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COURT FILE NUMBER 1169/2013
COURT OF QUEEN’S BENCH FOR SASKATCHEWAN
JUDICIAL CENTRE OF SASKATOON
PLAINTIFFS
DEFENDANTS
CHRISTOPHER ROBIN GRAHAM and TANYA
TOSCZAK
HOFFMANN LA-ROCHE LIMITED, and
MYLAN PHARMACEUTICALS ULC
Brought under The Class Actions Act
AMENDED STATEMENT OF CLAIM
NOTICE TO DEFENDANTS
1 The plaintiffs may enter judgment in accordance with this Amended Statement of Claim
or the judgment that may be granted pursuant to The Queen's Bench Rules unless, in
accordance with paragraph 2, you:
(a) serve a Statement of Defence on the plaintiffs; and
(b) file a copy of it in the office of the local registrar of the Court for the judicial
centre named above.
2 The Statement of Defence must be served and filed within the following period of days
after you are served with the Amended Statement of Claim (excluding the day of service):
(a) 20 days if you were served in Saskatchewan;
(b) 30 days if you were served elsewhere in Canada or in the United States of
America;
(c) 40 days if you were served outside Canada and the United States of America.
3 In many cases a defendant may have the trial of the action held at a judicial centre other
than the one at which the Amended Statement of Claim is issued. Every defendant should
consult a lawyer as to his or her rights.
4 This Amended Statement of Claim is to be served within 6 months from the date on
which it is issued.
5 This Statement of Claim is issued at the above-named judicial centre on the “27 th" day
of August 2013.
“B. W EREZAK
DEPUTY LOCAL REGISTRAR”
Local Registrar
This Statement of Claim is amended at the above-named judicial centre the 27th day of November, 2013.
I. PARTIES
1.
Tanya Tosczak resides in Weyburn.
2.
Christopher Robin Graham resides in Regina.
3.
Hoffmann-La Roche Limited (“Hoffman-La Roche”) and Mylan Pharmaceuticals
ULC (“Mylan”) were incorporated under Canadian laws and conduct business in Canada,
including in Saskatchewan.
II. FACTS
(1) accutane
4.
Hoffman-La Roche Limited researched, developed, designed, tested, manufactured,
marketed, and distributed prescription drugs containing the active ingredient isotretinoin
(“Accutane”).
5.
From 1983, Hoffmann-La Roche Limited manufactured and marketed Accutane in
Canada as Accutane, RoAccutane, and Accutane Roche. From 2005, Mylan
Pharmaceuticals ULC manufactured and marketed Accutane in Canada as Clarus
6.
In February 2002, Hoffman La Roche's patents for isotretinoin expired. In late 2005,
Health Canada approved an application by Mylan to distribute a generic version of a
prescription drug containing isotretinoin, under the name Clarus. Mylan began selling
Clarus in Canada on April 1st, 2005. Mylan was obliged to publish a product monograph
approved by Health Canada, and its version was so similar to the product monograph
published by Hoffman La-Roche that any differences are immaterial.
7.
The Defendants marketed Accutane to provide cosmetic relief from acne.
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8.
When used as directed in the product monographs, for short and long term and as
reasonably foreseeable, while Accutane is being used and after a patient ceases to use it,
Accutane can cause inflammatory bowel disease, including Crohn’s disease and ulcerative
colitis.
(a) Crohn’s disease is characterized by lesions and inflammation along the digestive
tract and can lead to intestinal blockage, bowel cancer, ulcers, incontinence,
infection, nutritional deficiencies, and removal of the colon and rectum.
(b) Ulcerative colitis is a painful inflammation of the large intestine or colon that
can lead to debilitating conditions such as a perforated colon, severe bleeding, colon
cancer, and liver disease.
Each of the Defendants acted in concert with the others. Each of the Defendants
is vicariously liable for the actions of the others. Each of the Defendants were part of one
worldwide corporate entity acting together and in common ways. The Plaintiff and Class
Members can not reasonably be expected to know which of the Defendants has committed
which individual wrong because the Defendants work secretively and collectively but each
is responsible for the wrongdoing of the other.
