It’s the holiday season, and we’re getting in the festive spirit. We like old-school jingle in our jangle (even though that’s not necessarily holiday themed), more recent, unquestionably holiday-focused jingle jangle, and even first-gift of Christmas jingle, But there may be nothing more festive than a rock-solid preemption win—particularly one from California. We think this one will put a spring in your step and a sparkle in your smile.
Continue Reading Jingle Jangle, California OTC Preemption
This is from the Holland & Knight side of the Blog only.
If you have followed the Blog, then you will know that we have long touted the importance of Erie deference by federal courts sitting in diversity. We have also questioned the expansion of tort law to allow governmental entities to use public nuisance to shift the costs of governmental services to private entities without calling it a tax. We have even discussed the issue of abrogation of common law claims, which can be seen as a lingering source of unchecked liability, when a state enacts a product liability act. For various reasons, however, we have largely declined to comment on the use of public nuisance as the primary theory for governmental entities as plaintiffs in opioid litigation. Today’s post is an exception, and it deals with a pretty significant decision, which we think is overdue.
Continue Reading Ohio Does Not Recognize Public Nuisance Claims For Products
It might seem that we talk about preemption incessantly on this blog, but a pretty good opinion from a pretty important jurisdiction went unremarked by us last September. We’ll rectify that right now. Call it an end of year clean up session.
The decision in Howard v. Alchemee, LLC, 2024 U.S. Dist. LEXIS 169359 (C.D. Cal. Sept. 20, 2020), actually addresses three California no-injury class actions alleging that certain over the counter (OTC) acne medicines were contaminated with carcinogenic benzene. The plaintiffs claimed that the manufacturers failed to warn that the active ingredient (BPO) in their acne products degrades into benzene under normal use, handling, and storage conditions. The plaintiffs did not allege any specific adverse events from benzene. They simply wanted their money back.
By the way, guess who says they found the benzene in the products? It was that good, old “independent” lab, Valisure — which proceeded to file a citizen’s petition with the FDA seeking action against BPO products. Sound familiar?
The defendants filed a motion to dismiss, based on lack of standing and on preemption. The former argument got rid of the request for an injunction, but not the request for money.
The latter argument was more successful. The court dismissed the actions with prejudice because they were expressly preempted by federal law. The “broad” OTC preemption clause precludes any claims that would have state law establish any requirement “that is different from or in addition to, or that is otherwise not identical with, a requirement under” the Food, Drug, and Cosmetics Act (FDCA). OTC acne drugs are governed by a Food and Drug Administration (FDA) monograph. The monograph expressly permits BPO in specified amounts. Compliance with the monograph means the product is “generally recognized as safe” (GRAS) and not misbranded. Thus, the plaintiffs’ claims are “fundamentally at odds” with the monograph for these products.
Further, the plaintiffs in these actions did not allege anything about the particular products they used. They cited no testing of their products. (This seems to be a theme in cases involving Valisure.) Essentially, the plaintiffs suggested that all BPO products contain benzene. The court interpreted the plaintiffs’ position as not “genuinely seeking a warning that the product unsafe – which would be stark enough – but rather are pursuing a ban on selling what they believe is an ‘adulterated,’ illegal product.” The plaintiffs’ claims were an attack on the FDA’s GRAS findings and constituted an attempt to make state law ban the defendants’ products.
The plaintiffs attempted to disclaim any beef with the FDA by suggesting that the FDA was ignorant of BPO’s dangers. But the plaintiffs’ complaint was replete with allegations “that the scientific community has known of BPO’s degradation into benzene for almost 90 years.” Sometimes plaintiff story-telling comes back to hurt them. The Howard court also cites Ninth Circuit authority noting the “scientific expertise of the FDA.”
In addition, there was a fatal flaw in the plaintiffs’ demand that benzene be disclosed on the product labels. Benzene does not fit the definition of an active or inactive ingredient. It is not a “purposefully added component of the drug.” Put simply, breakdown products are not disclosable under the FDCA.
