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It’s been a little less than a year since the Supreme Court’s rolling out the red carpet to forum-shopping plaintiffs in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023).  Mallory was, in places 5-4, and elsewhere 4-1-4, and everywhere extremely fact specific – to the point of including a defendant-specific image of its Pennsylvania contacts that, as far as we can tell, wasn’t even in the record, but rather was found on the Internet.  600 U.S. at 142-43.  The result – beyond the Dormant Commerce Clause flag waving in Justice Alito’s concurrence (discussed here) – was to punch this plaintiff’s one-time ticket against the Norfolk Southern Railway.  “To decide this case, we need not speculate whether any other statutory scheme and set of facts would suffice to establish consent to suit.”  Id. at 136.

Continue Reading Mallory in the States – A Year After the Deluge
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We brought you yesterday an example of a district court using Rule 23(d) to order a curative action vis-à-vis a putative class, but not in a good way.  In that case, a medical device manufacturer initiated a recall of certain lots and published recall information for patients, in coordination with the FDA.  Some enterprising plaintiffs’ attorney then filed a class action and succeeded in convincing the district judge to order the defendants to disclose in their recall communications that there was a pending case—one that is extremely unlikely to ever result in a certified class.  The defendant’s recall communications therefore turned into court-ordered plaintiff lawyer advertising.  Sheesh. 

Today we bring you a counter story, the yin to yesterday’s yang, an example of a district court using Rule 23(d) not to interfere with justice, but to promote it.  In Braswell v. Bow Plumbing Group, Inc., No. 2:21-cv-25, 2024 WL 2401782 (M.D. Ala. May 23, 2024), the product was not a medical device, but the facts are comparable to yesterday’s case because they too involved plaintiff’s lawyers trying to interfere with communications to putative class members. 

In Braswell, the plaintiffs sued over allegedly defective plastic plumbing and later agreed to a class settlement.  The district court approved the parties’ proposed settlement and directed notice to the settlement class.  Days later, attorneys representing several of the individual plaintiffs sent their clients emails that “contain[ed] misleading or inaccurate statements regarding the proposed class action settlement and associated proceedings in this case.”  Id. at *1.  These attorneys were essentially encouraging their clients to pursue individual claims and opt out of the settlement, but were doing do in a misleading way.  The court therefore entered an order finding that the emails “materially interfered” with class notice and the court’s efforts to “fairly, accurately, and reasonably inform[ ] the settlement class members of the proposed settlement terms.”  Id.  The court further found that counsel’s misinformation risked coercing class member to opt out of the settlement.  Id.

What did counsel do in response to this admonition?  They doubled down and emailed their clients again and falsely portrayed class counsel and the court as “delaying” their individual claims.  Worse yet, counsel emailed their clients yet again and suggested that they should not communicate with class counsel, despite a court order expressly allowing such communications.  Id.  The court-appointed settlement administrator ultimately received 322 opt-out requests, almost all from individuals represented by the email-happy, court-admonished attorneys.  Hundreds of the opt-out requests were dated before the settlement administrator even sent out class notice.  Id. at *2. 

You can see what was going on here.  Counsel did not like the terms of the settlement and were trying to use their individual clients to leverage a better deal.  They crossed the line, however, by sending serial emails that the court found to be misleading and inaccurate and by discouraging class members from communicating with class counsel.  As the district court saw it,

Based on these communications, as well as the date that many of the requests for exclusion were signed (i.e., before the Court’s curative notice or before the Court-approved notice of the settlement was even issued), the Court is highly concerned that a significant percentage of these requests for exclusion were caused, in whole or in part, by the inaccurate or incomplete information disseminated by [these] Attorneys . . . . 

Id. at *2.  This court certainly did not beat around the bush, and to correct the potential damage, the court basically ordered a do over. 

Invoking Rule 23(d)—which we conveniently laid out for you verbatim here—the court struck 319 opt-out requests and directed that each of those class members should receive additional curative notice of the proposed settlement terms.  Those class members would also receive a new opportunity to opt out, but this time with complete and accurate information about the settlement terms.  Id. at *3. 

We have to say, we like this solution.  If class members opt out, so be it.  But they need to make informed decisions.  That is the way the court saw it, too:

The Court finds that striking these opt-outs will protect the integrity of the class while imposing little to no prejudice on the affected class members because if those class members did, in fact, make a free and unfettered decision in choosing to [opt out], then they will do so again during the re-opened opt-out period.

Further, this Court has a responsibility to give class members “the best notice that is practicable under the circumstances.” FED. R. CIV. P. 23(c)(2)(b). It is essential that class members’ decisions to participate or to withdraw be made on the basis of independent analysis of their own self interest, and the vehicle for accomplishing this is the class notice. 

Id. at *3 (internal quotations and citations omitted).  Yes, this is a plastic pipe case, but after reading about the court’s misuse (in our opinion) of Rule 23(d) in yesterday’s medical device case, we thought it important to bring you this other side of the coin. 

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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.

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Happy Taxotere Week to all who celebrate.   We doubt that many of our plaintiff attorney friends will be putting out the bunting and frosting the cakes, as the Taxotere decisions we are discussing this week are mostly bad for the left side of the v.  

Today’s opinion, In re Taxotere (Docetaxel) Products Liability Litigation, 2024 U.S. Dist. LEXIS 90685 (E.D. Louisiana May 21, 2024), sees the district court’s denial of the plaintiff motion to reconsider the earlier entry of a Lone Pine order.  We discussed the Lone Pine order entered in the Taxotere MDL here.  If you haven’t committed Taxotere MDL history to memory, here is a brief primer: Many, many plaintiffs alleged that the chemotherapy drug caused them to suffer a certain form of alopecia.  After “extensive” discovery, 80% of the plaintiffs came up with no evidence of the hair loss injury and/or never spoke to their doctors about such injury.  The defendant requested a Lone Pine order (which in this case meant an order requiring evidence of an alopecia diagnosis), but the court deferred ruling on that motion.  Then there were bellwether trials, two waves of discovery, and settlement negotiations.  

It turned out that 427 of the 1000 wave 2 cases were deemed not amenable to transfer because there were serious questions regarding product usage.  Wow. That fact should have guaranteed issuance of a Lone Pine order.  But as we said in our earlier post, what ultimately prompted the court to issue the order requiring proof of a diagnosis was almost certainly the settlement negotiations.  The truth is that the high rate of meritless cases in the Taxotere MDL is by no means an outlier.  The truth is that most MDLs are weighted down by garbage inventories.  The truth is that Lone Pine orders would do a whole lot of good if they were entered early in the litigation. But the truth is that too many MDL judges worship at the altar of settlement, and refuse to enter a Lone Pine order until it can serve as a reward to parties who have committed to a settlement process.  Pity.

