Saturday, June 25, 2016
Professor Wendy Parmet (Northeastern Law) has posted to SSRN her article, Paternalism, Self-Governance, and Public Health: The Case of E-Cigarettes, 70 U. Miami L. Rev. 879 (2016). Here is the abstract:
This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty presents regulators with difficult challenges in determining whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws are impermissibly paternalistic. The self-governance rationale, which is the most robust, and most reflective of public health’s own population perspective, has been the least theorized. This article develops that theory, examining the basis for the justification as well as its limitations. The article then applies its normative framework to the regulation of e-cigarettes, focusing on the FDA’s so-called deeming regulations, which at the time the article was written were pending but have since been promulgated in a substantially similar form. The article supports the FDA’s ultimate decision to ban the sales of e-cigarettes to minors and to require the disclosure of warning labels based upon the impaired agency rationale. However, the scientific uncertainty renders the harm rationale inadequate. As a result, the regulations’ pre-market review requirement must rely on the self-governance rationale for its normative justification. Given the lack of clear legislative guidance and political engagement, the article concludes that the pre-market review provisions are normatively problematic: if public health advocates want to claim the mantle of self-governance, they must take it seriously.
Friday, April 1, 2016
Monday, February 8, 2016
In today's New York Times, Michael Wines & John Schwartz have an article called "Regulatory Gaps Leave Unsafe Lead Levels in Water Nationwide."
What they describe in the article are not only regulatory gaps - that is places such as certain waterways or sources of water that are un- or under- regulated, but also cases where regulations are ignored, poorly followed, etc.
On prawfsblawg, Rick Hills writes about the Flint water crisis in particular and the relationship between litigation and regulation. He correctly observes: "Darnell Earley, the emergency manager appointed by Governor Snyder to run Flint, had a bureaucratic mandate to save money and no electoral incentive to protect non-fiscal goals like voters' health. By switching Flint's water supply from the expensive Detroit water system to the cheaper and more corrosive Flint River, Earley maximized the first goal and ignored the second, with the result that Flint's residents now have elevated lead levels in their blood."
Wednesday, September 23, 2015
Thursday, September 5, 2013
Wednesday, August 21, 2013
Professor Kate Greenwood (Seton Hall) has posted to SSRN her article, 'Litigant Regulation' of Physician Conflicts of Interest, Ga. St. L. Rev. (forthcoming). Here's the abstract:
While physicians’ financial relationships with pharmaceutical and medical device manufacturers are increasingly of concern to legislators and regulators, plaintiffs have had only limited success pursuing private law remedies for the harms that result from conflicts of interest. Courts have long channeled individual patients’ claims against their conflicted doctors into the medical malpractice cause of action, where patients have difficulty establishing that their physicians’ conflicts caused them to suffer concrete and compensable injuries. With recent notable exceptions, courts have also blocked patients’ claims against drug and device manufacturers. Courts apply the learned intermediary doctrine to dispose of failure-to-warn personal injury suits, without regard to whether the plaintiff’s physician had a financial relationship with the defendant manufacturer. Third-party payers, such as employers, insurance companies, and union health and welfare funds, have similarly struggled to overcome a strong presumption of physician independence. Courts routinely find that a physician’s prescribing decision breaks the chain of causation between a manufacturer’s illegal promotional efforts and a payer’s obligation to pay for a prescription, even when those promotional efforts include the payment of kickbacks.
Courts can and should move beyond the often counterfactual presumption of physician independence. In personal injury cases, this can be achieved through a nuanced analysis of alleged conflicts of interest that distinguishes between kickbacks, on the one hand, and legitimate financial relationships between manufacturers and physicians, on the other. Limited early discovery would allow plaintiffs to develop their claims about the influence of conflicts on their physicians’ decision-making without putting an undue burden on defendants. In economic injury cases, courts can move beyond the presumption of physician independence by allowing plaintiffs to use standard statistical methods to demonstrate that physicians’ prescribing decisions were not independent in the aggregate. If the doctrine were to evolve in these ways, it would amplify the role “litigant regulation” plays in the regulatory structure governing physician-industry relationships and bring closer the goal of ensuring that patients and payers are fairly compensated for the harms caused by conflicts of interest.
