[1] This is an application to certify this proceeding as a class action and to appoint the plaintiff, James Hoy and Andrew Steeds as representative plaintiffs pursuant to s. 2 of the Class Proceedings Act, S.B.C. 1995, c. 21. Andrew Steeds has not, as yet, been added as a plaintiff in this action.

[2] The application defines the proposed class as:

[3] The plaintiff claims damages for injury, loss, and expense allegedly caused by the defendants' negligent design, manufacture, marketing, and distribution of the leads which the plaintiff alleges are unreasonably prone to degeneration and failure.

[4] The evidence filed on the certification application discloses the following facts.

[5] The artificial cardiac pacemaker is an electronic device that delivers electrical stimuli to the heart to treat bradycardias and tachycardias. The essential elements of an artificial pacing system are the generator, the lead, and the patient's body. The generator contains the power source, usually a battery, which supplies energy for the stimuli and circuitry. Chemical reactions in the battery are converted into electrical impulses inside the circuitry. The circuitry also functions like a mini-computer, which can be programmed by physicians to meet the needs of the particular patient. The generator is usually implanted some distance from the heart, either in the region of the upper chest or in the abdomen. The function of carrying information between the heart and the generator is performed by the lead.

[6] The second component of the pacing system is the lead.

[7] Leads are either unipolar or bipolar. Bipolar leads consist of two insulated conductors, two metal electrodes, a fixation mechanism, and a terminal (connector) assembly. The conductors carry the electrical signals between the generator and the electrodes. The electrodes perform both a sensing and a stimulating function. The pacemaker senses when the heart beats naturally, so that the artificial electrical signal can be withheld, and stimulates the heart to beat when it fails to do so on its own.

[8] The patient's body is the third component of the pacing system. Except for those relatively few people whose heart function is entirely dependent on their pacemaker, the artificial pacing system does not replace the body's natural system, but works with it. For example, an artificial pacing system senses electrical signals from the heart so that the stimulus from the generator can be withheld or timed appropriately.

[9] The leads in issue in this case were designed and manufactured by Medtronic Inc. ("Medtronic"). The leads used Pellethane 2363-80A ("P80A") as the inner and outer insulation of the lead. The plaintiff alleges that the leads are unsuitable for use in cardiac pacing systems because they are unreasonably prone to failure or degeneration by reason of the use of P80A. The plaintiff further alleges that the defendants were aware of the problem but nevertheless chose to insulate the leads with P80A. The leads in question were marketed in Canada by Medtronic of Canada Ltd. ("Medtronic Canada") from August 1983 until October 1993.

[10] A predecessor lead, Model 6972, was introduced to the U.S. market by Medtronic in 1978. That model was the subject of a recall in the United States in 1984 and was the subject of a U.S. Congressional investigation.

[11] In support of the claim, the plaintiffs will rely on evidence of the kind demonstrated by the August 1991 and January 23, 1993 letters from the United States Food and Drug Administration ("FDA") to Medtronic in which the FDA stated, in its August 1991 letter in respect of the 4012 lead:

[12] In response to the FDA's letter, Medtronic issued an urgent health safety alert on September 26, 1991 regarding the 4012 model.

[13] On January 21, 1993 the FDA wrote to Medtronic regarding the 4004/4004M lead and stated:

[14] In response to the FDA's concerns, Medtronic issued a health safety alert for the 4004/4004M model leads in October 1993 which recommended an increase, where appropriate, of the frequency of patient evaluation, giving careful attention to lead performance; consideration of whether prophylactic replacement would be appropriate, especially in high risk patients such as pacemaker dependent patients; and careful evaluation of lead integrity when performing routine pulse generator replacements.

[15] The plaintiff, James Hoy, received a model 4012 lead on or about February 20, 1990. The lead was removed on or about October 28, 1999. The proposed representative plaintiff, Andrew Steeds, received a model 4004 pacing lead in or about March 1989. His lead was partially extracted in 1994. The remnants of the lead were removed in 1999.

[16] The defendants will argue at trial that Medtronic was a pioneer in the development of pacemakers and has grown into a world-wide market leader on the strength of its reputation for innovation, quality, service and fair dealing. Medtronic will assert that it designed the leads and brought them to the market in a good faith attempt to advance the state of the art of pacing and did so with all due care and skill. In support of its argument, Medtronic will say that in 1983, in response to the unexpectedly high failure rates of the 6972 model leads, Medtronic voluntarily arranged for the collection of chronic performance data from a number of implant centres, and collated the data with the assistance of an independent panel of respected practitioners. As well, starting in 1984, Medtronic on a regular basis published the collated information in its product performance reports, together with explicit warnings concerning devices that had encountered problems.

