C A N A D A. (Class Action) SUPERIOR COURT PROVINCE OF QUÉBEC DISTRICT OF MONTRÉAL

Transcription

1 C A N A D A PROVINCE OF QUÉBEC DISTRICT OF MONTRÉAL N o : (Class Action) SUPERIOR COURT James Bolton, residing and domiciled at 451, Madeleine street, Saint-Jérôme (Québec) J7Z 3S4 Plaintiff v. Guidant Corporation,duly constituted corporation under the laws of the United States, having its head office and principal place of business at 111, Monument Circle, suite 2900, Indianapolis, Indiana, United States of America and- Guidant Sales Corporation, duly constituted corporation, having its head office and principal place of business at 111, Monument Circle, suite 2900, Indianapolis, Indiana, United States of America and- Guidant Canada Corporation, duly constituted corporation, having its principal place of business at 505, blvd. Apple Creek, suite 4, Markham (Ontario) L5R 5B1 -and- Cardiac Pacemakers Inc., duly constituted corporation under the laws of the United States, having its principal place of business at 4100, Hamline Avenue North, St-Paul Minnesota, United States of America Defendants

2 - 2 - MOTION FOR AUTHORIZATION TO INSTITUTE A CLASS ACTION (Articles 1002 ss. C.p.c.) IN SUPPORT OF HIS CLAIM, THE PLAINTIFF RESPECTFULLY SUBMITS THAT : 1. The plaintiff James Bolton, wishes to bring a class action on behalf of the persons belonging to the group hereinafter described and of which he himself is a member: All persons who, in Québec, were implanted with a Guidant defibrillator type AICD or CRT-D or a cardiac stimulator (whose models are indicated at paragraphs 2.26 and 2.27 of the present motion), which were conceptualized, tested, developed, manufactured, distributed and put on the market by the defendants hereinafter referred to as the class. 2. The facts giving rise to an individual action by the plaintiff are the following : THE DEFENDANTS 2.1 The defendant Guidant Corporation (hereinafter referred to as Guidant and encompassing the defendants as a whole) is an American company having its head office in Indianapolis in the United States; 2.2 Guidant is a company specialized in the field of cardiac medical devices, 50% of whose annual revenue comes from its products belonging to the «gestion du rhythme cardiaque» range, a division that included three families of medical devices, namely: cardiac defibrillators of type AICD («automatic implantable cardioverter defibrillator»

3 - 3 - cardiac defibrillators of type CRT-D («cardiac resynchronization therapy defibrillators») cardiac stimulators («pacemakers») 2.3 The defendant Guidant Sales Corporation (hereinafter referred to as Guidant Sales) is a wholly-owned subsidiary of Guidant and operates directly from Guidant s head office in Indianapolis; 2.4 Guidant Sales is responsible for the conception and the implementation of the marketing, for the distribution and the sale strategies of Guidant products across the world, which includes the marketing of different products of the «gestion du rhythme cardiaque» range in Canada; 2.5 The defendant Guidant Canada Corporation (hereinafter referred to as Guidant Canada) is located in Markham, Ontario and is a wholly-owned subsidiary of the defendant Guidant; 2.6 Guidant Canada is responsible for the implementation of the Canadian marketing strategy of Guidant and of the whole of the relations with Canadian health regulatory authorities (Health Canada); 2.7 Furthermore, Guidant Canada is responsible for all the communications with the medical profession and Canadian patients; 2.8 The defendant Cardiac Pacemakers Inc. (hereinafter referred to as Cardiac Pacemakers) is a wholly-owned subsidiary of Guidant and is located in the offices of the «gestion du rhythme cardiaque» division of Guidant in St-Paul, in the United States; 2.9 The defendant Cardiac Pacemakers is responsible for the research, trials, development and manufacturing of the various Guidant «gestion du rhythme cardiaque» products; 2.10 The defendant Guidant has complete control over the defendants Guidant Sales, Guidant Canada and Cardiac Pacemakers, so much so that it has actual control of them and this, in the pursuit of a common goal to develop, test,

