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All Press Releases for February 06, 2014 »
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Doctors free to use medical devices for conditions not tested by FDA

Unfortunately, data shows that many physicians are prescribing drugs and utilizing medical devices for "off-label" use--or uses not tested on or approved by the FDA.
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    February 06, 2014 /24-7PressRelease/ -- Before any drug can be marketed to consumers or medical devices implanted into patients, each must first be researched and tested in clinical studies to make sure they are safe for their intended usage.

Once the research is conducted, the U.S. Food and Drug Administration (FDA)--the federal agency in charge of regulating and supervising the production of medications and medical devices--reviews the data and decides whether to approve the drug or device. If the agency gives its approval, the drug is available to physicians and healthcare professionals for use.

Dangers of off-label use

Once legally accessible, physicians can use their discretion and utilize the product for uses not tested or approved by the FDA. This is known as "off label" use. Unfortunately, this can lead to medical errors.

For instance, a manufacturer of a medical device conducts research, tests the product and receives FDA approval for use in treating only condition A. However, a physician may use the device to treat condition B instead.

Unfortunately, this off-label usage can pose risks of harm to patients because of the lack of research conducted on unintended uses. Despite this risk, off-label use is completely legal--and common-for doctors, surgeons and other healthcare professionals in all types of fields. The practice is legal because the FDA cannot regulate the way physicians practice medicine.

One physician and current Director of the University of Minnesota's cardiac catheterization laboratory was quoted in the Minnesota Star Tribune, noting "It is a common practice in the cardiology world."

Safety advocates remain cautious

Nonetheless, patient safety advocates remain cautious about a doctor's choice to use products for unapproved usage. A product that has not gone through rigorous testing for a certain condition simply poses a higher risk of side effects and complications that can harm or kill a patient.

Unfortunately, since off-label use is legal, physicians all across the country will likely continue the practice.

Legal recourse

However, until tightened regulations are put in place, legal recourse is available for those injured from drugs or products as a result of a doctor's negligent choice to use a drug or product "off label."

An injured party may have a medical malpractice cause of action and is encouraged to consult with a knowledgeable attorney who understands the intricate areas of the law. A lawyer can offer guidance on the next steps to take for individual circumstances.

Article provided by Cavanagh Law Group
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