In the podcast called Know Your Enemy, political progressives take a probing look at the history of American conservative political thought. The podcast is somewhat unusual because it takes opponents’ opinions seriously. There is much more analysis than name-calling. The podcast considers the views of intelligent conservative theorists and writers (e.g., Leo Strauss, Garry Wills, Joan Didion(!)) and not mere performative chuckleheads. Straw men need not apply.
We wouldn’t call too many plaintiff lawyers “enemies.” After attaining a certain age, we finally figured out that visceral dislike was bad for our viscera. But we’d rather beat plaintiff lawyers than lose to them, so if knowing a little something about their world views will help us, then so much the better. It certainly helps to know about the thorny issues plaintiffs face in settling inventories, securing consents, and dealing with their learned cocounsel. That last category more often than not involves money – filthy-stinking lucre. For example, we are dealing with a plaintiff lawyer who wants to find a separate peace – a settlement that has nothing to do with the MDL. You, see, he doesn’t want to have to pay any money into a common benefit fund. We get that. Any such payment comes right off of profits.
Common benefit funds are, well, common in MDLs. There might not be a firm statutory basis for the practice, but it is a pragmatic way to prevent the problem of free riders. A common benefit fund is designed to ensure that attorneys who performed work benefitting all plaintiffs and their counsel would be reasonably compensated. That seems reasonable, doesn’t it? Who could possibly stir up trouble about such a fair-minded process? You’d be surprised. Or maybe you wouldn’t.
Consider the case of In re Bard IVC Filters Prods. Liab. Litig., 2022 U.S. Dist. LEXIS 91273 (D. Az. May 20, 2022), where some plaintiff lawyers in an MDL filed a motion to reduce and exempt their clients’ recoveries from common benefit and expense assessments. More specifically, the plaintiff lawyers argued that no assessment should be paid by clients whose cases were filed in federal court after the MDL closed, were filed in state court, or were never filed in any court. They also asked for some other reductions in assessments. The common benefit fund assessment in IVC Filters was originally 8% (6% attorney fees and 2% expenses) and later increased to 10%. It is not nothing.
The plaintiff lawyers relied upon a decision in the Roundup MDL, which carved out state court and post-MDL federal cases from common benefit fund assessments. The IVC Filters court considered Roundup to be an entirely different kettle of fish. In IVC Filters, the complaining plaintiff lawyers signed on to a participation agreement near the outset of the case, actually were part of the Plaintiffs’ Steering Committee (PSC), and benefited from massive work that mostly, unlike in Roundup, was not available on the public docket. That work included depositions, expert motions, summary judgment motions, and even a trial package. Further, the Roundup court set up a common benefit fund not nearly as early as in IVC Filters. The Roundup court also doubted that the common benefit work did much to advance the ball for the complaining plaintiff lawyers. By contrast, the IVC Filters court harbored no such doubts. The complaining attorneys in IVC Filters “enjoyed access to the MDL work product — whether online or by downloading it — only because [those attorneys] entered into the Participation Agreement and agreed to pay common benefit assessments.”
Plaintiff lawyers are often very good at coming up with winning themes. The winning theme in IVC Filters seems to be “a deal is a deal.”
Moreover, in Roundup the plaintiff lawyers had secured stratospheric verdicts, and the court believed the lead lawyers were not hurting for additional compensation. In addition, much of the settlement leverage in Roundup came from the state court, not MDL, proceedings.
The IVC Filters court also discussed its inherent authority to impose common benefit assessments. And here we enter the world of MDL folklore and mythology, where the absence of statutory authority inevitably yields to the practical demands of an inherently impractical structure. The IVC Filters court acknowledges that the “MDL statute is procedural in nature and does not clearly confer on federal courts the power to create a common benefit fund or make assessments for that fund.” That being said, an “MDL court’s ability to perform the task assigned to it by the MDL statute necessarily requires the power to assure reasonable compensation for the efforts of lead counsel.” Or — and hear us out on this – maybe some MDL courts have an inflated sense of the “task assigned to it by the MDL statute.” If the statute itself does not provide for common benefit funds, maybe you’re doing it wrong.
