VANCOUVER REGISTRY


















Brought under the Class Proceedings Act







1.         The Plaintiff, TINA KATHERINE BEER, is a Businesswoman, whose address is 4922 Martin Court, in the Municipality of West Vancouver, in the Province of British Columbia.


2.         The Defendant, GLAXOSMITHKLINE INC., (hereinafter referred to as “GSK”) is an Extra-Provincial company duly registered in the Province of British Columbia under number A0056297 and has its head office in British Columbia at c/o Blake Cassels & Graydon LLP, 2600 Three Bentall Centre, P.O. Box 49314, 595 Burrard Street, Vancouver, British Columbia.



3.            GLAXOSMITHKLINE is a multi-national corporation created in December of 2000 as a result of the merger of Glaxo Wellcome and Smithkline Beecham.  GSK and its parent organization research, design, manufacture and market pharmaceutical products.


4.         One of the drugs manufactured by GSK is called Paxil (genetically known as paroxetine).


5.         Paxil is in a class of drugs called  “selective serotonin reuptake inhibitors” or “SSRI’s” and is widely prescribed by physicians to treat depression, anxiety disorder, obsessive compulsive disorder, post-traumatic stress and generalized anxiety disorders.


6.         The Plaintiff was originally prescribed Paxil in the month of April 2000 by her family physician.  In the month of August 2000, the Plaintiff attempted to discontinue use of Paxil with her doctor’s approval.  Upon initial termination of the Paxil she experienced severe flu like symptoms including stomach pain, severe headaches, body aches, chills, fever and bloated stomach.  In addition to which she experienced severe dizzy spells, was photo sensitive and experienced vertigo. 


7.            Neither she, nor her doctor realized that she was suffering from Paxil withdrawal and was inappropriately treated for a non-existent kidney infection with antibiotics.  She was then wrongly diagnosed to have either an appendix or gallbladder problem.  Eventually she was advised to go back on the Paxil, which she did and she immediately experienced the cessation of the above-described symptoms.  In the month of February 2001 the Plaintiff again stopped taking Paxil and immediately experienced the return of the above-described symptoms and was forced to go back on the Paxil.


8.         In the month of July 2001 the Plaintiff tapered off her use of Paxil in an attempt to wean herself of the drug over a two month period.  The Plaintiff experienced hysteria, suicidal thoughts, shaking, electric zaps throughout her body, insomnia, nausea, headaches, high fever, chills, diarrhea, memory loss and lack of concentration.




9.         This is a class action on behalf of all individuals in the Province of British Columbia who were prescribed and took the drug Paxil which at all material times hereto has been and continues to be  manufactured, marketed and distributed by  GSK, and who experienced dependency/withdrawal reactions. 


10.            Thousands of Paxil users suffered dependency/withdrawal reactions.  The pain and suffering experienced by each of these individuals is a direct result of the Defendant’s failure to warn users of Paxil’s addictive nature, the drug’s inducement of physical and psychological dependency, and its infliction of dependency/withdrawal reactions when the patient’s Paxil dosage is reduced or terminated.  Paxil has caused some people who take it to experience serious and unexpected withdrawal reactions.  These reactions are “unexpected” to the victims and even their physicians because the manufacturer has deliberately failed to properly warn of this.  Both physician and patient unwittingly use Paxil without knowing the drug’s addictive traits.  The Plaintiff and members of the Plaintiff Class were never informed before starting Paxil that it was addictive, that it induced dependency, or that it caused withdrawal reaction when dosage was reduced or terminated. 


11.       Paxil creates both physical and psychological dependency and, because GSK has suppressed the information about the severe withdrawal reaction caused by its drug, many patients and their physicians are fooled into thinking that the withdrawal reactions the patients are experiencing are caused by another condition (such as kidney infection), thus promoting further incorrect and unnecessary medical treatment, including increased dosages of Paxil.  Some of the Class Members remain on Paxil today because they have become dependent and feel they cannot get off the drug.  GSK has known for years the distinct characteristics of Paxil which make it prone to cause dependency/withdrawal reactions  after its use is discontinued. 



12.       The Plaintiff brings this action on behalf of herself and all others similarly affected, as members of the proposed Class, defined as follows:


            “All British Columbia residents who have suffered, are suffering, or will suffer from dependency/withdrawal reactions following reduction or termination of their Paxil dosage.”



13.       The members of the proposed Class number in at least thousands.  As a result, the Class is so numerous that joinder in a single action is impracticable.  However, each Class member should be readily identifiable from information and records available to GSK.