9.
Accutane is more powerful than other acne medications as it attacks acne on
multiple levels. Accutane’s mechanism of action includes, inter alia:
(a) shrinking sebaceous glands which results in less sebum (oil) production;
(b) decreasing the build up of cells that cause whiteheads and blackheads;
(c) reducing inflammation; and
(d) helping to kill a microorganism called Propionibacterium acnes that
contributes to acne development.
10.
From when they introduced Accutane into the Canadian market, the Defendants
knew or should have known that Accutane can cause inflammatory bowel disease from:
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(a) their knowledge of a biologically plausible mechanism associated with the class
of drugs to which Accutane belonged; In Dr. U.B. Niederhauser's 2000 study on the
effects of Accutane's primary metabolite 4-oxo-isotretinoin in dogs, there were
cases of diarrhea, visible blood, and mucous in feces with visible damage to the
small and large intestine. In an internal 4-week pilot toxicity study in male beagle
dogs, daily administration of oxo-isotretinoin resulted in retinoid-typical lesions of
the skin and mucosa and intestinal irritation including blood in feces, adhesions,
and epithelial damage.
(b) animal studies that reported fecal bleeding and gastrointestinal lesions,
including dog studies from 1978 and 1981 and monkey studies; In Hoffman
La-Roche’s 1979 Dog Study, the incidence of visible lesions associated with the
gastrointestinal tract and suggestive of gastrointestinal irritation was dose-related.
Dogs that were administered a low dose of Accutane experienced a toxicity rate in
the gastrointestinal tract that was twice that of the control group which were not
administered Accutane. Dogs that were administered a medium dose of Accutane
experienced a toxicity rate in the gastrointestinal tract that was four times that of
the control group. Dogs that were administered a high dose of Accutane
experienced a toxicity rate in the gastrointestinal tract that was ten times that of the
control group. In Roche's 1981 Dog Study, there were cases of gastrointestinal
bleeding, hemorrhagic proctitis, diarrhea, bloody-mucoid stools, and observations
of fresh and digested blood in the feces of dogs who were administered Accutane.
(c) original clinical trial data that; In Hoffman La-Roche's human studies, which
were performed in 1981, out of 523 patients who were administered Accutane 113
patients experienced gastrointestinal problems and 5 had to leave the study due to
gastrointestinal problems. Original clinical trial data showed that 1 in 523 patients
dropped out for inflammatory bowel disease compared to an incidence of 1 in
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10,000 in the general population;.
(d) post-marketing adverse drug reaction reports;
(e) numerous challenges and rechallenges; Challenge–dechallenge–rechallenge
(CDR) is a medical testing protocol in which a medicine or drug is administered,
withdrawn, then re-administered, while being monitored for adverse effects at each
stage. If adverse events appear when the drug is administered, disappear when the
drug is removed, and reappear when the drug is re-administered, there is a basis to
establish a causal link. From 1985 onward, there have been several positive
re-challenge reports with adverse events such as colitis, fissures, proctitis,
ulcerative proctitis, hemorrhagic colitis, Crohn's disease, blood in stool,
hemorrhage rectum, ulcerative colitis, inflammatory bowel disease, which appeared
when Accutane was administered or re-administered.
(f) the 1985 and 1986 Schifferdecker reports; In Hoffman La-Roche's review of
post-marketing adverse events associated with Accutane for the first half of 1987,
1093 patients experienced 1692 adverse events, 115 of which were gastrointestinal
system disorders. In Hoffman La-Roche's review of post-marketing adverse events
associated with Accutane for the first half of 1988, 915 patients experienced 1566
adverse events, 112 of which were gastrointestinal system disorders.