[17] There is no question that issues of suitability of P80A as an insulator; failure rates of leads insulated with P80A; and Medtronic's knowledge of and response to these problems will form a significant part of any trial of this action, regardless of whether it is a class action. The evidence filed at the certification hearing concerning those issues is extensive and contradictory (or at least open to more than one interpretation). Considerable time and effort was taken by counsel in demonstrating the merits of the claim and the defences to it. However, the conflicts in the evidence and arguments on the merits of the case are not to be resolved at the certification hearing. The evidence, at this stage, demonstrates that there are serious issues to be tried and valid arguments to be made on both sides of the issues.

[18] The requirements to be met for the certification of a class action are mandated by s. 4 of the Act. Section 4(1) reads as follows:

4(1) The court must certify a proceeding as a class proceeding on an application under section 2 or 3 if all of the following requirements are met:

(a) the pleadings disclose a cause of action;

(b) there is an identifiable class of 2 or more persons;

(c) the claims of the class members raise common issues, whether or not those common issues predominate over issues affecting only individual members;

(d) a class proceeding would be the preferable procedure for the fair and efficient resolution of the common issues;

(e) there is a representative plaintiff who

(i) would fairly and adequately represent the interests of the class,

(ii) has produced a plan for the proceeding that sets out a workable method of advancing the proceeding on behalf of the class and of notifying class members of the proceeding, and

(iii)    does not have, on the common issues, an interest that is in conflict with the interests of the other class members.

[19] The purpose of the Class Proceedings Act was described in Abdool v. Anaheim Management Ltd. (1995), 21 O.R. (3d) 453 at 461 (Gen. Div.), 121 D.L.R. (4^th) 496 at 503, as follows:

[20] That passage, made in reference to the equivalent Ontario statute, has been adopted in British Columbia as similarly defining the British Columbia Class Proceedings Act. See: Collette v. Great Pacific Management Co. (2001), 86 B.C.L.R. (3d) 92 at 100 (S.C.); Koo v. Canadian Airlines International Ltd., [2000] B.C.J. No. 329 at para. 18 (S.C.); McKay v. CDI Career Development Institutes Ltd. (1999), 64 B.C.L.R. (3d) 386 at 391 (S.C.); Bittner v. Louisiana-Pacific Corp. (1997), 43 B.C.L.R. (3d) 324 at 331 (S.C.); Endean v. Canadian Red Cross Society (1997), 36 B.C.L.R. (3d) 350 at 357 (S.C.), rev'd on other grounds (1998), 48 B.C.L.R. (3d) 90 (C.A.).

[21] I turn to consider each of the statutory requirements of certification.

[22] The pleadings disclose a cause of action. The defendants do not contest that this requirement is met.

[23] I have already noted the definition of the proposed class. The defendants do not seriously contend that this requirement has not been met. They argue, however, that there is no evidence that any of the individuals who fall within the class definition, apart from Mr. Hoy and Mr. Steeds, have an interest in advancing claims against the defendants.

[24] In mounting their attack upon certification, the defendants emphasized, among other things, the second main object of the class proceedings legislation as enunciated in Abdool, namely access to justice. The essence of the defendants' argument in this regard is that there is no demand for access to justice in this case. Further, they say there is no reason to believe that certification would remove the cost barrier which is often seen as one of the benefits of class actions.

[25] In support of this argument, the defendants noted that although the first 4012 model was sold in Canada in 1983, and the last 4004 model was sold in 1993, this is the first action in British Columbia claiming damages in respect of faulty pacemaker leads. The defendants observe that any claims to be made in this action concern implants that were made between seven and 18 years ago. As well, the evidence suggests that the average age of patients in whom pacemakers have been implanted is 70 years. Therefore, the average age of plaintiffs can be expected to be between 77 and 87 years of age. The defendants contend that the average age profile of the proposed class make it a group unlikely to be interested in pursuing litigation of any sort.

