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REASONS FOR JUDGMENT
OF THE
HONOURABLE MADAM JUSTICE KIRKPATRICK
(IN CHAMBERS) |
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Counsel for the Plaintiffs: |
W.K. Branch C. Rhone
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Counsel for the Defendants: |
H. Poulus, Q.C. D.R. Brown, G.T. Palm B. Brent
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Date and Place of Hearing: |
October 25, 2002 Vancouver, B.C. |
[1] The defendants Medtronic Inc. and Medtronic of Canada Ltd. (“Medtronic”) apply in this class action for an order that the plaintiffs, within 21 days, further amend the amended statement of claim to bring it into conformity with the common issues as certified on September 27, 2001 and that the further amended statement of claim include further and better particulars in accordance with requests set out in Schedule “A” to the notice of motion. In the alternative, Medtronic seeks an order that the proceeding be decertified or that the certification order be amended to decertify the issue of entitlement to punitive damages; or in the further alternative, that the plaintiffs, within 21 days, deliver to Medtronic further and better particulars as set out in Schedule “A” to the notice of motion.
[2] I attach Schedule “A” to these reasons to demonstrate the breadth and detail of the demanded particulars.
[3] The issue as to Medtronic’s entitlement to demand further and better particulars was the subject of a hearing on October 25, 2002. The submissions in respect of the actual particulars demanded by Medtronic was adjourned to November 19, 2002, there being insufficient time on October 25, 2002 to hear submissions in respect of the demanded particulars. The continuation of the application has since been adjourned to December 16, 2002.
BACKGROUND
[4] Prior to the certification of this action as a class action, the defendants applied for an order that the then sole plaintiff, James Hoy, provide further and better particulars of his claim. In oral reasons for judgment delivered on May 3, 2000, I ordered that the plaintiff provide a limited number of the particulars which had been demanded. However, with respect to other of the defendants’ demand for particulars, I concluded that the particulars were not necessary at that stage of the proceeding. At paragraph 31, I held:
With respect to demands 4, 5 and 6 of the demand for particulars [concerning the negligence allegations], I have concluded that, at this stage of the proceeding, the answers to the demands dealt with above will be sufficient to permit the defendants to proceed to the certification hearing. The demands in paragraphs 5 through 6 are much more detailed and require, as counsel for the plaintiff asserted, information that will be disclosed by expert reports that the plaintiff does not yet have. I therefore conclude that it would be fruitless, at this stage, to order the production of those particulars. Furthermore, I do not consider that it is necessary at this stage to require production of those particulars.
[5] Counsel for the plaintiffs filed an amended statement of claim on May 12, 2000, which contained the particulars ordered on May 3, 2000.
[6] On May 12, 2000, counsel for the plaintiffs also filed and delivered a motion seeking to have this action certified as a class action. In support of that application, a number of affidavits were delivered, the deponents consisting of (among others) an expert medical witness, Dr. Tyers; Dr. Blais, an expert in medical devices and a former scientist of the Health Protection Branch of the Department of National Health and Welfare, Canada; and Dr. Dillon, a former employee of the U.S. Food and Drug Administration.
[7] It is common ground that counsel for the plaintiffs has access to a significant amount of information that they have termed “legal capital.” That so-called legal capital is available to counsel for the plaintiffs pursuant to an arrangement between plaintiffs’ counsel in British Columbia and attorneys in the United States who have been involved in litigation against Medtronic in the United States. One of those lawyers, John Emerson, in a letter pre-dating the agreement between him and counsel for the plaintiffs, described the information that he would be able to provide to plaintiffs’ counsel, as follows:
We have deposed the defendants’ employees and experts, have reviewed over a million documents, have retained internationally recognized experts on the plaintiffs’ side of the case, and can have the Canadian clients lined up to sign on for this.
[8] In connection with litigation in Texas, in which Mr. Emerson was counsel, the Texas court granted a protective order which permitted plaintiffs’ counsel to provide confidential information obtained from Medtronic to other counsel engaged in related litigation, which was defined as “polyurethane-insulated pacemaker lead litigation where Medtronic is a defendant in cases where a similar protective order was issued.”
[9] In order to gain access to that confidential information, plaintiffs’ counsel sought Medtronic’s agreement to the entry of a similar order in this litigation. On March 27, 2000, a protective order was made by consent in this proceeding.