The plaintiffs attempted to borrow the parallel claim exception from medical device law, even though such borrowing is generally questionable and the plaintiffs could not specifically find a parallel to a FDA requirement. First, there was no true parallel to the FDCA’s general misbranding provision because the monograph deals with ingredients specifically, and the plaintiffs did not claim any violation of the monograph. In any event, omitting a warning not required by the FDA cannot equal misbranding. Without a specific, affirmative violation of misbranding provisions, the misbranding notion as a generality cannot support a parallel claim. Second, the plaintiffs’ claim cannot add up to a parallel violation of “adulteration.” State laws prohibiting misleading advertisements on which the plaintiffs relied on these cases are not parallel or identical to the FDCA’s prohibition against selling adulterated drugs.
In sum, the plaintiffs endeavored to force the acne medicine manufacturers to make disclosures that would conflict with the FDA’s determination that BPO was safe and effective. Because the plaintiffs’ claims “would impose requirements that differ from and are in addition to those on the FDCA, they are preempted.”
Is the question we are asking ourselves after reading Butler v. 3M Company, 2024 WL 5054884 (S.D. Ohio Dec. 9, 2024). Because if plaintiffs get to amend their complaints post-remand to add whole new claims and allegations, then the MDL process of litigating based on a master complaint doesn’t seem to make a lot of sense, or create the efficiencies attributed to it.
Butler is a case from the Bair Hugger MDL in which plaintiffs alleged that defendants’ patient warming devices purportedly caused joint infections during surgery. The Master Long Form and Short Form complaints in that MDL have been on file since 2016. Plaintiffs filing suit after that date, like Ms. Butler, could file a short form complaint providing certain case-specific information, but essentially adopting the allegations of the long form complaint. Such plaintiffs were also given the right to file amended complaints, “upon the showing required by the relevant Federal Rules of Civil Procedure.” Id. at *1. Which became a key issue in Butler—what rule applied to plaintiff seeking to amend her complaint post-remand.
Where a plaintiff moves to amend her complaint before the deadline to do so, Federal Rule of Civil Procedure 15(a)(2) provides that “[t]he court should freely give leave when justice so requires.” But, if the deadline has lapsed, Rule 15’s liberal policy yields to the higher threshold for modifying a scheduling order found in Rule 16. In this case, the plaintiff must “show good cause” for not seeking leave before the deadline before the court will consider whether the amendment is proper under Rule 15. Id. at *2.
Butler was one of 28 cases remanded or transferred from the MDL to their home districts for trial. The remand court entered a scheduling order setting a deadline for filing motions to amend pleadings. Plaintiff moved to amend before expiration of that deadline, but long after the pleadings deadline in the MDL—creating a Rule 15 versus Rule 16 conundrum. Now, if Butler was the only case addressing this issue it may not be a big deal. But the Butler court acknowledged that “several” remand courts were being asked to allow plaintiffs to amend their complaints. Id. at *3. Including the MDL court itself in an individual case:
the MDL court concluded … that “any present motion to amend a complaint in this MDL is governed by Rule 16” and that “[p]laintiffs in the MDL seeking to amend a complaint after July 29, 2016 must proceed under Rule 16 and its good cause standard.”
Id. Seems hardly open to debate.
But the Butler court chose to “asum[e] without deciding” that Rule 16 applied and concluded that plaintiff demonstrate good cause based on some suspect reasoning. Such as, that plaintiff filed her motion to amend before the deadline set by the remand court. But that’s like saying she met Rule 16’s threshold because Rule 16 doesn’t really apply. More importantly, the court was persuaded to find good cause because “bellwether trials are designed to, among other things, test different claims and litigation strategies.” Id. at *4. And plaintiff is “entitled to select which to assert in her own case.” Id. No doubt she is. The same can be said of every plaintiff. That is the whole point of the short form, case-specific, complaint. That is the vehicle in which a plaintiff identifies which specific claims she is pursuing. That plaintiff is entitled to select her claims has nothing to do with whether plaintiff acted diligently in making that selection. This type of reasoning is an open invitation to any remanded plaintiff to cast off the centralized pleadings of the MDL. As defendants in Butler argued, amended pleadings at this stage are also likely to re-open discovery, further diminishing the efficiency MDLs are meant to create. That this plaintiff was a late filer in the MDL should have cut against allowing an amendment rather than in favor. Her counsel had the benefit of all of the proceedings and the discovery in the MDL at the time her complaint was filed and could have added whatever allegations she wanted at the time of filing, or certainly shortly thereafter and in any case, before remand. She did not.
