Taylor v. Canada (Attorney General), 2020 ONSC 1192

COURT FILE NO.: CV-181819

DATE: 20200227

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

KATHRYN ANNE TAYLOR

Plaintiff

– and –

THE ATTORNEY GENERAL OF CANADA

Defendant

John Legge, Steve Pengelly, David Steeves, and Brian Moher for the Plaintiff

Sean Gaudet, James Soldatich, Andrew Law, James Gorham, Roger Flaim, for the Defendant

James Newland, Neil Wilson for the Ontario Health Insurance Plan

HEARD: April 1-3, 5, 8-12, 23-26, 29, 30; May 1-3, 6-12, 15, 23-26. 29-31; June 3-5, 10-13, 17-21; September 16-20, 23; October 7-9, 2019

LEDERER J.

INTRODUCTION

[1] Government regulates many areas of our lives. This regulatory activity is part of what organizes our society, confirms its values and, in some circumstances, gives direction to what we can, should or might do. In a culture which values the individual and encourages other participants (say universities, research entities and corporations) to find solutions to common concerns, locating the balance between public and private responsibility when things go wrong is a complicated problem. This case enters into this difficult question but in what turns out to be a limited way.

[2] The area being regulated is a form of medical treatment, not the activity of the professionals involved (doctors and nurses), or the use of drugs but instead so called “devices” that may improve the circumstances of those in need of relief. This includes, for example, any apparatus that may be used to augment the structure of the body and improve its function. In this case, Vitek Inc., a corporation located in Houston, Texas was promoting and selling a proprietary product (“Proplast”) for a variety of uses associated with an array of physical issues of concern to many people. Of particular relevance was its use in implants designed to replace the meniscus in the jaw to alleviate discomfort and improve performance. This occurred at a time of growing government interest in the entry of these devices into the market and the perceived need for increased regulation to meet their arrival. Devices using Proplast were implanted into some Canadian citizens. Today, it is generally accepted that Proplast is frangible (fragile, brittle), breaks down and that the resulting particles may distribute themselves causing much suffering and pain such that the use of the jaw may become restricted, in some cases ineffectual. The Plaintiff says that the defective nature of the product was well-known and understood long before these implants were put in place. It is said that the fault for the harm that resulted lies, in part, with the government for its failure to properly regulate and control the entry of Proplast products into the market and its failure to respond appropriately after the difficulties of the recipients of these implants became apparent.

[3] This is a class action. It has a history, not a happy one. The implants which mark the beginning took place at some point between 1983 and 1990. This action was commenced in 1999. It has taken 20 years to bring it to trial. By my count, from the trial record, with the delivery of these reasons, no fewer than 23 judicial officers (Masters, Superior Court and Court of Appeal judges) will have touched this proceeding.

[4] The initial representative plaintiff was Judith Logan. In 2002 an effort was made to add, as a plaintiff, Wendy Bulloch-MacIntosh. She had commenced an individual action. The stated purpose of the motion was to add to the certification record information elicited from representatives of the Crown during the discovery in that separate proceeding. There was a threshold issue. Could the individual action be stayed but left in place if Wendy Bulloch-MacIntosh became a representative plaintiff in the class action? Initially, the judge considering the matter indicated a willingness to hear further submissions. In the end, the plaintiff withdrew the request.[^1] In 2003, Judith Logan was replaced by Kevan Drady and the present representative plaintiff, Kathryn Anne Taylor.[^2] Kevan Drady withdrew in 2006 to commence a separate class action alleging negligence over the regulation, by Health and Welfare Canada, of a different implant, that one using “silastic” (a combination of silicone and plastic), not Proplast. That action was struck out by the Court of Appeal in 2008 for failing to disclose a reasonable cause of action.[^3]

[5] The first substantive issue that comes to mind is whether, given the time lapse, the action was commenced outside the applicable limitation periods. At the time, there were two limitations that could have impacted this case. The first, 6 years as found in the Limitations Act[^4], and the second the Crown Liability and Proceedings Act[^5] which, in turn, adopted whatever provisions applied in the province where the cause of action arose being, in this case, the Proceedings Against the Crown Act of Ontario.[^6]That Act required that at least 60 days before the commencement of an action against the Crown a notice of the claim be served on the Crown. The issue of applicable limitations arose as part of a motion heard considering the substitution of the original representative plaintiff. The question was whether the substitution could not take place because, in the absence of certification, the putative class action remained an individual action. This would mean that the “tolling” of the applicable limitation period through the Class Proceedings Act, 1992[^7] had not become effective. The motion judge did not accept this submission. In any case, as he saw it, there was no need to start a new action. “The most appropriate approach to deal with the motion to substitute in the present circumstances is by way of amendment, pursuant to the jurisdiction granted to the court under ss. 12 and 14 of the CPA [Class Proceedings Act] rather than for the new representative plaintiffs to commence a fresh proceeding.”[^8] Apparently, the issue of whether the action as commenced in the name of Judith Logan was out of time did not come up. However, it did in the appeal that followed:

In any event the motion judge did not deal with that argument and I can only assume it was because the argument was not put in that way. In any event, however it is clear from the disposition made by the motion judge that because the claim is that the breaches by the appellant are continuing, the action was not, on its face, barred by the passing of the limitation period.[^9]

[6] The appeal was dismissed. The substitution was allowed.[^10] So far as I am aware the issue of whether this action was out of time has not been raised since. It was not raised at this trial.

[7] The certification of this action as a class proceeding was not finalized until July 6, 2012 following a determination made by a five-judge panel of the Court of Appeal. What did it take to get to that point? During May, 2000, the plaintiff (still Judith Logan) brought a motion to certify the action as a class proceeding.[^11] On October 3, 2000, a motion to strike certain materials included in the Motion Record filed, by the Plaintiff, in support of the motion to certify the action was heard. Of the six contested items, two were withdrawn, three were struck and for one, the issue declared moot.[^12]

[8] On July 25, 2001, Master MacLeod dealt with a motion, generally, concerning the refusal to answer questions during a cross-examination conducted in preparation for a motion to amend the pleadings. What is apparent is that the difficulties that have marked the overall conduct of this action had already appeared:

A form of procedural gridlock has arisen over this issue notwithstanding admonitions by the case management judge.[^13]

[9] An appearance was necessary to settle the order. The difficulties that had presented themselves continued. The Master was required to underscore that the order he had made required the deponents to the affidavits to reattend to answer the questions asked, as well as reasonable follow-up questions. As the Master noted, while the issue of a re-attendance is discretionary, the permission to permit a subsequent examination was, and remains, the “usual order”. The Master felt the need to go on:

I find it an extraordinary submission that the credibility of these witnesses will remain an issue on the motion.[^14]

[10] It seems the Master also had to consider and deal with an allegation of some sort of improper conduct of counsel for the Plaintiff:

I do not view the affidavits provided by Mr. Legge as an improper attempt to unilaterally determine the mode of examination but rather as an attempt to provide timely answers in a cost effective manner.[^15]

[11] The Master noted the Crown’s response to whatever problem it saw:

Nevertheless, the Crown insists on proceeding orally and there has been no persuasive argument why this should not be allowed.[^16]

[12] This all has to do with a refusals motion. One has to wonder why all this obfuscation was thought to be necessary.

[13] The certification motion was considered in reasons delivered on September 5, 2007. The action was certified:

The allegations are consistent with an interpretation that Health Canada's failure to take steps to enforce the regulations and its directions to the distributor of the devices - despite its knowledge that they were being breached - facilitated the continued sale of the devices and thereby created a risk to the health of the intended recipients. Health Canada’s alleged failure to enforce the regulations when it was aware that sales of the implants were continuing after it had given notice of breaches on a number of occasions over a period of six or seven years, could only have encouraged the importer/distributor to believe that it could ignore its statutory obligations, and Health Canada’s warnings, with complete impunity. In these circumstances, I believe it would be open to a court to find that Health Canada’s course of conduct – including the dissemination of the misinformation in its database - increased the risk to the health of the plaintiff and other potential recipients of the implants and gave rise to a relationship of proximity with them.[^17]

[14] The Court pointed out the limits of this determination:

It is possible that the plaintiff will not be able to prove the allegations of fact in the statement of claim - or that a different complexion may be placed on them when all the evidence on each side is before the court at trial. These are not matters I am concerned with on this motion.

[15] But went on to confirm the then pertinent conclusion:

On the basis of the pleading alone, I do not consider it to be plain and obvious that Ms. Taylor has no chance of success in establishing that a relationship of proximity – as required to establish a private law duty of care – existed in connection with operational acts of Health Canada. I believe this conclusion is consistent with the cases I have cited, and others…[^18]

[16] A motion was brought to the Divisional Court seeking leave to appeal the order certifying the class action. Leave was refused.[^19]

[17] This was not the end of the Court considering the question of certification of the proceeding as a class action.

[18] A year after the certification motion, the Court of Appeal released its decision in Drady v. Canada.[^20] It too considered implants to the jaw. In that case, in this Court, the year before, the same judge, as on the certification motion, had struck the Statement of Claim. Proximity was not apparent because the plaintiff was unable to identify the particular implant he had received as being manufactured by Vitek Inc.:

In these circumstances – independently of any other considerations - the facts alleged with respect to the Crown's operational negligence with respect to the Vitek Proplast implants are, in my judgment, insufficient to give rise to relationship of proximity between it and Mr Drady. Under the FDA and the regulations, the Crown does not regulate devices generically or by categories. Its powers and responsibilities are confined to dealing with particular devices sold, or to be sold, in Canada on a case by case basis. The Crown's alleged negligence in respect of the defaults of the Vitek Proplast implant vendor cannot create proximity with Mr Drady if it is not alleged that he received such a device.

