The Plaintiffs sue the Defendant pharmaceutical companies, Teva and Sandoz, for  
manufacturing and distributing the contaminated medicine. The causes of action are: (a)  
negligence/product liability; (b) strict liability; (c) toxic battery; (d) breach of consumer protection  
laws;5 (e) breach of the Civil Code of Québec;6 (f) breach of the Competition Act;7 and (g) unjust  
enrichment. A claim for breach of the Trademarks Act8 was abandoned during the hearing of the  
certification motion.  
[6]  
By way of remedies, the Plaintiffs and the Class Members seek: (a) the costs of medical  
services related to the recall (“medical bills”); (b) the costs of medical consulting and screening  
services (“medical monitoring”); (c) refunds for the amounts paid for the drug from 2012 to 2018;  
(d) the costs of the unused pills thrown away after the recall; (e) psychological harm damages; and  
(f) punitive damages.  
[7]  
Conspicuously, the Plaintiffs and the Class Members make no claim for compensation for  
consumers who, after ingesting valsartan, were diagnosed with cancer at present or in the future.  
Bluntly, the Plaintiffs assert that this case is about compensation for increasing the risk of a cancer  
diagnosis and is not about compensation for suffering cancer now or in the future as a result of  
ingesting valsartan. In their factum the Plaintiffs repeatedly dwell on this feature of their proposed  
class. For example, they state:  
9. Notably, the proposed class action is not intended to address specific causation for class members  
who have or will be diagnosed with cancer. [Plaintiffs’ Factum, paragraph 9]  
69. Although this case has some passing similarities to “side effect” cases […], in the sense that  
NDMA exposure is known to be associated with cancer, it is also distinguishable because  
fundamentally this is a contamination case. There is no reason for NDMA or NDEA to be present  
in valsartan. [Plaintiffs’ Factum, paragraph 69]  
141. […] Notably, this case is not about whether NDMA or NDEA caused the illness of a specific  
person (such as cancer). This case is about toxins causing molecular changes and mutations which  
had the effect of increasing the risk of cancer. The Plaintiffs do not intend for the Class Members to  
proceed to individual issue trials to prove specific causation of harm with the exception of the claim  
for psychological harm which does not require class members to establish causation of cancer.  
[Plaintiffs’ Factum, paragraph 141]  
[8]  
In this motion, the Plaintiffs seek to certify their action as a class action. The Defendants  
resist certification based on the arguments that none of the certification criteria are satisfied. The  
Defendants make many arguments, but the predominant arguments focus on the submission that  
the Plaintiffs have not satisfied the cause of action criterion because of doctrinal failures of  
pleading any legally viable causes of action and because of the absence of legally compensable  
5 BC: Business Practices and Protection Act, SBC 2004, c. 2; AB: Fair Trading Act, RSA 2000, c. F-27; SK:  
Consumer Protection and Business Practices Act, SS 2014, c. C-30.2; MB: Business Practices Act, CCSM c. B120;  
ON: Consumer Protection Act, 2002, SO 2022, c. 30; QB: Consumer Protection Act, RSQ c P-40.1; PEI: Business  
Practices Act, RSPEI 1988, c. B-7; NL: Consumer Protection and Business Practices Act, SNL 2009, c. 31.2.  
6 CQLR c. C-1991.  
7 RSC 1985, C C-34.  
8 RSC 1985, c T-13.  
harm. In addition to their other challenges to certification, the Defendants assert that in the  
immediate case, there are no legally viable causes of action for the fear of an increased risk of  
cancer and that the putative class members have no compensable losses for the fear of an increased  
risk of cancer.  
[9]  
For the reasons that follow, I dismiss the Plaintiffs’ certification motion.  
[10] The baffling and ultimately fatal feature of the Plaintiffs’ proposed class action is that  
putting aside the claims for compensation for psychological harm, which are not certifiable for a  
variety of reasons, without making a claim for and without establishing some basis in fact that  
NDMA or NDEA causes cancer, the Plaintiffs’ action is for pure economic losses for an alleged  
increased risk of being diagnosed with cancer after ingesting NDMA or NDEA. Such a case is not  
certifiable. Upon analysis, the proposed class action is an uncertifiable class action for pure  
economic losses from a shoddy in quality but not a proven to be imminently dangerous product.  
[11] The baffling and fatal feature of the Plaintiffs’ proposed class action is that unlike a  
products liability class action that is about compensation for concrete injuries caused by the  
defective product, the Plaintiffs’ proposed class action is about compensation for an apprehension  
of an abstraction (increased risk of diagnosis of cancer) when the normative risk of a Class Member  
being diagnosed with cancer in his or her lifetime is 50:50, regardless of whether the Class Member  
ingested valsartan. What the Defendant pharmaceutical companies allowed to happen in China at  
their supplier’s manufacturing plant and the Defendants’ failures to ensure the quality of their  
product was shameful, but the law provides remedies for concrete injuries not abstract or  
speculative ones.  
C. Parallel American Class Proceedings  
[12] In the United States there are two putative class actions about contaminated valsartan. On  
February 14, 2019, approximately seventy-five valsartan related actions from twenty jurisdictions  
were consolidated and transferred to the District of New Jersey and assigned to Judge Kugler. The  
action in the United States has survived a motion to have it dismissed.9  
D. Procedural and Evidentiary Background  
[13] On July 9, 2018, Sandoz and Teva and several other pharmaceutical companies voluntarily  
recalled valsartan from retailer distributors of the drug. Consumers were told to continue taking  
their valsartan unless advised to stop by their health care provider.  
[14] On July 13, 2018, Ms. Palmer commenced the proposed class action by Notice of Action.  
[15] Proposed co-Class Counsel are Charney Lawyers PC, an Ontario law firm, and Rice Harbut  
Elliott LLP, a British Columbia law firm.  
[16] On August 10, 2018, Ms. Palmer delivered her Statement of Claim.  
[17] On August 17, 2018, Teva voluntarily expanded its recall to include eight additional lots  
of valsartan.  
9 In Re: valsartan, Losartan and Irbesartan Products Liability Litigation, 2021 U.S. Dist. LEXIS 5908 (D.N.J. Jan.  
12, 2021).  
   
