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Category Archive for: ‘product liability’

Internal Failure Poses Shock Risks, Subwoofer Units Recalled Comments Off

The U.S. Consumer Product Safety Commission has stated that SuperCube 2000 Powered Subwoofers have been recalled over a possible internal failure that could potentially lead to shocks.

Definitive Technology issued the recall along the federal agency in order to reach out to consumers with the affected products and prevent any further incidents. The products with the serial number “0912HB” that have been affected by this recall were sold by BestBuy.com and Amazon.com between November 2012 and January 2013. According to the federal agency, at least two consumers reported being shocked while handling the affected units.

The issue with this product consists of an internal level input jack that could fail and lead to a shock. About 900 units of these products were affected by this recall. In order to obtain a replacement device, you may follow this link to reach the official recall announcement issued by the CPSC.

Stay alert and follow all recall news closely in order to learn more about products that could pose a serious hazard to you and your loved ones.

Posted on: 04-3-2013
Posted in: personal injury, product liability, Safety

More Evidence Shows DePuy Employees Were Aware Of Defect Comments Off

According to multiple news agencies, jurors are listening to testimonials during the second DePuy ASR trial in Chicago.

Reports show that, during the hearings, a former DePuy employee claimed he was aware of an e-mail that had been sent by a colleague that dealt with the issues patients and doctors were reporting concerning the all-metal hip implants. According to the testimony, the former employee is aware that the e-mail was sent a year before the device was recalled by the company over reported “clinical needs”.

This is the second lawsuit against Johnson & Johnson’s DePuy out of 10,000 to be tried. The e-mail stated that the implant had been designed defectively and that that was the reason for the high failure and revision rates related to the metal-on-metal hips.

Some of the complications patients experienced as a result of the faulty implant include necrosis of the surrounding tissues, increased levels of metal ions such as chromium and cobalt in the patient’s bloodstream, pain in the hip region, and even osteolysis, which is a form of bone loss.

The company maintains that the reason behind the recall of the ASR hip implants has nothing to do with the product’s defective design. According to DePuy, the product was recalled because of diverse clinical needs.

For the full article and more details on the DePuy second trial, follow this link.

Posted on: 04-3-2013
Posted in: News, personal injury, product liability

Monster Energy To Change Product Label After Lawsuit Comments Off

According to several news agencies, several companies that produce energy drinks have been scrutinized in the recent past by being reportedly linked to at least 13 deaths.

The company Monster Energy Drinks joined the American Beverage Association and has reportedly decided to change the contents of its labels in order to ensure consumers are fully aware of what they are drinking in order to prevent any potential incidents. The move does not change the contents of the drinks, but it does change what the label says. According to the news, the new labels will include the exact amount of caffeine content in each can.

Last year, the parents of a 14-year-old decided to file a lawsuit after their daughter consumed two Monster Energy beverages before dying. The two cans of the energy drink contained 480 milligrams of caffeine. A consumer must intake the contents of 20 8-ounce cans of soda to have that same amount of caffeine in their system, according to official records.

The Food and Drug Administration has indicated that the 13 deaths, which does not include the death of the 14-year-old, are under investigation. These deaths have been preliminarily linked to the consumption of 5-hour Energy drinks. Federal agents still don’t have a response as to whether the drink was directly linked to the deaths. As of now, “adverse events” are linked to the deaths, which does not rule the drinks as the sole factor that may have led to the 13 deaths.

The FDA has received 20 reports of adverse events linked to people who consumed Monster products. Five of the 20 reports are associated with fatalities. Important information is still missing for official reports, which does not lead to a resolution concerning how dangers associated with consuming these products.

Federal agents hope to get to a conclusion as soon as the investigations have been wrapped up.

Public health experts recently sent a letter to the federal agency stating that not enough evidence was presented to rule out the excessive amounts of caffeine in the serious cases of health issues and even deaths linked to the various energy drink beverages. Safety and health experts say that the correlation between the high levels of caffeine intake and the series of reported adverse reactions could conclude that, especially among children and teenagers, the consumption of certain energy drinks could increase the risk of serious health risks.

