NO.
VANCOUVER REGISTRY
BETWEEN:
DEBRA-LEA NELSON
AND:
MERCK FROSST CANADA LTD. , MERCK FROSST CANADA & CO.
and MERCK & CO. INC.
1. The Plaintiff, DEBRA-LEA NELSON, is an office manager and resides at **, in the Province of British Columbia.
2. The Defendant, MERCK FROSST CANADA & CO. (“Merck & Co.”) is a corporation with its headquarters in Halifax, Nova Scotia and maintains a principal place of business in Mississauga, Ontario. At all times Merck & Co. was involved in and/or responsible for the research, development and manufacturing of VIOXX. At all material times, Merck & Co. was an affiliate of MERCK & CO. INC.
3. The Defendant, MERCK FROSST CANADA LTD. (“Merck Ltd.”), is a Federal Corporation, with its registered head office in Kirkland, Quebec. Merck Ltd. is an Extra-Provincial company registered pursuant to the provisions of the Business Corporations Act in British Columbia under number A0054218 and has its mailing address and delivery address in British Columbia at P.O. Box 10026, Pacific Centre South, 26th Floor, 700 West Georgia Street, Vancouver, B.C. V7Y 1B3. At all material times Merck Ltd. was involved in and/or responsible for, the sales, distribution and marketing of VIOXX in British Columbia. At all material times, Merck Ltd. was an affiliate of Merck & Co. Inc.
4. The Defendant, MERCK & CO. INC. (hereinafter referred to as "Merck USA"), is a U.S. company with its headquarters in Whitehouse Station, New Jersey. At all materials times, Merck USA was involved in and/or responsible for the research, development, manufacturing, sales, distribution and/or marketing of VIOXX in Canada. At all material times, Merck USA manufactured, marketed, sold and/or distributed VIOXX in Canada directly or indirectly through an agent, affiliate or subsidiary.
5. The business of each of Merck Ltd., Merck & Co., and Merck USA is inextricably interwoven with that of the other and each is the agent of the other for the purposes of the manufacture, marketing, sale and/or distribution of VIOXX in Canada.
6. At all material times, the Defendants, all or any one of them, were carrying on business as, inter alia, the manufacturers and distributors of VIOXX in Canada.
8. VIOXX is a nonsteroidal, anti-inflammatory drug, specifically a COX-2 inhibitor, which is prescribed to relieve pain and swelling. It is typically used to treat arthritis, acute pain, acute migraine headaches, and menstrual pain and discomfort.
9. VIOXX was first approved for marketing and sale in Canada in or about October,1999. The Defendants immediately and heavily promoted VIOXX as a better option than other arthritis drugs on the premise that it was easier on the stomach.
10. Since its introduction into the Canadian market, sales of VIOXX in Canada have been strong. In 2002, VIOXX was the 10th most prescribed drug in Canada with more than 3 million VIOXX prescriptions written in Canada that year. In 2003, total sales of VIOXX in Canada were valued at $200 million, over $2.5 billion worldwide.
11. VIOXX has been associated with an increased risk of serious, adverse cardiovascular complications, including but not limited to, heart attack, stroke, angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heartbeat, palpitation, premature ventricular contraction, tachycardia, venous insufficiency, cerebrovascular accident, congestive heart failure, deep venous thrombosis, pulmonary embolism, transient ischemic attack, and unstable angina.
12. The Defendants knew or ought to have known at least as early as 2000 that there was a significant risk of serious adverse cardiovascular complications from ingesting VIOXX. The Defendants failed to apprise the Plaintiff or her physicians of that risk.
13. Neither the patient information pamphlet or the prescribing information provided to physicians and pharmacists in Canada, warned of the serious adverse cardiovascular risks associated with ingesting VIOXX. Unlike the information provided to Canadian consumers, the patient information pamphlet available to consumers in the U.S. contained, inter alia, the following warning:
What are the possible side effects of VIOXX?
* Heart attacks and other serious cardiovascular events, such as blood clots in your body have been reported in patients taking VIOXX.
THE EVENT
14. The Plaintiff was born on June 22, 1977 and is now 27 years of age. Since approximately age 17, she has suffered from psoriasis which progressed and in March 2003 she was diagnosed with psoriatic arthritis.
15. In the treatment of the Plaintiff’s arthritic condition, she was prescribed Vioxx by her physician in March of 2003 and ingested Vioxx daily thereafter until she was admitted to the Langley Memorial Hospital on August 14, 2004.
16. In early 2004, the Plaintiff began to experience symptoms including shortness of breath, sleeplessness, fatigue, swelling in the ankles, and others which culminated on August 14, 2004 with severe pain in her left arm and across her left shoulder blade. Upon admission to the Langley Memorial Hospital, she was diagnosed as having sustained congestive heart failure (CHF).
17. Further testing confirmed that the Plaintiff had developed a condition know as idiopathic dilated cardiomyopathy, or, an enlarged heart. She was advised that she had, because of her heart damage, become, at the age of 27 years old, a borderline candidate for a heart transplant operation.
18. Prior to the Plaintiff taking Vioxx, she had never experienced any of the symptoms hereinbefore referred to nor had she experienced or been diagnosed with ever having any cardiovascular complications whatsoever.