[18] On January 15, 2019, the Plaintiffs delivered an Amended Statement of Claim.  
[19] On June 21, 2019, the Plaintiffs delivered a Second Amended Statement of Claim.  
[20] On February 19, 2021, the Plaintiffs delivered their Notice of Motion and Motion Record  
for certification (1,227 pages).  
[21] On February 22, 2021, the Plaintiffs delivered another Notice of Motion and Motion  
Record for Certification (1,104 pages).  
[22] In support of their motion for certification, the Plaintiffs relied on the following evidentiary  
record:  
a.  
Affidavit dated January 28, 2021 of Ken Aitchison of Clarence-Rockland, Ontario.  
Mr. Aitchison is a Plaintiff. He was prescribed Sandoz valsartan for blood pressure.  
b. Affidavit dated October 27, 2020 of Dr. Neelanjan Bose of Foster City, California,  
U.S.A. Dr. Bose is an analytical chemistry and chemical biology specialist with  
experience in method development and validation of small molecules, which includes  
chemical analysis of pharmaceuticals. He reviewed the test results from the testing of the  
valsartan that was delivered to Rice Harbut Elliott LLP and Charney Lawyers PC on July  
29, 2019 and then delivered to Dr. Bose for analysis.  
c.  
Affidavit dated February 17, 2021 of Charlene Rogers Bourdon of Cornwall,  
Prince Edward Island. Ms. Bourdon is a Plaintiff. She was prescribed Sandoz valsartan  
for blood pressure.  
d.  
Affidavit dated February 17, 2021 of Devra Charney. Ms. Charney is an associate  
lawyer at Charney Lawyers, co-Class Counsel. She was not cross-examined.  
e. Affidavit dated October 28, 2020 of Dr. Andreas Groehn of Alexandra, Virginia.,  
U.S.A. Dr. Groehn is a PhD economist with experience conducting surveys to assess  
damages in commercial litigation. He provides services through East Bay Dispute  
Advisory, a subsidiary of Berkeley Research Group LLC. He was not cross-examined.  
f.  
Affidavit dated February 17, 2021 of Bradley Halayka of Birch Hills,  
Saskatchewan. Mr. Halayka is a Plaintiff. He was prescribed Sandoz valsartan for high  
blood pressure. He was not cross-examined.  
g.  
Affidavit dated January 27, 2021 of Murray Halbert of Winnipeg, Manitoba. Mr.  
Halbert is a Plaintiff. He was prescribed Sanis valsartan for high blood pressure.  
h. Affidavits dated November 10, 2020 and February 22, 2022 of Dr. Sam Kacew of  
Ottawa, Ontario. Dr. Kacew is a Professor of Pharmacology at the University of Ottawa  
and Associate Director of Toxicology at the McLaughlin Centre for Population Health  
Risk Assessment at the University of Ottawa.  
i.  
Affidavits dated October 30, 2020, March 4, 2022 and April 5, 2022 of Dr. Sid  
Katz of Vancouver, B.C. Dr. Katz is a pharmacology expert with experience in  
toxicology.  
j.  
Affidavit dated October 5, 2020 of Ying Lee. Mr. Lee is a paralegal of the law firm  
Rice Harbut Elliott LLP of Vancouver B.C., co-Class Counsel. He was not cross-  
examined.  
k.  
Affidavits dated February 19, 2019 and May 6, 2019 of Cisy Mahendralingham.  
Ms. Mahendralingham is a law clerk at Charney Lawyers, co-Class Counsel. She was not  
cross-examined.  
l.  
Affidavit dated October 27, 2020 of Dr. Roy O’Shaughnessy of Vancouver, B.C.  
Dr. O’Shaughnessy is a medical practitioner with a specialty in psychiatry. He is a clinical  
professor in the Department of Psychiatry at University of British Columbia. He practises  
forensic psychiatry, which is a law and psychiatry discipline.  
m. Affidavit dated February 4, 2021 of Gloria Palmer of Ameliasburgh, Ontario. Ms.  
Palmer is a Plaintiff. She was prescribed Sandoz valsartan for high blood pressure.  
n.  
Affidavit dated May 24, 2022 of Marie-Eve Pellicelli of Québec City, Québec. Ms.  
Pellicelli is a Plaintiff. She was prescribed Pro Doc Limitée valsartan for high blood  
pressure. She was not cross-examined.  
o.  
Affidavit dated January 26, 2021 of Diane Perehudoff of Nelson, British  
Columbia. Ms. Perehudoff is a Plaintiff. She was prescribed Sanis valsartan for high  
blood pressure.  
p.  
Affidavit dated January 27, 2021 of Dianne Tiedje of Edmonton, Alberta. Ms.  
Tiedje is a Plaintiff. She was prescribed Sandoz valsartan for high blood pressure.  
q. Affidavit dated October 20, 2020 of May Ventura of Vancouver, British Columbia  
Ms. Ventura was a Plaintiff but withdrew. She was prescribed Sandoz valsartan.  
r. Affidavit dated February 5, 2021 of Jo-Anne Wills. of Aurora, Ontario. Ms. Wills  
is a Plaintiff. She was prescribed Sandoz valsartan for high blood pressure.  
[23] In response to the Plaintiffs’ certification motion, the Defendant Teva Canada Limited  
relied on the following evidentiary record:  
a.  
Affidavit dated January 11, 2022 of Reni Caccamo of Toronto, Ontario. Mr.  
Caccamo is the Senior Director, Market Planning, Sales Operations for Teva Canada  
Limited.  
b.  
Affidavit dated December 23, 2021 of Dr. George Johnson of Swansea Wales in  
the United Kingdom. Dr. Johnson is an Associate Professor at the Swansea University  
with a primary appointment in the Department of Genetic Toxicology. Part of his teaching  
curriculum is genetic toxicology including mutagenic impurities, cancer biology and  
DNA repair. He is a member of the Steering Committee of the Health and Environmental  
Sciences Institute, Genetic Toxicology Technical Committee. He is a member of the U.K.  
Government’s Committee on Mutagenicity of Chemicals in Food, Consumer Products  
and the Environment. Dr. Johnson was not cross-examined.  
[24] In response to the Plaintiffs’ Certification the Defendants Sandoz Canada Inc., Pro Doc  
Limitée, Sanis Health Inc. and Sivem Pharmaceuticals ULC relied on the following evidentiary  
record:  
a.  
Affidavit dated March 10, 2022 of Martin Fournier of LaPrairie, Québec. Mr.  
Fournier is the Vice President, Finance and Chief Financial Officer of Sandoz Canada  
Inc.  
b.  
Affidavit dated March 14, 2022 of Ramzi Koleilat of Laval, Québec. Mr. Koleilat  
is the Sr. Director Strategic Procurement, of Sivem Pharmaceuticals ULC.  
c. Affidavit dated March 14, 2022 of Robert Labrosse of Pierrefonds, Québec. Mr.  
Labrosse is the President of Pro Doc Limitée.  
d. Affidavits dated December 23, 2021 and April 6, 2022 of Dr. Raj Padwal of  
Edmonton, Alberta. Dr. Padwal is a Professor of Medicine in the Department of Medicine,  
Division of General Internal Medicine, at the University of Alberta. Dr. Padwal was not  
cross-examined.  
e.  
Affidavit dated December 23, 2021 of the Dr. Dennis J. Paustenbach of Jackson,  
Wyoming, U.S.A., Dr. Paustenbach is the President and Senior Consultant at Paustenbach  
and Associates, a scientific consulting firm. He has a B.S in chemical engineering from  
the Rose-Hulman Institute of Technology (Terre Haute, Indiana), an M.S. in industrial  
hygiene and toxicology from the University of Michigan (Ann Arbour) and a PhD in  
toxicology from Purdue University. Dr. Paustenbach was not cross-examined.  
f.  
Affidavit dated March 10, 2022 of Christopher Potter of Toronto, Ontario. Mr.  
Potter is the Senior Vice President, Healthcare Business, of Shoppers Drug Mart Inc. and  
has been involved in the operations of SDMI and Sanis Health Inc. as they relate to  
valsartan products.  
[25] On January 12, 2022, Teva delivered its Responding Motion Record (86 pages).  
[26] On March 11, 2022, the Plaintiffs delivered a Reply Motion Record (42 pages).  
[27] On March 14, 2022, the Defendants Sandoz Canada Inc., Pro Doc Limitée, Sanis Health  
Inc. and Sivem Pharmaceuticals ULC delivered their Responding Motion Record (350 pages).  
[28] On April 6, 2022, the Defendants Sandoz Canada Inc., Pro Doc Limitée, Sanis Health Inc.  
and Sivem Pharmaceuticals ULC delivered a Supplementary Motion Record (15 pages).  
[29] On April 8, 2022, Mr. Aitchison, Ms. Bourdon, Mr. Halbert, and Ms. Ventura were cross-  
examined.  
[30] On April 12, 2022, Ms. Palmer, Ms. Perehudoff, Ms. Tiedje, and Ms. Will were cross-  
examined.  
[31] On April 13, 2022, Mr. Caccamo, Mr. Fournier, Mr. Koleilat, Mr. Labrosse, and Mr. Potter  
were cross-examined.  
[32] On April 14, 2022, Dr. Bose, Dr. Kacew, and Dr. Katz were cross-examined.  
[33] On April 20, 2022, Dr. O’Shaughnessy was cross-examined.  
[34] On May 6, 2022, the Plaintiffs delivered their Factum (85 pages).  
[35] On May 24, 2022, the Plaintiffs delivered the Third Amended Statement of Claim.  
[36] On June 10, 2022, Sandoz (85 pages) and Teva (35 pages) respectively delivered their  
Responding Factums. Sandoz’s authorities casebook was 3,277 pages; Teva’s authorities casebook  
was 782 pages.  
[37] On June 17, 2022, the Plaintiffs delivered a Supplementary Motion Record (204 pages).  
(The transcript brief for the certification motion was 855 pages.)  
[38] On June 20, 2022, the Plaintiffs delivered their Reply Factum (78 pages). (The authorities  
brief was a hypertexted index of 168 cases.)  
[39] On June 24, 2022, Teva delivered a Sur-Reply Factum (8 pages).  
[40] The Plaintiffs propose the following revised class definition:  
All persons in Canada who purchased or ingested one or more of the valsartan products  
manufactured and/or distributed by the defendants identified by the DINs listed on the Health  
Canada Recall List dated November 28, 2018 (the “Class Members”) between January 1, 2012 and  
December 1, 2018 (the “Class Period”);  
[41] The Plaintiffs’ originally proposed class definition was:  
Class Definition  
[A]ll persons in Canada who purchased or ingested one or more of the valsartan products identified  
by Health Canada in the Recall List dated July 9, 2018 or in any future such recall lists.  
[42] The Plaintiffs propose the common issues set out in Schedule “A” to these Reasons for  
Decision.  
E. Class Size  
[43] To date, 3,375 putative Class Members have registered with Plaintiffs’ counsel.  
[44] A study on the recall as it affected Albertans found that, at the time of the recall, 34,726  
Albertans were taking valsartan. The Alberta study found that the mean age of individuals taking  
valsartan was 67, with three quarters of them having prescriptions filled for a period of 90 days or  
longer.  
[45] Based on extrapolations from the Alberta study, Class Counsel estimates that at the time  
of the recall more than 315,000 Canadians were taking valsartan on at least a daily basis.  
F.  
Facts  
1.  
The Defendants  
[46] Pro Doc Limitée (“Pro Doc”) is a pharmaceutical company with its head office in Laval,  
Québec. It manufactured and distributed Pro Doc-valsartan. (Pro Doc, Sandoz, Sanis, and Sivem  
are collectively “Sandoz”).  
[47] Sandoz Canada Inc. (“Sandoz”) is a pharmaceutical company with its head office in  
Boucherville, Ontario. It manufactured and distributed Sandoz-valsartan. (Sandoz, Pro Doc, Sanis,  
and Sivem are collectively “Sandoz”).  
[48] Sanis Health Inc. (“Sanis”) is a pharmaceutical company with its head office in Brampton,  
Ontario. It manufactured and distributed Sanis-valsartan. (Sanis, Sandoz, Pro Doc, and Sivem are  
collectively “Sandoz”).  
[49] Sivem Pharmaceuticals ULC (“Sivem”) is a pharmaceutical company with its head office  
in St.-Laurent, Québec. It manufactured and distributed Sivem-valsartan. (Sivem, Sandoz, Pro  
Doc, and Sanis, are collectively “Sandoz”).  
[50] Teva Canada Limited (“Teva”) is a pharmaceutical company with its head office in  
     
Toronto, Ontario. In 2016, Teva acquired Actavis Pharma Company, which is the entity that  
Health Canada identifies as the market authorization holder for the Actavis products. Teva  
manufactured and distributed Teva-valsartan and Act-valsartan.  
[51] Each of the Defendants retained Zhejiang Huahai Pharmaceuticals (“ZHP”), a Chinese  
pharmaceutical company to manufacture, export, and supply the active ingredients for valsartan.  
[52] The Defendants held themselves out as manufacturers of high-quality generic medications,  
Teva represented that “[our] dedication to quality in everything we do is uncompromising.”  
Sandoz represented that “[w]e offer a broad line of high-quality generic, biosimilar consumer and  
specialty products.”  
[53] Teva’s declarations on its webpage are perhaps the most self-laudatory, but the webpage is  
indicative of the quality control assurances of all the Defendant generic drug manufacturers.  
Teva’s web page stated:  
Our state-of-the-art manufacturing facilities feature the most advanced testing equipment to  
guarantee the quality of our products. Equipment is tested and certified, and every manufacturing  
process is validated. All supplier procedures are strictly supervised to ensure that only the highest  
grade materials are used in our products. Teva’s impeccable adherence to Good Laboratory Practice  
(GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) is recognized by  
FDA approval of 26 of our plants, and EMA approval of 31 of our plants. Moreover, each of our  
pharmaceutical manufacturing facilities is inspected and approved by at least two regulatory  
authorities worldwide.  
[54] The Plaintiffs plead that the Defendant pharmaceutical companies represented that the  
valsartan Drugs were: (a) of high quality; (b) free of defects, including being free of any dangerous  
contaminants; and (c) fit for human consumption. The Plaintiffs plead that these representations  
were false, misleading, deceptive and an unfair practice under the consumer protection because:  
(a) the valsartan was not safe or free from defects; (b) it was not of a high quality; and (c) it  
contained a contaminant that can cause, materially contribute, and/or materially increase the risks  
of contracting cancer, liver disease, and other health conditions.  
[55] The Plaintiffs plead for the Class Members and the individual Plaintiffs deposed that but  
for the Defendants’ representations, they and the putative Class Members would not have  
purchased or ingested the Defendants’ valsartan.  
2.  
The Manufacture and Distribution of valsartan  
[56] Novartis, a pharmaceutical company, developed a drug containing the active  
pharmaceutical ingredient known as valsartan.  
[57] Valsartan is an antihypertensive drug belonging to the angiotensin receptor blocker class  
for the treatment of high blood pressure and the prevention of heart attacks. Typical dosage of  
valsartan ranges from 40 mg to 320 mg per day.  
[58] Valsartan was first approved for distribution in Canada in 1997, and it was marketed under  
the brand name Diovan®. Since about 2011, valsartan has been “off patent”, and generic  
pharmaceutical companies began to manufacture and market drugs containing valsartan.  
[59] The Defendants are manufacturers of bioequivalent generic drugs. Pursuant to the Food  
and Drug Regulation, they were under a duty to disclose a “list of the ingredients of the new drug,  
stated quantitatively, and the specifications for each of those ingredients”. They were required to  
 
provide a product that was “unadulterated” and “bioequivalent with the Canadian reference  
product.” If a generic drug contains non-medicinal ingredients that differ from the reference  
product, the manufacturer must demonstrate to Health Canada that the non-medicinal ingredients  
have not changed the quality, safety, or effectiveness of the generic drug. In the immediate case,  
the Defendants filed product monographs that included a list of all the active and non-active  
ingredients in their products.  
[60] Manufacturers of generic medication are required by statute in the United States and in  
Canada to ensure that their products are: (a) absent of significant differences (bioequivalent) to  
their name-brand counterpart;10 and (b) manufactured in accordance with Good Manufacturing  
Practices (“GMP”); and (c) free of contamination.11 GMPs are internationally accepted standards  
to ensure that drugs are manufactured, tested, stored, and distributed in a way that meets safety  
and quality standards.  
[61] Sandoz and Teva were supplied with the active pharmaceutical ingredient (“API”) of  
valsartan by Zhejiang Huahai Pharmaceuticals (“ZHP”) a Chinese drug manufacturer and supplier.  
[62] Commencing in 2012, ZHP changed its manufacturing process. ZHP had a history of  
deviations from GMP standards.  
[63] As described in more detail below, the valsartan supplied by ZHP and sold by Sandoz and  
Teva contained the nitrosamines NDMA and NDEA.  
[64] The Plaintiffs plead that if the Defendants had complied with the GMP regulations  
designed to ensure quality, safety, and effectiveness, they likely would have discovered the  
impurities and contaminants in the valsartan as of 2012, when the contaminants were likely first  
introduced into the valsartan because it was at that time that ZHP changed its manufacturing  
processes to reduce the costs of production.  
3.  
The Centerpiece Epidemiological Issues  
[65] 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.  
[66] The furiously contentious evidentiary centerpieces of this certification motion are twofold:  
(a) whether NDMA and NDEA are a cause of cancer in humans; and (b) whether the exposure to  
NDMA or NDEA in the contaminated valsartan increases the risk of being diagnosed with cancer.  
[67] The Plaintiffs’ position is that there was some basis in fact for both centerpiece  
propositions. The Defendants’ position is that there was no basis in fact for either proposition, and  
therefore the Plaintiffs’ action is not certifiable.  
[68] It is highly important to keep in mind that whether NDMA and NDEA cause cancer in  
humans and whether exposure to NDMA and NDEA in the contaminated valsartan increases the  
risk of being diagnosed with cancer are related but different concepts. It is highly important to  
10 Food and Drugs Regulations, C.R.C., c. 870, s.08.002.1(1)(a) and (b).  
11 Food and Drugs Act, R.S.C., 1985, c. F-27, ss. 8, 9.  
 
