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Pharmaceutical Product Liabilities: A Review of Current Status and Future Trends

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Abstract

Background: Drug liabilities become more frequent, more publicized, and more costly. They impact patients’ perception, physicians’ practice, clinical research, and medical communication.

Purpose: To familiarize physicians with products liabilities. Data sources and extraction: Product liabilities ongoing at the 12 largest drug manufacturers are reviewed. The 2005 company reports are source documents. Medical events triggering liabilities are further reviewed. Websites of companies and health authorities are explored, and a Google search is performed. A PubMed search since the year each liability started is done. Data synthesis: Liabilities are frequent, 4.3 per company, and predominate in the United States. Multiple safety events of varying severity and frequency led individuals to claim physical damages. Plaintiffs always allege the company failed to inform users properly about drug risk. Liabilities spread across therapeutic classes. The risk increases when the label is changed or a drug is withdrawn. Publications reporting new data are frequent triggers. Company costs ranged from US$62 million to US$21 billion.

Trends indicate an increase in liabilities and associated costs. New plaintiffs are third-party payers and company shareholders. Liabilities spread outside the United States and may include lack of efficacy claims. Insurers now consider the risk of liabilities too high to continue manufacturers’ coverage. Conclusions: Product liabilities impact health care. The registration of clinical studies and the posting of their results will bring more transparency to medical research and communication. This could counterbalance current liabilities trends. The future will establish whether drug liabilities are inversely proportional to the ability to be transparent with data and promptly adjust risks and benefits.

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    Pol F. Boudes MD

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Boudes, P.F. Pharmaceutical Product Liabilities: A Review of Current Status and Future Trends. Ther Innov Regul Sci 43, 253–261 (2009). https://doi.org/10.1177/009286150904300303

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