Anyway, the Taxotere plaintiffs are in a hole and can’t stop digging.  They sought reconsideration of the Lone Pine order and got clobbered. The plaintiffs argued that the Lone Pine order was “extraordinary” and “unwarranted,” was “unfair” because it “inequitably treats similarly situated plaintiffs,” and it “unnecessarily bifurcates expert discovery, which, in turn, will multiply costs and cause additional cross examination fodder at trial.” 

These word salad arguments are nonsense, of course. The court’s opinion reiterates the problems with the Taxotere inventory.  Not only were 80% of plaintiffs unable to obtain a medical diagnosis that they even had the complained-of condition, but many plaintiffs dismissed their cases when they were required to come up with something/anything. Moreover, the defendant did a good job of presenting specific examples of plaintiffs who had no real case. Where a record exists that shows plaintiffs cannot prove a certain element of their case, a court can legitimately focus on that element.  Further, expert affidavits or reports are often required by Lone Pine orders.  The plaintiffs griped that the order was burdensome because it “improperly front loads Plaintiffs’ expert obligations to provide a contested expert opinion,” but there is nothing intolerable about requiring a plaintiff to provide proof of an essential factual element.  The entire purpose of Lone Pine orders is to identify and cull meritless claims.  An appendix contains a useful form of order.The only thing the plaintiffs won was a little more time to find experts.  They pointed to a “lack of widespread expertise in diagnosing” the particular form of alopecia.  They wanted a stay of the order.  Instead, the court slightly extended the deadline for coming up with the diagnoses.  It is put up or shut up time.

Again, we think the Lone Pine order should have been entered a lot sooner – like when the defendant initially asked for it.  The Taxotere court congratulated itself on holding off, observing that it was the discovery that showed the high degree of frivolity in the MDL inventory.  Okay, but by now we all know that this is inevitably how MDLs work.  Too many plaintiff attorneys stuff too many bogus cases into MDLs, hoping sheer size will exert settlement pressure and that enough of the parked bogus cases will line up for a payday.  

Better late than never, we suppose.  But justice delayed can also be justice denied.  

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Late last Friday, we learned of Hickey v. Hospira, Inc., ___ F.4th ___, 2024 WL 2513487 (5th Cir. May 24, 2024) (thanks, Dick!), becoming the first appellate decision holding that preemption applies to FDA approved prescription drugs that came on the market via the so-called “paper NDA” process.  See 21 U.S.C. §355(b)(2).  Hickey arises out of the Taxotere MDL, which has produced defense-friendly decisions in a number of areas.

Continue Reading Preemption and “Paper NDAs” – Perfect Together
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This post is from the non-Reed Smith, non-Dechert , and non-Holland & Knight side of the blog. Everyone else is involved.

The Good, the Bad, and the Ugly is a classic Clint Eastwood spaghetti Western where even the Good may not be all good.  In California state court, a demurrer sustained is a defense win, right?  Although there are some bright spots, In re Ranitidine Cases is one of the ugliest defense wins we have seen in a while, providing leave to amend and a roadmap for further expansion of the Gilead duty-to-innovate.

Continue Reading Post-Gilead Heartburn in the California Ranitidine Litigation
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Every once in a while, we find ourselves on a federal government corner of the internet, and we usually are surprised to discover (or are reminded) that these webpages often have materials that are worth knowing about, even downright useful, for our type of practice. 

These sites are not always easy to navigate, however, so we put together some links that you may find handy one day.

The Federal Judicial Center

The first is the Federal Judicial Center’s site.  As they put it,

The Center educates federal judges and judiciary staff on law, case management, leadership, ethics, and court administration, using in-person programs, online resources, videos, and publications.

Do you want to know what your federal judges are being taught about case management, scientific evidence, appellate jurisdiction, mass torts, and litigation funding?  This is your place to find those nuggets of information.  Federal Judicial Center publications include:

The Federal Judicial Center and the Administrative Office of the U.S. Courts also maintain the “IDB”, a database of every federal district and appellate matter filed since 1977.  Did you strike out looking on Lexis or Westlaw matters to see if your assigned district court judge ever handled a particular type of case, say a product liability or Civil RICO case?  Search the database using “Nature of Suit” (for example, code 245 for “Tort Product Liability” or code 470 for “Civil (RICO)”) and add your relevant district and date limitations.  Get back a handful of results, pull the cases up in PACER and peruse for your judge and similarities to your case and issues.

The Federal Judicial Center also has a number of active projects that may result in significant publications or rules changes in the coming months and years, including:

  • Revising the Reference Manual on Scientific Evidence;
  • Revising the Manual for Complex Litigation;
  • Examining whether the electronic filing deadline should be changed from midnight to 5 p.m. (Noooooooooooooo!!!!!!);
  • Case study research regarding practical problems stemming from consolidation of cases under Federal Rule of Civil Procedure 42 (consolidation of actions involving a common question of law or fact);
  • A study into how many additional 28 USC § 1292(b) interlocutory appeals would result if the federal rules permitted more interlocutory appeals from case-determinative MDL rulings; and
  • A study of the “incidence and duration” of Federal Rule of Civil Procedure 23(f) appeals from orders granting or denying class actions.

The Federal Judicial Center site also has its final report on what has been an area of interest on this blog, the “Mandatory Initial Discovery Pilot” (“MIDP”) Project.  The MIDP was an experiment launched in the District of Arizona and the Northern District of Illinois to replace the ordinary initial disclosures required by Federal Rule of Civil Procedure 26(a)(1) with more onerous rules requiring:

  • Broad disclosure of all facts that are relevant to the parties’ claims and defenses, whether favorable or unfavorable, and regardless of whether the party intends to use the information in presenting their claims and defenses at trial;
  • The disclosures be made within a very short time after initiation of the case, regardless of pending motions to dismiss or other preliminary motions; and
  • Defendants to file answers regardless of whether a motion to dismiss or other preliminary motion was, or would be, filed. 

Early on, we had early concerns with the MIDP requirement that mandatory discovery exchanges had to occur regardless of whether a motion to dismiss was pending, in part because the Supreme Court in Ashcroft v. Iqbal, 556 U.S. 662 (2009), informed federal courts that an inadequate complaint “does not unlock the doors of discovery.”  Fortunately attorney complaints led to a relaxation of the requirement of disclosures irrespective of pending motions to dismiss half-way through the pilot project. 