Independently of any other consideration, a causal relationship between the plaintiff, the device and its vendor is an essential link in the creation of a relationship of proximity. …[^21]

[19] The device implanted in Kevan Drady did not use or contain Proplast. It relied on silastic. The Court of Appeal in Drady considered the Superior Court decisions in both that case and this one. It confirmed the decision that, in Drady, there was no proximity between the Crown and the plaintiff. There being no proximity, it was plain and obvious that the action could not succeed.

[20] At about the same time as the decision of the Court of Appeal in Drady v. Canada it also released its reasons in Attis v. Canada[^22] which considered the same issues, albeit in relation to breast implants rather than jaw implants. The legislative scheme did not demonstrate any intention to impose a private law duty of care[^23] and there was no direct communication or interaction between the government and the plaintiff in relation to the operation or implementation of a policy such that a duty of care could arise. There was no allegation of any representations by Health and Welfare Canada that were capable of supporting a relationship of proximity.[^24]

[21] Both Drady and Attis made reference to Sauer v. Canada (Attorney General).[^25] It runs counter to their determination concerning the absence of proximity. In Sauer, a farmer commenced a class action as a result of a cow, in Alberta, contracting “BSE” (colloquially “Mad Cow Disease”). Some countries closed their borders to Canadian beef. The law suit was for negligent regulation of the cattle industry and claimed for the financial losses suffered as a result. In certifying the action, the judge considering the motion held that a duty of care had been disclosed in the pleadings. The Court of Appeal made this observation even though the judge had not directly addressed the question.[^26] The motion judge had moved directly to the issue of whether there was a policy rationale for overriding the finding of proximity and the resulting duty of care as required by the second stage of the test in Anns v. Merton London Borough Council.[^27] In Sauer v Canada (Attorney General) the Court of Appeal upheld the certification. It dealt with the issue of proximity in a single paragraph:

On the other hand, Sauer argues that he has pleaded the facts required to show sufficient proximity between Canada and commercial cattle farmers to raise a prima facie duty of care. In particular, he points to the many public representations by Canada that it regulates the content of cattle feed to protect commercial cattle farmers among others. He says this shows that Canada was acting with their interests in mind rather than the broad public interest. Sauer says that Canada’s public assumption of a duty to Canadian cattle farmers to ensure the safety of cattle feed yields the conclusion that it is not plain and obvious that his claim of a prima facie duty of care will not succeed. I agree.[^28]

[22] Drady and Attis having been decided and based on what they determined, the Crown moved, in this action, to strike the Statement of Claim and decertify the class action. The Court determined that the pleading failed to disclose a reasonable cause of action but granted the plaintiff leave to amend the Statement of Claim. The Court denied the motion to decertify the class action.[^29]

[23] In coming to its decision, the Court took account of how each of Drady and Attis dealt with Sauer:

The treatment of Sauer in these cases is typified by the following comments in Attis and Drady:

[In Sauer] this court found a sufficient pleading of proximity at para. 62 on the basis of the many express "public representations by Canada that it regulated cattle feed to protect commercial cattle farmers among others" (emphasis added). Accordingly, the result in Sauer depended on the allegation of specific representations by the Government that it was acting in the interests of the plaintiffs. On this basis, Sauer is distinguishable because the appellants in this case do not plead any specific representations by Health Canada that it was acting to protect the particular interests of the consumers of breast implants. (Attis at para 49)

Proximity was also adequately pleaded in Sauer on the basis of the many express public representations by the government that it was acting for the explicit purpose of protecting the commercial cattle farmers. These representations supported the plaintiff’s allegation that the government assumed a private law duty to act on behalf of the farmers. (Drady at para 42)[^30]

[24] And concluded:

The significance attributed to the representations in Sauer would appear to have considerable precedential importance for counsel and motions judges when considering the kind of representations by the Crown that could give rise to a sufficiently close relationship with the plaintiff.[^31]

[25] In the end it was not plain and obvious that the proximity necessary to demonstrate a private duty of care could not be met:

In these circumstances, I believe I should accept the amended pleading on the ground that – when it is read generously - it is not plain and obvious that a finding of proximity could not be made at trial if the factual allegations pleaded are proven. At the very least, in view of the need for clarification of the requirements for an effective public assumption of a private law duty of care, I consider that this is a case in which it should be held that the particular issue on which proximity turns is not fully settled in the jurisprudence within the meaning of the decisions cited in paragraph 47 above. In such cases it has been held that the issue in dispute is best left to be dealt with at trial on the basis of a full evidentiary record.[^32]

[26] Instead of proceeding to the Divisional Court and recognizing the confusion the mix of cases then extant had caused, the Crown determined to move directly to the Court of Appeal. A motion was brought for leave to have a special case determined. The judge opened his reasons observing that “[t]his action has had a tortured history”.[^33] It was 10 years after the action had been commenced. There had been no progress. The motion was granted, in part out of concern for the delay:

The parties have indicated to me that this litigation has already become a procedural marathon. If the case was to follow through the normal course in the Divisional Court with leave to appeal and appeal in the Divisional Court, followed by the inevitable application for leave to appeal to this court and the appeal in this court, then several more months -- if not a couple of years -- will have passed. This action was commenced in December 1999 and pleadings have not yet closed. So much for access to justice!

It is time to get this case moving ahead…[^34]

[27] It is this order that placed the matter before the panel of five judges of the Court of Appeal. In its decision the Court of Appeal picked up on the general understanding outlined in Attis to the effect that the proximity necessary to found a duty of care can arise from the legislation or through direct interaction between the regulator and the individuals impacted:

The approach taken to the claims in Drady and Attis is consistent with that described above. In both cases, this court looked first at the relevant legislative scheme and found that it imposed no private law duty of care: see Attis, at paras. 53-62; Drady, at paras. 37-39. The court then turned to the pleadings in each case to determine whether the interactions between the regulator and the plaintiff set forth in the pleadings created a relationship of proximity such as to justify a finding of a prima facie duty of care.[^35]

[28] The Court rejected the finding, apparent in the determination in Sauer, that the “many public representations” made by the regulator as to its intention to protect farmers was sufficient to support a finding of the proximity required as the basis for the existence of a duty of care:

In my view, a finding of proximity based entirely on a regulator's public acknowledgement of its public duties to those affected by its actions, coupled with reliance by those affected on the regulator's public statements, is inconsistent with the Supreme Court's rejection in Imperial Tobacco of the claim that Health Canada owed a private law duty of care to consumers of low-tar cigarettes because it had made public representations as to the relative safety of those cigarettes.[^36]

[29] The Court concluded:

This is not the time or place to pass upon the ultimate sufficiency of the pleadings in Sauer. I am satisfied, however, that the detailed analyses of proximity in Attis and Drady, particularly in the light of the subsequent judgment in Imperial Tobacco, are more in line with the prevailing jurisprudence. The single conclusory observation in Sauer, standing alone, is not consistent with that jurisprudence.[^37]

[30] However, the Court of Appeal was not prepared to foreclose the possibility of the required proximity being available to the Plaintiff. The inquiry is broader than looking for immediate and direct interaction between the regulator and the prospective plaintiff:

Where the legislation is not determinative one way or the other, the courts explore the specific circumstances of the interactions between the regulator and the plaintiff in the context of the legislative scheme to decide whether a sufficiently "close and direct" relationship exists to justify the imposition of a prima facie duty of care…[^38]

[31] The Court addressed the substance of that inquiry:

Findings of proximity based on the interactions between the regulator and the plaintiff are necessarily fact-specific. The jurisprudence does, however, suggest there are two important factual features in those cases where the court has found a prima facie duty of care.[^39]

[32] And explained the two factual features it found important:

First, the facts demonstrate a relationship and connection between the regulator and the individual that is distinct from and more direct than the relationship between the regulator and that part of the public affected by the regulator's work.[^40]

And

The second feature of those cases in which the courts have found that the interactions between the plaintiff and the regulator created a prima facie duty of care arises out of the nature of the duty actually imposed by the legislative scheme. While the statutory duties are found to be public duties and not, therefore, themselves the basis for any private law duty of care, those public duties have been found to be consistent with the existence of a private law duty of care owed to an individual plaintiff.[^41]

[33] On this basis the Court concluded:

The jurisprudence permits no definitive answer for the first question. As counsel for AG Canada put it in his factum, "[t]he requirements for proximity are diverse and depend on the facts of each particular case".[^42]

[34] The Court of Appeal did not stop there:

…there is no allegation of any direct contact between the plaintiff [Kathryn Taylor] and Health Canada[^43]

[35] However, the possibility of proximity remained:

…In my view, it is arguable that the misrepresentations, combined with the failure to correct that misrepresentation in the face of knowledge of the serious and ongoing risk posed to a clearly definable and relatively small group of consumers, could be viewed as akin to the regulator's failure in Fullowka to act in the face of the known and ongoing dangers posed to the small and well-defined group of miners who worked in the specific mine which the regulator knew to be unsafe.[^44]

[36] With this, the action was certified and proceeded as a class action.

[37] Why review this history now? It is unacceptable that it has taken as long as it has for this action to proceed to trial. The case is premised on the idea that there is a group of people who have been harmed by the alleged neglect of the government. They have been waiting for twenty years, their suffering continuing, presumably with the hope, maybe even the expectation, of some assistance. No one should be content with the time this has taken. Those involved have to ask why they allowed this to happen. Moreover, what the reasons of the Court of Appeal demonstrate is that the foundational question to be answered: Did the government owe the members of the class a private duty of care, is a limited one. No duty of care is imposed by the legislation. Nor, in this situation, is there proximity as a result of direct and immediate interaction. What is left is narrow. Is there some identifiable group to which, as a result of some action by the government, proximity exists and a duty of care attaches?

[38] This is not the only limitation imposed through the history of this unfortunate litigation.