[26] In addition to the relatively aged population of potential class members, the defendants argue that there is no evidence of a wide-spread demand for access to justice, based on the fact that, to date, only Mr. Hoy and Mr. Steeds have indicated an interest in pursuing this litigation. The defendants suggest that two factors, other than cost, may explain why there has been no wide-spread demand for litigation to date:

(a) Of the 10,000 to 12,000 people in whom the leads have been implanted, many will not have suffered any adverse consequences or will have ceased using their leads for reasons unrelated to performance. The latest information published by Medtronic, dated March 2000, reports that of the 4012 leads implanted, less than 13 percent are estimated to still be active. Of the 4004 leads, just over 20 percent are estimated still to be active.

I observe that, even if that information is accurate, it still leaves open a potential class size of between 1,300 to 2,400 members. Although the average age may be between 77 and 87, there will undoubtedly be some, like Mr. Steeds (who is 21 years of age) who may have greater interest in pursuing litigation.

(b) A claim for a small loss, even a claim asserted in a class action, would still require active participation by the claimant in the proof of the claim and in addressing limitations defences.

I agree that class members will be required to participate in the action to the extent suggested by the defendants. However, it is reasonably clear that the preponderance of effort in the common issues trial will be engaged in the liability aspect of the claims. Causation and limitations issues, while by no means simple or straightforward, will be resolved at the individual claims level.

[27] Notwithstanding the innovative arguments forcefully made by the defendants, it must be remembered that s. 4(1)(b) of the Act requires only that there be an identifiable class of two or more persons. That requirement is clearly met in this case. As I read the statute, there is no discretion to deny certification based on an argument that the plaintiff has failed to show that there are sufficient class members to make the litigation economic.

[28] Furthermore, I must assume at this stage that if the action is certified as a class action, class counsel will act rationally and will not embark on what will undoubtedly be extremely complex and expensive litigation if there is insufficient demand by other potential claimants to justify the expense borne by class counsel.

[29] Furthermore, s. 7(d) of the Act provides:

(d) the number of class members or the identity of each class member is not known.

[30] As the court held in Robertson v. Thompson Corp. (1999), 171 D.L.R. (4^th) 171 (Ont. Gen. Div.) at 180:

[31] It is clear that all potential class members have a shared interest in the assessment of the appropriate standard of care of the defendants. There is no obvious conflict between class members in relation to that issue. The assessment of the two particular lead models can be conveniently (although not necessarily easily) tried in the same action given the similarity between the leads and the fact that the separate lead models represent a close generational change of product by the same manufacturer. This situation is significantly less complex than the circumstances posed in Harrington v. Dow Corning Corp. (1996), 22 B.C.L.R. (3d) 97 (S.C.) in which the court allowed one class proceeding to assess negligence in relation to breast implants produced by an array of manufacturers over an extended period of time. Harrington has since been upheld by the Court of Appeal, 82 B.C.L.R. (3d) 1, leave to appeal to S.C.C. refused [2001] S.C.C.A. No. 21, where Huddart J.A. held, at 21:

[32] In addition, the plaintiff proposes two sub-classes to address the requirements of extra-provincial class certification. The Act contemplates a class which can be subdivided into resident and non-resident sub-classes (s. 6(2)). Non-residents must opt in to the class proceeding (s. 16(2)).

[33] The courts in Harrington and Nantais v. Telectronics Proprietary (Canada) Ltd. (1995), 25 O.R. (3d) 331 (Gen. Div.) certified class actions against manufacturers on behalf of a national class. Both courts held that it was appropriate to determine common liability issues in one jurisdiction:

[34] The utility of a non-resident sub-class is also supported by the fact that Medtronic Canada is a wholly owned subsidiary of Medtronic USA which manufactured all of the product in issue. Medtronic Canada has a head office in British Columbia. Medtronic Canada distributed the product in Canada. I find later in these reasons that the issues of duty of care, standard of care, and breach of the duty of care are common issues. They are issues which will not be made more complicated by the inclusion of non-resident class members. There is no doubt that the issues are complex. However, that complexity stands in favour of the issues being decided at one trial rather than in multiple trials with potentially conflicting results and far greater cumulative cost.

[35] The propriety of certifying a national class was not fully argued because, at the time of the initial submissions on certification, the Court of Appeal had not handed down its reasons in Harrington v. Dow Corning Corp.

[36] The decision of the Court of Appeal was handed down on November 8, 2000. In respect of the jurisdictional issues, the Court held that the existence of a certified class action with a common issue provided a real and substantial connection between the province and the subject matter of the claim that a non-resident sought to have resolved in the same class proceeding.

