Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here. They are: Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).
Continue Reading Two New Appellate COVID-Related Developments
We start with the usual poodle report – actually with a comment that these may be drawing to a close, as Luca is only a few points from finishing his championship and coming home. We suspect this will cause little grief for readers of this blog (the Drug and Device Law Rock Climber and other family members and close friends long ago reached their “Luca talk” saturation point), but we have appreciated this outlet for our excitement about this unexpected adventure and our pride in our beautiful baby boy.
We will celebrate Luca’s final victories as we did his last, with an order from the new takeout cookie bakery that has appeared in our neighborhood shopping center. And this bakery provides our typical rickety bridge to today’s case. We read the nutritional information for the warm peanut butter cookie (roughly the size of a hubcap) studded with chunks of peanut butter cups – 180 calories per serving! Not bad, right? But readers of this Blog, and the author of this post, are smart enough to know that the line below the calorie count is the most important: four servings per cookie. Today’s case is about a butter substitute spray, not about cookies. But the plaintiffs/appellants disclaimed the intelligence to understand the relationship between serving size and calorie count and asked the court to require the spray’s manufacturer to slather on far more label information than the FDA required. The claims were preempted, of course. But we get ahead of ourselves.
Pardini v. Unilever United States, Inc., — F.4th —, 2023 WL 2980312 (9th Cir. Apr. 18, 2023), is a to-be-published appeal of the Northern District of California’s grant of the defendant/appellee’s Rule 12(b)(6) motion to dismiss. The plaintiffs were consumers of the defendant’s product, a “butter-flavored vegetable oil” dispensed with “pump action squirt bottles” with a “spray mechanism.” Pardini, — F.4th —, 2023 WL 2980312 at *2. As the court explained, the nutrition panel on the back of the spray bottle lists one serving size for use of the product as a “cooking spray” (1 spray = 0.20 g.) and a second for use of the product as a “topping” (5 sprays = 1 g.). Both serving sizes are listed as having no calories and zero grams of fat. The plaintiffs alleged that the entire bottle of the butter substitute spray contains 1160 calories and 124 grams of fat and claimed that, “because the [listed] serving sizes [were] “artificially small,” the product did not really have “0 calories” or “zero grams of fat” per serving. They alleged that the product’s nutrient content claims were “misleading because they [were] based on unrepresentative serving sizes.” Id. at *2-3. They argued that, for purposes of identifying the appropriate serving sizes for the nutritional information, the product should be classified in the “same product category as butter itself with a required serving size of one tablespoon, rather than as a ‘spray type’ fat or oil.” Id. at *3 (internal punctuation omitted). Obviously, in that case, neither the calorie count nor the fat gram total for a tablespoon of the vegetable oil product would be “zero.”
In the trial court, the plaintiffs “allege[d] that consumers [had] expressed confusion and frustration upon learning that larger servings of the product contain[ed] non-negligible amounts of calories and fat,” and that they would not have purchased the product, or would have paid less for it (one can only wonder how any consumer would have “paid less,” since the store price is what it is), if they had “known the true nature” of the product.” Id. They sought to certify a nationwide class of consumers. The court dismissed the claims as preempted by the FDCA, and the plaintiffs appealed.
The Ninth Circuit began its decision by commenting:
Over 125 years ago, the Supreme Court decided whether a tomato is a fruit or a vegetable (the answer: a vegetable). In a more modern iteration of this legal genre, we today decide, in effect, whether the [appellee’s product] is a butter or a spray. The question turns out to matter because the plaintiff consumers contend that the product’s label makes misrepresentations about the fat and calorie content based on artificially low serving sizes.
Id. at *1. The court went on to explain that a “vast regulatory scheme” governs food labeling, and that the FDCA expressly preempts “causes of action [that] would directly or indirectly impose nutrition label requirements different than those prescribed by federal law.” Id. at *3 (citation to Riegel omitted). Under the relevant regulations, if a product has less than five calories per serving, the calorie content may be expressed as zero calories per serving. Likewise fat content of less than five grams per serving. Because, obviously, “the larger the serving of a food product, the more calories and fat are ingested,” id. at *4, determination of the appropriate “serving size” is the tipping point of the analysis.
“Under FDA regulations,” as the Ninth Circuit explained, “the term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food.” Id. (internal punctuation and citations omitted). Serving size is identified using national consumption data with reference to “the major intended use of the food; for example, milk as a beverage and not as an addition to cereal.” Id. (internal punctuation and citations omitted).
Within the category “fats and oils,” there are two pertinent categories: “butter, margarine, oil, shortening” (serving size one tablespoon) and “spray types” (serving size expressed in fractions of a gram and duration of spray, in seconds). So the key to deciding whether the labeling for the defendant’s product correctly identified reference serving size is the determination of whether the product is in the former or the latter category (as the Ninth Circuit said at the beginning of the opinion); in other words, whether the “should be classified as a butter/oil or a spray.” Id. at *5.
The court held, “As a matter of legal classification, it is a spray.” Id. The court explained that federal regulations are interpreted based on their plain language. It emphasized,
There is no well-pleaded allegation in the complaint that, in form and function, [the product] is anything other than a spray. Images in the complaint and record indicate that the product comes in a spray bottle, with a finger-activated pump at the top. Plaintiffs at one point in their operative complaint themselves reference the product’s ‘spray mechanism.’ They similarly describe the product as on that is ‘dispensed in pump-action squirt bottles. These allegation support [the manufacturer’s] characterization of [the product] as a spray, based on the properties of the product and the liquefied form in which it is indisputably applied.
