Market share liability, which permits allocating proportional responsibility to each tortious member of an industry when victims cannot identify the exact source of their injurious exposure, enjoyed its judicial heyday in the 1980s. It originated in the peculiar setting of litigation over a distinctive cancer that developed decades after in utero exposure to the drug diethylstilbestrol (“DES”), which a few hundred companies had produced and sold for the prevention of miscarriages before federal regulators withdrew it from the marketplace. Although judges have occasionally attempted novel extensions of this theory to other products, and academic commentators remain fascinated by its use, market share liability has faded from the scene. In the meantime, a strange new variant emerged, and it could have far greater reach than market share liability, though so far it has flown mostly below the radar of the torts cognoscenti. In contrast to market share, it visits full responsibility on the manufacturer of a brand-name drug for patient injuries unmistakably caused by generic versions sold by its competitors. This Article denominates the newer approach as “market shift liability” and documents its gradual spread while critiquing the doctrine on a number of different grounds.
Four months after the first vaccines against Covid-19 became available to the public, and just as some universities announced plans to require inoculations, the Boston Globe quoted me as (alone) suggesting that mandates would conflict with federal law. When Congress created a special mechanism for the emergency use of still investigational products, it directed providers to reveal, among other things, that individuals remained free to decline such an intervention; only after full FDA approval of a medical countermeasure would this disclosure obligation become inapplicable. I have watched with dismay over the last three years as nearly everyone—including Executive branch officials, federal and state judges, and various academic commentators— cavalierly dismissed an entirely valid statutory objection. This Article probes what accounts for the universal rejection of an argument that, on further reflection, continues to strike me as far from frivolous.
The Table of Contents and Preface for this soon-to-be-published casebook can be found here. If you’re more conversant with constitutional law, administrative procedure and/or torts than health policy & ethics (and if teaching MPH students didn’t make your bucket list), then this might be the volume for you—providing an opportunity to offer what amounts to an applied Con. Law, etc. course in a fashion that’s more rigorous than possible with existing public health law casebooks while still being topical and hopefully accessible to JD students, especially those preparing for public sector practice. It includes a detailed Index and will be accompanied by a comprehensive Teacher’s Manual (appx. 130 pages plus 80 or so slides).
In April 2023, a federal court in Texas preliminarily invalidated the license for mifepristone, the abortion drug approved by the FDA more than two decades earlier. Two weeks later, the U.S. Supreme Court issued an emergency stay pending appeal, so mifepristone remains available for now, but this consequential litigation has several more rounds to go. Judge Kacsmaryk’s opinion richly deserves criticism at any number of levels, but one of the most fundamental objections to it misses the mark: while rare, judges before him have found fault with FDA drug approval decisions, so what happened in this particular case hardly qualifies as unprecedented, and the affiliated policy arguments offered by some of his critics strike me as largely misplaced as well. The lawyers for the government — and the group of self-anointed “FDA scholars” eager to offer their insights to the courts and the media — should know that overstating your case can end up leaving egg on your face.
In 2022, in West Virginia v. EPA, the U.S. Supreme Court officially adopted the “major questions” doctrine. Commentators have already spilled plenty of ink trying to make sense of what this might portend, but so far seemingly everyone has accepted at face value the Court’s framing of the issue that it confronted in that case. This symposium contribution offers a slightly different perspective on the decision and suggests that closer attention to the precise nature of the question posed therein might reveal a distinctive flaw at the heart of the majority’s newfangled clear statement rule—it only sows confusion to conflate fundamental legal questions about jurisdiction (i.e., had Congress empowered an agency to act in a particular regulatory space?) and more policy-laden questions about the substantive merits of a rule (i.e., did the agency act in an arbitrary and capricious fashion?).
In 2018, the U.S. Supreme Court decided National Institute of Family & Life Advocates v. Becerra, striking down a California law mandating that clinics for low-income pregnant women disclose, among other things, the availability of publicly-funded abortion services at other facilities. Although frequently maligned for allowing crisis pregnancy centers to mislead their clients, the decision gave private parties a powerful new tool for resisting government demands to carry unwanted messages: only genuinely “uncontroversial” disclaimer requirements pass muster, and only to the extent necessary to guard against potentially misleading claims. If applied in an even-handed fashion, then courts should just as readily invalidate laws recently adopted in almost a dozen states (and sponsored by pro-life groups) that obligate suppliers of the abortifacient mifepristone to incorrectly advise patients that they could reverse the procedure even after starting use of the drug. More straightforward state and federal disclosure requirements may, however, also fare poorly. Under the cover of a abortion-related dispute, Justice Thomas finally appears to have succeeded in his long-running campaign to collapse the distinction between core and commercial speech.
This paper explains why the application of restrictions on promoting off-label uses to bar manufacturers of generic drugs from touting uses newly approved by the U.S. Food and Drug Administration (FDA) but only for their brand-name competitors cannot possibly pass muster under the First Amendment, drawing parallels to similar questions recently raised about the enforcement of method patents.
In order to prevent further overuse of prescription opioids, states have adopted a variety of strategies. This paper summarizes the growing use of prescription drug monitoring programs, crackdowns on “pill mills,” prohibitions on the use of particularly hazardous opioids, limitations on the duration and dosage of prescribed opioids, excise taxes, physician education and patient disclosure requirements, public awareness campaigns, and drug take-back programs. Although occasionally challenged on constitutional grounds, including claims of federal preemption under the Supremacy Clause, discrimination against out-of-state businesses under the dormant Commerce Clause doctrine, and interference with rights of commercial free speech, this paper evaluates the possibility that patients might have substantive due process objections against the more aggressive initiatives for unduly burdening a fundamental right of access to narcotic analgesics. In particular, if these regulatory efforts put substantial obstacles in the way of terminally-ill patients seeking palliative care, then states would face a difficult burden of justification.
