Medical Product and Device Defects
By FindLaw Staff | Legally reviewed by Garrett Monteagudo, Esq. | Last reviewed December 09, 2022
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A product liability case can arise from injuries caused by defective or dangerous medical devices. These devices include appliances, equipment, organ transplants, prosthetic devices, surgical implants, surgical equipment, hospital supplies, diagnostic equipment, and hearing and visual aids. Other examples may include pacemakers, defibrillators, stents, transvaginal mesh, or hip implants.
Manufacturing defects may result in serious injury to the user. Examples of product defects include using the wrong materials during the manufacturing process, the erroneous assembly of the product, or harmful chemicals in the product. Any of these product defects can be the subject of a product liability lawsuit if it causes personal injury to a patient.
This article discusses product liability lawsuits regarding defective medical products or devices.
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.
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. Some states may also require notification to the medical device manufacturers informing them of the issue, and giving the manufacturer an opportunity to cure the mistake.
Product Liability or Medical Malpractice?
As in other product 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 warnings to the physicians, nurses, or other medical personnel who will be using the products.
After the product passes to healthcare professionals, they still have a duty to inform patients of the warnings, side effects, and other risks associated with the product. There is a fine line between a product liability action involving a defective medical device and a medical malpractice action. A lawyer experienced in this area can help both plaintiffs and defendants determine which law applies.
Manufacturing or design defects involving medical devices can pose a high risk to its users. Users should pay attention to medical device recalls and product recalls. If you have been using a product that has been recalled and you have been harmed, you should get a case evaluation from a defective medical device lawyer right away.
Regulation and the FDA
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. This includes the device safety of medical equipment. 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. 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 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 bar most state law claims to challenge the safety or effectiveness of a medical device that received market approval from the 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.
It is important to consult an experienced product liability attorney if you or a loved one suffers injury caused by a potentially defective product. You can get a case evaluation and your lawyer will help you understand your legal rights in this situation. Contact a personal injury lawyer today.
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