Do You Have A Medical Device Liability Case?

Do You Have A Medical Device Liability Case?

The use of medical devices to treat diseases or disabilities has expanded in recent years, and is a very common method of correcting ailments. Medical devices are used for joint replacements, alleviating heart problems such as blocked arteries and are also used as contraceptive devices.

However, when something goes wrong with a device there may be a liability claim available if the patient suffers harm or injury. If this has happened to you, then the primary question is: do you have a medical device lawsuit case?

The answer lies in the law surrounding product liability, and the duty of medical device manufacturers to produce safe products for patients.

If you have used a device that caused some type of injury, then you may have a case for compensation from the manufacturer, physician or medical facility. Current medical device liability cases include Transvaginal mesh surgery and metal hip implant surgery.

What Is The Liability Of Medical Device Manufacturers?

Patients expect to be treated with medical devices that are safe and free of defects. A medical device manufacturer can be held liable if their device was designed or manufactured with flaws or potential to cause harm to a patient. This duty includes ensuring adequate testing and inspection of devices prior to medical use.

If there are known risks, then the manufacturer also has a duty to warn the user about possible side effects or injuries that could occur. Failure to meet any of these responsibilities can result in liability for the manufacturer.

A claim for liability would be based on whether the manufacturer was negligent, and failed to act reasonably in protecting the consumer against harm. For example, if the manufacturer knew of a potential risk in the design, but then did not disclose that information to users, then they could be found negligent.

Medical Device Strict Liability

Strict Liability may apply to any medical device that is found to be “inherently or unavoidably unsafe”, and then causes injury to a patient. In other words, the injured patient does not have to show that the manufacturer was “negligent” to make a claim. For strict liability it is only necessary to show that they either knew of the defect and inherent risk, and failed to warn the user of danger.

This is an easier standard to meet than proving negligence, and will depend on whether the claim is based on design, manufacture or failure to warn. In some cases, simply putting an unsafe medical device on the market that causes injury could be sufficient to have a case. A claim based on strict liability will depend on the actual product defects and warnings involved, and will not apply in every situation.

Medical Device Liability Preemption

Many medical devices are submitted for approval to the Food and Drug Administration (FDA), and if approved the devices may be preempted from product liability claims in state courts. This preemption of claims will depend on whether the device was being used in a way that was consistent with the FDA approval.

Medical devices do have an express preemption for cases where the device is submitted to the FDA premarket, and is used according to the FDA’s specific approvals.

In those cases, federal law would preempt any liability claims brought under state law. However, there are many exceptions to medical device liability preemption, especially if the device was used in a way that was not approved by the FDA. For this reason, it is important to have your case evaluated by an attorney experienced in medical device product liability.

What Should You Do If You Think You Have A Case?

If you have been injured and suffered damages from the use a medical device, you may have a case for liability. The first step is to contact a medical product liability attorney as soon as you suspect that something has gone wrong with your device.

You should also compile all of your medical records related to your treatment with the device, as well as the information given to you regarding potential risks and consequences of using the medical device. Do not discuss the case with your physician or the manufacturer, and allow your attorney to evaluate your claim based on the facts that you share in your consultations.

You will want to detail the exact type of damages that you need to have compensated, such as medical expenses, lost wages or pain and suffering so your medical lawsuit lawyer will have as much information as possible to help your case.