In the end, the Federal Judicial Center’s final report on the MIDP suggests that the pilot project was a bit of a dud:

The findings of the Center study are mixed. With respect to disposition times, pilot cases were resolved in [slightly –ed.] less time, all else equal, than non-pilot cases. Still, to the extent the pilot did result in shorter disposition times, neither attorneys for plaintiffs nor those for defendants were particularly enthusiastic about the pilot in their responses to the surveys.  

The Administrative Office of the U.S. Courts

Our next government corner of the internet belongs to the Administrative Office of the U.S. Courts (“AOC”).  Technically, all of is run by the AOC, but today we are interested in their “Analysis & Reports” pages.  This is where the data lives. 

How many federal civil trials were completed in 2023?  Only 3,303.  For the whole country! 

Does your federal district court judge leave a lot of fully-briefed motions pending without decision for more than six months?  Find the list sorted by district and judge name, and the reasons provided for the delay in ruling on each motion.

How many federal cases were pending as of last year?  A lot.  The Courts of Appeal seem to have it under control, the District Courts less so:


12-MONTH PERIODS ENDING SEPTEMBER 30, 2014, 2019, 2022, AND 2023

  Judicial Caseload  2014  2019  2022  2023Percent Change Since 2014Percent Change Since 2019Percent Change Since 2022
U.S. Courts of Appeals       
Cases Filed54,98848,48641,83939,987-27.3-17.5-4.4
Cases Terminated55,21647,88944,90240,636-26.4-15.1-9.5
Cases Pending41,75138,83732,51232,039-23.3-17.5-1.5
U.S. District Courts       
Cases Filed295,310297,877274,771339,73115.014.123.6
Cases Terminated258,477311,900308,326293,67713.6-5.8-4.8
Cases Pending337,302357,566596,136642,01390.379.67.7


That is it for today’s tour of two federal government websites that we find interesting.  One of these days, we will do a tour of our favorite places on  Talk about a site with a lot of information, often buried in hard to find places!

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A long time ago, when we were wet behind the ears and still nervous about the prospect of drafting and arguing dispositive motions, we worked for a senior partner who taught us that clear writing flowed from clear thinking.  If that is true (and it is), then the opinion in McKnight v. Inc., 2024 U.S. Dist. LEXIS 86501 (E.D. Pa. May 14, 2024), must have been authored by a mind with shimmering clarity (and it was).  Judge Pratter was one of our favorite judges anywhere. We grieve at the use of “was.” We were shocked and saddened to learn that Judge Pratter passed away last Friday. Her death is an enormous loss for the Philadelphia legal community and beyond. Judge Pratter ran the University of Pennsylvania Inn of Court with uncommon grace.  She loved to see young lawyers get a chance to shine.

Judge Pratter’s writing always sparkled with lightning clarity. It also occasionally thundered with devastating humor.

Here is how the McKnight opinion begins:  

“ is a website that has oftentimes been called “The Everything Store.” See, e.g., Brad Stone, The Everything Store: Jeff Bezos and the Age of Amazon (Hachette Book Group 2013). Jamie McKnight,when he went to visit his barber Tyrese Skinner in Philadelphia, allegedly suffered injuries when Mr. Skinner applied a mole removal cream to his scalp.

Mr. McKnight alleges that Mr. Skinner bought the mole removal cream from Or if not from Amazon, then he bought it from WalMart. Or if not from Amazon, then from Target. Or if not from Amazon, then from eBay. In other words, Mr. McKnight has fashioned his complaint as its own type of everything store, where each retailer must have been the one who sold the mole removal cream. In doing so, Mr. McKnight has only marginally pled a sufficient case against Amazon, and as for the others, Mr. McKnight’s cart includes only speculation and implausibility. Thus, the Court grants Target’s, WalMart’s, and eBay’s motions to dismiss.” 

Some judges just know how to write.  (Good writing is not tied to ideology.  The two best writers on SCOTUS over the last couple of decades have been Justices Kagan and Scalia, and it is hard to think of judges more different in outlook.) 

So we have a plaintiff who claimed that he bought what sounds like an OTC drug (“mole removal cream”) from no fewer than four different and independent retailers.  That claim defies the law of TwIqbal and the law of physics.  He sued the barber and the manufacturer, along with the retailers. The case was originally filed in the Philadelphia Court of Common Pleas and then was removed to federal court.  The court denied the plaintiff’s motion to remand to state court. The plaintiff amended the complaint – more than once.  Now in front of the court was the plaintiff’s Second Amended Complaint, which included strict liability claims and “negligence and recklessness” claims against the retailer defendants.  The retailers moved to dismiss the Second Amended Complaint.

When the court held that the claims against Amazon were “marginally” plausible, the word “marginally” was doing a lot of work. To the extent the Second Amended Complaint’s naming of multiple retailers reached toward a theory of market share liability – which “Pennsylvania courts are reluctant to apply” – the plaintiff created enough uncertainty to make the claims against Amazon look rickety.  But the plaintiff did at least refer to some stray facts suggesting that the barber received delivery of the mole removal cream from Amazon (the cream was allegedly purchased on an Amazon website and was delivered on an Amazon truck), so the claim lived to see another day.  But as to the other three alleged sellers, no facts were pleaded.  All the plaintiff offered were a series of identical recitations of the elements of the cause of action, with a conclusion that each retailer “more likely than not” was a seller.  That is not close to being sufficient.  The plaintiff must identify the seller of the allegedly defective product. While alternative pleading can be fine and good, it must meet the general plausibility standard.  The plaintiff tried to preserve his claims against the non-Amazon retailers by insisting that those defendants had “not provided any verifiable proof” that they were not the sellers of the product.  That formulation (redolent of discredited market share liability) gets the burden all backwards of course.  The court raised a “judicial eyebrow” at this argument, and rejected it because it could not overcome the absence of facts in the Second Amended Complaint.   Accordingly, the court dismissed the claims against the non-Amazon retailers.  That dismissal was with prejudice because further amendment would be futile.

Then the McKnight court set about trimming away some of the claims against Amazon.  For example, the plaintiff alleged that Amazon continued to sell the cream after the plaintiff’s incident, despite allegedly being aware of the dangers posed by the cream.  But “Pennsylvania law does not recognize a duty to recall or retrofit products,” so allegations regarding post-sale conduct were stricken.  The plaintiff also included a claim that Amazon was reckless, but there is no separate cause of action for recklessness under Pennsylvania law.