Adam Abelkop (Graduate Student, Indiana U., Bloomington, School of Public & Environmental Affairs) has posted to SSRN his article, Tort Law as an Environmental Policy Instrument, 92 Or. L. Rev. (forthcoming 2013). Here's the abstract:
Policymakers aiming to tackle any environmental problem have a diverse tool chest of policy instruments at their disposal, including command and control regulations, taxes, marketable allowance, and liability entitlements. Scholars of public health and safety have been debating the effectiveness of tort law as a regulatory tool for decades. The legal literature on this topic, though, is muddled because the field has failed to adopt a set of criteria by which to compare tort law to public regulation. Heightened clarity on the usefulness of tort law as a complementary policy instrument to public regulations may have legal and policy implications. This article therefore adopts evaluation criteria from the policy analysis and public policy fields — equity, legitimacy, efficiency, organizational competence, effectiveness, and cost-effectiveness — to evaluate the strengths and weaknesses of tort law as an environmental policy instrument relative to public regulation.
Friday, October 12, 2012
A Wall Street Journal article, Pharmacy in Outbreak Acted Like Drug Maker, by Mark Maremont, Jonathan D. Rockoff, and Timony W. Martin explores the history of the companies allegedly involved in the fungal meningitis outbreak. The article notes that a class action has already been filed in federal court in St. Paul, Minnesota.
Friday, January 20, 2012
Tom Scott, the Executive Director of California Citizens Against Lawsuit Abuse, has posted on Fox&Hounds a 2012 wishlist for legal reform. While there are many proposed reforms helpful to business, I was struck by one not usually associated with business desires or law reform:
6. Stop cutting the funding of the California courts. Our court system is still reeling from cuts last year, and more cuts would only reduce access to the courts even more.
I am heartened to see that even those who are "fighting against lawsuit abuse" understand that adequate court funding is essential if suits are to be promptly adjudicated -- and found either meritorious and tried, or found unmeritorious and dismissed. Both pro-plaintiff and pro-business groups should be able to come together to advocate for court funding in a time of shrinking governmental budgets. And those who practice in mass tort litigation should be especially vocal, in light of the heavy demands such litigation places on state and federal courts. Moreover, as the election season approaches and disagreements multiply across the political spectrum, liberals and conservatives might remind themselves that they agree on government's core responsibility in providing a functioning court system for dispute resolution.
Tuesday, January 17, 2012
The New York Times reports that under new regulations to be announced by the Obama administration, pharmaceutical companies will have to report payments to non-employee doctors for "research, consulting, speaking, travel and entertainment." The reporting requirements are to cover any company that has a product covered by Medicare or Medicaid, and the reporting information is to be subsequently posted by the government on a publicly accessible website.
Sunday, January 23, 2011
Interesting article from the New York Times on services that offer loans to litigants and the high interest rates typically charged: Lawsuit Loans Add New Risk for the Injured, by Binyamin Appelbaum. The article discusses the movement to subject such loans, and their high interest rates, to regulation. Of course, if the interest rates able to be charged are limited by state law, the effect may be to destroy the lawsuit loan market, because the default risk for such loans may be high enough that only a high-interest rate lending model may be profitable over the long term. Losing such loans would be unfortunate, because litigants with meritorious cases may need access to funds while the the justice system processes the case. Instead of regulatory capping of interest rates, why not instead rely on clear disclosure of rates in contracts, and market forces of vying lenders competing over interest rates?
Wednesday, January 12, 2011
Thursday, December 16, 2010
Tuesday, October 12, 2010
Barry Meier of the NYTimes reports. The issue is whether the plaintiff can bring products liability suits or whether they must bring the suit only in the vaccine court, created by the 1986 National Childhood Vaccine Injury Act.
This case concerns a woman who suffered seizures as a result of a DPT vaccine administered when she was a baby and has resultant developmental problems. But there are many parents of children with autism who believe there is a link between vaccines and autism and would like to bring their cases outside of the adminsitrative system set up by the Act.
Thomas Burke, a political scientist at Wellesley College, has written on this topic. Click here for his website.
