Articles Posted in Medical Devices

sad womanEarlier 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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empty operating roomThis 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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book and gavelA 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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doctor with stethoscopeThe 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.bee

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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hand holding implantBreast implants are very common and have been used as a cosmetic modification for several decades. According to some reports, breast implants are the second-most common cosmetic operation that women seek out. The most common procedure is liposuction. In 2015 alone, more than 300,000 breast augmentation procedures were performed. There are many different types of breast implants that are approved in the U.S., including saline-filled or silicone gel-filled implants.

Recently, the United States Food and Drug Administration reported that breast implants may be linked to a rare type of cancer. In the same report, the FDA stated that at least nine incidences of this cancer have been linked to breast implants.

The cancer at issue is referred to as anaplastic large cell lymphoma, or ALCL. It is a type of non-Hodgkin’s lymphoma that the FDA first began investigating in 2011. The FDA is now examining 359 reports that purport to identify a link with both saline and silicone solutions in breast implants. So far, studies indicate that the cancer typically develops 10 years after the implants were inserted and usually develops close to the area where the implant was inserted. There are some reported instances in which the cancer spread, however. Some of the most common initial symptoms reported associated with the cancer include pain and swelling at the site.

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blue dialysis machinesMedical devices are intended to improve our ailments and make our lives easier. Although this is achieved in many cases, there are some instances where medical devices do more harm than good due to design defects or a manufacturer’s failure to provide adequate warnings about the potential side effects.

Recently, Fresnius Medical Care won the first trial in the pending multi-district litigation (MDL) involving its GranuFlo and NaturaLyte dialysis drugs. These products were intended to reduce the level of acid in dialysis patients’ blood during treatments. According to the plaintiffs’ allegations, these drugs contain a high concentration of acetone, which created unusually high levels of bicarbonate in the patients’ blood during and after treatments. The products contain more bicarbonate than other comparable dialysis treatment aids on the market. The high levels of bicarbonate can lead to a variety of health problems including fatal heart conditions and strokes. In many of the MDL lawsuits, the plaintiffs are estates or surviving heirs bringing claims on behalf of a decedent, alleging that the decedent died soon after receiving a dialysis treatment involving GranuFlo or NaturaLyte.

In the most recent trial, a Massachusetts jury concluded that the plaintiff failed to prove its case. The trial was the first of its kind to go forward in the MDL. The plaintiffs rejected a proposed $250 million settlement roughly one year ago.

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Serious Faced WomanA federal judge in California recently entered an order approving a $12.3 million settlement involving Caldera Medical’s transvaginal mesh product and associated insurance claims. According to the terms of the settlement, Caldera’s insurance company will provide $10.6 million in payments to nearly 3,000 members of the class, in addition to over $600,000 in payment for attorney’s fees and costs associated with the lawsuit.

The judge issued the order despite 36 objectors who wanted the court to order an independent audit. The objectors argued that there was not enough evidence regarding whether the payment would be larger if the company, based in Agoura Hills, CA, went through a liquidation.

Regarding the mesh product, Caldera’s Vertessa Lite mesh was made of polypropylene mesh and used repair pelvic organ prolapse. Some reports estimate that as many as 40 percent of women experience some type of prolapse and that as many as 250,000 surgical procedures are performed to address this condition each year. When marketing the product, Caldera claimed that it was 31 percent stronger than other comparable mesh products on the market, lighter, and that it featured stronger suture pull-out strength.

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woman stretching shoulderThe U.S. Food and Drug Administration (FDA) recently announced a Class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System, Model 115340 (“CRS”). A Class I recall is the highest level of recall according to the FDA’s regulations. This class of recall is used in situations in which there is a reasonable probability that using the subject product or exposure to the subject product will cause adverse health consequences or even death. Zimmer Biomet initiated the recall after reports indicated that the CRS device fractures at a higher rate than indicated on the label.

The CRS device is a shoulder replacement mechanism that is implanted into eligible patients, and it is designed with the intention of restoring arm movement. Some of the most common patients who have received the CRS device in a surgical procedure are patients who experience a tear in their rotator cuff and who experience severe arthritis in their shoulder as a result. This level of arthritis is commonly referred to as arthropathy. The patients have also typically experienced a failed shoulder joint replacement procedure prior to receiving the CRS implant.

According to the recall announcement, physicians who have used the CRS device in shoulder replacement procedures are affected. The announcement encourages them to review the safety notice and other associated information regarding the CRS device, identify any remaining devices that have not yet been used in surgical procedures, and contact any patients who received the CRS device in a surgical procedure. Patients who received or believe they have received the CRS device should consult their physician immediately. Devices subject to the recall were manufactured between August 25, 2008 and September 27, 2011.

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da vinci robotIntuitive Surgical, the company who developed and markets the da Vinci surgical robot, is facing another lawsuit challenging the sufficiency of the warnings that the manufacturer provided with the device. Recently, the Washington Supreme Court ruled that a plaintiff could proceed with a product liability lawsuit on behalf of her deceased husband against Intuitive Surgical. In his complaint, the plaintiff alleged that he suffered serious physical injuries during a prostatectomy using the da Vinci surgical device. According to the plaintiff’s allegations, the physician who performed the surgery noticed during the procedure that the plaintiff’s rectal wall had suffered lacerations. As a result of this complication, the physician had to perform immediate open surgery to repair the lacerations.

Following the surgery, the husband reported experiencing a serious reduction in his quality of life. During ventilation, the husband experienced respiratory failure requiring ventilation, renal failure, and an infection. The husband’s complaint also alleged that he was required to wear a colostomy bag and that he also experienced incontinence. The complaint also alleged neuromuscular damage and that the husband was unable to work correctly without assistance. Roughly four years after the procedure, the husband died. According to a physician who testified on behalf of the plaintiff, the da Vinci robot’s malfunction was a contributing factor in the husband’s death.

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