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
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
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.
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:
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 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.
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.
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.
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.
Models include the DePuy Attune and Zimmer Persona – linked to implant loosening, dislocation, and the need for revision surgery.
Insulin pump – linked to defects resulting in over or under delivery of insulin leading to serious illness and/or death.
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.
Contact Us Call 800-903-1643
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.
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.
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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