4 - 4 - manufacture, distribute, market, sell, communicate with the regulatory authorities before and after the marketing and ensure a follow-up of the safety of its products in Canada; 2.11 The plaintiff alleges that Guidant is entirely liable for the acts and omissions of the defendants Guidant Canada, Guidant Sales and Cardiac Pacemakers because Guidant controls the current operations of its subsidiaries and shares with them the same administrators and directors and operates as a sole corporate entity in Canada; GUIDANT S DEFECTIVE PRODUCTS 2.12 The heart is the organ whose function is to pump blood throughout the circulatory system, bringing the oxygenated blood to the different organs of the body and bringing the deoxygenated blood back towards the lungs in order to complete the cycle of circulation; 2.13 In order to function correctly, the two superior chambers and the two inferior chambers (ventricles of the heart) must contract in a harmonious and synchronized manner, and this, according to a certain rhythm calculated according to the number of beats per minute; 2.14 In order to ensure the synchronisation of the heart beats, channels located in each of the four chambers of the heart play the role of stimulating these channels by way of electrical charges; 2.15 When a patient suffers from heart disease or from a poor functioning of his electrophysiological functions, the heart s capacity to pump blood throughout the circulatory system is diminished, which results in a poor circulation of the blood; 2.16 If the internal channels of the heart are damaged, it may result in a cardiac rhythm that is too rapid (tachycardia), a rhythm that is too slow (brachycardia) or a rhythm that is not synchronized and chaotic (fibrillation); 2.17 In the last decade, the defendants and their competitors developed new products in response to the needs of patients with cardiac problems involving arrhythmia;

5 During all this time, Guidant aggressively marketed its products from the «gestion du rhythme cardiaque» range namely by emphasizing the value of their safety and their effectiveness, their durability and the fact that they had exceptionally low rates of malfunctioning; 2.19 All the Guidant «gestion du rhythme cardiaque» products are made up of a pulse generator which is implanted under the skin in the superior part of the trunk, between the heart and the shoulder; 2.20 One or more electrical leads link the generator to the heart; 2.21 Software installed in the generator is then programmed in order to offer patients personalized therapies, which are determined according to the electrophysiological needs of the patients; 2.22 Furthermore, these products are equipped with sensors allowing information originating from the heart to be capted and on which the medical device registers data in order to adjust its programming to the specific needs of the patients; 2.23 Finally, in order to preserve their electrical integrity, these medical devices must be completely isolated from the outside environment, that is to say the human heart; 2.24 When functioning correctly, the defibrillators (AICD or CRT-D) or the cardiac stimulators can save lives; 2.25 However, if one of these products fails to correctly carry out its function during an episode of arrhythmia, this can result in a patient having a heart attack, and consequently, this patient only benefits from a few minutes before irreversible and serious damage is caused or before death occurs, and only quick medical help can help avoid the worst situation; 2.26 Over time, Guidant developed, manufactured and distributed the defibrillator models, type AICD et CRT-D listed below, which proved to be faulty : a) Ventak Prizm 2 VR, Model 1860; b) Ventzk Prizm 2 DR, Model 1861; c) Ventak Prizm VR, Models 1850/1855;

6 - 6 - d) Ventak Prizm DR, Models 1851/1856; e) Ventak Prizm VR HE, Models 1852; f) Ventak Prizm DR HE, Models 1852; g) Ventak Prizm DR HE, Models 1853; h) Ventak Mini IV, Models 1790/1793/1796; i) Ventak Mini III HE, Models 1789; j) Ventak Prizm AVT (all series numbers) k) Vitality AVT (all series numbers) l) Contak Renewal 2, Model H155; m) Contak Renewal 3; n) Contak Renewal 4; o) Contak Renewal 3 AVT (all series numbers) p) Contak Renewal 4 AVT (all series numbers) q) Contak Renewal RF 2.27 Over time, Guidant developed, manufactured and distributed the models of cardiac stimulators listed below, which proved to be faulty : a) PULSAR MAX b) PULSAR c) DISCOVERY d) MERIDIAN e) PULSAR MAX II f) DISCOVERY II g) VIRTUS PLUS II h) INTELIS II i) CONTAK TR 2.28 The whole of the products mentioned in the two preceding paragraphs are subject to malfunctions and were consequently taken off the market by Guidant, being the object of worldwide warnings relative to their safety or the object of class 1 or class 2 recalls based on the American Food and Drug Administration (FDA) criteria; HISTORY OF THE DEFECTS OF THE GUIDANT PRODUCTS AND THEIR RECALL 2.29 The Ventak Prizm type AICD defibrillators were approved for the first time in the United States in June 1994 and rapidly after that in Canada;

