The US Food and Drug Administration (FDA) requires medical device manufacturers to produce safe and effective medical equipment. A flawed medical device can cause serious damage to a patient, but in some cases the effects do not immediately manifest. Physicians may use defective devices innumerable times before anyone recognizes their dangers.
It’s vital to understand how medical devices are classified as defective and the risks they pose to patients. The FDA regulates the medical device field heavily, from design and production materials to labeling and instructions for use. In some cases, they issue a recall once they positively identify a defective device.
Anyone with knowledge of medical devices that fail, harm patients, or present the risk of future adverse health effects, must report his or her findings, and those findings must also be investigated by the FDA. Once a manufacturer is aware of a defective product, they must launch an investigation to determine the cause of the incident. These companies must then address the damage and should institute corrective and preventative measures to prevent the incident from happening again.
Physician error in using the device or improper maintenance may cause isolated incidents of device failure. If the investigation identifies a pattern of failures with a particular device, the defect may be a flaw in the device’s design or raw materials. Faulty manufacturing processes or damaged equipment may also cause a device failure. The FDA requires device manufacturers to provide detailed and accurate device labels, descriptions, and measurements to their buyers.
Once the investigating parties identify the cause of a defect, the FDA requires them to report trending incidents and take corrective actions to prevent further incidents. The manufacturing, labeling, regulation, sale, distribution, and use of medical devices involve several entities, and any shortcomings or rushed processes can injure the end patient. When a patient is injured by a defective medical device, the responsibility may fall on:
Defective medical device cases fall under product liability law. Anyone injured by the use of defective device may need to prove any of the entities listed above was negligent in the production, sale, or use of the device. In the case of medical devices, manufacturers are required to produce safe and effective equipment, sales representatives must accurately describe the devices they sell to medical professionals, and physicians must use the devices as intended.
Navigating a defective medical device claim can be complex. The cause of an injury may be the fault of any number of entities. Experienced legal representation will certainly make the process easier. Sweeney Merrigan Law has an extensive background of successful personal injury cases.
In addition to obtaining just compensation for any medical bills and lost time from work, we have the experience to ensure wrongdoings that endanger other patients do not go unpunished. Our legal team can answer any questions about a defective medical device case, or recommend how to proceed with filing a product liability claim.