What is Medical Product Liability?

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  • Written By: Jessica Ellis
  • Edited By: Bronwyn Harris
  • Last Modified Date: 07 February 2020
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Medical product liability refers to the legal extent to which a manufacturer or provider of medical products is responsible for injuries or death caused by product malfunction or mislabeling. While medical products cannot guarantee success of treatment, it is generally assumed that they must not cause undue harm through negligence or failure to properly warn customers. Medical product liability is a frequent question in lawsuits against product manufacturers and sellers.

Usually, medical product liability cases arise when a person has been injured or killed while using a medical product. Products considered under this jurisdiction might include surgical or diagnostic equipment, or devices such as hearing aids, wheelchairs, and walkers. Pharmaceutical drugs, such as prescription medication, are usually not considered medical equipment, and thus are pursued under different liability claims.


Two of the most common types of medical product liability arguments are negligence and failure to warn. Negligence might involve an oversight in manufacturing procedures or inspection duties that allowed defective products to slip through. It some cases, it might also be considered negligence to put a product on the market that had not undergone sufficient testing to determine inherent risks. Failure to warn lawsuits usually involve claims that suggest that inherent risks were not properly explained to the user, either by omission or to hide certain facts about the product. In both types of claim, it is important that an actual physical injury has occurred as a result of the defect; cases in which an injury could occur are usually not viable, since no unlawful act that could result in damages has yet occurred.

In order for a medical product liability case to succeed for the plaintiff, it is important to prove that the product was in some way defective, and that an injury was caused because of the defect. While that may sound uncomplicated, the process of assigning liability for the defect can turn what appears to be a clean-cut case into a long, frustrating process. For instance, if a defect occurred, but the defendant manufacturer can prove that all due diligence was taken in manufacturing, labeling, and inspecting the product, liability may not be easy to determine. Moreover, the lawsuit may need to bring in every organization that had involvement with the design, development, production, and sale of the product, which can drag out trials even farther.

In order to reduce the amount of medical product-related injuries and deaths, many countries have imposed strict industry regulations that standardize testing, manufacturing, and labeling procedures. The goal of these standards is to create better, safer products, and to prevent manufacturing companies from cutting safety precautions in order to save costs. Though medical product liability has many gray areas in legislation and judicial precedent, the presence of regulations along with the citizen's right to sue for damages may serve as an inventive to improve safety and testing policies, in order to create safer products.


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