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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spilled baby powderEarlier this month, a Missouri jury returned a verdict assessing $110 million in damages against household product maker Johnson & Johnson in a lawsuit regarding its talcum powder products. This litigation marked the fifth trial that the company has faced regarding whether or not these products lead to the development of ovarian cancer. The plaintiff in this lawsuit, a woman from Virginia, alleged that she used the company’s talc-based products for over four decades and developed ovarian cancer as a result. The plaintiff was required to undergo chemotherapy after she was diagnosed with cancer, which later spread to her liver. In her complaint, the plaintiff specifically identified Johnson & Johnson’s Shower Powder and Baby Powder products.

The talcum powder that Johnson & Johnson uses for its talc-based products is sourced from a company called Imerys Talc America. This company is owned by another company based in Paris.

Currently, there are over 2,000 lawsuits containing similar allegations pending against Johnson & Johnson. One of the primary causes of action asserted in the complaints is that Johnson & Johnson failed to provide adequate warnings regarding the potential risk of developing certain cancers from the use of its talc-based products, despite evidence available at the time the product was marketed suggesting a linkage. These lawsuits are mostly still pending in St. Louis, Missouri.

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smartphone in carAdvancements in technology have made vast improvements in travel and transportation. Some of the biggest technological changes to how we get around are smartphones and other digital computer platforms. Nowadays, it is not uncommon for vehicles to be equipped with their own computer systems in the dashboard, which offer motorists a variety of assistance and luxury features. Now, developers are finding ways to put these technological advancements to use for driver safety.

A recent study from the National Highway Traffic Safety Agency (NHTSA) has identified some important questions regarding how smartphones and vehicles could interface in the future. The report could spur some smartphone makers to include vehicle safety technologies in their infotainment system applications. This feature would then lock out or prevent the driver from accessing certain features while he or she is operating the vehicle.

The NHTSA released another study in 2016 that discussed a safety proposal for smartphone manufacturers. It suggests that the smartphone operating systems be equipped with a Driver Mode that will prevent the driver from accessing certain features on the phone while in transit. Some of the features that would be off-limits during travel would be social media, video, web surfing, and manual text entry. The proposal also considered taking Driver Mode one step further and having it automatically activate if the driver has not engaged it prior to operating the vehicle or if the driver has not paired it with his or her vehicle.

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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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woman in hospitalBreast implants are one of the most popular elective surgeries throughout the world. Although breast implants have been around for several decades, the U.S. Food and Drug Administration has recently identified a possible linkage between these medical devices and anaplastic large cell lymphoma (ALCL). This condition is categorized as an uncommon type of non-Hodgkin’s lymphoma. The FDA first identified the potential connection in 2011.

Now, in 2017, the FDA has indicated that it has collected additional evidence regarding this linkage. When it first started its investigation six years ago, the FDA was only able to identify a few cases involving the development of the disease in relationship to breast implants. This made it more difficult to identify the factors that would contribute to the disease’s onset. The agency prepared a report detailing its understanding of the potential linkage and calling for the assessment of additional information and identification of additional cases.

In partnership with the World Health Organization, the FDA has now obtained additional information and data regarding the potential link between ALCL and breast implants. The World Health Organization is an international agency dedicated to improving human health throughout the world, particularly when it comes to combating diseases. The FDA’s latest announcement describes ALCL as a rare T-cell lymphoma that may develop after an individual receives breast implants.

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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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sad boyMajor retailer Target has announced a recall of over half a million toy eggs designed to absorb water after concerns that the toys could create a blockage in a child’s stomach if they are ingested. The toys were designed and packaged for Easter.

Since the toys are designed to absorb water, if a child accidentally ingests a toy, it will swell inside the body and create an intestinal obstruction. The reports also suggested that the toy may not show up on an x-ray, making a life-threatening condition even harder to identify and treat. This could lead to serious health consequences, including severe pain, discomfort, dehydration, nausea, vomiting, and even death.

Although there appear to be no reports of injuries associated with the toy at this time, the Consumer Product Safety Commission initiated a Fast Track Recall covering some 560,000 toys. They also alerted members of the medical community and instructed parents to take adequate precautions, including not giving the toy to children and returning the product immediately.

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full grocery cartThere have been several food contamination and food safety-related items in the news lately, including the shocking story of two Florida individuals who found a dead bat in their pre-washed salad mix package. The company that produced the product, Fresh Express, initiated a recall of packaged salads that may also be affected and began conducting tests on the package to determine if the salad mix was contaminated. According to one report, the bat was so decomposed that testing officials were unable to verify whether the bat carried rabies. This places consumers at serious risk for contracting harmful and dangerous diseases, including food-borne pathogens like salmonella and listeria. Both of these pathogens can lead to serious health consequences that often require hospitalization.

Next, Conagra Brands announced a recall of its Chili Kits after determining that the kits may contain salmonella, another harmful pathogen. For individuals with weakened immune systems like the elderly, pregnant women, and children, salmonella can have devastating consequences and even lead to death in some situations. To date, there have been no reports of salmonella-related illnesses associated with consumption of the chili kits, but the company is urging purchasers to refrain from consuming affected units.

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man smoking ecigaretteE-cigarettes have emerged as a popular alternative to traditional cigarettes. Created by a pharmacist in China, they offer a less toxic method for ingesting nicotine, compared to traditional cigarettes. A liquid solution containing propylene glycol, water, flavoring, and nicotine is heated, producing the vapor.

Although the companies that manufacture e-cigarettes and the many available accessories claim that they are a safe alternative to smoking, the U.S. Food and Drug Administration has yet to back that claim. In fact, the federal agency has proposed banning the sale of e-cigarettes to minors and is in the process of requiring companies that make these products to place warning labels on them. Additionally, the Centers for Disease Control have stated that there should be more regulations limiting the sale and advertising of these products to minors.

Beyond the health implications, there are concerns regarding whether the devices are safe. A recent article described one incident in which an individual was using an e-cigarette when the battery inside it exploded, causing him to suffer third-degree burns. Although the incident occurred over one year ago, the individual is still experiencing damaging effects and requires daily treatments and care.

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