Finally, the court addressed the plaintiff’s claim for punitive damages.  The only basis cited by the plaintiff for this claim was that Amazon’s webpage allegedly “deliberately hid/concealed or made less visible reviews which revealed that the [mole removal cream] causes burning and scarring….”  Once again, the court raised a judicial eyebrow at this assertion.  (Which is not to say that the court was being supercilious.) The court had “significant reservations” that the punitive damages claim could survive.  Only “extreme and brazen circumstances would support a claim for punitive damages based on the default methodology Amazon uses to sort product reviews.”  It is hard to believe that Amazon would, in an “online marketplace that sells hundreds of millions of products” [our household personally accounts for approximately half of them] bother or manage to “hide negative reviews of this one specific item,” but the plaintiff would get the chance to try.

We share the court’s skepticism as to whether the plaintiff will ultimately be able to deliver the goods.  .

We will miss Judge Pratter. We already do.     

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The 2024 Annual Meeting of the American Law Institute (“ALI”) got under way yesterday.  Therefore, based on what happened last year (described in detail here), we assume we are on the brink of the ALI taking the monumentally non-restating step of recognizing no-injury medical monitoring.  In a case of twisted timing, as we await this travesty to befall us, a contrary opinion was entered last week in Sommerville v. Union Carbide Corporation, 2024 WL 2139394 (S.D.W.Va. May 13, 2024).

Plaintiff, on behalf of herself and a purported class of neighbors, alleges that a manufacturing plant near her home has been emitting ethylene oxide, a carcinogen, for over forty years.  Therefore, plaintiff claims she has “suffered significant exposure” to the gas and is at an increased risk of developing cancer requiring her to undergo routine medical monitoring.  Id. at *1.  Defendant moved for summary judgment on the grounds that plaintiff does not have standing to bring her claims.

Before addressing the standing argument, the court runs through the history of medical monitoring claims.  First in federal courts which reject medical monitoring in the absence of present physical injury. Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424, 439-40 (1997).  Then in West Virginia where the state Supreme Court of Appeals “created a state cause of action for medical monitoring allowing for unrestricted relief absent present physical injury.”  Sommerville, 2024 WL 2139394, at *3, citing Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424 (W. Va. 1999).  For a complete rundown of which states require a present injury and which do not, see our 50-state survey

Seemingly not enthusiastic about applying West Virginia’s out-of-whole-cloth medical monitoring law, the court hopped onboard defendant’s standing argument and rode it all the way to a dismissal.  For a plaintiff to have Article III standing, she must show she suffered an injury-in-fact that is concrete, particularized, and actual or imminent (among other things).  Id. at *5.  This is “to ensure that the judiciary, and not another branch of the government, is the appropriate forum in which to address a plaintiff’s complaint.”  Id. (citations omitted).  Plaintiff here only passed the particularization requirement.  To be particularized, the claim was “affect the plaintiff in a personal and individual way.”  Id. at *6.  Personal or not, the court could not find an alleged injury that was actual or imminent.

Which standard applies—actual or imminent—depends on the relief requested.  A request for damages requires a present injury, whereas injunctive relief can be based on an imminent threat.  Id. Here, plaintiff was seeking monetary damages and therefore Article III requires a present injury.  Plaintiff’s claim of increased risk is based entirely on expert opinions, which the court properly notes are not facts and, more importantly, which the court already excluded as based on “patently unreliable data and methods.”  Id. at *7.  Standing cannot be premised on an “unreliable model” that was “used to assume that a speculative disease might someday materialize in some unknown person.”  Id.  Further undermining plaintiff’s speculative increased risk theory is the fact that plaintiff alleges that the period of exposure is forty-one years, yet in that entire time neither plaintiff nor any member of the class is alleged to have experienced even symptoms of a disease, let alone been diagnosed with cancer.  Id. at *8.  So plaintiff cannot even establish that it is more likely than not that she will develop cancer.  An injury must be more than conjectural to confer federal standing. 

Plaintiff also fails to meet the requirement that her injury be concrete—“real and not abstract.”  Id.  The court starts its analysis by pointing out that medical monitoring is not supported by any legislative enactment.  While Congress cannot grant standing to a plaintiff who does not have it, Congressional recognition of a cause of action would be “instructive.”  No medical monitoring instruction has been given. 

Next the court looked at the “vague” risk quantification standard under West Virgnia law.  To bring a no-injury medical monitoring claim in West Virginia, plaintiff must demonstrate a “significant increased risk of future disease.”  But the court in creating this state law claim did not offer any guidance on what constitutes a “significant” increased risk.  Plaintiff tried to use the Environmental Protection Agency’s one-in-a-million standard, but as the court points out in any other context a one-in-a-million chance is the exact opposite of significant.  So whether it is Article III’s requirement that the injury be more than a mere possibility or West Virginia’s requirement that the risk be significant, plaintiff fails under either standard.  Id. at *9. 

As if that was not enough, the court also found that plaintiff’s claims were not ripe.  While a claim can be based on an anticipated future injury, that future injury “cannot be wholly speculative” or rest on events that may not occur at all.  Id. at *10.   “Where a plaintiff has alleged that a hypothetical number of people may become injured at some time in the future to a hypothetical degree and thus will incur hypothetical damages,” that claim is not ripe for adjudication.  Id.  Since that is all plaintiff and her experts can say, plaintiff’s claim is not ripe. 

What does all this mean?  If followed, the decision means that West Virginia medical monitoring, and by extension, other states’ no-injury medical monitoring claims based on mere increased risk, cannot be adjudicated in federal court, even though substantive state law allows them.  So, can plaintiffs simply refile in state court and be immune from any basis for removal to federal court?  Or would the West Virginia high court–with completely different personnel and partisan makeup than in 1999, when it adopted no-injury medical monitoring, decide to retreat from that position?   Big questions that deserve big answers that we will have to watch and wait for. 

But we want to leave you with this.  The opinion finishes with one of the best rejections of what we have called “judicial triumphalism” that we have ever read in a judicial opinion:

A grave and persistent concern of this court is the metastasis of the malignant belief that courts are the solution to all problems recognized but unaddressed by the other two branches of government. It is not the province of federal courts to usurp the power of the other branches of government to solve social problems with legislatively phrased directives disguised in judicial language. “[N]o matter how admirable the result may seem[,] unless change occurs through legitimate means, it disparages the image of the judiciary and the principles of our system of government.”

