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When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.”  The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost always predominate.  If the glazed eyes do not deter us, then we might talk about how class actions for medical monitoring were hot for a while but largely fizzled out when the clear majority of states required cognizable clinical injuries before medical monitoring could be sought.  On this Blog, we write about a number of issues in purported class actions, such as economic classes that complain about issues like slack fill for their snacks and the font size of “organic” or “all natural” on their gas station supplements.  Many such purported class actions are pursued to be settled for the benefit of class action plaintiff lawyers without any meaningful impact on the consumers who allegedly were harmed by the amount of air in the bag or the details of product labeling they never read.  We are curmudgeonly skeptical of such classes, but we are right that the vast majority of product liability injury classes should not and do not get far.

We ran across an issue we had not seen before in a product liability class action case that involves a class II medical device that had a lot-specific recall.  Federal Rule of Civil Procedure 23(d)(1) authorizes the court dealing with a class or purported class to issue orders that:

(A) determine the course of proceedings or prescribe measures to prevent undue repetition or complication in presenting evidence or argument;

(B) require—to protect class members and fairly conduct the action—giving appropriate notice to some or all class members of:

(i) any step in the action;

(ii) the proposed extent of the judgment; or

(iii) the members’ opportunity to signify whether they consider the representation fair and adequate, to intervene and present claims or defenses, or to otherwise come into the action;

(C) impose conditions on the representative parties or on intervenors;

(D) require that the pleadings be amended to eliminate allegations about representation of absent persons and that the action proceed accordingly; or

(E) deal with similar procedural matters.

As a practical matter, 23(d)(1)(B) most often comes up either after a class has been certified or when there is going to be a fairness hearing before a decision on class certification.  That is how it is discussed in the advisory committee notes from the amendment of this rule in 1966.  In F.G. v. CooperSurgical, Inc., No. 24-cv-01261-JST, 2024 U.S. Dist. LEXIS 90329 (N.D. Cal. May 20, 2024), within three months of the initiation of the recall, the plaintiffs had already brought a proposed class action based on various theories and filed a motion for protective order related to communications about the recall.  As far as we can tell, that motion was filed before defendants had even been served with a summons and ages before class certification will be decided.

A little more detail, some from the decision itself and some from clicking through links on FDA’s website that started with the address of the recall notice in a footnote in the decision—in other words, potential judicial notice material available to the court if it chose to look.  Defendants’ “culture media” is a class II medical device cleared for the “culture of human embryos from zygote to blastocyst, embryo transfer,” and defendants initiated a recall of three lots after receiving complaints of “performance issues.”  In connection with the recall, FDA was informed, hence why there was information on the website about the recall.  The facts are lacking in the decision, but the submission to FDA for a class 2 recall like this is supposed to include plenty of information about the plan for communications concerning the recall.  Without recapping all the regulations and guidance in this area, some of which we discussed here, we note two things about FDA’s position on recall communications:

Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.

* * *

The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication. A recalling firm is encouraged to discuss the recall letter with its [FDA Office of Regulatory Affairs Division Recall Coordinator] prior to issuing the notification.

Keep these in mind as we return to the motion for protective order in F.G.

The plaintiffs’ motion for protective order complained that, since the day the suit was filed (including before it was properly served), the defendants had continued to conduct their recall communications—which had been coordinated with FDA—without mentioning the existence of the proposed class action that is very unlikely to ever get certified.  These communications have been relayed to certain patients “through third-party clinics” and have included an offer of compensation in connection with the use of recalled medium.  Because these patients could be part of a class one day, however unlikely, the plaintiffs asserted that the communications were unfair and that Rule 23(d)(1) authorized the court to require defendants to do various things that would benefit the plaintiffs and their lawyers.  Mind you, there has been plenty of litigation involving recalled drugs or devices where the plaintiffs complained that the recall communications were not sent directly to or relayed to patients.  Here, the fundamental complaint was that the clinics that would know which patients used the recalled medium relayed the recall communications to them, as FDA encourages.  (FDA can require the manufacturer to ask the clinics to pass over information, but it cannot require that the clinics that it does not regulate do anything.)  F.G. did not consider anything about FDA regulation, let alone that a protective order might compel the manufacturer to act contrary to any FDA requirements.