Substantively, while the amendment is being allowed, the court ruled it was futile to add claims under Minnesota law where plaintiff is an Ohio resident who was allegedly injured in Ohio. Id. at *5. But, other claims, such as Ohio common law claims which are subsumed under the Ohio Products Liability Act, were allowed to be pleaded in the alternative. Id. at *6.
Regardless of which amendments were or were not allowed, Butler stands for the proposition that the pleading framework under which an MDL is conducted (and any results of Rule 12 motion practice) can be jettisoned after remand. So, what’s the point?
Some of your bloggers recently attended the American Conference Institute’s annual Drug and Medical Device Litigation Conference in New York. One of the conference panels addressed a recent unsettling ruling in a non-drug-device case that held communications training provided by defense counsel for their client’s employees was not only discoverable but admissible at trial. In re Google Play Store Antitrust Litigation, 664 F. Supp.3d 981, 983 (N.D. Cal. 2023). Moreover, some of the “practices” that found their way into the opinions seemed to us not only privileged but entirely unobjectionable:
Plaintiffs also point out that, for years, [defendant] has directed its employees to avoid using certain [legal] buzzwords in their communications. . . . Eight years later, [defendant] still was telling employees . . . “[a]ssume every document you generate … will be seen by regulators.”
United States v. Google LLC, ___ F. Supp.3d ___, 2024 WL 3647498, at *113 (D.D.C. Aug. 5, 2024) (citation omitted). That’s only good sense, and no different than the other side (at least if they have good lawyers) tells its own individual plaintiffs before they have to testify.
Continue Reading Privilege and Lawyer-Provided Employee Training
A case we reviewed a couple of months ago came to mind recently, not only because of its result, but also because how long it has been kicking around in our federal court system, trapped in an MDL. What refreshed our recollection? As regular blog consumers have read this week, the annual ACI Drug and Medical Device Litigation conference was last week in New York, where we heard from an outstanding panel of attorneys on the Rule 16.1, the new Federal Rule that addresses multidistrict litigation. We recently presented a CLE on that topic too, along with our colleague Christina Olivos. One of our major beefs with MDLs is the tremendous overuse (abuse?) of MDLs by plaintiffs without tenable claims, sometimes by the thousands. The result is clogged dockets, inattention to actual merits, inevitable delay, and unfair pressure to enter into mass settlements. The new Rule 16.1 might help with this situation, but then again, it might not.
This is not only a defense issue, as plaintiffs and their lawyers likewise find themselves stuck in MDLs with little control over their individual cases and even less attention. The district court’s order in Mercier v. DePuy Orthopaedics, Inc., No. CV 23-0040, 2024 U.S. Dist. LEXIS 194642 (C.D. Cal. Oct. 25, 2024), illustrates the point. In Mercier, the plaintiff’s decedent had hip replacement surgery, although we are not told when. Regardless, he sued the hip implant’s manufacturer in 2015 alleging complications, and he filed directly into the Pinnacle Hip MDL in the Northern District of Texas.
Then he waited. And then he waited more. And then some more. As is common in multidistrict litigation, this patient’s case languished in the MDL for seven years, until being transferred to the Central District of California for pretrial and trial proceedings. During that time, life and death intervened. The patient moved from California to Nevada, and he sadly passed away in 2024 as the result of an opioid overdose.
The administrator of the patient’s estate filed an amended complaint alleging survival claims, but also adding claims for wrongful death—claiming that the patient’s alleged hip-related injuries caused his death, too. The issue was whether California law or Nevada law applied, since those states treat wrongful death and survival claims differently. California’s wrongful death claim requires the joinder of all indispensable parties, and at the time the action was filed, California followed the rule that a plaintiff’s pain and suffering damages dies with him. (California has since altered that rule.)
The district court ruled that California law governed. First, the court applied California’s choice-of-law rules, stating that choice-of-law rules “are substantive issues for Erie purposes, meaning federal courts in California will apply California choice of law rules.” Id. at *6. That’s fine, except that this case was filed in Texas, and we were taught back in the day that when a case is transferred, the substantive law transfers with it, including choice-of-law rules. We would have applied Texas’ choice of law, but we digress.