Id. at *12 (citations omitted).

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It seems like once every couple of weeks, we see a story about some plaintiff (such as this one) suing, or threatening to sue, a defendant product manufacturer over some product that, according to the plaintiff, “the company should have recalled sooner.”

That’s garbage.

There is no such claim.  Rather failure-to-recall theories are among the most widely debunked purported “torts” ever.  Today we present Part I of a two-part series on just why that is.  This post looks at state law.

The common law does not impose any duty on a manufacturer of any type of products to recall its products in the absence of a government order to do so.  The law does not require a defendant  to remove a product from the market entirely, or else face universal liability simply for selling that product.  The Third Restatement of Torts addresses recall-related liability, and for once it accurately restates the law.

Restatement (Third) of Torts, Products Liability §11 (1998) comprehensively reviewed the law and determined that recall-based liability has never been recognized outside of two limited situations:  (1) noncompliance following a government ordered recall, or (2) negligently conducting a recall that the defendant voluntarily undertook:

One engaged in the business of selling or otherwise distributing products is subject to liability for harm to persons or property caused by the seller’s failure to recall a product after the time of sale or distribution if:

(a)(1) a governmental directive issued pursuant to a statute or administrative regulation specifically requires the seller or distributor to recall the product; or

(a)(2) the seller or distributor, in the absence of a recall requirement under Subsection (a)(1), undertakes to recall the product; and

(b) the seller or distributor fails to act as a reasonable person in recalling the product.

Restatement Third §11 (emphasis added).

Thus, the Third Restatement’s black letter law rejects any purported common-law obligation either to recall a product in the absence of any governmental order, or for the anticipatory removal of products from the market earlier than any governmental recall required.  Sound reasons support these constraints.  An unlimited duty to recall would impose “significant burdens” on commerce:

Duties to recall products impose significant burdens on manufacturers.  Many product lines are periodically redesigned so that they become safer over time.  If every improvement in product safety were to trigger a common-law duty to recall, manufacturers would face incalculable costs every time they sought to make their product lines better and safer.

Restatement Third §11, comment a.  Further, decisions about whether the public as a whole should be deprived of access to otherwise legal products should not be the province of judges and juries in common-law tort litigation:

[A]n involuntary duty to recall should be imposed on the seller only by a governmental directive issued pursuant to statute or regulation.  Issues relating to product recalls are best evaluated by governmental agencies capable of gathering adequate data regarding the ramifications of such undertakings.


For similar reasons, in state after state, in both common-law and statutory product-liability regimes, and whether the state otherwise follows the Second or Third Restatement, courts have refused to expand liability by including claims that legal products should not have been sold, but rather should have been recalled.

For instance, in California, where strict liability was invented, no duty to recall an FDA-regulated product (an over-the-counter medicine) exists unless the FDA has decided to authorize such action:

We conclude … as a matter of law, that defendant may not be held liable for failing to withdraw its product from the market….  A few scientific studies had shown [the risk plaintiffs allege] but … the FDA had determined that further studies were needed to confirm or disprove the association.  Pending completion of those studies, the FDA concluded that product warnings were an adequate public safety measure.  Although the FDA’s conclusion is not binding on us, we think it deserves serious consideration.

Ramirez v. Plough, Inc., 863 P.2d 167, 177-78 (Cal. 1993) (citations omitted) (emphasis added).  Even if there were “a court judgment or administrative order for the removal of [a] drug from the market, … it would apply only for the time frame after the judgment or order.”  In re Ranitidine Cases, 2024 WL 2115449, at *16 (Cal. Super. April 23, 2024).

The New York Court of Appeals similarly rejected a purported “post-sale duty to recall or retrofit a product” in Adams v. Genie Industries, Inc., 929 N.E.2d 380, 385 (N.Y. 2010).  Adams involved a lift truck, rather than an FDA-regulated product.  The court found “no justification for creating” a duty to recall, since – again as here – “plaintiff merely asserted that [defendant] should have recalled or retrofitted the [product] for the same reasons that it should not have sold it in the first place[.]”  Id. at 386.  Like Adams, most of the cases rejecting failure-to-recall claims do not involve FDA-regulated products.

Likewise, Illinois law rejects both post-sale warning and recall duties.  Jablonski v. Ford Motor Co., 955 N.E.2d 1138, 1160 (Ill. 2011).  As to recalls, specifically:

A duty may be imposed upon a manufacturer by a statute or administrative regulation which mandates the recall of the product….  However, in the absence of such an obligation, or a voluntary undertaking, Illinois has not imposed such a duty on a manufacturer[.]

Id. at 1160 n.1 (citing Third Restatement §11).  Jablonski also approvingly cited Modelski v. Navistar International Transportation Corp., 707 N.E.2d 239 (Ill. App. 1999), which held:

The consequences of imposing upon manufacturers an extrastatutory duty to recall … would be the equivalent of mandating that manufacturers insure that their products will always comply with current safety standards.  This we are unwilling to do.

Id. at 247.

California, New York, and Illinois are hardly outliers.  “[V]irtually every court that has confronted the issue head-on has reached the same conclusion”:  “‘that it is unnecessary and unwise to impose or introduce an additional duty to retrofit or recall a product’ separate and apart from those duties to which manufacturers are already subject.”  Tabieros v. Clark Equipment Co., 944 P.2d 1279, 1298 (Haw. 1997).  Tabieros quoted Gregory v. Cincinnati, Inc., 538 N.W.2d 325, 333-34 (Mich. 1995), thus adding two more state supreme courts to the list of recall-based tort deniers,  since Gregory “did not recognize any theory that would impose a postmanufacture duty to … recall a product.”  Klein v. Caterpillar, Inc., 2023 WL 4760707, at *5 (E.D. Mich. July 26, 2023), aff’d, 2024 WL 1574672 (6th Cir. April 11, 2024).  That’s hardly all.

The Kentucky Supreme Court reached the same conclusion, rejecting liability “by judicial fiat” for alleged failure to recall products in Ostendorf v. Clark Equipment Co., 122 S.W.3d 530, 534 (Ky. 2003).  Product recalls “are properly the province of administrative agencies, as the federal statutes that expressly delegate recall authority to various agencies suggest,” and courts should not “arrogate to themselves a power equivalent to that of requiring product recall.”  Id.

As Congress has recognized, administrative agencies have the institutional resources to make fully informed assessments of the marginal benefits of recalling a specific product.

