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Sep
10
2014
2014 may prove a (dubious) record year for FDA drug recalls.

2014 may prove a (dubious) record year for FDA drug recalls.

The number of FDA drug recalls has risen each year, multiplying seven times over from 166 in 2004 to 1,225 last year. With nearly 840 already announced this year, 2014 is on track for an all-time record number of medications removed from the market. In fact, FDA data shows that the last 24 months have seen almost as many recalls (2,061) as the previous nine years combined (2,217). While the sheer numbers are troubling enough, what’s more concerning is that the nation’s health officials are unsure what’s pushing the continual surge.

Pharmaceutical and medical device manufacturers often have to recall drugs, devices and food products for an array of reasons, which can range from simple and relatively innocuous labeling mistakes to serious, potentially life-threatening issues. Common recall prompts include including improper labeling, packaging defects, contamination, improper testing or a product’s inherent safety and the potential that its use could cause harm to a patient or user.

Drug recalls are issued in three separate classes:

  • Class 1: A product undoubtedly will cause serious ill effect, including possible death, in a user.
  • Class II: A product has been known to cause an adverse, but reversible health effect.
  • Class III: A product is unlikely to cause adverse health consequences, but is being recalled simply for safety’s sake.

Class II recalls make up about 70 percent of the total drug recalls, followed by Class 1 at 21 percent and Class III at 9 percent.

Experts believe that one factor in the latest surge may be the fungal meningitis outbreak of 2012, which killed more than 60 people. In response, the FDA quickly initiated a crackdown on compounding pharmacies, noting that a large percentage of Class II recalls were related to issue with these pharmacies, including their provision of products that had possible, but unconfirmed microbial contamination.

Another factor may be continual efforts to improve current good manufacturing practices (cGMP). A single manufacturing plant found to be deficient in any one cGMP can lead to dozens, or even hundreds of recalls of its multiple products.

Whatever the reason, a rise in the number of FDA drug recalls is certainly a matter of concern. If you or your loved one has suffered adverse health consequences after using a recalled drug or device, you may be due fair compensation. Talk with a doctor immediately to assure your health issue is treated, then call 800-251-1111 and speak with a product liability or dangerous drugs and medical products attorney with Jacksonville’s Harrell and Harrell.

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Aug
26
2014
Ace Bayou and the CPSC have recalled 2.2 million bean bag chairs after the suffocation deaths of two children.

Ace Bayou and the CPSC have recalled 2.2 million bean bag chairs after the suffocation deaths of two children.

Bean bag chairs are fun favorites among families with children. They’re comfortable, casual and kid-sized. But some have proven dangerous, safety officials and product liability attorneys say.

After recent reports of two child deaths, the US Consumer Product Safety Commission and New Orleans-based Ace Bayou Corp. have issued a recall of nearly 2.2 million bean bag chairs. Company and federal safety officials warn that the zippers on the round and L-shaped bean bag chairs can easily be opened, allowing small children to crawl inside the bags and become trapped. Unable to escape, victims risk choking or suffocation on the chair’s foam beads.

That heartbreaking scenario is exactly what took the lives of a 13-year-old McKinney, TX boy and a 3-year-old Lexington, KY girl. Both were found dead inside Ace Bayou-made bean bags after inhaling and suffocating on the foam beads that fill and shape the bags.

Round-shaped recalled bean bag chairs were sold in three sizes – 30, 32 and 40 inches in diameter. L-shaped units affected measured 18 inches wide by 30 inches deep by 30 inches high. Both were sold in vinyl or fabric materials in a variety of colors including purple, violet, blue, red, pink, yellow, Kelly green, black, port, navy, lime, royal blue, turquoise, tangerine and multi-color. Customers nationwide bought recalled chairs at major retailers like Walmart and via online retailers such as Wayfair.com, Amazon.com and Meijer.com. All were manufactured before July 2013 and sold for between $30 and $100.

Owners of the recalled bean bag chairs can order a free repair kit by contacting Ace Bayou at 855-751-8151 or Acebayou.com. In the meantime, personal injury and product liability attorneys with Harrell and Harrell urge you to keep bean bags away from children until the faulty zippers can be replaced.

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Aug
06
2014
Your antique Lane or Virginia Made chest may be part of a nationwide recall over a dangerous automatic locking mechanism.

Your antique Lane or Virginia Made chest may be part of a nationwide recall over a dangerous automatic locking mechanism.

