Evidence of other similar acts can be devastatingly effective. It’s easier for us to believe somebody did something wrong on a specific occasion if we hear they have a prior history of doing the same thing. Federal Rule of Evidence 404(b) addresses this issue, and it is one that comes up in both civil and
More Mesh Mess
The first thing you learn as an appellate clerk is the importance of the standard of review. If the review is de novo – purely legal issues – your judge will not defer at all to what happened below. It’s a whole new (hence, de novo) ballgame. If the review is for abuse of discretion
EDNY Holds Glucosamine Claims Preempted
We call ourselves the Drug and Device Law Blog, but sometimes we cover cases outside the drug and device field because such cases can sometimes be helpful or inspiring. Perhaps it is an example of thinking outside of the box.
Jackson-Mau v. Walgreen, Inc., 2023 U.S. Dist. LEXIS12057 (EDNY Jan. 24, 2023), is
Bard IVC Filters MDL Denies Request for Exemption from Common Benefit Fund Assessments
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
A Hospital Can be a Product Liability Seller-Defendant in Oregon
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
C.D. Cal. Bids Arrivederci to Civil RICO Claim
Last week, in the course of discussing a vaccine case, we mused over the misuse of the due process clause of the fourteenth amendment. Just for a moment we were back at U. of Chicago Law (and, as Dan Fogelberg sang, “felt that old familiar pain”). In 1984, our waist and forehead seemed smaller
Court Upholds Washington State Covid-19 Vaccine Mandates
Our doctor advised it would not be a good idea for us to get Covid-19. We already wheeze after ascending the stairs or rolling the garbage bin to the curb or opening the mail, so any further respiratory burden seems like a bad idea. Thus, even though some have declared the pandemic over, we remain cautious. Good luck inviting us to any public place. Pascal may have said that all of humanity’s problems stem from man’s inability to sit quietly in a room alone, but he wasn’t talking about us. We’re quite happy to avoid the madding and infectious crowds by sitting home with a good book or mediocre tv show, or by planting a nose against the kitchen window, watching the red shouldered hawk wait for dinner to show up at the pond. You might even say that we live deliberately.
Our doctor also advised us to get every Covid booster vaccination as soon as possible, and we have done so. Some of our Twitter acquaintances and frenemies have told us that the boosters will kill us or will permit Melinda Gates to spy on our every movement. Those threats do not bother us. If anyone is going to go through all the trouble to plant a chip in our arm, they’re probably not looking to bump us off any time soon. And, as mentioned above, we don’t actually engage in a lot of movement, so fair play to anyone who chooses to spy on us. We’ll be a stationary dot on the screen, reading The New Yorker or glaring outside at the geese.
So, yes, we are unabashedly pro-vax. Bring on the hate emails. We’ll toss the virtual missives into the virtual fireplace. And we’ll wish you good luck.
But we do not wish good luck to litigants challenging vaccine mandates. When governments or employers insist that public-facing employees must be vaccinated in order to perform their jobs, we are relieved and grateful. If employees decide to give up their jobs rather than be vaccinated against Covid, we shake our heads at their tenacity and grieve for their health, but so be it. We might call it a remarkable sacrifice, or a stupid sacrifice. Or a remarkably stupid sacrifice. And yet, in truth, some employees do not want to sacrifice anything. They want to remain unvaxxed “truebloods,” inflicting their viral silliness on the rest of us. Luckily, pretty much every time the antivaxxers sue to get their way, they lose. Continue Reading Court Upholds Washington State Covid-19 Vaccine Mandates
So Long to All that Junk
As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. But it really is folly to plan the future without learning from the past. It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week, and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022. We’ve also been asked in various fora and by various inquisitors to hold forth on trends we espy. Clients and colleagues demand analyses and prognostications. We’ve also worked up presentations for ACI, DRI, and in-house CLEs. As we draw a curtain on a very interesting year (African safari, new house, introduction to pond management, Phillies World Series, and clients who gave us the gifts of trust and humor), so we’ll share some top-line observations and suspicions with you, our loyal readers:
- Since Covid-19 paid our society an unwelcome, prolonged visit, we’ve heard a lot about supply-chains. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.) or bolstering liability theories by taking out of context Materials Safety Data Sheets that list risks relevant for OSHA but not FDA issues.