Id. at *6. In other words, if it looks like a spray, it comes in a spray bottle, and you spray it to dispense it, it is a “spray” for purposes of the regulation. Moreover, the court commented, it would be implausible to conclude that the product could be classified as “butter, margarine, oil [or] shortening,” for which the reference serving size is one tablespoon – it would take 40 sprays to equal a tablespoon, and that is “not how such a product is typically used.” Id. So the label complied with federal law because the manufacturer properly categorized the product as a “spray type” of fat and used the reference serving size for that category. Moreover, the regulations did not prohibit the manufacturer from including the “five sprays” alternative serving size, for which the calories and fat grams were also zero.
The plaintiffs next argued that the label was misleading because people do not typically use only one spray of the product, and “serving sizes must reflect customary usage.” Id. at *7. According to the plaintiffs, this created an issue of fact because the manufacturer was required to “determine how their customers consume food products” in creating their labels. Id. The court didn’t bite, dismissing this argument as “backwards,” stating, “In a lawsuit such as this, whether the serving size listed on the nutritional label is lawful is not a factual question about consumer behavior, but rather a legal question that turns on whether the manufacturer identified the proper product category and complied with the applicable product category regulations.” Id.
The court concluded,
Because plaintiffs’ challenge to the [product’s] serving sizes would “directly or indirectly establish a requirement for food labeling that is not identical to federal requirements, the FDCA preempts their serving size claims. It follows that plaintiffs’ claims about fat and calorie content are preempted as well. . . . [I]f plaintiffs . . . believe that the FDA should not allow products to be labeled as containing zero fat or calories when a given serving size may contain some of each, they may raise the issue with the agency. This argument cannot overcome the FDCA’s express preemption provision.
Id. at *8. Dismissal affirmed.
We had a lot of fun reading and reporting this case (we rolled our eyes a lot), and we agree wholeheartedly with the Ninth Circuit’s decision. On to the weekend and its dog shows. In your leisure, raise a fourth of a cookie to our almost-champion puppy, and stay safe out there.
Attempting to stay up on every filing in every medication abortion case could be a full-time job these days. We have one of those already, so we tend to stick to court rulings. The filings in the Fifth Circuit on the AHM appeal are something of an exception. In addition to party briefs, the list of amici that have weighed in is long and impressive. A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. Of course, the current FDA, represented by the current DOJ, should also know about FDA law, FDA authority, and the history of its decisions regarding mifepristone.
As we have said, FDA is not infallible and we see where too much deference to FDA or any agency can produce some bad results and constitutional problems. However, FDA is supposed to be and, in our experience, really is the expert in evaluating whether and under what conditions a drug should be approved. More specifically, it employs a staff of subject matter experts and is not shy about enlisting outside experts, as with advisory committees, when it needs more expert firepower. Its staff has a broad view tied to public health considerations, available drug and non-drug treatment options, data that may not be publically available, and decades of experience with the subject matter. That all matters because judges lack that expertise, broad view, and experience. Second-guessing decisions made by someone with expertise you lack is a dicey proposition.
The internet and a variety of societal trends have contributed to what some have called “The Death of Expertise.” We wrote many posts about and saw many more examples of this phenomenon in connection with people following non-experts or “doing their own research” to pursue atypical “treatment” for COVID-19 and/or ascribe a wide range of “complications” to the COVID vaccines. This also includes “ology” confusion. For instance, an anesthesiologist or proctologist is not the right expert to consult for big questions about immunology, virology, epidemiology, gynecology, or cochlear implant audiology, for that matter. Rejecting the value of relevant expertise also make it much easier for personal views to predetermine the outcome of any “research” or “analysis.” There is a reason why studies should have formal protocols in place before they begin. Scientific method, the involvement of subject matter experts (e.g., a biostatistician for the stats), and efforts to maintain data integrity are among the criteria for doing good scientific research and analyzing the findings of research that has been done. People, even judges, do not like to hear it, but people can get confused and come to unsupportable conclusions when they stray beyond their own areas of competency (if any). Guidance from true experts with an interest in the truth may help, but only if you are willing to credit their expertise.
Without rehashing the analytical gaps of the decision in AHM from the Northern District of Texas and the partial stay order from the Fifth Circuit (later trumped by the complete stay from the Supreme Court), we can say that those judges did not have scientific or regulatory subject matter expertise and did not credit expertise (or discredit faux expertise) as they should have. The appellate brief from FDA bears that out well. We will not rehash the entirety of the brief, which you can see here. Each of the three arguments FDA makes for reversal relies in part on the incontrovertible facts that FDA had expertise to address the medical issues related to mifepristone and exercised its collective judgment in reaching decisions that related to its expertise. This is quite clear from the first ten pages of the brief, where there are (conservatively) eight separate references to FDA exercising its scientific judgment or utilizing its expertise to review scientific information. In other contexts, a similar recounting would support preemption, primary jurisdiction, or just plain deference. Here, even without all the legal trappings and detailed arguments, there is a sense in which this set of facts should be enough to conclude the AHM decision cannot stand within the context of a number of constitutional provisions, a bunch of federal laws, and a boatload of caselaw. As FDA wrote in its summary of arguments:
While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies, offering demonstrably erroneous characterizations of the record.
Brief at 16. FDA also noted that the court had relied on its “own interpretation of extra-record publications.” Brief at 12. See what we meant about the death of expertise and the likelihood that non-experts (i.e., those with a “lay understanding”) will get it wrong when they pretend to know more than the actual experts do?
