Femara (letrozole) is an oral, non-steroidal aromatase inhibitor, usually indicated for the treatment of hormonally responsive breast cancer after surgery and radiation. This medication lowers estrogen levels in postmenopausal women, which can slow the growth of certain types of breast tumors. It may be prescribed for women with ovulation problems, or for the ones with unexplained infertility, being used for ovarian stimulation. It also increases pregnancy chances in ovulating women.
The liability of any or all of the the parties involved in the chain of manufacture of any product for the damage caused by that product is called product liability. The manufacturer of component parts, the assembly manufacturer, the wholesaler or retail store owner can be responsible for product liability.
Negligence is the basis for product liability claims. The concept of negligence was developed under English Law and emerged as an independent cause of action in the 18th century. Negligence is defined as conduct that falls below the standards of behavior established by law for the protection of others against unreasonable risk of harm. It involves the failure to use reasonable care and in some cases, negligence is defined by statute, known as Negligence Per Se. Some acts are considered to be inherently negligent and do not require to prove the negligence was known or intended, when for example a doctor leaves a sponge inside their patient during surgery.
It is well known that U.S. Food and Drug Administration (FDA) is the oldest consumer protection agency in the U.S. Federal Government and it is responsible for protecting public health in the areas of:
- Human and Veterinary Drugs
- Biological Products
- Medical Devices
- Nation’s Food Supply
- Products that emit radiation
Product recall is defined as removal from the market when the company discovers a problem on their own and decides to recall the product or a product is removed by FDA. A correction can be made to the product due to its defects or potential harm. There can be three Classes of recalls. Class I recalls include products that would cause serious adverse health consequences or death. Class II recalls are applied for those products, which use may cause temporary reversible adverse health consequences. Class III recall is a situation in which a product is not likely to cause adverse health consequences.