(g) internal reports and causality assessments, including:
(i) the 1994 Lefrancq Report, Peck Patent,; Hoffman La-Roche's internal
causality assessments noted that there were 159 reports of exposure to
Accutane received by Hoffman La-Roche from world wide sources of
gastrointestinal inflammatory disorder and 51 reports of gastrointestinal
spastic hypermotility. Of the 159 reports, there were 64 cases of Crohn's
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disease, of which, 18 had resolved upon discontinuation of therapy, 1
recovered with sequelae, 24 were persisting at the time of reporting and 21
remained unknown at the time of reporting. Causality was assessed as
related in 27 cases and 37 were either unrelated or unknown. There were 29
cases of inflammatory bowel disease of which, 12 resolved upon
discontinuation of therapy and 7 were persisting at the time of reporting.
Causality was assessed as related in 13 reports while 16 remained unknown.
According to Le Francq's 1994 Report: 33 cases of colitis have been
spontaneously reported up to 1994. Roche internally concludes that “in rare
cases Accutane my induce or aggravate a preexisting colitis;
(ii) Peck Patent; In Dr. Peck's patent for using Accutane in the treatment of
acne, it is noted that inflammation of the intestines is a potential side effect
(colitis);
(iii) Core Data Sheet; according to Hoffman La-Roche's internal 1994 and
1998 Core Data Sheet, Toxicity Data, andlisted under undesirable effects
is gastro-intestinal system disorders including inflammatory bowel disease
such as colitis, ileitis, and hemorrhaging; and
(iv) Toxicity Data; according to Hoffman La-Roche's internal toxicity data,
toxicity includes intestinal effects (inflammatory bowel disease).
(h) medical and scientific articles published in 1986 (Brodin), 1987 (Martin), 1996
(Deplaix),based on publicly available reports, published in:
(i) 1986 (Brodin): “... inflammatory bowel disease is caused by isotretinoin”;
(ii) 1987 (Martin): “... strongly suggests that [isotretinoin] was directly
responsible”;
(iii) 1996
(Deplaix): “...Isotretinoin can induce hemorrhagic acute
colitides”;
(iv) 2001 (Reniers & Howard), 2003 (Sartor), and 2006 (Passier; Reddy):
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“... Probable isotretinoin-induced IBD”;
(v) 2005 (Yamada): “Isotretinoin, a vitamin A analog used in treating acne,
causes acute colitis and may reactivate quiescent inflammatory bowel
disease”;
(vi) 2006 (Passier): “inflammatory bowel disease induced by isotretinoin
use...”;
(vii) 2006 (Reddy): “Accutane was the ‘probable’ or ‘highly probable’
causes of IBD in 73% of cases - Remaining 27% rated as ‘possible’. No
cases were ‘doubtful’.
(2) tanya
11.
In 1993, Tanya Tosczak began taking Accutane manufactured by Hoffman La-
Roche for her acne. If Hoffman-LaRoche the Defendants had discharged their its duties
of care as outlined, Tanya would not have taken Accutane.
12.
Because she took Accutane, Tanya developed ulcerative colitis.
(a) Before taking Accutane, she was in good health and her family had no history
of inflammatory bowel disease.
(b) After she began taking Accutane, she began to experience stomach pain,
cramping, and blood in her stool. In 1994, she was diagnosed with ulcerative
colitis.
13.
As a result of her Accutane induced ulcerative colitis:
(a) Tanya was unable to perform the duties of her employment as a hair dresser.
During a 15 minute hair cut, 5-6 times, she had to use the bathroom or deal with
the immense abdominal pain she was experiencing. Sometimes, she had to leave
work and go to the hospital because of painful cramps, bloating, anemia, and the
passing of significant amounts of blood through her bowel movements. She has
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frequently missed work and lost income.
(b) She suffered physically and mentally, and her qualify of life greatly diminished.
(i) When she went to the bathroom, fecal blood sprayed up the back of the
wall and behind the toilet, due to the force that the stool came out at.
(ii) She has and will continue to have to spend an unreasonable portion of
every day for the rest of her life in the bathroom.
