Injury Law Blog : Florida Injury Lawyer & Attorney : LaBovick Law Group : Serving West Palm, Boynton, North Palm, West Palm Beach, Jupiter

We want to keep our readers informed and safe. Below, you will find a list recent recalls and alerts announced by the National Highway Transportation Safety Administration’s (NHTSA) Office of Defect Investigation (ODI). If you think your vehicle needs to be inspected, bring your car to your local dealership right away: 

Subaru Forester Recall Began at the End of April 2013

Subaru has issued a recall of Forester vehicles manufactured between January 2013 and March 2013. This recall was set in place because many floor mats were defectively manufactured, causing them to curl and therefore obstruct the driving pedals.  Brake or accelerator pedal interference may result in driver distraction, high driving speeds and difficulty stopping.

Couragia A/T Tire Recall Began at the End of April

A recall has been issued for approximately 8,513 defective Couragia A/T tires for failure to comply with safety standards regarding "New Pneumatic Radial Tires for Light Vehicles." Tire sizes P265/75R16 116S with DOT Serial Numbers UX77 3210-UX770813 may experience tread shoulder chunking that can cause crash and injury due to excessive heat.

Multiple Manufacturers Issue Defective Air Bag Recalls To Begin in May

A massive recall for Nissan, Honda, Toyota, General Motors and Mazda has been issued due to a safety defect of the frontal airbag that has the potential to cause significant harm to vehicle occupants.  These airbags may produce excessive internal pressure causing the bag to rupture with the potential for metal fragments striking and causing injury to occupants. More than 826,000 vehicles are included in this recall class.

·         Nissan:  2001-2003 Maxima, Pathfinder, and Infiniti I35; 2002-2003 Infiniti QX4; and 2003 Infiniti FX35 and FX45 and possibly certain Sentra vehicles. 

·         Honda:  2001-2003 Civic, 2002-2003 CR-V and 2002 Odyssey vehicles. 

·         Toyota & General Motors Recall Details: 2002 - 2004 Toyota Corolla, Corolla Matrix, Sequoia, Tundra, Lexus SC and Pontiac Vibe vehicles. 

·         Mazda Recall Details:  2003-2004 Mazda6 vehicles manufactured January 14, 2003 through May 29, 2003; and 2004 RX-8 vehicles manufactured June 25, 2003 through June 30, 2003.

Nissan Brake Failure Defect of Pathfinder and Infiniti JX vehicles Expected to Begin May

Nissan has issued a recall of these vehicles manufactured December 3, 2012 through January 29, 2013 due to structural weakness in the brakes, potentially causing brake failure and increasing crash risk.

Nissan Defective Tire Recall Begins May 3, 20103

Nissan has issued a recall of Altima vehicles manufactured between March 21, 2012 and March 26, 2013 due a spare tire defect. In some cases, these spare tires have been incorrectly inflated causing potential tire failure and a risk of great injury.  

Honda Fit Recall Expected to Begin May 17, 2013

Honda has issued a recall of Fit Sport vehicles due to safety issues of the electronic stability control system.  The safety defect in the ESC system of the affected vehicles may increase the risk of a crash.

Several Chrysler Recalls Begin in April and May

·         2013 Dodge Ram 1500: Vehicles manufactured December 17, 2012 through January 22, 2013 were recalled due to a parking brake cable equalizer that was set incorrectly.

·         2013 Dodge Ram 2500 and 3500:  Engine covers on vehicles manufactured January 7, 2013 through March 6, 2013 were recalled due to a manufacturing defect that may allow excessive heat to be trapped under the engine cover. 

·         2007-2008 Dodge Nitro and 2008 Jeep Liberty: More than 60,000 vehicles have been recalled due to a defect potentially causing the drive shaft to break. The defect may cause the transfer case heat shield to drop down and rub on the drive shaft, therefore weakening it and potentially causing the drive shaft to break.  If the drive shaft breaks, the car computer will deploy the airbags, thinking the vehicle is involved in a crash, thus potentially causing a crash.

·         2012 Jeep Patriot and Compass:  More than 20,000 vehicles manufactured October 18, 2011 through May 7, 2012 have been recalled due to a manufacturing defect causing the engine to stall.

·         2011-2012 Chrysler 300, Dodge Challenger and Dodge Charger: Air bags in vehicles manufactured April 11, 2011 through December 14, 2011 have been recalled due to airbag sizing issues in certain vehicles that may cause the seat side-airbags to malfunction and illuminate the airbag warning light. If a crash does occur, the airbags may not deploy as they were designed to operate, increasing the risk of injury.

• Email This
• Print
• Comments
• Trackbacks

Sometimes a news report just catches my attention and scares me.  At the end of 2012, just before New Year’s Eve four huge retailers, Buy Buy Baby, Diapers.com, Toy R Us/Babies R Us, and Amazon recalled more than 150,000 of Baby Matter LLC product called the Nap Nanny Baby Recliner.  These recliners are blamed for the death of infants who use them.  There are dozens of reports of children falling out or almost falling out of the chair and being hurt or killed. 