But who needs statutes when you’ve got a court’s inherent power? The IVC Filters court observed that “a district court’s inherent managerial power is particularly important in a large MDL like this one.” The court admits that such inherent power is not “limitless,” though the outer boundaries have not yet been “precisely delineated.” But the common benefit fund here was pretty standard, the plaintiff lawyers signed onto the Participation Agreement so, again, a deal’s a deal. The plaintiff lawyers were attempting to breach the Participation Agreement (which had been incorporated into a court order), so the IVC Filters court could prevent the breach.
The IVC Filters court also found support in the common fund doctrine. That doctrine cuts against the usual “American Rule” of each side bearing its own legal costs, and has been applied in class actions. The IVC Filters case did not conclude, as the Roundup court did, “that the common fund doctrine is limited solely to cases where a lawyer’s work creates a res that resides in the court and from which others seek to recover.” The IVC Filters court also considered the reliance interests of the PSC in being reasonably compensated for work they did on behalf of all plaintiffs.
The complaining plaintiff counsel argued that their work, not the common benefit work, had upped the settlement value of late-settled cases, and that, therefore, the common benefit assessment should be reduced. But, again, a deal is a deal. The complaining plaintiff lawyers had signed on for a fixed percentage; there was no room for post hoc revisionism. The court was in no position “to parse the value between the common benefit work” and the work done by the complaining plaintiff lawyers.
When it comes to common benefit fund disputes, we are much happier being spectators than participants.
Almost a year ago we wrote a post called Learned Intermediary – Not Just for Failure to Warn about a California putative economic loss class action that was dismissed for failing to plead any allegations about whether the drug manufacturer had adequately warned plaintiff’s prescribing physician. Fast forward about 9 months and we posted about the California Amiodarone decision that rejected plaintiffs’ argument that the learned intermediary doctrine was an affirmative defense and could not be the basis for a dismissal on the pleadings. We recently realized that just a few days after the Amiodarone decision, another California court reached the same conclusion in yet another putative economic loss class action. Sidhu v. Bayer Healthcare Pharmaceuticals Inc., 2022 WL 17170159 (N.D. Cal Nov. 22, 2022).
Having now read Sidhu and put it into context with these other decisions, we realize that the California plaintiffs’ bar has been making a concerted effort to pitch the “learned intermediary is an affirmative defense” argument all over California. And looking at the cases cited in Sidhu, this pitch has been going on for a few years. See Sidhu, at *4 (citing cases dismissed for failing to plead learned intermediary). Fortunately, plaintiffs have failed to make any headway. That’s because under California law, the learned intermediary doctrine defines the scope of the manufacturer’s duty to warn and the duty to warn is an essential element of plaintiffs’ claim and therefore something on which they bear burden of pleading and proof. Therefore, the learned intermediary doctrine applies at the pleadings stage.
That means plaintiffs are required to plead warning causation as to prescribing physicians. Warning causation means plaintiffs have to allege not only that the warnings or information that defendants provided to their physicians was inadequate but also that their physicians would have altered their prescribing decisions if they had received different information. And under TwIqbal, a bald assertion is not enough. These physician-related allegations cannot be conclusory and must contain sufficient factual support to make plaintiff’s claim “plausible on its face.” That is not an insignificant hurdle for plaintiffs to meet in any case, let alone in a purported class action like Sidhu. A physician-specific pleading requirement is just that—specific, individualized. The enemy of the one-size-fits-all class action. The need for individualized proof of causation should spell the downfall for any purported class, but the fact that California keeps it at the front, in the pleadings stage, should be enormously helpful to defendants faced with these types of failure to warn and fraud-based class actions.
While the learned intermediary ruling was the most significant in Sidhu, the decision also dismissed most of plaintiff’s claims on various grounds. The dismissals were largely without prejudice and plaintiff was given an opportunity to amend her complaint, but there are a few worth mentioning.
- Plaintiff’s purported nationwide class was dismissed for failure to plead what state law governs her common law claims and the court “reminded” her that a California plaintiff lacks standing to assert claims under the laws of other states. Id. at *3.
- Plaintiff could not assert a design defect claim in response to a motion to dismiss that was not pleaded in the complaint, and if the plaintiff does add such a claim to her amended complaint, the court said it is “not clear she should avoid application of the learned intermediary doctrine.” Id. at *5.