7 From 1998 to 2001, more than Ventak Prizm type AICD defibrillators were the object of recalls and this, for models 1850, 1851, 1852, 1853, 1857 and 1858 (the 1850 series) and this, due to defects regarding the isolation of the products; 2.31 The effect of this problem was the exposure of the electric components of the product to the outside environment (i.e. the human body) thereby provoking short-circuits and an interruption of the functioning for periodic twenty-four (24) hour cycles; 2.32 Following this, between 2000 and 2002, Guidant introduced type AICD defibrillators onto the market in the 1860 series which were destined to replace models 1850 which were recalled and consequently taken off the market; 2.33 In this same period of 2000 to 2002, Guidant had knowledge that its products in the 1860 series were the object of the same complications of the 1850 series in addition to another problem, namely the deletion of the device s memory; 2.34 This deletion of the device s memory had the effect of obstructing the detection and recording of the arrhythmia periods thereby compromising the treatment of such episodes; 2.35 In the second half of 2002, Guidant attempted to rectify the defects in the type AICD products in introducing changes in their manufacturing process and this, without having conducted the researches and experiments necessary, in order to be sure that these modifications would render the implant safe and effective throughout its life-span; 2.36 Even in recognizing that the type AICD defibrillators were faulty and in attempt to correct such defaults by changes to the manufacturing process, Guidant left these faulty models on the market; 2.37 In doing so, Guidant omitted to inform patients that were carriers of these faulty products, the medical profession and the regulatory bodies of these defects;

8 This breach by Guidant regarding the information transmitted to patients, the medical profession and regulatory bodies went on for the following three years and this up until may 2005 when the media reported the death of a young patient who had been implanted with a Ventak Prizm 2 DR model 1861 defibrillator, the whole as it appears namely from an article featured in the New England Journal of Medicine communicated in support of the foregoing motion as exhibit R- 1; 2.39 After an inquiry by the young man s physicians, it was determined that the cause of his death was the defibrillator s failure to provide the therapy required in time, this type of defect being the type Guidant wanted to prevent in introducing the changes to the manufacturing process of its product in 2002; 2.40 The death of this patient was therefore caused by a shortcircuit related to an isolation problem of the medical device, which had the effect of preventing the defibrillator of giving the appropriate electric shock when the heart attack occurred; 2.41 The young patient therefore died on March 14, 2005, more than three years after Guidant knew of the specific existence of this type of defect affecting its products; 2.42 On May 23, 2005, Guidant advised the medical profession of certain defects in its Ventak Prizm 2 DR 1861 type AICD products, specifying namely that it knew of twenty-six (26) cases of defects in its products, one of which caused the death of a patient implanted before November 2002; 2.43 On June 17, 2005, Guidant published a worldwide warning concerning its AICD and CRT-D defibrillators, the whole as it appears from a copy of this warning communicated in support of the present motion as exhibit R-2; 2.44 More than eighty-thousand (80 000) defibrillators were concerned by this worldwide warning; 2.45 A few days later, on June 24, 2005, Guidant published a worldwide warning concerning its Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF defibrillators because these presented a defect linked to certain magnetic elements

9 - 9 - that were faulty thereby causing the device s incapacity to adequately fulfill its function, the whole as it appears from the said warning communicated in support of the foregoing motion as exhibit R-3; 2.46 On July 1, 2005, the FDA determined that Guidant s worldwide warnings should be the object of class 1 and class 2 recalls, the whole as it appears from recall documents originating from the FDA, communicated in support of the foregoing motion as exhibit R-4; 2.47 A class 1 recall implies that there exists a reasonable probability that if the device malfunctions, this would result in serious and irreversible health consequences or death; 2.48 In the case of a class 2 recall, it is estimated that if the devices malfunction, serious temporary or reversible medical consequences would occur; 2.49 The families of products concerned by the FDA s class 1 recall are : Prizm 2 DR, model 1861 (made on or after April 16, 2002) Contak Renewal, model H135 (made on or after August 26, 2004) Contak Renewal 2, model H155 (made on or after August 26, 2004) 2.50 In the recall document that the FDA published, they indicate that, in relation to these three types of defibrillators, : «these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned. The device does not give any sign of impending failure and there is no test that predicts whether the device will fail.» 2.51 Always with respect to its intervention on July 1, 2005, the FDA determined that a class 2 recall should be applied to the following defibrillator models:

10 Ventak Prizm AVT Vitality AVT Renewal AVT 2.52 The FDA mentioned that these products in particular were subject to memory errors that, if manifested, could seriously limit the functioning of the medical device; 2.53 Moreover, the FDA also mentioned the following defibrillator models as being the object of the class 2 recall as well, namely : Contak Renewal 3 and 4 Renewal 3 and 4 AVT Renewal RF 2.54 Even more recently, on July 18, 2005, Guidant informed the medical profession that nine (9) of its cardiac stimulator models, made between 1997 and 2000, were to be the object of a replacement, the whole as it appears from the FDA document dated July 18, 2005, communicated in support of the foregoing motion as exhibit R-5; 2.55 The number of cardiac stimulators that are still implanted in patients on a worldwide scale is estimated at twenty-eight thousand (28 000); 2.56 On the same occasion, Guidant informed the medical profession that the defect in its cardiac stimulators was linked to the degradation of the isolation components in such stimulators, which resulted in an elevated risk of failure or malfunction; 2.57 From July 22, 2005, the FDA intervened in order to impose a class 1 recall concerning these defective cardiac stimulators. The FDA added in its communication to the medical profession and to the patients that the defects noted in the cardiac stimulators originated from the defect in the hermetic seal of the device allowing humidity to affect the electrical circuits which can in turn prevent the device from correctly regulating the patient s cardiac rhythm, the whole as it appears from the said document published by the FDA and communicated in support of the foregoing motion as exhibit R-6;

11 Moreover, the FDA indicated that the malfunctioning of this product could happen without warning and if it happens, the patient could lose consciousness, have a heart attack or die; 2.59 All of the cardiac stimulators subject to the class 1 recall were enumerated above at paragraph 2.27; 2.60 Finally, in the information given by the FDA following the class 1 recall of the defective cardiac stimulators, one can note that Guidant is not able to indicate the appropriate tests to be done in order to effectively detect if a particular cardiac stimulator is likely to fail; 2.61 At last, on August 4, 2005, Health Canada adopted Guidant s recommendation to the effect that patients who were carriers of cardiac stimulators subject to the July 18, 2005 recall, should seriously consider the replacement of their cardiac stimulator, the whole as it appears from Health Canada s said warning communicated in support of the foregoing motion as exhibit R-7; THE DEFENDANTS DUTIES 2.62 The plaintiff alleges and it appears from the aforementioned that the cardiac defibrillators of type AICD and CRT-D as well as the cardiac stimulators subject to the present action are medical devices with an extremely high usage risk; 2.63 These medical devices are implanted in patients presenting a history of poor circulation, of progressive cardiac degeneration, of dangerously slow or dangerously fast cardiac rhythm or of non synchronized cardiac rhythm, the whole of these complications place these patients before the possibility of irreversible consequences on their health or even death if these devices should fail; 2.64 Therefore, for these patients, the fact of having a defective device to manage their cardiac rhythm that could possibly be faulty and therefore fail to deliver the appropriate therapy on time is equivalent to having a time bomb linked to their hearts; 2.65 Consequently, the defendants had a duty towards the plaintiff and the group members to:

12 a) make sure the medical devices subject to the present action were capable of fulfilling the use for which they were intended; b) carry out researches prior to putting the product on the market and a development process of the product in order to meet sufficient standards of effectiveness and safety considering the devastating consequences of a defect in these medical devices; c) make sure that the medical devices subject to the present action were developed in a way that they were safe and effective, and this during the predicted lifespan of the medical device; d) manufacture the medical devices subject to the present action in such a way and by using adequate material in order to ensure that the devices are safe and effective; e) market the medical devices subject to the present action in a responsible manner, which implies, namely, a duty to give continued, complete and precise information to the patients and to the medical profession and this, namely with relation to the inherent defects in the product; f) create a rigorous surveillance mechanism following the marketing of the product which implies a serious and responsible study of all the adverse events and to report the whole of these adverse events in a precise, objective and timely manner to the regulatory bodies; g) warn the patients and medical profession in a precise, objective and timely manner of all the known defects, of all the risks of malfunctioning and of the recall of all the medical devices having defects;

13 THE BREACHES MADE BY THE DEFENDANTS 2.66 The plaintiff alleges that the damages he sustained were caused by the defendants negligence and this as it is more amply described in the following allegations; NEGLIGENCE IN THE RESEARCH, DESIGN AND PRE-MARKETING TRIALS 2.67 Before the medical devices subject to the present action were put on the Canadian market, the defendants were negligent, namely in the following aspects: a) they omitted to conduct adequate researches (including among others, animal testing and clinical trials) in order to ensure that these medical devices were safe and effective in that they could administer the foreseen therapy at the required moment; b) they omitted to proceed with adequate tests and/or to implement adequate clinical studies in order to ensure the safety and effectiveness of the medical devices subject to the present action in the short and long term in relation to the lifespan of each of these devices; c) they omitted to adequately test the insulating materials used in the manufacturing of the medical devices subject to the present action and this pertaining to the deterioration of these materials in the short and long term; d) with respect to the deterioration of the insulating materials and the different defects of these first medical devices, they omitted to conduct adequate research in order to discover the causes of this deterioration of the insulating materials and this before making the decision to modify their medical devices; e) they omitted to interpret and/or transmit the whole of the data resulting from the pre-marketing phase in an objective and precise manner to the Canadian and American regulatory bodies (the FDA and Health Canada);

