Defective Medical Devices

By FindLaw Staff | Legally reviewed by Garrett Monteagudo, Esq. | Last reviewed January 09, 2023

Dangerous or defective medical devices -- such as faulty surgical instruments, implants, pacemakers, and prosthetics -- can give rise to a product liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result.

Although closely monitored by the U.S. Food and Drug Administration (FDA), a product can be defective in its design, manufacturing process, or marketing strategy. In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention.

Below, you will find resources that highlight common high-risk medical devices such as stents and defibrillators and links to product liability lawyers in your area, as well as helpful forms and other resources.

The Burden of Proof: Strict Liability

If a person suffers injuries from the use of a defective medical device, the burden of proof is strict liability. Strict liability is applied in product liability cases. In these civil cases, strict liability claims mean that the plaintiff doesn't have to prove that the defendant acted in a careless (or negligent) manner.

Transvaginal Mesh Lawsuits

Many women suffering from pelvic prolapse or stress urinary incontinence have turned to transvaginal mesh implants for relief. Unfortunately, mesh implants have been linked to a number of painful and serious complications. Mesh erosion, the most common complication, occurs when the mesh begins to deteriorate into small sharp pieces that can perforate nearby organs. On July 13, 2011, the FDA announced that patients undergoing pelvic organ prolapse repair with a surgical mesh may be at a greater risk for mesh complications than women pursuing other surgical treatments.

Then, on April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately. These products have been withdrawn from the market because the FDA determined that the manufacturers did not demonstrate "reasonable assurance of safety and effectiveness" of these medical devices. Women suffering mesh complications may be able to file a claim seeking compensation for medical bills, pain and suffering, and other damages.

For more information, visit FindLaw's article on Transvaginal Mesh Lawsuits and Transvaginal Mesh Lawsuits.

LASIK Eye Surgery

LASIK surgery is widely used to correct several types of vision problems, and it is normally very successful. But when things go wrong, the patient may have a legal claim against the surgeon or against the manufacturer of the LASIK equipment. The consequences of complications from LASIK eye surgery can be significant. Improper use or malfunction of the equipment can result in damage to the cornea. Patients can also suffer cornea damage simply because they were not good candidates for the procedure. In particular, people with large pupils, thin corneas, or dry eyes are more prone to experiencing complications from the surgery.

For more information, visit FindLaw's article on LASIK Eye Surgery and our LASIK Eye Surgery FAQ page.

Metal Hip Replacement Lawsuits

Liability for injuries caused by metal-on-metal hip replacements is generally placed on the manufacturer. However, in certain circumstances, the surgeon who performed the procedure may be liable for medical malpractice. Medical malpractice occurs when a healthcare provider acts in a way that falls below the level of care practiced in the profession, and the patient is injured as a result. For example, a surgeon may have made an error while implanting a metal hip, misdiagnosed a patient, or failed to inform a patient about the known risks associated with the procedure.

For more information, visit FindLaw's articles on Metal Hip Replacement Lawsuit and Metal Hip Replacement Recall and Injury.

Da Vinci Robotic Surgery Lawsuits

In a robotically-assisted procedure, a surgeon uses a robot to manipulate instruments, allowing for more precise control of actions such as incision and removal. Robots reduce the stress and fatigue experienced by surgeons, especially during longer operations. In addition, the robotic arms are remarkably steady. Unfortunately, there have been numerous reports that the da Vinci robots have injured patients. These patients, in turn, are filing a growing number of lawsuits against the manufacturer, Intuitive. Some of these lawsuits have alleged that the da Vinci robot failed to let go of a patient's tissue.

For more information, visit FindLaw's articles on Da Vinci Robot Surgery Lawsuits and Da Vinici Surgical Robots Injury Overview.

How a Products Liability Attorney Can Help

Filing a product liability lawsuit alleging a medical device defect is a complicated undertaking, often requiring medical evidence, expert witnesses, and a detailed knowledge of product liability law. As a result, it's in your best interests to consult with an experienced attorney before deciding on a course of action.

Contact an experienced product liability attorney near you today.

Metal Hip Replacement Lawsuit

Tens of thousands of patients who received metal hip replacements have suffered injuries. Implant failures and metal poisoning have led to thousands of lawsuits and million-dollar awards.
Drug-Coated Stents

A stent is a small metal or plastic tube inserted into an artery or blood vessel. This article provides information on drug-coated stents including recent news, dangerous warning signs, and when they should or should not be used.
Guidant Defibrillators

Commonly known as a pacemaker and used to help treat heart disease, this section provides in-depth legal information and resources on Guidant defibrillators which were the subject of a major 2005 recall.
DePuy Hip Implants

DePuy hip implants are a popular brand used in thousands of hip replacement surgeries. However, high failure rates and patient injuries have led to recalls and lawsuits.
IVC Blood Clot Filter Lawsuits

While IVC blood clot filters were designed to stop dislodged blood clots from traveling to the lungs, the devices have been linked to several injuries and deaths. Learn about the issues associated with IVC filters and the lawsuits that have been filed as a result.

Transvaginal Mesh Injury Overview

Transvaginal mesh is a surgical patch implanted on the vaginal wall to correct pelvic organ prolapse and stress urinary incontinence. Many patients who received it have suffered from mesh erosion and organ perforation.
Da Vinci Surgical Robots Injury Overview

Da Vinci Surgical Robots are used for surgical procedures in hard to reach areas. Robot malfunctions and errors by surgeons controlling the systems have led to pierced organs, infections, and electrical burns.
Cobalt Toxicity and Other Metal Hip Replacement Side Effects

Thousands of patients with metal hip replacements have reported serious side effects. Implant failures, cobalt toxicity, and metallosis injuries have led to thousands of recalls and lawsuits.
Transvaginal Mesh Lawsuits

Transvaginal mesh is a surgical netting used to treat pelvic organ prolapse and stress urinary incontinence. Problems with mesh erosion and organ perforation have led women to sue manufacturers and doctors.
Da Vinci Robot Surgery Lawsuits

The da Vinci Surgical System is a surgeon-operated robot. Patient injuries from system failures and surgeon errors have led to government warnings and lawsuits.