What Are the Requirements for Suing Over a Defective Medical Device?

Medical devices are designed to improve health outcomes, but when they are dangerous or defective, they can cause serious injuries to patients. The FDA receives several hundred thousand reports annually, covering everything from malfunctions to serious injuries or device-associated deaths.

If you or a family member is harmed by a defective medical device, like a CPAP machine or heart balloon pump, you may be able to sue for compensation. However, this requires proving that the device was defective, the defect was due to manufacturer negligence, and that it caused your injuries.

Our experienced Green Bay defective product lawyers at Brian Hodgkiss Injury Lawyers can help you prove your case and get you the compensation you deserve.

What You Have to Prove to Win a Defective Product Claim

To succeed in a claim for a defective product, you must establish certain legal criteria, including:

• Product Defectiveness: This requires demonstrating that the medical product had an inherent flaw. This flaw could be due to its design (conceptual flaw), its manufacturing (production error), or its marketing (inadequate warnings or instructions). Establishing defectiveness means showing that the product, as sold, was not safe for use in any intended or reasonably foreseeable manner.

• Existence of Defect at Manufacturer’s Release: You must prove that the product had defects when it was dispatched by the manufacturer, indicating that these flaws resulted from the manufacturer’s actions or lack thereof, rather than from any alterations or misuse occurring after its production. This assigns responsibility to the manufacturer for ensuring the product’s safety.

• Causal Link to Injury: For a valid claim, there must be a direct connection between the defect and the injury suffered. This involves showing that the defect led to the harm or injury, without which the injury would not have occurred. These damages include medical expenses, lost wages, and pain and suffering.

• Intended Use of Product: You need to show that the medical product was used in the way the manufacturer intended or in a way they would expect. This ensures that any misuse exempting the manufacturer from liability is excluded. For example, if you’re injured using a syringe meant for insulin injections to administer non-prescribed substances, it would fall outside its intended purpose.

What Evidence Can You Use to Support Your Claim

To support your claim regarding a defective medical product, our attorneys can help you collect the required documents, witness statements, and other evidence to strengthen your case, including:

• Medical Records: We can gather records detailing the injuries or adverse reactions you suffered due to the faulty device, such as medical reports, records of treatment, and diagnostic exams, to demonstrate how the product has affected your health.

• Product Documentation: We can obtain relevant documentation for medical devices, such as use instructions, warnings, and labels, to demonstrate how the product was presented to consumers and any potential safety oversights.

• FDA Recalls: Although recalls are not required for a claim, they can bolster your case. If there have been FDA recalls of the product, we can use this information to indicate that there were known safety concerns or defects.

• Expert Testimony: Our team can call on specialists like doctors or engineers as expert witnesses. They’ll help explain how the device was defective, the injuries it caused, and whether it met industry standards.

• Manufacturing Records: We will obtain documentation related to the device’s manufacturing process, including quality assurance reports and any departures from established procedures, to identify potential sources of liability.

• Similar Incidents: Collecting information on similar incidents or grievances regarding the device can bolster the case that the product was fundamentally flawed and posed a recognized hazard to consumers.

Why You Need an Attorney for Your Case

Legal cases involving defective medical devices are complicated and require experienced legal support. Our qualified legal team offers these services to help you obtain the compensation you need for your recovery:

• Legal Knowledge and Experience: We know the relevant statutes for product liability cases and have experience handling similar claims. This allows us to build a successful case and maximize the chances of a favorable outcome.

• Investigation and Determining Liability: We conduct thorough investigations into the manufacture and use of defective medical products, taking into account all liable parties. This can include evidence proving that a manufacturer, medical provider, or retailer knew about the dangers but continued to make, use, or sell the device.

• Negotiation Skills: Our expertise in negotiation can help you achieve a fair settlement. We’ll ensure all your current and future expenses are accounted for, so your compensation covers what you’ve lost and had to spend.

• Courtroom Representation: If your case proceeds to trial, we will deliver persuasive arguments, question witnesses, and defend your rights in court.

Get the Recovery Award You Deserve After Harm from a Medical Device

Victims of defective medical devices can experience profound and lasting impacts on themselves and their families. At Brian Hodgkiss Injury Lawyers, we know the challenges you may face and the burdens your injuries may impose.

We are committed to supporting those harmed by defective medical devices, dedicating ourselves to securing the maximum compensation you deserve. If a defective medical device has injured you, contact us for a free initial consultation.