Id. at 434-35 (citation and quotation marks omitted).

The Kansas Supreme Court agrees:

[P]roduct recalls are properly the business of administrative agencies as suggested by the federal statutes that expressly delegate recall authority….  The decision to expand a manufacturer’s post sale duty beyond implementing reasonable efforts to warn … should be left to administrative agencies and the legislature.  These institutions are better able to weigh the benefits and costs involved in locating, recalling, and retrofitting products.

Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993).  Patton quoted V. Schwartz, “The Post–Sale Duty to Warn:  Two Unfortunate Forks in the Road to a Reasonable Doctrine,” 58 N.Y.U.L. Rev. 892, 901 (1983).  Accord Loredo v. Solvay America, Inc., 212 P.3d 614, 632 (Wyo. 2009) (quoting and following Ostendorf); Lovick v. Wil-Rich, 588 N.W.2d 688, 696 (Iowa 1999) (affirming that a manufacturer “ha[s] no duty to recall or retrofit” a product).

Other states’ intermediate appellate courts have also held that failure-to-recall claims would create excessive and unmanageable liability.  The most thorough discussion is in Ford Motor Co. v. Reese, 684 S.E.2d 279 (Ga. App. 2009), cert denied (Ga. Feb. 8, 2010).  Reese followed Restatement Third §11 and rejected failure-to-recall claims absent a government-mandated or negligently undertaken voluntary product recall.  Id. at 284-85.  “Georgia common law does not impose a continuing duty upon manufacturers to recall their products.”  Id. at 285.  Reese also invoked “important public policy concerns” that support leaving recall decisions to administrative agencies.  Id.

Because the cost of locating, recalling, and replacing mass-marketed products can be enormous and will likely be passed on to consumers in the form of higher prices, the recall power should not be exercised without extensive consideration of its economic impact.

Id. (citation and quotation marks omitted).  Cf. Ontario Sewing Machine Co. v. Smith, 572 S.E.2d 533, 535 (Ga. 2002) (“disapprov[ing]” of decision that had allowed a failure-to-recall claim, but not reaching issue).

Other intermediate appellate decisions to the same effect are: Lance v. Wyeth, 4 A.3d 160, 167 (Pa. Super. 2010) (“this Court is persuaded by the majority of modern jurisdictions that have decided not to impose a common law duty to recall on a manufacturer”) (citations omitted) (prescription drug case), aff’d in part & rev’d in part on other grounds, 85 A.3d 434 (Pa. 2014).  Bragg v. Hi-Ranger, Inc., 462 S.E.2d 321, 331 (S.C. App. 1995) (following the “law adopted by a majority of jurisdictions concerning a manufacturer’s duty to recall or retrofit its products”); Morrison v. Kubota Tractor Corp., 891 S.W.2d 422, 429 (Mo. App. 1994) (finding “no such duty absent a state or federal law mandating a recall of the product”), transfer denied (Mo. Feb. 12, 1995); Lynch v. McStome & Lincoln Plaza Associates, 548 A.2d 1276, 1281 (Pa. Super. 1988) (finding no “precedent that imposes such a broad duty on a manufacturer, nor do we think that the imposition of such a duty would be appropriate”).

Literally scores of federal courts have made state-law predictions that reject failure-to-recall claims under the laws of many other states.  The sheer range of products against which recall claims have been asserted demonstrates how radical a legal change recall-based liability would entail, were it to be accepted.

