In vitro fertilization (IVF) is one of the most common types of fertility treatment, but the process is also extremely sensitive, invasive, and expensive. All of these factors come into play in a series of recent lawsuits following CooperSurgical's December 5, 2023 recall of three lots of its embryo culture media—a substance that allows for the development of fertilized embryos. According to the company's announcement, CooperSurgical had received a high number of customer complaints indicating that its embryo culture media caused impaired embryo development.
Now, three different couples have sued CooperSurgical in the Los Angeles Superior Court, claiming that their developing embryos died after coming into contact with the company's defective embryo culture media and that they may no longer be able to have biological children. They also allege that CooperSurgical failed to properly inspect or test the embryo culture media. And certain plaintiffs also assert that CooperSurgical (1) breached a duty of care by destroying embryos and jeopardizing the viability of developing embryos, and/or (2) intentionally failed to immediately disseminate notice of the recalled lots after learning of the defect and the corresponding risk of impaired development.
In addition to their claims for strict liability and negligence, all plaintiffs assert a claim for negligent failure to recall or retrofit a product, which requires plaintiffs to prove the manufacturer (1) became aware of a defect or injury-causing propensities after the product was sold, (2) failed to recall or warn of the danger, and (3) that failure was a substantial factor in causing plaintiffs' harm. In support of this claim, plaintiffs allege that CooperSurgical knew, or should have known, that its embryo culture media posed a risk of contamination for a "significant period of time" before the recall.
This is not the only time that a voluntary recall of IVF-related products has led to litigation. Just over a year ago, FUJIFILM Irvine Scientific recalled three lots of "Oil for Embryo Culture"—a substance used to preserve embryos during the IVF process. Shortly thereafter, a couple filed suit in the Orange County Superior Court, asserting claims just like those now pending against CooperSurgical: strict liability, negligence, and failure to recall. In that case, plaintiffs similarly alleged that FUJIFILM negligently failed to recall the lots because the company knew or should have known that the lots "posed an unreasonable increased risk in toxicity to embryos" for "a significant period of time before" the company issued its recall. The couple voluntarily dismissed the action in December 2023 before FUJIFILM had an opportunity to respond to the allegations.
Although the FUJIFILM case does not provide much insight into whether plaintiffs will succeed against CooperSurgical, In re Pac. Fertility Ctr. Litig., No. 18-CV-01586 (N.D. Cal.) offers better guidance. That case involved a storage tank containing cryopreserved eggs and embryos and a corresponding controller—both of which allegedly malfunctioned. Plaintiffs claimed that the manufacturer, Chart Industries, (1) negligently failed to recall the tanks and controllers, (2) failed to warn consumers that the controller responsible for alerting issues with the tanks had malfunctioned, and (3) manufactured and placed into the stream of commerce a tank and controller with design defects. The court in In re Pac. Fertility Ctr. Litig. initially dismissed the claims with leave to amend, reasoning that plaintiffs' allegations failed to plausibly suggest that Chart Industries "was aware of the defect with the tank or vacuum seal prior to the incident." Plaintiffs amended their complaint, and ultimately Chart Industries moved for summary judgment, arguing (among other things) that plaintiffs lacked reliable expert testimony, and did not have sufficient evidence to prove the elements of their claims, including that Chart Industries knew about the alleged defect. The court denied summary judgment. Most notably, the court found that (1) plaintiffs had reliable expert testimony from a mechanical engineering expert sufficient to support their strict liability claims, (2) plaintiffs did not need expert testimony to support their failure to warn claim, and (3) there was sufficient evidence of Chart Industries' knowledge: internal emails from two years before the alleged malfunction discussing a complication with the controller that required immediate action. The individual claims went to trial, after which a jury granted all of plaintiffs' requested relief.
As In re Pac Fertility Ctr. makes clear, the success of the plaintiffs who recently filed suit against CooperSurgical will likely depend, among other things, on whether plaintiffs adequately allege and ultimately prove that CooperSurgical knew of the alleged defect in its embryo culture media, and whether the plaintiffs introduce reliable and admissible expert evidence on issues including causation and the existence of a design defect.
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