[10] As part of the agreement providing for the protective order, Medtronic also agreed to give plaintiffs’ counsel access to their document repository in the United States which contains approximately 800,000 pages of documents. In return, plaintiffs’ counsel agreed to accept the repository index as representing the list of documents of Medtronic Inc. in this proceeding and to provide Medtronic’s counsel with copies of all documents they received from sources in the United States.
[11] Medtronic’s application for particulars was delivered on March 24, 2000. The application was heard on May 1, 2000. The general position taken by plaintiffs’ counsel on the May 2000 application for particulars was that particulars were not necessary to enable the defendants to defend the certification proceeding and, in any event, the demand for particulars was premature. As I noted in my reasons of May 3, 2000:
The plaintiff takes the broad view that, if the action is certified to proceed as a class proceeding, then its future course will be highly dependent on the definition of the common issues and the plan approved by the court for the resolution of the common issues. Thus, the plaintiff contends that the original pleadings in the action will become of secondary importance after the issues are narrowed by the certification process.
[12] Pursuant to the protective order for the production of documents, plaintiffs’ counsel received 13 boxes of Medtronic documents and related materials from their colleagues in the United States. Those were in turn provided to counsel for Medtronic and occupy 50 four-inch binders and one two-inch binder. I am advised that this represents the entirety of the document production by Medtronic in relation to relevant and non-privileged documents.
[13] Among the documents provided to plaintiffs’ counsel were the following:
(a) 90 volumes of transcript from the depositions of 52 different Medtronic employees and former employees in other proceedings, including eight volumes of transcript from the depositions of Ken Stokes and six volumes of transcript from the depositions of Charles Swanson (both of whom provided evidence on the certification hearing);
(b) 39 documents marked as “Plaintiffs’ Exhibit”;
(c) approximately 25 individual articles and three collections of multiple articles on polyurethane leads and pacing generally;
(d) Mr. Emerson’s collection of pleadings and other court papers referable to the action in which he was counsel in Texas; and
(e) approximately 3,500 pages of documents from the Medtronic document repository.
[14] On July 26, 2000, the defendants filed a statement of defence in which they acknowledged that they owed a duty to users of their products to use reasonable care and denied any breach of that duty and all of the plaintiffs’ allegations of negligence, thus putting those allegations in issue.
[15] Between August 28, 2000 and September 8, 2000, the parties to this action conducted cross-examinations on the affidavits filed in connection with the certification application. At those examinations, counsel for the plaintiffs produced a number of documents that were marked as exhibits, including Medtronic documents, FDA documents, and transcripts from other proceedings in which Medtronic was involved in litigation in the United States.
[16] On September 27, 2001, I delivered reasons in which I ordered that the action be certified as a class action.
[17] On February 26, 2002, Medtronic delivered a demand for particulars to plaintiffs’ counsel. In correspondence with Medtronic’s counsel, plaintiffs’ counsel took the position that there was no need for any further particulars.
[18] In August 2002, the parties exchanged lists of documents.
[19] At a case management conference on September 12, 2002, plaintiffs’ counsel stated that because the document lists had only been exchanged in August, they needed time to review the documents and conduct examinations for discovery. Plaintiffs’ counsel submitted that until that time, it remained premature to provide further particulars. Following that case management conference, counsel for Medtronic wrote to plaintiffs’ counsel to put them on notice that if they intended to take the position that they were unable to give particulars at the present time, Medtronic would take the position that the point was not open to them unless they delivered affidavit material to displace the evidence on the record that indicates that class counsel have (and for many months have had) access to an extensive body of material.
[20] By letter dated September 25, 2002, plaintiffs’ counsel re-asserted their position that the provision of particulars is premature because discoveries have not been completed and document production and review is not yet complete.
POSITION OF THE PARTIES
[21] Drawing on the general principles distilled from the authorities cited by counsel for the defendants on the application, Medtronic argues that it is crucial that it receive particulars of the plaintiffs’ claims to enable Medtronic to make full answer and defence to the various allegations contained in the amended statement of claim.