According to a 2012 test performed by Consumer Reports, a single can of Monster Energy containing 8 ounces of the beverage also contains 90 milligrams of caffeine. Caffeine in coffee occurs naturally while caffeine in energy drinks are added during the manufacturing process, which is an activity that should be monitored by the FDA.

For the full article and more details on who may or may not make use of the energy drinks, click here.

 

Posted on: 04-2-2013
Posted in: personal injury, product liability, Safety

Green Hope soy processor cited for sanitation violations Comments Off

Following multiple Food and Drug Administration inspections uncovering repeated health code violations and unsanitary production conditions, Green Hope LLC, which manufactures and distributes organic tofu, soy milk and other food  as Rosewood Products, has agreed to a consent decree of permanent injunction. The decree requires the company to cease all operations until its production facilities have received approval from the FDA for the actions taken to comply with federal health guidelines including the Federal Food, Drug and Cosmetic Act.

The company must hire an independent expert to develop official employee training and sanitation control programs. An employee of the company must be designated to implement both of these programs. The FDA may at any time inspect the facilities in order to determine that these plans are being carried, and Green Hope must pay for the costs of FDA supervision and inspection.

Read the full article here:

Michigan soy processor is under court order to meet FDA food safety standards

Posted on: 03-15-2013
Posted in: product liability

Hepatitis C medication may cause deadly rash, authorities warn Comments Off

The hepatitis C medication Incivek may cause a severe skin rash that can be fatal in certain cases, according to an official advisory issued by the U.S. Food and Drug Administration. A black box warning label, the most serious federal warning label, will now be affixed to the packaging for these products, manufactured by Vertex Pharmaceuticals to be taken in conjunction with interferon injections and ribavirin pills for the treatment of genotype 1 chronic hepatitis C with compensated liver disease, meaning the liver is damaged but continues to function. Adults with compensated liver disease often suffer from cirrhosis scarring. Patients taking these three medications together should stop immediately in the event that they beging to develop a rash that becomes more increasingly severe or is accompanied by symptoms such as a fever, mouth sores, or diarrhea.

This rash may expand to cover more than half of the patient’s body. Though the drug’s original labeling warned patients to discontinue use if a rash developed, FDA officials said that some patients had been advised to continue using the medication despite the rash.

Several Incivek patients have died after developing these rashes, according to federal health officials. Late stage clinical trials conducted by Vertex Pharmaceuticals indicated that less than 1 percent of patients taking the medication developed these rashes.

Posted on: 03-12-2013
Posted in: product liability

DePuy accused of knowingly marketing defective all-metal hip joints Comments Off

In the closing arguments of the first of more than 10,000 lawsuits related to the recalled ASR XL all-metal hip joint to go to court, the plaintiff’s attorney accused the company of continuing to market the devices despite reports from the company’s own experts as well as leading surgeons that the device was defective. These implants, manufactured by Johnson and Johnson’s orthopedics division DePuy, were first marketed to U.S. medical patients in 2005, but they were recalled five years later in August of 2010.

The recall was prompted by studies that determined the metal-on-metal cup and ball joint implants, which were designed to have greater durability than their metal-on-plastic or metal-on-ceramic counterparts, failed at a significantly higher rate than other types of implants. At the time of the recall, the ASR XL hip joint’s premature failure rate was calculated at 12 percent in the U.S., but a 2012 study of Australian ASR XL hip implant patients revealed that 44 percent of the implants installed in the country have already failed. Hip implant failure requires a second revision surgery, which has a lower success rate and a longer recovery process than the initial surgery.

The plaintiff in the current lawsuit is a 65-year-old man who required a second revision surgery in February of last year, less than five years after surgeons installed DePuy’s ASR XL all-metal artificial hip joint. He is asking for $338,000 in reimbursed medical expenses and another $5 million to compensate for his pain and suffering. In addition, his attorney asked the jury to impose punitive damages of between 2 and 5 percent of the company’s net worth, or $72 million to $179 million.

Testimony heard by juror’s earlier this week indicated that Johnson & Johnson continued marketing the product to patients and medical professionals while leading surgeons and medical experts employed by the company warned executives of medical complications suffered by patients fitted with ASR XL all-metal hip implants. Legal experts estimate that the numerous lawsuits filed by ASR hip implant patients may cost Johnson & Johnson billions of dollars.

