Articles Posted in Medical Devices

Published on: October 13, 2026

Abbott Spine Stimulator Lawsuits

giuliamar-spinal-column-246273-scaled-e1791655542187 Chronic pain is debilitating. Neurostimulation or spinal cord stimulation (SCS) is one type of pain management; it works by sending low intensity electrical impulses to a patient’s nerve structures. Abbott makes various kinds of SCS systems that plaintiffs allege are flawed and caused injuries. Lawsuits have been filed that allege the SCS implants can break through skin, migrate, give painful shocks, cause nerve damage and fail outright; these may require expensive revision or removal surgery. On October 2, the JPML centralized 26 lawsuits against Abbott across 13 districts to be heard by the U.S. District Court for the Northern District of Illinois. If you were injured by the Abbott spine stimulator, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group about whether you have a claim. Billions have been recovered in cases with which we’ve been involved.

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Centralization permits lawsuits against the same manufacturer go through discovery and other pretrial proceedings together, which allows common questions to be decided consistently. In each case, plaintiffs still need to establish that the device in question cased their injuries. The plaintiffs in the initial cases that sought centralization in multidistrict litigation claimed that since the original premarket approvals, Abbott and Boston Scientific, another defendant, had introduced new devices that were significantly modified under supplements to their original premarket approvals. The plaintiffs alleged that they were implanted with spinal cord stimulators from these different companies and suffered injuries such as neurological problems, autonomic dysfunction, burning, shocking, lead migration and insufficient pain relief.

In June, the Judicial Panel on Multidistrict Litigation found that proponents of an industry-wide MDL had failed to meet their burden of showing that an MDL with a wide scope would be appropriate since each manufacturer had its own line of devices, each of which had different regulatory histories. It found that given the differences among the lawsuits naming various manufacturers, an industry-wide MDL would probably complicate case management, due to the need to protect confidential information and trade secrets. Additionally, there was no common mechanism of defect alleged among all the different spinal cord stimulators.

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Published on: October 6, 2026

Hamilton Medical Removes Coaxial Breathing Circuit Set

By Moll Law Group

fernandozhiminaicela-treatment-40994321-scaled-e1789337139404 Hamilton Medical, Inc. ventilator coaxial breathing circuits are used to connect HAMILTON-C1/T1/MR1 ventilators to a patient tube or respiratory mask in the course of ventilation of a patient. Recently, the Food and Drug Administration (FDA) announced that it is aware that the manufacturer Hamilton Medical has sent a letter to consumers recommending that specific coaxial breathing circuit sets used with HAMILTON-C1/ T-1/MR1 ventilators should be removed from where they are sold or used. The company has said that some of these sets, preassembled with an expiratory valve set, don’t perform as intended. Sometimes the expiratory valve membrane sticks to the sealing ring on the body of the expiratory valve, which can impair the valve opening and expiratory gas flow. The problem, the letter says, won’t be noticed during the pre-operative test of the ventilator unless a test lung is actively ventilated. If the expiratory valve membrane is stuck to the sealing ring, within the first breaths after ventilation starts, the problem becomes apparent. If your breathing or your loved one’s breathing was impaired and injuries were sustained, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group.

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Whether the expiratory gas flow is impaired, the end-expiratory flow is too low, or the end-expiratory pressure is too high, the ventilator’s “Exhalation Obstruction” alarm will be triggered. When expiratory flow is obstructed, there is an inappropriately low amount of ventilation and impeded gas exchange. This can result in acute respiratory compromise, which in turn can result in inadequate ventilation and hypoxemia. The latter exists when there is an unusually low amount of oxygen in the blood in the arteries.

As of July 2, the company has reported four serious injuries and no deaths linked to the impaired expiratory gas flow arising out of certain coaxial breathing circuit sets. If you were injured or a loved one died as a result of this issue, you should consider bringing a product liability lawsuit. These are lawsuits pursued when one or more product defects—whether a marketing, manufacturing, or design defect—can be proven. Manufacturing defects are flaws in how the product is made; generally, these occur when the manufacturer deviates from the design specifications. Design defects are flaws in the specifications or design itself. Marketing defects typically involve failure to warn of known dangers.