[22] There can be no question that this is a complex products liability case involving serious allegations against Medtronic, including a claim for punitive damages. Counsel for the defendants helpfully summarized the authorities and the general principles to be distilled from them in his argument, as follows:
…
(a) Proper particulars are any that tend to delineate the issues between the parties.[1]
(b) It is usual for particulars to be provided by the plaintiff where allegations of negligence are made.[2]
(c) Particulars are to be encouraged where they would bring the real issues between the parties forward and reduce the length of trials.[3]
(d) Particulars are especially important in complicated products liability cases. As this court said in GWL:
I consider the [Cominco] case illustrative of a practical approach to delineating the issues to be tried in a complex products liability case where the pleadings are broad and the need to avoid surprise requires the court’s discretion be exercised in favour of the party seeking to tie the hands of its adversary.[4]
(e) In cases of serious allegations, such as those involving claims for punitive damages, particulars are appropriate.[5]
(f) The functions of particulars include:[6]
(i) to inform the other side of the nature of the case they have to meet as distinguished from the mode in which that case is to be proved;
(ii) to prevent the other side from being taken by surprise at the trial;
(iii)to enable the other side to know what evidence they ought to be prepared with and to prepare for trial;
(iv) to limit the generality of the pleadings;
(v) to limit and decide the issues to be tried, and as to which discovery is required; and
(vi) to tie the hands of the party so that he cannot without leave go into any matters not included.
(g) The fact that the particulars sought are known (or even best known) to the demanding party is not a reason to refuse particulars. Particulars of such allegations should still be provided if the party of whom the demand is made is in a position to give them. A defendant is entitled to know what case is made against it.[7]
(h) The fact that the information sought by way of particulars might be obtained on an examination for discovery is no answer to a demand for particulars. The functions of the two are different. Discovery is not a substitute for particulars. Rather, particulars serve to define the issues on which examinations for discovery are based.[8]
[23] Counsel for the defendants argued that in this complex products liability case, much of the evidence will be given by experts. The experts will have to rely on factual assumptions which, if the expert evidence is to be accepted, will have to accord to the findings of fact that the court will make, that is, on evidence as to what occurred. Counsel for the defendants asserts that proper trial management requires that the issues – in the sense of allegations of fact made by the plaintiffs and denied by Medtronic – be defined with precision. The defendants say that a lack of precision in defining the facts in issue will conduce mismatches between the experts’ assumptions and the facts as found by the court and will result in a near interminable trial.
[24] Counsel for the defendants further argues that the issues as currently defined are conclusory and virtually devoid of factual content. Medtronic argues that the provision of particulars will define the scope of: further documentary discovery and review; examinations for discovery; and the evidence that will have to be marshalled as the factual substratum for expert opinions.
[25] Lastly, the defendants assert that allegations of reprehensible conduct on the part of Medtronic, upon which the claim for punitive damages is advanced, should not be made without an adequate basis, and if the adequate basis cannot be provided in the form of particulars, then the claim in that regard should be struck.
[26] Counsel for the plaintiffs in their written argument raised three main objections to the order for particulars:
(a) that the court lacks jurisdiction to order particulars of the common issues as defined by the certification order;
(b) that the application is res judicata because the defendants applied for many of the same particulars in April 2000 and the court made its order in respect of that application on May 3, 2000; and
(c) that the particulars sought by the defendants are entirely unnecessary.
DECISION
[27] Much of the argument between counsel concerned the jurisdiction of the court to order the plaintiffs to provide further particulars. That argument appears to have its genesis in the earlier notice of motion filed on October 9, 2002. In that notice of motion, the defendants stated that they sought particulars identified by reference to the common issues and sub-issues set out in the certification order of September 27, 2001. After receiving the plaintiffs’ argument, the defendants amended their notice of motion in an attempt to resolve any technical issues of jurisdiction.
[28] Rule 19(16) provides that:
The court may order a party to deliver further and better particulars of a matter stated in a pleading.
The common issues as defined in the certification order are, of course, not pleadings. However, as I stated in my reasons allowing certification of the action, the common issues as defined in the certification order were specifically taken from the statement of claim. The plaintiffs assert that Rule 19(16), because it refers only to pleadings, does not grant the requisite jurisdiction for the court to order the particulars sought by the defendants.
[29] The defendants have also relied on s. 12 of the Class Proceedings Act, R.S.B.C. 1996, c. 50, which provides:
The court may at any time make any order it considers appropriate respecting the conduct of a class proceeding to ensure its fair and expeditious determination and, for that purpose, may impose on one or more of the parties the terms it considers appropriate.
[30] Section 40 of the Class Proceedings Act provides:
The Rules of Court apply to class proceedings to the extent that those rules are not in conflict with this Act.