  • Alabama: Wilhite v. Medtronic, Inc., 2024 WL 968867, at *6 (N.D. Ala. March 6, 2024) (“no duty to recall under Alabama law”) (medical device); Harman v. Taurus International Manufacturing, Inc., 661 F. Supp.3d 1123, 1133 (M.D. Ala. 2023) (“no such duty exists under Alabama law” to “proactively recall[]” a product) (firearm); Harris v. Raymond Corp., 2018 WL 6725329, at *9 (N.D. Ala. Dec. 21, 2018) (“there is no duty to recall”) (pallet jack).
  • AlaskaNelson v. Original Smith & Wesson Business Entities, 2010 WL 7125186, at *3-4 (D. Alaska May 18, 2010) (following “the weight of jurisdictions that have previously determined that failure to recall … is not a valid cause of action”), aff’d, 449 F. Appx. 581, 584 (9th Cir. 2011) (firearm).  Cf. Jones v. Bowie Industries, Inc., 282 P.3d 316, 335 n.70 (Alaska 2012) (clarifying that recognizing a post-sale duty to warn does not include any duty to recall) (mulching machine).
  • ColoradoPerau v. Barnett Outdoors, LLC, 2019 WL 2145467, at *2-3 (M.D. Fla. May 15, 2019) (excluding all failure-to-recall evidence) (crossbow) (applying Colorado law).
  • DelawareSmith v. Daimlerchrysler Corp., 2002 WL 31814534, at *6 (Del. Super. Nov. 20, 2002) (“There is also no duty under Delaware law to recall defective [products]”) (automobile).  Yes, this is a state trial court decision, but we didn’t have any better place to put it.
  • FloridaHowey v. Pirelli Tire, LLC, 2017 WL 10978505, at *2 (S.D. Fla. Oct. 31, 2017) (following Wright) (tire); Wright v. Howmedica Osteonics Corp., 2017 WL 4555901, at *4 (M.D. Fla. Oct. 12, 2017) (“find[ing] no Florida case recognizing a cause of action for breach of the duty to recall”) (medical device), aff’d, 741 F. Appx. 624 (11th Cir. 2018); Thomas v. Bombardier Recreational Products, Inc., 682 F. Supp.2d 1297, 1302 (M.D. Fla. 2010) (“Florida law does not recognize that a manufacturer has a post-sale duty to recall or retrofit a product”) (personal watercraft).
  • GeorgiaClayton v. Alliance Outdoor Group, Inc., 2021 WL 1947886, at *2 (M.D. Ga. March 30, 2021) (“Georgia law generally does not recognize a cause of action based upon a manufacturer’s failure to recall a product”) (tree stand); Williamson v. Walmart Stores, Inc., 2015 WL 1565474, at *6 (M.D. Ga. April 8, 2015) (quoting and following Reese, supra) (gas container); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *4 (S.D. Ga. Sept. 13, 2010) (“product sellers are not required to issue recalls for defective products”) (pre-Reese) (prescription drug).
  • IndianaTimm v. Goodyear Dunlop Tires North America Ltd., 309 F. Supp.3d 595, 602 (N.D. Ind. 2018) (finding no “support” for a “claim of negligent recall”) (tire); Cincinnati Insurance Companies. v. Hamilton Beach/Proctor-Silex, Inc., 2006 WL 299064, at *3 (N.D. Ind. Feb. 7, 2006) (“no Indiana state law cases indicate the existence of a separate negligent recall cause of action”) (citations omitted) (toaster); Tober v. Graco Children’s Products, Inc., 2004 WL 1987239, at *9 (S.D. Ind. July 28, 2004) (rejecting “the existence of a separate ‘negligent recall’ cause of action”), aff’d, 431 F.3d 572 (7th Cir. 2005) (baby swing).
  • IowaBurke v. Deere & Co., 6 F.3d 497, 510 (8th Cir. 1993) (“we find no independent duty to retrofit or recall under Iowa law”) (combine); Doe v. Baxter Healthcare Corp., 2003 WL 27384538, at *5 (S.D. Iowa June 3, 2003) (“no court interpreting Iowa law has recognized a duty to recall”), aff’d, 380 F.3d 399 (8th Cir. 2004) (blood product).
  • LouisianaWeams v. FCA US L.L.C., 2019 WL 960159, at *23 (M.D. La. Feb. 27, 2019) (“failure to recall is not a theory of liability under the” exclusive Louisiana product-liability statute) (automobile).
  • MassachusettsAhern v. Sig Sauer, Inc., 2021 WL 5811795, at *4 (D. Mass. Dec. 7, 2021) (plaintiff “cites no legal duty to impose a mandatory recall”) (firearm); National Women’s Health Network, Inc. v. A.H. Robins Co., 545 F. Supp. 1177, 1181 (D. Mass. 1982) (“[n]o court has ever ordered a notification and recall campaign on the basis of state law”) (contraceptive device).
  • MinnesotaKladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sept. 2, 2008) (“Minnesota courts have not recognized a cause of action for negligent recall”) (inflatable swimming tube); Hammes v. Yamaha Motor Corp., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006) (“this Court declines to impose a separate duty to recall”) (motorcycle); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1016 (D. Minn. 2003) (quoting McDaniel) (power saw); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999) (“Minnesota would refuse to impose a duty on manufacturers to recall and/or retrofit a defective product because the overwhelming majority of other jurisdictions have rejected such an obligation”) (motorcycle helmet).
  • MississippiGoodwin v. Premier Ford Lincoln Mercury, Inc., 2020 WL 3621317, at *4 n.2 (N.D. Miss. July 2, 2020) (“there is no post-sale duty to warn or recall in Mississippi”) (automobile); Clark v. General Motors, 2016 WL 3574408, at *7 (S.D. Miss. June 23, 2016) (same) (automobile); Murray v. General Motors, 2011 WL 52559, at *2 (S.D. Miss. Jan. 7, 2011) (plaintiffs “cannot show that [defendant] breached its duty by not recalling their vehicle”), aff’d, 478 F. Appx. 175 (5th Cir. 2012) (automobile).
  • MissouriHorstmyer v. Black & Decker, (U.S.), Inc., 151 F.3d 765, 774 (8th Cir. 1998) (finding “no indication … that the Missouri Supreme Court would create a common law duty to recall under these circumstances”) (power saw); Smith v. Firestone Tire & Rubber Co., 755 F.2d 129, 135 (8th Cir. 1985) (“Since no duty to recall was established, a fundamental prerequisite to establishing negligence was absent”) (tire); Haskell v. PACCAR, Inc., 2021 WL 5407853, at *3 (W.D. Mo. Nov. 18, 2021) (“There is no common law duty to recall under Missouri law absent a mandated recall by a governmental agency.”) (citations omitted) (commercial truck); Hackethal v. Harbor Freight Tools USA, Inc., 2016 WL 695615, at *1 (E.D. Mo. Feb. 22, 2016) (“[t]here is no duty under Missouri law to recall”) (blow gun); Ardito v. ITW Food Equipment Group, LLC, 2016 WL 10677591, at *7 (W.D. Mo. Feb. 8, 2016) (“there is no general duty to recall”) (commercial mixer); Simon v. Select Comfort Retail Corp., 2014 WL 5849243, at *4 (E.D. Mo. Nov. 12, 2014) (“there is no common law duty to recall under … Missouri law”) (mattress); Dejana v. Marine Technology, Inc., 2013 WL 6768407, at *3 (E.D. Mo. Dec. 20, 2013) (same as Haskell) (boat); Stanger v. Smith & Nephew, Inc., 401 F. Supp.2d 974, 982 (E.D. Mo. 2005) (“under Missouri law, there is no cause of action for negligent recall”) (medical device); Efting v. Tokai Corp., 75 F. Supp.2d 1006, 1010-11 (W.D. Mo. 1999) (“no duty in Missouri to recall”) (lighter).