Second, the district court determined that California’s interest would be more impaired if its law were not applied to the case. The court noted that California’s choice-of-law cases “continue to recognize that a jurisdiction ordinarily has the predominant interest in regulating conduct that occurs within its borders” Id. at *14. Here, the patient’s hip replacement surgery was in California at a time when he resided in California, and the device was allegedly manufactured and sold in California. Moreover, because the plaintiff could cure any deficiency in the complaint with an amendment, applying California law would not impair Nevada law in the least. One wonders why the plaintiff did not amend the complaint to begin with, instead of engaging in this motion practice, but again, we digress.
So California law applies, and the plaintiff had to file an amended complaint joining all indispensable parties. But that is not the story. Instead we ask, What took so long? This patient filed his complaint nine years ago, and the exceptional passage of time since then saw him move from one state to another and eventually pass away. Imagine his frustration and that of the defendants, who have faced this claim for going on a decade and now face a wrongful death claim allegedly stemming from a surgery that occurred at least ten years ago, and maybe longer. Maybe a rule like Rule 16.1 would have help move things along, and maybe not.
Although Mark Herrmann co-founded the Drug and Device Law Blog (with Bexis) way back in the day, he now writes for Above the Law. Unlike Above the Law, the Drug and Device Law Blog generally does not feature benchslaps—judicial opinions that take a swipe at counsel for their professional misdeeds. Though we may secretly enjoy a public comeuppance in spite of our better selves, your bloggers’ overarching purpose is to spread information, authorities, and practical strategies that will help our clients defend medical device and pharmaceutical product liability cases. So while we try to write interesting, sometimes (hopefully) amusing posts, our usual subject matter is a bit more law-focused.
But today, we get to write about a benchslap (which, of course, Above the Law also has covered), and we also tie it to our more usual blogging purpose.
First, the benchslap: This comes to us by way of the Northern District of Alabama in an order from McCullers v. Koch Foods of Alabama, LLC, 2024 U.S. Dist. LEXIS 218902, 2024 WL 4907226 (N.D. Ala. Nov. 26, 2024) regarding an opposed motion to extend a responsive pleading deadline.
The dispute arose when defense counsel requested a routine extension of time to respond to the complaint, and the plaintiff’s counsel would not agree to the extension unless the defendant agreed to only file an answer and forgo any motion to dismiss. The Court was having none of it:
Plaintiff’s counsel’s conditioning of any agreement to an extension was wholly inappropriate, particularly in light of the looming Thanksgiving holiday. Such nonsense wastes time, damages professional relationships, and makes the lawyer withholding consent (or conditioning it) appear petty and uncooperative. Judges rightly expect lawyers to handle minor procedural issues like extensions without unnecessary conflict, and refusing to do so is unprincipled.
Conditioning or denying consent to an extension in this way is fiddle-faddle for an additional reason: it rarely provides any legitimate strategic advantage. Everyone encounters unexpected delays, and extending professional courtesy really costs nothing. But, fostering goodwill by agreeing to short extensions could benefit counsel later in this case—or in future dealings with opposing counsel. The court’s job is to address the merits of the case, not to navigate a world of technicalities. Refusing such a reasonable extension request stinks of petty gamesmanship. Professionalism demands that lawyers pick their battles wisely, and minor extension requests simply are not the place for unnecessary posturing.
The Court also imposed a creative punishment, if you will, designed to dissuade the parties’ counsel from further acts of professional discourtesy: Lunch.
[T]he court ORDERS that, on or before December 31, 2024, counsel for both Plaintiff and Defendants are to go to lunch together. Plaintiff’s counsel will pay the bill; Defendants’ counsel will leave the tip. The parties will discuss how they can act professionally throughout the rest of this case. Within ten (10) days of the lunch, the parties SHALL file a joint report describing the conversation that occurred at lunch and the amount of the tip. (Emphasis original)
As benchslaps go, this one was creative and funny, and not too harsh while most certainly getting the point across.
It also is a useful authority to file away for some rainy day in the future. Because of important threshold issues like federal preemption, we usually respond to complaints with a motion to dismiss, not an answer. That means that when we need extra time to respond to a complaint, we always ask for extensions of time to file our “responsive pleading”, not to file our “answer.” Almost every such extension request we have made has been granted with professionalism and courtesy. But maybe twice in our career we have encountered a plaintiff’s attorney who has refused a responsive pleading extension request outright, or–like in McCullers–has tried to make their agreement conditional on our client’s waiver of its right to move to dismiss the complaint.
