The Price of Generality: Certification Denied
A Significant Win for a Pharmaceutical Company in a Product Liability Class Action
Contrary to popular belief, certification is not always granted in pharmaceutical product liability class actions. Once again, the defendants have prevailed in the significant decision recently released by the Honourable Justice Glustein: Price v. H. Lundbeck A/S et al., 2022 ONSC 7160 (“Price”).
The decision is an excellent precedent for defendants in product liability class actions facing allegations of a failure to warn their consumers about alleged harms that their products might cause. Price holds that manufacturers have a duty to warn about specific risks, not generalized and unidentified risks of harm – so if a “failure to warn” common issue proposed by a plaintiff is too general, the answer will not advance the litigation for the class and the class action cannot be certified. The decision also affirms that defendants can defeat certification in pharmaceutical product liability class actions if plaintiffs fail to propose an appropriately framed general causation common issue. It is not enough for a general causation question to be answerable in theory – if that answer will not advance the litigation for the class, then the class action will not be certifiable.
In this case, the plaintiffs alleged that Celexa®, a very important anti-depressant that many Canadians rely on, was teratogenic if ingested during pregnancy. A teratogen is any agent that can, under reasonable circumstances of exposure, disturb the development of an embryo or fetus and thereby cause congenital malformations. The plaintiffs did not allege that there was any specific congenital malformation or birth defect that could be caused by Celexa®, but rather that there was a possibility that hundreds of malformations, ranging from minor cosmetic imperfections to major life-threatening conditions, might be caused by it. Despite Lundbeck’s warning in its product monograph that the safety of Celexa® in pregnancy had not been established, the plaintiffs alleged that Lundbeck breached a duty to warn that Celexa® “is or may be a Teratogen.”
By way of background, in order for a plaintiff to succeed in a pharmaceutical product liability class action, they must establish (among other things) two aspects of causation: general causation and specific causation. General causation is defined as “whether or not an agent has the capacity to cause a disease or medical condition” while specific causation is defined as “whether or not an agent did cause a disease or medical condition to be suffered by a specific person”. In these cases, if plaintiffs cannot establish that general causation can be determined in common across the class, that is a significant consideration for the Court as to whether or not the class action ought to be certified.
In Price, Justice Glustein held that a general causation issue that asked only whether Celexa® was a teratogen could not satisfy the common issues criterion because it would not advance the litigation. Justice Glustein recognized that the possibility that such an issue could be answered in favour of the class would still not relieve each class member from being required to demonstrate that Celexa® was capable of causing the particular defect that each of them allegedly suffered. Therefore, the issue did not meet the common issues criterion, because “a proposed common issue that is so general as to not advance the claim cannot be the basis of certification, even if a common answer can be provided”.
In addition to finding the proposed general causation issue did not meet the common issues criterion, Justice Glustein also found that the plaintiffs’ proposed failure to warn issue did not meet the commonality test. Similar to the general causation issue, the failure to warn issue asked whether Lundbeck failed to warn that Celexa® is a “teratogen”. Justice Glustein rejected this issue as capable of being answered in common on two alternative bases.
First, His Honour held that the inability to certify the general causation issue was itself fatal to the failure to warn issue, since “even if the Duty to Warn PCI [proposed common issue] could impose a general teratogenicity warning as proposed by the plaintiffs… each class member would still be required to establish general causation on an individual level for each particular congenital malformation at issue”. Accordingly, the failure to warn issue would not materially advance the litigation in the absence of a workable general causation issue.
Second, Justice Glustein held that, regardless of whether the general causation issue could be certified, the failure to warn issue could not stand even on its own terms, because the failure to warn tort requires that the defendant failed to warn about the risk of a specific defect rather than a generalized and unidentified risks of harm. Justice Glustein observed that focusing upon specific defects was necessary in order to apply the elements of the failure to warn tort, including whether the risk in question was so material as to require disclosure, whether it was reasonably foreseeable to the defendant, and whether any warnings the defendant did provide were sufficiently detailed to satisfy its duty in light of the gravity and probability of the risk. This was not an inquiry that could be carried out in common, because the hundreds of specific birth defects alleged varied greatly in terms of their characteristics.
In making this finding, Justice Glustein specifically rejected the submission by the plaintiffs that, if it were shown that Lundbeck failed to warn that Celexa® was a “teratogen” because it failed to warn about one specific defect, this would mean it also failed to warn class members who alleged different defects. Instead, he held that class members would need to establish a failure to warn about the specific defect they suffered, as well as “decision causation” in relation to that defect specifically (i.e., that they would not have used Celexa® had they been informed about the risk of that particular defect).
In the alternative to his finding that certification should be refused because neither the proposed general causation nor failure to warn issues satisfied the common issues criterion, Justice Glustein also denied certification on the basis that a class action was not the preferable procedure. He concluded that, in view of the many individual issues that would remain for determination after the common issues trial – particularly the general causation issue of whether Celexa® was capable of causing the specific defects class members alleged, as opposed merely to the proposed common issue that asked whether it was a “teratogen” – a class action would collapse into individual inquires and would not be a fair, efficient and manageable method of advancing the claims.
As an ancillary issue, Justice Glustein found that, if he had not dismissed the motion, he would have struck the children’s direct claims against Lundbeck that were based on the alleged failure of the manufacturer to warn their mothers about the alleged teratogenic effects of the medication. Justice Glustein noted that it is settled law that direct claims by children for damages arising from lack of informed consent of the mother before or after conception cannot be brought. This decision is the first time that this law has been held to apply to a pharmaceutical manufacturer.
Price will be an important precedent for defendants in pharmaceutical class actions going forward for three key reasons:
- The decision demonstrates that even where there is sufficient evidence that a court could determine an answer to a general causation question at a common issues trial, if the plaintiffs have framed that question too broadly, it will not be certifiable because its answer will not advance the litigation for the class;
- The decision affirms that a certifiable general causation issue is typically necessary in order for plaintiffs to not only succeed at having a “failure to warn” common issue certified, but also to satisfy the preferable procedure criterion that is required for a class action to be certified; and
- The decision holds that a pharmaceutical company has a duty to warn in its product monograph about specific risks that may occur from consumption of a medication (recognizing that some specific risks may be more broad than others, e.g., drowsiness), rather than a duty to warn about a generalized and unidentified risk of harm (e.g. “teratogenicity”).
 Lundbeck was successful in this case at the initial certification motion back in 2018, Price v. H. Lundbeck A/S, 2018 ONSC 4333. It was subsequently sent back for a rehearing by the Divisional Court: Price v. H. Lundbeck A/S, 2020 ONSC 913.
 Frank McLaughlin, Brandon Kain, and Dorothy Charach of McCarthy Tétrault LLP acted as counsel to the defendants on the motion.
 Price was decided under the Class Proceedings Act, 1992, S.O. 1992, c. 6 prior to the 2020 amendments that made the test for certifying a class action in Ontario pursuant to section 5 more stringent.
 Price, at para. 4.
 Price, at para. 8.
 Price, at paras. 6 and 41.
 Price, at footnote 4.
 Price, at para. 118.
 Price, at para. 124.
 Price, at para. 135.
 Price, at para. 6.
 Price, at para. 143.
 Price, at para. 148.
 Price, at paras. 150-176.
 Price, at para. 165.
 Price, at para. 168. See also para. 195.
 Price, at paras. 192-212.
 Price, at paras. 230-234.