- To avoid preemption, plaintiff is required to plead what newly acquired information would allow defendant to use the CBE regulations to change its label. It was not enough for plaintiff to cite to post-2010 studies; she has to plead what information was provided to the FDA and when. Id. at *6.
- Plaintiff’s fraud claims (including consumer fraud) were dismissed for failing to plead that her physician relied on any alleged omission—another claim dismissed under the learned intermediary doctrine. Id.at *8.
- Under California’s Unfair Competition Law (“UCL”), a claim for an unlawful act must be based on a predicate violation, but because plaintiff’s other claims failed for various reasons, so to did her UCL claim. A UCL claim based on unfairness cannot stand alone. Id. at *8-9.
- Under California law, plaintiff’s unjust enrichment claim was adequately pleaded, id. at *9, but failed for lack of equitable jurisdiction because plaintiff did not demonstrate the inadequacy of a remedy at law. Id. at *11-12.
- Plaintiff’s negligence claim was barred by economic loss rule because plaintiff failed to plead an exception. Id. at *10.
- Plaintiff’s punitive damages claim was dismissed because it was based on the dismissed fraud claims. Id. at *11.
Plaintiff’s amended complaint is due to be filed next month followed by another round of motions to dismiss. We will certainly be watching to see what plaintiff is able to “cure” and just how much the “cure” is detrimental to maintaining this as a class action.
We write from Tampa, Florida, where we attended the bridal shower of a lifelong friend’s daughter. In a happy coincidence, the event fell on the last weekend of a two-week stretch of dog shows in which our puppy’s sire, a spectacular white corded Standard Poodle named Joel, was being shown. A lovely interlude, except for the cold, rainy raw weather today and the mostly-equally-unpleasant decision in today’s case. In D’Addario v. Johnson & Johnson, et al., 2023 WL 239395 (D.N.J. Jan 18, 2023), the plaintiff was implanted with the defendant’s textured breast implant after undergoing a mastectomy. The defendant’s tissue expanders were used to prepare the plaintiff’s body for the implant. The plaintiff alleged that the products caused her to develop Breast Implant-Associated Large Cell Lymphoma (“BIA-ALCL”), a rare form of cancer. The plaintiff asserted claims under the Connecticut Product Liability Act (“CPLA”) for manufacturing defect, breach of implied warranties, negligent misrepresentation, and failure to warn. The defendant moved to dismiss all of the claims.
The plaintiff’s breast implants were class III medical devices, subject to the FDA’s full premarket approval (“PMA”) process. (The tissue expanders were class II devices, subject to the less rigorous 510(k) clearance process.) Under Riegel v. Medtronic, as the D’Addario court explained and as readers of this blog are aware, the express preemption provisions of the FDCA preempt most state-law product liability claims against manufacturers of Class III medical devices. As the court explained, there is a “narrow” exception for so-called “parallel” claims – claims that are based on violation of an FDA requirement, not on state requirements that are “different from, or in addition to,” the federal ones. In other words, “where a . . . claim for violating a state-law duty ‘parallels’ a federal-law duty under the MDA, the MDA will not preempt the state-law claim. . . ” if the plaintiff can link the alleged violation to her alleged injury. D’Addario, 2023 WL 239395 at *4 (internal punctuation and citation to Riegel omitted). Remember, the “parallel claim” exception is a “narrow one,” as the court emphasized, and as it promptly forgot.
In her “manufacturing defect” claims, sounding in both strict liability and negligence, the plaintiff alleged that the defendant’s manufacturing processes violated several of the FDA’s Current Good Manufacturing Practice regulations governing the manufacturing of medical devices. The defendant argued that these claims were preempted because the plaintiffs failed to demonstrate how the defendant’s manufacturing processes deviated from those approved by the FDA, and that the plaintiffs’ citations to regulations, without more, were not sufficient to overcome preemption. The defendant also argued that the manufacturing defect allegations were really just re-packaged design defect claims (which are preempted) and that the manufacturing defect claim failed because it did not claim that the plaintiff’s implants were defectively manufactured, but, rather, that the defendant’s manufacturing process itself was defective. (This last is really important: the gravamen of a properly-pled manufacturing defect claim is that the particular product unit a plaintiff received was not manufactured in compliance with the processes the manufacturer used for the universe of identical products. That is not what the D’Addario plaintiff alleged.)
