El aprendizaje para estudiantes de una institución

In medical device cases plaintiffs similarly plead that the manufacturer failed to warn of potential effects,47

but the thrust of the action is that the product implanted in the plaintiffs is defective and the defect has potential to cause future injury. For example, in Nantais v Telectronics Proprietary (Canada) Ltd.48

the plaintiffs had been implanted with pacemakers manufactured by the defendants which were alleged to have faulty lead wires that over time could become jagged, cut through the wiring insulation, and slice into the heart. One of the proposed common issues was determination of whether a person with a normally functioning pacemaker could have a cause of action. Evidence was put before the court that 16-25% of the leads showed breaks and medical experts concluded that there was a greater medical risk to plaintiffs who had not experienced breakage in undergoing surgery to remove the leads.49

The plaintiffs’ expert predicted that all of the leads would eventually fail.

46

Goodridge v Pfizer Canada Inc., 2013 ONSC 2686 at paras 26-27; Wilson Settlement, supra note 42 at para 31; Mignacca v Merck Frosst Canada Ltd., 2012 ONSC 4931 at para 34.

47

For example, Harrington v Dow Corning Corp., [1996] BCJ No 734 (SC), aff’d 2000 BCCA 605 was a case alleging failure to warn about certain diseases caused by rupture or leakage from the silicone breast implants manufactured by the defendants. The class action claim was bolstered by, but not related to, Hollis v Dow Corning Corp., [1995] 4 SCR 634, one of the Supreme Court of Canada’s leading decisions on the duty to warn.

48

[1995] OJ No 2592 (Gen Div).

49

The case was certified on behalf of all people who had been implanted with the devices. In denying the motion for leave to appeal the certification decision Justice Zuber held that the relevant point in time for liability was when the faulty lead was implanted; the plaintiffs’ taking the risk of either failure or removal was a matter of damages.50

The case ultimately settled without a reported decision on the merits.51

In Andersen v St Jude,52

one of the few class actions to go to trial,53

the plaintiffs were implanted with the defendant’s mechanical heart valves coated with its proprietary product Silizone, a silver, palladium and titanium compound intended to inhibit inflammation of the heart tissue and reduce other post-operative complications. The plaintiffs alleged that Silizone had an adverse effect on tissue healing and caused a risk of other complications. Justice Lax decided in favour of the defendants at trial because, among other reasons, she found the defendants did not fall below a standard of reasonable care and the plaintiffs did not make out general causation that Silizone increases adverse effects on tissue healing or materially increases the risk of medical complications.54

Whether plaintiffs who did not experience injury were entitled to a remedy for medical monitoring was moot in light of the

50

[1995] OJ No 3069 (Gen Div) at para 6.

51

There is no reported decision approving settlement, but Sutts Strosberg LLP, counsel for the plaintiffs, reportedly settled the case for $24 million (see Julius MeInitzer, “Class Actions Come of Age”, Canadian Lawyer Magazine (March 2005), online: http://investorvoice.ca/PI/1741A.htm.)

52

[2003] OJ No 3556 (SC) (certification).

53

2012 ONSC 3660 [Andersen Trial]. The defendants won the trial and there is no reported decision about an appeal or leave to appeal. There are actually more class actions that go to trial than is commonly thought (see Jon Foreman & Genevieve Meisenheimer, “The Evolution of the Class Action Trial in Ontario” (2014) 2 Western Journal of Legal Studies Article 3). Andersen is one of note in part because it took 138 days.

54

Ibid at para 594, summarized in “Answers to Common Issues”. See also para 6 for a summary of the issues and conclusions and paras 56-575 for the detailed analysis of the answer to the first three, and ultimately the only relevant, common issues.

finding that Silizone patients did not require any further monitoring than post-operative patients generally. In her obiter discussion regarding waiver of tort, Justice Lax opined that had she found the defendants breached the standard of care their negligence would have exposed Silizone patients to an increased risk of a serious medical condition.55

Whether this ought to lead to liability, however, was a question “as fundamental as what exactly it is that directs the law to deem certain conduct wrongful”; a question she therefore declined to answer.56

As was argued by certain experts in Andersen with regard to the waiver of tort debate,57

it is often said that compensating plaintiffs in any of the above categories of cases where the risk has not yet materialized into injury leads to the conclusion that “proof of injury” is no longer required.58

As Justice Lax rightly stated, these issues touch on the

fundamental nature of tort law; therefore answering whether plaintiffs in these kinds of cases can or should recover is not a class action-specific inquiry. The fact patterns in these

categories of cases are a helpful guide for the discussion. The goal is to understand and justify conclusions about whether in any of these categories of cases plaintiffs have sufficient actionable damage to maintain an action in negligence.

55 Ibid at para 589. 56 Ibid at para 593. 57

Ibid at paras 588-593; cf Edward M Iacobucci & Michael J Trebilcock, “An Economic Analysis of Waiver of Tort in Negligence Actions” (2016) 66 UTLJ 173. Professor Trebilcock testified as an expert in Andersen and the article is in part based on that case and the expert evidence culled for the trial.

58

See, e.g., David Hamer, “Medical Monitoring in North America: Does this Horse Have Legs?” (2010) 1 Defence Counsel Journal 50 at 50: “In the beginning, the tort of negligence required proof of injury before requiring compensation: ‘Proof of negligence in the air, so to speak, will not do.’”

2.3 Reconsidering the Definitional Framework