[31] Counsel for the plaintiffs say that s. 12 cannot be relied upon to order particulars of common issues citing Stern v. Imasco Ltd. (1999), 38 C.P.C. (4th) 347; [1999] O.J. No. 4235 (Q.L.) (Ont. Sup. Ct. J.) and MacDonald v. Dufferin-Peel Catholic District School Board, [1999] O.J. No. 4231 (Q.L.) (Ont. Sup. C.).
[32] Rule 19(16) is derived from marginal rule 203 of the English Rules of 1883. Order 19, Rule 7, Marginal Rule 161 of the British Columbia Supreme Court Rules, 1890, was proclaimed in force by Order-in-Council of October 22, 1892. The Rule long predates the Class Proceedings Act which came into force on August 1, 1995 in accordance with s. 45(1) Class Proceedings Act, S.B.C. 1995 c. 21. Rule 19(16) obviously did not contemplate the potential need for the particularization of common issues. At the time Rule 19(16) came into force, the concept of common issues in a class proceeding was unknown.
[33] In Kimpton v. Canada (Attorney General), [2002] B.C.J. No. 87 (Q.L.) (S.C.); 2002 BCSC 67, the court was confronted by an application for further and better particulars in the pre-certification stage of a proposed class action. Macaulay J. held, at para. 7:
The difficulty in reconciling the Act [the Class Proceedings Act] and the Rules lies not in their objectives but in their respective limitations. This is because the Act is largely silent on the procedural issues arising at the pre-certification stage, yet the Rules were drafted without directly addressing the different needs of litigants in potential class proceedings. Accordingly, there is a lacuna that must be filled by applying a flexible interpretation to the existing rules that is consistent with the procedural and substantive objectives of both the Act and the Rules.
As Macaulay J. also noted, at para. 10:
… The Act does not expressly address the right to either particulars or discovery of documents at any stage of the proceeding.
[34] Macaulay J. thereafter referred to the functions of particulars as enunciated in Cansulex Limited v. Perry: see para. 22(f) above. Implicit in those remarks is the recognition that class actions are subject to the same procedural safeguards as ordinary actions.
[35] I can think of no logical reason why the statements of principle in Kimpton should not also apply to the post-certification stage of class actions.
[36] This proceeding is now certified as a class action. The trial of the common issues is now scheduled to commence in September 2003. At this stage, this action, like any other complex products liability case set for trial, requires management and direction. The only significant difference is that the court has certified the common issues to be decided at the trial. It is those common issues which the defendants must address in their pre-trial preparation. If the common issues as presently defined do not permit the defendants to conduct an appropriate level of pre-trial preparation, including most importantly the instruction to experts as to the facts to be assumed, then this trial will spiral out of all control and will certainly exceed the 10 weeks currently reserved for trial.
[37] Whether particulars are ordered in respect of common issues or in respect of the plaintiffs’ amended statement of claim, the purpose is the same. It is ultimately to ensure that the defendants know the nature of the case they have to meet and are prevented from being taken by surprise at the trial. As well, particulars will limit the matters that are truly in issue and will restrict the parties from embarking upon matters that have not been defined either by the pleadings or by the common issues.
[38] On its face, Rule 19(16) does not permit me to order particulars of the common issues. I conclude, however, that s. 12 of the Class Proceedings Act permits me to make the order the defendants seek for the following reasons.
[39] I agree with counsel for the defendants that the cases upon which the plaintiffs rely to say that s. 12 of the Class Proceedings Act does not give the court jurisdiction are distinguishable from the case at bar. In Stern v. Imasco Ltd., the court was asked to make an order granting the plaintiff accelerated rights of documentary discovery prior to the close of pleadings in the face of provisions that the defendant was not required to deliver an affidavit of documents until ten days after the close of pleadings. In MacDonald v. Dufferin-Peel Catholic District School Board, the court was faced with an application to hear a certification motion outside the county specifically mandated by the rules.
[40] As I have already observed, Rule 19(16) does not refer to common issues under the Class Proceedings Act. It is plain that the Rules of Court have not been drafted with class proceedings in mind. However, I do not consider that, by making an order under s. 12 of the Class Proceedings Act for the production of particulars in respect of the common issues, I will be ousting or nullifying a clear direction in the Rules of Court. That is so because no such direction exists in the Rules.