- The assault on non-prescription products continues. Plaintiff lawyers seem to be paying more attention to over the counter and consumer products, alleging dangers from contaminants. These products have lots and lots of users (call them prospective clients), and there’s hardly a pesky learned intermediary in sight to get in the way of a failure to warn claim.
- That assault is aided by “independent” laboratories that masquerade as public-spirited do-gooders, when they are actually in league with plaintiff lawyers and treat science as a game. These labs follow good lab practices erratically if at all, and certainly not good practices that would produce bad results for plaintiffs. The bottom line is that these not-so-independent labs would find contaminants, degradation artifacts, and/or asbestos in unicorn tears.
- You got that reference to asbestos, right? The plaintiff playbook du jour comes from the talc asbestos litigation, and that litigation, in turn, is only the latest wave in the asbestos wars. If the first victim in war is the truth, then the asbestos wars have murdered truth, science, and anything approaching due process. Too many judges presiding over asbestos dockets have given up any gatekeeping, wave frail causation opinions along to juries, and grudgingly consider dispositive motions only on the eve of trial — all of which seems designed to force panic settlements.
- As the asbestos model gets applied to other mass torts, we are starting to see an unfortunate feature of asbestos litigation crop up in those mass torts: the use of bankruptcy proceedings as a necessary refuge from a mass tort run amok. The availability of bankruptcy as such a refuge is replete with controversy, of course. Results have been mixed. The consequences of such bankruptcy filings are obviously profound for the debtor and claimants, but also pose complex implications for codefendants. Some have called such bankruptcy filings a scourge, threat, and mess, but they are really rational responses to a litigation system that has become a scourge, threat, and mess.
- At the same time, some judges are willing to climb on top of the mountain of junk science and call a halt to the nonsense. Yesterday, Bexis summarized the Zantac MDL rulings on Rule 702 and summary judgment. The judge in that case did a heroic job of mastering the evidence and seeing the many ways in which the plaintiff experts practiced “situational science.” Even in advance of the new and improved Rule 702 expected to go into effect next year, the Zantac judge set the standard for testing whether plaintiffs met their burden of offering scientific opinion backed by rigor and reliability. That result should gladden the hearts of those who care about the civil justice system, but it should also remind defense lawyers of their responsibility to do the work necessary to reveal the shortcomings of the other side’s experts and provide the judge with the basis for closing the gate.
The Zantac decision was, without a doubt, a remarkable achievement. When a judicial opinion contains over 300 pages of erudition, one tends to sit up and take notice. Continue Reading So Long to All that Junk
S.D. Texas Says Nay to Doctors’ Ivermectin Claim; Refuses to Rein in FDA Criticisms of Ivermectin Off-Label Use
Apter v. United States, HHS, 2022 U.S. Dist. LEXIS 225612 (S.D. Texas Dec. 6, 2022), is yet another ivermectin case, but with a twist. Most of the ivermectin cases we have seen involve Covid-19 patients or their representatives complaining that they were denied ivermectin treatment by hospitals or doctors who insisted on following standard medical practice, which deems ivermectin to be ineffective against Covid. But in Apter, the plaintiffs were three doctors who sued the FDA and some of its officials, claiming the doctors’ ability to practice medicine was impaired by the FDA’s statements criticizing off-label use of ivermectin for Covid-19. The plaintiffs pointed to several statements issued by the FDA counseling against the use of ivermectin to treat or prevent Covid. They also pointed to republications of such FDA anti-ivermectin statements. For example, they cited a tweet/LinkedIn post/Facebook post that reads, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” which links to an FDA article. It is nice to see that the FDA enjoys equine jokes as much as we do.
While the plaintiffs acknowledged the FDA’s authority to regulate drugs (they get no credit for that; it’s like Margaret Fuller’s announcement that she “accept[ed] the universe,” and Thomas Carlyle’s retort that “By Gad, she’d better!”), they argued that the FDA lacked authority to “prohibit, direct, or advise against off-label uses of drugs approved for human use.” The plaintiffs relied on 21 U.S.C. section 396, which provides that nothing in the federal Food, Drug and Cosmetic Act “shall be construed to limit or interfere with the full authority of a health practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship.” Did you catch the word “device” in that quote? The plaintiffs did, but nevertheless contended that section 396 also applies to the prescription and administration of drugs. We have some sympathy with the overarching notion that the FDA does not regulate the practice of medicine, and we certainly have expressed some skepticism about some of the FDA’s efforts to limit off-label prescriptions (inasmuch as some of those off-label prescriptions are necessary and are within the standard of care), but we have little sympathy for the ivermectin pro-conspiracy and anti-vax crowd, and even less sympathy for the plaintiffs’ statutory construction in Apter.