(iii) Tanya’s ulcerative colitis spread to her mouth and body.
(iv) She had a difficult time eating and had to make extreme and
unpalatable changes to her diet. She is required to incur extraordinary
expenses associated with a special diet and nutritional supplements
(v) She is regularly in pain.
(vi) She regularly misses social events with friends and family, and
ordinary social events often end in humiliating and embarrassing episodes
related to her condition.
(c) Tanya was prescribed and paid for costly medications and treatments for her
inflammatory bowel disease including Prednisone, Buscopan, and Demerol.
(d) She has to undergo costly surgical procedures. In 1996, a gastroenterologist
required her to have immediate surgery to remove her large bowel. Since then,
Tanya had to undergo additional surgeries to deal with bowel obstructions. She
continues to suffer from obstructions which require hospitalization. Her bowel and
intestines are permanently scarred.
(e) Under the advice of specialists, Tanya is regularly required to receive costly and
intrusive physical examinations and biopsies of her ileo-anal pouch with flexiscopes to check for cancer and other issues that can develop. After these
procedures are completed, Tanya`s colon and large intestine are inflamed and she
experiences painful obstructions.
14.
The Defendants acted secretively. They deliberately kept information about their
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conduct and the dangers of Accutane from Tanya and Class Members, who only recently
could have been expected to know their injuries were caused by Accutane.
(3) christopher
15.
In 1991, Christopher Robin Graham began taking Accutane manufactured by
Hoffman La-Roche for his acne. If Hoffman-LaRoche had discharged its duties of care
as outlined, Chris would not have taken Accutane.
16.
Because he took Accutane, Chris developed ulcerative colitis.
(a) Before taking Accutane, Chris was in good health and his family had no history
of inflammatory bowel disease.
(b) 13 years after Chris concluded Accutane treatment, he began to experience
gastrointestinal problems. Symptoms in the beginning included abdominal pain,
diarrhea, and blood in his stool.
(c) In 2007, Chris' symptoms became so severe that he had to be hospitalized.
Shortly after, he was diagnosed with ulcerative colitis.
17.
As a result of his Accutane induced ulcerative colitis:
(a) Chris was unable to perform the duties of his employment as a photographer.
Because of the symptoms of ulcerative colitis, sometimes, he had to leave work and
go to the hospital because of painful cramps, bloating, anemia, and the passing of
significant amounts of blood through his bowel movements. This put Chris behind
in his work and resulted in a loss of income.
(b) He suffered physically and mentally, and his quality of life greatly diminished.
(i) When he was hospitalized, most recently for 10 days at a time, he would
experience immense pain and was given morphine to cope. On one
occasion, he lost 40lbs.
(ii) He experiences bowel pain from time to time.
Page 9 of 17
(iii) He was told that if his condition did not improve, he could lose his
colon.
(iv) He regularly misses social events with friends and family, and ordinary
social events often end in humiliating and embarrassing episodes related to
his condition.
(c) Chris was prescribed and he partially paid for costly medications and treatments
for his inflammatory bowel disease including Remicade, Azathioprine, and
Mesalamine, which he has been taking since March 2009. Saskatchewan's Special
Support Program paid for the rest.
18.
In or around March 2012, Chris saw an advertisement on US television in which
an American law office was suing on behalf of sufferers of ulcerative colitis and Crohn's
disease who had taken Accutane. This was the first instance where Chris was made aware
of the fact that his ulcerative colitis may have been caused by Accutane.
III. CAUSES OF ACTION
19.
On behalf of herselfthemselves and class members, the Plaintiffs pleads the
following:
(1) consumer protection
20.
The Defendants engaged in: unfair practices; deceptive acts or practices,
unconscionable acts or practices, unfair business practices, unfair consumer practices;
prohibited practices; false, misleading or deceptive representations; unfair trade practices,
and breached statutory, express, or implied conditions or warranties by marketing Accutane
in Canada and failing to include an adequate warning in the Accutane product monograph.
21.