This is exactly the type of case that frightens me.  The Consumer Product Safety Commission (CPSC) stated the recall would cover many of the Nap Nanny recliner models sold between 2009 and 2012 and that "the Nap Nanny contains defects in its design, warnings and instructions…[which causes a] "substantial risk of injury and death to infants."  The models to beware of are: The “Chill” model, which sold more than 100,000 units; the “Generation One,” which only sold 5,000 units; and the “Generation Two,” which sold more than 50,000 units.   We are investigating harm to children who used any of these models. 

Be aware if you see anyone using a Nap Nanny Baby Recliner you should warn that parent about the dangers the CPSC found.

• Email This
• Print
• Comments
• Trackbacks

As attorneys, we are often called about products that are defective.  Sometimes the facts are shocking.  We hear about a product and how it malfunctioned or failed and caused huge injuries.  At times, that failing product is a singular model.  Other times it is simply a defective design that dooms all the products.  It is in this second case that the multiple plaintiff cases and class actions are born.  There are instances when a product failure creates no real calls to attorneys, even from the injured patients.  Yet, when the product is really bad, the phone rings off the hook.
 

This is the case with the Stryker Rejuvenate Hip Implant Recall of last summer.  The phone has not stopped for months with stories of people who have experienced terrible pain and fluid buildup in their implant site.  Literally thousands of hip implant surgeries were performed in South Florida.  Our older population made our market a fertile ground for this failed implant.  When the implant was first approved it was hailed as a breakthrough technology.  But, like many things that are improperly tested and brought to market without adequate testing, it failed in what became human guinea pig trials.  Who knew that ultra small metallic particles were being rubbed off and released into the surrounding tissue causing metal poisoning, tumors and bone destruction?  Sadly, no one figured it out in the testing phase, which was rushed, assuming to beat competitors to market.  Of course, Stryker did not admit fault in this matter, but after so many hips failed, they finally, on June 6, 2012 recalled the entire product.
 

Due to the overwhelming need in the market, our firm has geared up to focus on hip replacement cases.  We are working with a combination of other attorneys who are also focusing on hip replacement cases to handle the discovery and other litigation tactics in a well organized group.  Stryker is a powerful company and they will not make any individual case easy.  Our group is going to act with laser beam intensity to bring these cases to what I like to call a Point of Justice.  That is where our client is either paid the right amount of money in a settlement or a jury awards our client the complete amount they are entitled too.  We are advising everyone who has had any Stryker artificial hip surgery to call our office upon the first feeling of pain, popping, noise, swelling or any changes in your blood metal levels, which special attention paid to the cobalt and chromium levels.  You are entitled to bring that claim.
 

• Email This
• Print
• Comments
• Trackbacks

On June 4, 2012, Ethicon, a subsidiary of Johnson & Johnson, announced the discontinuation of the following products:

The Gynecare Prolift Kit
The Gynecare Prolift +M Kit (A Prolift Kit with partially absorbable properties)
The Gynecare Prosima Kit
The Gynecare TVT Secur

The Recalled Products:

The “POP Kits”
The Prolift and Prosima products, made of a synthetic woven polypropylene mesh, are pre-formed and pre-packaged in "kits" for application in pelvic organ prolapse (POP) procedures. Commonly known as "POP Kits," these products are aggressively marketed to OBGYNs and gynecological surgeons as a minimally invasive answer to POP repair. Surgeons are misled into believing these surgeries offer little to no risk of complications and then wrongly pass that information on to their patients. Each year, about 75,000 women are given mesh implants for pelvic organ prolapse repair per yea. In most cases, women receive mesh implants such as the Prolift and Prosima kits in lieu of more "traditional" procedures such as the natural colporrhapy procedure or the abdominal sacrocolpopexy.

The TVT Mini-Sling

The Gynecare TVT Secur part of a class of Stress Urinary Incontinence (SUI) devices known as "mini slings." Synthetic SUI slings like the Gynecare TVT and the TVT-O have been on the market since the late 1990s, and thanks mostly to capitalistic medicine and the 510(k) process, synthetic mini slings were born as the next step in "sling technology." Their designs require only a single intra-vaginal incision (as opposed to standard TVT or TVT-O designs that entail two additional abdominal or upper-thigh incisions). Mini-slings are marketed as a "micro-invasive" approach to SUI surgery, and the TVT Secur is the only product involved in the recall.

More Recalls in the Near Future?

This recall is the first movement by a pelvic mesh manufacturer to stop production and withdraw a group of pelvic mesh products as a response to FDA scrutiny and rising pressure from potential litigation. Last July, the FDA issued a warning of the high incidence of adverse effects associated with the use of transvaginal mesh for pelvic organ prolapse procedures, and issued scrutinizing warnings and further recommendations. The FDA also plans further post-market studies on both pelvic organ prolapse mesh and synthetic "mini-slings."

Ethicon is also seeing pressure from a dual state court/federal court lawsuit attacks. More than 400 cases since September 2010 have come to light.