That antique cedar chest that’s been in your family for generations may be dangerous, say officials with Tupelo, MS-based Lane Furniture and the United States Consumer Product Safety Commission. They’ve recently announced a renewed recall on cedar chests made under the Lane and Virginia Made bands manufactured between 1912 and 1987, and product liability attorneys warn parents to take heed.

Lane Furniture issued an initial recall of 12 million cedar chests back in 1996, prompted by reports of six children getting trapped and suffocating in the chests. The most recent recall comes on the heels of another suffocation death and two near fatalities to children who became trapped when the chest lid closed and automatically latched shut.

Locks installed on chests made before 1988 featured a push-button mechanism used to lift the chest lid. The mechanism then instantly clicked back into place to lock the chest when the lid was lowered, with no way to unlock and open the chest from the inside. Plus, these cedar-lined chests were built with a tight seal to help keep out moths and protect cloth items stored inside.

Unfortunately, it’s believed that the chests’ size and shape make them desirable hiding spots for children playing games like hide-and-seek. Plus, many parents consider the chests ideal as toy boxes and storage spaces for clothes, blankets and other children’s items. Thus, children often have access to the chests, but parents may be unaware of the automatic locks and subsequent entrapment and suffocation danger.

Lane Furniture officials estimate that some 6 million chests sold nationwide feature these old style automatic locks, which were replaced with new safety locks on all chests made after 1987. The new locks feature a latching mechanism that remains disengaged unless a button is pressed or a key is used from outside the chest. Until then, the lid will remain open about a half-inch, ensuring that accidental entrapment won’t happen to another child.

If you own or use a chest affected in the recall and no entrapment, suffocation or other injuries have occurred as a result, Lane Furniture will send you a new safety lock free of charge, along with easy replacement directions. Call the company toll-free at 800-327-6944 or order a replacement lock online. However, if your child has suffered an injury, an experienced product liability attorney may be able to help secure you fair compensation for injuries and losses. Contact Jacksonville’s Harrell and Harrell, serving clients throughout Northeast and Central Florida as well as South Georgia, at 800-251-1111.

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Jun
17
2014
More than 1 million White-Rodgers AC thermostats have been recalled over a fire hazard.

More than 1 million White-Rodgers AC thermostats have been recalled over a fire hazard.

Summertime is in full swing, which means many Northeast Florida residents have their air conditioners operating in overdrive. If your AC unit is run via a thermostat manufactured by White-Rodgers, listen up. The St. Louis, MO-based company, along with the United States Consumer Products Safety Commission, has recalled more than one million White-Rodgers brand digital Home Heating and Cooling Thermostats sold throughout the US and Canada, citing a fire hazard.

At the time of this writing, the manufacturer has received seven reports of fires involving the thermostats, including two that caused property damage. Turns out the alkaline batteries used in multiple White-Rodgers thermostats can leak onto the circuit board, which can easily cause a blaze. Fortunately, these reports included no injuries. But clearly, any issue that involves a fire hazard holds the potential for serious injury or death.

Recalled units number approximately 740,000 sold throughout the US, and another 403,000 sold in Canada at prices ranging from $30 to $70. They were sold at hardware stores and heating and air conditioning companies from January 2006 to December 2013. They are white in color, feature blue lighted screens and have one of the following names printed on the front:

  • COMFORTSENTRY
  • DICO
  • Emerson
  • Frigidaire
  • Maytag
  • Nutone
  • Partners Choice
  • Rheem
  • Ruud
  • Unico
  • Water Furnace
  • Westinghouse
  • White-Rodgers
  • Zonefirst

If you own one of the thermostats included in the recall, and it has not caused an injury or property damage, you can request a repair or replacement free of charge by calling White-Rodgers toll-free at (888) 624-1901.

However, if you or your family have suffered an injury, or if your home or other structure has been damaged in an incident that you believe may have been caused by a faulty White-Rodgers thermostat, know that you may be due compensation for your losses. In the case of an injury, get medical treatment immediately. If you’ve experienced property damage, get a professional damage assessment. In either case, do not dispose of the thermostat, as it will be needed as evidence in a product liability or personal injury- case. Jacksonville’s Harrell and Harrell can help assure you get the compensation you deserve. Call us at 800-251-1111.

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Jun
10
2014
Research shows faulty GM ignition switches may be responsible for nearly 75 deaths.

Research shows faulty GM ignition switches may be responsible for nearly 75 deaths.

