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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

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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

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If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us.  Public mask usage seems to have increased.  We heard how the “tripledemic” of viruses had made hospital beds scarce.  We have had colleagues out of commission instead of completing our assignments.  The

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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

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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 

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We don’t do many “frivolous” posts anymore on the DDL Blog, unlike our earlier days.  We used to do music posts and the like, but as the pandemic got serious, so did we.

But here’s a post that has nothing to do with drug and device product liability litigation, and everything to do with Bexis being an inveterate geography nerd.  Since the Internet can be all things to all people, there is a site for geography nerds called “Worldle.”  Yes, a not-too-subtle play on the much more famous “Wordle” gamesite.

Continue Reading Are You a Geography Nerd?

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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 

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To anyone who needs a few more CLE hours before the end of the 2022, we wanted to let you know that sessions from Reed Smith’s recent Life Sciences CLE Week are now available on demand. Here are descriptions of the topics, and registration links.

The Ebb and Flow of the Law – A Year

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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