The companies that make prescription drugs and
medical devices have a responsibility to do what’s necessary to ensure their products are safe to use by citizens across the U.S.A. Drug makers also to let users know of risks and
benefits of their products in ways people can understand, and to continue to evaluate their products for safety as more people use them. When companies fail in these responsibilities, they can be
held legally responsible to the people they hurt.
These responsibilities, called legal liabilities,
- Failure to
Warn—While all medications have certain anticipated side effects, a drug manufacturer is
responsible, legally, for reporting any known risks associated with its drugs. Medical device makers also have a duty to warn of side effects and to provide doctors with all the information they need
to safely implant and monitor the device.
Warning—A drug or device manufacturer’s warning may be considered inadequate if it doesn’t
reflect true risks to patients, omits new information about risks, or is presented in such a way that it doesn’t convey the importance of the information.
- Negligence—A manufacturer can be accused of negligence, even of intentional
or malicious conduct, if it fails to meet reasonable standards of testing, safe production, delivery or handling of a drug or device.
Marketing—Over-promotion and aggressive marketing and advertising efforts by the manufacturer
can lead to more people being injured than otherwise would have occurred. Also, false marketing occurs when a company markets its products to doctors and the public for uses for which the product
wasn’t originally approved.
- Tainted or
Contaminated Drugs or Devices—Manufacturers that let factories become dirty or processes become
faulty can be held liable for adverse product reactions.
Inferior Vena Cava (IVC) filters are implanted in patients who are at risk of blood clots traveling into vital organs like the heart and lungs and blocking
pulmonary arteries. When this happens, patients may develop a condition called pulmonary embolism, which can cause serious health problems. The filters,
designed in spider-like, wiry shapes, prevent them from entering the heart and lungs.
In 2010, the Food and Drug Administration recommended that IVC filters only be used temporarily, based on medical
reports that suggested the devices were prone to detach or fracture inside a patient’s body. Many people were unaware of the dangers of IVC filters
and suffered serious harm as a result of the device malfunctioning.
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