| A medical device includes any instrument, machine or | | | | - Patients are being monitored for health risks |
| implant that is used to enhance your overall health. A | | | | associated with the product |
| defective device is one that fails to work properly, | | | | - The settings must be adjusted |
| resulting in patient injury and even death. | | | | - An inspection is required |
| Defective medical devices are generally products | | | | - New labels or warnings are needed |
| such as pacemakers and defibrillators that fail | | | | Companies that manufacture medical devices have an |
| because of improper design or harm a patient | | | | obligation to provide safe and dependable products |
| because of manufacturer negligence. However, | | | | that work as intended. Even when a medical device |
| devices such as x-ray machines and diagnostic | | | | works as it should, there are other risks that must |
| equipment can also be defective and result in patient | | | | be revealed. The law requires product manufacturers |
| injuries. | | | | to disclose any known issues about the side effects, |
| Why They Are Defective | | | | malfunctions or other potential problems associated |
| A majority of injuries caused by defective medical | | | | with a device. |
| devices are the result of manufacturer negligence. | | | | Common Defective Devices |
| Sometimes, companies are so eager to obtain | | | | There are a number of medical devices that may |
| approval by the Food and Drug Administration (FDA) | | | | contain defects, such as: |
| to begin earning profits that they do not perform the | | | | - Dialysis machines |
| necessary research or appropriate pre-clinical tests. | | | | - Defibrillators |
| A medical device recall does not always require | | | | - Stents |
| discontinued use or the removal of that device. It | | | | - Pain pumps |
| may mean that the device must be adjusted or | | | | - Spinal discs |
| checked. If it is discovered that your implanted | | | | - Prosthetics |
| device may fail, you should discuss with your doctor | | | | - Joint replacement parts |
| the risks of having it removed versus the risk of | | | | - Diagnostic equipment |
| potential failure. | | | | - Heart valves |
| A product recall can also be the result of budget | | | | Holding the Negligent Party Responsible |
| reductions. If funding for research and development | | | | In most defective device cases, the manufacturer is |
| has been cut, this may prevent necessary testing. A | | | | responsible for injuries sustained by a faulty device. |
| design defect can also occur during the drug’s | | | | However, wholesalers, distributors and marketing |
| planning process, and may not be uncovered until the | | | | companies can also be held liable. If one of these |
| drug has been widely distributed. | | | | parties is responsible for your injuries, you can file a |
| Reasons for a Product Recall | | | | product liability claim. |
| While there are many reasons a product recall, the | | | | If you were injured by a device and you believe your |
| most common include: | | | | doctor, surgeon, nurse or other medical practitioner is |
| - A device needs to be repaired | | | | responsible, you can file a medical malpractice suit to |
| - The device has a major defect and must be | | | | hold that person liable. |
| destroyed | | | | |