[41] In my view, it would defy common sense and logic to suggest that the court cannot control its own process under s. 12 of the Act. In my view, it makes good sense to allow for the production of particulars in relation to common issues because that is the basis upon which both the plaintiffs and the defendants will proceed in preparation for trial. If that common sense approach did not meet the technical requirements of the Class Proceedings Act, I would order that the plaintiffs amend their amended statement of claim to conform with the common issues and thereafter order that they provide particulars of the further amended statement of claim. However, I need not make that alternative order. In my view, the court has the capacity to make the order the defendants seek under s. 12 of the Act.
RES JUDICATA
[42] In my view, not much needs to be said in respect of this branch of the plaintiffs’ objection to the defendants’ motion. The application for particulars in April 2000 was made prior to the certification order. I specifically reserved the possibility that, if the matter proceeded to trial, particulars would have to be provided. My ruling on May 3, 2000, was restricted solely to the necessity of the production of particulars at that time, namely to address the issues concerning certification of the action. Furthermore, in my reasons for certifying the class proceeding, I noted that the common issues would be subject to further refinement and reduction and would have to conform to the pleadings, including particulars. That ruling clearly contemplated the very real prospect that particulars would be needed to refine the issues before trial.
PREMATURITY
[43] Counsel for the plaintiffs argues that very little has changed since the defendants’ application for particulars in May 2000. As plaintiffs’ counsel notes, the focus of the efforts on behalf of the plaintiffs to date has been with respect to the certification application; the appeal from that order; and the various issues associated with the notice program. Plaintiffs’ counsel says that it is only recently that the merits of the case have come into focus. Plaintiffs’ counsel also say that in addition to the legal capital to which they have access from the United States, they also intend to conduct their own examinations for discovery and to obtain their own expert reports.
[44] As I have noted, prior to the hearing of this application counsel for the defendants placed the plaintiffs’ inability to provide particulars at this time squarely in issue. In a letter dated September 17, 2002, counsel wrote to plaintiffs’ counsel in the following terms:
There is considerable evidence before the court to suggest that the plaintiffs are unusually well-positioned to give particulars now. If you were to take the position that you are unable to give particulars at this time, you would have to displace that evidence. That would require you to deliver affidavit material. … If you do not deliver evidence on this point, then we will take the position that the point is not open to you.
The plaintiffs have not filed evidence to the effect that they are unable to provide particulars.
[45] Defendants’ counsel took this position based on the decision in Proconic Electronics Limited and Far East United Electronics Ltd. v. Wong et al. (1985), 67 B.C.L.R. 237 (S.C.). In that case, the plaintiff argued that it was unable to give particulars because the facts were solely within the knowledge of the defendant and that, as such, they ought to await the completion of examinations for discovery. Southin J. (as she then was) held, at 240:
I might agree with the submission of counsel for the plaintiffs if the material had, for instance, included an affidavit from some officer of the plaintiffs:
(a) that they were unable to give particulars but,
(b) they believe that there was wrongdoing of the kind alleged in the plea at issue and giving the grounds of that belief.
[46] As counsel for the defendants argues, plaintiffs’ counsel have had the index and access to Medtronic’s repository of 800,000 pages of documents since March 2000. In addition, they have had the assistance of the United States attorneys, Mr. Emerson and Mr. Drakulich, and the 13 boxes of documents from Mr. Emerson, including numerous transcripts of depositions of Medtronic’s past and present employees, since July of 2000. As well, they have known and consulted with at least three of their own experts since at least July of 2000.
[47] The extent of the document discovery to date strongly supports an inference that plaintiffs’ counsel do not lack the knowledge or information from which they can produce particulars, but have been unwilling to invest the time and resources to inform themselves of the particulars demanded by the defendants.
[48] I appreciate the position in which plaintiffs’ counsel find themselves. As plaintiffs’ counsel stated in a case management conference held in June 2002:
… the Catch-22 of the class actions, is that until you actually know you are a certified class action it’s difficult to make the commitment to the financing and everything else that’s needed to bring the litigation. And we’re going to have that uncertainty hanging over our heads for another period of time.
[49] By those remarks, I understand plaintiffs’ counsel to be saying that they are not presently in a financial position to invest the time and resources necessary to examine all of the massive amount of material which has been produced in order to answer the defendants’ demand for particulars.
