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  • Andrew Littlejohn Johnson

Defective Medical Devices: Lawsuits and Patient Rights


Many patients rely on medical devices to improve their quality of life. With today’s advanced technology and medical advancements, it’s no wonder these patients expect a certain standard of quality with their medical devices. However, some medical devices intended to improve patients’ lives have caused harm, complications, and even death.


Defective medical devices raise questions about patient safety, manufacturer accountability, and the legal rights of those affected. Those affected and filing a defective medical device lawsuit should know the laws surrounding products liability to understand their situation better.


Products Liability and Defective Medical Device Lawsuits


When a person is harmed by defective or dangerous products, products liability law protects the user and can hold whoever was responsible for the error that caused harm accountable for the injuries. Defective medical devices fall under products liability, and a defective medical device lawsuit may be filed if it falls into one of these categories:


  • Design Defect: The medical device’s design is inherently defective and causes injuries to the user. In South Carolina, the plaintiff has the burden of proof to show that the design is defective.

  • Manufacturing Defect: The defect stems from the production that causes it to malfunction and harm the user.

  • Marketing Defect: The device’s labeling, packaging, safety labels, and instructions were inadequate and injured the user.


When patients purchase medical devices, they expect the product to work by assisting them with their medical condition or preventing it from worsening. If a medical device malfunctions, whoever was responsible for the malfunction should be liable to compensate the user for their damages.


The Burden of Proof: Strict Liability


One of the key differences between personal injury law and products liability law is strict liability. This applies to all products liability cases’ burden of proof, including defective medical devices. Under a strict liability claim, a person filing a defective medical device lawsuit does not have to prove the defendant’s negligence or proof of fault.


In product liability cases, a plaintiff doesn’t have to prove that the defendant acted carelessly or negligently. However, there are some legal defenses against strict liability, so seeking experienced legal representation in injury law can provide more information.


FDA Recalls on Medical Devices


The U.S. Food and Drug Administration (FDA) carefully monitors medical devices. However, there have been instances where medical devices were already sold to the public before the FDA could detect defects, FDA law violations, and potential harm to users. The manufacturer can then recall their devices independently or at the FDA’s request. These recalls can be classified into three categories:


  • Class I: There is a reasonable chance that the product will cause serious health problems or death.

  • Class II: The medical device may cause a temporary or reversible health problem or a slight chance that the product will cause serious health problems or death.

  • Class III: A recall on products not likely to cause health problems or injuries.


I’ve Used a Recalled Product: What Are My Options?


Manufacturers use recalls to take back defective medical devices. Doing this minimizes their liability as they provide refunds and opt to cover some of their customers’ expenses. It also reduces the risk of a defective medical device lawsuit, as those who accept payments typically have to sign a waiver regarding the manufacturer’s liability.


However, injured parties can file a product liability claim even if their device was recalled. With proper legal representation, victims of defective medical devices can seek just compensation for:


  • Current and Future Medical Bills: The medical devices were likely used to manage a condition that could have worsened because of the injuries due to the defective device. This may require a patient to seek additional medical treatment in the future.

  • Other Out-Of-Pocket Expenses: These could be expenses made because of the effects of the defective medical device. This includes the cost of travel to medical centers, caregiver support, and additional expenses outside of medical bills.

  • Lost Earnings and Earning Capacity: The injuries could have required a person to take extended unpaid time off or could impact their ability to earn in the future.

  • Emotional Damages: This includes the emotional pain and suffering a patient experienced because of the injuries.


An injured person could opt to settle with the liable party out of court, or they could file a claim. Whichever they decide is more practical for their situation, having adequate legal representation can ensure they know their legal rights and the best course of action.


I’ve Been Injured By a Defective Medical Device: What’s Next?


If you believe you’ve received a defective medical device, call Littlejohn Law LLC. Attorney Andrew Littlejohn Johnson practices law throughout South Carolina for cases under injury law.


Schedule an appointment to discuss your defective medical device lawsuit in a free initial consultation.


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