keep in mind that both concepts are studied and evaluated using statistical techniques and by the  
scientific analyses of experiments and studies of animals and humans.  
[69] It is highly important to keep in mind that if the statistics from the studies and experiments  
indicate that exposure to NDMA and NDEA increases the experience of cancer, that is a necessary  
but not a sufficient basis for concluding that NDMA and NDEA are carcinogens in humans.  
Statistics indicating an increase in the experience of cancer reveal only that there may be a  
relationship between NDMA and NDEA and cancer. Whether that relationship is incidental,  
coincidental, catalytical, associative, or causative remains to be determined. It is an axiom of  
epidemiology that statistical association does not equate to proof of a causative relationship. Thus,  
both the Plaintiffs and the Defendants and their respective experts agreed that from an  
epidemiological perspective, a statistical association between NDMA and NDEA is not proof of  
causation.  
[70] To foreshadow my conclusion on these two centerpiece evidentiary controversies, my  
review of the evidence described below is that at this moment in scientific time, while there is  
some basis in fact for concluding that exposure to NDMA and NDEA increases the risk of being  
diagnosed with cancer, there is no basis in fact for concluding that NDMA and NDEA cause  
cancer.  
[71] The current state of scientific knowledge is that the measure of the increased risk to humans  
from exposure to NDMA and NDEA is very small having regard to the already existing very high  
risk of human beings experiencing cancer of a lifetime. The current state of scientific knowledge  
is that the relationship between NDMA and NDEA and cancer remains to be determined but the  
relationship is worthy of being studied further, and in the meantime, prudence dictates that  
exposure to NDMA and NDEA be minimized.  
4.  
Nitrosamines, NDMA, and NDEA  
[72] Turning then to the evidence about the nature of N-nitrosodimethylamine (“NDMA”) and  
N-nitrosodiethylamine (“NDEA”), they are chemical compounds known as nitrosamines.  
[73] Nitrosamine exposure can occur through ingestion, inhalation, and absorption through  
skin. Nitrosamines are also formed endogenously within the human body’s digestive system,  
following ingestion of foods that contain nitrites or nitrates.  
[74] NDMA and NDEA are found in packaged/preserved meats and cheeses, preserved or  
canned fish, preserved vegetables, and malt-containing alcohols such as beer and whiskey. NDMA  
and NDEA are also found in drinking water and in the air.  
[75] At any given time, an average person may have varying quantities of NDMA in her or his  
system based on lifestyle choices, diet, geographical location, occupation, and endogenous  
production. NDMA or NDEA do not remain in the body, and they are eliminated in the feces or  
urine within 24-48 hours.  
[76] Nitrosamines have been shown to produce liver damage, hemorrhagic lung lesions,  
convulsions, and comas in rats. Acute, which is to say extraordinarily high exposure to NDMA  
may cause liver damage in humans.  
[77] Dr. Katz explained the process through which NDMA and NDEA could cause harm to  
humans:  
 
Nitrosamines such as NDMA and NDEA produce various adverse biological effects, including  
induction of tumours, following metabolic conversion (breakdown) by liver enzymes into reactive  
intermediates. This process releases an active carbonium ion which then seeks out cellular  
components such as DNA, RNA and Proteins. The fact that DNA and RNA form part of the gene  
classifies these chemicals as genotoxins which can produce carcinogenesis. The breakdown and  
conversion of these compounds in the body produces even more harmful chemicals than those  
ingested; this process is considered as a critical step in the cancer-causing activity of the  
nitrosamines.  
[78] Dr. Katz’s evidence satisfies a necessary first step in the process of determining whether  
NDMA and NDEA can cause cancer in humans. By itself, however, his evidence is not some basis  
in fact for the proposition that NDMA and NDEA are carcinogens in humans. This part of his  
evidence only goes so far as showing that there is a scientific basis or theory for how or why they  
might be carcinogens. That theoretical underpinning, however, is insufficient by itself to draw the  
conclusion that there is some basis in fact that NDMA and NDEA are cancer carcinogens in  
humans.  
5.  
Is There Some Basis in Fact that NDMA and NDEA are a Cause of Cancer in  
Humans?  
[79] The FDA called NDMA and NDEA a “genotoxic impurity”. Based on extrapolation from  
results of animal studies, Health Canada, the International Agency for Research on Cancer, the US  
Agency for Toxic Substances and Disease Registration, and the US National Toxicology Program  
classify NDMA and NDEA as “chemicals belonging to the probable category of carcinogens  
where there is sufficient evidence of a carcinogenic effect, regardless of the dose.”  
[80] It may be noted that none of these classifications are definitive. Although the  
carcinogenicity of NDMA and NDEA in humans has been scientifically examined for decades, no  
scientific or regulatory body has definitively classified NDMA or NDEA as a carcinogen for  
human beings. Conversely, no scientific or regulatory body has definitively classified NDMA or  
NDEA as a non-carcinogen for human beings. Based on extrapolation from results of animal  
studies, the International Agency for Research on Cancer (“IARC”) and Health Canada prudently  
and cautiously classify NDMA and NDEA as “probable carcinogens”.  
[81] Dr. Johnson, who is a toxicologist, testified for the certification hearing for the Defendants.  
Dr. Johnson’s opinion was that the available scientific evidence and literature do not support a  
causal association between exposure to the amount of NDMA or NDEA found in the Defendants’  
valsartan and cancer risk in humans. I shall discuss Dr. Johnson’s opinion further below.  
[82] Dr. Padwal, who is an epidemiologist, testified for the certification hearing for the  
Defendants. He was not cross-examined. It was Dr. Padwal’s opinion that there is no strong  
scientific evidence to support the proposition that exposure to NDMA or NDEA can cause cancer,  
or materially increase the risk of contracting cancer, in humans. He deposed that there is no direct  
scientific evidence establishing that valsartan that is potentially contaminated with NDMA or  
NDEA is a cause of cancer in humans. It was his opinion that the best scientific evidence available  
is that there is no statistically significant association between potentially contaminated valsartan  
products and overall cancer risk. He deposed that the best available evidence is a cohort study in  
Denmark (5,150 valsartan users over a 4.6 year median follow up) and a cohort study in Germany  
(780,871 valsartan users over a 3.1 year mean follow-up period) and these studies do not prove  
general causation.  
 
[83] It is the Plaintiffs’ internally inconsistent and contradictory position that: (a) there is some  
basis in fact that NDMA and NDEA cause cancer, although (b) it is presently undetermined  
whether NDMA or NDEA can cause cancer in humans, but with longer follow up periods for the  
studies, there will be sufficient evidence to conduct a meta-analysis to determine whether there is  
an association between NDMA or NDEA and cancer in humans.  
[84] Thus, Dr. Katz in his reply report, noted that: “the issue of carcinogenicity of NDMA  
exposure via valsartan and other medications is being investigated on an ongoing basis” and he  
“would expect that […] a meta-analysis of studies with greater than a seven-year latency period  
should yield more definitive results.”  
[85] Thus, while Dr. Katz conceded that a causative relationship remains unproven, he  
nevertheless testified that NDMA is considered to be a human carcinogen and has been implicated  
in the induction of stomach, liver, and pancreatic cancers. He said there is considerable evidence  
that NDMA is the etiological agent for bladder cancer associated with schistosomiasis, a parasitic  
infection.  
[86] Pausing here, it is necessary to emphasize that the Plaintiffs simultaneously submit that  
there is some basis in fact for NDMA or NDEA being carcinogens while conceding that there is  
at present no basis in fact that NDMA or NDEA can cause cancer. It is precisely because of this  
indeterminacy and illogic that the Plaintiffs construct their proposed class action based just on the  
evidence that there is some basis in fact that exposure to NDMA or NDEA increases the risk of  
being diagnosed with cancer.  
[87] Therefore, based on my review of the evidence proffered for this certification motion, on  
the first issue of whether valsartan causes cancer, I find that there is no basis in fact to come to that  
conclusion.  
[88] This conclusion about no basis in fact for a causal relationship between valsartan and  
cancer is not based on favouring the Defendants’ experts over the Plaintiffs’ and my conclusion is  
not meant to and does not resolve any battle of the experts. On the certification motion, both parties  
agreed that from an epidemiological perspective, an association - and in this case, the  
contemporary statistical evidence was modest in favour of a statistically significant relationship  
between valsartan and cancer - does not establish general causation. I repeat my legal conclusion  
is that at this moment in scientific time, there is no basis in fact for concluding that NDMA and  
NDEA cause cancer.  
6.  
Is There Some Basis in Fact that Exposure to NDMA or NDEA Increases the  
Risk of Being Diagnosed with Cancer?  
[89] Moving on and separating or isolating the centerpiece issue of whether ingesting valsartan  
increases the risk of being diagnosed with cancer, from the issue of whether valsartan causes  
cancer, the Plaintiffs’ position is consistent. Their consistent position is that there is some basis in  
fact for the proposition that exposure to the Defendants’ valsartan contaminated with NDMA or  
NDEA increases the likelihood of being diagnosed with cancer.  
[90] In understanding the parties competing evidence on this issue, it is helpful to know that  
that nanogram (ng) is a unit of mass derived of grams and kilograms (kg) and that one ng equals  
0.000000001 (1.0 x. 10-9) grams, or one billionth of a gram and that “ppm” means “parts per  
million.”  
 
