No.
Vancouver Registry
IN THE SUPREME COURT OF BRITISH COLUMBIA
BETWEEN:
** by his litigation guardian, **
and the said **
PLAINTIFFS
AND:
DEFENDANTS
STATEMENT OF CLAIM
1. The Plaintiff, **, (“**”) is a disabled person and resides in a group home operated for the benefit of mentally disabled people at **, in the City of Vancouver, in the Province of British Columbia.
2. The Plaintiff, **, is retired and is the litigation guardian and father of the Plaintiff, **, and resides at **, in the City of Vancouver, in the Province of British Columbia.
3. The Defendant, Eli Lilly Canada Inc., is an Ontario corporation registered extraprovincially within the Province of British Columbia on April 1, 1998 under number A0047013 and has its registered mailing and delivery addresses at Suite 2100, 1075 West Georgia Street, in the City of Vancouver, in the Province of British Columbia.
4. The Defendant, Eli Lilly and Company, is a foreign corporation with its head office and main place of business at Lilly Corporate Center, Indianapolis, Indiana, United States of America.
5. At all times material hereto, the Defendants, each on their own behalf and in conjunction with each other, were involved in and/or responsible for the research, development, manufacturing, sales, distribution and/or marketing of Zyprexa (also known as Olanzapine) in Canada.
6. At all times material hereto, the Defendants (hereinafter collectively referred to as “Eli Lilly”) were affiliates of each other, were inextricably interwoven and were agents of each other for the purpose of performing the activities described in the next preceding paragraph.
7. In bringing this action on behalf of a class of people in the Province of British Columbia who were prescribed Zyprexa, to be further defined in the motion for certification, the Plaintiffs plead and rely upon the provisions of the Class Proceedings Act, R.S.B.C. 1996, c. 50.
8. Zyprexa is among a group of drugs called the “atypical antipsychotic drugs” prescribed for the treatment of certain disorders. Among these disorders are schizophrenia and bipolar disorder. It works by blocking the action of the neurotransmitters serotonin and dopamine, thus producing a tranquilizing and antipsychotic effect.
9. Zyprexa was first approved for marketing and sale for the treatment of schizophrenia in Canada in 1996. Zyprexa was approved for marketing and sale for the treatment of bipolar disorder in 2003. Eli Lilly heavily promoted Zyprexa as a safe and effective treatment for psychotic disorders, with fewer adverse side effects than other treatments.
10. Eli Lilly further induced physicians to prescribe Zyprexa for treating disorders for which Health Canada had not approved Zyprexa. Zyprexa has been prescribed for the treatment of schizophrenia, bipolar disorder, depression and many of other mental illnesses and conditions.
11. Eli Lilly undertook advertising campaigns promoting the widespread use of Zyprexa. Since its introduction into the Canadian market, sales of Zyprexa in Canada have been strong. There were 6 million prescriptions for Zyprexa in Canada over the 12 months ending October 2003. Total sales of Zyprexa in Canada were valued at $223 million in 2002, and over $4 billion worldwide in 2003.
12. Zyprexa has been associated with an increased risk of developing diabetes, hyperglycemia, pancreatitis, ketoacidosis and other injuries.
13. Eli Lilly knew or ought to have known prior to the date upon which Zyprexa was prescribed for ** that there were significantly increased risks of serious adverse health complications caused by ingesting Zyprexa. Eli Lilly failed to properly apprise the Plaintiffs or physicians in Canada of those risks.
14. Eli Lilly purposefully minimized and understated health hazards and risks associated with Zyprexa. Eli Lilly, through literature and oral statements, deceived potential users of Zyprexa and their physicians by relaying positive information, including testimonials from satisfied users and by manipulating statistics to suggest widespread acceptability, while downplaying the known adverse and serious health effects of the drug. Eli Lilly falsely and fraudulently withheld relevant information from potential users of Zyprexa.
15. In an October 16, 2003 press release, Eli Lilly disclosed a Health Canada order directing it to include updated information on hyperglycemia and diabetes on the labels of their antipsychotics.
16. ** was prescribed Zyprexa by his physician and began ingesting it several years ago and continued taking it until August 19, 1997.
17. ** used Zyprexa in accordance with the package label and consumer information pamphlet and in the manner in which it was intended to be used.
18. In August 1997, ** collapsed, was hospitalised and was diagnosed with diabetes by his family physician. He will require lifelong medical monitoring in relation to his diabetes and is required to take medications in relation to this condition and will incur expenses for those medications for the duration of his life.
19. **’s diabetic condition was caused directly by his ingestion of Zyprexa and had he been made aware of the serious adverse health complications he might experience from ingesting Zyprexa, he would not have taken the drug.
20. Eli Lilly at all times material hereto, owed a duty of care to ** to:
(a) ensure that Zyprexa was fit for its intended or reasonably foreseeable use;
(b) conduct appropriate testing to determine whether and to what extent ingestion of Zyprexa posed serious health risks, including the increased risk of developing diabetes and other disorders; and
(c) properly warn ** and his physician that ingestion of Zyprexa carries increased risk of developing serious health related complications.