[50] On the other hand, the trial is due to commence in about 11 months’ time. I think it can be fairly said that the defendants’ examination for discovery of the representative plaintiffs will not serve as an adequate substitute for particulars. This is so, for the reasons stated by plaintiffs’ counsel. The representative plaintiffs were passive patients in whom the cardiac leads were implanted. They will be unlikely to have any knowledge as to the specific facts by which their counsel intend to prove negligence. However, it has long been held that the object of particulars is, in part, to enable the party asking for them to know what case it has to meet at trial, to save unnecessary expense, and to avoid being taken by surprise: see Anglo-Canadian Timber Products Ltd. v. British Columbia Electric Company Limited at 605 referring to Spedding v. Fitzpatrick (1888), 38 Ch. D. 410.
[51] In my view, it would be absolute folly to permit this action to proceed to trial without further refinement and elucidation of the issues that will require the court’s determination. All of the authorities cited at para. 22 of these reasons explain why particulars may be necessary in a given case. The remarks in G.W.L., at 129, are particularly applicable (cited at para. 22):
Discovery is not a substitute for particulars. The contention that what is demanded can be obtained, or that it has been obtained, on discovery is no reason to refuse particulars properly sought. Further, the fact that what is sought in a demand for particulars is best known to the party demanding is no reason to refuse. A party is entitled to know what case is made against it when (whether before or after discovery) the other side is in a position to give particulars of the facts it will prove at trial: Cominco Ltd. v. Westinghouse Can. Ltd. (1978), 6 B.C.L.R. 25 (S.C.)] at pp. 28-29.
[52] There is no evidence before me that the plaintiffs are not in a position to give particulars. On the contrary, the evidence strongly suggests that there is ample information available to the plaintiffs from which the particulars can be provided.
[53] Given the relatively aged population of the class, and the time since the last of the impugned cardiac leads was implanted, it is important that the trial of the common issues proceed at the earliest possible date. Counsel have secured a 10 week trial date to commence in September 2003. It is imperative that between now and the trial date both the parties and the court understand the precise nature of the common issues to be decided. Particulars will lead to precision and clarity in the definition of the common issues, either through pleadings or through a refinement of the common issues, which will in turn aid in the efficient conduct of examinations for discovery and, most importantly, in the preparation of expert reports. Due to the very significant amount of document production in this case to date, it appears that the information and knowledge necessary for the plaintiffs to answer the defendants’ demands for particulars is available. It will no doubt require a significant amount of time and work to examine that information and produce any necessary particulars. However, it is a task that is better done sooner than later.
[54] Accordingly, I propose to hear the defendants’ specific demands for particulars and the plaintiffs’ submissions concerning why the demanded particulars are unnecessary at this time. As noted earlier, those submissions will be heard on December 16, 2002.
“P.A. Kirkpatrick,
J.”
The Honourable Madam Justice P.A. Kirkpatrick
SCHEDULE “A”
The particulars that the defendants seek are identified by reference to the common issues and sub-issues as set out in the Order of the Honourable Madam Justice Kirkpatrick pronounced on September 27, 2001. The defendants seek particulars of the allegations made by the plaintiffs or the class as to those issues as follows:
1. With respect to paragraph 6 (a) (iii) of the order, which reads as follows:
“(a) Was the lead insulation unreasonably prone to degeneration and failure due to …
(iii) negligent processing of polyurethane during the manufacture of the Leads?”
As to each model of the Leads, please provide particulars of:
(a) the way or ways in which the processing of the polyurethane during manufacture was negligent, including each standard that the defendants should have met but failed to meet in manufacturing and each respect in which they failed to meet such standard;
(b) as to each such standard, when that standard first became applicable;
2. As to paragraph 6 (b) (i), which reads:
“(b) Did the defendants fail to …
(i) ensure that the Leads were free of defects;”
As to each model of the Leads, please provide particulars of:
(a) each act or omission that is alleged to amount to an actionable failure to ensure that such model was free of defects;
(b) each such defect;
(c) when each such defect is alleged to have occurred or been allowed to occur.
3. As to paragraph 6 (b) (ii), which reads:
“(b) Did the defendants fail to
(ii) perform sufficient pre-market tests on the Leads;”
Please provide particulars of:
(a) each standard of pre-market testing which applied to each model of the Leads;
(b) each act or omission that is alleged to amount to an actionable failure to perform proper and sufficient pre-market testing by reference to such standard or standards; and
(c) as to each such standard, when the standard first began to apply.