The Defendants deliberately withheld information from the public about the risk
of inflammatory bowel disease associated with Accutane use.
Page 10 of 17
22.
Accutane was not of acceptable quality, state, or condition; particular standard,
quality, grade, style, model, origin, or method of manufacture; or merchantable quality.
Accutane was used only for cosmetic results. The serious and life-threatening side effects
of the drug Accutane far outweigh its benefits.
23.
On behalf of class members, the Plaintiff pleads the consumer protection and trade
practice legislation in Canada, Saskatchewan, and other provinces, including:
(a) Business Practices and Consumer Protection Act, S.B.C. 2004, c.2, as am.,
including ss. 4-5 & 8-10;
(b) Fair Trading Act, R.S.A. 2000, c. F-2, as am., including ss. 6, 7 & 13;
(c) The Consumer Protection Act, S.S. 1996, c. C-30.1, as am., including ss. 5- 8,
14, 16, 48, 64 & 65;
(d) The Business Practices Act, S.M. 1990-91, c. 6, as am., including ss. 2 & 23;
(e) Consumer Protection Act, 2002, S.O. 2002, c. 30, Sched. A, as am., including
ss. 8, 11 & 14;
(f) Consumer Protection Act, R.S.Q. c. P-40.1, as am., including ss. 219 & 272;
(g) Consumer Product Warranty and Liability Act, S.N.B. 1978, c. C-18.1,
including ss. 4, 10, 12, 15-18, 23 & 27;
(h) Consumer Protection Act, R.S.N.S. 1989, c. 92, including ss. 26 & 28A;
(i) Business Practices Act, R.S.P.E.I. 1988, c. B-7, as am., including ss. 2-4;
(j) Consumer Protection and Business Practices Act, SNL 2009, c C-31.1, including
ss. 7, 8 & 10; and
(k) The Competition Act, R.S.C. 1985, c. C-34, including ss. 36, 52 and 74.01.
(2) negligence
24.
As manufacturers and marketers of a prescription pharmaceutical, the Defendants
owed class members duties: (a) not to market an unreasonably dangerous drug, or
Page 11 of 17
alternatively (b) to warn of the risk of inflammatory bowel disease, including ulcerative
colitis and Crohn’s disease and (c) to conduct proper testing and development.
25.
Before marketing Accutane in Canada, the Defendants
(a) conducted no gastrointestinal studies, no control studies regarding inflammatory
bowel disease, and no prospective or retrospective population studies,
(b) conducted no trials with inflammatory bowel disease as an end point, and
(c) hired no outside gastrointestinal experts.
(d) had the Defendants conducted proper testing and development, they would have
been aware of the risk of inflammatory bowel disease, including ulcerative colitis
and Crohn's disease, and they could have passed this information onto medical
professional and the public.
26.
On June 29th, 2009, Hoffman-La Roche Limited withdrew Accutane from 11
countries including the United States, France, and Germany because of complaints that
Accutane caused inflammatory bowel disease, including ulcerative colitis and Crohn's
disease.
27.
The Defendants breached their duty of care by marketing Accutane in Canada at all
and by failing to withdraw Accutane in Canada.
28.
Alternatively, the Defendants breached their duty of care by failing to include a
warning in the Accutane product monograph that Accutane could cause inflammatory bowel
disease. The Accutane product monograph should have stated that:
(a) Accutane can cause inflammatory bowel disease;
(b) in several reported cases, patients who took Accutane developed inflammatory
bowel disease that subsided when they stopped taking Accutane and reappeared
when they started taking Accutane again;
Page 12 of 17
(c) scientific analysis of post-marketing adverse events reports in patients who used
Accutane concluded that Accutane can cause inflammatory bowel disease even in
patients without a prior history of intestinal disorders; and
(d) Accutane is contraindicated in patients who have or are predisposed to
inflammatory bowel disease.
29.