14 f) they omitted to implement a testing program whose aim was to predict the defects of the medical devices subject to the present action; g) they omitted to proceed with the pre-marketing phase in a manner that was consistent with customs and international norms with respect to laboratory research (International Organization for Standardization - ISO); h) they knew or had to know that the insulating materials and the seals used in the various medical devices concerned by the present action were subject to a short and long term deterioration and that this situation significantly and unreasonably increased the risk of defects in the medical devices; NEGLIGENCE IN THE MANUFACTURING OF THE PRODUCTS 2.68 The plaintiff alleges and it appears from the aforementioned that the defendants were negligent in the manufacturing of the medical devices subject to the present action in that: a) these medical devices were not capable of fulfilling the function for which they were destined; b) these medical devices were manufactured in a way that they were particularly prone to defects; c) the defendants did not make sure that the medical devices subject to the present action were, once manufactured, safe enough for patients; d) they omitted to manufacture or to purchase from suppliers insulating materials that were not subject to a premature deterioration; NEGLIGENCE IN THE DISTRIBUTION AND SALE OF THE PRODUCTS 2.69 The plaintiff alleges and it appears from the aforementioned that the defendants were negligent in the distribution and sale of the whole of the medical devices subject to the present action and this with respect to the following aspects:

15 a) they omitted to adequately inform the regulatory bodies, the patients and the medical profession of all the pertinent aspects linked to the safety and effectiveness of the medical devices subject to the present action; b) they continued the sale of the medical devices subject to the present action in Canada and this despite their knowledge of the additional data emanating from postmarketing tests and of the adverse events in patients; c) they omitted to implement a surveillance mechanism of the post-marketing efficiency of the medical devices subject to the present action; d) they omitted to research and adequately follow-up the adverse events experienced by patients following the implantation; e) they omitted to adequately report in a timely, precise and objective manner the results of studies, if applicable, arising from the adverse events experienced by patients following their implantations; f) they omitted to communicate with the medical profession, the scientific community and the regulatory bodies about the whole of the adverse events experienced by the patients and this in a precise, objective and timely manner; g) they conducted themselves in a manner in which they let their commercial interests come before the safety of the patients; h) they made representations to the regulatory bodies concerning the safety and effectiveness of the medical devices subject to the present action while knowing or while they should have known that these representations were false, invalidated or impossible to validate;

16 THE DEFENDANTS BREACHES WITH RESPECT TO THE DUTY TO INFORM AND THE RECALL 2.70 The plaintiff alleges and it appears from the aforementioned that the defendants were negligent in that they omitted to inform and proceed with a recall in a timely manner, the whole as it appears from the following aspects: a) they omitted to implement an adequate follow-up program concerning the performance of the medical devices subject to the present action once implanted in patients; b) they omitted to adequately act after having been informed of the important proof of the unreasonable clinical performance and of the high defect rates of the medical devices concerned by the present action and also after learning that the defect affecting the most recent medical devices were the same as the defects affecting the preceding medical devices, these themselves having been the object of a recall or withdrawal from the market ; c) they stalled until the last minute or until they had no other alternative before announcing the recall of the medical devices subject to the present action, thereby endangering the health and safety of the carriers of such medical devices; DAMAGES SUFFERED BY THE GROUP MEMBERS 2.71 The members of the present proposed class action are placed in an extremely difficult situation by the defendants in that these patients are informed, contrarily to the representations made by the defendants, that the medical device implanted in them is subject to major defects, that there is no effective test that can predict if a medical device is likely to fail nor at what moment, and in the event that this medical device malfunctions, the patient is placed in a situation where death may result; 2.72 In so doing, the group members will take or have taken the decision, where possible, to proceed with the explantation of their medical device, in which case they will have to or have