4. As to paragraph 6 (b) (iii), which reads:
“Did the defendants fail to …
(iii) design and manufacture Leads that were adequate to protect against failure and degeneration during ordinary use in employing P80A as insulation;”
Please provide particulars of:
(a) the characteristics of the use or uses alleged to amount to “ordinary use”;
(b) each respect in which P80A was inadequate to protect against failure and degeneration during such ordinary use;
(c) each act or omission of the defendants which caused or contributed to any such failure; and
(d) each standard applicable to Lead design and manufacturer that such act or omission breached; and
(e) when each such standard first became applicable.
5. As to paragraph 6 (b) (iv), which reads:
“Did the defendants fail to …
(iv) produce a product capable of withstanding the stresses of ordinary and foreseeable uses;”
Please provide particulars of:
(a) the characteristics of the use or uses which are alleged to amount to “ordinary and foreseeable uses” of the Leads; and
(b) each act or omission of the defendants that is alleged to be such an actionable failure.
(c) each standard of Lead production that such act or omission breached; and
(d) when each such standard first became applicable.
6. As to paragraph 6 (b) (v), which reads:
“Did the defendants fail to …
(v) employ available design and manufacture techniques that would have reduced the likelihood of failure of the Leads;”
Please provide particulars of:
(a) each such design technique and when it first became available; and
(b) as to each such technique:
(i) each failure, the likelihood of which it would have reduced; and
(ii) how it would have reduced the likelihood of each such failure.
7. As to paragraph 6 (b) (vi), which reads:
“Did the defendants fail to …
(vi) ensure that the Leads did not deviate in a material way from their design and release specifications;”
Please provide particulars of:
(a) each respect in which each model of the Leads deviated from its:
(i) design specifications; and
(ii) release specifications; and
(b) as to each such deviation, each act and each omission that caused or contributed to such deviation.
8. As to paragraph 6 (b) (vii), which reads:
“Did the defendants fail to …
(vii) 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;”
Please provide particulars of:
(a) each risk of injury (including the nature of the injury) of which the defendant had knowledge, or the means of knowledge; and
(b) as to each such risk, the time at which the defendants first had, or ought to have had, such knowledge; and
(c) every source of information from which the defendants received, or should have received, such knowledge.
9. As to paragraph 6 (b) (viii), which reads:
“Did the defendants fail to …
(viii) obtain all required approvals;”
Please provide particulars of each required approval that any defendant failed to obtain.
10. As to paragraph 6 (b) (ix), which reads:
“Did the defendants fail to …
(ix) provide Health Canada (and its predecessors) and the U.S. Food and Drug Administration (“FDA”) with all relevant information regarding any risks posed by the Leads;”
Please provide particulars, as to each of Health Canada, its predecessors, and the FDA, of:
(a) each risk as to which the defendants failed to provide relevant information;
(b) each item of information that it is alleged that a defendant should have provided but failed to provide; and
(c) when each such item of information ought to have been provided.
11. As to paragraph 6 (b) (x), which reads:
“Did the defendants fail to …
(x) provide adequate warnings as to any risk 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?”
Please provide particulars of:
(a) each warning that a defendant should have provided but failed to provide, specifying:
(i) the nature of the warning that should have been provided;
(ii) when; and
(iii) to whom;
it should have been given;
(b) each failure to adequately or sufficiently inform:
(i) any doctor;
(ii) any surgeon;
(iii) any learned intermediary; or
(iv) any class member;
of potential risks or hazards associated with the use of such lead (identifying the person or persons whom such Defendant failed to inform) and, as to each such failure, specifying:
(v) when such failure is alleged to have occurred; and
(vi) the potential risk; or
(vii) the potential hazard (as the case may be)
and identifying each item of information that alerted, or should have alerted, any Defendant that it should warn any such person.
12. As to paragraph 6 (c), which reads:
“If the defendants breached the duty of care owed to the plaintiffs, are the plaintiffs entitled to an award of punitive damages having regard to the nature of the established breaches?”
Please provide particulars of any act of any defendant that alone or taken together with any other act of any defendant is alleged to have been:
(a) harsh;
(b) vindictive;
(c) reprehensible;
(d) malicious;
(e) high handed;
(f) arbitrary;
(g) deserving of condemnation; or
(h) <