We always have found a work-around in the past, but should it ever happen again, we will pull this order out of its file, send it to the opposing counsel, and trust we will get our point across. Worst case scenario, we end up filing a motion for an extension of time and then ourselves enduring an awkward shared meal with one of our less-reasonable colleagues from across the aisle.
December is both a festive and frantic month. Along with all the caroling, wassailing, and gift-buying, the last month of the year invariably sees us squeezing in continuing legal education (CLE) credits, reconnecting with old friends at the ACI drug and device conference in New York City, and wrapping up the Fall/Winter semester class we teach at Penn Law. This year, all three of those projects forced us to confront the increasingly busy intersection of artificial intelligence and the law.
First, there was a CLE webinar put on by Reed Smith’s vaunted e-discovery team. Like most lawyers planted in a large firm, we think of our own practice group (Life Sciences and Health Industry Litigation) as the crown jewel of the place. But as the breadth and complexity of our cases forces us to collide with adjacent practice groups, we learn that there are plenty of other top-drawer specialists lurking in our offices. We recently worked with False Claims Act lawyers who mastered a difficult area replete with traps for the unwary. We long ago found out that our Insurance Recovery Group sits comfortably at the top of the league tables. And our near-constant discovery battles have sent us again and again to seek guidance and assistance from our e-discovery folks, who are simply the best at what they do. They know all the latest e-discovery developments and are quick to come up with practical advice. They shake solutions out of their cuffs. They even put on CLE programs better than anyone else does. In the most recent class, they staged a series of debates between lawyers on hot discovery topics of the moment. Two of those topics involved AI. If these were issue-spotting exams, we would have flunked. One debate was whether employment of AI in sifting through the other side’s materials produced in response to discovery implicated ethics and confidentiality concerns. Our initial reaction was that it surely was none of the other side’s business how we were reviewing discovery materials. But if the AI tool was a large language model (LLM) that would learn from the information and then render that information available to the model’s owners and other users, you might have a very real confidentiality issue. You would certainly want to know if the other side was using an AI tool that would place your client’s materials in the public sphere. The answer might be to make sure the AI tool was a closed/enterprise model. Another debate topic was whether the client’s use of AI in business activities such as product development would end up being discoverable. You can easily imagine how a corporate defendant’s AI queries might look like admissions, or might look like evidence of who knew what when. Whether such AI queries and answers would be discoverable would likely turn on whether they could be characterized as “ephemeral.” The answer to these questions were by no means obvious, but before the CLE we would not even have been aware of the questions.
Second, there was a really excellent ACI panel on how AI is being used to analyze and brief legal issues. A group of in-house and outside lawyers, along with some AI consultants, brought us up to speed on AI capabilities. The panel showed examples of case analyses generated by law firm associates and AI tools. Which was which? In truth, it seemed reasonably clear that the longer, more comprehensive write-ups were the products of the AI tool, while the pithier summaries, which evinced a keener sense of prioritization, were the handiwork of human lawyers. That is not to say that either the software or the people were the better performers. Our takeaway was that a combination of the two would end up producing the best work product. Lawyer experience cannot be fully replaced by AI (not yet, anyway), but can certainly be enhanced.
