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.
Thursday, May 17, 2012
The United States District Court for the District of Columbia has awarded $300 million in punitive damages to plaintiffs bringing tort claims against Syria and Iran in connection with their alleged role in a 2006 suicide bombing attack in Israel; the recovering plaintiffs were all U.S. citizens. The opinion is noteworthy not only for the size of the punitive-damages award, but also for the opinion's application of the terrorism exception to the Foreign Sovereign Immunities Act and the opinion's finding that the organization allegedly responsible for the attack was acting as an agent of Iran and Syria. The Jurist also has an article on the opinion.
Although executing on such a judgment is likely difficult and sensitive matters of foreign policy may be implicated, the use of tort law (here, the claims included battery and intentional infliction of emotional distress) seems promising as a way to hold foreign states responsible for terrorism. Indeed, multiple such claims have been litigated recently in the District of Columbia. Apart from general attempts to execute on assets of the defendants seized abroad, perhaps payment of such claims might be raised by the U.S. Department of State in connection with any future regime change and new government in the defendant countries.
Sunday, January 15, 2012
California Supreme Court Limits Certain Manufacturers' Asbestos Liability in O'Neil, Describes Navy's Conduct Leading to Asbestos Injury for Service Members
In O'Neil v. Crane Co., the California Supreme Court this past week rejected asbestos liability for manufacturers whose products are added by third parties to other products that contain asbestos. No. S177401, slip op. (Cal. Jan. 12, 2012) Download O'Neil v. Crane Co_Cal Supreme Court_2012. The plaintiffs had argued that the defendants should be held liable because of the foreseeability that their products would be combined with other asbestos-containing products to which plaintiff was exposed, but in its opinion the Court highlighted that the defendant's product did not require asbestos-containing products and in fact could have been with used in combination with non-asbestos-containing products. Id. at 1, 12.
In its analysis, the opinion quotes Professor Alan Calnan's and my introductory asbestos article for the 2008 asbestos symposium at Southwestern Law School that Professor Calnan and I co-chaired, and at which co-blog editor Howard Erichson also spoke. Id. at 17 n. 19 (noting that "[s]ome commentators have observed that, due to the bankruptcies of...major suppliers of asbestos-containing products, asbestos personal injury litigants have shifted their focus in the past decade to 'ever-more peripheral defendants'"); Download Calnan & Stier_Perspectives on Asbestos Litigation_Overview and Preview_2008.
The facts in O'Neil underscore the federal government's role in asbestos injury to those in military service. From 1965 to 1967, plaintiff O'Neil served in the boiler room on the USS Oriskany, a Navy aircraft carrier authorized in 1942 and launched in 1945. Id. at 5. The Court notes that "[a]s early as 1922, the Navy was aware that airborne asbestos could potentially cause lung diseases," and "[i]ts industrial hygienists conducted studies on the health effects of asbestos exposure from the prewar period until well into the 1960s." Id. Nevertheless, the "Navy preferred asbestos over other types of insulating materials because it was lightweight, strong, and effective"; "Navy specifications required the use of asbestos-containing insulation"; and the Navy even ordered the conservation of asbestos in 1942 for the war effort. Id. at 2-3. Even if asbestos was beneficial militarily, the Navy might still have taken safety precautions to protect seamen. But as the Court notes, "the Navy did not warn seamen about the hazards of working with asbestos-containing materials and did not advise them to wear respirators or take other precautions during dusty work." Id. at 5-6.
The Navy is immune from suit because of the discretionary function exception to waivers of sovereign immunity. Id. at 6 (citing Collins v. Plant Insulation Co., 110 Cal. Rptr. 3d 241 (Cal. Ct. App. 2010), and Sea-Land Service, Inc. v. United States, 919 F.2d 888, 892-93 (3d Cir. 1990)). But through the Department of Veterans Affairs, the federal government does provide healthcare benefits, disability compensation, and dependency and indemnity compensation for veterans whose death stems from a service-related injury or disease, and has information specifically tailored to servicemen exposed to asbestos. See Dep't of Veterans Affairs, Occupational and Environmental Exposures: Asbestos. Removing such claims from litigation may be well-advised for the Navy, but one wonders if the apparently small and rigidly determined amounts of compensation by the VA offered are consistent with a government that also fully funds the 9/11 Victims Compensation Fund and demands a $20 billion Gulf Coast Claims Claims Facility from BP. To what degree has the low compensation offered by the federal government for its asbestos-related wrongs led to questionable claims against manufacturers, and the flooding of the courts with lawsuits?
Wednesday, January 12, 2011
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)
Monday, February 22, 2010
Professor David Owen (South Carolina) and I are quoted in a report tonight on All Things Considered on National Public Radio; the audio report -- Toyota Seen Facing Multiple Lawsuits, by Wendy Kaufman -- will also be posted on the web tonight at 7:00 p.m. EST.
February 22, 2010 in Aggregate Litigation Procedures, Class Actions, Informal Aggregation, Lawyers, Procedure, Products Liability, Regulation, Resources - Federal Agencies, Travel, Vehicles | Permalink | Comments (0) | TrackBack (0)
Tuesday, December 15, 2009
Today's Wall Street Journal has an article on increases in Black Lung Disease, Black Lung on Rise in Mines, Reversing Trend, by Kris Maher. Black Lung claims are covered by a federal Black Lung program, which provides an administrative mechanism for compensation, funded by a tax on coal. What's interesting is that the rise in claims occurs despite improving technology, which would be expected to decrease health problems. Thus, the article explores possible causes, such as longer workshifts or more productive machinery that might produce more dust. If machinery is the culprit, it's possible that individual mining companies might have had an incentive to prioritize powerful machinery over safe machinery, if the costs of worker illness are spread throughout the entire industry via a coal tax. (Remedy: return to a system of individual tort claims against mining companies, or at least some administrative/tax penalty for companies with higher Black Lung claims.)
But one other possibility for the rise in Black Lung needs to at least be considered and explored: fraud. Recent events with silicosis are similar: historically falling disease rates in tandem with improving technology, followed by an odd spike in supposed disease incidence. In a now-storied Daubert inquiry, Judge Janis Jack, who herself had a background in nursing, inquired into the basis of expert testimony and diagnosis and uncovered biased and unreliable procedures that may amount to fraud; her discoveries effectively ended what appeared to be a new mass tort. See NPR, Silicosis Ruling Could Revamp Legal Landscape. Concerns of fraud and abuse should be even greater in the context of an administrative program that lacks the adversarial scrutiny of formal litigation. And the Black Lung program has historically been plagued by such problems. A 1989 article in the West Virginia Law Review, authored by a former Department of Labor counsel and a private practitioner, concluded,
[T]he program has been plagued by fraud and abuse. There have been investigations, and indictments, and convictions of agency personnel, claimant's representatives, and medical care providers. The program has been infected by an undercurrent of “petty corruption.” If anything, the program is the most often cited example of why Congress should leave occupational disease compensation to the individual states.
Allen R. Prunty & Mark E. Solomons, The Federal Black Lung Program: Its Evolution and Current Issues, 91 W. Va. L. Rev. 665, 734 (1989).
Thursday, October 29, 2009
On October 14, 2009, the Washington Legal Foundation hosted a web seminar, Communicating on Off-Label Treatments: Navigating the Treacherous Path Paved by Civil and Criminal Law Enforcement, with speakers Robert Salerno and Adam Hoffinger of Morrison & Foerster. Streaming video of the event is available online.
October 29, 2009 in FDA, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Regulation, Resources - Federal Agencies, Resources - Organizations, Science | Permalink | Comments (0) | TrackBack (0)