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Published on: July 21, 2026

AngioDynamics Port Catheter Cases

By Moll Law Group

parentingupstream-hospital-840135-scaled-e1783883169792 AngioDynamics port catheters are devices that give patients long-term access to their veins for treatments like chemotherapy. Unfortunately, the Food and Drug Administration (FDA) received hundreds of reports of failures. Many lawsuits were filed claiming that the AngioDynamics’ and its subsidiary Navilyst Medical’s port catheters caused serious injuries, and these were consolidated into federal multidistrict litigation so that the lawsuits could be more efficiently and consistently handled. If you or a loved one was injured by an AngioDynamic port catheter, you should call the seasoned Chicago-based lawyers of Moll Law Group to find out whether you have a viable claim. Billions have been recovered in cases with which we’ve been involved.

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The AngioDynamic lawsuits allege that the manufacturer used too much barium sulfate in the port catheters. This substance caused cracking, pitting, and degradation in the devices, and made them more likely to fracture such that they could perforate organs or blood vessels or lead to blood clots and more. Some of the injuries reported have included pulmonary embolism, mechanical failures, infection, components getting embedded in tissue, and foreign objects migrating in patients’ bodies. When a catheter fractures inside a patient, other serious complications can occur including heart rhythm difficulties and bleeding, and further surgeries may be needed. In addition to being expensive, these procedures may come with substantial pain and suffering and emotional anguish.

The plaintiffs in 19 actions moved to centralize the litigation in the Western District of Missouri. The defendants opposed the motion and proposed, in the alternative, other districts. It was determined that the actions involved common factual questions about the excessive barium sulfate concentration that caused the material to degrade and fracture, and so centralization in the Southern District of California, where five of the actions were pending, would be in the interests of the parties’ and witness’ convenience and promote just and efficient litigation.

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Published on: July 22, 2025

Select Newport Ventilators and Service Parts Have Been Recalled.

By Moll Law Group

hospice-4135835_640-e1752357257868 In May of this year, the manufacturer Medtronic voluntarily recalled Newport HT70 and HT70 Plus ventilators, along with specific service parts related to those models. Consumers were asked to remove these devices from use and substitute an alternative ventilator for patients. In June, the FDA designated the voluntary recall as a Class I recall—the most serious type of recall as it means the product has a reasonable possibility of causing severe medical problems or death. If you were injured or a loved one died due to Newport ventilators, you should call the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases across the country with which we’ve been involved.

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Ventilators, as their name indicates, provide a patient with ventilation, helping him or her to breathe by themselves. When a patient can’t breathe on their own, the result may be lowered oxygen levels and heightened carbon dioxide in the patient’s body, which in turn can result in brain injury or death. One family of recalled ventilators, HT70, is meant to be used at home to provide continuous or intermittent positive pressure mechanical ventilatory support for people that need mechanical ventilation. They are also used in cases involving infant or pediatric patients in subacute care, a hospital, an emergency department, and for emergency response situations, specifically because this population is at heightened risk of death or injury due to unpredictable ventilator failures.

The company has advised that certain of its ventilators no longer be used in clinics. Customer complaints led to Medtronic finding two distinct capacitators that could and cause the ventilator to shut down while it was being used or the shutdown alert alarm not sounding properly. When a ventilator experiences one of these failures and adequate ventilation isn’t provided, the person using the ventilator might not be able to breathe by themselves.

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Published on: February 4, 2025

Seasoned Attorneys for Abbott Trifecta Valve Lawsuits

By Moll Law Group

surgery-1807541_640-e1737155771843 In February 2023, Abbott, which manufactures Trifecta Valves warned doctors and other providers that its valves were subject to early structural valve deterioration. In summer 2023, the company announced that it would stop sales of the Trifecta Valves, including Trifecta Valve with Glide Technology (Trifecta Valva GT). Meanwhile the Food and Drug Administration (FDA) has offered many recommendations and continues to work with the manufacturer to determine the risks and best practices in connection with the affected valves. If you were injured or a loved one’s death is because of an Abbott Trifecta Valve that deteriorated early after being implanted, call the seasoned Chicago-based attorneys of Moll Law Group. Our firm serves consumers around the country—billions have been recovered in lawsuits with which we’ve been involved.