Synthetic pelvic organ prolapse mesh has been strongly criticized in scientific literature and by members of the medical community. Several alternative options exist for POP repair that do not involve transvaginal placement of mesh. Further, these alternatives do not pose the terrible and disabling side effects that come with transvaginal mesh such as permanent tissue and nerve damage, and mesh degradation and erosion. It is now obvious to many that transvaginal pelvic organ prolapse mesh should be removed from the market.

Ethicon was the first to make this move and remove its pelvic organ prolapse devices. The company announced that it would no longer manufacture the above-referenced products and asked that it be allowed 120 days for full cessation. Ethicon also indicated that it would restrict the indication of its Gynemesh product (pre-formed Prolene sheet mesh) to use in abdominal sacrocolpopexy repair. This essentially means that Ethicon will be withdrawing its entire lineup of polypropylene synthetic mesh devices used in transvaginal POP repair.

We hope other manufacturers will follow Ethicon’s lead in withdrawing transvaginal pelvic organ prolapse mesh.

Other pelvic organ prolapse mesh kit products to look out for are C.R. Bard's Avaulta Family Products, American Medical Systems' Apogee/Perigee and Elevate Products, and Boston Scientific's Pinnacle and Uphold Products.

The high profitability of these devices makes recalls difficult, but human life is wroth the effort. If you had a POP Kit or Mini Sling implanted, it is important to act quickly to protect your rights because you may be entitled to compensation. For more information on this recall, contact LaBovick Law Group.

Details of the recall announced by Levin Papantonio Thomas Mitchell Rafferty & Proctor, P.A.

• Email This
• Print
• Comments
• Trackbacks

Every car company recalls their cars.  They don’t like it, but they do it because of their fear of being sued in a massive action for wrongful death.  So, General Motors (GM) is no exception to that rule.  Last month they issued two recalls.  The first was a 1,700 car recall due to their failure to meet federal safety requirements.  The requirement was a big one: the Occupant Crash Protection requirement number 208.  This recall was related to Chevrolet Express and GMC Savana automobiles manufactured between the summer of 2011 (6/2/2011) through the fall of that year (10/17/2011).  Some of the vehicles have a defective second stage airbag issue that caused the airbag to fail under certain circumstances, including front end collisions.  Don’t mess around with an airbag defect.  You will need that airbag if someone blows a red light or stops short on the highway!  This recall started last year in November or December and will continue through getting all the cars repaired at no cost to the owners.  If you have questions, please contact the General Motors Company (800)462-8782 or Chevrolet at (800)222-1020. You can tell them that you’re calling about NHTSA ID Number: 11V543000.

The second recall was for a seat belt problem in 5200 cars.  The same safety rules (Safety Rule 208) were violated when they manufactured the seat belt warning device, which did not have the proper electronic connections when the seat belt buckles were fastened.  This defect is apparent on the GMC Canyon and Chevrolet Colorado vehicles.  The time period that the seat belt defect occurred was short, between September 9, 2011 and October 19, 2011, but it involved a LOT of vehicles.  So, if you have either a Canyon or a Colorado, get it checked.  The repair is free and your seat belt may save your life someday.  If you have any concerns about whether your vehicle fits this recall lot please contact GMC at (866)996-9463 or Chevrolet at (800)630-2438 for NHTSA ID Number: 11V552000.

• Email This
• Print
• Comments
• Trackbacks

In a continuing effort to update our readers on Auto Recalls, Toyota has recalled 210,000 Sienna minivans because their tires and/or rims fail to satisfy the Federal Safety Standards.  The failure to properly rate the load capacity on the Sienna’s display could cause an overload of the car and lead to tires which fail!  Don’t risk crashing.  Get the corrected Sienna information from Toyota by calling Toyota at (800) 331-4331.  You can use NHTSA ID number 11V560000.

Toyota also recalled 420,000 additional vehicles, which include the 2004 Avalon, the 2005/2005 Camry, Highlander and Sienna, 2006 Highlander Hybrid and Lexus models 2004 and 2005 Lexus ES330 and 2006 RX400H.  The recall is due to the power steering pump which can detach from the system.  Only the 1MZ-FE and 3MZ-FE engines were affected by this problem. The recall should start this month with local dealers ready to inspect and repair your Toyota.  Owners may contact Toyota at the number noted above.  You can look up this recall using the NHTSA ID Number: 11V539000. 

• Email This
• Print
• Comments
• Trackbacks

The other day we warned our readers about a Honda car airbag recall.  Today, we are back looking at Honda again but at the Motorcycle division.  Honda Motorcycles division is recalling 126,000 Goldwing GL 1800 motorcycles due to installation of defective brakes.  The braking system has a major problem in the master cylinder.  The model years affected are from 2001 to 2012  (the 2011 year may be exempt, we are still investigating that year’s defect).  Yes, you read that right. ELEVEN years of defective brakes are being recalled!  The defect can cause the rear brakes to start a brake fire.  This recall is scheduled to start on January 2012 and will be a free fix for Goldwing owners.  Motorcycle owners can call Honda directly at 1-800-784-1870.  The recall is noted as Number S03 and can be found at www.NHTSA.gov under 11V567000.  Make sure, if you own a Goldwing, that you get your brakes fixed.