And D’Addario muffed the analysis. Citing conclusory allegations that the manufacturing process for the universe of identical implants failed to comply with the PMA and with FDA regulations, it concluded, “Plaintiffs have therefore plausibly pled that the product was defective and that the defect existed when the product left the manufacturer’s control. . . . Accordingly, D’Addario concluded that the [complaint] sufficiently alleged that the implants and tissue expanders contained a manufacturing defect.” Id., at *5. Sorry, but this is a non-sequitur. Nowhere did D’Addario explain how the plaintiff satisfied the elements of a manufacturing defect claim, yet it allowed the claim to proceed. And we agree with the defendant: if the claim alleged anything, it alleged a design defect which, for the Class III implants, was preempted.
And D’Addario rested on the same flawed reasoning to hold that the plaintiff’s implied warranty claim was not preempted. In their motion, the defendants argued that that the plaintiffs’ negligent misrepresentation and implied warranty claims were preempted because, while packaged as misrepresentation and warranty claims, both just asserted the same (preempted) conclusory “safety and effectiveness” defect allegations. D’Addario held that warranty claims were not preempted because they were tied to the manufacturing defect claim already allowed to survive. In the one bright spot, D’Addario did dismiss the negligent misrepresentation claim, holding, “. . . Plaintiffs’ negligent misrepresentation claim cannot succeed because failing to disclose a risk by not complying with the reporting regulations or federal disclosure requirements does not satisfy the standard required to sufficiently claim negligent misrepresentation.” Id. at *7. The court also held that the claim, sounding in fraud, failed to satisfy the heightened pleading requirement of Rule 9(b) because it “[did] not specify the statements that Plaintiffs contend[ed] were fraudulent, identify the speaker, state where and when the statements were made, and explain why the statements were fraudulent.” Id.
Finally, D’Addario allowed the plaintiff’s failure-to-warn claim to proceed. While the plaintiff conceded that the defendant included warning labels with its devices, she argued that the particular implant provided to her doctor lacked the warning label. The defendant argued that the allegation was implausible (we agree) but the court held that it created a fact issue allowed the claim to survive a motion to dismiss. Ironically, this “warning” claim is the closest thing in the case to a real “manufacturing defect” claim.
A mostly bad decision, plagued by reasoning that lacks the rigor demanded by preemption analysis. We will keep you posted on further developments. Meanwhile, cross your fingers for sun for the last day of the dog show, and stay safe out there.
We know that the Federal Judicial Conference’s Committee on Civil Rules is considering creating a rule specifically applicable to multi-district litigation – which now comprises some 70% of all cases filed in the federal court system. We remain hopeful the new rule will forcefully encourage the early vetting of MDL plaintiffs’ bona fides, since most MDLs ignore the existing rules that require pre-complaint investigation of claims.
The recent decision in In re Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 17850260 (D.N.J. Dec. 12, 2022), provides the latest graphic example that early vetting simply isn’t happening, now, in MDLs.Continue Reading Another Poster Child for Early Vetting of MDL Plaintiffs
This post is from the non-Reed Smith side of the blog.
We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in the District of New Jersey.
Like the product-liability plaintiffs in the MDL, the securities-law plaintiffs alleged that Allergan failed to disclose that the incidence of a certain cancer, BIA-ALCL, was, supposedly, higher among patients who had received its textured breast implants than among those who had received other manufacturer’s implants. But rather than claim to have suffered personal injuries, the securities-law plaintiffs claimed to have suffered economic damages because, they said, Allergan’s failure to disclose comparative incidence rates caused them to purchase its stock at inflated prices.
The court found that Allergan had no duty to disclose that its textured breast implants had a higher incidence rate than other manufacturers’ implants. Significantly, the court found that Allergan had no duty to disclose that purported “fact” because the evidence presented on summary judgment demonstrated that it was not true. As the court found, “neither the scientific studies nor the regulatory community has determined that Allergan’s textured implants are in fact more closely associated with BIA-ALCL than competitors’ textured breast implants.” In re Allergan, 2022 WL 17584155, at *11.