17 had to endure additional pain and suffering as well as be exposed to the inherent risks of a new surgery; 2.73 However, certain patients will not be able to or have decided not to proceed with the explantation of their defective medical device and will suffer an increased emotional stress as well as important anxiety, stemming evidently from having to endure an increased risk of their medical device malfunctioning, such a risk possibly even leading to death; 2.74 Moreover, the plaintiff and the group members have endured and/or will endure damages associated with loss of income and incurred costs (medical costs, hospital costs and other expenses linked to the diagnosis, to the treatment and to the monitoring of their medical device s functioning); MEDICAL MONITORING 2.75 In mid-2002 at the latest, Guidant was aware of or knew of the defects linked to its type AICD defibrillators, defects which are likely to increase the risk of malfunction of the device and which can result in serious consequences for patients health or even their death; 2.76 In trying to correct these defects, Guidant did not estimate it necessary, for three years, to withdraw the defective products from the market and omitted to inform the patients, the medical profession and the regulatory bodies of these defects; 2.77 Only in May of 2005, after learning of the New York Times intention to publish a feature article on the death of a patient who was a carrier of a type Ventak Prizm 2 DR, model 1861 defibrillator, that the defendants deemed it necessary to publish, for the first time, a warning concerning the inherent defects of these products; 2.78 Following this, only because of the important pressures from the regulatory bodies, did the defendants proceed to make warnings concerning other models of defibrillators of type AICD and CRT-D and of cardiac stimulators; 2.79 However, details concerning the moment at which the defendants were aware of the defects for the first time is known by them only;

18 EXEMPLARY DAMAGES 2.80 The plaintiff alleges and it appears from the aforementioned that the market of type AICD defibrillators is in rapid expansion and that it is an extremely lucrative trade for the defendants, which evolves in a fierce realm of competition with its competitors with the objective of obtaining an important share of the market; 2.81 The plaintiff alleges and it appears from the aforementioned that the defendants, in omitting to adequately inform the patients, medical profession and regulatory authorities of the defects and dangers associated with the use of these products, exposed the group members to an increased risk of serious and irremediable health consequences or death, opting to maximize its profits to the detriment of the safety of its patients; 2.82 Consequently, the plaintiff alleges that the defendants highly negligent behaviour must allow for the awarding of exemplary damages; THE PLAINTIFF 2.83 The plaintiff, Mr James Bolton, was born in 1936 in England; 2.84 He arrived and settled down in Canada in 1960; 2.85 During his career, the plaintiff worked in the field of retail sale of encyclopaedias and of musical instruments; 2.86 Since his retirement, the plaintiff gives private English courses to people of his region in the Laurentians; 2.87 Before knowing of his first hearth problems, the plaintiff was in perfect health, labelling himself as someone active and in good physical shape; 2.88 On or around April 7, 2003, in the evening, the plaintiff experienced severe chest pains on his left side for the first time;

19 During the same evening and following an ambulance ride to St-Jérôme Hospital, the plaintiff learned from the attending physicians that he was the victim of cardiac arrhythmia; 2.90 Once in stable condition and following a battery of medical tests, the plaintiff learned that his cardiac incident had not caused any permanent damage to his heart; 2.91 However, his doctors told him it was imperative for him to be operated in order to be implanted with a cardiac defibrillator; 2.92 The doctors clearly indicated that there was no alternative to this operation and that only a type AICD 1861 cardiac defibrillator made by Guidant would be suitable for the situation; 2.93 The plaintiff had no other choice but to accept his doctors recommendations and to proceed with the implantation of the cardiac defibrillator, which was carried out on April 28, 2003, the whole as it appears from the card given to the plaintiff by Guidant which is communicated in support of the foregoing motion as exhibit R-8; 2.94 According to his doctors, the operation undergone by the plaintiff went well and his recuperation was satisfactory; 2.95 After this and until spring 2005, the plaintiff experienced many episodes of cardiac spasms, at a frequency of about 2 to 3 times a week; 2.96 The treating doctors could not identify the precise cause of the cardiac spasms experienced by the plaintiff, in that the plaintiff lives with the continuous worry of having to undergo new incidents of arrhythmia; 2.97 In addition to his cardiac condition, the plaintiff lives in continuous fear of carrying a medical device that is lifethreatening due to its likelihood of malfunctioning when he is in need; 3. The facts giving rise to an individual action on behalf of each of the group members against the defendants are, in addition to the facts set out in paragraph 2 with the necessary adjustments, the following :

20 Each of the group members was the object of an implantation of at least one of the medical devices subject to the present class action; 3.2 Each group member suffered physical and psychological damages associated with the implantation of a medical device subject to the present action; 4. The composition of the group makes the application of article 59 or 67 C.p.c impracticable in that : 4.1 The medical devices subject to the present action were the object of a large distribution in Canada and in Québec; 4.2 As a consequence, hundreds of people are members of the group concerned by the present motion; 4.3 Due to the confidentiality of medical files, it is impossible to know the identity of the people in which these medical devices were implanted; 4.4 Based on the previous allegations, the composition of the group makes the application of article 59 or 67 C.p.c impossible; 5. The identical, similar or related questions of fact and of law raised by the recourses of the members against the defendants and that the plaintiff wishes to settle are: 5.1 Do the medical devices subject to the present action, as developed, manufactured, marketed and sold by the defendants cause an increased risk of serious and irremediable health problems or possibly death for the group members? 5.2 Seeing that the medical devices subject to the present action are destined to be implanted in the human body, do the defendants have duties towards the group members to ensure the safety, effectiveness and aptitude of the product for the use for which it was intended? 5.3 If so, did the defendants breach their duties and are they liable towards the group members for the consequences of this breach?

