Pharmaceutical Liability Medical Devices
Claims for injuries caused by medical devices are also included under the heading of pharmaceutical liability. Under Section 201 of the federal Food, Drug and Cosmetic Act, a medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Examples of medical devices include: defibrillators, breast and other cosmetic implants, orthopaedic screws, hip implants, knee implants, heart valves and many other items. If you or a loved one has been injured by a medical device or experienced adverse side effects, you may be able to recover for your injuries. Medical device litigation is complex. Contact us today and we will evaluate your situation and help you build a case.
As with medications, plaintiffs who are injured by medical devices can bring product liability claims alleging negligence, strict liability or a failure to warn. In addition to the company that manufactured the device that injured you, you may also be able to pursue claims against the following parties:
- Doctor who implanted the device
- Hospital that employed the doctor
- Company that distributed the device
The Role of the FDA
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA) is responsible for regulating medical devices and radiation-emitting products. The CDRH screens and approves medical devices. Before granting approval to manufacturers to sell their new devices, CDRH scientists review the manufacturer’s data from investigational studies to see if the device does what it claims to do effectively and the device does not present any unreasonable risks to the patient.
Medical Device Recalls
There are three classes of recalls. Class I is the most serious recall in which there is a reasonable chance that the product will cause serious health problems or death. In a Class II recall there is a less serious risk than in a Class I recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems or there is a remote chance that the device will cause serious health problems. In a Class III recall there is little chance that using or being exposed to the device will cause health problems.
Conclusion
Problems with medical devices such as defibrillators and breast implants have led to massive litigation. If you used a medical device and you believe it caused you injuries, or if a medical device you use has been recalled, you may be able to recover from the manufacturer or other party. An experienced medical device and pharmaceutical liability attorney at The Ausband Firm can explain your legal options.
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