[37] Huddart J.A. held, at 34-35:

[38] Having regard to the recent holding in Harrington, I conclude that it is indeed appropriate to certify a non-resident sub-class.

[39] Counsel for the plaintiff set out a detailed list of common issues, categorized as follows:

(1) Duty of care;

(2) Breach of the standard of care, with sub-issues related to:

(3) Limitation periods; and

(4) Punitive damages.

[40] The defendants concede that some of the issues raised are common issues. However, they submit that the common issues identified by the plaintiff lack particularity and go beyond the allegations contained in the amended Statement of Claim and, as well, lack a sound basis in fact.

[41] Counsel for the defendants further argue that the common issues as defined by counsel for the plaintiff, if defined as common issues, will result in a "commission of inquiry", the purpose of which would be to delve into the investigation of general issues which would fail to address specific allegations or claims.

[42] The defendants say that only six specific factual matters are identified:

(a) Lack of canine testing of the 4004 lead;

(b) the alleged changes in platinum sputter specifications for the 4004 lead;

(c) the disclosure to the FDA regarding solution A testing;

(d) the level of Medtronic Canada knowledge of data available to Medtronic USA;

(e) the failure of Medtronic to report specific failure data in the health safety alert regarding the 4004 lead; and

(f) the suitability of pellethane 2363-80A as a lead insulator.

[43] The Class Proceedings Act requires that the plaintiff demonstrate that the claims of the class members raise common issues, whether or not those common issues predominate over issues affecting only individual members. Counsel for the plaintiff is in possession of a considerable amount of evidence relating to claims against Medtronic in the United States. They have formulated the proposed common issues accordingly. In particular, I regard the issues of the duty of care, standard of care, and breach of the standard of care as issues common to all potential class members. Resolution of those issues would move the litigation forward and would satisfy the requirements of s. 4(1)(c) of the Act.

[44] In addition, the question of punitive damages is an appropriate common issue which satisfies the requirements of the Act. See: L.R. v. British Columbia (1999), 72 B.C.L.R. (3d) 1 (C.A.), aff'd [2001] S.C.J. No. 39 (Q.L.)

[45] However, having regard to the period of time during which the leads were implanted (1983 to 1993) and the highly individualized nature of individual plaintiffs' awareness of their claims, I conclude that limitations issues should not be certified as a common issue.

[46] Although the defendants vigorously oppose certification, they say that, if the action is certified as a class action, the common issues should be focussed and crisply defined. In an effort to achieve that end, I would define the common issues (as they are disclosed by the amended statement of claim) as follows:

(a) Did the defendants owe a duty of care to persons in whom the leads were implanted?

(b) Did the defendants breach the standard of care in designing, manufacturing and distributing the leads, and if so, when did the breach begin?

(c) In considering (b), the following sub-issues are:

(i) Was the lead insulation unreasonably prone to degeneration and failure due to:

A. Metal Ion Oxidation ("MIO");

B. Environmental Stress Cracking ("ESC"); and

C. negligent processing of polyurethane during the manufacture of the leads?

(ii)    Did the defendants fail to:

A. ensure that the leads were free of defects;

B. perform sufficient pre-market tests on the leads;

C. design and manufacture leads that were adequate to protect against failure and degeneration during ordinary use in employing P80A as insulation;

D. produce a product capable of withstanding the stresses of ordinary and foreseeable uses;

E. employ available design and manufacture techniques that would have reduced the likelihood of failure of the leads;

F. ensure that the leads did not deviate in a material way from their design and release specifications;

G. recall the leads when they knew or ought to have known of the risk of injury prior to the implantation of leads into class members;

H. obtain all required approvals;

I. provide Health Canada (and its predecessors) and the FDA with all relevant information regarding any risks posed by the leads; and

J. provide adequate warnings as to any risks of the leads to physicians, surgeons and all other intermediaries as well as class members of any potential risks or hazards associated with the use of the leads?

(d) If the defendants breached the duty of care owed to the plaintiff, is the plaintiff entitled to an award of punitive damages having regard to the nature of the established breaches?