[91] In refocusing their proposed class action on increased risk and not on a causative  
relationship between the contaminated valsartan and cancer, the Plaintiffs relied on the fact that  
the amount of contamination in the valsartan exceeded the regulators advice about the acceptable  
daily intake (“ACI”) of NDMA and NDEA.  
[92] The FDA set the ACI of NDMA at 96 ng per day and NDEA at 26.5 ng per day. Health  
Canada has not set its own acceptable daily intake levels, but its public statements reference the  
FDA levels. Based on its extrapolation from results of animal studies, Health Canada and the FDA  
have advised that individuals exposed to NDMA and NDEA in pharmaceuticals at or below the  
recommended ADI levels each and every day for 70 years are not expected to have any increased  
risk of cancer.  
[93] Health Canada’s study on the alleged theoretical increased risk from valsartan containing  
NDMA found that the theoretical additional cancer risk in a worst case scenario, range between  
one additional cancer case in every 11,600 persons to one additional cancer case in every 93,400  
persons (i.e. a theoretical increased risk of cancer between 0.0086% and 0.0011%) which, as  
Health Canada points out, must be considered in the context of the existing lifetime risk of a 50:50  
(50%) chance of developing cancer.  
[94] In contrast to the Plaintiffs’ experts, it was Dr. Johnson’s opinion that the regulators use of  
ACI as a measure of the risk of cancer was not supported by the scientific evidence and ignored  
that the underlying DNA mechanisms of humans that can re pair NDMA and NDEA damage.  
[95] It was Dr. Johnson’s opinion that there is no increased risk of being diagnosed with cancer  
in humans based on the regulators’ measurements using the ACI measure. It was his opinion that  
the available scientific evidence and literature do not support a causal association between  
exposure to low doses of NDMA or NDEA in valsartan and cancer risk in humans. Instead of  
calculating an ACI, Dr. Johnson calculated a Permitted Daily Exposure (“PDE”), and it was his  
opinion that a 50kg patient exposed to NDMA below 6,200 ng and a 100kg patient exposed to  
NDMA below 12,400 ng do not have an increased risk of cancer.  
[96] Dr. Paustenbach, one of the Defendants’ toxicology experts, stated in his report, that  
estimating the quantitative risk to humans from animal data is problematic because the data is  
unreliable and because humans have DNA repair mechanisms that don’t exist in animals. He  
testified that the ADI is artificial, not based on a scientific methodology, and is not predicative of  
the human cancer risk.  
[97] As was noted by Dr. Paustenbach, the Defendants’ toxicology expert, every day through  
food and beverage consumption, humans are exposed to NDMA and NDEA far above the  
regulators’ ACI. Moreover, every day NDMA and NDEA can be compounded in the stomach  
(endogenous production) in amounts that enormously exceed the ACI. (NDMA has been found to  
be produced endogenously in the stomach in amounts ranging from 22,900 ng of NDMA per day  
to 1,260,000 ng of NDMA per day.) It may also be noted that if Canadians followed the ACI  
recommendation for NDMA (96 ng) and NDEA (26.5 ng), they would forgo eating: (a) fish, which  
was a 315 ng exposure to NDMA; (b) cooked bacon, which has a 774 ng exposure to NDMA; (c)  
meat, which has 1,290 ng exposure to NDMA; and (d) cheese, which has a 3,400 ng exposure to  
NDMA.  
[98] Pausing here, while I do not ignore it, I do not find the evidence and the analysis of the  
evidence of ADI determinative or particularly helpful in determining whether exposure to NDMA  
or NDEA increases the likelihood of a cancer diagnosis. However, that does not end the analysis  
because there was helpful and probative evidence about whether the exposure to the contaminated  
valsartan increased the risk of a cancer diagnosis.  
[99] While conceding that a causative relationship is not known to exist, the Plaintiffs relied on  
a variety of studies to establish an increased risk of cancer diagnosis from exposure to NDMA and  
NDEA. Visualize:  
a.  
Hidajat et. al followed 36,000 subjects who worked in the rubber industry and were  
exposed to NDMA through rubber dust and fumes. Hidajat et. al found a statistically  
higher risk of cancer including prostate, esophagus, stomach, and pancreas cancers.  
b.  
Larsson et. al followed 61,000 Swedish subjects for 18 years. Larsson et. al found  
that the high intake of NDMA contained in processed meats was associated with an almost  
two-fold increase in the level of stomach cancer following adjustment for potential  
confounding variables (age, body mass index, vegetable intake).  
c.  
Knekt et. al. found that subjects with a high intake of NDMA have a higher risk of  
colorectal cancer compared to those exposed to lower doses.  
d. Canadian studies conducted by Zhu et. al. reported that NDMA increases the risk  
of gastrointestinal cancer in humans.  
e. In the German study, (also mentioned by Dr. Padwal), the results indicated that  
although there was no association found between exposure to NDMA-contaminated  
valsartan and the overall risk of cancer, there was a significant association found between  
potentially NDMA-contaminated valsartan and liver cancer.  
f.  
Pottegard et. al. in a study of valsartan contaminated with NDMA, concluded that  
increases in risk were observed for colorectal cancer and for uterine cancer but that  
uncertainty persists about single cancer outcomes, and studies with longer follow-up are  
needed to assess long term cancer risk.  
g.  
Gomm et al in a study of valsartan contaminated with NDMA detected a small, yet  
statistically significant increase in the risk of liver cancer and monitoring and studies with  
longer follow-up were needed.  
h.  
Based on ingesting valsartan for a three-year period, Health Canada calculated the  
risk to affected individuals of developing cancer as up to one additional case per 11,600  
people. The FDA calculated it as one additional case per 8,000 people. Dr. Katz opined  
that this is considered to be a high risk. Dr. Kacew described it as a medically significant  
risk.  
[100] In addition to the evidence from scientific studies, some of them directed precisely at  
NDMA and NDEA in valsartan, there was evidence from the immediate case about linking  
contaminated valsartan to a diagnosis of cancer.  
[101] Dr. Kacew, who testified for the Plaintiffs, was asked based on the data from Emery  
Pharma laboratories (discussed below) and based on his own expertise, whether consumers of the  
Defendants’ valsartan are at risk of developing cancer. His answer is set out below:  
In dealing with cancer, it is important to bear in mind that the designation of a chemical as a probable  
carcinogen reflects the fact that the amount of the carcinogen within the pill is not a key factor but  
rather the knowledge that the chemical induces carcinogenesis and that over time the presence of  
the chemical will increase the risk of cancer development.  
The consumers of valsartan consumed NDMA in the range of 540 to 32,457 ng per tablet. To place  
this in perspective, the Health Canada 60 ppm or 60,000 ng inducing increased cancer risk in 1 in  
11,600 occurs for patients ingesting valsartan (320 mg) containing 60,000ng daily for a 3 year period  
over a lifetime. For patients taking the lowest valsartan dose (40mg) containing 60,000ng daily for  
a 3 year period, the increased cancer risk is 1 in 93,400 over a lifetime.  
Taking the Health Canada risk assessment 60 ppm (60,000 ng) value as the standard, the  
concentrations of NDMA are lower in Emery Pharmacy lab tested pills (7), however the risk of  
cancer induction is still increased in patients ingesting these pills over a lifetime based upon our  
knowledge that NDMA and NDEA are probable carcinogens. It is recognized that even in the  
absence of epidemiologic data sufficient evidence exists that NDMA and NDEA for practical  
purposes should be regarded as if these chemicals are carcinogenic to humans.  
[102] In addition to their analysis of these case studies, on the matter of risk assessment, the  
Plaintiffs and their experts rely on the statements of Health Canada and of the FDA. In particular,  
they rely on a document published on April 9, 2019 entitled “Transcript: Angiotensin II Receptor  
Blockers (ARBs) – A Message for Patients” which was part of the FDA’s announcements “Recalls  
of Angiotensin II Receptor Blockers (ARBs) including valsartan, Losartan and Irbesartan” which  
document stated:  
Hello. I’m Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA.  
I’d like to talk to you about the ongoing recall of drugs called ARBs. You may know them as  
valsartan, Losartan, or Irbesartan, or perhaps you just call them “my blood pressure medicine” or  
“my heart medicine.”  
For over 35 years, ARBs have been helping people who have heart conditions, high blood pressure,  
or may be at risk of a stroke or heart attack. These medicines help control the conditions, and they  
don’t have a lot of terrible side effects. […]  
In July, the FDA learned that some of these ARBs may contain chemicals known as nitrosamines.  
These chemicals can cause cancer when taken for long periods of time, even in relatively small  
amounts. You may have heard of the chemical names like NDEA or NDMA in connection with  
these ARBs. These chemicals are forms of nitrosamines. As soon as the FDA discovered that some  
ARBs contained nitrosamines, we moved quickly to remove them from the market. We know from  
all the calls we’ve received that people are worried that they might get cancer from these drugs. So,  
I want to talk to you about that risk for a moment.  
The FDA calculated that if you took the very highest dose of one of the affected medicines over  
four years, and you took the medicine that was the most contaminated, the risk is an additional one  
case in 8,000 people. To put this in context, currently one out of every three people in the U.S. will  
experience cancer in their lifetimes. Here’s the reality for all of us.  
We’re exposed to these nitrosamines every day in small amounts in our food, our water, and our  
soil. For example, low levels of nitrosamines are present in smoked foods like bacon and grilled and  
processed meats. They also occur naturally in fresh vegetables and water.  
The risk estimate is a worst-case scenario, and in fact no one would have been exposed to that much  
nitrosamine from ARBs, because most batches of the drugs contained much lower levels.  
Nitrosamines are allowed in our food and water supply in small amounts, and we seldom give it  
much thought. But, they shouldn’t be in our drug supply, and the FDA is going to make sure that  
they are removed completely from any drug that you might take.  
There have been nearly 40 recalls of ARBs since last July. This is happening as the FDA and  
companies continue to test medicines to make sure none of these medicines contain the nitrosamines.  
What can you do to be safe? Well, first, don’t stop taking your medicine! The risk of exposure to  
cancer is so much lower than your risk of a heart-related or other problem if you would stop your  
medicine.  
[…]  
[103] Based on my review of all this evidence on the issue of whether ingesting valsartan  
increases the risk of being diagnosed with cancer, I reach the following conclusion. Although the  
standard of proof would be different at a common issues trial, based on the evidence on this  
certification motion, I conclude that as a general matter, there is some basis in fact for the  
proposition that the exposure to NDMA and NDEA in the Defendants’ contaminated valsartan  
very modestly increases the risk of being diagnosed with cancer.  
7.  
The Recall and the Advice of Health Canada  
[104] In 2016, inspectors from the United States’ Food and Drug Administration (“FDA”)  
inspected ZHP’s manufacturing plant. The FDA identified violations of GMPs which it described  
in its Inspectional Observations (Form FDA 483). The FDA identified numerous failures,  
including failures to follow quality control procedures to ensure drug purity. The inspections  
continued, and in July and August 2018, the inspector’s reports, among other things, found that  
ZHP had not adequately evaluated the effect of its changed manufacturing process.  
[105] In the summer of 2018, Sandoz and Teva (which includes Actavis) recognized that its  
valsartan did not comply with the requirements of the American Food and Drugs Act. On July 9,  
2018, Sandoz and Teva voluntarily recalled valsartan because it had been discovered that the active  
pharmaceutical ingredient of the drug supplied by Zhejiang Huahai Pharmaceuticals (“ZHP”)  
might contain NDMA. The Recall was later expanded after it was determined that the valsartan  
supplied by ZHP might also contain NDEA. Not all Teva and Actavis valsartan products were  
recalled. The recalls were to retailers and applied only to certain lots of certain valsartan products.  
[106] On July 9, 2018, Health Canada issued a public advisory that the Defendants were recalling  
specified lots of drugs containing valsartan because a contaminant had been found. The Health  
Canada advisory stated:  
Public advisory  
Several drugs containing valsartan being recalled due to contamination with a potential  
carcinogen  
Issue  
Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An  
impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The  
valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human  
carcinogen, which means that it could cause cancer with long-term exposure. Five companies have  
affected products, which are being recalled (identified in table below).  
Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart  
attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart  
attack.  
 
