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b2ap3_thumbnail_johnson.jpgA bedroom mirror reflects a young woman, hand on her arm, facing a worn teddy bear and plastic bottle of Johnson’s baby powder. The 1980s advertisement claims “It’s a feeling you never outgrow. The powder that kept you feeling soft as a baby keeps you feeling soft today. Johnson’s baby powder. It’s the softest powder there is.” Alleged “softness” aside, recent studies have shown genital use of powder is linked with 44 percent higher risk for ovarian cancer.

 

A number of lawsuits against Johnson & Johnson have brought the cancerous risks of talc (the main ingredient in Johnson’s Baby Powder) to the public’s attention. 49 year-old Deane Berg of Sioux Falls, S.D., an everyday user of the product for over 30 years, understood the talcum powder as the probable cause of her advanced ovarian cancer almost immediately.

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Zofran congenital heart defects, Chicago prescription drug defect lawyerParents want their infants and children to be healthy and thrive. It can be a devastating blow when they find out their child may or will have a life-long condition that may be life threatening. Congenital heart defects are heart problems that develop before the child is born and are often referred to as a hole in the heart.  Congenital heart defects can lead to heart failure, high blood pressure, infection, or other problems from the moment they are born or later on in life. In some cases, the congenital heart defect is caused by defective drugs, such as Zofran.

Zofran is manufactured by GlaxoSmithKline and has been approved by the Federal Drug Administration (FDA) for use as an anti-nausea medication for cancer patients going through chemotherapy. It has not been approved, or ever tested or studied, as an anti-nausea drug for pregnant women. This has not stopped GlaxoSmithKline from marketing Zofran for “off-label” use to hospitals and consumers as an anti-nausea medication for pregnant women with severe morning sickness, according to a report from the Department of Justice.

A mother from Oakland, California, filed a lawsuit against GlaxoSmithKline, stating they knew about the negative side effects Zofran caused during the prenatal stages of growth in infants and still marketed the drug to pregnant women. She alleged that the use of Zofran during her pregnancy caused her son’s supraventricular tachycardia, a serious heart defect. Supraventricular tachycardia (SVT) causes the heart to beat too fast or irregularly. It causes an insufficient about of blood supply throughout the body. SVT is treated with medication, surgery, or a combination of both and in the future may cause heart failure.

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Mazda Takata recall, Chicago product liability lawyersThe Takata airbag recall has affected ten car companies and over 30 million vehicles. Mazda announced they are adding an additional 540,000 older vehicles to the recall list. With Takata airbags being used in almost every automotive manufacturer, many are left to wonder if their vehicle will be added to the recall list. Automotive companies and Takata are responsible for the product liability of the defective airbags.

Consumers only have two options with this recall. They can choose to not drive their vehicle until the defective airbag is replaced or they can take the chance and hope they do not get into an accident where the airbag will deploy, possibly killing or injuring themselves or their passengers. Neither option is acceptable and in most cases consumers have no other option that to continue to drive their cars with the defective airbag.

Takata and investigators have not been able to determine which inflator in the airbag design is the cause of the problem. Reports are now saying it is multiple causes. This is an unsatisfactory answer to the largest recall in automotive history. If the company that designed the defective airbag and independent researchers cannot fix the design, consumers are being put at risk longer because the defective airbag will take longer to be replaced.

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black decker lawnmower recall, Chicago product liability attorneyWhen companies receive reports and supporting evidence of safety hazards for a product they produce, they have a 24-hour window in which they are supposed to report it to the Consumer Product Safety Commission (CPSC). Not doing so can cause other consumers using the product to injure themselves due to the defect. Black & Decker did not comply with the requirement to report the safety defect for allegedly 11 years. They have a responsibility to consumers to report safety defects immediately and compensate them for product liability.

This will be the fifth time Black & Decker has been fined for not reporting safety hazards to consumers immediately concerning their products. The company is being required to pay a $1.575 million civil penalty to settle the allegations.

The products in question this time are two electric lawn mowers. Consumers reported that the lawn mower models would turn back on after the handle was released and the safety key removed. In some cases, the lawn mower would run for hours after it had originally been turned off and it had restarted on its own. The defect in the products has caused several injuries and the company had received over 100 reports.

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zimmer knee recall, Chicago medical device liability attorneyWhen a patient undergoes surgery of any kind, they expect that they will be able to recover and move on with their life. Having to undergo surgery again because of a defective product, like Zimmer’s Persona Trabecular Metal Tibial Plate knee placement, is not in their plans. Going through recovery the first time for a knee replacement is hard enough. Having to endure through it again is unacceptable and the company who designed the defective product is responsible for product liability.