[47] The plaintiff has proposed 28 sub-issues which generally relate to issues related to the alleged breach of the duty of care such as the fitness of P80A as lead insulation; the reasonable failure rates for bipolar ventricular pacing leads manufactured between 1983 and 1993; the testing of the leads; whether the leads were defectively designed or manufactured; whether the defendants owed a duty of care to disclose adverse information to Health Canada and the FDA before regulatory approval was obtained; and information and safety alerts.

[48] I have incorporated many of those sub-issues in my list of common issues. However, I have attempted to define the common issues by reference to the allegations contained in the amended statement of claim. I think that defining all 28 of the suggested sub-issues as common issues would be unwieldy and would unduly complicate the process. In addition, many of the 28 sub-issues are not pleaded. In my view, only those issues disclosed by the pleadings should be certified as common issues.

[49] This list of common issues will undoubtedly require further refinement and reduction as the litigation moves forward. The common issues must conform to the pleadings, including particulars. The defendants must know the case they have to meet. The trial judge must know that evidence which is not relevant to particular allegations so that it may be excluded.

[50] By far the most contentious aspect of this certification application is the question of whether a class action is the preferable procedure for the fair and efficient resolution of the common issues.

[51] The defendants approached this issue by applying the concept of access to justice as formulated in Abdool as an analytical tool. The defendants argue that the notion that certification creates access to justice is based on three assumptions:

(i) that a widespread demand exists for access to judicial relief;

(ii) that demand is being stifled by the expense of individual litigation; and

(iii) that certification will eliminate the expense barrier.

[52] The defendants, in an innovative and detailed submission, argue that none of the above assumptions are met in the circumstances of this proceeding.

[53] I have already reviewed the defendants' argument that there is no evidence of widespread demand for access to judicial relief and the speculated reasons for that (an aged population; diminished appetite for the stress of litigation; and the prospect that many of the leads in question are no longer in use for reasons unrelated to performance).

[54] Based on that argument, the defendants therefore assert that if there is no demand for access to justice, then there is no reason to grant it; and if the demand is not widespread, then certification - which they say tends to increase the cost of trying common issues - will not yield cost savings by spreading those increased costs over a number of class members.

[55] While it is true that the plaintiff and Mr. Steeds have not provided the court with a list of proposed class members, I have already determined that the requirements of the Act do not oblige the applicant to provide the names of any more than two proposed class members. Furthermore, while I agree with the defendants' submission that certification will not yield cost savings unless it is spread over a sufficiently large class, I must assume that if the certified action does not attract a sufficiently large class, then rational class counsel will abandon the field. Indeed, if there are an insufficient number of class members, it would be open to the class action judge to de-certify the class action. The defendants' submission, if accepted, would require the plaintiff to assemble much of the information that is only available after certification and implementation of the notice provisions under the Act. There is no such requirement under the Act.

[56] The defendants place even greater emphasis on the notion that certification will remove cost as a barrier to otherwise desirable litigation only if two conditions are met:

(i) certification will reduce the per-litigant cost of trying each class member's case to judgment; and

(ii) the cost reduction is so great as to turn "negative-value" claims into "positive-value" claims.

The defendants say that neither condition will be fulfilled in this case.

[57] It is, of course, impossible at this stage of the proposed class action to know the absolute number of individuals who may form part of the class. Under the Act, those implantees in British Columbia are deemed to be a member of the class unless they opt out. Their number will therefore be uncertain for a very long period of time. Non-residents must opt in, which makes knowledge of their number more readily ascertainable.

[58] However, even based on the defendants' calculation of leads still in use, there is a potentially large number of claimants. Even if only a small fraction (say 10 percent) of those implantees wish to pursue litigation, there are still significant numbers (130 to 220 individuals). In order to ensure that those numbers do not represent negative value claims (i.e. where the costs of trial exceed the probable award of damages), many of that number will likely have to be implantees whose leads have been explanted or will have to be explanted prophylactically, because it is those individuals who will have potentially significant damage claims.

[59] The defendants submit that even if the numbers of claimants justify the cost of a class action (which, of course, is yet to be determined), the trial of the claims will be very expensive compared to the modest potential recovery of most claimants (except, perhaps, explantees). The defendants' submission is supported by the pacemaker history of Mr. Hoy which is complicated by a medical history including cancer, several surgeries unrelated to this action, and subsequent infections, which may or may not be related to his pacemaker lead.