Posted on: 02-28-2013
Posted in: product liability

Engine failures prompt federal investigation into Ford vehicles Comments Off

A potential partial engine failure issue affecting as many as 725,000 late-model Ford and Mercury vehicles has prompted an official National Highway Traffic Safety Administration investigation. The vehicles included in this investigation are model year 2009 through 2011 Ford Fusion and Mercury Milan sedans and Ford Escape and Mercury Mariner sport utility vehicles. According to nearly 1,500 consumer complaints, including three involving collisions and one involving an injury accident, the engine power in these vehicles may cut out even, in many cases, while the vehicle is traveling at highway speed. According to NHTSA investigators, the engines aren’t completely losing power but are erroneously shifting into a reduced power emergency mode designed to allow the driver of a malfunctioning vehicle to travel at low speed to a mechanic’s shop.

Read the full article here:

Feds to probe Ford car, SUV engine fault

Posted on: 02-26-2013
Posted in: product liability

Authorities allege false claims in DePuy metal hip joint lawsuit Comments Off

The U.S. Justice Department is investigating the possibility that claims related to the DePuy ASR XL metal-on-metal artificial hip joint and surgical mesh manufactured by Johnson & Johnson may have been false. The Justice Department has requested documents to study to determine the validity of the reports that DePuy, the orthopedics unit for Johnson & Johnson, may have made false claims about their ASR XL hip devices to federal health-care regulators. These all-metal hip implant devices were recalled in August 2010 after regulators determined that they prematurely fail at a higher rate than artificial hip joints made from other materials.

More than 10,000 lawsuits have been filed in the U.S. by ASR XL hip joint patients who allege that the artificial hip implants caused them suffering through premature failure or shedding metal particles.

Additionally, state health authorities in California have launched an investigation into the marketing of mesh products for hernia and urogynecological purposes across 42 states. Currently, at least 1,800 lawsuits have been filed against Johnson & Johnson regarding its Gynecare Prolift vaginal mesh implant. These devices were taken off the U.S. market in August of last year, and Johnson & Johnson has announced that it would cease international sales as well. The company cited a lack of sales and not health or safety concerns as the reason for ceasing production, however.

Posted on: 02-25-2013
Posted in: product liability

Babyhome high chairs pose strangulation hazard, consumer advocates say Comments Off

Due to a strangulation hazard, the Babyhome Eat high chair has been given a Don’t Buy: Safety Risk designation by Consumer Reports. According to the magazine, the high chair’s design does not include important safety features designed to prevent an unsecured child from sliding out of the seat and becoming entangled and potentially strangled. These metal-framed folding high chairs, manufactured in China and imported by Babyhome USA, Inc. of Chester, New Jersey, do not conform to voluntary safety standards established by the American Society for Testing and Materials which suggest that high chairs should have a passive crotch restraint to prevent the child from falling or sliding out of the chair.

Read the full article here:

Babyhome Eat high chair designated Don’t Buy: Safety Risk due to strangulation hazard

Posted on: 02-20-2013
Posted in: product liability

British officials open criminal inquiry into Depuy metal hip joints Comments Off

According to a report from the Telegraph, Johnson & Johnson subsidiary Depuy continued to sell its all-metal artificial hip joints even after a company executive received emails from a British surgeon warning that patients were suffering after these joints were implanted. The Telegraph also reports that the company continued to market the hip joints even after tests concluded that these implants were more likely to prematurely fail than other models. These test results were allegedly not shared with the public or British regulators.

For this reason, some British officials have suggested that the company should be prosecuted criminally. The National Health Service is opening a criminal inquiry into this matter.

These facts came to light during an American lawsuit, the first of the many lawsuits filed in relation to Depuy’s metal-on-metal artificial hip joints.

More than 10,000 English patients have been fitted with Depuy all-metal hip implants, which not only have been shown to fail at a higher rate than other types of implants, but may also shed metal into patient’s bloodstreams and tissue, potentially causing damage.

Fears of blood poisoning from the metal these implants shed have caused many patients to have them replaced, despite the fact that this procedure is more risky than the original implant surgery.

Posted on: 02-1-2013
Posted in: product liability
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