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Defective Medical Devices

The purpose of a medical device is to help the patient, and all products have risks. However, a medical device manufacturer has a duty to make a reasonably safe product. Simply put, the benefits must outweigh the risks. A device manufacturer may be held responsible for defective manufacturing, negligent design, and failing to warn of serious risks they knew about but didn’t disclose. They may also be held accountable for failing to following FDA rules.

With over 31 years of medical device experience representing thousands of clients, national leadership, and a strong record of obtaining substantial settlements for our clients, GoldenbergLaw and our defective medical device lawyers in Minneapolis are here to help you recover physically, emotionally, and financially.

Defective Medical Device Quick Facts

Overview

The FDA approves medical devices for sale, but it does not guarantee that a particular product is safe. Medical device defects are often categorized as either design defects (which are part of the basic design of the product, including the marketing and warnings), or manufacturing defects (which occur as an unintended consequence of the manufacturing process such as contamination). Whether a claim is based on strict liability or negligence depends on the type of defect involved and the warnings that were given (or not given). The type of FDA approval process will often determine whether litigation is allowed under the law. We can usually tell you this in the initial phone call.

Design
While competition can fuel innovation, it also can lead medical device companies to design products quickly and rush them to market. This can sometimes lead to design flaws. Additionally, if a device is similar enough to an existing model, the FDA allows a fast-track approval process that can miss key dangers.

Manufacturing
While the government requires drug and medical device manufacturers to perform adequate tests on their products, there are ways to bypass more stringent testing — and medical device manufacturers know all the tricks to get a product to market. Flaws in making the product and contaminations are all theories we will fully investigate with our national experts.

Marketing
Manufacturers of medical devices have a legal duty to follow the FDA label and to warn doctors of potential risks associated with their products. The risks must also be updated when manufacturers learn of new additional risks even after FDA approval. We have succeeded in cases where manufacturers have over-promoted the product to doctors and failed to discuss the real risks of using the product.

 

Injuries and Liability

Injuries

Depending on the device, the injuries that you suffered from a defective medical device can be wide-ranging. However, not all injuries are physical. There are also emotional and financial damages that a defective medical device can cause.

Liability

The liability for injury caused by a defective medical device depends on the individual facts of your case. GoldenbergLaw does its research on the science before we take any case. The medical literature, case reports, or reports to the FDA may all help us prove your case. We then consult with top medical and scientific experts to understand the defect in the product and how we will prove it. This research allows us to formulate a criteria that all cases must meet for us to proceed.

What We Are Working On

The best way to determine who is liable for your injury and if you meet this criteria is through a one-on-one consultation with a medical device lawyer in our Minneapolis office. Here are some cases that we can help you with:

Bair Hugger

A warming blanket used during surgeries that is alleged to spread contaminate air over open wounds – linked to deep joint infections and need for revision surgery.

Hernia Mesh

Hernia mesh failing to integrate into patient’s bodies can cause migration, hernia recurrence, bowel obstructions, require removal surgery, and puncture organs, among other injuries. Some devices have been recalled.

Hip Replacement Devices

Models include DePuy ASR, DePuy Pinnacle, Stryker Rejuvenate, Stryker ABG II, Zimmer Durom Cup, and others – linked to implant loosening, pain, high metal levels in blood, and need for revision surgery. Some devices have been recalled.

INRatio

A monitoring system used by patients taking Warfarin to measure the blood’s ability to clot. Recalled for giving inaccurate results potentially leading to an improper dose of Warfarin causing excessive bleeding, hemorrhagic stroke, and death.

IVC Filters

Blood clot filters placed in the large vein leading to the heart – shown to migrate or fracture after a period of time and can puncture parts of the vein or other internal organs.

Knee Replacement Devices

Models include the DePuy Attune and Zimmer Persona – linked to implant loosening, dislocation, and the need for revision surgery.

Medtronic Paradigm Pump

Insulin pump – linked to defects resulting in over or under delivery of insulin leading to serious illness and/or death.

Penumbra JET 7 Xtra Flex Catheters

Penumbra JET 7 Xtra Flex catheters are frequently used in thrombectomy procedures to remove blood clots in the brain. However, reports have shown that the distal tip of the catheter can expand or fracture causing injuries such as brain bleeds, hemorrhagic strokes, and death. In December 2020, the FDA announced the recall of all Penumbra JET 7 Xtra Flex catheters. If you or a loved one suffered a serious injury during a thrombectomy procedure where a Penumbra JET 7 Xtra Flex catheter was used, contact the Penumbra Jet 7 Recall Attorneys at GoldenbergLaw for a free consultation.

Stöckert 3T Heater-Cooler Units

Studies have shown that Stockert 3T heater-cooler devices used in surgical procedures may be causing potentially-fatal nontuberculosis mycobacterium (NTM) infections. NTM infections can be caused by bacteria growing in the heater-cooler’s water tank which then circulates through the exhaust fan where it contaminates the air in the operating room and can reach the patient’s wounds. If you or a loved one has suffered an infection after an open heart surgery, contact the experienced Heart Surgery Infection Lawyers at GoldenbergLaw today.

Surgical Staplers

Surgical staplers are commonly used in bariatric and gastric surgeries in place of sutures. The goal of surgical staplers is to connect or remove internal tissue and organs or to close high-tension wounds externally. However, the FDA’s review of surgical staplers resulted in a recall of thousands of staplers due to receiving more than 41,000 adverse event reports as of 2019. If you or a loved one suffered harm after a gastric or bariatric surgery that may have been caused by a defective surgical stapler, contact the Minnesota Defective Product Attorneys at GoldenbergLaw today for a free review of your case.

