Medical devices are capable of miraculous results for many people affected by illnesses, injuries, and chronic conditions. However, medical devices – like all products in our society – do not always perform perfectly. Sometimes a device does not perform as the manufacturer intended. Other times, the device is rushed to the market in order to gain a competitive edge, without fully testing the product to determine that it is safe for all of its anticipated uses. Faulty medical devices cause injury to many Americans every year.
The U.S. Food and Drug Administration (FDA) oversees America’s medical device market, and approves new devices that are marketed. The FDA also classifies medical devices according to the risk of harm to the patient, tracks the safety of medical devices and drugs, and institutes recalls of devices that present an unreasonable risk of harm to the public. In some cases, medical device makers themselves will initiate recalls of unsafe products.
Simply because a device has been recalled does not mean that you have a claim against the maker of the device. As in any personal injury action, you must have suffered harm. In addition, you must be able to support a products liability claim in order to recover for your harm. A recall is only one piece of evidence in this process.
Several types of products liability claims can arise from a faulty medical device. One such claim is based on the manufacturing of the device. This means that the device maker’s quality control was probably not up to par, and that the specific version of the device you used was not manufactured according to the maker’s requirements. It is important in all medical device cases – but especially manufacturing defect cases – that the faulty device be retained and not discarded.
In other instances, the device is defectively designed and is not safe for its intended purpose. Where safer known alternatives exist, or where the device does not perform as the patient would expect, a design defect claim may be pursued. Another category of products liability claims against device makers is for a failure to adequately warn of the risks of the device. Particularly where the device maker does not adequately test the device before marketing it, the device may have dangers that the maker does not discover and does not warn the public about. Injured consumers frequently may have both design and warning defect claims.
Proving a medical device products liability claim is difficult. Medical device cases often rest on expert testimony, which can create great expense for a plaintiff. Complex scientific issues can be involved, which must be presented in a way jurors can understand. Device makers have every interest in defending their profitable products, and will usually fight even a viable claim tooth-and-nail. In addition, an injured plaintiff must often overcome preconceptions from jurors that the device must be safe since it was on the market.
At Cross & Smith, we understand how to research and prepare a medical device defect claim, and how to present that claim to a jury. As experienced Alabama defective medical device lawyers, we will cut through the science and technical jargon and focus on obtaining the compensation that you are due. Call us today at (877) 791-0618 for a free confidential consultation.