The court began by examining the scientific literature. It found that “[t]he scientific studies” cited by the plaintiffs “in support [of their] allegation that Allergan had the highest incidence rate of BIA-ALCL do not reach that conclusion.” 2022 WL 17584155, at *11. Several of the studies reported that the number of BIA-ALCL cases associated with Allergan implants was greater than the number associated with other manufacturers’ implants but raw case numbers, the court explained, say nothing about comparative incidence rates absent data on how many of each manufacturer’s implants had been implanted and how long they had been implanted.
The fact that Allergan was aware of more BIA-ALCL cases associated with its implants than associated with its competitor’s implants was, the court found, also irrelevant to comparative incidence rates, both because Allergan did not have access to its competitor’s data and because in approximately one-third of the cases known to Allergan the implant’s manufacturer could not be determined. 2022 WL 17584155, at *11.
Although the plaintiffs cited two studies that they said reported a higher incidence of BIA-ALCL among recipients of Allergan implants, the court found that the plaintiffs had grossly overstated the studies’ findings, which were subject to significant caveats that prevented any firm conclusions about comparative incidence rates across manufacturers. 2022 WL 17584155, at *12.
Moreover, the court noted, when one of the studies was ultimately completed, it showed that the incidence of BIA-ALCL associated with Allergan’s implants was lower, not higher, than that associated with a competitor’s implants. 2022 WL 17584155, at *12.
The court then surveyed what regulators around the world had said regarding textured breast implants and the incidence of BIA-ALCL. The court found that during the relevant period regulators in various countries “repeatedly stated publicly that no reliable conclusions could be drawn regarding relative incidence rates of BIA-ALCL by manufacturer.” 2022 WL 17584155, at *12. The FDA, for example, said that data limitations, including lack of data regarding “what type of breast implant” individual patients received, “make it more difficult to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer.” Id. at 13.
On this record, the court rejected the plaintiffs’ contention that Allergan had failed to disclose necessary information when it failed to disclose that its implants were associated with a higher incidence of BIA-ACLC than competitor’s implants. To the contrary, because “both the scientific studies and the global regulators refused to draw any definitive conclusions regarding the incidence rates of BIA-ALCL and particular breast implant manufacturers, Allergan would have been lying, not telling the truth, if it had stated publicly that its implants were more closely associated with BIA-ALCL than were implants manufactured by other companies.” 2022 WL 17584155, at *13.
Of course, dismissal of the securities litigation still leaves the product-liability MDL, In re Allergan Biocell Textured Breast Implant Product Liability Litigation, MDL No. 2921 (D.N.J.). We have previously reported on that sad affair, and the decision largely denying Allergan’s motion to dismiss earned a spot on our The Ten Worst Prescription Drug/Medical Device Decisions of 2021.
Allergan’s motion to dismiss having been largely denied, discovery is now ongoing in the MDL. Although the court’s findings in the securities case are not binding on the MDL court, we hope that the MDL judge gives the evidence the same close attention as the judge in the securities litigation and likewise concludes that there is no scientific merit to the plaintiff’s claims.
You’ve no doubt heard of the 5 W’s (who, what, where, when, why) as applied in journalism or police investigations. They also apply to litigation. For example, personal jurisdiction and forum non conveniens are “where” issues, statute of limitations and statute of repose are “when“ issues, and the metaphysical doubt we defense hacks experience while laboring under the skeptical eyes of pro-plaintiff judges and the vast indifference of the skies is a big – perhaps the biggest – “why” question.
There are also “who” questions, such as whether the plaintiff has standing or whether the right entities are being sued. That last issue crops up all the time, including when plaintiffs pursue parent or innovator companies, pharmacies, sales reps, distributors, etc.
In Brown v. GlaxoSmithKline, LLC, 323 Or. App. 214 (Oregon Ct. of App. Dec. 14, 2022), the issue was whether a hospital that charged for a pharmaceutical drug administered to a patient in its emergency department was a “seller” engaged in the business of selling the drug subject to strict product liability under Oregon’s product liability statute. The trial court granted the hospital’s motion for summary judgment, holding that the hospital was not “in the business of selling” the drug. The plaintiff appealed, got the appellate court to overturn the summary judgment, and kept the hospital in the case.Continue Reading A Hospital Can be a Product Liability Seller-Defendant in Oregon
This post is from the non-Reed Smith side of the blog.