As federal investigations into General Motor’s failure to inform the public of a decade-long issue with a faulty ignition switch continue, the much-maligned company just suffered another hit. GM has publicly acknowledged that the defective switches are to blame for 13 known deaths. But new research suggests that the death toll is likely far higher.

News of the issue first hit in February when GM recalled 780,000 vehicles. At that time, 22 crashes resulting in six deaths believed to have been caused by the defective switches had been reported. Investigations showed that in each incident, the ignition switch had shifted out of place, causing the vehicle’s engine to stall and shutting down power steering, power brakes and airbag deployment mechanism as a result. GM quickly responded with a statement that deflected blame to vehicle owners’ use of heavy key rings and driving on bumpy roads.

Weeks later, when six more deaths had been attributed to the issue, GM expanded the recall to include additional models. The company also admitted that it had known about the problem for more than a decade, and that fixing the problem before affected vehicles rolled off the assembly line would have cost just 57 cents each.

Now, journalists with Thomson Reuters, the world’s largest international multimedia news agency, say results of their independent investigation suggest that the actual death toll attributable to the issue may be several times higher – as many as 74 fatalities. Their analysis of statistics from the Fatality Analysis Reporting System (FARS), a national database of crash information, shows that 74 car accident deaths occurring between 2003 and 2010 involved GM cars with the recalled ignition switches, and details of the crashes were typical of those that prompted the recalls. The rate of this type of accident was far higher among GM vehicles than those of other carmakers.

“The news agency compared the incidence of this kind of deadly accident in the Chevrolet Cobalt and the Saturn Ion, the highest-profile cars in GM’s recall of 2.6 million cars with defective switches, against the records of three popular small-car competitors: Ford Focus, Honda Civic and Toyota Corolla,” Reuters reported. “The analysis found that the frequency of such accidents in the Ion was nearly six times that of the Corolla and twice that of the Focus.”

Though Reuters’ investigation does not definitively prove that the faulty switches caused these accidents and resulting deaths, the details were consistent with those of fatal crashes that GM had acknowledged.

If you drive one of the recalled vehicles and have not suffered an injury as a result, auto accident attorneys with Harrell and Harrell urge you to take the risk seriously. Take your vehicle to your nearest GM dealer for repair free of charge. However, if you or a loved one have suffered an injury that you believe was caused by a malfunctioning ignition switch, get medical attention and contact an experienced attorney as you may be eligible for compensation for your damages. Call 800-251-1111.

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Apr
02
2014
GM CEO Mary Barra testified on Capitol Hill that she doesn't know why her company waited a decade to publicly acknowledge a deadly ignition switch problem. Photo by Mark Finkenstaedt for General Motors.

GM CEO Mary Barra testified on Capitol Hill that she doesn’t know why her company waited a decade to publicly acknowledge a deadly ignition switch problem. Photo by Mark Finkenstaedt for General Motors.

General Motors CEO Mary Barra was in the Capitol Hill hot seat today, testifying to Congress about a decade-long issue with GM vehicle ignition switches that to date is to blame for more than a dozen deaths. It’s the latest development in a controversy involving the recall of more than 2.6 million vehicles and an ongoing risk to any one driving or riding in certain GM vehicles, auto accident and product liability attorneys say.

News of the issue first hit in February with the recall of 780,000 GM vehicles after reports of 22 crashes and six deaths. In each of those incidents, the ignition switch shifted out of place, causing the engine to stall and all electrical components, including the mechanism that deploys air bags, to immediately shut down. GM initially laid part of the blame on heavy key rings and bumpy roads. Weeks later, however, the death toll rose to 13. The company expanded the recall to include additional models, and admitted that it had known about the problem for more than a decade. What’s worse – GM officials now acknowledge that the ignition switch falls short of the company’s own specifications, and that fixing the problem before these vehicles rolled off the assembly line would have cost just 57 cents each.

As it currently stands, the recall affects more than 2.6 million GM vehicles and the issue has prompted two congressional investigations and probes by the Justice Department and the National Highway Traffic Safety Administration. On Tuesday, Barra testified before Congress, maintaining that she does not know why it took GM, which she has helmed for just two months, to publicly acknowledge the problem, but assured that an internal investigation would provide answers in time.

Meanwhile, the company last week announced two additional, unrelated recalls. One affects 490,000 late-model pickup trucks and SUVs with transmission oil lines improperly secured in their fittings. The issue allows transmission oil to leak, potentially causing fires if the oil hits hot surfaces. The second affects 172,000 2013 and 2014 Chevrolet Cruz cars with defective right front axle shafts that can fracture and separate during operation. Wheels then could lose power without warning, causing the car to coast to an unexpected stop.

