Products Liability E-Newsletter

Medical Products & Devices

Medical appliances, equipment, and supplies include blood and blood products, anatomical gifts, prosthetic devices, surgical implants, surgical equipment, hospital furniture and supplies, diagnostic equipment and supplies, and hearing and visual aids. Any of these products can be the subject of a products liability law suit if it is defective and causes an injury. With regard to blood products, many states have enacted blood shield statutes that declare that providing blood is rendering a service rather than selling goods, and therefore not be the subject of a products liability suit.

One of the major concerns in cases of defective medical products and devices is the statute of limitations (the time limit for bringing a lawsuit). All states allow a fixed period of time in which to bring a suit, but in many cases involving defective medical products a significant period of time can elapse between a patient's exposure to a defective product and the patient's awareness of the injury. Because of that problem, many states have adopted a discovery rule, under which the time limit for bringing suit does not begin to run at the time of the injury, but rather when the injured person knows or should have become aware of the resulting illness or other damage.

As in other products liability cases, plaintiffs in medical product cases sometimes raise the issue of the manufacturer's or other provider's failure to warn about the potential dangers of their products. Many times, manufacturers of these types of products can fulfill their duty by providing the warnings to the physicians, nurses, or other medical personnel who will be using the products, and then the duty passes to those professionals to inform the patient. There is a fine line between a products liability action involving a defective medical device and a medical malpractice action, and a lawyer experienced in this area can help both plaintiffs and defendants determine which law applies.

The Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. The amount of control the FDA exercises over the manufacturers depends on how likely the goods being produced are to cause injury. The FDA has promulgated standards and practices with which manufacturers must comply, and in some cases, plaintiffs are not permitted to pursue claims that manufacturers should have done more than what the FDA required. Even if such a claim is permitted, evidence of compliance may bolster a defendant's case that it was not negligent, and evidence of failure to comply can support a plaintiff's claim that the injury-causing product was defective. The FDA also prescribes labeling requirements for certain medical products. A manufacturer's compliance with these requirements, however, does not itself relieve the manufacturer from failure-to-warn liability.

Plaintiffs may bring breach of warranty claims against manufacturers of defective medical products by arguing that the products failed to perform as promised. Another possible claim is that the product was defectively designed. An experienced products liability attorney can help a potential plaintiff determine what type of claim he or she may have. Products liability defense attorneys can advise medical product manufacturers on whether claims against them are valid and can defend them against those claims and inform the manufacturers of ways to avoid litigation in the future.

Checklist: Documents Your Attorney Will Need

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Documents Your Attorney Will Need

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