21 Did the defendants know or should they have known the risks associated with the use by the group members of the medical devices subject to the present action? 5.5 If so, did the defendants breach their duty to warn and their continued duty to inform the public authorities, the medical profession (learned intermediaries) and the patients who were implanted with the medical devices concerned by the present action? 5.6 If so, are the defendants liable towards the group members for the damages resulting from the lack of warning and information? 5.7 Did the use of the medical devices subject to the present action by the group members cause or contribute to causing or was the use likely to cause or contribute to damages to their mental or physical well-being? 5.8 What is the nature of the damages and the amount of the damages that the group members can claim from the defendants? 5.9 Does the Consumer Protection Act apply to the present proceeding? 5.10 Do the group members have the right to claim the payment of exemplary damages in addition to the compensatory damages awarded? 6. The questions of fact and of law that are particular to each group member are : 6.1 The nature and seriousness of the damages incurred; 6.2 The amount of the indemnity that each member has a right to claim from the defendants; 7. It is suitable to authorize the class action for the benefit of the group members; 8. The nature of the action that the plaintiff wishes to bring on behalf of the group members is :

22 An action in damages based on the liability of the manufacturer of a medical device; 9. The conclusions that the plaintiff seeks are : GRANT the class action of the plaintiff and of each group member he intends to represent; CONDEMN the defendants to pay to the plaintiff a sum of $, which can be adjusted, for damages incurred, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; CONDEMN the defendants to pay to each group member a sum to be determined for damages incurred, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; CONDEMN the defendants to pay to each group member a sum of $, which can be adjusted, in exemplary damages, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; ORDER the collective recovery of member claims if the proof allows for it; ORDER the individual recovery of member claims; CONDEMN the defendants to fund an adequate medical monitoring program for the group members for a sum to be determined by the Court; THE WHOLE with costs, including the cost of notice and expertise; 10. The plaintiff James Bolton asks that the status of representative of the group be assigned to him; 11. The plaintiff is in a position to adequately represent the members for the following reasons: 11.1 The plaintiff is disposed to invest the resources and time necessary to the accomplishment of all the formalities and

23 tasks necessary for the bringing of the present class action and he undertakes to fully collaborate with his counsel; 11.2 The plaintiff is able to give his counsel information that is useful to the exercise of this class action; 11.3 The plaintiff acts in good faith with the sole goal of obtaining justice for himself and each group member; 11.4 The plaintiff intends to seek financial assistance from the Fonds d aide aux recours collectifs; 12. The plaintiff proposes that the class action be brought before the Superior Court for the district of Montreal for the following reasons : 12.1 Counsel for the plaintiff s offices are in Montreal; 12.2 An important portion of the group members reside in the district of Montreal and its surroundings; FOR THESE REASONS, THE PLAINTIFF PRAYS THIS HONORABLE COURT TO : GRANT the plaintiff s motion; AUTHORIZE the bringing of the following class action : An action in damages based on the responsibility of the manufacturer of a medical device ATTRIBUTE the status of plaintiff to James Bolton for the bringing of the aforementioned class action on behalf of the physical persons being part of the group described as such: All persons who, in Québec, were implanted with a Guidant defibrillator type AICD or CRT-D or a cardiac stimulator (whose models are indicated at paragraphs 2.26 and 2.27 of the present motion), which were conceptualized, tested, developed, manufactured, distributed and put on the market by the defendants IDENTIFY as follows the principal questions of fact and of law to be treated collectively:

24 Do the medical devices subject to the present action, as developed, manufactured, marketed and sold by the defendants cause an increased risk of serious and irremediable health problems or possibly death for the group members? Seeing that the medical devices subject to the present action are destined to be implanted in the human body, do the defendants have duties towards the group members to ensure the safety, effectiveness and aptitude of the product for the use for which it was intended? If so, did the defendants breach their duties and are they liable towards the group members for the consequences of this breach? Did the defendants know or should they have known the risks associated with the use by the group members of the medical devices subject to the present action? If so, did the defendants breach their duty to warn and their continued duty to inform the public authorities, the medical profession (learned intermediaries) and the patients who were implanted with the medical devices concerned by the present action? If so, are the defendants liable towards to the group members for the damages resulting from the lack of warning and information? Did the use of the medical devices subject to the present action by the group members cause or contribute to causing or was the use likely to cause or contribute to damages to their mental or physical well-being? What is the nature of the damages and the amount of the damages that the group members can claim from the defendants? Does the Consumer Protection Act apply to the present proceeding? Do the group members have the right to claim the payment of