Monday, May 17, 2010
Recent crises stemming from BP's oil spill and Toyota's acceleration problems have brought a swarm of media coverage, congressional hearings, regulatory agency activity, corporate news conferences, and lawsuits. Indeed, theories of liability may stem not only from the initial traumatic incident or incidents, but from the corporation's putative mishandling of the crisis once it unfolds. On the corporate side, what's called for is thoughtful and coherent crisis management that moves the corporation through the crisis in a way that resonates with corporate core values, thereby maintaining the value of the ongoing enterprise, and that is mindful of impending theories of liability.
Despite the great need for such a coherent approach to mass tort crisis management, what's remarkable is the apparent paucity of attention given the subject by legal scholars. That may be because crisis management involves public relations and communications, as well as management and leadership; hence crisis management has been the focus of public relations consultants and some professors in communications schools and business schools. But at the heart of corporate crises are frequently the law and liability, so law professors should not be absent. Lawyers and law firms already occasionally promote their ability to handle an emerging corporate crisis by quickly assembling a team of lawyers from a broad array of areas -- see, e.g., Skadden's Crisis Management; and lawyer practitioners have delivered various continuing education talks and papers on crisis management, as well as an interesting short symposium paper by Harvey L. Pitt and Karl A. Groskaufmanis, When Bad Things Happen to Good Companies: A Crisis Management Primer, 15 Cardozo L. Rev. 951 (1994). But while practitioners bring on-the-ground expertise, they may lack the theoretical depth and interdisciplinary zeal of law professors, and practitioners present a conflict-of-interest risk in preferring, for example, fee-heavy litigation over other methods of mass tort crisis management and resolution. A full academic account of mass tort crisis management would entail an awareness and integration of various legal areas -- tort, procedure, litigation, ethics, regulatory action, congressional investigations and activity (including possible compensation funds), and pertinent constitutional issues -- with public relations and management. I look forward to turning my attention increasingly to that task.
Where do you look for corporate crisis management expertise in mass torts? Books, articles, law firms, or consultants? Does your law firm market itself as offering corporate crisis management; if so, what's your approach? If you work at a consulting group that does crisis management, do you have in-house lawyers that assist you or do you work with the corporation's outside counsel? Feel free to post a resource or comment.
May 17, 2010 in Aggregate Litigation Procedures, Current Affairs, Environmental Torts, Ethics, Lawyers, Mass Disasters, Mass Tort Scholarship, Procedure, Regulation, Vehicles | Permalink | Comments (0) | TrackBack (0)
Thursday, April 29, 2010
Tony Sebok (Cardozo) has posted his piece "The Inauthentic Claim" to SSRN. This is a very important paper arguing against the usual rule limiting types of litigation financing. The implications of the thesis for mass torts is significant. If people could sell lawsuits the landscape of aggregate litigation would change in significant ways. Here is the abstract:
This Article argues that third parties should be able to invest in lawsuits to a much greater degree than is currently permitted in most jurisdictions in the United States. The laws of assignment and maintenance limit the freedom of litigants to sell all or part of their lawsuits to strangers. I argue in the Article that the foundation of both doctrines is based on something I call the theory of “the inauthentic claim.”
The theory of the inauthentic claim asserts that there is a quality, separate and in addition to legal validity, which confers “authenticity” to a lawsuit. It does not presuppose that “inauthentic” lawsuits are more likely to be spurious, fraudulent, or frivolous than “authentic” lawsuits. It holds, instead, that the mere fact that a third party involved him or herself in the suit for the wrong reasons (either by taking an assignment in the suit or supporting the suit), is proof that the suit is against public policy.
This Article examines two arguments that might be used to defend the theory of the inauthentic claim, one from history and one from jurisprudence. I conclude that neither argument is persuasive. I conclude the Article by sketching a research agenda based on empirical evidence that would help policymakers and judges choose the socially optimal set of rules for third party investment in litigation.
(h/t Chris Robinette at Torts Prof Blog)
Monday, March 29, 2010
Panel on Pluralism in Tort Law and Litigation at Annual Conference of the Association for the Study of Law, Culture and the Humanities
As previously mentioned, I was part of a panel on Pluralism in Tort Law and Litigation at the annual conference of the Association for the Study of Law, Culture and the Humanities, which took place on Saturday, March 20 at Brown University. Professor Alan Calnan (Southwestern) moderated the panel, and other participants included Professors Christopher Robinette (Widener) and Sheila Scheuerman (Charleston). Below are the abstracts and links to audio from the presentations and Q&A. Thanks to Alan Calnan for moderating and to all for participating.