Federal Rule of Civil Procedure 8(a)(2) requires that a complaint contain “a short and plain statement of the claim, showing that the pleader is entitled to relief.” TwIqbal requires a complaint contain sufficient facts to make the claim for relief “plausible on its face.” Often that “short and plain statement” is anything but. We have certainly reproached plaintiffs’ counsel over the years for muddying the waters with so much conjecture and supposition that it is difficult to separate fact from theory. Add to that often complicated and/or unsettled law and we do not envy the courts that have to do the deep dive to find both the statement of the claim and the facts on which it is premised within the pages of a complaint. Sometimes, however, both the allegations and the law are straightforward, concise, and clear. When that happens you can get a decision like Cowen v. Walgreens Co., 2022 WL 17640208 (N.D. Okla. Dec. 13, 2022). A short and plain opinion. This one just happens to be about preemption, the PREP Act, and a COVID-19 vaccination.
Plaintiff alleges that she went to defendant’s drugstore to get a flu vaccination. However, she erroneously received a COVID-19 vaccination. Plaintiff sued defendant for the mix-up seeking in excess of $75,000 in damages but suffering apparently no physical injury or adverse consequences from the vaccination. Plaintiff alleged only general negligence on the part of the defendant. Id. at *2. Those are the facts and the allegations.
The PREP Act immunizes from state or federal liability anyone who administers pandemic countermeasures, which the COVID-19 vaccine was declared to be:
[A] covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure…
42 U.S.C. §247d(a)(1), 247d-6d(b). There is one exception to this broad immunity. An individual can bring a federal claim for “death or serious physical injury proximately caused by willful misconduct.” Cowen, at *2. That action must brought in the federal district court for the District of Columbia and exhaustion of administrative remedies under the PREP Act are a prerequisite. Id. at *2 & n.1&2. That’s the law.
Applying the law to the facts and allegations—plaintiff’s claim is preempted. Plaintiff is suing over the administration of an approved pandemic countermeasure and she alleges no serious injury or willful misconduct that would bring her claim into the sole preemption exception. Plaintiff argued that her claim should be construed “more broadly” because her “injury” could have happened whether she received the COVID-19 vaccine or any other vaccine. But she didn’t receive any other vaccine. Even if not sought, what she received was the COVID-19 vaccine and the PREP Act is unambiguous.
While possibly factually accurate that the vaccine mix-up could have happened with any vaccine, that is not a defense to preemption. Plaintiff provided no case law to support her “it-could-have-been-a-different-vaccine argument,” and the court’s own research found no support either. Coulda, woulda, shoulda “does not change the fact that Plaintiff’s injuries actually resulted from administration of the COVID-19 vaccine.” Id. at *3. Since “all” means “all claims,” the PREP Act applies and plaintiff’s claim was dismissed.
One of the decisions we were looking forward to at the end of 2022 has occurred. In In re Zofran (Ondansetron) Products Liability Litigation, ___ F.4th ___, 2023 WL 128570 (1st Cir. Jan. 9, 2023), the court unanimously affirmed the MDL-wide preemption order dismissing all claims. Since the history of the Zofran litigation is well covered in our prior posts, we’ll stick to the First Circuit’s preemption rationale here.Continue Reading MDL-Wide Preemption Win in Zofran Affirmed
We have posted quite a bit about the Taxotere MDL and some Fifth Circuit decisions on appeals from it. The decisions have mostly been pretty good. We have posted even more about the treatment of broad preemption issues in MDLs in recent years. From our perspective, there have been too many denials of strong defense preemption motions because the MDL format often works against rulings that will knock out a wide swathe of claims. There was a similar denial of defense motions for summary judgment in five cases in the Taxotere MDL several months ago that we did not write about then. However, the district court certified an interlocutory appeal and the Fifth Circuit accepted it last week. So, now we think the decision is Blogworthy.