[39] It should go without saying that there are other parties who would have been involved in the importing, marketing, selling, purchasing, implanting and observing the results of any surgery associated with the placing of Vitek Proplast devices. These would include the manufacturer, the distributor, the hospital and various doctors and other professionals. Not surprisingly, given that the only defendant in this action is the Crown, it issued Third Party Claims. The Trial Record includes an order, dated September 14, 2006, allowing the Crown, on consent, to deliver its Amended, Amended, Amended, Amended Third Party Claim.[^45] There is no earlier form of the Third Party Claim in the Trial Record. Clearly, it had been subject to a series of changes. There is another order, this one issued on September 25, 2005, as I read it, in furtherance of the amendment allowed 10 days earlier. It allowed for the discontinuance of the Third Party action against those that, with the amendments that had been ordered in place, were no longer the subject of any allegations in the Third Party Claim.[^46]

[40] The motion that determined that, in Drady, the Statement of Claim disclosed no reasonable cause of action was joined by a motion to strike the Third Party Claims in both Drady and this case. The question that arose concerned what the Plaintiff was claiming and, in particular, did it leave open the prospect that the Crown, if found liable, could have a claim to contribution and indemnity as allowed for by the Negligence Act.[^47] At the outset, counsel for the Plaintiff was insistent that the Plaintiff’s claim perceived that the Crown was liable for all of the damage she had suffered. Counsel for the moving parties (the Third Parties) relied on “a few references to the Crown’s several liability that appeared in the Plaintiff’s pleadings”.[^48] The Court determined that “several” liability did not foreclose the possibility of contribution from others:

I do not believe there is any doubt that the great majority of situations in which a right to contribution arises in practice involve several, rather than joint, tortfeasors.[^49]

[41] On this basis, one would expect that the motion was dismissed. It was. But not before counsel for the Plaintiff had a change of heart. On a subsequent appearance, counsel indicated a willingness to make clear that while the position remained that the Crown was liable for all the damage suffered, should it be found that others shared the blame, the Plaintiff was seeking an award only for the Crown’s proportionate share. This being so there would be no basis for a claim for contribution. The motion was dismissed but on the understanding that it was open to the Plaintiff to amend the Statement of Claim to make clear that the liability of the Crown was limited to its relative degree of fault. An application could then be made for a declaration with respect to that relative degree of fault.

[42] The order was appealed. By the time the appeal was heard, the Statement of Claim had been amended to meet the suggestion of the motion judge. Thus, there was no basis for a claim for contribution. The appeal was dismissed. The Court of Appeal took it that the motion judge had struck the Claim and that he was right to do so.[^50]

[43] This is another limitation as to what can be accomplished in this trial. The Court of Appeal, in dealing with the Third Party claim, observed that the Court maintains the jurisdiction to apportion fault against a person not a party to the action or, as put by the Court of Appeal: “…nothing in the language of s. 1 [of the Negligence Act[^51]] precludes a court from doing so.”[^52] No one is asking for this kind of apportionment. In this situation it would not be appropriate as a common issue. The answer would be, or could be, different for every member of the class depending on who was involved and what role they played. Thus, all that can happen in this common issues trial is the recognition that there was a duty of care owed and that it was, or was not, breached. Nothing can be done to assess the degree of fault or the proportion of the liability attributable to any party. Still it seems not unreasonable to propose, as a possibility, that once any liability of the manufacturer, distributor, doctors, hospitals and others are accounted for, any degree of liability attributable to the government might be small, in relative terms and as to its value.

[44] Another limitation is in respect of the class. How many people are there who could benefit from a finding in favour of the class? Not many.

[45] How was the class to be defined?

…The classes that the plaintiffs seek to represent consist of persons resident in Canada, outside British Columbia and Quebec, who received the TMJ implants.[^53]

[46] This is a highly generalized statement. A true understanding of the class requires refinement. I begin by repeating that the reason Kevan Drady’s individual action failed is because he was unable to identify Vitek Inc. as the manufacturer of the implant he had received:

In this case, although the allegations relied on by the plaintiff appear to relate to the same implants (Vitek Proplast implants) of the same vendor/importer whose breaches of duty were allegedly ignored by the Crown in Baric, it is not pleaded that Mr. Drady received any such implant.[^54]

[47] This class action concerns those who received Vitek Inc. Proplast temporomandibular joint (jaw) implants. What follows from Drady is that if the individual did not receive one of these implants, he or she cannot be a member of the class:

It follows that the scope any duty of care that might exist between the Crown and those who received the Vitek Proplast implants cannot, in my opinion, extend to a person who did not receive them.[^55]

[48] Understood in this way, membership in the class is narrowly defined: implants made by a particular manufacturer, utilizing a proprietary product in its manufacture (Proplast), implanted without the requisite acceptance by the regulator (the granting of a Notice of Compliance), where the recipient or his caregivers were misled into believing a Notice of Compliance had been granted when they had not been, or, in circumstances where the Notice of Compliance, though issued, should not have been.

[49] All of this when the suggestion is that there were few of these implants used in Canada. There have been doubts about the numbers since the beginning. The following paragraph appears in the reasons responding to the first certification hearing, the one that took place during June 2007 with the decision being released on September 5, 2007:

Plaintiff's counsel estimated the size of the class to be approximately 2600 individuals. The evidence in support of a number this large is not persuasive. The estimate is based on information from Health Canada that 26,000 Vitek TMJ implants were distributed in the United States and an assumption that, based simply on the relative populations of Canada and the United States, "it would not be unreasonable" to conclude that 2,600 units were implanted in Canada. The information from Health Canada on which counsel relied only in part suggests that the class might not exceed 200 persons.[^56]

[50] To the Court of Appeal, at the hearing of the special case, the assumption was that the group was small:

In my view, it is arguable that the misrepresentations, combined with the failure to correct that misrepresentation in the face of knowledge of the serious and ongoing risk posed to a clearly definable and relatively small group of consumers, could be viewed as akin to the regulator's failure in Fullowka to act in the face of the known and ongoing dangers posed to the small and well-defined group of miners who worked in the specific mine which the regulator knew to be unsafe.[^57]

[51] This perception is fundamental to the ultimate determination made by that Court. The finding that it was not plain and obvious that the action could not succeed was based on the understanding that the interaction that was the foundation of the required proximity was to other than those affected by the regulator’s regular work, by definition a smaller group. Inspite of all of this, as late as November 27, 2018, a motion was brought before Master McGraw who, while acknowledging that some members would have died, understood the size of the class to have “approximately 2500 -2600 members”.[^58] The Submissions of the Plaintiff made at the end of the trial use the same estimate.[^59]

[52] As will become apparent later in these reasons, there is some reason to wonder whether any of the individuals who testified are, in fact, members of the supposed class. This leaves open the prospect that there is no class.

[53] There are serious limitations to the impact of any decision the Court may render. There is only a narrow route to the necessary proximity; it is only the alleged negligence of the Crown that is at issue, its proportionate share of liability, if any, cannot be determined as a common issue and the size of the class cannot be determined but could be small.

[54] In this consideration of the history, I move on to production. This was an issue of controversy throughout the twenty years leading to this trial which continued, despite the efforts of the Court to bring it to an end, up to and including the last days of the trial. It does not reflect well on the parties, either of them. To my mind, it contributed substantially to the delay in bringing this matter to resolution.

[55] On October 17, 2003, Master MacLeod released reasons in a motion dealing with production.[^60] Viewed from the perspective of the time (the beginning of the process) it was both comprehensive and prescient. It concerned the fundamental obligations of the Crown:

(1) Was it obliged to swear an affidavit of documents in the usual form?

(2) What was the range of documents to be produced?[^61]

(3) Given the volume of documents to be produced and the production of copies on CD ROM, what special rules should apply?[^62]

(4) Should Health Canada disclose how the search for documents was conducted, who conducted it and what search criteria were used?

[56] In answering the questions that were put to him, the Master made an observation pointing to the problem the parties faced:

A large document case, requires a specific plan for organized access to the documents. Tracking document locations and permitting inspection of originals is particularly problematic if the documents or files are required for the day to day operations of an organization or if they may be subject to production in more than one proceeding and may be required in the future. In such situations, the immediate production obligation must be balanced against the need to maintain the ongoing viability of the filing system. Production obligations can be onerous and disruptive to an organization and some balance must be struck.[^63]

[57] He made plain the risk and advised as to the solution:

Finally, to avoid complete chaos on both sides, the organization and production of the documents for the purpose of the litigation should ideally utilize a jointly accepted plan of organization, authentication, identification and retrieval. What is necessary therefore is definition of the scope of production, a production procedure that is understood and accepted and liberal doses of procedural collaboration and common sense. In these actions, I invite counsel to agree on the plan but if agreement cannot be achieved, court management and supervision of the production and discovery process appears necessary.[^64]

[58] The Master understood that, in this situation, there were practical limits to the process:

The plaintiffs wish paper copies of every document and wish to inspect every original document. As I understand it they also wish to see every document in its original file folder in original order and they wish production of the file tracking documents or stamps which are believed to show who within Health Canada had possession of any file and at what time. In the particular circumstances of this case with the volume of documentation involved, that demand is unrealistic, onerous, expensive and excessive. It is unnecessary for every document to be subjected to this level of scrutiny. There is a right to inspect original documents and there may be relevance to file tracking information or file organization but it is necessary for such rights to be exercised in a focussed and targeted manner.[^65]

[59] All of which speaks to the clear-headed observation that some cooperation and understanding needed to be applied to the difficulties of this particular document search.

