Articles Posted in Medical Device Injuries

Nevro received FDA approval for the Senza spinal cord stimulator system (SCS) providing HF10 therapy in May 2015. This system was different from conventional stimulators because it was designed to provide electrical pulses at a much higher frequency directly to the spinal cord. The Nevro spinal cord stimulator (SCS) lawsuits claim that specific Senza, HF10, and HFX systems don’t offer the pain relief they promise and cause significant complications. These lawsuits allege there were inadequate warnings, manufacturing defects, misrepresentations, improper device programming, and post-market reporting failures. Plaintiffs claim that changes made through the FDA’s premarket approval supplements changed the components of the device with inadequate clinical validation and disclosure. Plaintiffs requested centralization of the lawsuits. In June, an industry-wide multidistrict litigation was denied, but on October 2, 20 lawsuits against Nevro were centralized. If you were injured by a Nevro spinal cord stimulator, call the seasoned Chicago-based product liability lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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The Nevro HF10, later called the HFX, which is a 10kHz high frequency therapy, was marketed as being better than traditional SCS therapy for back and leg pain because the HF10 didn’t cause paresthesia (abnormal skin sensations) the way the traditional therapy did. In July 2021, the FDA expanded its approval for the device to treat diabetic neuropathy. Later the indications were expanded to include refractory back pain and chronic neuropathy, and then even further expanded to treat leg pain, low back pain, and management of failed back surgery syndrome. Eventually various lawsuits were filed against Nevro because of problems that allegedly arose in connection with use of Senza, HF10, and HFX systems.

In one product liability lawsuit filed in a federal court in Ohio, the plaintiff alleged that two Nevro spinal cord stimulators didn’t offer the necessary relief and instead caused permanent nerve damage, weakness, numbness, electrical shocks and burning pain. It also alleged that Nevro representatives claimed the problems were the result of programming and sometimes adjusted the devices without a treating doctor present.

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The Cartiva Synthetic Cartilage Implant (Cartiva SCI) is a hydrogel implant created to treat painful toe arthritis at the big toe’s base. Recently, plaintiffs in five lawsuits moved under 28 U.S.C. section 1407 to centralize litigation about Cartiva toe implants in the District of Maryland or the Northern District of Illinois. There are plaintiffs in nine potential tag-along lawsuits in seven districts, and some of them also supported centralization in the Northern District of Illinois. If you were harmed by Cartiva toe implants, you should give the seasoned Chicago- based medical device lawyers of Moll Law Group a call to determine whether you have a viable claim. Billions have been recovered in cases with which we’ve been involved around the country.

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Each of the plaintiffs was implanted with the Cartiva Synthetic Cartilage Implant. These implants, which are put in place during a minimally invasive 30-minute outpatient procedure, are supposed to provide a cushioning effect, and allow for the replacement of painful, damaged cartilage without fusion of the joint.

In their lawsuits, the plaintiffs alleged that the implant was defective and that, as a result, they suffered from persistent pain and limited range of motion after being implanted with them and then needed further surgery to remove the failed implants and fuse their arthritic joints. Their claims were for strict product liability, negligence, and breach of express and implied warranties.

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Manufacturer Medline Industries initiated a recall of its Hudson RCI Addipak Unit Dose Vial, 0.9% full normal saline solution in July of this year. The FDA has categorized this recall as a Class I recall, which is the most severe kind of recall, reserved for cases in which use of a device could cause death or serious injuries. The recall affects lot 3B085 with distribution dates April 20, 2023 – July 14, 2023. 18,000 devices were recalled across the country. If you were harmed by units from the recalled lot, you should contact the seasoned Chicago-based attorneys of Moll Law Group. Billions have been recovered in cases with which we’ve been involved. We represent consumers across the country.

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Medline Industries’ recall is based on the Lot 3B085 vials being non-sterile. While the affected lot passed the sterility testing, Lot 3B087, which was within the same cleaning cycle failed testing and exposed the impacted lot to possible contamination. When saline is non-sterile, there may be severe adverse health repercussions including infection, wheezing, nausea, discomfort, and difficulty breathing, along with potentially fatal sepsis and death. However, consumers have not reported injuries or deaths connected to the issue.

The recalled vials are used in connection with irrigation and inhalation therapy. Sometimes it is paired with a non-ventilator nebulizes to cleanse the lungs and irrigate the trachea. When irrigation therapy is used, the saline solution helps to clean wounds and flush the area. With inhalation therapy, the solution returns moisture to the lunches and reduces cold and allergy-created congestion.

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Bard’s PowerPort devices are implanted under the skin and pump intravenous chemotherapy and other fluid into a patient’s bloodstream. These are two-part devices with an injection reservoir and a catheter. Recently, plaintiffs in eight lawsuits against Becton, Dickinson & Company, C.R. Bard, Inc., and Bard Access Systems made a motion under 28 U.S.C. § 1407 to centralize litigation arising out of Bard’s Power Port devices in the Western District of Missouri. They allege that due to the catheters on the devices breaking, they suffered blood clots, infections, chest pain, and other life-threatening complications; many of them needed to undergo emergency surgeries to extract pieces of catheter. If you or a loved one suffered harm as a result of a Bard Power Port device, you should call the seasoned Chicago-based attorneys of Moll Law Group about your potential claim. Billions have been recovered in product liability lawsuits around the country with which we’ve been involved.

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The Panel determined that the lawsuits involved common questions of fact and that just and efficient litigation would be promoted by centralizing the case in the District of Arizona. They found that the common factual questions involve allegations that there is too great a concentration of barium sulfate used during the manufacturing of the catheter in the port devices.

This concentration, purportedly, reduces the catheter’s material integrity, which can in turn result in fracture or migration of the catheter, infection, and thrombosis. The multidistrict litigation will be looking at whether the design of the Bard port catheters requires too high a concentration of barium sulfate, as well as whether the defendant’s tested the devices sufficiently and whether they appropriately monitored and reported adverse events related to product failures.

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Earlier this month, the Food and Drug Administration (FDA) issued a warning regarding

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two breast implant manufacturers for their failure to comply with specific regulatory requirements. According to the official FDA press release, the FDA sent warning letters to Allergan and Ideal Implant Incorporated.

The Warning Letters

Under United States regulations, the manufacturers of silicone breast implants must conduct studies to ensure the continued safety of their products, even after the product has obtained FDA approval. According to the FDA, these post-approval studies are designed to “further evaluate the safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.”

Notably, the FDA requires this follow-up testing even if the manufacturer voluntarily recalls a product. These post-approval studies are crucial to evaluate the continued safety of recalled breast implants for those who already have had the devices implanted.

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