[60] A number of subsidiary issues arise from Mr. Hoy's circumstances which the defendants say are also likely to arise in respect of many other claimants. These include:

(i) Whether the lead failed: the defendants argue that Mr. Hoy's lead functioned until it was removed in 1999; it was the pulse generator which failed because the battery was at that point four months beyond its expected nine year shelf life.

(ii) Electrical failure may be caused by factors unrelated to insulation problems with the leads. Sub-clavicular crush (which occurs when the lead is pinched between the clavicle and the first rib) is an historical source of failure.

(iii) Explantation of leads may be required for reasons other than insulation failure, as the defendants argue was the case with Mr. Hoy whose leads were explanted because of infection.

(iv) Pacemakers must be regularly monitored to ensure that the pacemaker is performing properly. Patients are responsible for attending at clinics or with their physician for monitoring. Failure to attend for pacemaker monitoring may result in the claimant being held contributorily negligent.

(v) The potential contributory negligence of health care providers arising from, as in Mr. Hoy's case, the alleged error in implanting a single chamber ventricular pacemaker when Mr. Hoy's condition required a dual chamber unit. This resulted in the presence of a third lead which essentially crowded the field and did not permit the implantation of another lead when replacement was required. As well, the defendants allege that Mr. Hoy was not informed by his physician of the health safety alert for 4012 leads. The defendants also say that Mr. Hoy was not properly followed-up for monitoring which, if it had occurred, would have shown that Mr. Hoy's pacemaker battery was dying. This neglect, the defendants say, resulted in a delay of a year or more in the removal of the pacer system. The defendants argue that these delays resulted in Mr. Hoy's October 1999 surgery being performed in an atmosphere of crisis that required him to be hospitalized ten days prior to the surgery (all of which may impact on Mr. Hoy's claim for damages).

(vi) Limitations considerations will have to be addressed for many claimants for the simple reason that the leads were implanted between seven and 17 years ago.

[61] This list, which is not exhaustive, highlights the many individual issues which are likely to arise in the trial of the individual claims. It is obvious that the issue of damages will be unique to each claimant and will have to be assessed on an individual basis.

[62] I note, however, that common issues concerning duty of care, breach of the standard of care, and punitive damages are, generally speaking, unaffected by the individual issues which will undoubtedly arise. I do not perceive that, in respect of the common issues, a class action would become the "monster of complexity and cost" feared by Esson C.J.S.C. (as he then was) in Tiemstra v. Insurance Corp. of British Columbia (1996), 22 B.C.L.R. (3d) 49 (S.C.); affirmed (1997), 38 B.C.L.R. (3d) 377 (C.A.).

[63] In making their argument, the defendants also emphasize the many individual issues which may arise in support of their contention that a class action is not the preferable procedure. Indeed, they say that, quite apart from the overwhelmingly individual nature of these claims, if this proceeding is certified as a class action, it will attract claims of dubious merit which the defendants say should weigh against certification.

[64] The defendants' argument in respect of dubious claims must be considered in light of s. 37(2) and (4) of the Act:

37(2) A court referred to in subsection (1) may only award costs to a party in respect of an application for certification or in respect of all or any part of a class proceeding or an appeal from a class proceeding

(a) at any time that the court considers that there has been vexatious, frivolous or abusive conduct on the part of any party,

(b) at any time that the court considers that an improper or unnecessary application or other step has been made or taken for the purpose of delay or increasing costs or for any other improper purpose, or

(c) at any time that the court considers that there are exceptional circumstances that make it unjust to deprive the successful party of costs.

(4)    Class members, other than the person appointed as representative plaintiff for the class, are not liable for costs except with respect to the determination of their own individual claims.

These provisions in the Act permit the court to award costs against individual claimants (at the trial of the individual claim) if there has been vexatious or abusive conduct on the part of any party. It is difficult to imagine that the court would resist applying this section in the face of an unmeritorious claim. In this respect, each claimant, before advancing to the stage of the determination of individual issues, would be well advised to seek advice concerning the merits of their individual claim, cognizant of a potentially adverse award of costs.

[65] At this stage, however, the spectre of dubious claims is wholly speculative. If the problem materializes, there are sufficient statutory safeguards to protect the defendants.

[66] A further argument advanced by the defendants concerns the so-called "power of aggregation." This refers to the strengthening of the plaintiff's claim as a result of the aggregation of individual claims, regardless of the underlying merits of the individual claims. This, the defendants say, can lend a case of very little merit tremendous settlement value.