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Some patients with diseased aortic heart valves or who have malfunctioning or damaged prosthetic aortic heart valves were treated with Trifecta and Trifecta Valve GT. The FDA first approved first generation Trifecta valves in 2011. While the first generation model is no longer in service, many other kinds of Trifecta Valves have been implanted since. Studies show that the Abbott Trifecta Valves require more reintervention than other commercial valves. They’ve deteriorated in some instances just three to four years after being implanted.

Health care providers have been told about the potential dangers of early structural valve deterioration (SVD), but the full risks are not known. If you were harmed by a valve or a loved one died because of the deterioration of an Abbott Trifecta Valve, you should let the FDA know about the adverse event, so that it can get a better sense of the dangers. You can also expect that your health care provider is now aware of the possible risks and if you have one implanted, you should see your provider to determine the next best steps.

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Published on: June 25, 2024

More Cases Join the Bard PowerPort MDL

By Moll Law Group

catheter-e1718067147367 Bard PowerPort devices have been linked to serious injuries and deaths. As of May 2024, the Bard PowerPort Multidistrict Litigation (MDL) has increased by 189 cases. These lawsuits are consolidated in MDL 3081, or In re: Bard Implanted Port Catheter Products Liability Litigation before Judge G. Campbell. These lawsuits request financial compensation on the grounds that the catheters are defective and have injured them. The court rejected efforts to delay bellwether trials, which are expected to proceed according to schedule. Bellwether trials are a small group of lawsuits selected to be determined early, in order to predict the outcome in similar lawsuits in the MDL. If you were injured by an implanted Bard PowerPort, please call the Chicago-based product liability lawyers of Moll Law Group to learn your options. Billions have been recovered in lawsuits with which we’ve been involved and we represent clients around the country.

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The Bard PowerPort is a catheter device, implanted under a patient’s skin, used to put fluids or medicine directly into his or her veins. They are usually used in the course of medical IV therapy, including chemotherapy, and to give fluid to a patient. Bard PowerPorts are housed in titanium and plastic. They’re made with a polyurethane that combines barium sulfate and polyurethane. Bard Access Systems Inc., which Becton, Dickinson and Company’s subsidiary, makes this device.

The consolidated lawsuits against the manufacturer allege the catheter device is linked to defects and complications and can result in harm as severe as death due to its fractures and migrations, as well as infections, embolisms, blood clots, and thrombosis.

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Published on: May 28, 2024

ResMed Notified Consumers About Potential Danger of Masks With Magnets

By Moll Law Group

corona-6278444_6401-e1715227682690 Manufacturer ResMed makes CPAP masks that contain magnets. These masks have varying coverage of a patient’s face. Recently, the company gave consumers updated instructions for using the masks and held a voluntary global field action to update its guide for these masks. The notification warned consumers of a potential magnetic interference when magnets in the ResMed masks are close to certain implants and medical devices in a patient’s body. The ResMed masks that contain magnets are considered safe when used in line with the updated instructions for use and the field safety notice. If you were harmed by a ResMed mask with a magnet, or another medical mask containing a magnet, you should consult the experienced Chicago-based product liability attorneys of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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Masks with magnets that were listed in the notice from the manufacturer include AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i. You can locate your mask’s model number on its frame or cushion. Affected masks include full face masks, non-vented masks, and nasal masks used to provide positive airway pressure therapy; they have magnets that make it easier for users to adjust the masks’ fit. The notice to consumers was issued because the masks not only potentially interrupt the function of some medical implants, but because they can also move the implant, whether a stent or a cranial plate or another device, within the patients’ bodies, causing serious injuries and necessitating additional, likely expensive medical care.

The affected ResMed masks were sold around the country and the world from 2014 to November 2023. The company has submitted to authorities five reports they received in which there was either medical intervention or hospitalization necessary that may have been related to magnetic interference of a mask with an implanted device. So far, users have not reported deaths or serious, permanent injuries.

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Published on: May 7, 2024

The FDA Informs Providers About Labeling Updates

By Moll Law Group

surgery-1822458_6401-e1712683689856 Surgical mesh products are used to repair and reinforce soft tissue in patients where the tissue has some weakness. In particular, mesh is used to help reinforce the hernia. However, doctors have increasingly been using surgical mesh products, even though the safety and effectiveness in breast surgery hasn’t yet been determined by the FDA. The United States Food and Drug Administration has informed doctors, nurses and other health care providers of new labeling updates for Becton, Dickinson and Company mesh products. These products include the following: GalaFLEX Lite Scaffold, GalaFLEX Scaffold, GalaFLEX 3D Scaffold, GalaFLEX 3DR Scaffold, Phasix ST Mesh, Phasix Plug and Patch, Phasix ST Mesh with Open Positioning System (OPS), and Phasix ST Mesh with Echo 2 Positioning System. If you were injured by any of these types of surgical mesh products, you should call the seasoned Chicago-based product liability lawyers Moll Law Group.