I. Prof. Alan Calnan -- Introduction (audio)
II. Prof. Christopher Robinette -- "The Instrumentalism in Tort Reforms" (audio)
The traditional view among legal historians is that tort was largely deontic private law until the late nineteenth century. Due to factors such as the Industrial Revolution and the advent of liability insurance, tort became (more) instrumentalist. A survey of major tort reforms over the course of the last century provides evidence to support this view. Each of the reforms--workers' compensation, no-fault automobile insurance, products liability, and "modern" tort reforms (such as damage caps)--is based in instrumentalism. Furthermore, the reforms become increasingly integrated into tort law as time passed. The earliest reform, workers' compensation, was a substitute for tort law. By the time of the modern reforms, instrumentalism is operating within tort itself, and covers a multitude of tort cases.
III. Prof. Byron Stier -- ""Examining Litigant Autonomy in Mass Torts: Insights from the Individualism of Ayn Rand" (audio)
Class actions and other aggregate procedural methods raise questions about the relationship of the individual to the group. Litigant autonomy -- the litigant's interest in controlling his or her lawsuit -- has generally been considered merely one value among others in mass tort litigation, and only recently has a robust commitment to litigant autonomy been seen to call into question the entire structure of class action practice. In looking for insight into the proper place for litigant autonomy in class actions or other management methods, we might fruitfully turn to political debates concerning the relationship of the citizen to the state, for both settings examine the rights of the individual against the perceived needs of the group or collective. For discussion of that political question, I look to an unusual source -- outside law, to the literature of one known for her radical political individualism, Ayn Rand. Her novel, "We The Living," which was published in 1936 and is set in the aftermath of the communist revolution in Russia, puts forth a moral argument for individualism stemming from the sanctity of one's own life, and of one's control of one's own life, for one's own ends, not the group's; she also argues that personal tragedy and systemic corruption accompany an approach that fails to respect individuals' lives and choices. Turning back to mass tort litigation, I suggest that our notion of litigant autonomy can be informed by Rand's themes and that current class action rules show flaws similar to the collectivism that Rand critiques. Viewing litigant autonomy not merely as one value among others, but instead as an organizing principle that must be respected as a core right, I suggest that current class action rules regarding notice, opt-out, and settlement are problematic because they do not allow adequate expression of individual preference and they blunt each class member's individuality. In addition, by avoiding individual control, the current class action rules create fertile ground for corruption and collusive settlements.
IV. Prof. Sheila Scheuerman (audio)
In my presentation, I examine whether and when tort law should permit "no injury" claims -- claims where the plaintiff's harm has not yet materialized. Examples of these suits include medical monitoring actions, products liability claims where a known defect exists, but the product has not yet malfunctioned, as well as consumer fraud claims where the consumer's decision was not affected by the defendant's alleged misrepresentation. Recent years have seen an influx of these suits under an array of tort and contract theories. Traditionally, however, tort doctrine has premised liability on an injury to an identified party. But is "injury" a necessary pre-requisite? I address whether tort values support these "no injury" causes of action. In other words, should "no injury" claims be actionable under the varied rationales for the tort system and, if so, under what circumstances?
V. Questions and Answers (audio)
March 29, 2010 in Aggregate Litigation Procedures, Books, Class Actions, Conferences, Informal Aggregation, Lawyers, Mass Tort Scholarship, Procedure, Products Liability, Regulation, Settlement | Permalink | Comments (0) | TrackBack (0)
Thursday, March 25, 2010
Tuesday, March 23, 2010
Tuesday, March 16, 2010
The Albany Law Journal of Science & Technology has published a symposium issue on Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-Label. My article, Promotion of Off-Label Drug Use: In Favor of a Regulatory Retreat, 19 Alb. L.J. Sci & Tec. 609 (2009), is included.
March 16, 2010 in Aggregate Litigation Procedures, FDA, Mass Tort Scholarship, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Products Liability, Regulation, Resources - Federal Agencies, Science | Permalink | Comments (0) | TrackBack (0)