[67] This phenomenon is recognized in the United States which has a longer history of class actions. The problem was described by Chief Justice Posner in re Rhone-Poulenc Rover Inc. 51 F. 3d 1293 (7^th Circ. 1995) at LEXIS, 4:

[68] The defendants accordingly argue that for similar reasons the court in this case should act as a gatekeeper and screen claims that are not appropriate for class action treatment. Support for that submission is found in the Canadian context. In 909787 Ontario Ltd. v. Bulk Barn Foods Ltd. (1999), 128 O.A.C. 317 (Div. Ct.) the court held, at para 29:

[69] The court in 909787 adopted the holding in Robertson in the course of granting leave to appeal a certification ruling in which the defendant agreed that the plaintiff had failed to plead the basis for finding a breach of fiduciary duty in the context of a franchise agreement. That, combined with the conflicting authority as to the existence of a fiduciary duty in the franchise context, necessitated an appeal.

[70] No such frailties in pleading nor concerns as to the existence of a cause of action are alleged in the case at bar. Nevertheless, I accept that the principle is one of general application to class actions, as further exemplified by the following reference at para. 30 in 909787:

[71] I think it can be fairly assumed from the experience gained in the United States and, more recently, in Ontario, that the courts there have been driven by their experience to a more cautious scrutiny of proposed class actions. My perception is that this court, which is only now facing the full implications of this legislation on the court's limited resources, is anxious to avoid the mistakes of other jurisdictions and to learn from their experience. Having said that, however, I am nevertheless obliged to apply the requirements of the Act to the circumstances of the case before me.

[72] The defendants assert that they will vigorously defend the plaintiff's claims (whether or not in a class action context). Of that I have no doubt. The lengthy procedural history to date is exquisite evidence of the defendants' resolve. Indeed, it is that very determination which favours the certification of this action. No individual plaintiff could possibly afford to litigate their claim in the face of, to use the defendants' words, "a determined and solvent defendant" when the claim involves, as it does here, complex issues of a scientific and medical nature.

[73] The defendants' determination is demonstrated by the fact that, in the United States, Medtronic has been successful in defeating applications for certification of class actions involving pacemaker leads on eleven occasions. The defendants say that this court should also decline certification for the reasons given in the U.S. actions. Reliance on American authorities must, however, be treated with caution because of the fundamental distinctions in the statutory framework in the United States and Canada.

[74] In order for a suit to be maintained as a class action in the United States, the plaintiffs have the burden of establishing each of four threshold requirements. They are numerosity, commonality, typicality and adequacy of representation. A failure to satisfy any of these four requirements is fatal to a motion for class certification. Once these requirements are met, the plaintiffs must satisfy one of three further alternative requirements. They are as follows:

(1) that individual adjudication would create incompatible standards of conduct thereby allowing for certification;

(2) that the present action is appropriate for class certification; and

(3) that questions of law or fact common to the class predominate over questions affecting individual class members and a class action is the superior method to adjudicate the controversy.

[75] Several of the American authorities relied on by the defendants denied certification solely on the ground that the individual issues overwhelmed the common issues and that a class action was not the superior method to adjudicate the controversy. See: Adcox v. Medtronic, Inc., No. LR-C-96-333 (E.D. Ark. Feb 19, 1998); Haley v. Medtronic, Inc., 169 F.R.D. (C.D. Cal. 1996); Haley v. Medtronic, Inc., No. CV 94-4113, (unreported) (C.D. Cal. Oct. 30, 1997); Linkous v. Medtronic, Inc., No. 84-1909, 1985 WL 2602 (E.D. Pa. Sept. 4, 1985); Lyons v. Medtronic Inc., No. 95-198 (E.D. Ky. Mar 7, 1997); Lyons v. Medtronic Inc., CV No. 95-198 (E.D. Ky. April 24, 1998); Raye v. Medtronic Corp., 696 F. Supp. 1273 (D. Minn. 1988); Re Medtronic, Inc., No. C-1-97-103 (S.D. Ohio Feb. 10, 1998); Seider v. Medtronic, Inc., No. 95-2614-CIV (S.D. Fla. Oct. 10 1996), magistrate opinion adopted as amended (S.D. Fla. Dec. 27, 1996).