If you own or drive a GM vehicle, check with your nearest dealer to find out if yours is affected by the recall. If there have been no injuries to you or your dependents related to any of the recall-involved issues, take your vehicle to your dealership where workers will repair issues free of charge and, in some cases, may provide you with a loaner car. However, if you or someone you love has suffered an injury that you believe was caused by one of these defects, get medical treatment, stop driving the vehicle and contact an experienced auto accident or product liability attorney. Jacksonville’s Harrell and Harrell, serving clients throughout Northeast and Central Florida and Southern Georgia, can be reached at 800-251-1111.

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Mar
31
2014
The 2014 Nissan Altima is included in recall of more than 1 million vehicles prompted by an ongoing airbag issue.

The 2014 Nissan Altima is included in recall of more than 1 million vehicles prompted by an ongoing airbag issue.

A problem with airbag sensors in certain Nissan and Infinity models first addressed over a year ago still is not resolved – and it’s prompted a recall of more than 1 million vehicles across North America and Canada. In affected units, the front passenger air bags may fail to inflate in an accident, leaving adult passengers at risk for serious injury.

The problem lies in faulty software. Front passenger seats of the recalled vehicles have sensors designed to determine the passenger’s weight, then turn airbags off if the sensors indicate that a child is on board. That’s because children’s still-developing bones are far more fragile than those of adults, which means they’re more vulnerable to injury from a deployed airbag. Keep in mind that airbags are not soft, billowy pillow-like buffers. Rather, they deploy from a vehicle’s dashboard at speeds of up to 200 miles per hour and the impact against a body or face can be severe enough to cause fatal injuries.

In at least three incidents reported to Nissan officials, the sensors malfunctioned, turning off front-seat passenger airbags despite those passengers being adults of sufficient weight to keep the airbags turned on. Though no deaths were reported and it’s unclear whether those passengers were injured, the risk is clear. Airbags are credited with saving the lives of thousands of adults involved in car crashes nationwide each year.

Vehicles affected in the latest recall – nearly 990,000 in the United States and another 60,000 in Canada – include:

  • 2013 and 2014 Nissan Altima;
  • 2013 and 2014 Nissan Leaf electric car;
  • 2013 and 2014 Nissan Pathfinder SUV
  • 2014 and 2014 Nissan Sentra;
  • 2013 NV200 Taxi Van
  • 2013 Infiniti JX35 SUV
  • 2014 Infiniti QX60 SUV
  • 2014 Infiniti Q50 SUV

If you drive one of these vehicles and had yours repaired after the February 2013 recall, you may need to get a second repair. Dealers replaced seat sensors in those vehicles, but Nissan officials said the company continued to receive customer complaints and warranty claims in vehicles that had been repaired. Nissan and Infiniti will notify registered owners of affected units and will update the software free of charge.

If you or your dependents are injured as a result of a failed airbag, whether in one of these recalled vehicles or a different one, get medical treatment and contact an experienced auto accident or product liability attorney. Jacksonville-based Harrell and Harrell, serving clients throughout North and Central Florida and Southeast Georgia, can help assure you receive fair compensation for your losses.

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Mar
04
2014
The 2007 Saturn Sky is among the cars affected in GM's expanded recall over a decade-long problem with faulty ignitions.

The 2007 Saturn Sky is among the cars affected in GM’s expanded recall over a decade-long problem with faulty ignitions.

Two weeks ago, we told you about a massive recall of 780,000 GM cars prompted by an ignition defect that already had been blamed for 22 car crashes and six deaths. Now, another nine accidents and seven deaths reportedly have resulted from the problem, forcing an expansion of the recall to include more than 1,367,140 cars in North America. Even more troubling, auto accident and product liability attorneys say, is the automaker’s admission that it has known about the problem for more than a decade.

Faulty ignition switches installed in various GM models made between 2003 and 2007 can cause a car’s engine to shut off unexpectedly and disable the airbags. Heavy key rings and driving on rough roads or terrain can trigger the problem by moving the ignition switch out of position, causing all electrical components, including the mechanism responsible for deploying air bags, to immediately shut down.

The recall originally affected Cobalt and Pontiac G5s from the 2005 to 2007 model years sold in the US, Canada and Mexico. Now, company officials also are recalling Saturn Ions made between 2003 and 2007; and Chevrolet HHR, Pontiac Solstice and Saturn Sky cars made in the 2006 and 2007 model years.