[60] Fifteen years later, on October 29, 2018, a motion was brought before Master McGraw. The motion was, in part, for an order striking out the Statement of Defence for “…the alleged failure to produce documents pursuant to court orders, specifically the order of Master MacLeod (as he then was) dated October 17, 2003”.[^66] This was taken in the face of a trial date that had been set by Mr. Justice Firestone, a year earlier, on October 31, 2017. The Master was aware of the problematic nature of this request. He wondered if some other remedy, one that would allow the action to continue to trial, had been considered. He was advised that a proposal had been made by the Plaintiff and rejected by the Crown. The motion began. Counsel for the Plaintiff, at the conclusion of his submissions (approximately three hours into the motion) changed his position. He advised the Court that rather than the striking of the defence, the Plaintiff was seeking an order requiring further production including examination of a non-party, a former employee of Health and Welfare Canada. The Crown was unable to respond. It had prepared to answer what the Master referred to as the Plaintiff’s “aggressive and exclusive pursuit of dismissal of the Defence”.[^67] The Master was confronted with a problem. As he saw it, even if the Court was to make the order on that day, it was not practical to expect that it could be complied with by the trial date that had been set, January 14, 2019:

Given the age and volume of the documents sought, some of them over 30 years old and others which may no longer exist or are in dated electronic format that must be located and searched, I am not satisfied that all steps contemplated by the Proposed Order can even be completed in time for trial, let alone in time for any documents produced or examination transcripts to be used as evidence at trial. Further, if the Defendant wishes to oppose certain terms of the Proposed Order, it is entitled to additional time to properly respond to the Plaintiff’s change of position and the late filed materials. All of this must be balanced with the Plaintiff’s entitlement to relevant documents prior to trial, particularly in a procedurally and substantively complex matter such as this.

[61] It seems there was the risk of a further motion seeking a further examination:

Further, there is still the possibility that the Defendant will be bringing a motion to examine Dr. Blais…[^68]

[62] The Master, relying on rules 37.02(2)(b) and 1.04 adjourned the motion sine die (without a day), and returned the matter to Mr. Justice Firestone for directions with respect to the fixed trial date, the motion and the changed relief being sought by the plaintiff.

[63] Justice Firestone issued a procedural order on November 5, 2018. A new trial date was set, April 1, 2019, peremptory to all. The parties were ordered to attend before Master McGraw, on November 27, 2018 and November 29, 2018, for the return of the motion. To ensure there were no further delays, Mr. Justice Firestone added as a term of his order that there were to be no further motions prior to trial other than those that might be heard by the trial judge.

[64] The motion was brought back before the Master who released his reasons on December 3, 2018. There were no fewer than ten motions (eight by the plaintiff, two by the Crown), all dealing with production and requests for further examinations.[^69] The situation confronting the Master was complicated by the history and the circumstances:

These 10 motions proceed in less than ideal circumstances. This is a 19-year, procedurally and substantively complex class proceeding where the parties have been engaged in ongoing production disputes for over 15 years. The documents produced and sought are voluminous with many of them over 30 years old and some even over 40. Some documents may no longer exist, previous searches may not have located them and the potential places to search for documents is overwhelming. Combined with the fixed peremptory trial date of April 1, 2019, this strikes at the heart of proportionality and requires a balancing of the parties’ entitlement to know the case they must meet through the production of relevant documents and right to oral discovery prior to trial and the efforts and costs imposed on the other party. Quite simply, there is not enough time until trial to complete the additional, comprehensive procedural steps which the parties seek and which would be ideal for a case of this nature in the current circumstances.[^70]

[65] Master McGraw recognized that there had been delay, that both parties were at fault:

With the volume of available and searchable documents and a trial commencing in 4 months, it is not possible to reconcile all of the parties’ positions and allegations with respect to the Production Motions. They have not been resolved over the last 15-plus years and there is no time to resolve them now. Both parties must bear responsibility for the delayed, late and inadequate productions over the last two decades and no purpose would be served in determining who is more to blame at this time. This includes issues arising from the AGC’s alleged and/or apparent non-compliance with the 2003 Order and Master Haberman’s directions and the Plaintiff’s late delivery of documents in the possession of her key witness 19 years into the proceedings and 21 years after his involvement with related actions. It is also inevitable that the de-certification, appeal and related pleadings amendments have also contributed to the delays and complexity of these proceedings. In my view, any allegations regarding the sufficiency, timing and propriety or production are more appropriately issues for costs, either on these motions or at trial, together with whatever conclusions or inferences the trial Judge may draw generally. Allegations of spoliation are more appropriately an issue for the trial Judge in any event (Muskoka Fuels v. Hassan Steel Fabricators Ltd., [2009] O.J. No. 4782 (S.C.J.) at paras. 5-7).[^71]

[66] Master McGraw considered each of the ten motions. The decisions he made ordered some targeted searches and some specific searches; some to be done electronically, with the provision of a description in each case of the Crown’s best efforts including where it searched, the search terms; and at least one physical search (material associated with Pierre Blais). Orders were made requiring two witnesses (Pierre Blais and Francine Jacques (Gaudette)) to be examined, one in Toronto and the other in Montreal, and for the Plaintiff to submit interrogatories to be answered by various of the Crown’s employees (Dr. Freedland, Dr. David Taylor and Lindsay Blaney). Time limits were imposed: 45 days for some of the items ordered, by February 28, 2019 for others and 60 days for the interrogatories.

[67] What is clear is the intention of both Mr. Justice Firestone and Master McGraw that this would be the end of what had been an ongoing dispute concerning production. It was not. On March 19 and 20, 2019, less than two weeks before the trial was to begin, the Crown produced a book of fresh documents. Counsel for Plaintiff submitted he had been asking for some of them over an extended period of time. Not surprisingly, the Plaintiff complained. This required an appearance on March 22, 2019. Counsel for the Plaintiff cited the long history of attempts to get complete production from the Crown. Counsel asked for an adjournment. Counsel for the Crown acknowledged that some of the documents should have been produced earlier but also suggested that the Plaintiff was already aware of some of those that were the subject of this late production. The adjournment was refused. A series of directions were provided to overcome the difficulties the situation presented. Among them, that of the documents that were the subject of the motion, the only ones that could be produced at trial were those the Plaintiff agreed to or those the Plaintiff indicated an intention to rely on.

[68] There was a further and subsequent complaint. During March 2018 the Plaintiff produced some documents from Dr. Pierre Blais. He had had the documents for at least 30 years. The Crown had indicated an intention to question the authenticity of certain of those documents. This was among the ten motions heard by Master McGraw and considered by him in his reasons of December 3, 2018. Expert reports were referred to. The Plaintiff did not have them. This spawned another request for an adjournment by the Plaintiff. The adjournment was refused but the issue delayed to be dealt with after all the other evidence was completed, if the Crown remained intent on raising the issue.

[69] As late as September 13, 2019, the Friday before the trial was to resume following a ten week break, with only one defence witness remaining to be called, counsel for the Plaintiff wrote to the Court seeking a motion for directions for, among other things, production and examinations surrounding the issue of the authenticity of the impugned documents of Pierre Blais. Counsel for the Crown responded by letter, the same day, sparking a response, in turn, from counsel for the Plaintiff which included the following paragraph:

Mr. Gaudet’s letter revives the Plaintiff’s concerns about the AGC’s continuing non-compliance with prior production Orders. This noncompliance vitiates the Plaintiff’s ability to advance her case. Relevant documents were and continue to be withheld from production and discovery. Trial fairness cannot be restored without focussed remedial relief and sanction.

[70] I have reviewed the letter from Mr. Gaudet. I am hard pressed to understand how it would be a catalyst for going back to Master MacLeod’s order of October 17, 2003. It does not matter. What this exchange demonstrates is that to the very end, 16 years after the order of Master MacLeod, the parties continued to battle over productions. Like Master McGraw I see no purpose in trying to assess blame. I say only that it is clear that the injunction of Master MacLeod, that cooperation was required, was not adhered to. This was to the detriment of the parties and to the proceeding.

THE COMMON ISSUES

[71] Out of the history of this proceeding and its certification was the identification of the common issues to be dealt with in this trial. They are:

(1) Did Canada owe a duty of care to class members?

(2) If so, did Canada breach the applicable standard of care?

(3) If so, can Vitek Proplast temporomandibular joint implants cause injury to those receiving them?

THE REGULATORY REGIME

[72] The Food and Drugs Act was passed in 1920. Statutory provisions specifically dealing with medical devices were first enacted on May 14, 1953 and came into force on August 16, 1954.[^72] The Food and Drugs Act was introduced at the material time, as it is now, as “An Act respecting food, drugs cosmetics and therapeutic devices”.[^73] What is a “medical device”? The Food and Drugs Act did defined the term “device”:

“device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, migration or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in man or animal,

(b) restoring, correcting or modifying a body function or the body structure of a man or animal,

(c) the diagnosis of pregnancy in humans or animals, or

(d) the care of humans or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug.[^74]

[Emphasis added]

[73] For the purposes of these reasons, we are concerned with subparagraph (b). Temporomandibular joint implants replace the meniscus that separates two elements of the jaw, the fossa and the condyle, to allow for its proper movement.[^75]

[74] Beginning in December 1954 and through August 1975 “devices” were also subject to the provisions of the Food and Drug Regulations. The concern for and interest in the regulation of medical devices galvanized in and around 1975. This was occasioned by two unfortunate examples: the Dalkon Shield, an intrauterine contraceptive device, and the nuclear batteries utilized in pacemakers inserted into the heart. The former caused infection; the latter disintegrated in the body. A third factor was the “beginning of intraocular surgery”.[^76] As a result, on September 2, 1975, the Medical Devices Regulations, a regulation specific to these devices, was introduced.[^77] Among other things, the Medical Devices Regulations govern the entry of devices into the market in Canada. From the outset, the Medical Devices Regulations prohibited the importation into Canada of any device the sale of which would violate any part of the Food and Drugs Act or the Medical Devices Regulations.[^78] On March 25, 1977, a limited form of pre-market review was introduced into the Medical Devices Regulations.[^79] It was restricted to “new devices”. “New devices” were, and remain in the current version of the regulations, defined as:

