Pharmaceutical companies litigation

MerlT states that a proactive risk management plan reduces product liability lawsuits, but it can also reduce drug sales "for reasons that turn out to be ephemeral." He warns pharmaceutical companies, however, that being defensive — such as described by Fitzgerald — is extremely risky. "Ongoing product liability litigation can damage a company s bottom... 

The Human Development Report 2001 reveals that under pressure from Europe and the usa developing countries fear that they may lose foreign investors if they legislate for or use compulsory licenses (undp, 2001). In addition, developing countries also lace the threat of long, expensive litigation brought by pharmaceutical companies. 

Post-marketing safety studies are considered in their own chapter of this book. However, it should be noted here that patient registries have been associated with grave jeopardy of litigation in the United States, and not necessarily on a sound scientific basis. On more than one occasion, pharmaceutical companies have been deterred from marketing new drugs when FDA has required a patient registry as a condition of NDA approval. 

ICH GCP provides detailed guidance on the information and structure of both the subject information sheet and the informed consent form (ICF). Some lECs provide alternative requests to the international requirements, perhaps in an effort to reduce the length of the information sheet or to simplify the information. Some pharmaceutical companies provide too much information, particularly with reference to possible adverse events, to provide (debatably) protection from litigation. In fact, the language should be non-technical and only pertinent aspects of the trial provided, as described in Chapter 4 of the ICH guidelines (also see Section 6.4.6.3). 

In summary, Congress has the power to request R D and marketing cost data from the industry. But, given the past history of litigation on the issue it is safe to predict that pharmaceutical companies are not likely to make such a request easy, and Congress has so far been unwilling to exercise this power. 

Product liability has become one of the fastest-growing, and perhaps the most economically significant, applications of tort law. Pharmaceutical companies have been defendants in some of the most widely publicized and costly product liability lawsuits in the USA and Europe, prompting many companies to lobby vigorously for tort reform and prepare years in advance for the possibility of litigation (Nace et al, 1997). The liability burden of pharmaceutical companies has been described as extremely disproportionate to their sales when compared with other manufacturing industries (The Progress and Freedom Foundation 1996,... 

Uses class action litigation and public education to challenge what it calls illegal pricing tactics and deceptive marketing by drug companies and others in the pharmaceutical industry. 

Systematic attempts to determine product liability costs borne by the pharmaceutical industry, and the impact of product liability on fins R D decisions, innovation, and drug safety would require data from several sources, much of which is currently unavailable. Firms do not routinely report to the public on liability claims made on their products or settlements made by the firm or their insurers. Insurance companies collect data on claims made under their policies but do not report on claims associated with particular companies or products. For the minority of claims proceeding to litigation, court records exist but are not centralized across different State and local jurisdictions. 

Hospttal>acquired (nosocomial) infections are not uncommon. However, those that have been conclusively attributed to supposedly sterile but actually nonster lie pharmaceutical products or medical devices are quite rare. The consequences of these incidents have not confined themselves to the companies responsible for the failure to achieve sterility but have reverberated throughout the whole steriles" industry. No company wishes to face the litigation, loss of sales, loss of goodwill, and generally bad publicity that accompanies nonslerility. Most of all, ethical companies are in the business of preserving life, not in the business of killing people—and death is often the consequence of nonslerility. 

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