Liability considerations

In Guidance Note 14, the Medicines and Healthcare Products Regulatory Agency states that hospital trusts, health authorities and independent hospitals should have clear policies on the use of unlicensed medicines, explaining liability considerations and requiring all those involved in the supply chain to ensure that the unlicensed status of a product is commimicated and fully understood. 

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. 

Product development public-private partnerships (p-PPPs) are collaborative organizations between non-profit and for-profit organizations. They are institutionalized with public intervention and/or funding because markets are perceived as unable to adequately connect relevant resources and capabilities between science and industry in basic research. Clearly, diseases such as malaria, tuberculosis, and others that are even less well known are rampant in developing countries but are far less of a threat in most developed countries (Wheeler and Berkley 2001 Kaplan and Laing 2004). There is, therefore, little or no economic incentive to develop pharmaceutical products for these diseases (Biel 2001 Milne, Kaitin, and Ronchi 2004 Kaplan and Laing 2004). The industry s lack of enthusiasm is also a result of distribution challenges in countries with poor infrastructures and lack of awareness about these diseases in more developed countries, liability considerations, inadequate science base, and underestimation of the disease burden. Product PPPs have been developed to address... 

This volume and the following are both written with a view to product liability considerations. 

Experience has demonstrated that manufacturers of forklifts and attachments are reluctant to provide written approval due to liability considerations. Are any other options available to employers who wish to use manufactured or fabricated attachments with a forklift Are a safety analysis and marking of the forklift by the employer acceptable If so, must the analysis be performed by a registered engineer. 

Additional separation and recycling. Once the possibilities for recycling streams directly, feed purification, and eliminating the use of extraneous materials for separation that cannot be recycled efiiciently have been exhausted, attention is turned to the fourth option, the degree of material recovery from the waste streams that are left. One very important point which should not be forgotten is that once the waste stream is rejected, any valuable material turns into a liability as an effluent material. The level of recovery in such situations needs careful consideration. It may be economical to carry out additional separation of the valuable material with a view to recycling that additional recovered material, particularly when the cost of downstream effluent treatment is taken into consideration. 

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. 

The life of the product- access to the records will probably not be needed for some considerable time, possibly long after the contract has closed. On defense contracts the contractor has to keep records for up to 20 years and for product liability purposes, in the worst case situation (taking account of appeals), you could be asked to produce records up to 17 years after you made the product. 

The focus of this element is on the enhancement of product safety and the minimization of product liability through the use of standards, initial tests and evaluations, human factors considerations, and subsequent analyses of problems. For ESH/PSM, safety might be viewed more broadly as safety, health, and environmental protection. 

The liability of an employer to his or her employees in respect of injury arising out of or in the course of their employment usually falls for consideration under either common law (the law of tort) or statute. 

While not exhaustive, the following points for consideration will go far towards optimizing the control of safety and liability standards within the engineer s sphere of influence. 

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. 

Economic, liability, public image, and opinion considerations are involved. Catastrophic hazards are less acceptable than smaller ones even if the absolute risk is identical. Voluntary risks are a way of life for most people, but there is minimal tolerance for involuntary risks, particularly if they are unknown or not understood. 

For corporations the same reasoning applies. To offer the prime interest rate the lender must be sure he can get his capital back plus interest. This means that the borrower s total assets must be considerably greater than the current liabilities and debts. Consider the simplified balance sheet given in Table 10-13. By current assets is meant cash and everything involved in working capital-feedstocks, unsold product, plus all the product that has been shipped but for which no payment has... 

In the early 1960s, drug companies began to lobby for government indemnity for the vaccines they developed, tested, and produced. Because so many people are vaccinated at one time, particularly school-age children, ADRs from a vaccine can carry considerable liability. As more diseases have become vaccine-preventable, more ADRs have been reported. In 1974, impetus for indemnity increased when the courts upheld a jury verdict of 200,000 for a child who developed polio from the Sabin live-polio vaccine. ... 

A CERCLA response or liability will be triggered by an actual release or the threat of a hazardous substance or pollutant or contaminant being released into the environment. A hazardous substance [CERCLA 101(14)] is any substance requiring special consideration due to its toxic nature under the Clean Air Act, Clean Water Act, or Toxic Substances Control Act (TSCA) and as defined under the RCRA. Additionally [CERCLA 101(33)], a pollutant or contaminant can be any other substance not necessarily designated or listed that will or may reasonably be anticipated to cause any adverse effect in organisms and/or their offspring. 

These differences in the behavioural properties of the opioid receptor sub-types are of considerable interest because the clinical use of currently marketed opioid analgesic drugs is limited by their undesirable side-effects, which include respiratory depression, constipation and an abuse or dependence liability. These side-effects have been associated with mu receptor ac-... 

Abuse Liability as a Function of the Formulation Implications for Consideration... 

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