The Food and Drug Administration (FDA) issued a Class 2 recall on the product. This means that while the Persona knee replacement is used it may cause temporary or medically reversible adverse health consequences. The recall affects all sizes and lots of Persona knee replacement products for both the left and right knees.

The Persona Trabecular Metal Tibial Plate knee replacements were meant to be used without cement and still adhere to the bone. Complaints from patients found that the knee replacement became loose or caused radiolucent lines or gaps between the bone and knee replacement. The gaps can fill with fluid or debris and cause more health issues. In all cases, patients complained of increased pain and some cited increased immobility.

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Takata airbag recall fines, Chicago personal injury attorneyThe United States is fining Takata Corporation, a Tokyo, Japan based company that manufactures airbags, $14,000 each day due to non-compliance in the investigation into their faulty airbags. Late last year, the National Highway Traffic-Safety Administration (NHTSA) initiated a product recall on vehicles using Takata airbags. The company is responsible for covering product liability to consumers affected by the recall.

With over 7.8 million vehicles affected by the recall, Transportation Secretary Anthony Fox said Takata will be fined each day they do not comply with the investigation and withhold documentation and other materials necessary for the investigation.

Takata gave NHTSA 2.4 million pages of documentation but did not give any guidance or explanation as to what information is in the documents. Employees have to sift through the pages, wasting time, money, and resources that could be spent on other claims and the investigation, to find information they need for the investigation. It is also delaying being able to accurately fix and recall all affected vehicles.

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pulmonary embolism, Cook IVC, Chicago product liability lawyerCook Inferior Vena Cava (IVC) filters have been found to be ineffective at stopping blood clots in many cases. Cook IVC filters are designed to stop blood clots traveling to the lungs through a small device inserted into the vein.

The filters are used in patients at risk of having the veins or arteries in their lungs blocked by blood clots, a condition known as a pulmonary embolism. Companies that produce products that cause consumers serious injury or death are held responsible for product liability, the legal responsibility the company incurs for producing or selling a faulty product.

The Cook IVC filter is the oldest filter approved for use and designed to be removed after 12 weeks or the risk of a pulmonary embolism has passed. An investigation into the filters found that serious complications could arise from use or prolonged use of IVC filters, including:

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herbal supplement product liability, Chicago personal injury lawyerIn an independent test by the New York State Attorney General’s office, it was found that four major retailers’ name brand herbal supplements did not contain the herbs listed. Instead, the supplements contained filler ingredients, some of which may cause allergic reactions.  Mislabeling products is considered a product liability issue. For example, if you are allergic to an ingredient in the product or you have an adverse side effect because it is not labeled correctly, the product manufacturer is responsible for compensating you, the consumer.

The New York State Attorney General’s office sent Wal-Mart, Walgreen’s, GNC, and Target a “Cease and Desist Notification” to pull the named products in the notification off their shelves and explain their process about how they verify the ingredients on the labels of the listed supplements. The tests found that four out of five products did not contain any of the herbs listed on their labels. The tests did find fillers, such as wheat, asparagus, powered rice, and house plants, in the supplements.

Supplements are not regulated by the Food and Drug Administration (FDA) like prescription medications are. They are not required to go through the same rigorous testing that prescriptions are before they are sold to consumers. Supplement regulation is based on an honor system that operates with the understanding that the manufacturer is being truthful about what ingredients are in the product and the labeling on the product is true.

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Xarelto side effects, drug makers, Chicago product liability attorneyDrug manufacturers have to put drugs through testing before they are approved for use by consumers. But what happens when adverse side effects start appearing in patients using the drug because information given to the Food and Drug Administration (FDA) was incomplete? Eventually the drug may be pulled off the shelf, but patients who used the drug become a statistic to be used for further tests. Patients should not be another defective drug product liability statistic for pharmaceutical companies.

study by the Institute for Safe Medication Practices revealed that drug manufacturers often do not file complete, basic reports about adverse side effects with the FDA. Just over 50 percent of the reports filed did not meet the basic reporting standard, which should contain age, gender, and an event date.

