Holding Negligent Parties Accountable
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 follow FDA rules.
With over 38 years of medical device experience representing thousands of clients and a strong record of obtaining substantial settlements and verdicts, Goldenberg Lauricella, PLLC and our defective medical device lawyers in Minnesota 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 during an 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 & 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. The Minnesota defective products liability lawyers Goldenberg Lauricella, PLLC do their 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 criteria that all cases must meet for us to proceed.
Do I Qualify? 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.
Medical Device Recalls
Exactech Knee and Ankle Replacement Recall
In February 2022, Exactech recalled the inserts after discovering the product packaging exposed the inserts to high levels of oxygen. This oxidation weakens the insert prior to implantation, which leads to early wear, fracture, and ultimately revision surgery. The inserts are placed between the metal components in knee and ankle replacement devices.
StrataMR Adjustable Valves & 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.
Bair Hugger
3M’s Bair Hugger system is used in a hospital or surgical setting to help patients maintain their core body temperature throughout their procedure. It’s comprised of a disposable inflatable blanket and a reusable forced-air warming blower, which have been linked to increased risk of infection following joint replacement surgery.
CPAP Injuries
On June 14, 2021, Philips announced the recall of millions of ventilators, BiPAP, and CPAP machines due to the degradation of its polyester-based polyurethane (PE-PUR) noise-canceling foam. The PE-PUR foam was found to disintegrate into particles that can enter the device’s air pathway and be inhaled and ingested by users. The foam may also release dangerous gas chemicals. Inhalation of the foam particles or gas chemicals is linked to serious injuries, including cancer.
Hernia Mesh
Hernia mesh implant surgery is one of the most common surgeries in the world, and more than one million hernia repair surgeries occur each year in the U.S. alone. Unfortunately, the large number of surgeries that occur mean there is also an increased number of reported complications and injuries. If you or someone you loved has been injured by hernia mesh, it’s possible that the manufacturer is to blame, meaning thousands of others are likely to have faced the same injuries. Goldenberg Lauricella, PLLC has handled countless mass tort claims since 1986, including defective medical device cases, and we know how to take your case from here so the only thing you need to concern yourself with is healing.
Hip Replacement Devices
Hip replacements can be an unpleasant experience, no matter what your artificial hip is made from. Metal-on-metal hip implants carry with them additional risks on top of those generally associated with hip replacement surgery. Manufacturers have known of the additional risks metal-on-metal hips carry since the 1970s.
IVC Filters
Inferior Vena Cava (IVC) filters are designed to prevent blood clots from traveling to a patient’s lung (pulmonary emboli). They are most often implanted in patients who are not good candidates for blood thinners. Unfortunately, many of these filters fail, and frequently, a patient will have no idea that their filter is not functioning as intended. This can happen in the form of a leg breaking off of the filter, the filter migrating out of its intended position, and/or the filter puncturing the vena cava by rotating into an improper position. These filter failures can cause severe injuries or death.
Knee Replacement Devices
Knee replacement devices should always greatly benefit the lives of patients through increased mobility and diminished pain. However, such devices can cause tremendous problems when they fail. Premature device failure can cause severe pain, bone density loss, muscle damage, and other serious health complications.
Transvaginal Mesh
If you or a loved one has suffered an injury due to a vaginal mesh implant, contact the medical device lawyers at Goldenberg Lauricella, PLLC for a free vaginal mesh lawsuit consultation. We are currently accepting cases nationwide.
Stöckert 3T Heater-Cooler Devices
An infection after heart surgery can be a devastating and, at times, fatal diagnosis. Multiple studies have found that the Heater-Cooler devices used operating rooms may be the cause of these heart surgery infections. The Stöckert 3T Heater-Cooler unit is a device used in open-heart surgeries to regulate a patient’s body temperature. Recent studies have found that these devices can cause deadly infections from bacteria that grow in the unit’s water tank and circulate through its exhaust fan. The bacteria contaminates patients when the exhaust fan blows tainted air over exposed wounds during surgery.
Surgical Staplers
Surgical staples are used in bariatric and gastric surgeries in place of sutures to connect or remove internal tissue and organs. They’re also used externally to quickly close high-tension wounds. Staples are applied by a medical professional with a disposable or reusable stapler.
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 Goldenberg Lauricella, PLLC 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.
Zimmer Biomet Shoulder Replacements
In December 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder Humeral Replacements implanted from August 2008 to 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.
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 Goldenberg Lauricella, PLLC. We have over 30 years of experience litigating defective medical device lawsuits for thousands of clients and obtaining justice through settlements.
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 attorneys at Goldenberg Lauricella, PLLC. We will evaluate your case to review any offer and help you make the best decision possible.
What is a multidistrict litigation, & 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 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.
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 (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.