Product liability evidence

More typically, the failure to preserve evidence can hurt the company in a lawsuit. For example, where a defense expert in a product liability case conducts destructive testing on the product, thereby rendering it unfit or unavailable to the plaintiff s expert, the court may sanction the conduct by excluding the testimony of the defense expert. Alternatively, if crucial documents are destroyed or lost, thejudge may instruct thejury to assume the worst—that the documents contained information harmful to the defendant s position in the litigation. 

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. 

In 1983, Merrell Dow Pharmaceuticals, Inc. voluntarily removed Bendectin from the market because of the many product liability suits pending. However, subsequent in-depth analysis of epidemiological and scientific data indicated that the therapeutic use of Bendectin had no measurable teratogenic effects. Nevertheless, despite the overwhelming scientific evidence, a number of jury decisions were rendered against the company (providing an argument for tort reform). 

Berman J. 1984. Beshadav. Johns-Manville Products Corp. The function of state of the art evidence in strict products liability. Am J Law Med 10 93-114. 

Traditionally, a plaintiff has two tasks known as burdens of proof. First, he or she must meet the burden of production by providing factual evidence for each element of a particular cause-of-action (e.g., negligence, battery, etc.) Second, he or she has a burden of persuasion. That is, she must convince the jury that her version of the facts is worthy of their collective belief with a minimum level of certainty, as defined by a standard of persuasion. The four commonly used standards are (a) beyond a reasonable doubt in criminal cases (b) by clear and convincing evidence in some civil cases and (c) more likely than not or (d) by a preponderance of the evidence in most civil cases, including workers compensation, toxic tort, products liability, and occupational disease claims. 

Judicial decisions in nonregulatory contexts such as toxic tort and product liability suits are likewise inconsistent in their consideration of the linear, no threshold model. As in the regulatory context, most cases find no problem with an expert s reliance on a risk assessment using the linear model. In a handful of cases, however, the court rejects reliance on a linear dose-response assumption. Eor example, one court in addressing the cancer risks from a low concentration of benzene in Perrier held that there is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance (Sutera 1997). Another court decision concluded that [t]he linear non-threshold model cannot be falsified, nor can it be validated. To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the scientific community. It has no known or potential rate of error. It is merely an hypothesis (Whiting 1995). The inconsistency and unpredictability of judicial review of risk assessments adds an additional element of uncertainty into the risk assessment process. 

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... 

The greatest impediment to understanding the effects of product liability on the drug R D process is the lack of evidence on trends in pharmaceutical liability cases. Data on court cases are limited because the legal system adjudicates only a small fraction of all product liability claims and because there is no... 

Assessing the impact of increased product liability on pharmaceutical firms is difficult. No data exist to measure R D and other business costs attributable to product liability. The little systematic research done to date on whether product liability affects the rate of pharmaceutical innovation has yielded inconclusive results. Evidence drawn from the experiences of particular products or from interviews with industry executives indicates liability may inhibit or preclude R D or marketing of reproductive-related vaccines and products. 

OTA found no studies or other evidence that allow one to test the first of these hypotheses. In addition, it was not cited by pharmaceutical industry officials in any of OTA s interviews at eight drug fins. Hence, OTA is unable to shed any additional light on this possible corporate response to product liability. However, there is evidence (albeit largely anecdotal) that bears on the second hypothesis. 

Much of the remaining evidence on product liability and pharmaceutical innovation is anec-... 

Meeting other legal or moral requirements, e.g. child resistance, tamper-evidence, etc., including product liability issues. 

The scope of the product liability law has recently been increased. If the manufacturer of a product cannot produce adequate evidence of sufficient product quality, the manufacturer may be held liable for any damages which have occurred in connection with the product. 

The plaintiff in a products liability lawsuit must bring certain evidence in support of a claim. Except in expressed warranty cases, the plaintiff must prove ... 

In reference to the four theories of product liability, each has its own requirements for evidence presentation (Brauer, 1990) ... 

When urgent data collection is completed, have sources of technical expertise identified for examination and testing of evidence. Make sure that the company has communicated and interfeced with suppliers of equipment and materials on product liability. 

Independence. Since accountability is becoming a more important aspect of product liability, a documented report containing solid evidence of testing and fail-safe analysis by an independent firm carries much weight in establishing the intent of the manufacturer to design and make safe products before they reach the market. 

In order to prevail in a products liability action under a negligence theory, a plaintiff must prove all of the four elements listed and discussed below. Negligence claims are civil actions based on the law of torts. In such actions, the presumption is that the accused party is not liable and the plaintiff has the burden of proof by a preponderance of the evidence. Preponderance of the evidence is the standard of proof required in ordinary civil actions and refers to proof which leads the finder/trier of fact to find that the existence of the fact is more probable than not. Preponderance of the evidence is a lower standard of proof as compared to the standards of clear and convincing and beyond a reasonable doubt. 

The manufacturers of a mass product that is far from the end-user, such as cement or concrete, are under extreme price competition and slightest changes in, say, the cost stracture can be decisive. Elimination of water-soluble chrome-VI compounds that cause chromate-induced eczema would only increase the price of the product minimally. And even if the severe price competition did in fact permit this increased margin (which is highly probable in this example), there has been no significant iimovation push. Uirfortunately, this occupational disease is hardly perceived by the public and the costs incurred by this type of eczema evidently can be externalised by the cement industry (and covered by the employer s liability insurance). 

Customer Remedies Plunkett Research, Ltd. and its suppliers entire liability and your exclusive remedy shall be, at Plunkett Research Ltd. s sole discretion, either (a) return of the price paid, if any, or (b) repair or replacement of the product that does not meet Plunkett Research, Ltd. s Limited Warranty and that is returned to Plunkett Research, Ltd. with sufficient evidence of or receipt for your original purchase. 

In case of use date extension an additional label should be affixed to the investigational medicinal product. This additional label should include the new use date and repeat the batch number. It may be superposed on the old use date, but, for quality control reasons, not on the original batch number. This operation may be performed on site by the clinical trial monitor(s) or the clinical trial site pharmacist, in accordance with specific and standard operating procedures and under contract if applicable. The operation should be checked by a second person. Documented evidence of this additional liability should be available in the trial documentation and in the batch records. 

It is evident that aldehyde-containing saponins, particularly those from Quillaja saponaria Molina, have unique features which provide them with particular immune stimulating properties. However, some of their chemical properties cause instability and toxicity which interfere with their utility as adjuvants. A better understanding of the underlying relationships between the saponin s chemical structure and biological functions, such as immune system modulation and toxicity, would allow the future development of semi-synthetic and synthetic molecules having the advantages but not the liabilities of these natural products. 

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