In terms of FDA’s arguments, we will focus on the core standing issue and why FDA’s actions were lawful (and not arbitrary and capricious). The time-bar of the challenge to the 2000 approval of mifepristone is, as we said before, pretty obvious. Enough has been written on the district court’s resurrection and misinterpretation of the Comstock Act. In addition, the lack of a particularized injury to create standing largely determines why the district court’s granting of sweeping “preliminary relief” under the guise of 5 U.S.C. § 705 was an abuse of discretion. The core standing issue, from our perspective, is whether individual physicians who did not prescribe mifepristone demonstrated particularized injury from a violation of a legally protected interest by the specific FDA actions about which they have complained in a timely fashion. The brief does a good job of explaining why the “injuries” the physicians claim they will suffer are tied to the 2000 approval of mifepristone and not to any FDA action they have challenged in a timely fashion. Brief at 27. The FDA actions properly at issue do not affect the physicians’ legally protected interests. As Justice Kavanaugh wrote back when he was on the D.C. Circuit, complaints like these physicians’ are required by the Constitution to be directed “to the Executive and Legislative Branches, not the judiciary.” Brief at 19-20 (quoting Coalition for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275, 1283 (D.C. Cir. 2012)). The standing arguments that the district court had accepted were on all fours with the standing arguments the Supreme Court rejected in Summers v. Earth Island Inst., 555 U.S. 488, 495 (2009), where it said expanding standing as proposed would “make a mockery” of Article III. Brief at 21-24.
The Fifth Circuit’s motions panel obviously came down, in that particular context, on the side of the district court on the standing issues discussed above. A few things are worth noting, though. First, as we pointed out previously, the Fifth Circuit stay order’s evaluation of standing relied heavily on arguments based on alleged impacts from 2023 FDA actions. Those should not be considered because, in addition to occurring after the suit was filed, these plaintiffs did not challenge them. Brief at 11 n.1. Second, while it cited Spokeo, Inc. v. Robins, 578 U.S. 330, 339 (2016), and Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013), on the requirement of a particularized injury—but did not apply them correctly, as far as we are concerned—it did not cite Summers and account for its rejection of statistical arguments that some member of a plaintiff organization is likely to suffer a concrete injury at some point in the future. See FDA v. Alliance for Hippocratic Med., ___ F.4th ___, 2023 U.S. App. LEXIS 8898, *13-23 (5th Cir. Apr. 12, 2023). Third, FDA directly addressed some of the motions panel’s misunderstanding of the science and statistics in the record, including that “mifepristone does not exacerbate ectopic pregnancy; it simply is not effective in treating that condition.” Brief at 29. Given how overly sympathetic the motions panel was to the plaintiffs’ theorized “stress” and the possibility that they would have to face “the irreconcilable choice between performing their jobs and abiding by their consciences,” it seems that reversing on standing—at least with the initial panel—will be difficult.
In its argument that the record did not support that any FDA actions were arbitrary and capricious—as the Administrative Procedures Act requires to strike down an agency decision—FDA did argue for deference. The decisions it cited were interesting choices. Rather than Chevron, Auer, or Kisor, FDA cited the Roberts concurrence in the stay order in FDA v. American Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 578-79 (2021), and the Fifth Circuit’s decision in Sierra Club v. EPA, 939 F.3d 649, 680 (5th Cir. 2019). Brief at 38-39. The former spoke of FDA’s “background, competence, and expertise to assess public health” in the context of mifepristone and the latter to the “evaluation of complex scientific data within its technical expertise.” As expected from the early pages of the brief, FDA also spelled out its exercise of medical and scientific judgment at each step of its evaluation of mifepristone. It also explained the relevant provisions of the FDCA and its regulations over the relevant time period, including how the district court essentially invented FDA requirements so that it could then claim FDA did not follow its own requirements—and thus acted arbitrarily and capriciously. See, e.g., Brief at 42-44 & 60-61. If you are following medication abortion litigation, then we recommend reading this section of the FDA brief to gain an understanding of how the judgment of experts was the driving force for a number of decisions that plaintiffs later challenged based on their own non-expert, personal preferences.
Speaking of preferences, any evaluation of what the Fifth Circuit will do has to look at the panel assigned to decide the merits of the appeal. When that panel was announced on Monday, we noted that two of the three judges had sat together on a panel that issued a truly bad decision last year reversing a defense verdict from the Taxotere MDL. Because the reasoning in that decision was so lacking and ignorant of rules that civil litigators ought to know, we said this:
We will deviate from our general rule of not talking about the panel, but this one was quite unusual in its composition. Although there are 26 judges on this court, all three of the judges on the panel were appointed by a recent one-term president. Only one had any prior judicial experience—a short stint on a state intermediate appellate court—and the other two were political appointees under a particular governor. Rather than speculate about the panel’s mastery of the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and Louisiana product liability law, we will just speculate that just about any other panel of the Fifth Circuit would have a different perspective.
This does not leave us very hopeful about this panel and underscores how labeling a jurist “conservative” has little meaning when it comes to the issues at play in AHM. The fact remains, however, that this panel is not likely to have the last say. It may very well fall to a rehearing en banc and/or the Supreme Court—each stocked with mostly “conservative” jurists—to restore some sanity to the mad world where FDA approvals can be wiped out retroactively more than two decades later. In this case, as FDA notes, the drug at issue is one declared an “Essential Medicine” by the World Health Organization and is used in more than half of all medical interventions within its approved indication. Brief at 1. But what do all those public health experts and prescribing physicians know compared to a lay person who did his own research?