“new device”, in relation to a manufacturer, means a device listed in the table to this Part that

(a) has not been sold previously in Canada by that manufacturer,

(b) it is, in respect of any characteristic, different from any device sold previously in Canada by that manufacturer, or

(c) is, in respect of all characteristics, identical with a device sold previously in Canada by that manufacturer that has previously been recalled or withdrawn from the market or that he has ceased to manufacture or sell.[^80]

[Emphasis added]

[75] As of the promulgation of the Medical Devices Regulations on March 25, 1977, the “device[s] listed in the table to this Part” included only: (1) Intra-uterine devices and (2) Cardiac pacemakers. A manufacturer of a “new device” was prohibited from selling or advertising that device unless the manufacturer received a Notice of Compliance from Health and Welfare Canada. To obtain a Notice of Compliance, the manufacturer was required to submit to Health and Welfare Canada evidence establishing the safety and efficacy of the new device. On October 8, 1982, the Table to Part V of the Medical Devices Regulations was amended to extend the pre-market review to any “new device” designed to be implanted into the tissues or body cavities of a person for 30 days or more.[^81] This amendment became effective on April 1, 1983. From this, it is apparent, and it was not disputed, that what in 1977 was Part IV of the Medical Devices Regulations and is now Part V applied to the Vitek Proplast Implants that are at the centre of this proceeding. To be clear it was understood and accepted by all parties that in order to be mandated for sale in Canada these products required Notices of Compliance. It should be said that a Notice of Compliance allows the product involved to be sold and used in Canada. However, it signifies only that the submissions made in support of the application “complied” with the legislative requirements. A Notice of Compliance is not a statement by the government that the product is safe, only that the work required to justify its entry into the Canadian market according to the tests set out in the Medical Devices Regulations has been completed. In short, a Notice of Compliance is not a guarantee, by the government, that the device is safe for use and will assist in reducing pain or benefit the problem being treated. The review it conducts is as to the sufficiency of the work; it is not a peer review as to how it was conducted or a replication that confirms the results. The legislation makes clear that the responsibility to conduct proper studies lies with the manufacturer.

[76] At the time the submissions seeking Notices of Compliance for the products of interest to this case were made there was some suggestion, by those applying, that the product had been “sold previously in Canada” and that they should be “grandfathered” and not treated as “new devices”. Documents that purported to confirm those sales were not accepted as such by the representatives of Health and Welfare Canada. As the Plaintiff has asserted, and as the Defendant has readily conceded, they had to be treated as they were, that is, as new devices to which the requirements of Part V of the Medical Devices Regulations applied.

[77] There were criteria applicable to the content and assessment of the submissions made to support the request for any Notices of Compliance for “new devices”. Under the heading: “Submission” the Regulation noted:

s. 35(1) For the purpose of obtaining a notice of compliance, the manufacturer of a new device shall submit to the Director

(a) evidence of the safety of the device consisting of at least

(i) the name and mark under which the devices to be sold,

(ii) the purpose of the device and its method of use,

(iii) the performance characteristics of the device,

(iv) the specifications and limits set for those materials of the device that may come in contact with body tissues or fluids and a summary of the test methods used to ensure conformity with those specifications and limits,

(v) if sold as sterile, the method of sterilization and the recommended method of resterilization, if applicable,

(vi) a general description of the plant, equipment and procedures used in the manufacture of the device,

(vii) the quality control program and procedures used ensuring manufacturing, packaging and sterilization of the device, and

(viii) that full data of all chemical studies, analysis and animal studies carried out to determine the bio-compatibility of those materials of the device that may, in the normal use, come in contact with body tissues or fluids;

(b) evidence of the effectiveness of the device, consisting of at least

(i) the results of all clinical trials to show the effectiveness of the device,

(ii) where clinical trials have not been made, the results of animal studies or appropriate tests that demonstrate a probability of effectiveness in humans, and

(iii) all known adverse reactions or contra-indications to the use of the device under the recommended conditions; and

(c) drafts of all labels, package inserts, product brochures and file cards to be used in connection with the device.

(2) Where the Director is of the opinion that the evidence and materials submitted by a manufacturer pursuant to subsection (1) are not sufficient for him to determine whether or not he should issue a notice of compliance for the purpose of selling or advertising the new device, the Director may require the manufacturer to submit to him further information concerning the device or any samples of any of the ingredients or components of the device and of the device itself.

[78] Under the heading: “Issue of Notice of Compliance”:

s. 36. Within sixty days after the latest date of the receipt by the Director of evidence, materials or information submitted by a manufacturer under section 35,

(a) where that Director is satisfied that the manufacturer has provided substantial evidence that

(i) the conditions of production and quality control are suitable for controlling the quality, stability, safety and performance of the new device,

(ii) the new device can be used for the purpose and under the conditions of use recommended by the manufacturer without undue risk to humans,

(iii) the new device is clinically effective for the purpose and under the conditions of use recommended by the manufacturer or that sufficient animal studies have been carried out to establish a probability of effectiveness in humans, and

(iv) the drafts of all labels, package inserts, product brochures and file cards to be used in connection with the device are adequate,

the Director shall issue to the manufacturer a notice of compliance; or

(b) where that Director is not satisfied that the manufacturer has provided the evidence referred to in paragraph (a), the Director shall refuse to issue a notice of compliance and shall notify the manufacturer of his refusal and of the reasons therefore.[^82]

[79] Accordingly, the regulation, in the form applicable when the requests for Notices of Compliance were made, first in 1987 and again in 1988, continued to require a demonstration of both “safety” and “efficacy”. As was acknowledged by at least two witnesses called by the Plaintiff[^83], these two requirements do not stand as independent standards to be treated and considered separate and apart, one from the other. They are not absolute tests measurable on a bi-lateral basis: either safe or not safe; either effective or not effective. Instead they function as two ends of a spectrum: at one end devices which are safe but do nothing to alleviate the illness or disfunction which requires treatment, and at the other end, devices which may cure the concern but at the price of some other undeniable harm. Obviously, neither of these two extremes would generate the issuance of a Notice of Compliance. The determination of whether to issue a Notice of Compliance is a consideration of where, on the continuum between these two extremes, taking into account the degree and likelihood of relief measured against the risk of further harm, the predicted functioning of the device may fall and whether on that basis it is appropriate to issue a Notice of Compliance:

Q. And we hear the terms evidence of safety and efficacy throughout the last month. Can you give us your overview of what that means?

A. Safety and efficacy are the two essential attributes that are demanded of a medical device, offered up matter of drug as well. It is a quantity that is measured against the importance of the need that it fulfills. For example, a product can be highly efficacious and very safe, but totally useless medically. Conversely a product can be extremely dangerous and would have a strong possibility of being an inefficacious but is essential surgically. The balance between the two is the area that we are now discussing.[^84]

[80] What this demonstrates is that there is no, and can be no, certain or definitive answer. It is a balancing and, thus, inherently contains a high degree of discretion and consideration specific to the individual case.

[81] The limitation imposed by the regulation sets the context in which the choice is to be made. There is a time limit. The decision is to be taken within 60 days. This is not much time to consider the kind of detailed studies new approaches to science and treatment, by their nature, require. Hence the proposition that the determination to be made is not as to the rectitude of the studies but as to whether they comply with the regulations that govern these submissions.

[82] The evidence shown by the studies was required to be “substantial”: first in showing “safety” measured as use “without…undue risk” and second, either clinical efficacy (efficacy demonstrated through trials on humans) that shows the device to be effective under the conditions of use recommended by the manufacturer or efficacy shown through animal studies that establish a probability of effectiveness in humans.

[83] The answer as to whether a Notice of Compliance should be issued is to be arrived at within the time frame set and consistent with the standards to be met. Finding the balance between “safety” and “efficacy” reflects on the two competing policy values at the core of the regulatory scheme. On the one hand, our desire to have those in the industry find, develop and produce devices that will assist those who are suffering and on the other to avoid causing more harm. Later in these reasons I will be referring to “Cotrel rods” which were, and may still be, implanted in some, particularly teenagers, to assist in remedying curvature of the spine. Surgeons complained because these devices could not be sold and used because the necessary Notices of Compliance had not yet been issued. They wanted to help their patients. They had to wait for the issuance of a Notice of Compliance that was first refused pending the delivery of more information and later granted. On the other hand, it is generally known (I believe I can take judicial notice) that Dalkon Shields which were made available for sale were not sufficiently tested and caused considerable damage. The policy formulation is directed to avoiding both these results but inevitably will not always succeed. Heather Sheardown is a Professor in the Department of Chemical Engineering at McMaster University. I will say more about her qualifications later in these reasons. For the moment I only point out an example she provided where despite the best intentions, the balance failed. A cornea transplant was approved by the Federal Drug Administration in the United States in 2001. It was received by thousands of patients. By 2007 the failure rate of 50% became widely known. Some patients went blind. Heather Sheardown noted that in many cases we simply do not know what the long-term impacts of these new medical devices will be.[^85] Nirmala Chopra, who was for a time, in charge of the premarket review of medical devices, advised the court that there was an expectation that some new devices would cause some difficulty and that generally they would be identified within the first five years of any new device entering the market.