14.            Individual members of the proposed Class do not have a significant interest in individually controlling the prosecution of separate actions, and individualized litigation would also present the potential for varying, inconsistent, or contrary judgements and would magnify the delay and expense to all parties to the court system resulting from multiple trials of the same factual issues.  The cost to pursue individual action would effectively deny individuals access to the court. 


15.       There is a well defined list of common questions of law and fact. These common legal and factual questions do not vary from one Class member to another, and may be determined without reference to the individual circumstances of Class members.  These include, but are not limited to, the following:


1.                  Whether GSK properly and adequately warned the

Plaintiff and proposed Class members that Paxil can cause dependency/withdrawal reactions.


2.                  Whether GSK properly and adequately warned physicians in British Columbia that Paxil can cause  dependency/withdrawal reactions.


3.                  Whether GSK over-promoted its drug Paxil to such an extent that any warnings it may have given regarding dependency/withdrawal reactions were nullified.


4.                  Whether GSK wrongly asserted in its advertising material that Paxil was non-addictive and not habit forming.


5.                  Whether the drug Paxil is addictive and does cause dependency/withdrawal reactions.


16.       The claim of the Plaintiff is typical of the Class. The Plaintiff and the proposed Class members were uninformed of the hazards in reducing or terminating their Paxil dosage.  The Plaintiff says, and the fact is, that she and the members of the proposed Class experienced one or more of the following dependency/withdrawal reactions upon cessation or reduction of their Paxil dosage:


                        (a)            Jolting electric “zaps”.

(b)               Dizziness.

(c)               Lightheadedness.

(d)               Vertigo,

(e)               Incoordination.

(f)                 Gait disturbances.

(g)               Sweating.

(h)               Extreme nausea.

(i)                 Vomiting.

(j)                  High fever.

(k)               Chills.

(l)                  Anorexia.

(m)             Diarrhea.

(n)               Agitation.

(o)               Tremulousness.

(p)               Irritability.

(q)               Aggressions.

(r)                 Insomnia.

(s)               Nightmares.

(t)                 Tremor.

(u)               Confusion.

(v)                Memory and concentration difficulties.

(w)              Lethargy.

(x)                Malaise.

(y)                Weakness.

(z)                Fatigue.

(aa)          Paraesthesias.

(bb)          Ataxia, and/or myalgia.


17.       Each patient victim and potential Class member on the cessation of Paxil became very ill without realizing the cause of their distress.  Severe physical and psychological anguish developed and persisted.  Typically, the patient went to see his/her physician, who, ignorant of Paxil’s withdrawal inducing traits, started down an erroneous path to diagnose the problem.  This included suggesting unnecessary tests and diagnoses, including “relapse”, which in the physicians’ mind warranted an increase of Paxil dosage – thus compounding the problem.  The physician, in many instances, was the last person to acknowledge that Paxil withdrawal was in fact the culprit behind the patient’s suffering.  As a result, the patient’s pain and suffering and resulting disabilities were prolonged, often lasting weeks, even months.  Some patients, after a lengthy regime of gradually tapering down their Paxil dosage, were successful in completely weaning themselves off the drug.  Some patients remain on Paxil today because they are “hooked” on the drug and feel they cannot get off of it.  The only difference among Class members is the amount of damage sustained, which can be readily determined, and does not bar class certification.


18.       The Plaintiff will fully and adequately protect the interests of the proposed Class, and have retained class counsel who are experienced and qualified in prosecuting class action complex litigation.  Neither the Plaintiff nor her solicitors have interests which are contrary to, or conflicting with those of the proposed Class. 


19.       GSK knowingly and deliberately promoted the use of Paxil as a non-addictive drug to physicians and the general public when it knew, or ought to have known, that patients would become addicted to the use of Paxil and that the cessation of Paxil use would cause the patient to experience severe dependency/withdrawal  reactions as described above. 


20.       In reliance on the misrepresentation of GSK the Plaintiff and Class Members were induced to purchase and use Paxil.  If the Plaintiff and Class Members had known the true facts and the facts concealed by GSK, the Plaintiff and Class Members would not have used Paxil.  The reliance of the Plaintiff and Class Members upon GSK’s misrepresentations was justified because such misrepresentations were made and conducted by GSK who was in a position in which it knew or ought to have known the true facts.


21.       The Plaintiff and Class Members say that GSK’s misrepresentations as to the addictive nature of Paxil are unlawful and deceptive trade practices.  Specifically, the Plaintiff and the Class Members say that GSK is in violation of Section 52 (1) of the Competition Act and that thereby the Plaintiff and the Class Members are entitled to damages.


