Pharmaceutical Product Liabilities: A Review of Current Status and Future Trends
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Pharmaceutical Product Liabilities: A Review of Current Status and Future Trends
Pol F. Boides, MD Hackettstown, New Jersey
Key Words Product liability; Drug safety; Lawsuit; Medical communication
Correspondence Address Pol E Boudes, MD, 10 Setting Sun Drive, Hackettstown, NJ 07840 (ernail: [email protected]).
Background: Drug liabilitiesbecome more fiequent, more publicized, and more costb They impact patients' perception, physicians' pmctice, 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 firther reviewed. Websites of companies and health authon'ties are explored, and a Google search is performed. A PubMed search since the year each liability started is done. Data synthesis: Liabilities are fresuent, 4.3 per company, and predominate in the United States. Multiple safq events of varying severity and fiequency led individuals to claim physical damages. Plaintifi always allege the company failed to infnm users proper!^ about drug risk. Liabilities
INTRODUCTION Drug liabilities are becoming more frequent, more publicized, and more costly. These events, when plaintiffs allege damage resulting from the use of a drug, impact patients' perception of drug treatment as well as physicians' practice. Liabilities hurt the image of manufacturers and divert companies from their strategic mission of improving our life (1). Beyond the personal, economic, and public relations aspects, product liabilities also significantly impact the way new chemical entities are developed, data are published, and drugs are promoted (2,3). Physicians who prescribe drugs and researchers who develop them will have to better understand drug liabilities to prevent them. In this article, product liabilities ongoing in 2005 at the 12 largest pharmaceutical companies are reviewed. Some common risk factors for liabilities are identified, and the discussion explains
spread across thempeutic classes. Ihe risk increases when the label is changed or a drug is withdrawn. Publications reporting new data are fiequent trigers. Company costs mnged j b m US$62 million to US$21 billion. Trends indicate an increase in liabilitiesand associatedcosts. New plaintifi are third-party payers and company shareholders. Liabilities spread outside the United States and may include lack of efficacyclaims. Znsurers now consider the risk of liabilities too high to continue manufacturers' coverage. Conclusions:product liabilities impact health care. The registmtion of clinical studies and the posting of their results will bring more tmnsparency to medical research and communication. This could counterbalance current liabilities trends. The fiture will establish whether drug liabilities are inversely proportional to the ability to be tmnsparent with data and promptly adjust risks and benefits.
why in the future drug
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