PROPLAST

[84] Proplast is a trademark that is used to describe a family of composite materials that were designed, manufactured and sold by Vitek Inc., a Houston-based company founded by Dr. Charles Homsy in 1969.[^86] Proplast is composed of a fluorocarbon polymer matrix and a reinforcing material, such as fibre or powder. The fluorocarbon polymer matrix includes Polytetrafluoroethylene (“PTFE” commonly referred to as Teflon) and may include Fluorinated Ethylene Propylene (“FEP”) polymers and/or fluorocarbon polymer fibres. The reinforcing fibres or powder may be an organic or inorganic material, including carbon fibre, aluminum oxide or hydroxyapatite. The added fibres or powder are intended to provide enhanced mechanical strength while the fluoropolymer is intended to provide a chemically inert, continuous host material, or polymer matrix.[^87]

[85] Proplast has been produced in at least three standard types: Proplast I (PTFE/carbon competent material), Proplast II (PTFE/aluminum oxide competent material) and Proplast HA (PTFE/hydroxyapatite competent material).[^88] Proplast has been manufactured in a variety of forms including films, sheets, blocks and coatings. In each case, Proplast may be different – different composition, different manufacturing processes and different physical and chemical properties.[^89] All types of Proplast have in common soft PTFE fluorocarbon polymer resin and fibre that dominate their surface properties and form a porous matrix. The Proplast types are distinguished by differences in the filler that lead to differences in mechanical and other physical properties between the Proplast types.[^90]

[86] The Plaintiff does not agree that the various Proplast products are different. Relying on the evidence of Elliot Wayne Tunis, a physician who had implanted Vitek Proplast temporomandibular implants, the Submissions of the Plaintiff (the written submissions presented on her behalf at the conclusion of the trial) note:

There was no difference between the Proplast IPIs and Proplast sheeting with Teflon laminated to it, other than that the IPIs were manufactured from these sheets by cutting the sheet into an anatomic size.[^91]

[87] What is important is that for the purpose of regulating the devices in issue, those responsible for premarket review of the many Proplast products saw differences. As we shall see, the complaint made at the time the first applications for Notices of Compliance were received was that they had been lumped together such that it was not possible to attribute the supporting data to the specific devices to which it applied. The applications were refused. When a second attempt was made, the same concern arose. Eventually the regulator (not the applicant) organized the devices into eight groups, presumably to assist Vitek Inc. Even so, as will become apparent, the various Vitek Proplast products were treated differently. Some were issued Notices of Compliance (Proplast Block and Sheeting); many were not (Proplast IPI’s).

[88] Proplast was used as a material component of temporomandibular joint implants produced by Vitek Inc. and available to Instrumentarium Inc. to be distributed in Canada. Proplast was intended to anchor the implant to the upper bone of the temporomandibular joint. it’s porous nature and potential for tissue ingrowth were intended as a feature that would encourage stability in the temporomandibular joint.[^92] Over time it became apparent that the PTFE (Teflon) included as part of certain forms of Proplast could, after being implanted, fragment, delaminate or otherwise be damaged. Debris in the joint from implants could contribute to progressive bone degenerative change and giant cell reaction.[^93] In time there was a product recall.

WHAT WAS KNOWN ABOUT PROPLAST, BY WHOM AND WHEN WAS IT KNOWN

[89] Science does not tend to develop understanding in moments of immediate and complete insight. Rather it evolves over time. Robert Pilliar testified at the trial. He is an engineer by training but has worked, taught and studied in the area of medical devices for many years. When he first appeared, he seemed to acknowledge this perspective but when called in Reply he demurred. As he perceives it, evolution is a process generally applicable in biology. As he sees it, science does not evolve so much as it moves through steps.[^94] For the purposes of these reasons such a distinction does not matter. The point is that our understanding of science changes and becomes more complete as our knowledge and experience increase. Nonetheless, movement “in steps” suggests a linear progression (both forward and backward). Evolution in its current understanding is a broader concept. Among its definitions:

A process of change in a certain direction…a process of continuous change from a lower, simpler or worse to a higher, more complex or better state…a process of gradual and relatively peaceful social, political and economic advance…a theory that the various types of animals and plants have their origin in pre-existing types and that the distinguishable differences are due to modifications in successive generations… a process in which the whole universe is a progression of interrelated phenomena[^95]

[90] Each of these meanings connotes continuous and gradual change that can occur in a variety of circumstances. In this case, in the overall appreciation of the risks and harm associated with Proplast, one of the issues raised was whether this potential should have been appreciated sooner by Health and Welfare Canada such that entry into the market of any Proplast related product, at least for use as temporomandibular joint implants, should never have taken place, should have been recalled sooner and patients directly advised of the risks. To analyse this proposition (and using what has become a too often used colloquialism) it is important to come to an understanding of who knew what and when they knew it.

[91] The evidence addressing the question of the degree and timing of any understanding concerning the usefulness of Proplast products began with Pierre Blais. He was a research scientist employed by the Medical Devices Bureau (and its successors) from its inception until his departure in 1989. In the context of this trial, he was a controversial figure. From the perspective offered by the Plaintiff, Pierre Blais was central to the understanding, within Health and Welfare Canada, of Proplast and its dangers. Attention was drawn to meetings and conferences he said he attended, papers he wrote, a book he contributed to and warnings he said he instilled in more senior officials at Health and Welfare Canada. With a closer look, the idea of this pivotal role dissipates in the uncertainty and confusion that accompanied his participation in the events he referred to and in the trial. He left his employment with Health and Welfare Canada under difficult circumstances. He was terminated for an alleged failure to comply with internal policy governing, among other things, release of information to the media.[^96] He grieved. The grievance was settled. He was reinstated but retired a day later.[^97] He was called as a witness, not by the Crown, but on behalf of the Plaintiff. He had been available to the Plaintiff’s counsel for many years. Even so, in 2017, he produced documents that had not previously been seen.[^98] He happened on them when going over files he maintained in his home. The authenticity of four of these documents was questioned by the Crown. At a pretrial conference during the weeks leading up to the commencement of the trial, counsel for the Plaintiff advised they were unprepared to deal with the issue. One of the reports on which the Crown sought to rely had not been delivered. The Plaintiff required time to retain an expert, prepare a response. This resulted in one of the adjournment requests to which I have already referred. This was refused. The issue was set aside. The documents in issue were to be admitted without reference to their authenticity. That issue, if the Crown still intended to proceed with it, would be heard in a separate proceeding at the end of the evidence but before final submissions were made. Although not without difficulty, as the end of the evidence approached, that is what happened.

[92] I will refer to each of the four documents as they become relevant. This is provided at the outset of these reasons in response to a proposition put in the “Submissions of the Plaintiff”. It is said there that the allegations made against Pierre Blais should be rejected. This is not surprising but it is not all that was submitted. Counsel for the Plaintiff goes on:

But in the aftermath of those findings, the Plaintiff submits that Dr. Blais’ evidence must be accepted as true. Indeed the AGC resiled from its decision to call Health Canada witnesses who would have been in positions to refute Dr. Blais’ evidence.[^99]

[93] In other words, as counsel sees it, if the four documents are found to be authentic, there need be no further inquiry into the reliability of what those documents say, or it would seem, the value of any of the other evidence provided by Pierre Blais. To my mind, this is wrong in a profound way. If the documents are authentic, their reliability, probative value and impact in contrast to what others have said would remain open for the Court to examine. I go further. It would be a failure of the Court, in carrying out its responsibilities, if it did not do so. If the Crown had other relevant evidence that it could have called and chose not to do so, that is a risk it took.

[94] For all of his experience, the Plaintiff did not seek to qualify Pierre Blais as an expert. In the Submissions of the Plaintiff, Pierre Blais is referred to as a “non-party, lay witness”. He is not a party but I am uncertain as to the implication of his being a “lay witness”. It is undeniable that he was employed through the material time, by Health and Welfare Canada, at the Medical Devices Bureau, through whatever name changes and restructuring that occurred during that period. The meaningful distinction, at least as I understand it, is as a “fact” as opposed to an “expert” witness. I take this to be the import of the Submissions of the Plaintiff where the following is said:

The Plaintiff called Dr. Blais as a lay witness because of his first-hand knowledge that Health Canada’s middle and senior management knew that Proplast was unsafe from the early 1980’s onward.[^100]

[95] I mention this because much of the evidence of Pierre Blais dealt with the state of knowledge concerning Proplast as time progressed. What may be interpreted as fact today may not have been understood as such at an earlier time. As will become apparent as these reasons proceed, what the Plaintiff, relying on Pierre Blais, believes should have been understood early in the progress of these events is not so certain. This is especially so when the evidence of Pierre Blais is fully examined and considered in the context of what was said by others. At the time, perhaps still, there are experts who do not agree with what the Plaintiff takes to be fact. Some of this is better understood, at least at the times in question, as opinions. Nonetheless, so far as I can recall (there were 55 days of evidence) not once was the evidence given by Pierre Blais objected to as crossing from fact to opinion. I take his evidence to be demonstrative of what he saw as fact but which others may have seen differently. I believe this to be consistent with the evidence and how it was provided but also sensitive to the understanding that broad scientific acceptance is not generally a matter of immediate insight but the result of the sort of evolution that occurs over time as experience increases knowledge.

[96] As explained by Pierre Blais, the Medical Devices Bureau was formed in 1975. It was a consolidation of those parts of the Health Protection Branch that were concerned with non-drug health care products. Pierre Blais recalled that he was the fifth employee brought into the new Bureau.[^101] The catalyst for this consolidation was the appearance of non-drug medical devices (such as the Dalkon Shield, pacemaker batteries and the beginning of intraocular surgery), and the need for the responsibility for their regulation to have a home. As depicted by Pierre Blais this reorganization was not a well-planned response to the developing concerns. “It was opportunistic in a sense. It was done piecemeal. And there was no precedent…”[^102]

[97] In summer of 1976, Pierre Blais attended a Gordon Conference.[^103] While the origins, source and substance of “a Gordon Conference” was not reviewed, it seems that this was one of a series of such conferences covering wide areas of scientific interest. Dr. Charles Homsy, the person recognized as the developer of Proplast, made a presentation. It concerned Proplast and its properties. Those in attendance were identified by Pierre Blais as “one half of the contributors to the biomaterials of tissue and bone in the world”[^104][Emphasis added]. He stated his own immediate response:

I was very disappointed by the lecture, but other attendees had other views.[^105]

[98] He went on to describe the general reaction of those in attendance. It was more than disappointment. It was outrage. As witnessed by Pierre Blais the scene was one of “pandemonium.” Charles Homsy was besieged by questions from an audience angered by what he was saying. As outlined by Pierre Blais, the expressed concerns included:

…why Doctor Homsy was promoting the use of a product where the components were individual carcinogens or collective carcinogens, firstly. The second concern was that they were complaining that the mere totality of his formula were so irritating that they would produce an outright rejection reaction on simply being there. A third concern was that the photographs and the photo micrographs that Doctor Homsy had shown before showed the Proplast to be disintegrating and they had not discussed this.

