Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation
Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation
Pages 253-272
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From page 253... ...
Today, tort liability's role in food and medical product regulation can be analyzed by considering its impact on four objectives: safety, compensation, product availability, and product innovation. The extent of the tort system's impact on those objectives is a product of the liability rules that are laid down (for example, strict liability versus negligence)
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From page 254... ...
At the same time, the common law permitted a buyer to sue a seller of substandard food for damages.3 Owners of restaurants were subject to strict liability for sales of food and drink.4 Nevertheless, before industrialization, at least in common law countries, tort suits based on product quality were few, perhaps in part because the costs of litigation outweighed the benefits.5 Beginning in the mid-19th century, the development of mass production, industrialization, science, and national markets led to changes in both how the state oversaw food and medical products. In the United States, the rise of the modern regulatory agency in the first half of the 20th century also coincided with expansion of the scope of product liability.
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From page 255... ...
Lawyers for industry told their clients: "[W] ith minor, if any, exceptions, a manufacturer, canner, packer, or processor is presently held to be liable to a consumer for lack of care in the preparation or inspection of his product, where such lack of care proximately results in injury to the consumer."9 At the same time, the pressure from litigation was also at work: some well-known manufacturers made greater efforts to institute product safety measures in response to the concern of potential exposure to lawsuits.10 Tort liability for goods developed into a specialized area of product liability law, with its own plethora of detailed rules and doctrines.
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From page 256... ...
In the next section, this review considers these objectives and the factors that influence the effectiveness of the product liability system. ANALYSIS OF THE RELATIONSHIP BETWEEN ADMINISTRATIVE SYSTEMS FOR FDA-REGULATED PRODUCTS AND PRODUCT LIABILITY Modern administrative systems and tort liability systems today have different purposes and methods to achieve their goals.
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From page 257... ...
Second, it identifies access rules and the quality of civil justice institutions as additional factors that must be considered when examining a tort system's effectiveness. Third, it discusses ways in which other significant product liability systems, namely the European and New Zealand models, vary from the U.S.
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From page 258... ...
This may produce a social benefit by driving out substandard products. The Dalkon Shield case is often described in this way.21 In other instances, actual or potential tort liability may cause producers in key industries to consider exiting the market or to raise prices significantly, which may result in greater social harm.
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From page 259... ...
With respect to foodborne illness litigation, experts that reviewed jury verdicts noted the difficulty in determining "exactly how 22 Supply concerns were central to the passage of the National Childhood Vaccine Injury Act of 1986.
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From page 260... ...
Factors Influencing Results and Effectiveness of the Tort Liability System The way in which the tort system affects regulatory outcomes such as safety for food and medical products is largely affected by three main factors: (1) substantive rules governing liability; (2)
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From page 261... ...
The importance of access is reflected in a recently commissioned study by the European Union in which "greater access to legal assistance" was most frequently mentioned as a "major factor" in "contributing to the success of product liability claims in European jurisdictions."36 30 riChard a. nagareda, mass torts in a worLd oF settLement 8 (2007)
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From page 262... ...
Product liability suits against medical device manufacturers can no longer be brought if the claim is based on standards "different from" or "in addition to" FDA requirements. Accordingly, plaintiffs cannot bring cases under theories of design defect or inadequate warning defects under state tort law for medical devices that have undergone pre-market authorization.
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From page 263... ...
For example, New Zealand significantly curtailed its tort law and replaced substantial portions with a government-administered "no-fault" system in 1974.46 Under the New Zealand system, personal injury lawsuits are replaced with application to a state-run compensation fund. As a general matter, lawsuits for accidental injuries caused by FDA-regulated products cannot be brought under tort.47 Instead, the injured party applies to 40 stapLeton, at 45.
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From page 264... ...
Because FDA-regulated products, particularly pharmaceuticals and medical devices, require substantial scientific expertise to develop and to evaluate, a developing country may have a smaller pool of domestic scientific expertise. Those individuals may be highly sought after by both regulators and industry, increasing the risk of inappropriate conflicts of interest.50 48 One current domestic example of this situation: U.S.
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From page 265... ...
This brief review is not exhaustive, but is meant to introduce the central legal doctrines and institutions that bear on the matter of product liability, particularly for food and medical products. Brazil Brazil's current product liability system is primarily founded on the Consumer Protection Code, which it adopted in 1990.51 The code was the result of a constitutional amendment and sought to widen consumer access to courts.
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From page 266... ...
The courts crafted their own tenure, pay, and disciplinary systems, with little oversight by other branches of government.59 Serious cases of judicial corruption and waste continued, however, severely undermining the credibility of the courts and resulted in a constitutional amendment that now seeks to rein in the judiciary.60 From a case management perspective, today, the judiciary continues to face a high backlog of civil cases.61 Different localities face severe institutional challenges: in Sao Paolo, each judge has an average of 8,000 to 10,000 cases.62 In sum, while the rules governing product liability liberalized, the practical difficulties that plaintiffs face in accessing the courts, together with the state of the civil justice system, indicate that the tort system is likely to play a constrained role in product regulation. India India's modern legal system is grounded in the common law tradition.
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From page 267... ...
Plaintiffs can also file class actions, but such actions have been rare in mass tort lawsuits.67 Access is also hindered because attorneys cannot take cases on a contingent fee basis. As an institution, India's courts also face the problem of corruption, which is reportedly quite severe at lower levels of the system.68 It is estimated that use of the regular civil courts in India is "among the lowest in the world."69 This may be the result of the massive backlog of cases in the courts: estimated to be 20 million in the lower courts.70 The administrative system for FDA-regulated products has similarly undergone significant change and reorganization.
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From page 268... ...
Usually, these are organized as periodic crackdowns, and in recent years, such campaigns have been waged on identified products of public concern, such as dairy and cooking oil.73 With respect to the substantive law, China formally adopted a tort law in 2009 that re-codified and provided greater detail on the scope of tort liability in various specific areas. It provides for strict liability for defective products.74 A defect is an "unreasonable danger existing in a product" that "endangers the safety of human life" or is not compliant with relevant safety standards.75 It appears that Chinese law also includes a development risk clause similar to the European one.76 In its new Food Safety law, China also provided for damages equivalent to 10 times the cost of the product if 71 Food Safety and Standards Act, 2006, No.
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See Wang Shengjun: "Three Supremes" shall always be the guiding thought of the courts, Xinhua net, June 23, 2008, at http://news.xinhuanet.com/legal/2008-06/23/content_8420938.htm (crediting original source as Legal Daily) (site last visited Nov.
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From page 270... ...
The agency recognized the country's consumer laws as "outdated, fragmented and predicated on principles contrary to the democratic system."84 This effort culminated in the country's Consumer Protection Act in 2008. Under the new law, producers are strictly liable to consumers for producing goods that are unsafe, defective, or hazardous, regardless of whether the producer was negligent.85 There is no liability, however, if the harm caused is "wholly attributable" to compliance with existing regulatory standards.86 One can infer from this language that producers of FDA-regulated products that comply with South Africa's regulatory standards may be shielded from liability but only as long as it can be shown that the harm was completely caused by compliance with the relevant rules.
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From page 271... ...
CONCLUSION Assessing the role that the tort system has in the regulation of food and medical products in developing countries requires a highly factual and context-dependent understanding of the potential capacity of both the civil justice and administrative regulatory systems. As this committee recognizes, "developing countries" for the purposes of this study may encompass "a heterogeneous group of 150 or more low- and middle-income countries." In countries where administrative agencies are under-resourced or challenged by lack of independence, efforts to support the civil justice system, particularly in the area of tort liability may help support the regulation of food and medical products.
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