• Email This
• Print
• Comments
• Trackbacks

People are unaware of how often the automobile industry is forced to recall cars for defects.  This continues to affect drivers and passengers who are catastrophically injured due to the automobile companies poor designs and defective products.  Certainly cars are far safer now then 20 years ago, but we have a long way to go.  Recently Honda Motor Corporation recalled 1.7 million vehicles due to an airbag defect that was apparent in the 2001 and 2002 Honda Accord.  They were also installed in the 2001, 2002 and 2003 Civic (both the 2 door and the 4 door model).  They are also a part of the 2002, 2003 CR-V and the 2003 Pilot.  You might expect Acura to have a similar problem, and you would be right.  The Acura CL and Acura TL are both effected in the years 2002 and 2003.  The recall means that Honda will replace the defective part free of charge.  The problem with the original airbag is that when they are activated they can explode releasing metallic parts which will enhance injury to the occupant!.  The recall starts this month (December 2011) and can be investigated by referencing the National Highway Traffic Safety Administration (www.NHTSA.gov) site under campaign ID number 11V260000.  Honda owners are allowed to contact Honda directly at 1-800-999-1009.  Don’t wait to get your Honda fixed today!  You may ask why it took Honda so long to recall the vehicles?  One theory is obvious, unless the automobile industry is sued and Plaintiff’s prove there are defective parts which are injuring occupants, the automobile industry will continue to deny the problem.

• Email This
• Print
• Comments
• Trackbacks

Recalls and Alerts announced by the National Highway Transportation Safety Administration’s (NHTSA) Office of Defect Investigation (ODI):

General Motors

General Motors recall began November 9, inspecting 2012 Chevrolet Equinox and GMC Terrain vehicles free of charge. This recall is checking certain Tire Pressure Monitoring Systems that are not properly warning owners of low tire pressure. For more information, contact Chevrolet at 1-800-630-2438 or GMC at 1-866-996-9463, and reference safety recall No. 11261.

GM has another unscheduled recall to evaluate a sensor defect affecting front airbags on Pontiac G8 vehicles manufactured between November 2, 2007 and January 22, 2009. When a recall is set, owners will be notified for a free inspection and/or replacement. Concerned owners may contact Pontiac directly at 1-800-620-7668 and by referencing NHTSA CAMPAIGN ID Number: 11V534000. 

Volvo

Volvo issued a recall of approximately 19,600 vehicles for failure to comply with Federal Motor Vehicle Safety Standard No. 110 regarding “Tire Selection and Rims.”   Certain 2006-2012 C70 and 2011-2012 S60 vehicles’ tires were mislabeled. Improper tire inflation can result in tire failure and significantly increase the risk of a crash. Additional details can also be found by referencing NHTSA CAMPAIGN ID Number: 11V508000.   

Jeep Wrangler

Beginning November 2011, Right Hand Drive Jeep Wrangler vehicles manufactured between February 1, 2007 and October 10, 2011 have been recalled due to a potentially compromised driver’s airbag. If you’re a concerned owner of one of these vehicles, contact Chrysler at 1-800-853-1403 and reference safety recall No. L37.

Yamaha

Yamaha has issued 2 separate recalls due to defects affecting the fuel systems in some newer model motorcycles including certain 2012 XTZ12B/BC (Super Tenere) motorcycles manufactured from June 01, 2011 through August 31, 2011; 2009-2012 XVS95/CT (V STAR 950/V STAR 950 TOURER) motorcycles manufactured from October 2008 through August 2011; and 2007 XVS1300/CT (V STAR 1300/V STAR TOURER) motorcycles. Both recalls are scheduled for November 2011. For more information, contact Yamaha directly at 1-800-962-7926.

Owners are encouraged to contact the National Highway Traffic Safety Administration's Vehicle Safety Hotline at 1-888-327-4236 (TTY 1-800-424-9153) or go to www.safercar.gov, with any questions or concerns surrounding these or any other recalls or safety campaigns.

• Email This
• Print
• Comments
• Trackbacks

Recently a Palm Beach County jury returned a verdict in an amount of just under $40 million for the families of one girl killed and another severely injured in a wave runner accident. The Plaintiffs alleged that Yamaha Motor Corporation was negligent for a design defect and failing to warn of the dangers of one of their personal watercrafts commonly referred to as a wave runner or jet ski. The accident happened in March of 2005 and two young girls under the age of sixteen took off on a borrowed 2001 Yamaha wave runner. They were driving the wave runner in the Intracoastal Waterway near West Palm Beach, Florida. One of the girls was killed and the other severely injured when the wave runner collided with a boat. It was the plaintiffs’ contention that the wave runner possessed a design defect that when the throttle is released the operator losses all navigation function of the watercraft. Evidently, Yamaha knew of this, failed to correct the problem and failed to warn of the defect. This had been an ongoing problem for Yamaha since 2001 and they had been sued multiple times for similar allegations. The problem has since been corrected, but at what price?

