Product Liability Lawsuits: Medical Device Defects

Some product liability cases arise from injuries caused by defective and dangerous medical devices. Sometimes, these products are hazardous because of manufacturing defects. Other times, the product suffers from a design defect.

Some of the more common defective medical devices include:

• Equipment
• Prosthetic devices
• Surgical implants and equipment
• Hospital supplies
• Diagnostic equipment
• Pacemakers
• Defibrillators
• Stents
• Transvaginal mesh/Hernia mesh
• Hip implants and hip replacements
• Contraceptives
• IVC filters

Manufacturing defects may result in serious injury to the user. Examples of product defects include:

• A company using the wrong materials during the manufacturing process
• The manufacturer failing to assemble the device correctly
• A manufacturer using harmful chemicals in the product

Any product defect 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.

Legal Standards Used in Defective Medical Device Lawsuits

In most defective medical device cases, the courts will apply a strict liability standard. This means the plaintiff doesn't have to prove the defendant was negligent. All they have to demonstrate is that they used the device and suffered an injury.

There are times when the court will require the plaintiff to prove negligence instead of pursuing a case under the strict liability standard. For example, if a medical device is inherently dangerous or risky, the courts will not want to hold the manufacturer, distributor, wholesaler, or retailer liable in all situations.

If this is the case, your product liability attorney must demonstrate the following four things:

• The defendant owed you a duty of care
• They breached this duty of care
• You suffered an injury
• The defendant's breach of duty caused your injury

If you demonstrate these elements of negligence, there's a good chance you will recover damages.

Be Aware of the Applicable Statute of Limitations

Regardless of the type of lawsuit you file, your product liability lawyer must do so before the statute of limitations expires. You can't wait until the last minute to talk to a lawyer.

Your attorney will need plenty of time to prepare your case. While there is a good chance your lawyer will settle your case long before trial, there are no guarantees. Your lawyer must presume that your case may go to trial.

Preparing for trial is a long and arduous task. It can also be expensive. Your product liability law attorney will need several months or longer to prepare for trial properly. Some of the tasks they must complete include:

• Gathering evidence to prove your claim
• Interviewing witnesses
• Conducting depositions
• Securing affidavits from witnesses and your healthcare providers
• Researching other cases involving the same defective medical device
• Negotiating with the defendants' insurance companies
• Creating exhibits for the jury
• Drafting motions as needed
• Conducting discovery
• Hiring and consulting with expert witnesses

If you wait too long to hire an injury attorney, they may not have enough time to prepare adequately. If this happens, they may not be able to secure you the compensation you deserve.

Product Liability or Medical Malpractice?

Sometimes, it is hard to determine whether you should file a product liability claim or a medical malpractice claim. If a manufacturer sells a medical device with warnings, your healthcare provider must read and communicate the warnings to their patients.

If a doctor or other medical professional fails to communicate a warning to a patient, they can be liable for damages. For example, imagine that a manufacturer warns doctors that a medical device can be harmful to someone with atrial fibrillation. The doctor ignores this warning and prescribes the device to a patient who was recently diagnosed with A-Fib. If the patient is hurt, the doctor could be liable for medical malpractice.

When you first meet with your attorney, they will review all the facts surrounding your claim. They will let you know which type of claim you should pursue. There are cases where you would need to sue both the manufacturer and your healthcare professional. It all depends on the facts and the strength of your evidence.

Regulation and the FDA

The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. This includes durable medical equipment. The amount of control the FDA exercises over medical device manufacturers depends on how likely the produced goods are to cause injury. The FDA has implemented standards and practices with which manufacturers must comply.

Evidence of compliance may bolster a defendant's claim that it is not liable for your injuries. For example, a manufacturer may point to evidence of a 100% compliance score on an FDA inspection as proof that they made the device correctly.

Conversely, evidence showing that the defendant didn't comply with FDA regulations can help prove your case. If you can point to a process cited by the FDA, it will help show that the device was defective.

FDA regulations can also help prove a defective marketing claim. The FDA maintains labeling requirements for certain medical products. However, even if a manufacturer can prove they complied with these requirements, the court may still hold them liable.

Getting Legal Help for a Defective Product Injury

Product liability actions can be complex. You may need an attorney to help pursue your claim. This is especially true in a defective medical device case. You will need to focus on making a full recovery. The last thing you'll want to do is argue with insurance companies and follow up on legal claims.

You should contact an established product liability attorney near you immediately after your injury. Consult FindLaw's attorney directory for assistance finding an experienced product liability lawyer in your area.