What you should do  
Keep taking your medicine if it contains valsartan unless you have been told to stop by  
your doctor or pharmacist.  
If you are taking any medication containing valsartan, speak to your pharmacist who can  
tell you if your medicine is being recalled.  
If you have been using an affected product, contact your health care practitioner as soon as  
possible to discuss your treatment options.  
If you are in a clinical trial with a product containing valsartan and have any questions,  
speak to the doctor treating you in the trial.  
Report side effects (adverse events) to health products to Health Canada by […]  
Report complaints about health products to Health Canada by […].  
Who is affected  
Consumers who use any valsartan products in the table below.  
[…]  
[107] On August 18, 2018, Health Canada issued another advisory stating that as a precautionary  
measure, Teva Canada was expanding its voluntary recall to include eight additional lots of  
valsartan products because they might contain NDMA. The advisory stated:  
OTTAWA – Health Canada is advising Canadians that, as a precautionary measure, Teva Canada  
is expanding its voluntary recall to include eight additional lots of valsartan products in Canada  
because they may contain an impurity, N-nitrosodimethylamine (NDMA).  
valsartan is used to treat high blood pressure and heart failure.  
This latest action is further to an initial recall of certain valsartan products because of the presence  
of NDMA in the active ingredient (valsartan). All of the recalled products use a valsartan ingredient  
manufactured by Zhejiang Huahai Pharmaceuticals in China.  
Products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals  
Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on  
patients. NDMA is classified as a probable human carcinogen based primarily on animal studies,  
which means that exposure above acceptable levels over the long term could increase the risk of  
cancer. The review, which will be completed in the coming weeks, will include an assessment of  
how much NDMA patients may have been exposed to and for how long. Although Health Canada  
believes that the NDMA was introduced as a result of a change in manufacturing processes at  
Zhejiang Huahai Pharmaceuticals in 2012, some Canadian companies may have been using the  
affected valsartan active ingredient for less time.  
The additional Teva Canada products are being recalled after sample testing of the active ingredient  
by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA. Testing is ongoing. In the  
meantime, Health Canada has asked Teva Canada to recall these additional products as a  
precautionary measure, and to conduct a full investigation to determine the root cause of this most  
recent issue.  
Health Canada is monitoring the recalls. The Department continues to work with the companies and  
its international regulatory partners to gather and assess information to determine whether additional  
actions are necessary. We will keep Canadians updated. This includes communicating the results of  
our health risk assessment once it is complete in the coming weeks.  
A complete list of recalled products is provided below.  
Products containing valsartan ingredient from other suppliers NOT impacted by the recall  
Health Canada has contacted all companies selling valsartan medications in Canada and has  
confirmed that all of the products NOT being recalled:  
do not contain valsartan manufactured by Zhejiang Huahai Pharmaceuticals, and  
were manufactured using different processes from the ones that have been  
identified as having introduced the impurity.  
[…]  
A complete list of products that are NOT recalled is provided below.  
What you should do  
Patients taking affected valsartan medications should:  
Continue taking their valsartan medication unless they have been advised to stop  
by their health care provider.  
Contact their health care provider as soon as possible to discuss treatment options  
if they have been using an affected product. Pharmacists may be able to provide  
a product not affected by the recall, or doctors may prescribe a different  
medication for their patients’ conditions.  
Ask their pharmacist if they are unsure whether they are using a recalled product.  
[…]  
[108] On September 10, 2018, as promised in the earlier releases, Health Canada issued an  
update on the health risks for recalled valsartan. The update stated:  
Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs  
containing NDMA  
Issue  
OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects  
involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine  
(NDMA). Health Canada scientists have assessed the available data to determine the potential  
increased risk of developing cancer, to help put the risk into context for Canadians.  
Based primarily on animal studies, NDMA is classified as a probable human carcinogen. This means  
that exposure over the long term could increase the risk of cancer. We are all exposed to low levels  
of NDMA. NDMA can be found in some foods (such as meats, dairy products and vegetables) and  
in drinking water. It is not expected to cause harm when ingested in very low levels.  
Health Canada believes that NDMA was introduced to the affected valsartan drugs as a result of a  
change in manufacturing processes at Zhejiang Huahai Pharmaceuticals (the manufacturer of the  
valsartan ingredient) in 2012. The longest time affected products were on the Canadian market was  
approximately three years.  
The amounts of NDMA present in the valsartan active ingredient varied, but on average were higher  
than levels that are considered reasonably safe, which is why the valsartan products were recalled.  
Health Canada has derived estimates of the possible increased cancer risk using internationally  
accepted methods and information available to the Department at this time. The estimates are based  
on the following assumptions:  
the valsartan active ingredient contained 60 parts per million (ppm) NDMA. This is the  
average reported level of NDMA in a sampling of batches.  
the exposure was approximately 3 years.  
It is important to keep in mind that the actual health risk varies from person to person, and depends  
on factors including daily dose, how long the affected valsartan was taken, and the actual level of  
NDMA present in the finished product.  
Estimated potential increased cancer risk for patients taking various doses of NDMA-  
containing valsartan products for 3 years  
valsartan dose (mg/day) containing 60  
Risk estimate  
ppm NDMA  
40  
80  
160  
320  
1 additional case per 93,400 people  
1 additional case per 46,700 people  
1 additional case for 23,300 people  
1 additional case per 11,600 people  
For patients taking the highest dose of valsartan (320 mg) containing 60 ppm NDMA per tablet once  
daily for three years, Health Canada estimates that the potential increased risk of cancer over a  
lifetime could be 1 additional case of cancer for every 11,600 people taking the product. For patients  
taking the lowest valsartan dose (40 mg) containing 60 ppm NDMA per tablet once daily for three  
years, Health Canada estimates that the potential increased risk of cancer over a lifetime could be 1  
additional case for every 93,400 people taking the product. To put these estimates into a broader  
context, nearly 1 in 2 Canadians is expected to develop cancer during their lifetime.  
Health Canada is working closely with international partners to share information and coordinate  
efforts on inspections, risk assessments and public communications. Notably, Health Canada’s  
estimated potential increased cancer risk is lower than those reported by the United States (US)  
Food and Drug Administration (FDA) and the European Medicines Agency (EMA) because the  
contaminated valsartan products were on the Canadian market for a shorter period of time, compared  
to the exposure timelines used in the assessments communicated by the FDA and EMA. Health  
Canada will take action should any new safety issue be identified and will continue to keep  
Canadians updated.  
[…]  
What you should do  
People taking valsartan drugs should check these lists of valsartan products that have and have NOT  
been recalled to see if their medication is affected.  
Patients taking affected valsartan medications should:  
Ask their pharmacist if they are unsure whether they are using a recalled product.  
Contact their health care provider as soon as possible to discuss treatment options if they  
have been using an affected product. Pharmacists may be able to provide a product not  
affected by the recall, or doctors may prescribe a different medication for their patients’  
conditions.  
Continue taking their valsartan medication unless they have been advised to stop by their  
health care provider. Since the risk of cancer is with long term exposure to the NDMA  
impurity, there is no immediate health risk, and patients can continue to take this drug to  
treat their medical condition until they can discuss treatment options with their health care  
provider.  
Contact their health care provider if they have taken recalled valsartan products and they  
have concerns about their health.  
[109] On September 13, 2018, Health Canada advised of the second impurity linked to the  
recalled valsartan drugs from ZHP. The Health Canada advisory stated:  
Impurities found in certain angiotensin II receptor blocker (ARB) products, also known as  
sartans  
Overview  
In the summer of 2018, several valsartan products were recalled in Canada and worldwide because  
of the impurity, N-nitrosodimethylamine (NDMA), found in the active ingredient manufactured by  
Zhejiang Huahai Pharmaceuticals in China.  
Since that time, NDMA and other similar impurities, N-nitrosodiethylamine (NDEA), N-  
Nitrosodiisopropylamine (NDIPA) and N-Nitrosomethyl-n-butylamine (NMBA), have been found  
in valsartan or other drugs in the same class as valsartan (referred to as angiotensin II receptor  
blockers or ARBs) made by several different manufacturers in different countries and has prompted  
additional recalls in Canada and worldwide.  
ARBs are used to treat patients with high blood pressure to help prevent heart attacks and stroke.  
NDEA, NDMA, NDIPA and NMBA are nitrosamines that are classified as probable or potential  
human carcinogens, which means that long-term exposure could increase the risk of cancer. Since  
the risk of cancer is with long-term exposure, there is no immediate health risk associated with the  
use of ARBs containing these impurities.  
Health Canada recognizes the stress caused by this issue to Canadians who rely on these important  
medications. The Department has been working with companies and international regulatory  
partners to determine the root cause of the issue and to verify that appropriate actions are taken to  
prevent it from happening again.  
Health Canada continues to hold manufacturers responsible for the safety and effectiveness of drugs  
sold on the Canadian market and has taken several actions to mitigate the risk to Canadians,  
including:  
Requested, confirmed and monitored the effectiveness of recalls due to this issue. A list of  
recalled products is provided below and will be updated as needed.  
[…]  
Determined that the Chuannan site of Zhejiang Huahai Pharmaceuticals and Hetero  
Laboratories Limited, Unit 1 are Non-Compliant with Good Manufacturing Practices  
requirements. This means that no products can be imported from those sites, unless they  
are considered medically necessary.  
Tested samples of ARBs on the Canadian market. Test results are provided below and will  
be updated as additional test results become available.  
[…]  
Recalls  
Health Canada is publishing a complete list of angiotensin II receptor blocker (ARB) products  
recalled in Canada due to the presence of or the potential for nitrosamine impurities. […]  
Patients taking recalled medications should:  
Continue taking your medication unless you have been advised to stop by your health care  
provider.  
Contact your health care provider to discuss treatment options if you have been using an  
affected product.  
Ask your pharmacist if you are unsure whether you are taking a recalled product.  
Contact your health care provider if you have taken a recalled product and you have  
concerns about your health.  
[…]  
[110] On October 2, 2018, Health Canada announced that based on a review of an inspection  
conducted by the FDA, ZHP’s manufacturing site was determined to be non-complaint with  
requirements for GMPs for the manufacture of the valsartan. The Health Canada announcement  
stated:  
Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with  
requirements for the manufacture of drug ingredients  
Health Canada has found the Chuannan manufacturing site of Zhejiang Huahai Pharmaceuticals  
located in Linhai, China, to be non-compliant with requirements for Good Manufacturing Practices  
(GMPs) for the manufacture of active pharmaceutical ingredients. Health Canada’s decision is based  
on a review of information from a recent inspection conducted by the U.S. Food and Drug  
Administration (FDA).  
GMPs are internationally accepted standards that help ensure that drugs are consistently  
manufactured, tested, stored and distributed in a way that meets Canada’s high safety and quality  
standards.  
A non-compliant rating means that Canadian companies can no longer import drugs that contain  
active pharmaceutical ingredients from this site unless they are medically necessary. Health Canada  
will allow the continued importation of medically necessary drugs under conditions that verify their  
safety, such as additional testing. At this time, no products containing active pharmaceutical  
ingredients from this site have been identified as medically necessary.  
[…]  
Zhejiang Huahai Pharmaceuticals is the manufacturer of the valsartan active pharmaceutical  
ingredient that, to date, is the only active ingredient from this site found to contain the impurities  
N‑nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).  
Health Canada reviewed the FDA inspection as part of its continuing assessment of the issue with  
valsartan. All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have  
already been recalled in Canada. […]  
Background  
[…]  
Canadians with questions or concerns about any health product they are taking should speak to a  
health care professional. Canadians should not make any changes to their medication without first  
consulting with a healthcare professional.  
[111]  
On November 29, 2018, the Center for Drug Evaluation and Research, United States,  
issued a warning letter to ZHP, which is stated, in part:  
Failure to evaluate the potential effect that changes in the manufacturing process may have on the  
quality of your API. In November 2011 you approved a valsartan API process change […] that  
included the use of the solvent (b)(4). Your intention was to improve the manufacturing process,  
increase product yield, and lower production costs. However, you failed to adequately assess the  
potential formation of mutagenic impurities when you implemented the new process. […]  
According to your ongoing investigation, (b)(4) is required for the probable human carcinogen  
NDMA to form during the valsartan API manufacturing process. NDMA was identified in valsartan  
API manufactured at your facility.  
[112] On December 20, 2018, Health Canada released an information update entitled, “Health  
Canada releases test results of certain sartan drugs”. The information update states, in part:  
Health Canada releases test results of certain sartan Drugs  
Issue  
Health Canada has released the results […] of its testing of sartan drugs in Canada. Health Canada  
tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan),  
which represent numerous products, as part of its ongoing collaborative work to address impurities  
found in some sartan drugs in Canada and internationally.  
Sartans, also known as angiotensin II receptor blockers (ARBs), are a class of drugs used as a  
treatment for patients with high blood pressure to help prevent heart attacks and stroke. They are  
also used in patients who have had heart failure or a recent heart attack.  
Several valsartan products have been recalled in Canada since this summer, after the impurities  
N‑nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) were found in the active  
pharmaceutical ingredient. Both NDEA and NDMA are classified as probable human carcinogens,  
which means that long-term exposure could increase the risk of cancer. Health Canada has  
previously communicated cancer risk estimates (http://www.healthycanadians.gc.ca/recall-alert-  
rappel-avis/hc-sc/2018/67734a-eng.php) for NDMA based on the levels detected in certain recalled  
valsartan products.  
Health Canada tested 48 samples representing 43 different products and did not identify any new  
safety concerns. Of the 48 samples, six valsartan samples representing four products were found to  
contain levels of impurities that were, on average, higher than what is considered to be reasonably  
safe. All four of the products have already been recalled from the Canadian market.  
[…]  
What you should do  
As with previous communications regarding NDEA and NDMA, Health Canada is advising that  
there is no immediate risk to patients taking these medications, since the risk of cancer is with long-  
term exposure to the impurities that exceed safe levels. Patients should not stop taking their  
medication unless on the advice of their healthcare provider.  
[113] Health Canada’s test results of some of the recalled lots were as set out in the chart below:  
Market Authorization  
Holder  
Product Name  
Strength (mg)  
NDMA RESULT  
ng/tablet  
NDEA RESULT  
ng/tablet  
Actavis Pharma Company ACT VALSARTAN  
Actavis Pharma Company ACT VALSARTAN  
320  
320  
320  
320  
320  
320  
15,242  
12.78  
10,770.8  
186.67  
Sandoz Canada Inc.  
Teva Canada Limited  
Teva Canada Limited  
Teva Canada Limited  
SANDOZ VALSARTAN  
2,703.76  
Not detected  
Not detected  
1,770.87  
TEVA-VALSARTAN/HCTZ  
TEVA-VALSARTAN/HCTZ  
TEVA-VALSARTAN/HCTZ  
14,538.35  
258.19  
13,367.64  
Not detected  
[114] Since 2018, Health Canada’s advisories have been consistent in their messaging. In April  
2022, Health Canada posted an updated guidance advisory about nitrosamine impurities in  
medications. The advisory stated:  
Nitrosamine impurities in medications: Overview  
[…]  
Background  
In the summer of 2018, several medications containing the active ingredient valsartan were recalled  
in Canada and elsewhere in the world. This was because the nitrosamine impurity, N-  
nitrosodimethylamine (NDMA), was found in the active pharmaceutical ingredient (API). APIs are  
the substances in pharmaceutical medications that are responsible for the beneficial health effects  
experienced by patients or consumers. Since then, some other medications made by different  
manufacturers have been found to contain NDMA or other similar nitrosamine impurities, such as:  
N-nitrosodiethylamine (NDEA) […]  
About nitrosamine impurities  
Based primarily on animal studies, nitrosamine impurities are probable human carcinogens. This  
means that long-term exposure to a level above what is considered safe may increase the risk of  
cancer.  
There is no immediate health risk associated with the use of medications containing low levels of a  
nitrosamine impurity. Foods such as meats, dairy products and vegetables as well as drinking water  
may also contain low levels of nitrosamines.  
We don't expect that a nitrosamine impurity will cause harm when exposure is at or below the  
acceptable level. For example, no increase in the risk of cancer is expected if exposure to the  
nitrosamine impurity below the acceptable level occurs every day for 70 years.  
The actual health risk varies from person to person. The risk depends on several factors, such as:  
the daily dose of the medication  
how long the medication is taken  
the level of the nitrosamine impurity in the finished product  
Patients should always talk to their health care provider before stopping a prescribed medication.  
Not treating a condition may pose a greater health risk than the potential exposure to a nitrosamine  
impurity.  
[…]  
8.  
The Plaintiffs’ Testing of the valsartan  
[115] In this certification motion, the extent to which the valsartan was contaminated was another  
highly contentious and complicated issue. Some of the complications were that: (a) not all Teva  
valsartan products were recalled; and (b) neither Sandoz nor Teva supplied any test results of their  
own testing of lots of their valsartan that were recalled.  
[116] As noted above, Health Canada did limited testing, and it provided the information set out  
in the above chart of the test results.  
[117] In August and September 2018, the Plaintiffs retained a laboratory to conduct testing on a  
collection of leftover pills from various lots manufactured by the Defendants.  
[118] Dr. Neelanjan Bose of Emery Pharma tested the samples. His testing provided the  
following information:  
a.  
b.  
c.  
No samples were found to contain NDEA.  
One sample did not contain NDMA.  
The other samples contained NDMA ranging from 540 ng to 32,457 ng per tablet.  
[119] More precisely, Dr. Bose’s findings are set out in the following chart:  
Name  
DIN  
#Tablets  
Dose  
80  
80  
Ng NMMA  
0
540  
2,842  
2,335  
3,718  
15,451  
16,782  
28,131  
17,575  
2,335  
Ng NDMA/tablet  
0
540  
Meszaros  
Fournier  
Aitchison  
Tiedje  
Palmer  
Creighton  
Halbert  
2356651  
2367734  
2356758  
2356767  
2356767  
2384531  
2366959  
2366959  
2356767  
2356775  
2386975  
2366975  
1
1
5
2
2
5
5
5
2
1
1
2
80  
568  
160  
160  
80  
80  
80  
160  
320  
320  
320  
1,168  
1,856  
3,090  
3,66  
5,626  
8,785  
13,135  
25,534  
32,457  
Halbert  
Tremblay  
Ventura  
Perehudoff  
Perehudoff  
25,534  
64,914  
9.  
Physical Harm  
[120] As noted, several times above, the Plaintiffs do not propose to advance claims of damages  
for bodily harm caused by the ingestion of the contaminated valsartan. Class Counsel  
acknowledged during oral argument that persons with such claims or persons anticipating such a  
sad prospect would have to opt out of the class proceeding to preserve the claim for physical  
injuries.  
[121] In this regard, it should be noted that the doctrine of res judicata bars not only the causes  
of action that were brought but also the causes of action that could or ought to have been brought  
based on the same factual footprint. The idea of res judicata (“a matter adjudicated”) is the legal  
rule and the public policy that a final judgment on the merits by a court of competent jurisdiction  
is binding and determinative of the rights of the parties or their privies in all later suits with respect  
   
