Cumulative Harm and Resilient Liability Rules for Product Markets
Cumulative Harm and Resilient Liability Rules for Product Markets
Research from the UK appears to present a lesson in smart product design, in this instance as to nanoparticles. Prior studies have shown that nanoparticles cause inflammation in the lung, and show signs of having the adverse health impacts of asbestos. So, the researchers experimented with fiber length to see if different fibers produced different impacts.
Sure enough, there were indeed differences. Particles at or above 4 microns are more inflammatory than are shorter fibers (and there are some further subtleties on length/width ratios). The research paper is online, and the abstract is pasted below. The results are consistent with prior research on less uniform asbestos fibers. Hat tip to RJ Lee Group for flagging the research.
"Suspicion has been raised that high aspect ratio nanoparticles or nanofibers might possess asbestos-like pathogenicity. The pleural space is a specific target for disease in individuals exposed to asbestos and by implication of nanofibers. Pleural effects of fibers depends on fiber length, but the key threshold length beyond which adverse effects occur has never been identified till now because all asbestos and vitreous fiber samples are heterogeneously distributed in their length. Nanotechnology advantageously allows for highly defined length distribution of synthetically engineered fibers that enable for in-depth investigation of this threshold length. We utilized the ability to prepare silver nanofibers of five defined length classes to demonstrate a threshold fiber length for acute pleural inflammation. Nickel nanofibers and carbon nanotubes were then used to strengthen the relationship between fiber length and pleural inflammation. A method of intrapleural injection of nanofibers in female C57Bl/6 strain mice was used to deliver the fiber dose, and we then assessed the acute pleural inflammatory response. Chest wall sections were examined by light and scanning electron microscopy to identify areas of lesion; furthermore, cell–nanowires interaction on the mesothelial surface of the parietal pleura in vivo was investigated. Our results showed a clear threshold effect, demonstrating that fibers beyond 4 µm in length are pathogenic to the pleura. The identification of the threshold length for nanofiber-induced pathogenicity in the pleura has important implications for understanding the structure–toxicity relationship for asbestos-induced mesothelioma and consequent risk assessment with the aim to contribute to the engineering of synthetic nanofibers by the adoption of a benign-by-design approach."
Here is an interesting post from the Mass Torts Profs Blog on Judge Moss in Philadelphia granting a defense motion to seal a punitive damages verdict for plaintiffs that was entered in one Prempro trial. The defense argument was that the punitive damages verdict for the plaintiff might bias the jury in an ongoing Prempro trial in the same court.
What to do with sponsored research - take it at face value, disregard it completely, or use it subject to considering whether to reduce its weight due to the sponsorship (assuming the sponsorship is disclosed). The debate today ranges across a wide spectrum of information sources and decision-makers.
Of note yesterday, an NYT article by Reed Abelson reports that the Cleveland Clinic announced plans to make disclosure of all payments from drug companies and other sources. According to the article:
"It appears to be the first such step by a major medical center to disclose the industry relationships of individual doctors. And it comes as the nation's doctors and hospitals are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.
The Cleveland Clinic's Web postings are the most recent part of a conflict-of-interest effort at the clinic after some of its leading doctors came under fire several years ago when the news media disclosed some of their financial links."
On the topic more generally, one good source for general reading is a cogent New York Times article by Adam Liptak regarding the Exxon Valdez case and its footnote 17 regarding the Court's refusal to rely on research sponsored by Exxon. Titled From One Footnote, a Debate Over the Tangles of Law, Science and Money," the article also details a like ruling by Judge Weinstein in a drug class action.
The sponsored research topic also is being aired through symposia, such as Cornell sponsoring a symposium on Empirical Legal Studies (agenda here). There also is a good blog devoted to Empirical Legal Studies.
A new en banc 5th Circuit opinion from a strongly divided court grants the extraordinary remedy of mandamus to overturn perceived forum shopping related to a "rocket docket" in the Eastern District of Texas. Much is being made of this opinion in many contexts, including patent law and product liability cases.
Opinions on venues and "rocket dockets" are taking on even more importance as litigants seek fast outcomes and ROI. That said, the Illinois Supreme Court has been issuing rulings since 1983 trying to stop perceived forum shopping in Illinois with respect to Madison and St. Clair counties (and other venues) but those counties remain extraordinarily active venues.
For some time now, I've been writing about potential changes in product liability law due to rapid changes in communication and science. In a February, 2007 article for Corporate Counsel, I addressed various changes, including the widespread availability of scientific information and its impact on information-related tort claims. The article included my prediction that "sophisticated intermediary" types of defenses would change in light of all the available information. I'll pat myself on the back and note that I was right - in a drug case in 2007, the West Virginia Supreme Court cast aside the "learned intermediary defense due to the wide availability of information to consumers. See Johnson and Johnson v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007). The Court there said many things, including the following:
"When the learned intermediary doctrine was developed, direct-to-consumer advertising of prescription drugs was utterly unknown . . . Since the 1997 proliferation of drug advertising, only four high courts have adopted the learned intermediary doctrine . . . None of those courts gave thorough consideration to the changes that have occurred in the prescription drug industry with respect to direct-to-consumer advertising. We however, find such changes to be a significant factor in deciding this issue . . "
So, with that as background, I particularly enjoyed reading an excellent new article by Sarah (Sally) Olson of Wildman regarding the Johnson case and other additional specific examples of the Internet's effect on tort claiming. The article is titled: Net's Impact on Strict Product Laibility Law. The effects she describes include increased numbers of public consumer complaints of defects, consumer input into design, whether a company needs to monitor blogs, whether a company run blog or website will produce its own liability if a company is not accurate in what it says publicly, and various other points. Ms. Olson's article is well worth reading in full and considering how it might apply in your context.
After that, think also about reading a 2008 book titled: Stop The Presses: The Crisis and Litigation PR Desk Reference. Written by Richard Levick and Larry Smith of Levick Strategic Communications, the book's chapters 7 and * deal with blog strategies and lots of other "crisis" issues that did not exist 5 years ago in any material way. Then I'd suggest reading their chapter 9 on the impacts of media as related to increased prosecutorial activity. That's a topic I've also covered in a more limited context in a 2006 Corporate Counsel article focused on "toxic torts" and criminal prosecutions.
For those interested in "mass tort" issues, well worth reading is today's National Law Journal article regarding the recent wave of manufacturing defect product liability claims arising from drugs manufactured in China. The interesting points discussed include whether or how federal preemption principles will apply, and some aspects of claiming against Chinese entities.
Not mentioned in the article are other interesting issues. For example, down the line, these suits could produce some interesting discovery into and facts regarding the manufacturing processes in China, and the efforts of US companies and the FDA to ensure that products are made well. It will be interesting to see how their practices compare to safety practices used in other industries. Consider, for example, McDonald's and its decades of "Happy Meal" toys made in China, but distributed without incident in the US and around the globe. The great success of the McDonald's system includes the system's foresight in many years ago implementing design and manufacturing standards well above minimum standards, and having put trained observers into factories, along with using significant testing of products before they leave the manufacturing plant.