The case was a hard fought, contentious battle in Palm Beach County Circuit Court. At the end and after much deliberation, the jury found in favor of the plaintiffs but attributed some negligence to the parents of the girls but not enough to taint the victory.

The brave lawyers who took on this case against Yamaha must be commended. They expended considerable money and countless hours in the preparation and prosecution of their claim. They spent in excess of a million dollars to bring justice for the families. The two Plaintiffs lawyers went up against a very large corporation and their army of lawyers and justice prevailed. Plaintiff attorneys over the years have gotten a bad name and have been called everything from ambulance chasers to parasites but if not for the plaintiff’s lawyers, who is going to keep these profiteers and corporations, lacking social conscious, in check.

There are multiple instances where corporations have taken advantage of the public at large and have only been found out by the litigation process from the brave lawyers who had the guts to take these companies into the courthouse to obtain justice on behalf of their clients. All lawyers, like those in the above wave runner case, need to be commended for their bravery, tenacity and commitment to justice. If not for the few, the many could continue to harm innocent victims in the name of profit.

• Email This
• Print
• Comments
• Trackbacks

Parents with small children that use Child Booster seats should be aware that Target has recalled 375,000 of their Circo Booster Seats because the "booster seat's restraint buckle can open unexpectedly, allowing a child to fall from the chair and be injured."

The Consumer Product Safety Commission, states that they have received at least 10 reports of the Circo booster seat buckles unexpectedly opening, including at least 3 reports of children suffering minor injuries after they fell out of the booster seat and hit the floor. There were 8 reports of the Circo booster seat buckles opening unexpectedly when 43,000 of these seats were originally recalled in 2009.

• Email This
• Print
• Comments
• Trackbacks

Click on the following link to read more on  Child safety: New registration system alerts parents to vital recalls - Sun Sentinel

Consumer Product. Safety Improvement Act of 2008 - CPSC


 

• Email This
• Print
• Comments
• Trackbacks

DePuy Orthopaedics Inc., a division of Johnson and Johnson is voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

These type of "metal-on-metal" hip implants can cause particles to go into a patient leading to harmful, painful reactions, and frequently lead to further surgeries.

The following statement was released by Depuy to the public:

"Data recently received by the company shows that more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery. For this reason, DePuy Orthopaedics is voluntarily recalling its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and treatment may be necessary to ensure the hip is functioning well. In some cases, patients may need additional surgery."

Click on the following links to read more on the Depuy Orthopaedics Hip Replacement Recall

Medical News Today: Hip Replacement Recall By Depuy Orthopaedics Is Big News

Depuy Recall: (A J&J Division) DePuy Orthopaedics Voluntarily Recalls ASR™ Hip System

FDA Warning Letter to Depuy Orthopaedics 8/19/10

• Email This
• Print
• Comments
• Trackbacks

Evenflo Inc. has issued a recall involving 13,792, Evenflo Maestro child safety seats. In the event of a crash, a crack could form at the front of the seat, adjacent to the harness adjuster, causing the child to be improperly restrained.

The recall involves child seats with model numbers beginning with 310. Those include 3101198; 3101980; 31011048; 31011049; 31011059 produced between November 24, 2009, and April 9, 2010. The model number and the manufacture date are located on a label on the side of the car seat/carrier.

As a solution to the problem, Evenflo is providing consumers with a metal reinforcement plate to provide additional structural support in the area of the harness adjuster. Owners of the affected seats should contact Evenflo at (1-800-233-5921) immediately to obtain a free reinforcement plate. Until the repair kit is received, seats can continue to be used in accordance with the owner’s manual.

According to a report by the NHTSA on Children Injured in Motor Vehicle Traffic Crashes, injuries suffered in a motor vehicle traffic crashes are the leading cause of death among children in the United States. Several studies have shown that children who are correctly using the appropriate restraint for their sizes and ages are at a significantly lower risk of sustaining serious or fatal injuries.

The injury outcome in children can be worse than similar injuries sustained by adults. For example, children who suffer traumatic brain injuries can experience lasting or late-appearing neuropsychological problems, highlighting the need for careful monitoring of children as they grow older. For this reason, head injuries are of particular concern when studying children injured in motor vehicle traffic crashes.

In children, some neurological deficits after head trauma may not manifest for many years. Frontal lobe functions, for example, develop relatively late in a child's growth, so that injury to the frontal lobes may not become apparent until the child reaches adolescence when higher level reasoning develops.

If you are a Parent or a caregiver, sign up with NHTSA to automatically receive updates about child seat recalls. Protect the safety of your children by being aware of safety issues early.

Consumers with questions about this safety recall campaign may call NHTSA’s toll-free Vehicle Safety Hotline at 1-888-327-4236 or Contact Evenflo at (1-800-233-5921) for additional information. Click on the following link to read more on children injured in motor vehicle accidents. 

