Issue: Medical Product Liability and Medical Malpractice 

**This issue has been archived, the information on this page has not been updated since 2007.**

The current medical product liability system is slow and costly. Additionally, it can have significant adverse effects on our nation’s health. The consequences for women’s health, which is dependent on access to care and a vigorous research community, can be devastating.

The liability and malpractice situation has reached crisis proportions and patient care is being affected by this system when:

1. doctors modify their practices, move, or quit – causing a disproportionate effect on the poor and elderly due to difficulty in finding a doctor accepting new Medicaid/ Medicare patients and on women because obstetrics and family practice are among the medical specialties most affected
   
   
2. patients stop or modify treatment based on fears
   
   
3. products are removed from the market because of defense costs – one product, Bendectin, to treat severe nausea in pregnancy, was voluntarily removed from the market because its manufacturer found related legal costs to be greater than its profits, despite FDA’s determination that none of the purported injuries were due to the drug. In the decade after Bendectin’s removal from the market there have been no new drugs developed and the treatment costs for severe nausea have totaled $40 million.

In addition to the healthcare crisis, research is affected by current malpractice insurance premiums and liability. Young clinicians who are considering combined careers in both research and medical practice sometimes find they cannot afford to conduct research; the reduced salary such a career provides is insufficient to pay malpractice insurance premiums.

Further, women were not traditionally included in drug clinical trials for fear of liability, especially woman in their reproductive years. Despite strides made in last decade women still are not included in clinical trials at appropriate percentages.   Therefore, researchers are not learning about biological and physiological sex-based differences that can help explain why men and women respond differently to many diseases and treatments.

In the current climate of legal decisions finding drug manufacturers liable for damages despite meeting all Food and Drug Administration (FDA) guidelines and fulfilling the legal duty to warn (via patient labeling), many manufacturers end certain research. Innovation is especially stifled in areas that affect women solely or disproportionately. The study of vaginal microbicides, compounds that can prevent pregnancy, as well as fight HIV/AIDS and sexually transmitted diseases, is in decline. So is development of implantable drug delivery systems and treatments for obesity and depression.