It is looking very much as if the U.S. Supreme Court will hear a case this upcoming October term that will permit it, at long last, to inter the Chevron doctrine. Under that doctrine, if there is ambiguity about the scope of rule making powers provided to an agency by Congress, courts will defer to the agency with respect to that scope. As a matter of separation of powers, the Chevron doctrine was always problematic. At the same time, some deference to agencies made sense because agencies possess two things that Congress lacks: expertise and energy. If the executive branch, including agencies, expanded its powers, such expansion was aided and abetted by a legislative branch that succumbed to partisan gridlock, know-nothingism, and torpor.
Preemption is not the same thing as Chevron deference. But it is also supported by agency expertise and energy. The FDA, for all of the criticisms leveled against it, has a lot of expertise and energy when it comes to approving drugs and devices. And then there is the Supremacy Clause. It is simply unworkable, even nonsensical, to permit the states to impose varying, contradictory requirements on FDA-approved products. We generally salute the concept of states as laboratories, but jury verdicts in product liability cases are often rotten laboratory experiments gone awry. As a matter of science and interstate commerce, it is well and good that FDA regulations preempt inconsistent state tort laws.
Speaking of separation of powers, now we commence another love letter to the judicial branch – specifically, a court applying preemption against a tort claim that would countermand FDA regulation of drugs. In Heslin v. New Jersey CVS Pharmacy, LLC, 2023 WL 3249820 (D.N.J May 4, 2023), the plaintiff asserted a wrongful death claim based on the decedent’s abusive overuse of a generic over the counter (OTC) anti-diarrhea medicine. The plaintiff initially filed the complaint against only the pharmacy where the decedent allegedly purchased the medicine. The plaintiff’s theory was the pharmacy should have restricted the sale of the anti-diarrhea medicine once it was on notice that some customers were buying too much. This theory sounds a bit like the opioid litigation. Hello, nannyocracy. Anyway, the pharmacy was the only, no doubt lonely, defendant for approximately 20 months, until the plaintiff got the bright idea of amending the complaint to join the manufacturer. Why leave the deepest pockets out of the party? Except it really was not such a bright idea, because the amendment ran straight into preemption. The manufacturer filed a motion to dismiss, and the court granted the motion.
The plaintiff filed two causes of action against the manufacturer under the New Jersey Wrongful Death and Survival Acts. One cause of action was for negligence and the other was for willful and wanton disregard for the manufacturer’s “invitees and customers.” The plaintiff claimed that the manufacturer failed to comply with state and federal laws, including FDA safety announcements regarding the dangers of taking too much of the anti-diarrhea medicine. What was the manufacturer supposed to do? Simply stop selling the medicine? Find a way to restrict its sale of the drug by limiting the amount that could be sold to that mentioned in an FDA safety announcement? Warn abusers to stop abusing?
The Heslin court sorted through the preemption issues in a clear, logical, and blissfully succinct fashion. The court interpreted both claims against the manufacturer to amount to failure to warn claims, violations of the Food, Drug, and Cosmetics Act (FDCA), and “failure to restrict sale” claims.
First, the warning claim against the generic manufacturer was preempted by the sameness requirement of the FDCA. The generic manufacturer must use the same label as the brand manufacturer even when its product is OTC. “The FDA’s duty of sameness preempts any state law duty that would require a generic drug manufacturer to change its label.” See Mensing.
Second, the demand that the manufacturer comply with an FDA safety announcement was a preempted private attempt to enforce the FDCA because it existed “solely by virtue” of the FDA safety announcement. There is, of course, no private enforcement of the FDCA. See Buckman. Moreover, the safety announcement did not change any of the FDA requirements regarding dosage form, strength, or labeling.
Third, the Mensing sameness requirement would extend to the manufacturer’s inability to restrict sales by changing the maximum approved daily dose. Generic drugs must have the same dosage form, strength, and labeling as the name brand versions.
The Heslin court dismissed the claims against the manufacturer with prejudice. In addition to the preemption grounds, the court also pointed out that claims that the manufacturer should have known of the particular plaintiff’s overuse, and that disregard of such fact constituted “willful and wanton” conduct, made no sense in light of the fact that the manufacturer sold the medicine to the pharmacy, not the plaintiff.
The pharmacy is still in the case. We wish the pharmacy good luck, because this case looks to us like one in which all the bad behavior was on the left side of the v.
This post is from the non-Reed Smith side of the blog.
Today would not be the first time that we complained about current MDL processes and the need for changes that embrace early and rigorous vetting of plaintiffs’ claims. There is no dispute that MDLs contain an abundance of meritless claims and, therefore there should be no dispute that having clear procedures for identifying them and weeding them out is in everyone’s best interest. Unfortunately, it often takes years not only to shine light on the problem plaintiffs but also to get them dismissed. Don’t get us wrong, when it comes to dismissals we firmly believe better late than never. As it turns out, in the Proton Pump litigation late was not necessarily better.
Eighteen months ago, the Proton Pump MDL court recognized that almost 1000 pending plaintiffs had failed to serve their complaints on defendant. In re Proton Pump Inhibitor Products Liability Litigation, 2023 WL 3173373, at *1 (D.N.J. May 1, 2023). The court ordered those plaintiffs to either file proof of service, dismiss the defendant, or show good cause why the defendant should not be dismissed. Importantly, the order did not give plaintiffs an extension of time to serve the complaint. Id. at *2. But that did not stop 640 plaintiffs from serving defendant after entry of the order (another 61 failed to serve at all). And none of these plaintiffs were just a few days late. Where service was made, it was between one and four years after the time allowed by Rule 4. Id.