• Email This
• Print
• Comments
• Trackbacks

In response to the circumstances surrounding McNeil Consumer Healthcare’s (McNeil) voluntary recall of multiple well-known pediatric medicines including Children’s Tylenol, the House of Representatives Committee on Oversight and Government Reform opened an investigation into the matter. Reuters reports that the Congressional committee is looking into whether McNeil, a unit of Johnson & Johnson, “failed to investigate consumer complaints that could have identified the contamination problems.”

The committee also plans to scrutinize the adequacy and performance of the U.S. Food and Drug Administration’s (FDA) inspection process following a routine inspection of McNeil’s Fort Washington, Pa. facility in April in which federal health officials found contamination, grime, thick dust and quality control violations.

Committee Chairman Edolphus Towns, a New York Democrat, and the panel's ranking Republican, Darrell Issa of California, had this to say about the committee’s investigation in a jointly filed news release:

“We are deeply concerned about the recall of popular pediatric medications widely used by infants and children across the country. When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.”

Towns and Issa also noted in the news release that it is important to investigate the circumstances surrounding the recall due to the potentially adverse effects the products could have on children. According to the Washington Post, the recall affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines.

Towns, Issa Announce Investigation into Recall of Popular Pediatric Medication – Committee on Oversight and Government Reform’s News Release about the Investigation

House committee will look into recall of children's drugs after Tylenol recall – The Washington Post

Congress probing J&J Children's Tylenol recall – Reuters

• Email This
• Print
• Comments
• Trackbacks

A report issued  by the U.S. Food and Drug Administration (FDA) states that federal health inspectors found that Johnson & Johnson unit McNeil Consumer Healthcare (McNeil) knowingly used materials contaminated with bacteria to make certain lots of its infant’s and children’s Tylenol products. McNeil issued a voluntary recall on April 30 of more than 40 different sizes and flavors of seven of its most popular products, including Children’s Tylenol and Children’s Motrin. The company has also suspended production at its Fort Washington, Pa facility. For now, FDA officials are saying that no final product batches contain contamination, but that the agency needs to review the inspectors’ assessments further to rule out any such possibilities.

Following a routine FDA inspection of McNeil’s Fort Washington, Pa. facility in April, federal health officials noted the following:

“The Quality Control Unit (QA) authorities most responsible for overseeing daily operations at the Fort Washington facility did not ensure that the responsibilities of the Analytical, Microbiological, Compliance, and Quality Assurance departments were enforced for rejection and withholding from approval any raw material component that contained known contamination of gram negative organisms. Raw material…lots…had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration date(s) on the market.”

The FDA’s report also indicated that its inspectors found grime and thick dust covering certain types of equipment at McNeil’s Fort Washington, Pa. facility. In addition, the report, dated April 30, notes that the company handled consumer complaints poorly. Reuters reports that consumers filed 46 complaints between June 2009 and April 2010 involving “dark material in the liquid products.” The FDA is urging consumers to use generic over-the-counter medicines in place of the recalled products.

FDA: Drug maker McNeil knew of contamination – USA Today

FDA finds grime at J&J plant, urges use of generics – Reuters

FDA Inspection Report of McNeil’s Fort Washington, Pa. Facility

• Email This
• Print
• Comments
• Trackbacks

McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc. (McNeil) issued a voluntary recall of some of its most popular children’s medicines on Friday, including multiple varieties of the popular Children’s Tylenol and Children’s Motrin. The Johnson & Johnson unit issued the voluntary recall in consultation with the U.S. Food and Drug Administration (FDA) due to “manufacturing deficiencies” and because the products “may not meet required quality standards.” The FDA is urging consumers to stop using the affected products immediately.

According to the FDA, the manufacturing deficiencies have the potential to affect the purity, quality and even potency of the recalled over-the-counter children’s medicines. The New York Times reports that certain lots of the products may contain a larger amount of the active drug ingredient than specified, and that other recalled products could contain ingredients or foreign particles that may not meet McNeil’s testing requirements.

The recall involves more than 40 different sizes and flavors of seven well-known products, including:

•    TYLENOL® INFANTS’ DROPS
•    CHILDREN’S TYLENOL® SUSPENSIONS
•    MOTRIN® INFANTS’ DROPS
•    CHILDREN’S MOTRIN® SUSPENSIONS
•    CHILDREN’S ZYRTEC®  LIQUIDS IN BOTTLES
•    CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

McNeil’s voluntary recall comes in response to a routine inspection of the company’s Fort Washington, P.a. facility on Friday in which federal health inspectors found multiple manufacturing violations. According to the New York Times, this is McNeil’s second major recall of 2010, the other taking place in January involving over-the-counter adult and children’s medicines manufactured at a plant in Puerto Rico.