Firearms continue to cause tremendous losses in the United States, prompting increasingly frustrated calls for a public health response to this endemic problem. Although Congress has legislated repeatedly on the issue over the last century, it has not managed to do anything remotely comprehensive in the aggregate. This paper offers a radical new approach that has gone entirely unnoticed. Much as it tried to do a quarter of a century ago in asserting jurisdiction over tobacco products, the U.S. Food and Drug Administration (FDA) could try to use its "device" authority to rein in companies that manufacture firearms and accessories with far too little oversight at present. "Device" jurisdiction brings with it a wide range of powers that would give the agency tremendous flexibility in designing various ways of making guns and ammunition less hazardous to the community. Such an initiative would confront serious political hurdles, of course, to say nothing of an undoubtedly skeptical response by the federal judiciary on both statutory and constitutional grounds. Nonetheless, as happened with the FDA's ultimately unsuccessful tobacco product rulemaking, simply making the effort might generate some much needed momentum for seriously addressing this scourge.
This paper explains why the application of restrictions on promoting off-label uses to bar manufacturers of generic drugs from touting uses newly approved by the U.S. Food and Drug Administration (FDA) but only for their brand-name competitors cannot possibly pass muster under the First Amendment, drawing parallels to similar questions recently raised about the enforcement of method patents.
This short paper responds to Nick Parrillo's recent article in the Yale J. on Reg., summarizing my previously expressed misgivings about guidance-making by regulatory officials in an intentionally provocative manner. That journal's Notice & Comment section had invited me to participate in a mini-symposium on the subject but then decided that my contribution was too saucy for the imagined readers of their blog.
This paper suggests that the medical establishment shares more blame for the prescription opioid crisis than many commentators seem to appreciate. It canvasses a variety of ways in which the federal government has responded to the problem during the last few years before delving more deeply into the role of the U.S. Food and Drug Administration (FDA), assessing the different risk management tools that the agency tried to use as well as some that it failed to employ. This paper concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical community would have pitched a fit about any such an intrusion on its prerogatives, to say nothing of the drug manufacturers aghast at the prospect of far more modest sales. Greater use of such restrictions on distribution might have worked to nip this disaster in the bud, and it needs more serious consideration by the FDA before the next one comes down the pike.
The pharmaceutical and medical device industries aggressively market their wares to health care professionals, and the giving of gifts has become a central feature of this process. Most observers regard financial incentives tied to the use of specific therapeutic products as ethically impermissible, and various institutions have tried combating inappropriate gifts and payments to physicians: medical and industry groups adopted voluntary codes, federal agencies published advisory guidelines, and, most recently, state and federal legislatures enacted reporting laws. Self-regulation, threats of prosecution, and transparency initiatives have tempered the practice, but manufacturers continue to find clever ways of purchasing the loyalty of prescribers. Fairly minor modifications in tort doctrine might help to discourage such payments. Courts could include potential conflicts of interest as material information that health care professionals must reveal when securing consent from their patients, but expanding the duties of drug and device manufacturers to convey warnings directly to patients offers a more promising way to curb gift giving. The prospect of having to communicate complex risk information to laypersons might make companies think twice before lavishing gifts and payments on physicians, which in turn would help to ensure that those “learned intermediaries” continue to serve the best interests of their patients.
Once a prescription drug has transitioned into the nonprescription marketplace, a variety of factors conspire against moving it back. Instead, as worrisome additional hazards of use come to light, the U.S. Food and Drug Administration (FDA) simply shares the new risk information with consumers. In spite of evidence that laypersons pay little or no attention to such disclosures, and the mounting injuries suffered by consumers, the agency persists in its unproductive strategy of larding up product labels rather than reconsidering the wisdom of its original judgment to authorize over-the-counter (OTC) availability. This represents a potentially serious public health problem that deserves more than the passing attention it has received to date. Although tort litigation might serve as a partial counterweight to manufacturers’ lack of incentives to request a return to prescription status, judicial resistance to negligent marketing claims coupled with receptivity to the implied federal preemption defense severely limit this prospect. In the absence of a greater willingness by the FDA to confront this issue (or some sort of broad-based legislative reforms designed to facilitate such a process), the dangers associated with giving consumers largely unsupervised access to powerful pharmaceutical agents have become largely intractable.
Like direct-to-consumer advertising of prescription drugs undertaken by pharmaceutical companies, client-seeking advertising sponsored by lawyers that highlights the dangers of such products may pose health risks to patients. Unlike the drug industry, whose advertising the federal government subjects to various restrictions, personal injury attorneys face essentially no oversight regarding campaigns that target therapeutic products. Lawyers enjoy no greater rights, however, when engaging in such commercial speech, so the U.S. Constitution would not stand in the way of crafting a sensible response. Nonetheless, because state bar authorities do not seem up to the task of doing so, and tort claims for either negligent misrepresentation or product disparagement would encounter serious obstacles as well, this paper recommends that the federal agency with the greatest stake in the matter — notwithstanding its conceded lack of regulatory jurisdiction over these speakers — take the lead in trying to define what types of attorney drug advertising cross the line. Only then might state officials and courts get the message that some client-seeking advertisements might well mislead patients in ways that threaten their health.