The Defendants marketed Accutane without clear, complete, and current warnings
that Accutane could cause inflammatory bowel disease. No Accutane product monograph
contained a reasonably worded warning that:
(a) the product monograph failed to stated that Accutane was developed as a
chemotherapy;
(b) the labels vaguely referenced nonspecific gastrointestinal symptoms;
(c) there were subsequent references to inflammatory bowel disease, but the
information did not adequately communicate the scope of the risk and the extent of
the defendant’s knowledge;
(d) there was no reference about the permanency of the risk of causing inflammatory
bowel disease;
(e) the monograph did not state that the risk of inflammatory bowel disease is dose
related; and
(f) between 1984 and 1989 there was no change to the Accutane monograph
regarding the risk of inflammatory bowel disease despite an ever escalating increase
in the Defendants’ knowledge thereof.
30.
If the Defendants had discharged their duties, physicians would not have prescribed,
and class members would not have used Accutane and suffered personal injuries and losses
consequent thereon.
(3) subrogated medical claims
Page 13 of 17
31.
The Plaintiffs claims on behalf of the:
(a) Minister of Health of Saskatchewan, for the cost of health services received by
class members under The Department of Health Act, SS 1978, c D-17, s. 19(5);
(b) Minister of Health of British Columbia, for the cost of health services received
by class members pursuant to s. 2 of the Health Care Costs Recovery Act, S.B.C.
2008, c. 27, including necessary operating and care room facilities, diagnostic or
therapeutic X-ray and laboratory procedures, anesthetics, prescriptions and drugs;
(c) Minister of Health of Alberta, for the cost of health services received by class
members pursuant to Part 5, Division 1, of the Hospital Act, R.S.A. 2000, c. H-12,
as am., including in-patient and out-patient services, transportation services, public
health services, mental health services and drug services;
(d) Minister of Health of Manitoba, for the cost of health services received by class
members under s. 106(1) of The Health Services Insurance Act, C.C.S.M. c. H35.
(e) Ontario Health Insurance Plan, for the cost of insured services received by class
members pursuant to Health Insurance Act, R.S.O. 1990, c. H.6, as am., s. 31(1),
including, prescribed services of hospitals and health facilities, prescribed medically
necessary services rendered by physicians, and prescribed health care services
rendered by prescribed practitioners;
(f) Minister of Health and Social Services of Quebec, for the cost of all insured
services furnished or to be furnished pursuant to the Hospital Insurance Act, R.S.Q.
c. A-28, s. 10;
(g) Her Majesty the Queen in right of New Brunswick, for the cost of entitled
services received by class members pursuant to Health Services Act, R.S.N.B. 1973,
c. H-9, as am., s.10, including accommodation and meals, nursing services,
laboratory, radiological and other diagnostic procedures, drugs, use of operating
rooms, case rooms and anaesthetic facilities, and routine surgical supplies;
(h) Her Majesty the Queen in right of Nova Scotia, for the cost of insured hospital
services received by class members pursuant to the Health Services and Insurance
Page 14 of 17
Act, R.S.N.S. 1989, c. 197, as am., s. 18, including benefits under the Insured
Prescription Drug Plan, ambulance services, and insured professional services; and
(i) Minister of Health of Newfoundland and Labrador, for the cost of insured
services received by class members pursuant to s. 5 of the Hospital Insurance
Agreement Act, R.S.N. 1990, c. H-7, s. 5, as am.
(4) estates and derivative claims
32.
On behalf of the estates and families of class members, the Plaintiffs pleads:
(a) Survival of Actions Act, R.S.A. 2000, c. S-27, ss. 2, 5(1), 5(2); The Survival of
Actions Act, S.S. 1990, c. S-66.1, ss. 3 and 6(1)-(3); Trustee Act, R.S.O. 1990, c.
T.23, s. 38(1); Survival of Actions Act, R.S.N.S. 1989, c. 453, ss. 2(1)-(2) and 5;
Survival of Actions Act, R.S.N.B. 2011, c. 227, ss. 3(1)-(2) and 6(1)-(2); Survival
of Actions Act, R.S.P.E.I. 1988, c. S-11, ss. 2 and 5; Survival of Actions Act,
R.S.N.L. 1990, c. S-32, ss. 2 and 4.