Children’s Tylenol and Other Drugs Recalled – New York Times

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products – McNeil Press Release (includes list of recalled products)

FDA News Release about Recall

• Email This
• Print
• Comments
• Trackbacks

Additional fines may be imposed against Toyota Motor Corporation (Toyota) , by U.S. safety regulators, for failure to promptly take action to fix the sticky accelerators. This would be in addition to the historic $16.4 million penalty imposed by the National Highway Traffic Safety Administration (NHTSA) on the automaker, April 5, that we discussed previously on the Injury Law Blog.  The NHSTA noted that the fine would have been $13 billion if not for caps set by U.S. law.

Automakers are required by law to inform regulators about a safety defect within five days of its discovery. Toyota’s records indicate that the automaker issued repair notices for sticking accelerators in Europe and Canada in September, but waited until January to take action in the United States. The possibility of this new penalty comes in response to an ongoing review of Toyota’s documents by NHTSA that indicates there were two separate defects in the recalled pedals.

United States District Judge James V. Selna in Orange County, Calif. will handle the trial, including important pretrial decisions such as deciding what documents and materials Toyota will need to provide as evidence.

According to an investigative Associated Press article, Toyota has a reputation of withholding documents and using evasive legal tactics in previous product liability, personal injury and wrongful death cases. A prime example is a product liability case in Colorado involving a young girl s killed in a 4Runner rollover crash. Court records show that a federal judge ordered Toyota to produce documents about internal roof strength tests. Unfortunately, the jury ruled in favor of Toyota, since they were not privy to important documents that may have helped shape a different opinion.

A former Toyota attorney, Dimitrios Biller and Whistleblower, accuses the automaker of  withholding evidence in former rollover cases. Rep. Edolphus Towns, D-N.Y., chairman of the House Oversight and Government Reform Committee, found many of  Biller's claims to be substantiated after reviewing some of Biller's still-undisclosed records. It is important to note that Rep, Edolphus Towns, had to subpoena Biller's records.

Toyota now must decide whether to appeal the initial fine or not. According to NHTSA Chief Counsel O. Kevin Vincent,

"If Toyota will not agree to pay the demanded penalty, NHTSA will refer this matter to the U.S. Department of Justice with the recommendation that the Attorney General commence a civil action in federal court ."

It is hard to believe that the previous largest fine was against General Motors Company for only $1 million. Surprisingly, this fine was for not promptly recalling  windshield wipers in vehicle model years 2002-2003.

US regulators consider 2nd fine against Toyota – Reuters 

AP IMPACT: In Toyota cases, evasion becomes tactic – Associated Press

Toyota Acceleration Suits Combined in California Federal Court – Bloomberg 

• Email This
• Print
• Comments
• Trackbacks

The U.S. Department of Transportation (DOT) is seeking the maximum civil penalty of $16.375 million, against Toyota for failing to notify the government about its sticky accelerators in a prompt manner. This would be the the largest civil penalty ever assessed against an automaker by the agency. According to records, Toyota knew about the problem as early as late September 2009 when the problem was confirmed in Europe and Canada but waited until late January 2010 to recall 2.3 million cars in the U.S. for the same issue. This is unacceptable behavior for a company that prides itself on "quality, dependability and reliability".

U.S. DOT Secretary Ray LaHood stated the following on the Toyota issue
Automakers are required to provide the National Highway Traffic Safety Administration (NHTSA) with notification of a safety defect within five days of its discovery. Why did it take Toyota so long to inform U.S. officials and the American public about about the threat of sticky accelerator pedals on certain models? Were they testing the cars to be sure of the defect or was it corporate greed?

“We now have proof that Toyota failed to live up to its legal obligations. Worse yet, they knowingly hid a dangerous defect for months from U.S. officials and did not take action to protect millions of drivers and their families. For those reasons, we are seeking the maximum penalty possible under current laws.”

At least 52 deaths have been linked to crashes allegedly caused by accelerator problems in Toyotas, according to government records. The sticky accelerator pedal recall involves the 2007-10 Camry, 2009-10 Corolla, 2009-10 Matrix, 2005-10 Avalon, 2010 Highlander and 2007-10 Tundra. The recalls have led to congressional hearings, a criminal investigation by federal prosecutors, dozens of lawsuits and an intense review by the Transportation Department.

Toyota has attributed the problem to sticking gas pedals and accelerators that can become jammed in floor mats, and has cited no evidence of an electrical problem. Toyota dealers have fixed 1.7 million vehicles under recall so far. Consumer groups have said electronics could be the culprit, and dozens of Toyota owners who had their cars fixed in the recall have complained of more problems with their vehicles surging forward unexpectedly

Toyota could face additional violations and further penalties, if more evidence is found in the ongoing investigations. Toyota must now decide whether it will contest the fine

Click on the following links to read more on the proposed Toyota penalty:

Secretary LaHood Announces DOT is Seeking Maximum Civil Penalty from Toyota - NHTSA 
U.S. Seeks $16 Million Penalty Over Toyota Recalls - NPR
U.S. seeks to hit Toyota with top fine for delays in disclosing problems - LA Times 

.

