Product liability example cases

For instance, in September 2004, Bayer settled 2861 product liability cases for 1.09 billion for its cholesterol medicine cerivastatin (Baycol), which was linked to 100 deaths and withdrawn from market in 2001. In July 2004, the company settled 2771 cases for 1.06 billion. Bayer still has 7577 additional cases to settle (see Section 28.4.4.5 for additional information). In another example, a 1 billion jury verdict was upheld against Wyeth for its fenfluramine or dexfenfluramine and phentermine (Fen-Phen) drug combination, which was linked to primary pulmonary hypertension (PPH). Wyeth has set aside 16.6 billion to cover future liability on the drug (see Section 28.4.4.2 for more on this case). ... 

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. 

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. 

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) ... 

If the facts in a legal case involve specialized and technical subject areas, expert witnesses may testify in the case. A case may require the expertise of engineers, safety professionals and other specialists. For example, physicians usually testify about product injuries. In products liability cases, engineers often testify about a product, existence of defects, use of the product, design alternatives, negligence, compliance with published standards or standards of practice, the state of the art, and other matters. 

Product liability is also a major concern for many companies. The McDonald s coffee award is a good example. In this case, a woman placed a cup of McDonald s coffee between her legs in a car. The coffee spilled and the woman was severely burned. McDonald s was found liable for the injuries, even though McDonald s cups contain a warning stating the contents are hot. 

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. 

The legal aspects of medical device safety have become an important issue. Three commonly used theories to make manufacturers liable for injury caused by their product are shown in Figure 9.1 [3,13]. These are breach of warranty, negligence, and strict liability. Breach of warranty may be alleged under three scenarios breach of an expressed warranty, breach of the implied warranty of merchantability, and breach of the implied warranty of suitability for a specific case. For example, if a medical device causes an injury to a person because of its failure to operate as warranted, the device manufacturer faces liability under the expressed warranty scenario. 

Severity is the potential loss when an event occurs. Some express potential losses in human terms, such as loss of life, serious injury, serious illness, number of cancer cases or similar terms. Some express a loss in financial terms. Examples are dollar value of production interruption, cost to replace lost equipment, cost to replace facilities, or cost of medical treatment, pay compensation for those injured or increased insurance premiums. Some express loss in legal terms, such as number of claims or lawsuits and the liability incurred. For a company, a loss can be a reduction in public image or product image or lost market share. 

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