The first issue the court decided was whether any of the plaintiffs demonstrated good cause warranting an extension of time to serve. Since they served virtually identical good cause statements with no mention of defendant’s conduct and little mention of plaintiff’s individual cases—it was not a reach for the court to find good cause was missing.
The factors for deciding good cause are the reasonableness of plaintiff’s efforts to serve, prejudice to the defendant, and whether plaintiff moved for an extension of time. Considering the cookie-cutter submissions, plaintiffs offered the court no explanation for failing to serve nor an adequate description of any efforts made to serve. The defendants had been prejudiced by expending time and resources just “to determine whether plaintiffs intended to pursue litigation against them.” Id. at *3. And plaintiffs did not move for an extension until after the court’s show cause order which was at least one year after the time to serve in each case.
Finding no good cause, plaintiffs asked the court to grant a discretionary extension. But plaintiffs also failed to meet those standards. The first factor is actual legal notice. Plaintiff argued that defendant was on notice of their claims because they were on a tolling agreement. But at most, the tolling agreement informed defendant that these plaintiffs may potentially bring a claim, not that any particular plaintiff did file an actual claim. Id. Nor did the court find it persuasive that the statute of limitations had run for most plaintiffs given the length of time between filing and service and no allegations of any conduct by defendant to impede proper service. Id. at *4. Finally, all plaintiffs were represented by counsel and inadvertence of counsel need not be excused. Id.
Plaintiffs’ next argument was that defendant had waived its defense to untimely service by filing motions to dismiss that did not raise the issue, filing answers, or by engaging in the litigation overall. Untimely service is a waivable defense. But defendant’s motion to dismiss was governed by an order in the case that allowed it to only move to dismiss for failure to comply with the tolling agreement and expressly preserved all other defenses, which could only be raised with leave of court. Since all other defenses were deferred, defendant did not waive its untimely service defense. Id. at *5. Nor did defendant file any answers in any of the cases at issue, negating that argument. Finally, while defendant did participate in and defend against the litigation generally, plaintiff could not identify any specific action it took in any of the particular cases at issue that would suggest a waiver by conduct. Id. at *6. Therefore, all 640 cases were dismissed without prejudice. It may have taken a few years to get there, but in the end it’s a good decision that thinned the MDL herd.
Some things make sense only in the topsy-turvy, litigate-everything-to-death world of multidistrict litigation. One recent example is In re Taxotere (Docetaxel) Products Liability Litigation, 2023 WL 2982464 (E.D. La. March 8, 2023), where MDL-related considerations led a defendant to oppose a plaintiff’s motion for voluntary dismissal with prejudice.
Why? Think chess. In MDLs the other side treats plaintiffs like pawns, regularly sacrificing them in the hope of putting one or more defendants in zugzwang (a chess term for forcing an adverse move). That’s what happened in Taxotere.
Continue Reading Only in an MDL….
We are in New Orleans for the annual DRI Drug & Medical Device Seminar, so we would be remiss if we passed up the opportunity to write on a Louisiana case. The case will sound familiar. We reported six months ago on the dismissal of a case brought by the same plaintiff alleging that benzene in antiperspirant caused cancer. That order was noteworthy for at least two reasons. First, the plaintiff based her allegations on testing performed by Valisure, a lab that holds itself out as “the pharmacy that checks,” but has become better known lately for producing test results that drive litigation. Second, the Eastern District of Louisiana dismissed the complaint mainly because the plaintiff did not allege sufficient facts showing that the plaintiff had used antiperspirant that contained benzene or that the alleged contaminant caused the type of cancer at issue.
Well, this plaintiff is at it again—this time by filing a second lawsuit, in the same judicial district, alleging that she used a different antiperspirant that also allegedly contained benzene. Rooney v. Unilever United States, Inc., No. 22-716, 2023 U.S. Dist. LEXIS 74052 (E.D. La. Apr. 28, 2023). Comically, the plaintiff alleged in this second lawsuit that she used the defendant’s antiperspirant exclusively for ten years. Uh, what about that other federal lawsuit, the one where you alleged, under threat of Rule 11 sanctions, that you used another antiperspirant? This plaintiff’s dueling lawsuits remind us of the scene from the movie musical Singin’ in the Rain, where the fictional silent film star Lina Lamont (played beautifully by actress Jean Hagen) boasts of giving an “exclusive interview to every paper in town.”
Ms. Lamont and the attorneys representing our antiperspirant plaintiff have something in common: They all hold a similarly loose understanding of the word “exclusive.” (As an aside, many people consider Singin’ in the Rain to be the greatest movie musical of all time, and the film is best known for the dancing trio of Gene Kelly, Donald O’Connor, and Debbie Reynolds. Fewer people know that Singin’ in the Rain was only a modest commercial success when it was first released in 1952, and that it earned only two Academy Award nominations: Best Musical Score and Best Supporting Actress—for Jean Hagen as Lina Lamont. She did not win, but for the record, your bloggers would have voted for her.)
The plaintiff in Rooney wised up and amended her complaint to allege that she used the defendant’s antiperspirant “almost exclusively,” so she fixed that self-contradiction. But she did not and could not fix the core problem with her complaint—the inability to plead causation. Even Valisure purported to find benzene in only some antiperspirant samples, not all. This variability from one lot to the next left plaintiff unable to allege that she was exposed to an allegedly contaminated lot. She tried to fill that gap with the Universal Product Code (or UPC) for the product she used. UPC barcodes are ubiquitous and are on virtually every retail product that is bought and sold, but they do not identify a product’s lot. Without that link, the plaintiff could not plausibly allege benzene exposure. 2023 U.S. Dist. LEXIS 74052, *7-*8.
