For The Defense, November 2012 - DRI Today

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Product Liability risk.” Again, “relative risk” is an umbrella term used to describe the various measurements of association used in both cohort and case- control studies mentioned above, which can include a standardized mortality ratio (SMR), a standardized incidence ratio (SIR), a proportionate mortality ratio (PMR), an odds ratio (OR), others, or a combinations of them. Testimony offeredon these topics moves from the scientific to the hypothetical and has spawned a variety of unspecific and very unscientific “catch phrases” summarizing the bases of causation opinion theories. As mentioned above, a scientific study (case- control or cohort study) that shows a relative risk of 2.0 indicates a two-fold association between the agent and the disease or suggests a doubling of the risk that the agent, in fact, will cause the disease. This means that the incidence of the particular disease or mortality is attributable to the agent and one-half is attributable to other factors. Thus a relative risk of 2.0 suggests that the disease is just as likely to be related to the exposure to the agent as it is to be unrelated to the exposure to the agent. Again, as mentioned above, a study that shows a relative risk of greater than 2.0 indicates that more than one-half of the incidence of the particular disease or mortality is attributable to the agent, in other words, more than 50 percent, and less than one-half is attributable to other factors. Thus a relative risk of > 2.0 suggests that more likely than not the disease is related to the exposure to the agent: a > 50 percent chance of causation. A relative risk of > 2.0 is equivalent to the “more likely than not” preponderance of the evidence legal standard. To learn more about the “more 72 ■ For The Defense ■ November 2012 likely than not” standard, epidemiological evidence, and a “relative risk” of 2.0, see DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941, 957–59 (3d Cir. 1990). While sometimes referred to as a “talisman,” there is nothing particularly magical in science or epidemiology about a relative risk of 2.0, particularly when compared with a 1.99999999 or a 2.00000001. However, in a toxic tort case, 2.0 is the actual scientific statistic delineating the difference between more likely and less likely and the place where relative risk, indeed, becomes a magic number. Take Another Look Also worth reexamining, and essential if you are litigating your case in a federal court, is the Federal Judicial Center Reference Manual on Scientific Evidence. See Reference Manual on Scientific Evidence (3d ed. 2011). In 2011, the National Academy of Sciences published the third edition of the Reference Manual on Scientific Evidence, which was created by a panel of judges, scientists, engineers, and doctors and serves as a resource for judges to consult when dealing with scientific evidence. The topics covered in the third edition of the manual are the admissibility of expert testimony, how science works, forensic identification expertise, DNA identification evidence, statistics, multiple regression, survey research, estimation of economic damages, exposure science, epidemiology, toxicology; medical testimony, neuroscience, mental health evidence, and engineering. Many judges, both state and federal, rely on this manual as the first and perhaps even the last word on certain issues. The reference manual addresses the necessary link between exposure and disease and how that causal nexus may be established, reliable exposure assessment, and the valid and reliable scientific reasoning necessary to support the link between the exposure of a plaintiff to the specific agent at issue and the disease in that plaintiff. The manual offers questions relevant to evaluating science in a legal context, including the following: • What are the sources of exposure • What are the specific agents involved in the exposure • What is the duration of exposure, and what is the basis for that conclusion • What are the pathways from the source to the exposed individuals • Have those pathways been established • What is the concentration of the agent in the media with which the exposed population came into contact • What is the basis for these answers Direct measurement Estimates Modeling • If models or estimates were used, how reliable are they • What is the variability over time in concentrations in the media of concern • What is the variability over time in concentrations in the pathways of concern • How has the variability been determined • What is the variability among members of the population in their exposure to the chemical of concern and how is this known • What dose, over what period of time, by which routes, has the individual received • What cumulative dose did the individual receive • What calculations and evidence support this documentation • What is the likely error rate in the exposure estimates • What uncertainties are associated with the dose and duration findings • What has been omitted from the exposure assessment, and why • Has the cumulative dose of the exposure that the individual received to this specific agent been shown by reliable and statistically significant scientific evidence to cause the particular disease 2.0 Is a Magic Number Before an expert may offer an opinion that an “exposure” to an agent was more likely than not the cause of an alleged injury, a plaintiff must show that the plaintiff was “exposed” to a quantifiable estimated dose of a specific agent and that that dose of that specific agent has been shown by reliable scientific evidence to more likely than not cause the injury. Thus, there should be reliable epidemiological studies in the peerreviewed published medical and scientific literature that suggest that the dose of that specific agent creates a statistically significant increased relative risk of greater than 2.0 of developing the particular alleged injury. Magic Number, continued on page 81
Product Liability Be Armed with Good Science By Douglas R. Morr and Gary J. Heydinger Defending Claims Against ROV Manufacturers Reliable and scientifically valid information on how restraint systems work in real-world events can be the backbone of a strong defense against opinions based on inaccurate theories. One of the critical components of any successful product liability defense is comprehensive knowledge of the product. This includes having a firm understanding of the performance characteristics, capabilities, and limits of the product. Knowledge of this type coupled with an evaluation of the product under circumstances specific to a claimed event is desirable. Inaccurate opinions and accusations can be combated with clear, comprehensive, and credible scientific information. These statements are true for all products, including Recreational Off- Highway Vehicles (ROVs). ROVs, also known as side by sides, differ from on-road passenger vehicles in both their intended uses and their features. In general, ROV customers want vehicles with superior levels of “off- roading” capability, the ability to maneuver through narrow spaces, and a tight, low-speed turning radius. Accordingly, ROVs are designed to travel over rough terrain with a track width narrow enough to fit on many existing off- highway trails. To satisfy this demand, manufacturers provide high ground clearances, large ranges of suspension deflections, large low- pressure tires, and responsive steering. Some consumers also want vehicles that are capable of higher speeds. This desire has led to the development of more powerful ROVs. As with many cases involving onhighway vehicles, accidents involving ROVs are often attributed to insufficient levels of stability or safety. Assertions such as “The vehicle’s center of gravity height is too high and its track width is too narrow,” or “The vehicle’s tip-up resistance is not high enough,” or “The vehicle’s occupant restraint system is inadequate,” are often made regarding ROVs. Although these types of allegations are generally vague, they must be addressed to defend a product liability case successfully. Claims against ROV manufacturers stem from allegations of one or more occupants being injured while riding in an ROV, and purportedly involve one or more of the following: ■ Douglas R. Morr, M.S., P.E., leads S-E-A’s Biomechanical Group in conducting investigations and research relative to injury mechanisms and causation. He oversees research and testing programs at S-E-A’s Research Center, including Roll Simulator testing of occupant response and protection, as well as Minor Impact Simulator and Drop Tower testing. Gary J. Heydinger, Ph.D., P.E., is the Director of Vehicle Dynamics for S-E-A, and was integral to the design of the Vehicle Inertia Measurement Facility (VIMF), which measures vehicle CG height, moments of inertia and SSF for automotive manufacturers and the National Highway Traffic Safety Administration’s New Car Assessment Program. For The Defense ■ November 2012 ■ 73
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