Medical Product and Device Defects​

medical sign

A product liability case can arise from injuries caused by defective or dangerous medical appliances, equipment, organ transplants, prosthetic devices, surgical implants, surgical equipment, hospital supplies, diagnostic equipment, and hearing and visual aids. Any of these products can be the subject of a products liability lawsuit if the cause injury to a patient.

First Concern: Statute of Limitations

One of the major concerns in cases of this nature 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.

Product Liability or Medical Malpractice?

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.

Regulation and the FDA

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. 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.

People filing state court lawsuits over the safety of federally-approved medical devices may face stricter legal hurdles, after a decision handed down by the U.S. Supreme Court in February 2008. In Riegel v. Medtronic, Inc., the Court held that the Medical Device Amendments of 1976 bars most state law claims to challenge the safety or effectiveness of a medical device that received market approval from the U.S. Food and Drug Administration (FDA).

Getting Legal Help for a Defective Product Injury

Product liability actions are often quite complex, and establishing legal fault often requires the assistance and testimony of experts. There are several theories under which a plaintiff might bring a claim and several defenses that might defeat such a claim. Additionally, every state has its own laws and specific statutes that will affect a product liability action. Accordingly, it is important to consult an experienced attorney if you or a loved one suffers injury caused by a potentially defective product.

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