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The FDA issued its letter to ensure that doctors, nurses, and hospitals knew that Becton, Dickinson and Company had updated its product warnings to indicate that surgical mesh products haven’t been determined to be safe and effective for purposes of breast surgeries by the FDA. Health care providers have been asked to read the warnings.

However, if you are asymptomatic after mesh was used in your surgery, the FDA has not recommended that the mesh be removed or operated upon. The FDA has called for clinical evaluations to figure out whether the mesh products have benefit when they’re used for breast surgery. It also commented on the lack of clinical evaluations at a General and Plastic Surgery Devices Panel in 2019.

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Published on: April 2, 2024

FDA Warns of Serious If Rare Drug Reactions to Certain Antiseizure Medicines

By Moll Law Group

tablets-5620566_640-e1709791284942 Certain antiseizure medications involve serious risk of drug reactions. One of these is levetiracetam, which has been FDA approved for 24 years, and is used both by itself and with other medications to control seizures. It’s sold under the brand names Keppra, KeppraXR, Spritam, and Elepsia XR. It is also sold in generic form. Another such drug that can cause serious drug reactions is the benzodiazepine, clobazam, which is sold under the brand names Sympazan and Onfi and is used to treat a severe epilepsy known as Lennox Gastaut Syndrome. The FDA has issued a drug safety communications warning with regard to levetiracetam and clobazam, notifying consumers that they can cause a rare but potentially life threatening reaction that must be treated quickly: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). If you suffered harm as a result of your antiseizure medication, you should call the seasoned Chicago-based dangerous drug attorneys of Moll Law Group.

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Antiseizure drugs have a number of side effects, but DRESS is particularly harmful. Hypersensitivity to antiseizure drugs is rare, but when there is that sensitivity the reaction can be quite severe.

The FDA has warned that Keppra, Keppra XR, Spritam, Elepsia XR, Sympazan, and Onfi can trigger DRESS. This hypersensitivity reaction to these medicines is serious but rare. In the event that you develop a mysterious rash, fever or swollen lymph nodes while taking one of these medications, you should talk to your doctor and get medical attention right away. The rash can progress and lead to internal organ injuries involving the liver, kidneys, lungs, heart, and pancreas. that require you to be hospitalized and that could result in death.

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Published on: March 26, 2024

The FDA Issued a Safety Communication About the Synovo Total Hip Resurfacing System

By Moll Law Group

human-874979_640-e1709789373108 Doctors sometimes perform total hip arthroplasty or total hip replacement using the Synovo Total Hip System, which features resurfacing implants. The United States Food and Drug Administration (FDA) has recommended that health care providers not use Synovo Total Hip Resurfacing System. While it’s also advised that the hip systems be removed under certain conditions of pain or other symptoms, the FDA does not recommend removal of implanted Synovo Total Hip Systems, if patients find their hip implant is working and they don’t have new or increasing symptoms or pain. If you were injured by the Synovo Total Hip System, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group to learn your options. Billions have been recovered in cases with which we’ve been involved.

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There are three parts to the Synovo Total Hip System: the Acetabular Bearing, the Acetabular Fixation Cup, and the Femoral Resurfacing Cup. They are used together in the system. In 2022, the FDA found out that these three components had been significantly modified, such that it no longer followed the specifications originally improved by the FDA. It issued a warning to Synovo specifying the violations and telling the manufacturer it needed to stop making modified devices and act quickly to correct its legal violations.

The FDA has specifically asked that providers not buy or implant the Synovo Total Hip System and warn they should remove from inventory all the Synovo Total Hip Systems including the Acetabular Bearing components, Acetabular Fixation Cup, and the Femoral Resurfacing Cup. Moreover, The FDA asks consumers to get in touch with their doctors if they experience any symptoms in connection with the system such as weakness of the hip or knee, new or worsening pain, loosening, grinding, or inability to bear weight.

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