It was the overlying, the fact that the material did not have enough strength to remain together and that the debris was being disseminated throughout the tissue and the living organism through fluids, such as the lymphatic fluid were the key concern to the whole thing and was the basis for why the audience was very unfavorably inclined.[^106]

[99] This evidence was anecdotal. There is no data, analysis, report or reviewable assessment of any potential risk on which a regulator could rely in examining the overall value of the product. There are some handwritten notes made at the time by Pierre Blais. They include negative comments with respect to another of the presenters (“PURE BULL” repeated 13 times) but only technical observations insofar as what was said by Charles Homsy.[^107] Even so, those at Health and Welfare Canada took account of what Pierre Blais described. Upon his return he reviewed what had taken place with his immediate superior, Dr. Ronald Campbell and the director of the Medical Devices Bureau, Dr. Ajit DasGupta. As Pierre Blais recalled, they met with the personnel of the Bureau responsible for those devices treated by Part V of the Medical Devices Regulations (“new devices”) as well as those responsible for the notification requirements applicable to other medical devices.[^108] The investigation went beyond the Bureau through telephone calls with, and visits to, parties known to be reliable. A conclusion was reached. The product was not being sold in Canada through any recognized means or distributor.

[100] In the period following the Gordon Conference, Pierre Blais says he continued to raise concerns:

Q. Between 1977 and your ultimate final leaving of Health and Welfare Canada at the end of 1989, were you engaged in any debate with any co-worker at Health and Welfare Canada of any rank about the safety of Proplast?

A. Yes.

Q. With whom?

A. The mere totality of the early generation of evaluators and then later in formal lectures that I would give to other members of the department who were not part of the Bureau, specifically, the field operations group. I recollect, and I may even have notes about a lecture that I delivered on frangible implants in connection with the Montreal group, and in connection also with the Toronto field operations group.[^109]

[Emphasis added]

[101] Pierre Blais told the Court that by 1981 there was a common view extant in Health and Welfare Canada that the product was “damaging”:

Q. I’m asking if there was any debate within Health and Welfare Canada that there was a safe use or an efficacious use for Proplast?

A. Such debates did take place, but only in the academic sense. There was unanimity in the belief that the product was very much damaging from certainly 1981 onward, and that was general. It was not just one, one view, or even the official view of our directorship, it spread to everybody...[^110]

[Emphasis added]

[102] To suggest that there was no one at Health and Welfare Canada who wondered whether the product had value is not accurate. Dr. John Orpin, Medical Advisor, Division of Clinical Assessment, Bureau of Medical Devices[^111] voiced a caution that patients not be deprived of something useful.[^112] As put by Pierre Blais this was explained as follows:

John Orpin, who was also a colleague and a co-worker under Dr. Campbell, and his comment was that – how did he put it – he said but what if perchance it has some value. By declaring it unsuitable and unacceptable, could we be depriving a patient of something that could be useful. But it was not a criticism. It was not someone who supported Proplast. Quite on the contrary. He was simply advocated that could we possibly have made mistake. It was the only exception.[^113]

[103] The source of any information that contributed to this “unanimous belief” was Pierre Blais. No additional work or research was referred to. There is no suggestion that over these years any notification or application for a Notice of Compliance, along with the data that would be required with such a submission, was received for any Proplast product, much less for use as a temporomandibular joint implant. There is no suggestion that prior to 1981 there were any sales or use of Proplast temporomandibular joint implants in Canada.[^114]

[104] The evidence, taken as a whole, suggests that Pierre Blais did not play the role he has defined for himself. Some of the employees at the Health Protection Branch had never met him, others say he played no role they are aware of in respect of Proplast and others say his primary interest was with the difficulties being encountered with breast implants. There were people who disagreed with him. They were referred to by Pierre Blais as dissenters:[^115]

However, there were [dissenters] who were not within the community, who were not within Health and Welfare who occasionally advocated that there were potential useful applications for Proplast, but they were not National Health and Welfare people.

[105] Who were they? The quotation immediately above is followed by:

They were individuals representing manufacturers associations. They were individuals who might have presented in connection with a clinical trial, for example, the hernia patch issue. There were people who may have been a third party or agents acting on behalf of Vitek or Novamed, but these were not people from National Health and Welfare. You could deem them to be promoters or stakeholders, I think is the word we used for the product.[^116]

[106] In other words, they were the people interested in having the product come to market. The same people who would have conducted any tests necessary to show that it could be used safely and to the advantage of patients who were suffering.

[107] Can the attitude of Pierre Blais, demonstrated by the broad statements he made, be explained or at least a context for understanding be identified? The controversy that surrounded his departure from Health and Welfare Canada was not the first time he had run afoul of its senior representatives. In April 1981, Pierre Blais was interviewed by a journalist working for the Ottawa Citizen in respect of the use of DEHP [“di(2-ethylhexyl) phthalate[^117]] in blood transfusion products. He was quoted as saying that “those who give blood through plasmapheresis… Could face a long-term risk of kidney or liver injury” and that “the use of plastic containing DEHP is a senseless and unnecessary risk”[^118]. Pierre Blais’ comments generated considerable consternation among senior officials at Health and Welfare Canada. In a memo dated May 4, 1981, addressed to the Director of the Medical Devices Bureau, the Director General of the Environmental Health Directorate, Dr. Emanuel Somers, expressed his concerns over Dr. Blais’ conduct:

Let me say that I regard Dr. Blais' performance to be alarmist, misleading, and, in the final analysis, irresponsible. To elaborate, Dr. Blais is employed as a research chemist to study and advise on the physical and chemical properties of biomaterials and polymers. He has not the expertise or capability to advise on the toxicology of chemical materials. That responsibility rests with the Bureau of Chemical Hazards, whose staff comprise a number of experienced toxicologists with the required knowledge and ability… Once again, Dr. Blais is pontificating beyond his responsibility or expertise.[^119]

[108] There is a memo dated May 4, 1977. It is shown as being from “P. Blais, Materiaux De Las Medecine” to “B.N. Thivierge, Chef Division Des Affaires Reglementaires”.[^120] It is one of the four documents the authenticity of which was questioned by the Crown. The document along with the other three where the issue was raised was subjected to forensic analysis by experts employed by the Canada Border Service Agency in the Analytical and Forensic Services Division, Science and Engineering Directorate. I begin by observing that regardless of whether the document was “authentic”, which in the context of this case means that it was written on the date shown on its face as opposed to sometime later, it would be of little probative value. The document asked about the existence of files related to several stated subjects (“Sacs A Sang, Sac Pour Parenteraux, I.V., Specimens, Notification”) and asked specifically whether the recipient had a recollection of a file named “Silicone Injectable, Polytef and Proplaste”. The reference to Proplast in a memorandum asking whether there is a file that includes in its name the word Proplast does not help in understanding what was known or not known about material associated with that word.

[109] The work done by the experts does not support a finding that the document was not prepared on the date shown, for the purpose stated. The document is not typed. It is “handprinted”. It has a handwritten signature above the printed name “P. Blais” and, in the upper righthand corner, above the printed letterhead, “MEMORANDUM NOTE DE SERVICE”, it has, in handwriting, words identified in evidence as “plastics site”. For the purpose of “Hand printing Comparisons” the document is included in the first of two groups of documents being examined. The conclusion respecting its authenticity, insofar as the hand printing is concerned, was stated as:

Conclusion: this finding provides more support for the belief that the questioned hand printing entries in Group 1 were written during the latter period of the specimen hand printing from 1989 or later, rather than on the dates they are purported to be produced. However, this support, while greater for the belief that the writing is anachronistic than it being contemporary, is limited or weak.

This comparison was hampered, and the conclusion severely limited, by 1) the small amount of specimen writing for the time period after 1989, and 2) the subtle and variable nature of the features upon which the assessment is based which creates significant uncertainty in the final conclusion.[^121]

[Emphasis added]

[110] This document is dominated by the hand printing. Even so the experts go on to examine the signature found above the hand printed “P. Blais”. Under the heading “Signature Comparisons” this signature is dealt with in the second of two groups. The conclusion is as follows:

Conclusion: This finding provides support for the belief that the questioned signatures on Items Q1 [the document presently being considered]…were written during the latter time period of the specimen signatures (2000 and after), rather than in the time period of the earlier specimen signatures (1966-1991). The level of support is considered to be strong.

The comparison and the conclusion were limited somewhat by the relatively small amount of specimen material provided for the timeframe after 1991.[^122]

[Emphasis added]

[111] To place the noted concern (being the small number of specimens available for the period after 1991) in context, the number of specimens relied on for the identified period are: two from 1991, one from 2000, one from 2005 and three from 2018. To put it differently, “After 1991” but before 2018 there are only two specimens. The three from 2018 are all signatures by which Pierre Blais swore to the accuracy of three affidavits that bear his name. The expert acknowledged that this is an unusual circumstance. It is one which may lead a party to be more attentive of the act of signing.

[112] The question being asked is a serious one. It is about the fundamental integrity of the individual involved. I am not prepared to find, on a balance of probabilities, that this document is anything other than what it appears to be.