21. The Plaintiffs state that Eli Lilly negligently breached their duty of care and that their damages were caused by the negligence of Eli Lilly. Such negligence includes but is not limited to the following:
(a) Eli Lilly failed to ensure that Zyprexa was not dangerous to recipients during the course of its use and that the drug was fit for its intended or reasonably foreseeable use;
(b) Eli Lilly failed to adequately test Zyprexa in a manner that would fully disclose the magnitude of the risks associated with its use, including but not limited to the increased risk of developing serious adverse health related complications;
(c) Eli Lilly failed to give Health Canada complete and accurate information;
(d) Eli Lilly failed to conduct adequate follow-up studies on the efficacy and safety of Zyprexa;
(e) Eli Lilly failed to provide ** and his physician with adequate warning of the risks associated with ingesting Zyprexa, including but not limited to the increased risk of developing serious health related complications;
(f) Eli Lilly failed to provide ** and his physician with adequate information and warnings respecting the correct usage of Zyprexa;
(g) Eli Lilly failed to provide adequate updated and current information to ** and his physician respecting the risks and efficacy of Zyprexa as it came available from time to time;
(h) Eli Lilly failed to provide adequate warnings of the potential hazards of ingesting Zyprexa on package labels;
(i) Eli Lilly failed to provide adequate warnings of the risks associated with Zyprexa, including the increased risk of developing serious adverse health related complications, on the customer information pamphlets in Canada;
(j) Eli Lilly failed to warn ** and his physician about the need for comprehensive regular medical monitoring to ensure early discovery of potentially fatal health related complications from the use of Zyprexa;
(k) Eli Lilly failed to establish any adequate procedures to educate their sales representatives and prescribing physicians respecting the correct usage of Zyprexa and the risks associated with the drug;
(l) Eli Lilly represented that Zyprexa was safe and fit for its intended purpose and of merchantable quality when they knew or ought to have known that these representations were false;
(m) Eli Lilly misrepresented the state of research, opinion and medical literature pertaining to the purported benefits of Zyprexa and its associated risks, including the increased risk of developing serious health related complications;
(n) the misrepresentations made by Eli Lilly were unreasonable in the face of the risks that were known or ought to have been known by Eli Lilly;
(o) Eli Lilly actively encouraged and/or affirmatively failed to take effective steps to discourage aggressive dispensation of Zyprexa;
(p) Eli Lilly breached other duties of care to the Plaintiffs and the class of Plaintiffs, details of which breaches are known only to Eli Lilly.
22. The risks associated with the ingestion of Zyprexa, including the increased risk of serious health complications, were in the exclusive knowledge and control of Eli Lilly. The extent of the risks was not known and could not have been known to the Plaintiffs. **’s injuries would not have occurred but for the negligence of Eli Lilly in failing to ensure that Zyprexa was safe for use or, in the alternative, for failing to provide an adequate warning of the risks associated with the use of Zyprexa to ** and to his physician.
23. In its sales brochures, advertisements and other forms of representations to the public, Eli Lilly made statements that had the capability, tendency or effect of deceiving or misleading consumers which constituted deceptive and unconscionable acts and the Plaintiffs plead and rely upon the provisions of the British Columbia Business Practices and Consumer Protection Act, S.B.C. 2004.
24. As a result of the conduct of Eli Lilly as hereinbefore set out, the Plaintiffs and other proposed class members have, and will continue to incur, medical expenses, home care expenses, loss of income, loss of opportunity, pain and suffering, and an inability to enjoy their lives.
25. The conduct of Eli Lilly as hereinbefore set out showed reckless disregard for the well being of the public, including ** and members of the potential class. Eli Lilly’s negligence was callous and arrogant and offends the ordinary community standards of moral and decent conduct. The actions, omission, or both, of Eli Lilly involved such want of care as could only have resulted from actual conscious indifference to the rights, safety or welfare of ** and all other members of the proposed class and the Plaintiffs on their own behalf and on behalf of all proposed class members hereby claim for aggravated and punitive damages.
WHEREFORE the Plaintiffs claim on their own behalf and on behalf of members of the proposed class as follows:
(a) General damages;
(b) Aggravated damages;
(c) Punitive damages;
(d) Special damages;
(e) Costs;
(f) Interest pursuant to the Court Order Interest Act; and
(g) Such further and other relief as to this Honourable Court may seem just.
PLACE OF TRIAL: VANCOUVER, BRITISH COLUMBIA.
DATED at the City of North Vancouver, in the province of British Columbia, this __ day of January, 2005.
James M. Poyner
Solicitor for the Plaintiffs
THIS STATEMENT OF CLAIM is filed by JAMES M. POYNER of the law firm of POYNER BAXTER, Barristers & Solicitors, whose place of business and address for delivery is: Lonsdale Quay Plaza, #408 – 145 Chadwick Court, North Vancouver, B.C. V7M 3K1 – Telephone: 604-988-6321 – Fax: 604-988-3632