Product Liability Concerns

A manufacturer who can show that the materials (or products) made cannot be faulted because nothing better is available to meet the usage guidelines put forward by the final customer (and not necessarily the specifications), using the most modem experimental techniques and mathematical models is most likely to be successful in preventing product liability concerns, and may even not face many lawsuits of this kind. 

To provide data to support potential product liability concerns... 

Biotechnology companies already anguishing over U.S. product liability concerns, as well as the lack of available coverage, are now facing strict liability laws in Europe. On July 25, the European Economic Community adopted new liability laws for defective products which member states "shall bring into force, not later than three years from the date of notification of this Directive," that is by July 25, 1988. 

The life cycle cost of a process is the net total of all expenses incurred over the entire lifetime of a process. The choice of process chemistry can dramatically affect this life cycle cost. A quantitative life cycle cost cannot be estimated with sufficient accuracy to be of practical value. There is benefit, however, in making a qualitative estimate of the life cycle costs of competing chemistries. Implicit in any estimate of life cycle cost is the estimate of risk. One alternative may seem more attractive than another until the risks associated with product liability issues, environmental concerns, and process hazards are given due consideration. Value of life concepts and cost-benefit analyses (CCPS, 1995a, pp. 23-27 and Chapter 8) are useful in predicting and comparing the life cycle costs of alternatives. 

There are no hard-and-fast rules to follow in setting safety factors for any given material unless experience exists. The most important consideration is of course the probable consequences of failure. For example, a little extra deflection in an outside wall or a hairline crack in one of six internal screw bosses might not cause concern, but the failure of a pressure vessel or aircraft wing might have serious safety or product-liability implications. 

Although the legislation assumes that a doctor requiring a special has made a clear decision and has evaluated the product and its use in the patient(s) concerned, it seems clear from a liability standpoint that if a company has information relevant to the safe and effective use of a special product, it should supply that scientific/factual information to the practitioner. Moreover, it is not acceptable for a company to make a supply despite reservations it may have about the intended use of the product. In circumstances such as these, both the regulatory and the product liability considerations would demand careful reconsideration of a decision to supply product, and may dictate a refusal. 

Regulatory and Legal Concerns Does the technology fall under a govem-mental regulatory regime In what ways What government licenses or pennis-sion must be obtained before the product can be manufactured and sold What potential uses or misuses of the product or service will open the company to product liability or other lawsuits ... 

Most of my inside information concerning Paxil was accumulated in late 1999 and remains valid to this day. At that time, I was asked by California attorney Don Farber to be the medical expert in a product liability... 

Liability cost rating. Each project was evaluated qualitatively for its potential to affect future remediation and catastrophic and product quality liability concerns. 

Concern about product liability can both decline and increase as phase IV proceeds. If, on the one hand, the sudden exposure of large numbers of patients to a new drug (i.e. large in comparison to those in the PLA/NDA) does not result in a flurry of serious adverse events, nor any signal of a qualitatively new type of adverse event, then there is reassurance that the label is probably doing its job properly. 

Criterion 6. The public is generally ambivalent to the needs of a large company. The public fears concentrated power that is self-serving and haraiful to the general welfare. It is particularly concerned with product availability and price, product liability, encroachment on the rights of individuals, pollution of the environment, safety, and depletion of natural resources. 

What liability concerns there are from the manufacture of this product,... 

Basic directives (type A). The basic directives apply to all manufacturers of products and address trade, enforcement, liability, and other issues. It is important to understand the implication of these directives, especially concerning enforcement against product manufacturers. Examples of the basic directives are CE Marking, Conformity Assessment, General Product Safety, and Product Liability. Products, components, and materials not covered by Type B or C directives must still be safe according to the General Product Safety Directive (e.g., comply with standards). 

Any decision taken by virtue of this directive shall be without prejudice to Product Liability directive 85/374/EEC and without prejudice to the assessment of the liability of the party concerned, in the light of the national criminal law applying in the case in question (see Product Liability). 

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