[113] I feel obliged to make a further observation. This is not the only one of the four documents being questioned which has little if any probative value in respect of the issues raised in this case. None of them do. From this, one has to wonder why the Crown felt compelled to continue with the issue of their authenticity. I asked about the purpose. The first time the question was asked, counsel indicated concern for what this might say about the integrity of Pierre Blais. When the issue arose again the Court was advised that there is a separate application brought by the Plaintiff by which her counsel seeks to demonstrate that the Crown destroyed documents presumably knowing them to be relevant to this case. Counsel for the Crown expressed the view that any decision made in these reasons respecting this issue could impact that further application. To the extent that the rationale for the inquiry into the authenticity of these documents is the impact these reasons may have on a further application, it is collateral to the matters of concern in this trial. If it is the only true purpose, it is improper. The issue of the destruction of documents is not before the Court. To my mind, any findings made here should not be taken as determinative of issues to be raised after what would be a more complete evidentiary investigation specifically directed to those questions.

[114] There was some confusion as to what exactly Pierre Blais did upon his return from the Gordon Conference. In an affidavit he swore on January 16, 2000 he deposed that “after my return to Canada I wrote a proposal recommending the prohibition against materials like Proplast/Vitek.” In this affidavit Pierre Blais goes on to say that he took his recommendation that Proplast be prohibited to his superior, Dr. Ron W. Campbell, that “to the best of [his] information knowledge and belief” Dr. Ron W. Campbell passed the recommendation on to the Director of the Medical Devices Bureau, Dr. Ajit K. DasGupta, that on the same basis he understands that Dr. Ajit K. DasGupta agreed with the recommendation and passed it on to Dr. Emmanuel Somers, who according to the information, knowledge and belief of Pierre Blais rejected the proposal. There is no document that would support this recollection. The Rules of Civil Procedure, at the time this affidavit was sworn, as they do now, required that when a fact is attested to on “information and belief” the source of that asserted knowledge is to be “specified”[^123] It was not. The affidavit goes on:

The reasons for my proposal were included in the written material, which was part of a Bureau proposal for amending the Medical Devices Regulations.

[115] There is a document directed to amending the regulations. It is entitled “A Need for Enhanced Regulatory Control of Invasive Medical Devices.”[^124] It first appears in company with a covering memo dated May 28, 1981.[^125] It does not mention the prohibition of Proplast products. In cross-examination counsel tried to clarify the uncertainty. Counsel suggested that the proposal for prohibition must be in some other document and Pierre Blais answered:

Q. So that, this, I take it, sir, is a different, because of the timing, a different proposal or recommendation that you wrote…That's a different one than the one we looked at that's dated, that's at Exhibit 27, tab 7, from 1981. This is a different one. Is that right?

A. It -- what you're referring to is probably the first ancestor to the series of memoranda of which you have one, what we have called the 1981 memorandum. The -- there was -- we discussed a few minutes ago my preparation of documents for Dr. Campbell to brief his superior, and it did -- that was the very first of the documents which ultimately led to many others, including the last one on ophthalmic products. It was the first ancestor.[^126]

[116] There is no series of documents as referred to. The one that was produced does refer back to the Gordon Conference albeit five years later, as of May 28, 1981:

During the late seventies, Dr. Homsy and his associates made numerous conference presentations and published a series of papers presenting Proplast applications and the outcome of clinical studies. All conveyed information which seemed contrary to basic medical and scientific principles. The findings also had promotional overtones and were met with scepticism [sic]. At a 1977 conference of assembled biomedical leaders, pathologists and regulatory affairs specialists, Dr. Homsy’s presentation was savaged by members of the audience.[^127]

[117] The document does not propose the prohibition of Proplast or similar products. Rather it proposes the following:

In light of the present information, all Vitek, Proplast and Proplast-like implants should be placed in a special category subject to close supervision by hospital or professional ethics committees. If adverse events continue to be reported, the product should be sequestered by the field operations directorate until the regulatory status is clarified. A similar caveat should apply to any medical implant based on graphite, glass or other high-performance fibers with or without a consolidating matrix substance.[^128]

[118] Pierre Blais said, in his evidence, that this document was prepared as part of submissions to be made to Treasury Board. This is confirmed by the covering of memo:

PLASTIC FLUID HANDLING SYSTEMS AND IMPLANTED DEVICES Rationale for regulatory amendments

Following our discussions with Dr. DasGupta, I have updated the Divisions rationale for regulatory amendments for our next Project Review.

As requested, I have added a discussion on countermeasures and regulatory options. Expanded briefings can be drafted for TB [Treasury Board] submissions.

[119] The document appears more than once. Not only is it presented as of May 28, 1981, it and the memorandum which encloses it, reappear. On the second version the typed date “May 28 1981” is struck out and replaced in handwriting by the date “Feb. 18, 82.” As explained by Pierre Blais the document was used twice to assist in the preparation of the annual submission made to the Treasury Board on behalf of the Bureau.[^129] The second version has a further handwritten note asking “Linda” to have the file printed with large type “for Dr. DasGupta’s TB sub”.[^130]

[120] These submissions produced a positive result. They led to the amendments to the Medical Devices Regulations that added to the Schedule to Part V any “new device” designed to be implanted into the tissues or body cavities of a person for 30 days or more. As already noted, the amendment was made on October 8, 1982 and became effective on April 1, 1983. Following a review of the document I asked and Pierre Blais responded:

THE COURT: All right. Now, looking not backwards from that but looking forwards to where this went ultimately, ultimately, if I understand this correctly, all of this concern leads in the end to the amendment in the regulation Part V in 1983, in which now we see these kinds of implants, implants that are going to be input and last for more than 30 [days], becomes part of Part V.

A. Exactly.[^131]

[121] As it turned out, these three documents, the two versions of the covering memorandum and the paper, “A Need for Enhanced Regulatory Control of Invasive Medical Devices” are the second set of documents where the authenticity is challenged. The primary concern with the paper arises not from handwriting or hand printing but from the type face used. In the early 1980’s modern office machines were beginning to appear. However, Health and Welfare Canada, as most offices of the day, still used typewriters. This was determined by a review of documents produced at the time. Typewriters are distinguishable from more modern machinery as impact printers: the paper is struck by a letter either on an arm or ball. Typewriters utilized “mono spaced” print. The letters, regardless of their form, take up the same width. The letter “m” takes up the same space as the letter “i”.[^132] More modern office machines use “proportional spaced” print. The width of the letters varies.[^133] The printing on the documents was proportionally spaced. The type face (font) was identified as Helvetica which had existed since 1961 and was based on designs that go back to 1957.[^134] This design was not seen on any known documents with typewritten entries at Health and Welfare Canada.[^135] Glyphs (described as letter/character design) for example ^“TM”^ and ^“R”^ were observed to be different from those of Helvetica and other similar versions. The experts from the Canada Border Service Agency concluded:

A Helvetica style of typeface was not seen on any known documents with typewritten entries at Health and Welfare Canada.[^136]

[122] They went a step further; they searched typewriter databases to see whether the typescript on the documents in question could be found in any proportional spacing typewriter. Such spacing was not common in typewriters at the time. No typeface in any of the identified classification systems were observed that corresponded to the typed entries being examined. The glyphs ^“TM”^ and ^“R”^ were not commonly available in any typewriters from the time.[^137] The experts found that:

Accordingly, no features were observed to indicate that the typed entries depicted on documents Q2 (1-22) were produced on any typewriter, at Health and Welfare Canada or available elsewhere, in the time period in question.[^138]

[123] The forensic experts also examined the handwriting that appeared on the covering memorandum. This includes the note asking “Linda” to print the document in larger script, the handprinted date and the signature “P. Blais”. In each case the determination is the same. The script tends to be consistent with the specimens of the date shown on the document: it is “contemporary” rather than “anachronistic”. Thus, these results are different than those associated with the typed script. However, as a result of the lack of later specimens from the later time frame the experts do not foreclose the possibility that the hand writing was nonetheless from a later date than shown on the face of the document.[^139]

[124] Obviously, this leaves the situation confused. The handwritten and printed script tends to the documents being contemporary and the typed script to a later anachronistic date. The experts acknowledged that while at the contemporary time the typed script was unlikely to have been produced by a typewriter, there were “commercial printers” that were capable of producing the script used. Work they had done to establish the equipment utilized by Health and Welfare Canada, at the time contemporaneous to the dates shown on the face of the covering memoranda, provided no indication that there was machinery available from contractors involved, who might have had access to printers with the capacity to produce the script used.

[125] Although not a party to the action, Pierre Blais was examined for discovery. In the course of this questioning Pierre Blais alluded to the possibility of the printing of these documents having been done out of the normal context:

In 1982 the printing that you see in your hand is an alien printing. It comes from a contractor or a machine that was not familiar to me. It was a wizardry of a computer specialist who essentially reprocessed obsolete medium in order to extract the original text.

[126] During that examination Pierre Blais referred to a company that he said had a contract with what was then Health and Welfare Canada “for our word processing system”:

They produced software…and they produced customize systems for correlative data at National Health and Welfare, and probably other departments as well. They also did some kind of service on printers. And, they periodically, I think, loaned us printers, including kinds that I’ve never seen before.[^140]

[127] Counsel for the Crown was quick to point out that, in the absence of the ability to cross-examine Pierre Blais on these matters this evidence was, at best, hearsay.[^141] However, the question was not whether it should be accepted for its truth but whether it stood as a suggestion the experts were aware of as they undertook their work. The forensic expert providing this evidence was Tobin A. Tanaka. He had read some transcripts before coming to his conclusions. It was his recollection that he had read of the individuals named in the transcript as associated with the suggestion that an outside printer could have been involved. Neither he nor the