19. The Defendants at all material times owed a duty of care to the Plaintiff to:
(a) ensure that VIOXX was fit for its intended or reasonably foreseeable use;
(b) conduct appropriate testing to determine whether and to what extent ingestion of VIOXX posed serious health risks, including the risk of serious adverse cardiovascular complications; and
(c) warn the Plaintiff and her physicians that ingestion of VIOXX carries the risk of serious adverse cardiovascular complications.
20. The Defendants negligently breached their duty of care.
21. The Plaintiff states that her damages were caused by the negligence of the Defendants. Such negligence includes but is not limited to the following:
(a) the Defendants failed to ensure that VIOXX 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) the Defendants failed to adequately test VIOXX in a manner that would fully disclose the magnitude of the risks associated with its use, including but not limited to the risk of serious adverse cardiovascular complications;
(c) the Defendants failed to give Health Canada complete and accurate information;
(d) the Defendants failed to conduct any or any adequate follow-up studies on the efficacy and safety of VIOXX;
(e) the Defendants failed to provide the Plaintiff and her physicians with any adequate warning of the risks associated with ingesting VIOXX, including but not limited to the risk of serious adverse cardiovascular complications;
(f) the Defendants failed to provide the Plaintiff and her physicians with any or any adequate information and warnings respecting the correct usage of VIOXX;
(g) the Defendants failed to provide any or any adequate updated and current information to the Plaintiff and her physicians respecting the risks and efficacy of VIOXX as it came available from time to time;
(h) the Defendants failed to provide warnings of the potential hazards of ingesting VIOXX on package labels;
(i) The Defendants failed to provide warnings of the risks associated with VIOXX, including the risk of serious adverse cardiovascular complications, on the customer information pamphlets in Canada despite the inclusion of such warnings in the customer information pamphlets available to U.S. consumers;
(j) the Defendants failed to warn the Plaintiff and her physicians about the need for comprehensive regular medical monitoring to ensure early discovery of potentially fatal adverse cardiovascular complications from the use of VIOXX;
(k) the Defendants, after noticing problems with VIOXX as early as 2000, failed to issue adequate warnings, timely recall the drug, publicize the problem and otherwise act properly and in a timely manner to alert the public, including warning the Plaintiff and her physicians of the drug’s inherent dangers, including but not limited to the danger of serious adverse cardiovascular complications;
(l) the Defendants failed to establish any adequate procedures to educate their sales representatives and prescribing physicians respecting the correct usage of VIOXX and the risks associated with the drug;
(m) the Defendants represented that VIOXX 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;
(n) the Defendants misrepresented the state of research, opinion and medical literature pertaining to the purported benefits of VIOXX and its associated risks, including the risk of serious adverse cardiovascular complications;
(o) the misrepresentations made by the Defendants were unreasonable in the face of the risks that were known or ought to have been known to the Defendants;
(p) the Defendants failed to timely cease the manufacture and/or distribution of VIOXX when they knew or ought to have known that this drug caused or could cause serious adverse cardiovascular complications;
(q) the Defendants actively encouraged and/or affirmatively failed to take effective steps to discourage aggressive dispensation of VIOXX;
(r) the Defendants breached other duties of care to the Plaintiff and the class of Plaintiffs, details of which breaches are known only to the Defendants.
22. The risks associated with the ingestion of VIOXX, including the risk of serious adverse cardiovascular complications, were in the exclusive knowledge and control of the Defendants. The extent of the risks was not known and could not have been known to the Plaintiff. The likelihood that the Plaintiff has or will sustain an adverse cardiovascular complication would not have occurred but for the negligence of the Defendants in failing to ensure that VIOXX was safe for use or, in the alternative, for failing to provide an adequate warning of the risks associated with VIOXX to the Plaintiff and to the Plaintiff’s physicians.
BUSINESS PRACTICES AND CONSUMER PROTECTION ACT
23. In its sales brochures, advertisements and other forms of representations to the public, the Defendants made statements that had the capability, tendency or effect of deceiving or misleading consumers which constituted deceptive and unconscionable acts and the Plaintiff pleads and relies upon the provisions of the British Columbia Business Practices and Consumer Protection Act, SBC 2004.
DAMAGES
24. As a result of the conduct of the Defendants as hereinbefore set out, the Plaintiff and other proposed class members have sustained serious personal injuries and pain including but not limited to adverse cardiovascular complications.
AGGRAVATED AND PUNITIVE DAMAGES
25. The conduct of the Defendants as hereinbefore set out showed reckless disregard for the well being of the public, the Plaintiff and members of the potential class. The Defendants’ negligence was callous and arrogant and offends the ordinary community standards of moral and decent conduct. The actions, omissions, or both, of the Defendants involved such want of care as could only have resulted from actual conscious indifference to the rights, safety or welfare of the Plaintiff and all other members of the proposed class and the Plaintiff on her own behalf and on behalf of all proposed class members hereby claims for aggravated and punitive damages.
WHEREFORE the Plaintiff claims on her 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 15th day of November, 2004.
James M. Poyner
Solicitor for the Plaintiff
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