In re: Taxotere (Docetaxel) Prods. Liab. Litig. (Adams), 2022 WL 16923721 (E.D. La. Aug. 2, 2022), concerned the summary judgment motions of three defendants who manufactured generic versions of the prescription cancer medication at issue in the litigation. The motions were teed up as to the claims of five plaintiffs whose use occurred solely during a period when it was uncontested that the generics had FDA-approved labeling that matched that of the branded drug. In November 2015—eight to forty-six months after the plaintiffs’ use had ended—the branded drug manufacturer submitted a CBE to amend the existing information on alopecia in multiple locations within the labeling. Timing of how long each generic manufacturer took to file its own CBE to match the new labeling varied (but, of course, all occurred well after each plaintiff’s use ended). The preemption issues should have been fairly straightforward: the defendants could not have changed their generic labels before or during each plaintiff’s use of the prescription drug because that would have violated their terms of approval, but plaintiffs argued their warnings claims were not preempted because defendants had some mysterious burden they did not meet.
For once, we are not feeling particularly verbose and we will be waiting to see how the Fifth Circuit addresses the appeal. So, we will shorten up our discussion of how the MDL court managed to fumble the ball on a simple handoff at the end of the game. First, the court tripped itself up trying to come up with a framework for the various burdens in assessing impossibility preemption in the context of a warnings claims against a generic drug. Since Mensing, this is not much of a question. If the generic drug’s label was as approved by FDA and matched the branded drug’s label, then any warning claim would be preempted. Period. The Fifth Circuit has a number of decisions on our scorecard holding exactly that. After a fair amount of unnecessary back and forth, the court settled on the approach to burdens spelled out in a case called Silverstein v. Boehringer Ingelheim Pharms., Inc., No. 19-81188, 2020 WL 6110909 (S.D. Fla. Oct. 7, 2020). Silverstein involved the preemption of warnings claims against the manufacturer of a branded drug. Our italics do not do justice to how misguided we think this whole analysis was.
The Silverstein approach required a two-step analysis, with an initial burden on plaintiffs to identify the information they say should have led to a labeling change and then the defendants had to prove they could not have used the CBE regulation to make such a change. (As the court’s own recounting of the regulations showed—and Mensing makes really clear—generic manufacturers cannot use the CBE regulation to change the label before the branded manufacturer does, so the analysis was way more extensive than it should have been.) Saying preemption is an affirmative defense, Adams did not even require plaintiffs to show that the information they claimed should have led to a labeling change was “newly acquired information” according to FDA regulations. So, the court jumped to defendants’ argument that the plaintiff’s information could not trigger a CBE labeling change because it “was previously submitted to the FDA” and “did not reveal risks of a different type or greater severity than previously included in submissions to the FDA.” These are part of the analysis for preemption for warnings claims against the manufacturer of a branded drug, for sure, but not for cases like this. (Here is one of many of our deep dives into how this plays out with branded drugs.)
But Adams further bungled things by putting the burden on defendants to show they knew at the time plaintiffs’ medical literature was published how it related to the clinical trial data in the branded drug manufacturer’s NDA. We have no idea how some sort of contemporaneous knowledge requirement got engrafted onto the analysis of whether medical literature constituted “newly acquired information” as defined in the CBE regulation, which generic manufacturers cannot use in any event. This fool’s errand got even sillier as Adams walked through plaintiffs’ proposed newly acquired information and determined it “provided further evidence of the potential causal relationship between docetaxel and permanent alopecia” and “could have formed the basis of a CBE change to the Adverse Reactions section of the label.” This could not have been a basis for a CBE change initiated by these generic manufacturers, though. (Adams also looked to when the plaintiffs finished taking the drug, not when prescriptions occurred, but that was a small error compared to the stuff above.) Taking things a step further, Adams offered that the generic manufacturers could have conducted analyses that might have led them to conclude the branded manufacturer’s labeling was inadequate. That would still not, of course, allow the generic manufacturers to use the CBE regulation to make their labeling different than the branded manufacturer’s.
