Articles Posted in Medical Devices

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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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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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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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 decided.  The United States Food and Drug Administration has informed doctors, nurses and other health care providers that it is imposing 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 been asked to update its labels. The company did update its product warnings to indicate that surgical mesh products haven’t been determined to be safe and effective for purposes of breast surgeries. 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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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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Recently, Baxter International, Inc. announced that its Novum IQ syringe infusion has the potential to provide an incomplete infusion. It issued an Urgent Medical Device Correction for the product. The company is developing a software upgrade to fix the problem. There have been no serious injuries reported so far. However, if you were injured or a loved one died due the Novum IQ syringe infusion pump, or another infusion pump, consult the seasoned Chicago-based attorneys of Moll Law Group to see whether you have a viable claim. Billions have been recovered in product liability lawsuits with which we’ve been involved.

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The Urgent Medical Device Correction affects users who use a Novum IQ syringe infusion pump with product code 40800BAXU. Baxter, the manufacturer of the syringe pump, has found that once one or more downstream occlusion alarms go off on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm even though there is still fluid inside the syringe.

The remaining liquid to be infused may be different than what’s left in the syringe based on not only the number of occlusion alarms that are encountered while a patient is receiving therapy, but also the syringe size. Because the display reflects a completed infusion when it’s not complete, a patient may be underdosed with the fluid or the therapy may be interrupted. Depending on the medication and condition being treated, a patient could suffer adverse medical consequences as a result of interruption or cessation of the infusion.

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The United States Food and Drug Administration (FDA) recently warned consumers that certain antiseizure medications can cause a rare but serious response called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). When not diagnosed and treated rapidly, these can prove fatal. The affected seizure medications are levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). Patients are advised to seek medical attention if they develop swollen lymph nodes, fever, or unexplained rash. If you develop an adverse drug reaction to anti-seizure medications, you should call the seasoned Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in product liability cases with which we’ve been involved.

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The antiseizure medications are approved for different uses. Levetiracetam, which has been FDA-approved for 24 hours and can be accessed in several formulations under the brand names Keppra, Keppra XR, Elepsia XR, and Spritam, and as generics. It can be used along to treat seizures or with other medicines and can be accessed in many formulations under brand names.

Clobazam, for instance, is a benzodiazepine that is FDA-approved for use with other medicines to control linked to a type of epilepsy called Lennox-Gastaut Syndrome. Benzodiazepines depress the central nervous system, but DRESS and other skin reactions are associated with Clobazam, which has been approved by the FDA for 12 years, and not the other benzodiazepines. It can be accessed under the brand names Onfi and Sympazan, and as generics.

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