(b) Family Compensation Act, R.S.B.C. 1996, c. 126, ss. 2 and 3(8)-(9); ss. 1, 2,
and 3(1) of the Fatal Accidents Act, R.S.A. 2000, c. F-8; The Fatal Accidents Act,
R.S.S. 1978, c. F-11, ss. 2, 3(1), and 4(1)-(3); Family Law Act, R.S.O. 1990, c. F.
3, ss. 61(1)-(2); Fatal Accidents Act, S.N.B. 2012, c. 104, ss. 3, 4, 7; Fatal Injuries
Act, R.S.N.S. 1989, c. 163, ss. 2-3 and 5; Fatal Accidents Act, R.S.P.E.I. 1988, c.
F-5, ss. 1-2, 6; Fatal Accidents Act, R.S.N.L. 1990, c. F-6, ss. 2-4.
(5) medication and medical monitoring
33.
Class members incurred
(a) costs to treat Crohn’s disease including expenses for anti-inflammatory
medication, special diets, and surgeries to remove damaged intestinal tissue, and
(b) costs to treat ulcerative colitis including expenses for anti-inflammatory
medication, immune suppressors, steroids, and surgeries to remove damaged
portions of the colon.
Page 15 of 17
34.
As a result of using Accutane, class members will require annual colonoscopies for
the rest of their lives.
(6) waiver of tort
35.
The Plaintiff iss are entitled to elect to waive the tort and require the Defendants to
account for all or part of the revenue they received from the sales of Accutane in
Saskatchewan and Canada.
36.
As a result of failing to warn medical professionals and consumers about the
potentially serious side effects associated with ingesting Accutane, sales of Canadian
Accutane reached $15 million in 2012 alone.
37.
In March of 1997, the Government of Saskatchewan added Accutane as an eligible
drug on the Saskatchewan Drug Formulary as an eligible benefit under the Ministry of
Health’s Exception Drug Status program. In April of 2006, it added Clarus.
38.
To achieve the listing of Accutane on the Saskatchewan Formulary, the Defendants
misrepresented its safety. If the Defendants had provided full information about the risks
of Accutane, the Ministry of Health would not have placed Accutane on the Formulary.
39.
If the Defendants had complied with the standard of care expected of them,
Accutane would not have been approved for sale in Canada or become listed on the
Saskatchewan Formulary, and the Defendants would not have received revenue associated
with Accutane sales in Canada.
40.
The Defendants may not in good conscience keep their Accutane profits. The
integrity of the pharmaceutical industry in Saskatchewan and Canada would be undermined
if the Defendants did not account to the class for their Accutane revenue.
Page 16 of 17
(7) punitive
41.
The defendants prioritized corporate profits over patient safety. They made a
calculated decision not to appropriately change the product monograph, because they knew
that providing proper warnings would adversely impact the number of prescriptions and
volume of sales of Accutane. Additionally, the Defendants made a calculated decision to
market and notwithstanding mounting evidence of profound danger, to continue to market
Accutane, a drug that providing cosmetic care only which had the significant potential to
cause lifetime and debilitating injury.
III. RELIEF SOUGHT
42.
On behalf of herselfthemselves and other class members, the Plaintiffs claims
compensatory and punitive damages, restitution, the costs of medical monitoring, and prejudgment interest.
DATED AT Regina, Saskatchewan, this 26th day of August, 2013.
“E. Merchant”
___________________________________
AND AMENDED this 27th day of November, 2013.
Address of legal firm:
Name of lawyer in charge of file:
MERCHANT LAW GROUP LLP
2401 Saskatchewan Drive
Regina, Saskatchewan
S4P 4H8
E.F. Anthony Merchant, Q.C.
Telephone number:
(306) 359-7777
Fax number:
(306) 522-3299
Email Address:
[email protected]