“The chronology shows that the process employed to examine this phenomenon was not as robust as it should have been,” Alan Batey, GM’s North American president, said in a written statement addressing the company’s waiting over a decade to publicly acknowledge the problem. “Today’s GM is committed to doing business differently and better. We will take an unflinching look at what happened and apply lessons learned here to improve going forward.”

GM says it will notify registered owners of recalled vehicles by mail and expedite repairs. If you belie that your vehicle is affected by the recall and you have not been involved in an accident cause by the faulty ignition, take your car to a licensed GM dealership where the company will replace the ignition switch free of charge. However, if you have suffered an injury while driving or riding in one of the recalled cars, get medical attention immediately. Then, call 800-251-1111 and speak to an auto accident or product liability attorney with Jacksonville’s Harrell and Harrell.

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Feb
14
2014
The 2007 Pontiac G5 is among the 780,000 cars recalled by GM over an ignition defect blamed for six deaths.

The 2007 Pontiac G5 is among the 780,000 cars recalled by GM over an ignition defect blamed for six deaths.

General Motors this week announced the recall of nearly 780,000 vehicles due to an ignition defect blamed for six deaths. Auto accident and product liability attorneys are urging drivers of Chevrolet Cobalts and Pontiac G5s to take heed.

Company officials warn that faulty ignition switches installed in Cobalts and Pontiac G5s from the 2005 to 2007 model years a sold in the US, Canada and Mexico can cause the engine to shut off unexpectedly and disable the airbags. The problem thus far has caused 22 crashes, all while the cars were traveling off-road at high speeds. Six people (all drivers or front-seat passengers) have been killed as a result, and the potential for more deaths exists so long as affected vehicles continue to travel the roadways.

If you drive one of the cars, know that US safety regulators warn that heavy key rings and rough roads or terrain can trigger the problem by moving the ignition switch out of the run position. As a result, the engine and all electrical components, including the mechanism responsible for deploying air bags, immediately shut down.

In a media statement, GM noted that each of the five fatal crashes “occurred off road and at high speeds, where the probability of serious or fatal injuries was high regardless of airbag deployment. In addition, failure to wear seat belts and alcohol use were factors in some of these cases.”

If you own one of the recalled vehicles and have not been injured, take your car to a licensed GM dealership where the company will replace the ignition switch free of charge. However, if you have suffered an injury, either as a driver or passenger, in an incident that you believe the defect caused, get medical attention immediately. Then, contact an auto accident or product liability attorney with Jacksonville’s Harrell and Harrell. Call 800-251-1111.

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Feb
11
2014
Ikea's popular Kritter and Sniglar junior beds have been recalled over a laceration hazard.

Ikea’s popular Kritter and Sniglar junior beds have been recalled over a laceration hazard.

Ikea again is issuing a voluntary recall of two popular junior beds after receiving an additional report of a child in the United Kingdom receiving a small scratch to the arm. The company’s Kritter and Sniglar Junior Beds feature a metal rod connecting the guard rail to the bed frame. Unfortunately, that rod can break during use, posing a laceration hazard to children.

The recall of 22,000 units initially was issued in August 2013 and was expanded to include another 3,500 upon news of the latest injury. The pine wood Kritter beds feature animal cut-outs, including a dog and cat, on the headboard. Look for a date stamp of 1114 to 1322 indicating the year and week of production; a 600.904.70 model number; and 19740 supplier number on the underside of the bed.

The Sniglar natural beech wood beds have a white painted fiberboard insert on the headboard and footboard. A label on the headboard or underside of the bed has a date stamp of 1114 to 1318, a 500.871.66 model number, and 18157 or 19740 supplier number. This recall expands the date code for Sniglar beds to 1049 to 1318.

Affected units were sold exclusively at Ikea stores nationwide and online at www.ikea-usa.com from July 2005 through May 2013 for between $60 and $90. If your child is using one of these beds and has not been injured, contact Ikea at 888-966-4532 and ask for a free repair kit which includes a replacement metal rod, tools and instruction sheet.

However, if your child has been injured, seek medical attention – even if the injury is minor. Keep the bed and all parts intact and contact a product liability attorney with Jacksonville’s Harrell and Harrell at 800-251-1111. We serve clients throughout Northeast and Central Florida, as well as Southeast Georgia.

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