Liability laws

George Eads and Peter Reuter, Designating Safer Products Gorporate Responses to Product Liability Law and Regulation, The Rand Corporation Institute for Civil justice, Santa Monica, CA, 1983. 

Critics have long complained about the ineffectiveness of medical liability law both as a means of reducing the risks of injuries and as a system of compensation for injuries. So far, none of these critiques has led policy makers to jettison our fault-based medical liability system and to replace it with some type of no-fault system as proposed by some scholars. Thus some form of medical liability is going to be a feature of the social and regulatory... 

Policy makers, practitioners, and scholars from a variety of disciplines have recently embraced a new approach to risk reduction in health care—a "systems approach"—without proposing any specific reforms of medical liability law. The Institute of Medicine (IOM) placed its imprimatur on this approach in its recent reports (Kohn et al., 2000 IOM, 2001). In its simplest form, a systems approach to risk reduction in health care posits that an injury to a patient is often the manifestation of a latent error in the system of providing care. In other words, a medical mishap is the proverbial "accident waiting to happen" because the injury-preventing tools currently deployed, including medical liability law, are aimed at finding the individuals at fault rather than the systemic causes of error. Coexistence of a systems approach to error reduction and medical liability law as a conceptual framework for policy makers implies that the latter is likely to evolve in an incremental fashion as the former makes more visible different aspects of the medical error problem. 

At first blush, the increased risk of harm suit against a drug manufacturer on a negligence theory that pharmacogenomics could have been used to determine the increased risks to a portion of the population appears to be a logical extension of the doctrinal shifts in liability law signaled by Moore. The likelihood of success of this particular lawsuit is in fact small because of the nature of existing medical liability doctrine in Pennsylvania. 

The conditions are different in the USA because of much more stringent liability laws. Cf www.vci.de... 

This is a case where the court chose not to legislate beyond traditional product liability law. There has been a great increase in gun liability litigation in recent years, and it is far from clear whether most courts will even-mally follow the approach in Kelley or the one here. 

Huber, Peter. 1988a. Environmental Hazards and Liability Law. In Liability Perspectives and Policy. Edited by Robert E. litan and Clifford Winston. Washington Brookings Institution. 

Products Liability Law and the Accident Rate. In Liability Perspectives... 

While efficiency dictates that different prices are charged in different markets, observable price differentials are not always due to reasons of economic efficiency or profit-maximization. Pharmaceutical prices are widely subject to nation-specific government regulation and a host of other factors. Bale (1998) provides a comprehensive review of potential reasons for price differences across countries. These include differences in such factors as IPR regimes, product liability laws, inflation rates, exchange rates, governmental price controls, per capita income, and regulatory systems. 

Product liability law, generally and as it pertains to pharmaceutical companies, is broadly based on legal principles involving contract law, the law of torts and the relevant statutory provisions of the country or jurisdiction where the action is brought (Jones, 1993). However, there are three fundamental legal principles under which a seller of a product can be liable for damages incurred from the use of that product strict liability, warranty and negligence. 

Garbutt BJ, Hofmann ME. 2003. Recent developments in pharmaceutical products liability law failure to warn, the learned intermediary defense, and other issues in the new millennium . Food Drug Law J. 58(2) 269-286. 

These tendencies can only be transformed into practical results if existing and future laws, regulations, and framework conditions are taken into account. The European legislative process, and the expansion of the European Union, will play important roles, in particular the chemical policies product liability laws. The particular relevance of these aspects to the adhesives industry and development of new adhesives, and the chances and risks involved, are treated in greater detail later. 

Even assuming that businesses in the small and medium-sized sector do manage to pay the costs of certification of harmlessness and the hazard potential descriptions, the result will be large numbers of duplicate tests, since every supplier bears responsibility for the raw materials, intermediate products and end products he uses or produces and must answer to the product liability laws. 

The liability insurance industry is a poor source of information on the drug industry s product liability experiences because companies now largely self-insure for all but the highest liability losses. The best source of information on the costs and implications of product liability law in this industry are drug companies themselves. The Office of Technology Assessment (OTA) found no published data summarizing industry experience.1... 

Although the Federal Government has not adopted product liability reforms for therapeutic pharmaceuticals, several States have, and the Federal Government has adopted no-fault compensation schemes for swine flu and childhood vaccines that could offer potential models for Federal underwriting of other product liability risks. The U S. Congress has also considered several proposals to adopt a Federal product liability law that would supersede current State law. 

Liability law in this country draws more from the common law precedents of previously de-... 

Even with these complexities, there are some common elements in pharmaceutical liability law. In determining whether the manufacturer is indeed liable for any injuries caused by the product in question, the courts tend to establish liability for pharmaceuticals in one of two ways ... 

Review of the effect of external factors on costs and returns on pharmaceutical R D, including new drug regulation, tax policy, product liability law, direct R D subsidies by the National Institutes of Health (NIH) and other government research bodies, and reimbursement policies (both private and public) for prescription drugs. 

Lasagna, L., The Chilling Effect of Product Liability on New Drug Development, The Liability Maze The Impact of Liability Law on Safety and Innovation, R.E. Litan and Peter W. Huber (eds.)(Washington, DC The Brookings Institution, 1991). 

Schwartz, T. M., Products Liability Law and Pharmaceuticals Developments and Divergent Trends, Food Drug and Cosmetic Law Jour-nal 43 33,1988. 

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