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Articles Posted in Medical Devices

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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.

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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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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

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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

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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

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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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A Pennsylvania jury recently returned a $20 million verdict against major household product and medical device maker Johnson & Johnson in a lawsuit regarding its pelvic mesh products. The lawsuit is part of the ongoing pelvic mesh multi-district litigation (MDL), and it constituted the third bellwether trial to proceed. According to some reports, there are over 54,000 additional lawsuits pending against the company, which is the largest health care product manufacturer in the world.

MDLs are similar to class actions in that they involve grouping claims that assert similar factual allegations and legal claims. They are different from class actions, however, in that each plaintiff must still prove his or her damages. In a class action, the entire class is awarded a collective settlement that is then distributed according to amounts and procedures approved by the court. To gauge the legal soundness of the plaintiffs’ claims, bellwether trials are conducted to gauge the likely level of liability and to assess the likely damages award against the defendant. These trials are crucial indicators of how the remaining cases pending in the MDL may play out.

In the most recent case, the plaintiff alleged that she received a TVT-Secur mesh product during a surgical procedure to address her stress urinary incontinence and that the product began to erode after two months. The plaintiff stated in her complaint that she underwent three surgeries to remove the mesh product and that Johnson & Johnson marketed the product despite its risks and without providing warnings about these risks.

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The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it begins to beat irregularly or cease beating entirely. The device is implanted in the patient’s chest and is battery powered.

The letter also indicates that St. Jude may have failed to notify management officials within the company, in addition to its medical advisory board, that these battery-related issues resulted in the death of a patient.

The letter also indicates that the agency has determined that St. Jude Medical has not taken sufficient or adequate measures to resolve the issue with the batteries. The company has 15 days to provide the FDA with a revised reporting plan.

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There are countless allergy sufferers in the United States. For many of these people, having an allergy to certain foods or insects is a relatively minor health aspect. But for others, being exposed to an allergen can result in death. Some common examples of severe allergies include bee stings, seafood, and peanuts. Recently, the manufacturer of the anti-allergy medicinal medication EpiPen initiated a recall after learning that some of the units may not work as intended, placing patients and other individuals who rely on the device in serious jeopardy. The device contains epinephrine, a chemical that counteracts the effects of a severe allergic reaction in the body.

Meridian Medical Technologies, the manufacturer of EpiPen and EpiPen Jr, recently expanded this recall to include South America, Europe, and Asia. The recall covers 13 lots of the devices, which are auto-injector pens that are used to help treat severe allergic reactions in emergency situations. The recall notice states that the covered lots may suffer from a defect that prevents the pen from activating.

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