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Articles Posted in Medical Devices

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surgery-1822458_6401-e1712683689856Surgical 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.

Consult Moll Law Group About Surgical Mesh

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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tablets-5620566_640-e1709791284942Certain 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.

Call Moll Law Group If You Develop a Drug Reaction

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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human-874979_640-e1709789373108Doctors 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.

Call Moll Law Group About a Synovo Claim

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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hospital-834152_640Recently, 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.

Call Moll Law Group About Your Claim

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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pills-6605907_640-e1702315800250The 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.

Contact Moll Law Group About DRESS

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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align-fingers-g52339b334_640-1CoolSculpting is a brand name for an FDA-approved fat reduction procedure, cryolipolysis, in which the more stubborn fat deposits on a patient’s body—love handles—are frozen, for purposes of getting rid of them. Skin freezes at a lower temperature than fat, and the CoolSculpting device works by taking advantage of that. It is intended to cool a person’s fat deposit sufficiently to destroy that tissue while also letting the skin survive without damage. Unfortunately, there may be problems with CoolSculpting, and a lawsuit by model Linda Evangelista was filed last year to recover damages that may have been caused by the procedure. If you were injured by CoolSculpting, you should call the seasoned Chicago product liability lawyers of Moll Law Group. Billions have been recovered in lawsuits with which we’ve been involved, and we represent patients across the nation.

Call Moll Law Group About Your CoolSculpting Lawsuit

The CoolSculpting System is administered by a plastic surgeon, dermatologist or another aesthetic medicine practitioner. Rather than use needles, the practitioner targets fat deposits by hold them with paddles for around 35 minutes to 1 hour and 15 minutes. During that period, around 20% – 25% of the fat cells in the targeted location are destroyed. Typically a patient’s immune system disposes of dead fat cells for a few weeks, and the final result is seen in a few months.

There are certain medical conditions that the provider administering the procedure is expected to consider in determining whether you’re a candidate including cold urticaria, bad skin tone, cryoglobulinemia, loose skin, Raynaud’s phenomenon, and paroxysmal cold hemoglobinuria. A provider should not give you the CoolSculpting procedure if you have one of these conditions.

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man-g4698b989e_640-e1655155803670A broad range of chronic conditions are treated with the Volara System, which provides continuous positive expiratory pressure (CPEP) to expand your lungs and airways, along with continuous high-frequency oscillation pulses to free mucus plugs and make it easier to cough and breathe less effortfully. However, if you use the Volara System, it’s important to be aware that its manufacturer, Baxter International Inc., issued an Urgent Medical Device Correction for the Volara System and then a recall. This is a home care system prescribed by doctors when a patient needs a ventilator in the home environment. Unfortunately, it’s been found that use of the system comes with a possible risk of oxygen desaturation, as well as the danger of overexpansion resulting in lung tissue damage. If you were injured or a loved one was killed due to the malfunctioning of the Volara System, you should give the seasoned product liability lawyers of Moll Law Group a call. You may have grounds to sue for damages, and it is important to seek counsel.

Give Moll Law Group A Call About Injuries From Defective Products

Baxter voluntarily issued the Urgent Medical Device Correction after receiving a report of a patient suffering from oxygen desaturation while using the device at home. The device was recalled in a class 1 recall because the device poses serious risks such as lung infection that restricts oxygen to the brain, brain injury such as hypoxia, death, and choking on mucus.

Initially caregivers and patients were warned to continue to use Volara therapy as prescribed, but were supposed to monitor for respiratory distress signs such as an increase in breathing rate, bluish color around the mouth or inside it, wheezing, or changes in alertness, when using it. Patients were told potential issues could occur when using the device with a ventilator and adaptor or the patient circuit kit oscillation and lung expansion therapy.

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operating room

Photo Credit: nimon / Shutterstock.com

Breast augmentation, or augmentation mammoplasty, has been the most common elective cosmetic surgery in the United States for over a decade. Last year alone, there were over 300,000 breast augmentation surgeries performed across the United States. This figure represents a 3% increase from the year before, and a 41% increase from the number of similar surgeries performed in 2000.

The science behind breast augmentation surgery is sound, and the FDA has approved cosmetic breast augmentation surgery. However, the popularity of the surgery has resulted in a situation in which medical providers rush to fill the perceived demand, often overlooking critical safety protocols along the way. Indeed, the FDA estimates that approximately 1% of all patients undergoing a breast augmentation surgery will experience some form of complication or adverse medical event. These may include:

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medical verdict

Photo Credit: vchal / Shutterstock.com

Earlier this week, a federal appellate court upheld a jury verdict in favor of Boston Scientific in a lawsuit regarding its Uphold brand pelvic mesh product. In the lawsuit, the plaintiff alleged that she suffered injuries after a surgical procedure involving Uphold mesh that took place in 2010. The plaintiff alleged that Boston Scientific’s product was designed in an unreasonably dangerous manner and that it failed to provide warnings regarding the potential risks and dangers associated with the product.

In October 2016, the Federal District Court for the Western District of North Carolina concluded that the plaintiff failed to offer sufficient evidence showing that the product was designed in an unreasonably dangerous manner and granted a motion for partial summary judgment in favor of Boston Scientific. Additionally, the court concluded that the plaintiff did not support her claim that the company breached the implied warranty of merchantability regarding Uphold mesh. For a product to be “merchantable,” it must meet the reasonable expectations of buyers.

Also, the District Court concluded that the plaintiff did not provide sufficient evidence showing that her physician reviewed or relied on the allegedly insufficient warnings. After the court issued its ruling against the plaintiff, the plaintiff sought a reconsideration. At this time, she also offered evidence indicating that the doctor had read the materials, but the court concluded that the plaintiff would still have difficulty showing that the alleged harm and allegedly inadequate warnings were the cause of the injuries she sustained.

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witness stand

Photo Credit: aerogondo2 / Shutterstock.com

This month, the Judicial Panel on Multidistrict Litigation (JPML) will hear arguments regarding whether to consolidate the numerous pending cases against Ethicon, a subsidiary of Johnson & Johnson, regarding its physiomesh products. The JPML is the body responsible for overseeing multi-district litigation (MDL), which is a legal process that is somewhat similar to class actions. When dangerous products harm numerous victims, the cases often involve similar factual allegations and legal claims. To streamline the process and promote efficiency, the cases can be organized in an MDL proceeding before one judge. Unlike a class action, each plaintiff maintains his or her individual case and must prove that he or she is entitled to damages.

Physiomesh is a product targeted toward hernia repair surgeries. It is a synthetic mesh material that is marketed to be used in laparoscopic herniorrhaphy procedures. The product’s unique design features five separate layers. Two types of material make up the first four layers, while the final layer is polypropylene mesh. This design has not been used in other mesh products. According to Ethicon, the multi-layer feature is designed to reduce adhesions and inflammation and to help fixate and incorporate the mesh into the abdominal area.

The concern regarding Ethicon’s physiomesh arose in May 2016 when the company issued a recall after discovering that the product leads to higher revision rates when used in a specific type of hernia repair. Revision surgeries can be extremely painful and expensive for patients, especially when they anticipated having their medical issue resolved during the first procedure.

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