The issue of product recalls rears its head a lot in our medical device practice. Or non-recalls, to be more precise. In the unsavory world of plaintiff solicitation, we have seen, over and over again, that plaintiff firms and their "phone banks" recruit potential plaintiffs by telling them that devices that remain in their bodies have been recalled by the FDA when no such recall has occurred. Plaintiffs file lawsuits under this misapprehension, and no one ever tells them it's false. It is fear mongering at its most unscrupulous.
Today's case is about something different in the world of recalled products. In Christian v. Altaire Pharms., Inc., 2020 WL 6051255 (E.D. Ky. Oct. 13, 2020) the plaintiff sued the manufacturer and seller of a nighttime eye lubricant ointment, alleging that it caused her permanent eye injury.
A bit of relevant history: on July 15, 2019, the manufacturer voluntarily recalled the product "as a precautionary measure" because of "management concerns" about the "sufficiency of quality assurance controls over critical systems in the manufacturing facility." Christian, 2020 WL 6051255 at *. The plaintiff claimed that, unaware of the recall, she used the product two days later before she went to bed. She learned about the recall four days after that. She alleged that she was diagnosed with "toxic conjunctivitis" on an unspecified future date, and that the product had caused her to suffer from chronic eye inflammation and discharge that "interfere[d] with her vision and use of both eyes." She filed suit in state court in Kentucky, asserting claims for manufacturing defect, negligent testing and marketing, negligent failure to warn, and breaches of warranties. The defendants removed the case to the Eastern District of Kentucky and moved to dismiss the plaintiff's claims.
In response to the first motion to dismiss, the plaintiff amended her complaint to provide "more detailed facts." Id. The defendants moved to dismiss that one, too. The plaintiff moved to amend again, attaching her proposed Second Amended Complaint to her opposition to the defendants' motion.
The court first addressed the plaintiff's motion for leave to file her Second Amended Complaint. The court explained that, under Fed. R. Civ. P. Rule 15(a)(2), a court should "freely give leave when justice requires," but that cases construing the Rule have identified circumstances justifying denial of leave to amend. The court pointed out that the plaintiff had been granted leave to amend her complaint once but "did not make meaningful changes." In addition, according to the court, the plaintiff's "failure to offer any argument in support of her motion and her misleading insertion of facts contradicted by a public record (more on that later) could provide reasons to deny leave to amend." But the "most appropriate" justification for denial, according to the court, was futility. As the court explained, "a proposed amendment is futile if the amendment could not withstand a 12(b)(6) motion." Id. at *2 (citation omitted).
For her strict liability and negligence claims, the plaintiff was required, under Kentucky law, to "plausibly allege the existence of a defect" in the eye ointment. The only facts she alleged in support of her "defect" claim concerned the voluntary recall issued by the FDA. She alleged that the FDA "issued a recall on [the] product due to bacteria in the product, it not being sterile, and possibly leading to life-threatening infection." Id. at *4. But although the court acknowledged that it could take judicial notice of the recall notice, it pointed out that claims can either be corroborated or contradicted by such public records. Here, "the recall notice ma[de] no mention of bacteria, clearly state[d] that the recall [was] both voluntary and precautionary," and stated that the manufacturer had received no reports of adverse events or of out-of-specification in-house or third party sterility testing results. Id.
So the recall notice contradicted the plaintiff's factual allegations. More explicitly, the notice didn't say anything the plaintiff said it said. The court explained that, under Twiqbal, it was not enough for the plaintiff to "simply rely on [her] basic injury allegations" to state a "defect." Id. at *5. So the "inquiry" into whether the plaintiff had stated her claim "turn[ed] on one question: whether [the plaintiff could] plausibly allege [that the product] was defective by relying only on her allegation that a voluntary recall notice was issued." Id. In other words, when the text of the notice did not support the plaintiff's factual assertions, was the mere fact that a voluntary recall notice was issued, without more, enough to support a claims that the product was defective.
The court answered this question in the negative: "Standing alone, a voluntary recall notice which fails to identify a specific contamination issue and expressly states that no product has been identified as out-of-specification does not constitute a plausible allegation of a product defect. Accordingly, the strict liability and negligence claims in [the plaintiff's] proposed Second Amended Complaint cannot survive a Rule 12(b)(6) motion, and any amendment would be futile." Id. The plaintiff similarly had failed "to offer even a formulaic recitation of the elements" of her breach-of-warranty claims. Id. (internal punctuation and citation omitted). "Thus," the court concluded, "any amendment to [the] breach of warranty claims also would be futile." Id.
Because "the proposed Second Amended Complaint and the First Amended Complaint contain[ed] the same allegations and share[d] the same weaknesses," the court held that its 12(b)(6) analysis of the proposed Second Amended Complaint was also fatal to the First Amended Complaint, which also "fail[ed] to state a claim to relief that was plausible on its face." Id. (citation to Twiqbal omitted). And the court granted the motion to dismiss. (One claim remained pending, as the seller did not move to dismiss on all of the claims against it.) A couple of nice takeaways: the mere fact of a voluntary recall is not probative of anything, and a plaintiff who asks a court to take judicial notice of public documents shouldn't lie about what the documents say. A tidy decision and a well-deserved knuckle rap, all in one. We like this case, and we'll keep you posted on other decisions related to product recalls. In the meantime, stay safe out there.
This article is presented for informational purposes only and is not intended to constitute legal advice.