Throughout the years, “blockbuster drugs” have been approved by the FDA, and then later pulled off the shelves, but not before the cost of lives or life-altering side effects were paid. A blockbuster drug is one that:

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Posted on in Product Liability

Takata airbag recalls, Chicago product liability lawyerWith 7.8 million U.S. vehicles affected by the recent Takata airbag recall, many people are wondering if their vehicle is affected by the recall and if it is safe to drive. Airbags can deploy, even in low-impact crashes, causing injuries and damage. If your vehicle is affected by the defective airbags, you may be at risk if your airbags deploy and may have a product liability case against the manufacturer.

In light of all the recent rolling recalls, people are also wondering who knew about the defects before the recalls started happening. The National Highway Traffic Safety Administration (NHTSA) issues recalls based on accident, individual, and car manufacturer reports. They did not start investigating Takata airbag defects and issuing recalls until 2009. Alleged evidence from Honda and Takata state they both knew as early as 2004 that there was a defect in the airbags.

In addition to Honda and Takata allegedly knowing about the defects, they did not notify NHTSA about the defects. At a hearing before the House Committee of Energy and Commerce, a Takata executive, Hiroshi Shimizu, would not clearly answer if the airbags were defective, but did apologize for the deaths and injuries.

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OtisMed recall, knee replacement liability, Chicago injury attorneyThe OtisKnee device, made by OtisMed Corporation, was not approved by the Food and Drug Administration (FDA) to be used in knee replacement surgeries. The OtisKnee devices were not proven to be safe or effective. OtisMed Corporation distributed and marketed the OtisKnee and is responsible for product liability and the injuries patients have been caused due to the defective product.

“The OtisKnee device was used by surgeons performing total knee arthroplasty, known as knee replacement surgery. OtisMed advertised the cutting guide as a tool to assist surgeons in making accurate bone cuts specific to individual patients’ anatomy based on magnetic resonance imaging (MRI) performed prior to surgery,” according to the FDA’s statement about the OtisKnee, following a lengthy investigation.

The OtisKnee device was marketed to surgeons as a means to match the size and placement of the implant to an individual’s normal knee alignment. It was supposed to allow surgeons to be able to keep more of the patient’s bone and ligaments, which meant a quicker recovery and greater range of motion. Patients claimed their recovery was longer and many have had to undergo a second knee replacement surgery to remove the defective product, more bone, and have a new implant placed in their knee, costing them more recovery time and more medical expenses.

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Takata airbag recall, Chicago product liability attorneyTakata airbags, used in many major car companies, are being recalled following reports of metal shards piercing victims’ faces and necks after the airbags deployed in accidents. The National Highway Traffic Safety Administration (NHTSA) has released a consumer advisory listing vehicle makes, models, and years affected by the recall.

Takata airbags are manufactured and sold by Takata Corporation of Japan to many car companies throughout the world. Those companies that have issued recalls are BMW, Chrysler, Ford, General Motors, Honda, Mazda, Mitsubishi, Nissan, Subaru, and Toyota, affecting over 7.8 million vehicles.

The NHTSA is urging car owners who own vehicles from the affected companies to check their VIN number to see if their vehicle is included in the recall. If your car is included in the recall, contact your car manufacturer for replacement details. The defective Takata airbags are linked to four deaths and over 100 injuries in accidents where the recalled airbag deployed, sometimes shooting metal shards into the inside of the car, caused by a potentially deteriorated propellant that ruptured the inflator housing.

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energy drink dangers, product liability attorney in ChicagoOver the past few years, concerns and controversy have been linked to energy drinks and the dangers that have been reported in adults, but now Health Day has published a new study that discusses young children, under the age of six, who are also at risk when they consume these products. The study reported data from 55 separate poison control centers over a three-year period, resulting in conclusive statistics that revealed 40 percent of reports to poison control centers in the U.S. involved children in this age range.

Although energy drinks are typically marketed to teenagers and young adults, the national poison control data system has linked these reports to children’s unintentional exposure to the beverages. Over 50 percent of these reported cases included serious health incidents such as heart problems and seizures.

The study clearly shows the availability and level of exposure that young children have to these beverages. Canned energy drinks that contain herbal ingredients plus caffeine can be labeled as dietary supplements without evaluation of health safety by the FDA. As a result, people may then be given inaccurate or incorrect product information about the amount of caffeine they are consuming, especially if the company chooses not to disclose the specific amount of caffeine per drink.

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transvaginal mesh, Illinois product liability lawyerWomen who suffer from stress urinary incontinence (SUI) or pelvic organ prolapse (POP) may be implanted with transvaginal mesh (TVM), a medical device that gives added support when weakened or damaged tissue is being repaired. According to statistics, up to 70,000 women have this medical device implanted each year, illustrating a reliance on TVM to correct certain medical problems.