  • NebraskaAnderson v. Nissan Motor Co., 139 F.3d 599, 602 (8th Cir. 1999) (“limiting [Nebraska] products liability law to actions or omissions which occur at the time of manufacture or sale”) (forklift); Dubas v. Clark Equipment Co., 532 F. Supp.3d 819, 830 (D. Neb. 2021) (“claims asserting post-sale duties to … recall … are dismissed”) (forklift).
  • New HampshireBartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *10 (D.N.H. Sept. 14, 2010) (“‘almost all of the opinions which have addressed the issue have found that there is no common law duty to recall’ products from the market, even if they are unreasonably dangerous”) (quoting 5 L. Frumer & M. Friedman, Products Liability, §57.01[4], at 57–9 (2010)) (generic prescription drug)
  • New JerseyLeslie v. United States, 986 F. Supp. 900, 913 (D.N.J. 1997) (“no authority … requires manufacturers of legally distributed [products] to ensure instantaneous removal of their products”) (ammunition), aff’d mem., 178 F.3d 1279 (3d Cir. 1999).
  • New MexicoMorales v. E.D. Etnyre & Co., 382 F. Supp.2d 1285, 1287 (D.N.M. 2005) (rejecting a “duty to retro-fit or recall”; following Third Restatement §11) (road paving machine).
  • North DakotaEberts v. Kawasaki Motors Corp., 2004 WL 224683, at *2-3 (D.N.D. Feb. 2, 2004) (following Third Restatement §11 and “the overwhelming majority of other jurisdictions [that] have refused to impose a duty on manufacturers to recall … a defective product”) (ATV).
  • OhioKondash v. Kia Motors America, Inc., 2016 WL 11246421, at *14 (S.D. Ohio June 24, 2016) (given the weight of contrary precedent, “[t]he Court cannot conclude that Ohio law recognizes a duty in negligence to recall”) (automobile).
  • PennsylvaniaMcKnight v. Amazon.Com Inc., 2024 WL 2156223, at *6 (E.D. Pa. May 14, 2024) (quoting Liebig) (OTC drug); Liebig v. MTD Products, Inc., ___ F. Supp.3d ___, 2023 WL 5517557, at *4 n.6 (E.D. Pa. Aug. 25, 2023) (“Pennsylvania law does not recognize a duty to recall or retrofit products”) (snow blower); Bradley v., Inc., 2023 WL 4494149, at *5 (Mag. E.D. Pa. July 12, 2023) (quoting and following Boyer) (phone charger), certif. denied, 2023 WL 7196427 (Mag. E.D. Pa. Sept. 20, 2023); Cleaver v. Honeywell International, LLC, 2022 WL 2442804, at *4 (E.D. Pa. March 31, 2022) (“Under Pennsylvania law, manufacturers and distributors do not have a duty to recall or retrofit products.”) (vacuum truck); Talarico v. Skyjack, Inc., 191 F. Supp.3d 394, 401 (M.D. Pa. 2016) (no “independent negligence cause of action exists in Pennsylvania under a duty to recall”) (forklift); Padilla v. Black & Decker Corp., 2005 WL 697479, at *7 (E.D. Pa. March 24, 2005) (Pennsylvania law “does not, however, extend to the duty to recall”) (miter saw); Boyer v. Case Corp., 1998 WL 205695, *2 (E.D. Pa. Aug. 28, 1998) (“Pennsylvania does not recognize a duty to recall”) (industrial equipment).
  • South CarolinaAndrews v. CBS Corp., 2015 WL 12831309, at *1 (D.S.C. June 24, 2015) (“there is no-post sale duty to recall or retrofit products”; citing and following Bragg, supra) (asbestos containing products).
  • South DakotaRobinson v. Brandtjen & Kluge, Inc., 2006 WL 2796252, at *8 (D.S.D. Sept. 27, 2006) (“[n]othing … indicates that South Dakota permits a claim based on a manufacturer’s duty to recall”; citing Restatement Third §11), aff’d, 500 F.3d 691 (8th Cir. 2007) (printing press).
  • TennesseeSpence v. Miles Laboratories, Inc., 810 F. Supp. 952, 959 (E.D. Tenn. 1992) (product-liability statute did not “require manufacturers and suppliers of [their] products to recall and test a product already on the market”) (blood product).
  • TexasSyrie v. Knoll International, 748 F.2d 304, 311-12 (5th Cir. 1984) (“Texas does not impose on manufacturers the duty … to recall products”) (stool); Gomez v. ALN International, Inc., 2021 WL 3774221, at *8 (S.D. Tex. March 24, 2021) (“there is no general, post-sale, duty to retrofit or recall under Texas law”) (medical device); Nester v. Textron, Inc., 2015 WL 9413891, at *13 (W.D. Tex. Dec. 22, 2015) (Texas rejects failure-to-recall claims prior to any actual recall) (utility vehicle); Hernandez v. Ford Motor Co., 2005 WL 1574474, at *1 (S.D. Tex. June 28, 2005) (“Texas law generally does not recognize a common law post-sale duty … to recall defective products”) (automobile); Flock v. Scripto-Tokai Corp., 2001 WL 34111725, at *8-9 (S.D. Tex. Sep. 11, 2001) (following Restatement Third §11) (cigarette lighter).
  • UtahMarcovecchio v. Wright Medical Group, Inc., 2019 WL 1406606, at *7 (D. Utah March 28, 2019) (“Plaintiff has alleged only that [defendant] failed to recall the product, which is insufficient to state a claim”; following Restatement Third §11) (medical device); Dowdy v. Coleman Co., 2011 WL 6151432, at *3 (D. Utah Dec. 12, 2011) (“declin[ing] to recognize a post-sale duty to recall or retrofit”; citing Restatement Third §11) (propane heater).
  • VirginiaBoyer v. Abbott Vascular Inc., 2023 WL 4269764, at *2 (N.D. Cal. June 29, 2023) (predicting that Virginia would follow Restatement §11 and dismissing recall claim; quoting Powell, supra) (catheter) (applying Virginia law); Putman v. Savage Arms, Inc., 2019 WL 1007527, at *9 (W.D. Va. March 1, 2019) (“no such duty to recall is recognized under Virginia law”) firearm); In re General Motors LLC Ignition Switch Litigation, 202 F. Supp.3d 362, 371-72 (S.D.N.Y. 2016) (same) (automobile) (applying Virginia law); Powell v. Diehl Woodworking Machinery, Inc., 198 F. Supp.3d 628, 634 (E.D. Va. 2016) (“Virginia law does not recognize a duty to recall”) (ripsaw); Paschall v. CBS Corp., 2011 WL 4345283, at *4 n.2 (E.D. Va. Sept. 15, 2011) (“a duty to recall [is] not recognized under Virginia law”) (asbestos products).
  • WashingtonBear v. Ford Motor Co., 2007 WL 870344, at *3 (E.D. Wash. March 20, 2007) (failure-to-recall claim does not exist because “the issue of recall is not addressed in the Washington Products Liability Act”) (automobile).
  • Wisconsin:  Carlson v. Triton Industries, Inc., 605 F. Supp.3d 1124, 1138 (W.D. Wis. 2022) (rejecting “failure to recall” theory as “much more drastic” than anything Wisconsin law has permitted) (boat).

That’s not even everything.  Where we have state high court authority, we haven’t looked for decisions by other courts bound by such precedent.  Nor have we included any related “duty to retrofit” cases.  For additional precedent, see our prior recall-related posts here and here.

It is quite clear to us that the  overwhelming weight of precedent nationwide rejects failure-to-recall claims except in the limited circumstances mentioned in Restatement Third §11.  That a recall occurred later, or was “voluntary,” does not matter.  Recall-based claims go far beyond ordinary negligence and strict-liability theories.  They usurp executive and legislative powers to regulate the public’s access to lawful products.  Moreover, even if a failure-to-recall claim did exist against an FDA-regulated product, it would be preempted – which will be the subject of our forthcoming Part II (hint, see our New Hampshire law citation), above).