[76] The remaining American authorities relied on by the defendants denied certification because the potential plaintiffs did not meet one of the first four requirements. However, the cases did go on to say that even if the first four requirements could be satisfied, certification would be denied in any event because the individual issues overwhelmed the common issues. See: Rall v. Medtronic, Inc., No. CV-S-84-741-LDG, 1986 WL 22271 (D. Nev. Oct. 15, 1986); Seider v. Medtronic, Inc., supra.

[77] By contrast, the Class Proceedings Act in this province (s. 4(1)(c)) specifically mandates that an action be certified "whether or not those common issues predominate over issues affecting only individual members."

[78] In the case at bar, the common issues of duty of care, standard of care, breach of the duty of care and punitive damages are unlikely to be overwhelmed by individual issues to the degree found in Tiemstra, supra, or in Bittner, supra. If the determination of the common issues is favourable to the plaintiffs, it will advance their claims to a significant degree.

[79] In addition, there is no evidence that there is an extra-judicial procedure in place for the resolution of the plaintiffs' claims. Their only possible recourse is through the mechanism of a class action. Accordingly, I find that the requirement of s. 4(1)(d) of the Act is satisfied. A class proceeding is the preferable procedure for the fair and efficient resolution of the common issues.

[80] The defendants take no issue with the satisfaction of this requirement.

[81] The defendants do take issue with the plaintiffs' satisfaction of this requirement. The defendants say that the litigation plan is inadequate in that:

(a) it does not provide adequate time for the exchange and consideration of experts' reports;

(b) it does not provide an adequate mechanism for dealing with the individual issues which will arise in that:

(i) there is no provision for dealing with the claims of non-British Columbia residents;

(ii) there is no provision for the fact that there may be other parties involved in the individual issues trials;

(iii)   there is no support provided for the proposition that the individual trials should be dealt with by reference;

(iv) there is no allowance made for individual discovery procedures;

(v) there is no allowance for the time which will be required for such procedures and for preparation with respect of the individual trials; and

(vi) there is no consideration given to the amount of time which will be required for each of the individual trials, or for the total resolution of the class proceeding.

[82] In my view, the defendants' complaints concerning the proposed litigation plan are, at this stage, premature. Notwithstanding the protracted procedural history to date, so far as I am aware, there remain only two persons who are prepared to litigate claims against the defendants. Until such time as the size and location of the class is known and the nature of the individual claims has been determined, the adequacy of the plaintiffs' litigation plan cannot be assessed. The proposed plan attached to the May 2000 affidavit of Mr. Hoy was intended as an aid to the court to demonstrate the likely framework within which the class action would proceed. It is obvious that any plan will have to be modified as the exigencies of the litigation become known. In the meantime, I conclude that the plaintiffs have produced a plan which is workable, but which will undoubtedly change as the litigation moves forward.

[83] The defendants contend that Mr. Hoy is not an appropriate representative plaintiff because he has an interest in naming certain of his health care providers as potentially liable parties and because he has an interest, shared with other 4012 lead recipients, but not 4004 recipients, in proving the more factually difficult issues connected with the 4012 lead.

[84] I am not persuaded by the defendants' assertions in this regard. First, in respect of Mr. Hoy's interest in naming health care providers as potentially liable parties, I am unable to see how that speculative interest would affect the common issues of duty of care, standard of care, breach of the duty of care and punitive damages. Nor am I able to see how, even if Mr. Hoy joined such persons as defendants, that would place him in conflict with other class members rendering him unable to properly represent the interests of the class.

[85] Insofar as the defendants' concerns may become reality, I take some comfort in the remarks in Bendall v. McGhan Medical Corp. (1993), 14 O.R. (3d) 734 (Gen. Div.) at 747:

[86] Second, it is proposed that Mr. Steeds, a recipient of the 4004 lead, will act as a representative plaintiff. If there are issues connected with the 4012 leads which are more factually difficult than the 4004 leads, then Mr. Hoy may represent those interests while Mr. Steed may represent the interests of the 4004 lead recipients. Given the close generational development of the two leads, I think that Mr. Hoy and Mr. Steeds are appropriate representative plaintiffs with no obvious conflicts of interest in respect of the common issues.

[87] I am satisfied that s. 4(1)(e) of the Act has been met.

[88] In conclusion, I find that all of the requirements for certification have been met. I therefore grant the plaintiff's application that the within action be certified as a class action.

"P.A. Kirkpatrick, J."
The Honourable Madam Justice P.A. Kirkpatrick