Be that as it may, the plaintiffs in Apter asserted five claims for relief: (1) ultra vires acts by the FDA; (2) violation of the Administrative Procedure Act (the good old APA – taking us back to a third-year law school class we thought had been safely packed away in our life experience attic forever) by virtue of the FDA acting in an “arbitrary and capricious” fashion; (3) violation of the APA by virtue of the FDA acting “not in accordance with law,” which seems like a clumsy catch-all; (4) violation of the APA by virtue of the FDA acting in “excess of statutory authority” (and now we sigh at the monotony and redundancy); and (5) declaratory judgment in accordance with all the other claims. The defendant filed a motion to dismiss the complaint. Purely on aesthetic grounds, Judge DDL (woe betide the plaintiffs’ bar if Judge DDL should ever actually ascend to the bench – the first dispositive motion wins!) would grant the motion. Purely on legal grounds, the non-fictitious judge in Apter did grant the motion.
The complaint in Apter was structured the way it was (ultra vires and APA) because the chief barrier facing the plaintiffs was sovereign immunity. The plaintiffs were suing the United States which, like the rest of us, does not enjoy being sued but, unlike the rest of us, cannot be sued absent the existence of consent. A waiver of sovereign immunity cannot be implied. It must be expressed unequivocally. One way for plaintiffs to overcome sovereign immunity is to claim that the governmental body acted ultra vires. If a governmental officer acted beyond statutory limitations, such action is considered that of an individual, not the sovereign. In Apter, the court held that the FDA did not act in an ultra vires manner, because section 396 prevents the FDA from interfering with the practice of medicine only with respect to medical devices. Remarkably, the Apter court’s analysis of this issue turned on another case’s employment of a “See” citation rather than a simple, straight-up citation to authority. That “See” meant that the other case (Fifth Circuit) had not quite cozied up the extension of section 396 to drugs. Don’t let anyone tell you that the Bluebook does not matter. Moreover, the Apter court simply did not believe that the FDA, which is charged with protecting public health, lacks any authority to make public statements in furtherance of that mission. At the same time, the Apter court allowed that the FDA “ should have been more prudent in their communications.” That, friends of the DDL blog, is dicta. Continue Reading S.D. Texas Says Nay to Doctors’ Ivermectin Claim; Refuses to Rein in FDA Criticisms of Ivermectin Off-Label Use
Second Circuit Upholds New York Measles Vaccine Mandate
On Monday, Bexis blogged about a very bad vaccination decision — bad in its reasoning and bad in its maleficent effect on vaccine policy in this country. Over the past couple of years, we’ve written quite a few posts on vaccination cases. The law in this area has gotten a vigorous workout largely because of Covid-19, of course. That particular vaccine became a subject of massive political debate for reasons that seem entirely stupid to us.
Why stupid? Let us count the ways. First, the biggest vaccine haters are often supporters of the former President, whose administration did a lot to hasten development of the Covid vaccine. Second, the distrust of the Covid vaccine is largely premised on ignorance and conspiracy mongering. Third, the claims that Covid vaccine mandates undermine the Bill of Rights not only ignore logic, they ignore clear precedents involving other vaccines.
Indeed, we think that observing the treatment of other vaccines, free of the fog of political warfare, might help clarify thinking on vaccine mandates. Perhaps people can at least doff their tin foil hats temporarily.
In Goe v. Zucker, 43 F.4th 19 (2d Cir. 2022), the Second Circuit reviewed a proposed class action challenging the scope of medical exemptions to New York’s mandatory school immunization requirements. Prior to June 2019, New York allowed exemptions from the immunization requirements for both nonmedical and medical reasons. But after a big measles outbreak, New York repealed the nonmedical exemption (as we said in our vaccine post last week: yay) and clarified the medical exemption. The plaintiffs filed a lawsuit, contending that the new vaccine regulations violated their fourteenth amendment due process rights, as well as section 504 of the Rehabilitation Act, 29 USC section 794. The district court dismissed the complaint and the plaintiffs appealed to the Second Circuit. Continue Reading Second Circuit Upholds New York Measles Vaccine Mandate