Pharmaceutical Liability Information Center

• Return to Main
• Pharmaceutical Liability - An Overview
• Building a Pharmaceutical Liability Case
• Protecting Yourself Against Risks
• Dietary Supplements and Herbal Remedies
• Medical Devices
• Frequently Asked Questions about Pharmaceutical Liability
• Pharmaceutical Liability Resource Links
• Pharmaceutical Liability Contact Form

Dan Dolan has secured substantial settlements and verdicts from physicians, pharmacists, hospitals, and pharmaceutical companies for prescription drug errors. He is a former insurance defense lawyer whose insights enable him to maximize compensation of behalf of permanently injured clients. Call (305) 371-2692 to discuss your potential claim. We can come to you.

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, and an experienced attorney at Dolan Law Firm in Miami can 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

Recalls happen in a number of circumstances: when a medical device is defective; when it could cause a health risk; or when it is both defective and a health risk. A company can voluntarily recall a medical device or the FDA can require a company to recall a device. If a particular medical device is recalled, it does not always mean that you must stop using the device. It could just mean that the device needs to be checked or fixed. A recall can be a correction (which addresses a problem with a medical device in the place it is used or sold) or a removal (which addresses an issues with a device by removing it from the market or place it is used). The following are examples of actions that are considered recalls: inspecting the device for problems; fixing the device; making adjustments to the device; changing the label on the device; destroying the device; notifying patients of a problem; and monitoring patients for health problems. See Learn About Medical Device Recalls, available at http://www.fda.gov/cdrh/recalls/learn.html.

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 ((firm name)) in ((city)) can explain your legal options.

Copyright ©2009 FindLaw, a Thomson Business

DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter.

Return to Main