22.       GSK’s failure to provide physicians and the public with sufficient and adequate notice of the addictive nature of Paxil was negligent.


23.       GSK actively deceived the Plaintiff and potential Class members by representations in written labeling, oral communications and television advertising suggesting that Paxil is not addictive, that it does not cause physical or psychological dependency, and that it would not cause dependency/withdrawal reactions if dosage was reduced or terminated. 


24.       GSK used false and misleading techniques to hide the linkage between dependency/withdrawal reactions on one hand, and Paxil on the other.  After censoring the word “withdrawal” from company files and instructing its agents similarly, GSK began to dilute the medical vocabulary by using misleading medical terms to substitute for withdrawal such as “discontinuation syndrome”.


25.       GSK over promoted Paxil in order to increase its sales at the expense of revealing the truth about the addictive/dependency nature of Paxil.


26.       GSK deliberately and falsely conveyed to all healthcare providers in British Columbia that Paxil side effects were only “mild” when in fact GSK knew many of the drug’s withdrawal side effects were severe.


27.       As a result of GSK’s acts and omissions it has deceived the medical community, including the Plaintiff’s physicians, into believing Paxil does not have addictive qualities and does not cause dependency/withdrawal reactions which GSK knows it in fact does. 


28.       The said representations were made by GSK when it knew those representations to be false, or in the alternative, willfully and wantonly and recklessly disregarded whether the representations were true.  These representations were made by GSK with the intention of deceiving the public in general and the medical community and to induce the medical community to recommend and prescribe Paxil and to induce  the public to take it.


29.       GSK impliedly warranted that Paxil was of merchantable quality and safe and fit for its intended and foreseeable uses.  GSK breached this implied warranty because Paxil was not, and is not, of merchantable quality or safe for its intended use.


30.       The Plaintiff and Class Members plead and rely upon the Sale of Goods Act R.S.B.C. 1996, s. 18. 


31.       At the time the aforesaid representations were made by GSK and at the time the Plaintiff ingested Paxil, both the Plaintiff and her prescribing physician were unaware of the falsity of the said representations and reasonably relied upon the GSK’s assertions, promulgated through its aggressive sales force to the medical community that the drug was safe.  In reliance upon the said representations the Plaintiff’s physician did prescribe Paxil and the Plaintiff was induced to, and did take Paxil.  Had the Plaintiff known of the actual dangers of Paxil through her physician or otherwise, she would not have ingested Paxil.


32.       GSK’s motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems was for financial gain and its fear that, if properly labeled, Paxil would lose its share of the SSRI market through the efforts of competing manufacturers who would adversely compare GSK’s drug to their own.  GSK’s goal, at the expense of those who took its drug Paxil, was for Paxil to become the dominant SSRI on the market.


33.       As a result of the conduct described above GSK has been unjustly enriched by receipt of millions of dollars from the sale and prescription of Paxil, sold in large part as a result of the acts and omissions described above.


34.       At all material times the conduct of GSK as set forth above, was malicious, deliberate and oppressive towards the Plaintiff and the public generally, and the said GSK, conducted itself in a willful, wanton and reckless manner as set forth above.  Despite its specific knowledge as set forth above, GSK deliberately recommended, manufactured, produced, marketed, sold, distributed, merchandized, packaged, promoted and advertised the dangerous and defective drug Paxil.  As a result of GSK’s deceitful conduct and representations and due to Paxil’s addictive quality, inducement of physical and psychological dependency, and inducement of dependency/withdrawal reactions, the Plaintiff and Class members unexpectedly suffered prolonged physical and mental harm.  As a further consequence of taking the drug Paxil  the Plaintiff and the Class Members have  and will continue to incur medical expenses, care expenses, losses of capital assets, loss of income, loss of ability to perform housework, loss of opportunity, pain and suffering and inability to enjoy their lives. 





            (a)            General damages;

(b)              Punitive damages;

(c)               Exemplary damages;



(d)              Special damages;

            (e)            Court Order Interest pursuant to the Court Order Interest Act;

            (f)            Costs;

            (g)            Such further other relief as to this Honourable Court may seem meet; 



                        DATED at the City of North Vancouver, Province of British Columbia, this            day of April, 2002.


Solicitor for the Plaintiff




THIS STATEMENT OF CLAIM is filed by KENNETH J. BAXTER ESQ., Poyner Baxter, Barristers & Solicitors, whose 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)