The plaintiff’s causation allegation faltered for other reasons as well. Her bare allegations that she was “exposed to impermissibly high levels of benzene” were too conclusory to warrant credit. And, more significantly, while long-term exposure to benzene has been associated with various health issues, none of those factual allegations suggested any connection between benzene and the plaintiff’s alleged type of cancer. Id. at *9-*10. Moreover, this plaintiff knew that because the judge in the plaintiff’s other case told her so: “As Judge Vance observed in her order dismissing plaintiff’s parallel claims against [another company], the manufacturer of [plaintiff’s other] antiperspirant, ‘[p]laintiffs’ failure to allege facts showing a causal connection between [Rooney’s] injury and defendant’s allegedly inadequate warning renders plaintiffs’ claim implausible.’” Id. at *9 (some internal quotations omitted). We also wrote it in our blog, but we suppose the plaintiff and her attorneys are not regular readers.
The district court dismissed the plaintiff’s remaining claims for various reasons. Claims such as negligence, strict liability, and deceptive advertising were outside the Louisiana Product Liability Act, which is the exclusive means under Louisiana law to recover damages caused by a product. Id. at *10-*11. There likewise is no private right of action under the FDCA. Id. at *11. Finally, the plaintiff sought injunctive relief, but because the defendant has discontinued the product, she had no standing. Id. at *11-*12.
The district court denied leave to amend and dismissed the action with prejudice. This is the correct result, given the incurable defects in the plaintiff’s allegations. This court, however, was exceptionally patient. The plaintiff had already amended her complaint twice, and when it because clear that the plaintiff had not addressed the difference between a lot number (which identifies a particular product lot) and a UPC number (which does not), the court offered the plaintiff an opportunity to file a supplement. The plaintiff declined. Id. at *12-*13.
We will enjoy our remaining time in New Orleans. We will surely have some chicory coffee, and we may even stand in line (again) to eat a delicious bowl of gumbo. We highly recommend that you all do the same.
If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and the use of a drug or medical device does not, without more, prove causation. When you put together the trifecta, it means a plaintiff should need much more than an injury after exposure to the defendant’s medical product to get past a motion to dismiss. When a court understands preemption, the bar gets higher.
The preemption primarily at issue in Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2023 WL 3075403 (S.D. Ohio Apr. 25, 2023), is one we have been talking about for a long time. As detailed here, the decision in Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6th Cir. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. The Supreme Court had found preemption of the design defect claims for generic drugs in Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended. We are pleased to see how, at least in the Sixth Circuit, Yates is leading to easy analyses and dismissing claims with prejudice at the pleading stage. When you add in the narrowing of the CBE loophole in the years since Levine opened it up, the preemption cocktail offered up in Brashear reflects positive changes in the law in this space over the last decade or so.
The facts in Brashear—at least those set out in the decision and discussed here—are pretty straightforward. Plaintiff had a shoulder replacement surgery and received defendant’s branded prescription non-opioid analgesic via a nerve block infiltration. She claimed the drug partially paralyzed her diaphragm, which resulted in a cascade of other issues. Although she brought the obvious claims under the Ohio Product Liability Act, along with its quirky supplier liability claim that we are not discussing, she did not have any specific criticisms of the manufacturer, the drug, or the drug’s labeling other than that its warning of “paralysis . . . which may have slow, incomplete, or no recovery” did not mention diaphragms by name. 2023 WL 3075403, *3. Defendant moved to dismiss on preemption and TwIqbal.
First up was plaintiff’s vague claim for design defect. Rather than decide whether Ohio law required the plaintiff to specify a defect in the product and how it caused plaintiff’s injury, the court addressed preemption with icy efficiency. (The allegations were clearly insufficient under TwIqbal, but plaintiff probably would have been allowed to amend her boilerplate complaint to try to fix that issue.) Yates made that an easy analysis. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. Id. Yates also dispensed with the argument that the drug should have been different before an NDA was filed, which does not work because you cannot just assume FDA would have approved a hypothetical different drug based on the hypothetical results of its hypothetical preclinical and clinical testing. Id. (See here for more.) So, the design defect claim was dismissed with prejudice. It seems that plaintiff did not get multiple shots at amending because preemption was going to be the end result anyway.
Next up was the plaintiff’s somewhat incongruous warnings claim, which the court generously construed as complaining about the specificity of the paralysis warnings. Id. The court correctly understood from Albrecht and Fulgenzi that the label for an FDA-approved drug can be changed through a supplement requiring FDA approval (which cannot be assumed) or a CBE, which allows a temporary change under limited circumstances. Here, because there was already pertinent risk information in the “Warnings and Precautions” section of the Full Prescribing Information portion of the label, FDA regulations required that any proposed change be done through a prior approval supplement because the “Highlights” section would also need to change. Id.at *4. Because the defendant could not change the label independently, the claim was preempted.
For some reason, however, the court also went ahead and analyzed a claim contingent on utilizing a CBE. This was unnecessary: the requirement of prior approval supplement means that a CBE could not be used for the labeling change at issue. End of story. Nonetheless, plaintiff did not identify newly acquired safety information after approval or any basis that FDA would have changed the label to refer specifically to diaphragmatic paralysis. Id. at *4-5. Rather than muddle things, this provided an alternate ground for the holding. We would also be stunned if plaintiff alleged facts to support that plaintiff’s prescribing physician would have altered her behavior based on such a change. The sprig of mint of top of the analysis, if you will, is that Levine was not mentioned, something almost inconceivable for a drug warnings preemption analysis in the years after it came out.
Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim. The only thing approaching a misrepresentation that plaintiff identified in her complaint was a general criticism of the label. This was insufficient under TwIqbal, but it also meant that the preemption analysis for the warnings claim applied equally. Id. at *5. Rather than cutting off plaintiff on this claim, she was given another shot at pleading a non-preempted claim based on a misrepresentation outside of the label.
An argument that is often a long-shot at the pleading stage also came through. Ohio is one of several states, with New Jersey being the most notable, with statutes precluding punitive damages in product liability cases based on FDA approval or compliance. The intersection between these statutes, or the more complete “FDA defense” provisions in Michigan and Texas, and Buckman’s prohibition on fraud-on-the-FDA claims has been the subject of variable treatment from courts. This was seen most starkly in the non-precedential affirmance of a bad decision on the Michigan statute’s exception in Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-66 (6th Cir. 2004). The Ohio statute has an exception in its provision providing the punitive damages bar where the plaintiff proves the manufacturer “fraudulently and in violation of applicable regulations of the food and drug administration withheld from the food and drug administration information known to be material and relevant to the harm that the claimant allegedly suffered or misrepresented to the food and drug administration information of that type,” which runs right into Buckman. Drawing on the Sixth Circuit’s decision in In re Aredia & Zometa Prods. Liab. Litig., 352 Fed. App’x 994, 995 (6th Cir. 2009), which looked at the Michigan statute and followed Garcia, the Brashear court concluded the only way to avoid the bar on punitive damages was “if FDA (or some other federal agency) has already discovered that [the manufacturer] made some sort of fraudulent representation about [the drug].” 2023 WL 3075403, *7. We can quibble that the proof needs to be even more specific than that (e.g., final determination, about the risk of diaphragmatic paralysis, material), but plaintiff did not offer any facts supporting the more general formulation. That meant plaintiff’s claim for punitive damages was preempted and dismissed with prejudice. Usually, one-off product liability cases are worth taking across the finish line only if there is a legitimate chance for an award of punitive damages. We will not lay odds on whether this observation has anything to do with how often punitive damages stays on track as other claims fall away through motions to dismiss and motions for summary judgment.
In case we were too subtle, enjoy your mint juleps on Derby Day. (Were you expecting a Star Wars theme for a post on May the Fourth? Do that already we did.)
Today’s case, Adams v. 3M Company, 2023 WL 2997420 (6th Cir. April 19, 2023), is not, strictly speaking, a drug or device case, but it is about constraining plaintiff lawyer attempts to aggregate litigation. That issue is near and dear to our flinty, defense-hack hearts. We never forego a chance to quote our old buddy Hegel, so here we go again: “Quantitative differences after a point become qualitative differences.” Mass litigations, whether in the form of class actions, multidistrict litigations, consolidations, or whatever, are designed to achieve economies of scale without altering substantive rights. Except that they almost always do alter substantive rights, and almost always to the detriment of defendants. Once litigations become massive enough, defendants face exposures massive enough to alter settlement calculations. Size overwhelms merit. Just like the complexity of the tax code is itself a tax on citizens, aggregating plaintiffs becomes a tax on defendants.
Congress passed the Class Action Fairness Act (CAFA) (28 U.S.C. section 1332(d)(11)(B)(i)) to prevent plaintiff lawyers from cobbling together mass actions and running them through certain state courts that have earned a rather, er, inflammatory nickname. We usually refrain from using that nickname because we do not want to irritate the fine judges in such lovely places as Southern Illinois, or the City Hall that is only a stone’s throw from where we sit, or coal country.
That last location is where the Adams case was filed. Initially, two complaints were filed in state court, with each listing over 100 coal miners, bringing product liability actions against respirator manufacturers, distributors, and retailers. The defendants removed the cases to federal court based on CAFA, which extends federal jurisdiction to certain “mass actions” involving “100 or more persons.” The district judge granted the plaintiffs’ motion to remand, the defendant obtained leave to file an interlocutory appeal, and the issue ended up in the hands of the Sixth Circuit. The Sixth Circuit is a good court with many good judges, and it issued a good decision in Adams. That is to say (and to avoid burying the lead any further), the Sixth Circuit reversed the district court’s remand, and held that CAFA applied and the litigation belonged in federal court.
CAFA permits removal of “any civil action … in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs’ claims involve common questions of law or fact.” 28 U.S.C. section 1332(d)(11)(B)(i). The parties agreed that the lawsuits qualified as “civil action[s]” seeking “monetary relief.” The issue in dispute was whether the plaintiffs “proposed” to “tr[y]” “claims of 100 or more persons … jointly on the ground that” the claims “involve common questions of law or fact.”
Did the plaintiffs “propose” a joint trial? The Sixth Circuit held that when the plaintiffs “filed complaints with more than 100 co-plaintiffs, they offered to try their co-plaintiffs’ claims jointly.” To confirm that point, the complaints sought a “trial by jury” and a singular “judgment,” not multiple jury trials and multiple judgments.
Did the plaintiffs propose a joint trial “on the ground[s] … [of] common questions or law or fact”? Yes, indeedy. Kentucky’s permissive joinder rules provide that a complaint may join multiple plaintiffs in a single action when there is “[a] common question of law or fact” that is “common to all” the plaintiffs’ cases. By filing complaints predicated on a “common” “question of law or fact,” the plaintiffs offered the presence of common questions as a ground for pursuing a joint trial.
