Defective Medical Device Laws

Dangerous or defective medical devices can give rise to a product liability claim. These devices can be faulty surgical instruments, implants, pacemakers, and prosthetics.

Although closely monitored by the U.S. Food and Drug Administration (FDA), a product can still be defective in its design, manufacturing process, or marketing strategy. Or perhaps the product suffers from a labeling defect.

In many casesa, state lawsuits over federally approved medical devices often receive national attention.

Below, you will find information on:

• Common high-risk medical devices, such as stents and defibrillators
• Medical device recalls
• Damages you can recover if you’ve been injured by a defective medical device
• How to find a product liability lawyer in your area
• And more

Burden of Proof: Strict Liability

If a person suffers injuries from using a defective medical device or defective product, strict liability is the burden of proof. The courts apply strict liability in product liability cases. In such cases, the plaintiff doesn’t have to prove negligence. All they have to prove is that the device was defective and that it directly caused their injuries or illness.

Proving fault regarding a defective or dangerous medical product can be difficult. This is why many defective medical device lawyers rely on medical and scientific experts at trial. The same is true for many medical malpractice lawyers.

Not only does your defective medical device attorney need to prove the device suffered from a design defect or manufacturing defect, but they also need to prove causation. Most of these cases don’t make it to trial. However, you must still prove a prima facie case to collect damages.

Ideally, they can settle the case with the medical device manufacturers’ insurance company. If not, they’ll file a defective medical device lawsuit on your behalf.

Damages in a Defective Medical Device Lawsuit

You can demand significant damages if you sue a product manufacturer or third party for a defective medical device. It depends on whether you file a lawsuit or join a class action. It also depends on the nature and extent of your serious injuries.

In most defective medical product cases, plaintiffs can recover some or all of the following:

• Medical bills and healthcare expenses (including durable medical equipment)
• Any lost wages and lost future income
• Pain and suffering (including emotional distress)
• Loss of consortium in a wrongful death case
• Other related costs and expenses

Your personal injury lawyer will do a free case review when you first meet with them. This will give them a better idea of the worth of your claim.

Defective Implants and Prosthetics

Many plaintiffs file product liability lawsuits for defective implants and prosthetics. As with other defective medical device cases, learning that there’s a defect can take some time. That’s why it’s essential that you retain a defective medical device attorney immediately upon learning that there’s a problem.

Some common types of defective implants include:

• Pacemakers
• Stents
• Hip replacements
• Medical mesh products (including hernia mesh and transvaginal mesh)
• The types of defects with these devices also vary. Some of the defect types include:
• Toxic or degradable material
• Poor construction
• Sharp edges

All these things can harm patients and cause long-term medical issues.

Defective Surgical Equipment

You should expect surgical equipment to be clean and safe when you undergo surgery. You may recover damages if you learn that the hospital used defective surgical equipment during your procedure.

Some of the more common types of damaged or defective surgical equipment include:

• Robot-assisted surgery systems
• Lasers
• Surgical tools and instruments like staples, scalpels, etc.

There may be several types of defects in a piece of surgical equipment. Your attorney must prove not only that a defect exists but that the defect caused your injuries. Some of the common types of defects include:

• Malfunctioning
• Power or electrical issues
• Improper maintenance
• Infection

If you or a loved one is harmed by a defective surgical equipment, you should contact an attorney immediately. The sooner you file your claim, the sooner you’ll have a verdict.

Defective Hospital Devices

Hospitals and healthcare providers use certain medical devices in the hospital rather than in the patient’s home. This includes:

• Scanning devices
• Temperature control devices like lab refrigerators or warming blankets
• Ventilators
• Monitoring and test systems

If any of these devices are defective, a diagnosis delay or misdiagnosis may occur. If this happens, a patient could become severely sick or even die.

Medical Device Recalls

Every year, the FDA issues a recall for medical devices that create more hazards than potential benefits to consumers. The FDA will also identify what medical providers need to do to keep up with recalls.

The FDA may fine a manufacturer that fails to comply with a recall. The FDA may also require that the company remove the defective medical device or product from the market until it meets the recall’s terms.

If a medical device injures a patient after a recall, they may still have a valid claim for damages. It depends on the facts of their claim.

Suing Companies and Providers for Medical Device Injuries

Sometimes, the medical device company is the only party responsible for your injuries. The courts should hold them liable if they sold a defective medical product and failed to warn patients and their doctors of potential adverse events.

Other times, you may need to pursue both the manufacturer and your medical provider. If your physician should’ve known about any negative side effects and risks, they had a duty to disclose these to you.

Your personal injury attorney will help determine which parties you should include in your initial complaint.

How an Attorney Can Help With a Medical Device Claim

Filing a product liability lawsuit for a medical device defect is complex. It often requires expert witnesses and a detailed knowledge of product liability law. It’s best to consult an experienced personal injury attorney before moving forward.

The legal process for a defective medical device claim can be challenging and overwhelming. The right attorney will guide you through the legal process and advocate for your best interests along the way.

FindLaw’s directory of product liability attorneys can connect you with qualified legal advisors in your area. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with medical device litigation.