Instead, the decision treated the recall communications like any other communication with a potential class member, such as an alleged aggrievedly franchisee or shareholder as in the cases the court discussed.  The first step in the court’s analysis was to determine if Rule 23(d)(1) applied before class certification that would probably never happen.  Acknowledging the unlikelihood with a quote from the famous Amchem decision, the court nonetheless moved on with the conclusion that “it is well-established that a Rule 23(d) protective order can precede class certification.”  2024 U.S. Dist. LEXIS 90329, *9-10.  The accompanying case citation had a parenthetical quotation that would seem to caution against messing with a recall communication:  “Pre-certification communications to potential class members by both parties are generally permitted, and also considered to constitute constitutionally protected speech.”  The next step in the court’s analysis was to determine whether the defendants’ recall communications had been sufficiently misleading or coercive so as to require some correction.  Per the Supreme Court’s decision in Gulf Oil Co. v. Bernard, 452 U.S. 89, 101 (1981), there should be a high bar for issuing a protective order in this context:  “[A]n order limiting communications between parties and potential class members should be based on a clear record and specific findings that reflect a weighing of the need for a limitation and the potential interference with the rights of the parties.”  Not mentioning the existence of the nascent proposed class action was determined to be misleading and, in the context of offering compensation, created “a potential for unknowing waivers from a lack of information.”  2024 U.S. Dist. LEXIS 90329, *13 (citation omitted).  Without apparent consideration of the details of the communications, defendants’ rights, or FDA’s role, the court concluded that “[c]aselaw is clear that omitting mention of a pending class action—even an uncertified one—can be misleading.”  Id.  The cases cited in support of this conclusion were a handful of district court decisions that seemed, on our quick look at least, to involve very different fact patterns.  No appellate decisions were cited in support of a protective order being issued.

The first of those district court decisions cases did cite some circuit court cases that, at a minimum, raised cautions about requiring pre-certification communications to potential class members alert them to the existence of a lawsuit.  In Jackson v. Motel 6 Multipurpose, Inc., 130 F.3d 999, 1004 (11th Cir. 1997), the court stated:

While we cannot say that orders authorizing communication with potential class members may never precede class certification, district courts must strive to avoid authorizing injurious class communications that might later prove unnecessary. . . . In such circumstances, the danger of abuse that always attends class communications [is that] plaintiffs might use widespread publication of their claims, disguised as class communications, to coerce defendants into settlement[.]

Williams v. U.S. Dist. Court, 658 F.2d 430, 432-33 (6th Cir. 1981), contained a discussion of the potential issues with pre-certification communications, including those identified in the non-partisan Manual for Complex Litigation.  The Manual noted that “Attorney solicitation of clients, funds, and fee agreements are among the most prevalent perceived evils of the class action procedure.”  We see no real consideration of these issues in F.G. in granting a protective order or even in shaping the order for what the defendants would have to do to cure the perceived failures of the prior recall communications.

We could walk through the eight “remedies” authored by the court and question how they meet the standards in Gulf Oil, but we will not.  Instead, we will return to the advisory committee notes from when Rule 23(d) was adopted.  As we said, the gist of them that pre-certification orders related to notice would focus on fairness hearings and the class certification process, not on helping plaintiff lawyers solicit clients or encouraging courts to second-guess recall communications that had been run by FDA.  The notes also provided that, “In appropriate cases the court should notify interested government agencies of the pendency of the action or of particular steps therein.”  Maybe, before weighing in on communications on a recalled medical device that were relayed to relevant patients by the clinics that treated them—something FDA encourages—the court should have notified FDA.  We wonder what FDA might have said had it been given a chance.  One obvious concern might have been to not violate the privacy of patients who sought in vitro fertilization by giving their names to plaintiff lawyers without their consent.  After all, even the named plaintiffs and wannabe class reps in F.G. asked to proceed anonymously.