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Home » Blog » Determining pharmaceutical product liability is often not easy

Determining pharmaceutical product liability is often not easy

The U.S. Food and Drug Administration has certain industry standards that are applied to many medications and drugs produced and sold in the United States. The agency requires that manufacturers properly test the drugs before releasing them for public use. The purpose is to assure the drug’s safety or to warn medical professionals and the consumer of potential side-effects related to the drug in question.

For prescribed drugs, there is what is called a learned intermediary, which the fancy term for the person between the manufacturer and end user. In most cases, this is the doctor who writes the prescription, a nurse who serves the drug, or the pharmacist who fills the prescription.

Many drugs are deemed unavoidably unsafe and are often administered only when the benefits outweigh the potential side-effects, which can often be unsafe and harmful. There are also certain circumstances such as asbestos-exposure cases or injuries or illnesses to babies that do not reveal themselves until later in life. These are considered time-lapse issues; the laws and rulings vary on the level of guilt or burden of proof necessary to make one’s case.

Proving a product liability suit is difficult, whether it is a pharmaceutical or a defective product such as a dangerous automobile or negligently designed children’s toy. Typically, the injured will need expert witnesses to testify about how the drug or product could have been better designed, manufactured or marketed. A skilled lawyer can help the injured and their families to understand their legal options and the evidence they will need to make an effective claim.

Source:, “Pharmaceutical Drug Liability,” Accessed Feb. 7, 2017