Third, we shuttled back to Philly to oversee the final session of the litigation strategy class we have taught at Penn for the past 14 years. The students keep getting younger. And they keep getting smarter and more techno-savvy. We always end the semester with exercises we call “120 Seconds.” Each student (there are typically 15-16 in the class) selects one of the cases we’ve used throughout the semester and then delivers a two minute ‘clopening’ for both the plaintiff and defense sides. After all the analyses, case assessments, and deployment of discovery devices, the culmination is whether the students could synthesize compelling stories and persuasive themes. After each student declaims both the plaintiff and defense clopenings, the question for the other class members is which side did the speaker appear to favor. Then the speaker would confess their preference. Most of the students managed to do such good jobs for both sides that it was tough to identify their preferences. One of the LLM students (that’s LLM as in Master of Laws, not large language model) told us that he had run his presentations through a ChatGPT program to test whether they had mounted the strongest possible cases for each side. Now the use of AI in schools is hardly free from controversy. There is worry that students will ‘cheat’ by using AI to do their work for them. Some teachers utilize AI programs to detect the use of AI by students. But in this situation, we did not see anything wrong with the use of AI to stress-test the 120 seconds presentations. Indeed, as with our sense at the end of the ACI panel, we saw AI as a collaborative tool. It could be used either at the outset of an assignment, to generate a preliminary outline, or it could be used at the end, as a kind of second set of eyes. Or it could be used somewhere in between. Let’s face it – we’re not in the best position to dream up all the ways in which AI can add value to legal services. Our students will be – and are already – much better than we are at taking AI and its advantages on board. AI is coming whether we like it or not. We do not view its arrival with dread. We are not quite ready to kneel down and welcome our software overlords. It’s a tool, just as Shepardizing was, and Westlaw, Lexis, and spell-check is. We’re not worried about AI replacing lawyers. But lawyers who know how to use AI might very well end up replacing lawyers who don’t.
Just last week we blogged about our disappointment over the Third Circuit’s resurrection of a “benefit of the bargain theory” of standing in Huertas v. Bayer US LLC, 120 F.4th 1169 (3d Cir. 2024). But we also recognized that Huertas had a silver lining that defendants could still use to challenge standing—by challenging the quality/quantity of plaintiff’s allegations of product testing. Mere days later we happened upon a defendant that did just that in Pineda v. Lake Consumer Products, Inc., 2024 U.S. Dist. LEXIS 220895 (E.D. Pa. Dec. 5, 2024).
Plaintiff filed a putative class action lawsuit against defendant, the manufacturer of coal tar shampoo products, alleging its products were contaminated with benzene. Just like in Huertas, plaintiff alleged that she suffered an economic injury because the presence of benzene in the shampoo made the product “worth less” than what she paid for it. Under Huertas, the district court was obligated to conclude that was a cognizable injury. Id. at *7. But to confer standing, the injury also needs to be “concrete and particularized.”
Standing requires plaintiff to “plausibly allege that her product was defectively manufactured—or that it contained benzene.” Id. at *8. Again, like in Huertas, plaintiff alleged that testing revealed the presence of benzene in defendant’s “coal tar shampoo products.” But as used in the complaint, that term referred to several of defendant’s products, of which plaintiff used “at least one.” In other words, plaintiff did not have proof that the shampoo she bought was contaminated, so she was attempting to rely on “representative testing.” And while the hurdle for establishing standing via representative testing isn’t high, it does exist. In Huertas, plaintiff cleared that hurdle by demonstrating that the sample of products tested all came from the same lot, which was same lot as the recalled products that plaintiff had purchased. Plaintiff was able to demonstrate a connection between his products and the alleged harm.
But the allegations in Pineda were “incredibly vague.” Id. at *13. Plaintiff did not allege which products were tested. She did not allege when the tested were products were purchased which “could give rise to a reasonable inference that Plaintiff’s products were similarly contaminated.” Id. at *14. No lot numbers were mentioned, and no allegations gave the court any reason to infer that the contamination was “so widespread” as to reasonably include plaintiff’s products. Leading the court to find that plaintiff’s “broad” allegations regarding testing are “so unspecified” that they “stop short of the line between possibility and plausibility.” Id.
As we predicted, the scope of available testing directly impacts who has standing to bring this type of economic loss contamination-based class action. And while we would prefer no “benefit of the bargain” standing, keeping it narrowly focused will have to do for now.
The last time we looked into Bueno v. Merck, it was anything but bueno. Taking the position that, “if there is a cause of action, there must be jurisdiction,” a misguided decision had held that a branded drug manufacturer could be haled to court under an innovator liability claim, despite the defendant having never sold anything to the plaintiff in the state. See Bueno v. Merck & Co., 626 F. Supp.3d 1154 (S.D. Cal. 2022). That decision made our bottom ten list in in 2022.
Two years later – and who knows how many $$$ spent in the interim – the result on the merits was incomparably better. All claims dismissed with prejudice for a variety of excellent reasons. Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024). Ditto for a companion case decided the same day. See Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).
Here’s what happened.
Continue Reading Bueno and More Bueno