25 exemplary damages in addition to the compensatory damages awarded? IDENTIFY as follows the conclusions sought : GRANT the class action of the plaintiff and of each group member he intends to represent; CONDEMN the defendants to pay to the plaintiff a sum of $, which can be adjusted, for damages incurred, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; CONDEMN the defendants to pay to each group member a sum to be determined for damages incurred, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; CONDEMN the defendants to pay to each group member a sum of $, which can be adjusted, in exemplary damages, the whole with interest at the legal rate plus the additional indemnity provided by law from the summons; ORDER the collective recovery of members claims if the proof allows for it; ORDER the individual recovery of member claims; CONDEMN the defendants to fund an adequate medical monitoring program for the group members for a sum to be determined by the Court; THE WHOLE with costs, including the cost of notice and expertise; DECLARE that unless they opt out, the group members are bound by all judgements to come on the class action in the manner provided for by law; FIX the deadline for opting out at thirty (30) days, at which time the group members who did not avail themselves of the means of opting out will be bond by all judgements to intervene; ORDER the publication of a notice to members, one time, in the Saturday edition of the following papers : La Presse, le Journal de

26 Montréal, Le Soleil, le Journal de Québec, Le Droit, Le Quotidien, Le Nouvelliste, La Tribune, la Voix de l Est and The Gazette, the whole according to the model set out in the Rules of Practice of the Superior Court of the Province of Québec; ORDER the publication of said notice on the defendants web site and on counsel for the plaintiff s web site; FIX the deadline for publication of the notice to members at thirty (30) days from the final judgement to intervene on the present motion; REFER the file to the chief justice for the determination of the district before which the class action shall be brought and appointment of the judge who will hear it; ORDER the bailiff of the court, in the case that the class action should be brought before another district, to transmit the file, upon decision of the chief justice, to the bailiff of this other district; ORDER the defendants to provide counsel for the plaintiff, in the thirty (30) days of the judgement to intervene, with the complete list of group members as well as their coordinates; ORDER the sending of a personalized notice to each group member concerned by the present class action; THE WHOLE with costs, including the cost of notice and expertise. Montréal, August 26, 2005 (s) Lauzon Bélanger LAUZON, BÉLANGER, S.E.N.C.R.L. Counsel for the plaintiff

27 NOTICE OF PRESENTATION To : Guidant Corporation 111, Monument Circle Suite 2900 Indianapolis, Indiana United States Guidant Canada Corporation 505, blvd. Apple Creek Suite 4 Markham (Ontario) L5R 5B1 Guidant Sales Corporation 111, Monument Circle Suite 2900 Indianapolis, Indiana United States Cardiac Pacemakers Inc. 4100, Hamline Avenue North St-Paul Minnesota United States PLEASE BE ADVISED that the foregoing motion to institute proceedings will be presented for adjudication before one of the Honourable Justices of the Superior Court, sitting in and for the district of Montreal, on October 12, 2005 at the Montreal Courthouse, 1 Notre-Dame Street East, in room 2.16, at 9 a.m. or as soon as counsel can be heard. Please govern yourselves accordingly. MONTREAL, August 26, 2005 (s) Lauzon Bélanger LAUZON, BÉLANGER, S.E.N.C.R.L.. Counsel for the plaintiff

28 C A N A D A PROVINCE OF QUÉBEC DISTRICT OF MONTRÉAL N o : James Bolton (Class Action) SUPERIOR COURT Plaintiff v. Guidant Corporation -and- Guidant Sales Corporation -and- Guidant Canada Corporation -and- Cardiac Pacemakers Inc. Defendants LIST OF EXHIBITS IN SUPPORT OF THE MOTION TO INSTITUTE PROCEEDINGS R-1 Article featured in the New England Journal of Medicine dated July 21, 2005; R-2 Warning published by Guidant on June 17, 2005; R-3 Warning published by Guidant on June 24, 2005; R-4 Recall documents originating from the FDA; R-5 FDA document dated July 18, 2005; R-6 Document published by the FDA on July 22, 2005; R-7 Health Canada advisory dated August 4, 2005;

29 - 2 - R-8 Card given by Guidant to the plaintiff James Bolton; Montreal, August 26, 2005 (s) Lauzon Bélanger LAUZON, BÉLANGER, S.E.N.C.R.L. Counsel for the plaintiff