Unlike Georgia in the lopsided National Championship game, we will call off the dogs on the poor preemption analysis in Adams before late in the fourth quarter. But we will point to three last bugaboos that we hope will resonate with the Fifth Circuit. First, very late in the analysis, Adams stated that it was “assuming that under state law [one manufacturer] had a duty to include a warning regarding permanent alopecia, which necessarily means that under state law [the manufacturer] had a duty to know the risk of permanent alopecia existed at the time.” Ruling on summary judgment motions is not the time to assume anything about state law and duty. Decide the law applicable to each plaintiff and rule. Second, Adams followed up with this gem: The generic manufacturer’s “post-marketing pharmacovigilance duties under federal law may be relevant” to the breach of a state law duty, but the court did not need to decide that now. Not correct for several reasons. Third, Adams ended with a series of quotes from Levine about the high bar for preemption and that Congress intended for manufacturers to update their labels because they are ultimately responsible for them. Without even getting into how Levine got it wrong about branded manufacturers using the CBE regulation and what the law is now, we can say this is off-base for the preemption issues in these generic drug cases.
The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment: What is a REMS, and why do I care?
REMS stands for Risk Evaluation and Mitigation Strategy, and it refers to a risk management strategy that the FDA can require to ensure that the benefits of certain drugs outweigh their risks. As we have harped on for the life of the blog, all prescription drugs have risks and benefits, which is why a prescription is required in the first place. In the product liability world, those risks and benefits are managed most often by disclosing known and reasonably knowable risks to physicians so they can weigh those risks, and benefits, when treating their patients.
For some medications, the FDA can determine that a more structured strategy is required, which is where a REMS comes in. For certain drugs with serious safety concerns, the FDA can require additional requirements to support the safe use of that product. A REMS might require the drug manufacturer to develop materials for distribution to patients or pharmacists, or it might require additional communications to healthcare provides about particular safety concerns. It might require additional training or certification for prescribers or dispensers, or even require specific clinical interventions, such as specialized consent or specific patient monitoring. Or it might require some combination of all of the above, or more.
The point is that a REMS can take many forms, but the overall goal is safety. The new Guidance is intended to ensure that REMS documents are clear, understandable, and presented in a standardized format (consistent with the FDA’s Structured Product Labeling or SPL format). The Guidance also provides updated recommendations for the format and content of a REMS document for a prescription drug, including biologics. Like every other FDA guidance, the Guidance itself is nonbinding and does not carry the force of law. An FDA-adopted REMS, however, is a formal FDA requirement, comparable in the law to FDA-required product labeling.
So why do we care? We care because we care about product safety. But as product liability litigators, we care because a REMS can impact the potential liability for a prescription drug manufacturer in at least two ways.
First, prescription drug product liability cases almost always question the adequacy of the drug’s warnings. While every prescription drug has FDA-required labeling, a REMS can sometimes require additional warnings on a particular risk, which adds another layer of information for prescribers and additional protection for the manufacturer. The best example we could find was a case we blogged on a few years ago, Nelson v. Biogen Idec, No. 12-7317, 2018 WL 1960441 (D.N.J. Apr. 25, 2018). The prescription drug in Nelson had a REMS requiring that each patient acknowledge receipt of a medication guide before receiving the product. The risk information in the patient-acknowledged medication guide was part of a robust set of warnings provided on the exact risk that allegedly befell the plaintiff, which led to summary judgment for the manufacturer on the plaintiff’s failure-to-warn claim.
Second, as we have already noted, the REMS Guidance document is not binding law, but an FDA-adopted REMS is a requirement in federal law, and is thus preemptive “law” as required by even the most restrictive reading of the Supremacy Clause in the Supreme Court’s Albrecht decision. As a result, any state law requirements—such as additional warnings compelled by a state-law product liability lawsuit—that conflict with a REMS should be preempted. This is something to keep an eye on. REMS are expressly intended to address safety in light of particular risks; they are developed specifically for particular drugs or types of drugs (they are generally “bespoke,” as our British colleagues would say); and they impose particular restrictions and limitations on prescription and use of those drugs. To the extent a state requirement conflicts with a REMS, preemption ought to apply.
Preemption and REMS is a new frontier. We have not seen any post Albrecht preemption cases involving REMS, only the non-product liability decision in PhRMA v. McClain, 2022 WL 18145579, at *7-8 (E.D. Ark. Dec. 12, 2022), which suggests that safety-related claims could well be preempted, while denying the preemption argument in that case. If any useful cases come down the pike, we will let you know.