Docstoc

Motion to institute a class action - CANADA

Document Sample
Motion to institute a class action - CANADA Powered By Docstoc
					          CANADA                               (Class Action)
                                             SUPERIOR COURT
          PROVINCE OF QUÉBEC
          DISTRICT OF MONTRÉAL     James Bolton, residing and domiciled
                                   at 451, Madeleine street, Saint-Jérôme
          No : 500-06-000303-053   (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 46204-5129

                                   -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 46204-5129

                                   -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 55112-5798

                                                                 Defendants



LAUZON BÉLANGER
Société en nom collectif
                                                   -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 »




LAUZON BÉLANGER
Société en nom collectif
                                                    -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,

LAUZON BÉLANGER
Société en nom collectif
                                                   -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 de-
                           oxygenated 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;


LAUZON BÉLANGER
Société en nom collectif
                                                 -5-



                 2.18 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;

LAUZON BÉLANGER
Société en nom collectif
                                                  -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;




LAUZON BÉLANGER
Société en nom collectif
                                                 -7-



                 2.30 From 1998 to 2001, more than 13 000 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;




LAUZON BÉLANGER
Société en nom collectif
                                                 -8-



                 2.38 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 short-
                      circuit 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

LAUZON BÉLANGER
Société en nom collectif
                                                     -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:

LAUZON BÉLANGER
Société en nom collectif
                                                - 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;

LAUZON BÉLANGER
Société en nom collectif
                                                 - 11 -




                 2.58 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:

LAUZON BÉLANGER
Société en nom collectif
                                                  - 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;




LAUZON BÉLANGER
Société en nom collectif
                                                  - 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);


LAUZON BÉLANGER
Société en nom collectif
                                                  - 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:




LAUZON BÉLANGER
Société en nom collectif
                                                 - 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 post-
                                marketing 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;




LAUZON BÉLANGER
Société en nom collectif
                                                 - 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

LAUZON BÉLANGER
Société en nom collectif
                                                 - 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;

LAUZON BÉLANGER
Société en nom collectif
                                                 - 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;




LAUZON BÉLANGER
Société en nom collectif
                                                 - 19 -



                 2.89 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 life-
                      threatening 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 :


LAUZON BÉLANGER
Société en nom collectif
                                                    - 20 -



                  3.1      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?

LAUZON BÉLANGER
Société en nom collectif
                                                   - 21 -




                  5.4      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 :

LAUZON BÉLANGER
Société en nom collectif
                                                  - 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
                  1 000 000$, 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
                  50 000$, 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


LAUZON BÉLANGER
Société en nom collectif
                                                    - 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:

LAUZON BÉLANGER
Société en nom collectif
                                                    - 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

LAUZON BÉLANGER
Société en nom collectif
                                                 - 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
                  1 000 000$, 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
                 50 000$, 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

LAUZON BÉLANGER
Société en nom collectif
                                                 - 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




LAUZON BÉLANGER
Société en nom collectif
                              NOTICE OF PRESENTATION



          To :

          Guidant Corporation                     Guidant Sales Corporation
          111, Monument Circle                    111, Monument Circle
          Suite 2900                              Suite 2900
          Indianapolis, Indiana 46204-5129        Indianapolis, Indiana 46204-5129
          United States                           United States

          Guidant Canada Corporation              Cardiac Pacemakers Inc.
          505, blvd. Apple Creek                  4100, Hamline Avenue North
          Suite 4                                 St-Paul Minnesota 55112-5798
          Markham (Ontario) L5R 5B1               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



LAUZON BÉLANGER
Société en nom collectif
          CANADA                                        (Class Action)

          PROVINCE OF QUÉBEC                          SUPERIOR COURT
          DISTRICT OF MONTRÉAL

          No :                              James Bolton

                                                                            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;



LAUZON BÉLANGER
Société en nom collectif
                                              -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




LAUZON BÉLANGER
Société en nom collectif

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:14
posted:2/19/2011
language:English
pages:29