However, the American Association for Justice reported the impact of dangerous medical devices such as these in 2013 and noted that there were early detections of problems linked to TVM even during its rising popularity in the early 2000s. TVM has been known to cause:

  • Bleeding;
  • Infection;
  • Pain;
  • Erosion or hardening of the device; and
  • Difficulty in removal of the device.

Additional surgeries are required to repair complications with mesh erosion and still do not solidify a guaranteed resolution to the adverse effects originally caused by TVM. These procedures mean costly hospital stays, prolonged medical care, and a diminished quality of life for a medical device that the FDA said did not necessarily improve post-surgical outcomes in many cases.

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toy related injuries, Illinois product liability lawyerThe most active retail months are barely over and toy manufacturers have generated billions upon billions in revenue worldwide. The estimated cost for toy production is over two billion dollars in the United States alone as last reported in 2010. It is a booming industry that may be growing faster than safety officials can monitor.

Toys have evolved over time to include detailed parts and extra gadgets that require additional testing for their safety. They are packaged with age limit recommendations to keep babies and toddlers from choking on small pieces, but there are also unforeseen hazards in toys manufactured today which include:

  • Asbestos;
  • Carcinogens;
  • Lead; and
  • Product defectiveness.

The American Association for Justice reports a 54 percent increase of toy-related injuries from 1999-2008 ranging from choking to amputations to asphyxiation. The number of toys hitting the market largely outnumber the resources for inspection and safety tests available via the Consumer Product Safety Commission (CPSC).

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car manufacturer safety issuesThe recent air bag recalls have affected millions of Americans who own vehicles that contain the faulty equipment. Only one car manufacturer to date has taken its recall nationwide, despite the demand of the National Highway Traffic Safety Administration for others to follow suit with repairs and the hundreds of injuries that have already been reported.

The American Association for Justice (AAJ) explored how this kind of passiveness is historically common among car manufacturers. In a published report released in June 2014, the AAJ emphasizes failure on the part of these companies to take responsibility unless required to do so in court.

Among its long list of examples the AAJ names the following defective car parts corrected only after manufacturers have faced litigation:

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infant medical device recall, Chicago product liability attorneyPhilips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.

As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant’s head and body. The following models have been recalled:

  • Gel-E Donut 92025-A;
  • Gel-E Donut 92025-B;
  • Gel-E Donut 92025-C; and
  • Squishon 2 91033-2.

The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:

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Chicago medical device recall lawyerPatients rely on hospitals to ensure that safety protocols and education for medical staff are current and privy to any changes regarding medical device recalls. For over 45 years, ECRI has helped in this effort by focusing on improved patient care by studying the effectiveness of medical products, procedures, and processes. Based on an article published by Modern Healthcare, ECRI experts reveal certain hospitals are failing to update their medical device recall programs to meet today’s standards.

Over 1,000 medical device recalls were reported by the Food and Drug Administration in 2012, a figure almost doubling the number reported nearly a decade previous. The number and complexity of recalls have increased over the years, which carries concerns regarding hospital efficiency in tracking its defective products.

A Medical Equipment Management Plan issued by the Joint Commission has issued standards for hospitals to:

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FDA product recalls, Chicago product liability lawyerThe FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a factor critical when determining potential health risks and dangers to consumers.

Many in the medical device industry were concerned about additional paperwork rather than focusing on the importance of detailed documentation for the benefits of safety. Certain devices have been approved for market that have represented an upgrade, innovation, or correction to a previous device and have resulted in recalls.

It is a manufacturer’s responsibility to find the original source of the problem and not look at a defect as an isolated incident. One of the main intentions of the new guidance is to clarify when a change to a device constitutes a product recall. One example states, “a change to a marketed device to address false or misleading labeling or other labeling violations would generally constitute a medical device recall.”

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Chicago airbag recall lawyerHonda has become the first and only automotive company thus far to meet the demand from the National Highway Traffic Safety Administration (NHTSA) to repair vehicles nationwide after the recent recall of Takata airbags.

Previously, the recall for airbags were limited to high-humidity states only. An increase in humidity was found to cause the airbags to inflate too fast, leading to an explosion, which caused shrapnel to spew out.

According to a report, Honda is expanding its repairs to over 2.6 million for a total of 5.4 million vehicles. The following models are included in this expansion:

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