According to the Sixth Circuit, “[l]awsuits like the miners’ complaints fits the bill” for CAFA. The two complaints asserted “parallel claims on behalf of more than 100 plaintiffs, all proceeding on the theory that the claims are similar enough to merit adjudication in tandem. It should not come as surprise that CAFA covers them.”
The Sixth Circuit’s reasoning was animated by the notion that CAFA establishes simple “bright-line” rules. The plaintiffs’ efforts to escape the consequences of their own pleadings were unavailing. Each complaint on its face proposed a joint trial of more than 100 separate plaintiffs. The miners tried to walk that back by suggesting that their claims might ultimately not involve common questions of fact or law. But removability is judged at the moment of removal, not on future maybes. In any event, not only is the denial of common questions at odds with plaintiffs’ intentional joinder, it is irrelevant because the plaintiffs’ complaints did, in fact, propose joint trials. Maybe the defendant could succeed on a motion to sever the plaintiffs. But that would not alter the fact that plaintiffs proposed a joint trial.
Even if the plaintiffs now promised to seek only individual trials (a promise that the Sixth Circuit observed was “easy to make but harder to keep”), such promise would “not defeat federal jurisdiction.” Jurisdictional rules should be simple. “Requiring district courts to divine counsels’ unexpressed intentions and compare different cases’ trial-management plans would be anything but.”
The plaintiffs invoked federalism and concern for “the independence of state governments.” Huh? The Sixth Circuit brushed off that incoherent, rather desperate objection. Congress set forth clear jurisdictional rules, and “no antiremoval presumption attends cases invoking CAFA.”
Finally, the plaintiffs argued for affirmance of the remand order based on the “local controversy” exception. But the “core” of the miners’ complaints alleged that the defendant and other out-of-state defendants “designed, manufactured, and sold defective respirators, then lied about their faults.” It is true that the miners also named local Kentucky merchants as defendants, but their liability would be wholly derivative of the manufacturer’s liability. The manufacturer was the true target in this case. The court had no basis to “conclude that this controversy is local.”
The Adams decision means that CAFA means what it says. If you count to 100, you can count on CAFA to get you to federal court.
Last week we told you about two decisions in the In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, that were improvements over last November’s debacle of a preemption decision. Today we report on a decision that makes it a trilogy. We are still reserving judgment, but with hope.
This MDL is premised on a purported risk that in utero exposure to acetaminophen causes autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD)—an allegation that is skating on thin causation ice. Plaintiffs have sued both the manufacturer and several retailers. As is common in MDLs, Plaintiffs filed two master complaints, one against each category of defendants. Individual plaintiffs then file short form complaints (“SFCs”) identifying specifics about their claims, such as product usage, state of residency, etc., and adopting the allegations of the master complaints. The plaintiff who is the subject of the most recent ruling sued Walmart under Tennessee law alleging claims for failure to warn, design defect, misrepresentation, breach of implied warranty, and violation of Tennessee’s Consumer Protection Act (“TCPA”). Walmart moved to dismiss the TCPA claim as preempted, and plaintiff’s remaining claims as subsumed under the Tennessee Products Liability Act (“TPLA”). The court granted the former and denied the latter. So, maybe this is just a baby step, but at least it is a step.
The preemption question was one of the scope of express preemption for OTC drugs under 21 U.S.C. § 379r(a) which preempts any state regulation of OTC drugs that is “different from or in addition to, or that is not otherwise identical with, a requirement under” the FDCA and two other federal statutes. But there is an exception–§ 379r(a) does not apply to “any action or the liability of any person under the product liability law of any State.” So, the real question was whether a TCPA claim is a products liability claim. While the court’s analysis is of the Tennessee statute, the conclusion should apply equally to all state consumer protection statutes which are largely the same.
The TCPA bars “unfair or deceptive practices” or misrepresentations about a product’s uses and benefits. In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2023 WL 3045802, *3 (S.D.N.Y Apr. 21, 2023). Section 379r(a) does not define “product liability law.” So, the court had to afford it its common law meaning. Id. at *4. At its core, product liability law is “aimed at providing relief for personal injury and property damage caused by defective products.” Id. A definition with roots in Black’s Law Dictionary and the Restatement (Third) of Torts: Products Liability. Therefore, the court concluded that the exception to express preemption applied to “traditional theories of liability, largely grounded in tort law, for personal and property damage caused by defective products.” Id.
The TCPA, however, is modeled on the Federal Trade Commission Act, not state tort law. Its primary purpose is not to hold defendants liable for defective products. And TCPA claims are solely for economic loss—no personal or property damage required. Id. at *5. Therefore, the TCPA is not a product liability law and accordingly not exempt from express preemption. Id. That the Tennessee statute does not allow recovery for personal injury was a useful fact, but the tenor of the opinion was that, even if personal injury recovery were allowed (as some states do) that would not have prevented preemption, since consumer fraud statutes are not “traditional” product liability. That’s a nice win.
On the flip side, the court rejected defendant’s argument that because the TPLA subsumes all product liability claims, and the plaintiff’s SFC did not mention the TPLA, all the claims should be dismissed. The court found the argument was one of form over substance. Plaintiff adequately pleaded the claims and the failure to cite the statute was not by itself fatal. Comparing the two halves of the decision, defendants walked away with the bigger victory.
