Product liability litigation

MerlT states that a proactive risk management plan reduces product liability lawsuits, but it can also reduce drug sales "for reasons that turn out to be ephemeral." He warns pharmaceutical companies, however, that being defensive — such as described by Fitzgerald — is extremely risky. "Ongoing product liability litigation can damage a company s bottom... 

Priest (1988,190-94), however, argues that the explosion in product liability litigation has not measurably deterred accidental or job-related death rates. But he recognizes that simple time-series bivariate analysis is rather crude evidence, because there is no coun-terfactual of how many accidents would have occurred if a noliability, first-party-insurance regime had existed. 

Product liability Litigation with Risk Aversion. Journal of Legal Studies... 

Cancer risk assessments are also sometimes used in toxic tort and product liability litigation. In this context, courts express a much stronger preference for risk assessments based on human data and are more skeptical of animal studies. For example, the U.S. Supreme Court rejected the reliance of plaintiffs experts on animal studies showing that polychlorinated biphenyls (PCBs) can cause cancer, holding that the studies were so dissimilar to the human exposure and toxicity at issue in that case as to be without any value (GE 1997). This difference in the evidentiary approach of courts and agencies flows from the different institutional objectives (Allen 1996) ... 

In toxic tort and product liability litigation, the admissibility of new risk assessment methods and data must be approved by the trial judge before being presented to the jury. The U.S. Supreme Court announced a new standard for the admission of scientific data in 1993 in its Daubert decision (Daubert 1993). Under this new standard, federal judges must serve as a gatekeeper to ensure that scientific evidence is reliable and relevant, which includes an assessment of whether the evidence (i) has been empirically tested, (ii) has a known rate of error, (iii) has been peer-reviewed and published, and (iv) is generally accepted within the relevant scientific field. Many state courts have adopted a similar standard, although some still apply the earlier standard on admissibility (Frye 1923), which is whether the evidence is... 

Despite the lack of data, it is possible to sketch a rough picture of product liability trends in the research-based pharmaceutical industry from a variety of sources that are incomplete by themselves, including trends in law and insurance markets, a few in-depth studies of product liability litigation in particular jurisdictions, and anecdotal accounts of products particularly vulnerable to liability claims ... 

The increase in liability claims is not uniform across all pharmaceutical products. Contraceptives, vaccines, and drugs taken during pregnancy appear to be particularly susceptible to liability claims. The vast majority of all product liability litigation in the health care sector over the past two decades is attributable to two products—the Daikon Shield contraceptive and Bendectin,... 

I Overall Trends in Pharmaceutical Product Liability Litigation... 

Despite a lack of systematic data, it is possible to piece together the major implications of product liability on pharmaceutical R D. Although health care products appear to be a part, if not a significant part, of the increase in product liability litigation over the last 20 years, the vast majority of health-care-related cases have involved only certain types of products, contracep-... 

Misuse analysis examines the corollary to Murphy s Law that states What can be misused, will be misused. Product liability litigation has been a major driving force in misuse analysis because many times a manufacturer may be held liable for damages resulting from purchasers using or attempting to use products for other than their intended purpose. 

Influence product liability litigations and judgments in court cases. 

Products liability litigation is one means for society to cope with the technological risks imposed on it. In the past, buyers carried most of the risk for use of products. The changes in products liability law shifted much of the responsibility to manufacturers and suppliers. They acquired a greater role in ensuring that products are safe. 

There are four important theories that form the basis of product liability and provide a fundamental understanding of product liability litigation ... 

System safety is an important part of the product life cycle. Allowing the individual employee to find the problems associated with work is no longer acceptable. A proactive approach is necessary because of increased product-liability litigation and increased employee awareness of process-safety concerns. Therefore, the safety professional must make every effort to understand the concepts of system safety. 

Unless appropriate actions are taken by a company, defective and harmful products may reach customers. They may trigger incidents with unwanted outcomes, leading to product liability litigations, damage to the company s reputation, and even financial ruin. Often, it is relatively less expensive to recall the product and compensate the customers for damages, if any. 

Many methods require instrument cost and expertise in their operation. But solving failure cases may require sueh capability. For product liability litigation, penalty of millions of dollars may hinge on an analytical result. It is important to know the limits and range of applicability of methods. For example, IR is usually not a practical method for trace analysis. The reflectance IR method (ATR) may provide a spectrum of 2 microns of surface (2000 nanom ers) when what is needed is information on 2 nanometCTS. In that case the method of choice is XPS. 

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