Wright Profemur Hip Devices

Although the goal of a hip replacement procedure is to extend mobility, several types of hip devices can actually cause harm to patients instead of relief. Hip devices made with metal-on-metal components can cause metal wear, metallosis, and even the degradation and fracture of the artificial hip. The complications from these defective devices can be severe and require a revision surgery. Minnesota Hip Replacement Attorneys at GoldenbergLaw have been handling defective hip replacement lawsuits for over a decade. Contact us today for a free consultation.

Zimmer M/L Taper Hip Devices

Zimmer M/L Taper and the Zimmer M/L Taper with Kinectiv Technology hip implants are supposed to result in increased mobility due to the flexibility of the components. However, studies have connected the devices to dangerous metal poisoning and other severe complications resulting from the metal-on-metal wear. The Hip Replacement Lawsuit Attorneys at GoldenbergLaw are investigating cases where a person needed a revision surgery after a Zimmer hip replacement.

Your consultation is free of both obligation and charge, allowing you to ask questions freely and gain a full understanding of your options.

Do I Qualify?

Free Consultations

If you think that you may have a case, reach out to one of our defective medical device attorneys in Minnesota today. There is no charge and there is no obligation.

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True Story

“Joe” worked at a local hospital as an EMT. In the past, he had injured his back and required a fusion. His doctor used a medical device to assist with this surgery. Unfortunately, Joe had a severe adverse reaction to the product and ultimately had seven additional surgeries. Joe contacted GoldenbergLaw, and found out that we represented hundreds of other injured clients on the same device. Our firm became the co-lead counsel on 850 cases litigated around the country. After three hard-fought years of litigation, Joe and the other clients were able to receive a confidential settlement for their injuries.

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Medical Device Recalls

StrataMR Adjustable Valves and Shunts

In April 2017, Medtronic and the FDA issued a worldwide recall on Strata MR adjustable valves and shunts sold from February 22, 2017 to April 24, 2017. The devices can malfunction causing headaches, nausea, vomiting, lethargy, coma, and death.

Zimmer Biomet Shoulder Replacements

In December 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder Humeral Replacements implanted from August 2008 – September 2011. The devices were recalled after reports of higher than expected fracture and failure rates.

Zimmer Biomet Implantable Spinal Fusion Stimulators

On April 10, 2017 Zimmer Biomet issued a Class I Recall on its SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators distributed from March 28, 2017 to April 6, 2017. The device was recalled after finding that the device could release chemicals into the body that can be toxic to tissue and organs. A negative reaction to these chemicals can lead to chronic infection, long term hospitalization, paralysis, and death.

What Our Clients Are Saying

“I wanted to write you a short note to express my sincere thanks for your efforts on my case. It was greatly appreciated and I am very grateful for your help. It was a long and difficult struggle and I am sure without your help I would not have had any success with them. You are a real professional.”

– Scott M.

What Our Clients Are Saying

“I just don’t think that there are words to express my gratitude for all you have done for Rey and me. It is not often in life that one gets a second chance, a “do-over.” Nothing will ever replace “…” but with your persistence and hard work a settlement was received and for that Rey and I are extremely grateful.”

– Anne N.

What Our Clients Are Saying

“Thank you again for your outstanding work on my case. I’ll never forget how much you helped me!”

– Barbara A.

FAQs for Defective Medical Devices

What Can Make a Medical Device Defective?

A device manufacturer may be held liable for defective design, defective manufacturing, and/or failure to warn of serious risks they were aware of with the medical device but did not disclose. Medical device defects are categorized as either design defects or manufacturing defects.

What Is a Design Defect?

A design defect is a defect that is part of the basic design of the product and renders the product unsafe for use.

What Is a Manufacturing Defect?

A manufacturing defect can occur as an unintended consequence of the manufacturing process.  Examples include contamination and flaws in making the product.

What Should I Do If I am Injured By a Defective Medical Device?

Being injured by a defective medical device is a scary experience, and the process of filing a defective medical device lawsuit can be complex. If you or a loved one have been injured by a defective medical device, contact the team at GoldenbergLaw.  We have over thirty years of experience litigating defective medical device lawsuits for thousands of clients and obtaining justice through settlements. The defective medical device attorneys at GoldenbergLaw will be here for you to help you recover physically, emotionally, and financially.

Should I Accept a Direct Settlement From a Device Manufacturer If One is Offered?

If you receive a direct settlement offer from a device manufacturer, contact the Defective Medical Device Attorneys at GoldenbergLaw who will review your case to review any offer and help you make the best decision possible.

What Is a Multidistrict Litigation, and Why Is It Used for Defective Medical Device Cases?

A multidistrict litigation (“MDL”) is a procedural creation where federal civil (noncriminal) cases throughout the country are transferred to one court. The establishment of an MDL is intended to reduce the burden on federal district courts, make litigation more convenient for all the parties involved, and promote overall efficiency by resolving common questions throughout the case that occur in often large-scale defective medical device lawsuits. In order for the cases to be consolidated, they must have one or more questions of fact in common. Once the cases are consolidated, one judge manages the litigation during the pretrial and discovery processes. However, each case will be resolved based on its own merits.

Why Choose GoldenbergLaw?

If you have any questions, or if you would like to speak with an attorney regarding your defective medical device injury, please do not hesitate to call our medical device attorneys at our Minneapolis office toll-free at 800-903-1643. If you prefer, you may fill out the form on the Contact Us page of this web site, and a representative from our office will be in touch with you shortly. Call us. You will sleep better.

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