to fundamental issues decided in the former suit (issue estoppel),12 and with respect to causes of  
actions and defences that were decided (cause of action estoppel) or could and ought to have been  
decided in the former suit (the rule from Henderson v. Henderson).13  
[122] Class Counsel during oral argument and in its factum acknowledged that in the notice of  
certification, the putative Class Members would be advised that if they chose to be Class Members,  
then they would forgo a claim for damages for actually experiencing cancer from ingesting  
valsartan.  
10. Psychological Harm  
[123] The Plaintiffs advance a claim for compensation for the psychological harm of having  
ingested valsartan and then being advised of it probably being a carcinogen in humans. More  
precisely, the Class Members claim that they suffered compensable psychiatric harm from being  
advised that their risk of a cancer diagnosis had increased because they had ingested valsartan.  
[124] In Mustapha v. Culligan of Canada Ltd.14 and in Saadati v. Moorhead,15 the Supreme Court  
of Canada established the contemporary approach of the law with respect to damages for  
psychological harm.  
[125] Before the Saadati v. Moorhead decision, the conventional view was that recovery for  
psychological harm required a claimant to prove with expert medical opinion evidence a  
recognized psychiatric illness, which came to mean an illness within the classification of mental  
disorders contained in the Diagnostic and Statistical Manual of Mental Disorders (“DSM”),  
published by the American Psychiatric Association, and the International Statistical Classification  
of Diseases and Related Health Problems (“ICD”), published by the World Health Organization.  
[126] After Saadati v. Moorhead, while an expert’s opinion is relevant, it is not a necessity, and  
to establish a compensable psychological injury, the claimant need not prove that he or she was  
suffering a recognized psychiatric illness. Rather, the claimant needs to prove that as a result of  
the defendant’s negligence he or she suffered a mental disturbance that is serious and prolonged  
and that rises above the ordinary annoyances, anxieties and fears that come with living in civil  
society.  
[127] In the immediate case, anticipating the challenge that did in fact come from the Defendants  
that the Plaintiffs’ action was vulnerable to the argument that it should not be certified in the  
absence of some evidence of compensable harm having occurred, the Plaintiffs marshalled  
evidence to show some basis in fact that a significant portion of the membership of the class will  
have sustained compensable psychological harm and that the Class Members or their surrogates  
would suffer the pure economic loss of medical bills, medical monitoring, refunds, and costs for  
drugs thrown away.  
[128] The Plaintiffs retained Dr. O’Shaughnessy, who has a specialty in psychiatry. He  
12 Penner v. Niagara (Regional Police Services Board), 2013 SCC 19; British Columbia (Workers’ Compensation  
Board) v. Figliola, 2011 SCC 52; Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460; Angle v. M.N.R.  
(1974), 47 D.L.R. (3d) 544 (S.C.C.).  
13 (1843), 67 E.R. 313, 3 Hare 100 (V.C. Ct.); Hoque v. Montreal Trust Co. of Canada, [1997] N.S.J. No. 430,  
(C.A.), leave to appeal refused, [1997] S.C.C.A. No. 656; Grandview (Town) v. Doering, [1976] 2 S.C.R. 621.  
14 2008 SCC 27.  
15 2017 SCC 28.  
 
interviewed eight of the Plaintiffs and provided reports. He diagnosed four of the group as having  
had adjustment disorders and the others as having had no problems after learning about the  
contamination of the valsartan. At the time of the interviews by Dr. O’Shaughnessy, none of the  
Plaintiffs had any symptoms of psychological harm. Every single person Dr. O’Shaughnessy  
interviewed was so-to-speak “better” two years after the recall.  
[129] Dr. O’Shaughnessy found a significant range in psychological reaction to the recall with  
some individuals describing modest symptoms, while others had more persistent and disturbing  
symptoms of anxiety and/or depressed mood that he thought met the criteria for an Adjustment  
Disorder with Anxiety and Depression.  
[130] There was also survey evidence from Dr. Groehn, an economist, that Dr. O’Shaughnessy  
reviewed and that the Plaintiffs relied on in support of certification of their claim for psychological  
harm damages.  
[131] Dr. Groehn surveyed putative Class Members that had registered with Class Counsel. Of  
the 3,275 registrants/respondents, 1,497 (46%) responded to the survey. Dr. Groehn designed a  
survey not as a diagnostic tool but to detect psychological distress symptomatology in the putative  
Class Members.  
[132] Dr. Groehn’s survey results revealed:  
a.  
48.0% of the respondents to the survey learned of the recall from their pharmacist;  
20.6% from social media; 20.5% from a physician; 17% from a TV advertisement; 13.2%  
from print media; the balance of 10.5% learned from word of mouth, notice from the  
regulator, or did not know how they found out about the recall (The total percentage  
exceeds 100% because the Class Members could select more than one source.). (In  
assessing the shock value of the notice, it may be observed that 68.5% of the respondents  
learned about the recall from a pharmacist or physician.)  
b.  
c.  
80.1% of the respondents reported that the recall was a great burden to them.  
76.5% of respondents reported feeling “nervous, anxious, worried, or on edge about  
their health” during the first three months after the recall.  
d. 67.7% of respondents reported having a consultation with their physician within  
the first three months of the recall.  
e. 10% of the respondents reported physician consultations related to the recall two  
years after the recall.  
[133] With respect to the medical monitoring claim, the Plaintiffs led evidence that early  
diagnosis from medical monitoring or screening is critical to prevent Class Members from  
developing diseases and to treat diseases caused by the valsartan. The Plaintiffs submitted that the  
medical monitoring would ameliorate their anxiety whether the ingestion of valsartan has caused  
or will cause them to develop cancer or organ damage.  
[134] My conclusion from all this evidence about psychological harm is that as  
medical/psychological matter, the Plaintiffs have succeeded in showing some basis in fact that a  
small proportion of the membership of the class will have sustained psychological harm for a  
relatively short period of time as a result of learning about the contamination of the valsartan that  
they had been ingesting.  
[135] However, although there is some basis in fact that the mental harm occurred for a small  
proportion of the class, as I shall explain later in this judgment - as a legal matter – this suffering  
of psychological harm is not compensable in law because it arises from anxiety associated with an  
increased feeling of risk and is not anxiety associated with the materialization of that risk.  
G. Certification: General Principles  
[136] 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.  
[137] 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.16 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) to provide access to justice for litigants; (2) to  
encourage behaviour modification; and (3) to promote the efficient use of judicial resources.17  
[138] For certification, the plaintiff in a proposed class proceeding must show “some basis in  
fact” for each of the certification requirements, other than the requirement that the pleading  
discloses a cause of action.18 The some-basis-in-fact standard 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.19 In particular, there must be a basis in the evidence  
to establish the existence of common issues.20 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.21  
[139] The some-basis-in-fact standard does not require evidence on a balance of probabilities and  
does not require that the court resolve conflicting facts and evidence at the certification stage and  
rather reflects the fact that at the certification stage the court is ill-equipped to resolve conflicts in  
the evidence or to engage in the finely calibrated assessments of evidentiary weight and that the  
certification stage does not involve an assessment of the merits of the claim and is not intended to  
16 Hollick v. Toronto (City), 2001 SCC 68 at para. 16.  
17 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.  
18 Hollick v. Toronto (City), [2001] 3 S.C.R. 158 at para. 25; Pro-Sys Consultants Ltd. v. Microsoft Corporation,  
2013 SCC 57 at paras. 99-105; Taub v. Manufacturers Life Insurance Co., (1998) 40 O.R. (3d) 379 (Gen. Div.),  
aff’d (1999), 42 O.R. (3d) 576 (Div. Ct.).  
19 Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57; McCracken v. CNR Co., 2012 ONCA 445.  
20 Singer v. Schering-Plough Canada Inc., 2010 ONSC 42 at para. 140; Fresco v. Canadian Imperial Bank of  
Commerce, [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.).  
21 Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 at para. 110.  
 
be a pronouncement on the viability or strength of the action.22  
[140] Although it has recently garnered renewed attention, it has been for a long time, and it  
continues to be a fundamental principle that for an action to be certified as a class proceeding there  
must be some evidence that two of more putative Class Members suffered compensable harm.23  
H. The Cause of Action, the Common Issues, and the Preferable Procedure Criteria  
Ensemble  
[141] Given the nature of the Defendants’ arguments and the Plaintiffs’ response to them, it is  
both convenient and necessary to consider the cause of action criterion (s. 5 (1) (a) of the Class  
Proceedings Act, 1992 together with the common issues criterion (s. 5 (1)(c)) and the preferable  
procedure criterion (s. 5 (1)(d)). Simultaneously analyzing the Plaintiffs’ causes of action through  
the lens of these three criteria reveals that all the various causes of action are not certifiable.  
[142] I will also return later to the common issues criterion and the preferable procedure criterion  
discretely to address some miscellaneous issues about these criteria in the immediate case.  
1.  
General Principles: Cause of Action Criterion  
[143] The first criterion for certification is that the plaintiff's pleading discloses a cause of action.  
[144] The “plain and obvious” test for disclosing a cause of action from Hunt v. Carey Canada,24  
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, 1992.25  
[145] 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.26  
[146] Bare allegations and conclusory legal statements based on assumption or speculation are  
not material facts; they are incapable of proof and, therefore, they are not assumed to be true for  
22 Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 at para. 102.  
23 Marcinkiewicz v. General Motors of Canada Co., 2022 ONSC 2180; MacKinnon v. Volkswagen, 2021 ONSC  
5941; Maginnis v. FCA Canada Inc 2021 ONSC 3897 (Div. Ct.), aff’g 2021 ONSC 3897, leave to appeal dismissed  
April 8, 2022 (Ont. C.A.); Setoguchi v. Uber B.V., 2021 ABQB 18; Atlantic Lottery Corp Inc. v. Babstock, 2020  
SCC 19; Richardson v. Samsung Electronics Canada Inc., 2018 ONSC 6130, aff’d 2019 ONSC 6845 (Div. Ct.);  
Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57; Singer v. Schering-Plough Canada Inc., 2010  
ONSC 42.  
24 [1990] 2 S.C.R. 959.  
25 Wright v. Horizons ETFS Management (Canada) Inc., 2020 ONCA 337 at para. 57; Amyotrophic Lateral  
Sclerosis Society of Essex County v. Windsor (City), 2015 ONCA 572; Hollick v. Metropolitan Toronto  
(Municipality), 2001 SCC 68.  
26 Cloud v. Canada (Attorney General) (2004), 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), 65 O.R. (3d) 492 (Div. Ct.); Hollick v. Toronto (City), 2001 SCC 68  
at para. 25; Abdool v. Anaheim Management Ltd. (1995), 21 O.R. (3d) 453 at p. 469 (Div. Ct.).  
   
the purposes of a motion to determine whether a legally viable cause of action has been pleaded.27  
[147] Matters of law that are not fully settled should not be disposed of on a motion to strike an  
action for not disclosing a reasonable cause of action,28 and the court's power to strike a claim is  
exercised only in the clearest cases.29 The law must be allowed to evolve, and the novelty of a  
claim will not militate against a plaintiff.30 However, a novel claim must have some elements of a  
cause of action recognized in law and be a reasonably logical and arguable extension of established  
law.31  
2.  
General Principles: Common Issues Criterion  
[148] 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.32  
[149] 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.33  
[150] 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.34 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.35 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.36  
[151] The common issue criterion presents a low bar.37 An issue can be a common issue even if  
27 Deluca v. Canada (AG), 2016 ONSC 3865; Losier v. Mackay, Mackay & Peters Ltd., [2009] O.J. No. 3463 at  
paras. 39-40 (S.C.J.), aff’d 2010 ONCA 613, leave to appeal ref’d [2010] SCCA 438; Grenon v. Canada Revenue  
Agency, 2016 ABQB 260 at para. 32; Merchant Law Group v. Canada Revenue Agency, 2010 FCA 184 at para. 34.  
28 Dawson v. Rexcraft Storage & Warehouse Inc. (1998), 164 D.L.R. (4th) 257 (Ont. C.A.).  
29 Temelini v. Ontario Provincial Police (Commissioner) (1990), 73 O.R. (2d) 664 (C.A.).  
30 Johnson v. Adamson (1981), 34 O.R. (2d) 236 (C.A.), leave to appeal to the S.C.C. refused (1982), 35 O.R. (2d)  
64n.  
31 Silver v. Imax Corp., [2009] O.J. No. 5585 (S.C.J.) at para. 20; Silver v. DDJ Canadian High Yield Fund, [2006]  
O.J. No. 2503 (S.C.J.).  
32 Hollick v. Toronto (City), 2001 SCC 68 at para. 18.  
33 Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 at paras. 39 and 40.  
34 Fehringer v. Sun Media Corp., [2003] O.J. No. 3918 at paras. 3, 6 (Div. Ct.).  
35 McKenna v. Gammon Gold Inc., [2010] O.J. No. 1057 at para. 126 (S.C.J.), leave to appeal granted [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] B.C.J. No. 529 at para. 51 (B.C.S.C.), var’d on other  
grounds (2004) 42 B.L.R. (3d) 161 (B.C.C.A.).  
36 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.  
37 203874 Ontario Ltd. v. Quiznos Canada Restaurant Corp., [2009] O.J. No. 1874 (Div. Ct.), aff’d [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)  
 
it makes up a very limited aspect of the liability question and even though many individual issues  
remain to be decided after its resolution.38 Even a significant level of individuality does not  
preclude a finding of commonality.39A 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.40  
[152] From a factual perspective, the plaintiff must show that there is some basis in fact that: (a)  
the proposed common issue actually exists; and (b) the proposed issue can be answered in common  
across the entire class, which is to say that the Plaintiff must adduce some evidence demonstrating  
that there is a colourable claim or a rational connection between the Class Members and the  
proposed common issues.41 The plaintiff must establish some basis in fact for the existence of the  
common issues in the sense that there is some factual basis for the claims made to which the  
common issues are connected.42  
3.  
General Principles – Preferable Procedure  
[153] 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.43  
[154] In AIC Limited v. Fischer,44 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. 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.45 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.46 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;  
(2004), 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),  
65 O.R. (3d) 492 (Div. Ct.); Carom v. Bre-X Minerals Ltd. (2000), 51 O.R. (3d) 236 at para. 42 (C.A.).  
38 Cloud v. Canada (Attorney General), (2004), 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), 65 O.R. (3d) 492 (Div. Ct.).  
39 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.  
40 Harrington v. Dow Corning Corp., [2000] B.C.J. No. 2237 (C.A.), leave to appeal to S.C.C. ref’d [2001] S.C.C.A.  
No. 21.  
41 Jensen v. Samsung Electronics Co. Ltd., 2021 FC 1185; Kuiper v. Cook (Canada) Inc., 2020 ONSC 128 (Div.  
Ct.).  
42 Simpson v. Facebook, Inc. 2022 ONSC 1284 at para. 25 (Div. Ct.); Jensen v. Samsung Electronics Co. Ltd., 2021  
FC 1185; Singer v. Schering-Plough Canada Inc., 2010 ONSC 42 at para. 140.  
43 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.  
44 2013 SCC 69 at paras. 24-38.  
45 Cloud v. Canada (Attorney General) (2004), 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), 65 O.R. (3d) 492 (Div. Ct.).  
46 Markson v. MBNA Canada Bank, 2007 ONCA 334; Hollick v. Toronto (City), 2001 SCC 68.  
 
(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.47  
4.  
Products Liability  
[155] The analysis of the certifiability of the Plaintiffs’ various causes of action may begin with  
the critical core claims in negligence, more precisely, product liability negligence. In its existential  
essence, the Plaintiffs’ proposed class action is a product liability claim.  
[156] The fundamental constituent elements of any type of negligence cause of action 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.48  
[157] By way of a preliminary point, it should be noted that there are four established genres of  
product liability causes of action in negligence.49  
[158] First, there is design negligence; manufacturers have a duty of care in designing the product  
to avoid safety risks and to make the product reasonably safe for its intended purposes.50  
[159] Second, there is manufacturing negligence; manufacturers have a duty of care to consumers  
to see that there are no defects in manufacture that are likely to give rise to injury in the ordinary  
course of use.51  
[160] Third, manufacturers have a duty of care to compensate consumers for the cost of repairing  
a dangerous product that presents an imminent real and substantial danger.52  
[161] Fourth, there is a duty to warn; 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.53  
[162] In the immediate case, the Plaintiffs’ products liability claim has two branches to it. The  
first branch is a personal injury claim for psychological harm. The Plaintiffs purposefully eschew  
a physical injury claim for damages for valsartan causing cancer; rather, the Plaintiffs’ case is built  
47 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.  
48 Mustapha v. Culligan of Canada Ltd., 2008 SCC 27 at para. 3.  
49 Harris v. Bayerische Motoren Werke Aktiengesellschaft, 2020 ONSC 1647; Vester v. Boston Scientific Ltd., 2015  
ONSC 7950; Arora v. Whirlpool Canada LP, 2012 ONSC 4642, aff’d 2013 ONCA 657, leave to appeal ref’d [2013]  
S.C.C.A. No. 498; Goodridge v. Pfizer Canada Inc., 2010 ONSC 1095; Hollis v. Dow Corning Corp., [1995] 4  
S.C.R. 634; Rentway Canada Ltd. v. Laidlaw Transport Ltd., [1989] O.J. No. 786 (H.C.J.), aff’d [1994] O.J. No. 50  
(C.A.).  
50 Vester v. Boston Scientific Ltd., 2015 ONSC 7950; Ragoonanan v. Imperial Tobacco Canada Ltd. (2000), 51 O.R.  
(3d) 603 (S.C.J.); Rentway Canada Ltd. v. Laidlaw Transport Ltd., [1989] O.J. No. 786 (H.C.J.), aff'd [1994] O.J.  
No. 50 (C.A.); Nicholson v. John Deere Ltd. (1986), 58 O.R. (2d) 53 (H.C.J.), aff’d [1989] O.J. No. 495 (C.A).  
51 Donoghue v. Stevenson, [1932] A.C. 562 (H.L.).  
52 1688782 Ontario Inc. v Maple Leaf Foods Inc., 2020 SCC 35; Arora v. Whirlpool Canada LP, 2012 ONSC 4642,  
aff’d 2013 ONCA 657, leave to appeal ref’d [2013] S.C.C.A. No. 498; Winnipeg Condominium Corporation No. 36  
v. Bird Construction Co., [1995] 1 S.C.R. 85.  
53 Andersen v. St. Jude Medical, Inc., 2012 ONSC 3660; Bow Valley Husky (Bermuda) Ltd. v. Saint John  
Shipbuilding Ltd., [1997] 3 S.C.R. 1210; Hollis v. Dow Corning Corp., [1995] 4 S.C.R. 634; Lambert v. Lastoplex  
Chemicals Co., [1972] S.C.R. 569.  
 
on the notion that the putative class members have a claim for psychological harm arising from  
the contaminated valsartan being recalled and their being advised that NDMA and NDEA are  
possible carcinogens increasing the risk that the Class Members will be diagnosed with cancer.  
[163] The second branch of the Plaintiffs’ products liability claim is the claims for the pure  
economic losses of medical bills, medical monitoring, refunds, and costs for the drugs thrown  
away.  
[164] In the following discussion of the cause of action, common issues, and preferable procedure  
criteria ensemble, I shall consider the two branches of the Plaintiffs’ products liability claim  
separately, beginning with the psychological harm damages cause of action.  
(a) Products Liability and the Claim for Psychological Harm  
[165] The Plaintiffs seek damages for the psychological harm arising from their learning of the  
increased risk of being diagnosed with cancer as a consequence of ingesting the contaminated  
valsartan. The fatal flaw in seeking damages for the harm of an increased risk is that the current  
law is that the creation of risk is not wrongful conduct.54  
[166] The Plaintiffs submit that the shock and trauma of learning that one has been ingesting a  
carcinogen on a daily basis for months or years is self-evidently a traumatic event that rises above  
the ordinary annoyances of life. As noted above, the Plaintiffs marshalled evidence in an effort to  
show some basis in fact that a significant portion of the membership of the class sustained  
compensable psychological harm. The Plaintiffs submit that the Defendants’ argument regarding  
a negligible risk cannot form part of the section 5(1)(a) test and that the degree of risk is a matter  
that goes to the merits and not to the certifiability of the proposed class action.  
[167] The Plaintiffs’ efforts to establish a cause of action and some basis in fact for a claim for  
psychological harm, however, avail them naught, because as explained in Atlantic Lottery Corp.  
Inc. v. Babstock,55 the contemporary law is that the creation of risk as such is not wrongful conduct.  
[168] Atlantic Lottery Corp. Inc. v. Babstock, was a proposed class action against the Atlantic  
Lottery Corp. The action was on behalf of persons who played video lottery terminal games  
operated by the Atlantic Lottery. The plaintiffs alleged that the video games were inherently  
dangerous.  
[169] In Atlantic Lottery Corp. Inc. v. Babstock, it was a litigation strategy feature of the  
Plaintiffs’ case – similar to the case at bar – that the plaintiffs purposefully did not propose to  
prove that the video games action actually caused psychological harm (addiction or suicides). The  
Plaintiffs’ allegation rather was that all the putative class members suffered the injury of an  
increased risk of addiction and suicidal ideation. They alleged that the Atlantic Lottery had a duty  
to warn about the risk of addiction and of suicidal ideation. The plaintiffs advanced three causes  
of action: waiver of tort, breach of contract, and unjust enrichment. The alleged breached terms of  
contract were, among other things to provide video games that were safe.  
54 Kaissieh v. Done, 2022 ONSC 425; 1688782 Ontario Inc. v Maple Leaf Foods Inc., 2020 SCC 35; Atlantic  
Lottery Corp. Inc. v. Babstock, 2020 SCC 19; Ring v. Canada (A.G.), 2010 NLCA 20, leave to appeal ref’d [2010]  
S.C.C.A. No. 187; Rothwell v. Chemical & Insulating Co. Ltd. [2007] UKHL 39.  
55 2020 SCC 19 (Justice Brown, Abella, Moldaver, Côté and Rowe, JJ. concurring; Justice Karakatsanis,(Wagner,  
C.J., Martin and Kasirer, JJ, dissenting in part).  
 
[170] In the result, the Supreme Court would not allow certification. The action was dismissed  
because the plaintiffs failed to satisfy the cause of action criterion. The Supreme Court was  
unanimous that the waiver of tort, disgorgement, and unjust enrichment claims did not have any  
reasonable chance of success. A majority of the Court comprised of Justice Brown with Justices  
Abella, Moldaver, Côté, and Rowe concurring, also held that there was no reasonable cause of  
action for breach of contract. A minority, Justice Karakatsanis with Chief Justice Wagner, Justices  
Martin and Kasirer concurring, dissenting in part, would have certified only the breach of contract  
claim.  
[171] In Atlantic Lottery Corp. Inc. v. Babstock, the Supreme Court was unanimous that waiver  
of tort was not a cause of action and as a legal term it should be abandoned. In discussing the  
demise of waiver of tort as a doctrine and in discussing in what circumstances, there might be a  
gains-based remedy requiring a defendant to disgorge its ill-gotten gains, Justice Brown discussed  
the nature of culpable wrongdoing. Justice Brown stated at paragraph 33:  
33. It is therefore important to consider what it is that makes a defendant's negligent conduct  
wrongful. As this Court has maintained, "[a] defendant in an action in negligence is not a wrongdoer  
at large: he is a wrongdoer only in respect of the damage which he actually causes to the plaintiff"  
(Clements v. Clements, 2012 SCC 32, [2012] 2 S.C.R. 181, at para. 16). There is no right to be free  
from the prospect of damage; there is only a right not to suffer damage that results from exposure  
to unreasonable risk (E. J. Weinrib, The Idea of Private Law (rev. ed. 2012), at pp. 153 and 157-58;  
R. Stevens, Torts and Rights (2007), at pp. 44-45 and 99). In other words, negligence "in the air" --  
the mere creation of risk -- is not wrongful conduct. Granting disgorgement for negligence without  
proof of damage would result in a remedy "arising out of legal nothingness" (Weber, at p. 424). […]  
[172] For present purposes, what is particularly important to observe is that the Plaintiffs’  
approach in Atlantic Lottery Corporation is similar to the approach of the Plaintiffs in the  
immediate case that focuses on damages from an increased risk of physical harm rather than actual  
damages having been occasioned by the manifestation of actual harm.  
[173] Atlantic Lottery Corporation v. Babstock demonstrates that for negligence actions not to  
be doomed to fail there must be wrongful conduct causing actual harm. As Justice Brown noted at  
paragraph 34 of his judgment “Tort law does not treat plaintiffs "merely as a convenient conduit  
of social consequences" but rather as "someone to whom damages are owed to correct the wrong  
suffered"” and, in a passage that could be applied to the immediate case, Justice Brown stated at  
paragraph 37 of his judgment:  
37. Causation of damage is a required element of the tort of negligence. As I have explained, the  
conduct of a defendant in negligence is wrongful only to the extent that it causes damage (Clements,  
at para. 16). While the plaintiffs allege that ALC had a duty to warn of the inherent dangers  
associated with VLTs, including the risk of addiction and suicide, those dangers are not alleged to  
have materialized. […]  
[174] The principle that legally culpable wrongdoing cannot be based just on conduct increasing  
the plaintiff’s risk of harm and that for a legally viable tort claim there must be actual physical  
injury to person or property or psychological harm to person that has actually materialized has  
been recognized in cases both before and after Atlantic Lottery Corporation v. Babstock.56  
56 In addition to the cases discussed next see: Kaissieh v. Done, 2022 ONSC 425; Kane v. FCA US LLC, 2022  
SKQB 69; Carter v Ford Motor Company of Canada, 2021 ONSC 4138.  
[175] In 1688782 Ontario Inc. v. Maple Leaf Foods Inc.,57 discussed further below, in a majority  
decision written by Justices Brown and Martin, the Supreme Court dismissed a negligence claim  
in a proposed class action by Mr. Submarine franchisees, whose supply chain for sandwich meats  
was disrupted for several months when the defendant Maple Leaf Foods, the franchisor’s supplier,  
recalled its goods because of a listeria outbreak at its processing plant.  
[176] 1688782 Ontario Inc. v. Maple Leaf Foods Inc. demonstrates that the legal policy of the  
law of negligence is that with a few exceptions that can be justified on public policy grounds, tort  
law leaves pure economic losses to be addressed by the law of contract. I shall discuss the  
Plaintiffs’ claims for pure economic losses in the next part of this decision, but for present  
purposes, in Maple Leaf Foods, in their explanation of the law, Justices Brown and Martin  
confirmed the “liability rule” from Atlantic Lottery Corp. Inc. v. Babstock,58 that negligence law  
does not recognize the risk of injury or harm or the increased risk of harm or injury as a  
compensable type of damages. Justices Brown and Martin stated at paragraphs 44 of their  
judgment:  
44. At first glance, the liability rule in Winnipeg Condominium may appear curious, since it appears  
as though liability is imposed not in respect of damage that has occurred to the plaintiff's rights, but  
in respect of a real and substantial danger thereto. As a general principle, there is no liability for  
negligence "in the air", for "[t]here is no right to be free from the prospect of damage" but "only a  
right not to suffer damage that results from exposure to unreasonable risk" (Atlantic Lottery Corp.  
Inc. v. Babstock, 2020 SCC 19, at para. 33 (emphasis in original); Clements v. Clements, 2012 SCC  
32, at para. 16; Ratych v. Bloomer, [1990] 1 S.C.R. 940, at p. 964).  
[177] I appreciate that before the clarification of the law provided by Atlantic Lottery Corp. Inc.  
v. Babstock and 1688782 Ontario Inc. v. Maple Leaf Foods Inc., there were cases in which claims  
for pure economic loss for an increase of the potentiality harm from a defective pharmaceutical or  
medical product or safety product were certified,59 but this law does not represent the current state  
of the law in Canada.  
[178] In Ring v. Canada (A.G.),60 a class action was brought on behalf of persons who were at  
the Gagetown, New Brunswick, Canadian Forces Base (“CFB”) during the period when CFB  
Gagetown was sprayed with a toxic herbicide. The class action was brought on behalf of the  
persons: (a) who had been diagnosed with lymphoma and (b) who had been at the military base  
but who were lymphoma asymptomatic. It was not disputed that for those who have been  
diagnosed with lymphoma and who alleged that the lymphoma was the result of exposure to the  
toxin, the Plaintiff had pleaded a reasonable cause of action. However, the Court of Appeal of  
Newfoundland and Labrador held that there was no reasonable cause of action for the  
asymptomatic proposed class members who were not claiming damages for physical or  
psychological injuries but were claiming the costs of medical testing to determine whether there  
was agent orange in their bodies. The Court of Appeal also concluded that the entire proposed  
57 2020 SCC 35. (Brown and Martin, JJ, Moldaver, Côté, and Rowe JJ, concurring; Karakatsanis, J., Wagner C.J.  
and Abella, and Kasirer JJ, dissenting).  
58 2020 SCC 19.  
59 Banerjee v. Shire Biochem Inc., 2010 ONSC 889; Anderson v. St. Jude Medical Inc. [2003] O.J. No. 3556  
(S.C.J.); Hughes v. Sunbeam Corp (Canada) Ltd. (2002), 61 O.R. (3d) 433 (C.A.); Wilson v. Servier Canada Inc.  
(2000) 50 OR. (3d) 219 (S.C.J.), leave to appeal ref’d [2001] O.J. No. 4716 (Div. Ct.); Nantais v. Telectronics  
Proprietary (Canada) Ltd., [1995] O.J. No. 2592 (Gen. Div.), leave to appeal ref’d [1995] O.J. No. 3069 (Div. Ct.);  
Anderson v. Wilson (1999), 44 O.R. (3d) 673 (C.A.).  
60 2010 NLCA 20, leave to appeal ref’d [2010] S.C.C.A. No. 187, rev’g [2007] N.J. No. 273 (SCTD).