• Email This
• Print
• Comments
• Trackbacks

How can Toyota have actual knowledge of their cars sticky accelerators, give wrong information to the United States National Highway Traffic Safety Administration, and NOT face criminal penalty?

Presently there is a Federal Grand Jury proceeding in New York, which is investigating the “timeliness of Toyota’s reporting of its sudden-acceleration complaints and fixes.” I am betting that the United States Attorney will open an investigation soon for criminal penalties against the company.  Many innocent victims have died because Toyota hid the truth about safety issues.

Human lives are not to be counted on an actuarial chart and compared to the financial impact on a company before making a known defect public.  When you are producing a dangerous product and putting it in the stream of commerce, you must correct know defects; otherwise, you are acting with reckless abandon in harming human life.

The very definition of manslaughter is the unlawful killing of a human being without premeditation or intent through gross negligence.  The difference between this and actual murder is that murder requires actual malicious intent.  Former Toytota counsel Dimitrios Biller said that Toyota had systematically disregarded the law.  He said to CNN that the material he had reviewed was “very, very disturbing.”  Toyota continues to fight the litigation requests to review their most important documents.  They are also not permitting their old lawyer to say what he knows. 

Hopefully, the public will not feel bad for Toyota because tough minded trial attorneys want to hold Toyota accountable for their reckless conduct.

 

• Email This
• Print
• Comments
• Trackbacks

Toyota owners, there is a new problem facing yet another popular Toyota brand, the Toyota Corolla.  Driver complaints of  power steering related problems are causing Toyota to consider a recall of the very popular subcompact Toyota Corolla. 

This potential new recall may come in addition to the Toyota recall of approximately 8.5 million vehicles worldwide due to floor mat hazards, sticking gas pedals, and braking problems. Toyota has yet to disclose the vehicle model year(s) or regions that may be affected.

Reports show that the most recent Data from the National Highway Safety Administration (NHTSA), puts the alleged death toll due to Toyota vehicles at 34 deaths since 2000, with the numbers continuing to rise.

According to Toyota quality controls executive, Shinichi Sasaki, Corolla drivers may feel as if they were losing control of their ability to steer. Sasaki also mentioned that a link between the Corolla’s possible steering problems might involve the vehicle’s braking system or tires.

Word of this new issue comes on the heels of Toyota President Akio Toyoda’s statements regarding the forthcoming U.S. Congressional meeting. During a recent news conference, Mr. Toyoda stated that he does not plan to appear before the Congressional committee scheduled for February 24. Rather, he stated that he wanted to remain focused on improving the quality and image of his company on a global scale.

Toyota owners continue to address complaints to Federal safety officials about the potential problems. With approximately 100 reported complaints regarding the possible steering trouble, Toyota is poised to take yet another blow to its already tarnished image. When will this saga end?

In addition to decreases in the company’s image and stock value, news of this potential new recall, in conjunction with the other worldwide recalls, continues to draw legal woes for Toyota. According to the Financial Times, Toyota is facing a multitude of class action lawsuits in the United States that may cost the automaker billions of dollars. Experts estimate that more than 40 suits have been filed against Toyota under federal and state law. Claims reportedly involve wrongful death, personal injuries, property damage, and more.

Toyota is working to determine the source of the Corolla complaints and has not ruled out the possibility of issuing yet another recall.  Toyota sold roughly 1.3 million Corollas worldwide in 2009, making it the best-selling car in the world.

To read more on Toyota's latest woes regarding the looming Toyota Corolla stering probe and possible recall, click on the following links to New York Times, CNN,  Financial Times (Registration Required) and the WSJ Blog.

• Email This
• Print
• Comments
• Trackbacks

As though it could not get any worse for  Toyota Motor Corp., a new report shows that two former Toyota regulators helped ward off four U.S. investigations of unintended acceleration by Toyota vehicles. This was uncovered in recent court and government records. Who can we trust to make sure that safety standards are being followed for consumer products, especially automobiles?

Two people at the heart of this new revelation are: Christopher Tinto, vice president of regulatory affairs in Toyota's Washington office, and Christopher Santucci, who works for Tinto. Allegedly, these individuals encouraged the National Highway Traffic Safety Administration to discontinue looking into 2002-2003 Toyota Camrys and Solaras, court documents show. The most alarming revelation is that Tinto ans Santucci were former NHTSA employees before joining Toyota.

Unfortunately, criticism of NHTSA and Toyota is pretty high right now, for the handling of defects in Toyota and Lexus models tied to 19 deaths between 2004 and 2009. Three congressional committees have scheduled hearings on the recalls Feb. 24 and Feb. 25. The Senate Commerce Committee plans a hearing March 2.

Joan Claybrook, an auto safety advocate and former NHTSA administrator in the Jimmy Carter administration stated the following: "Toyota bamboozled NHTSA or NHTSA was bamboozled by itself. I think there is going to be a lot of heat on NHTSA over this."

Toyota, the once media darling, is facing one of the largest scandals in the history of the automaker.  Years of carefully building a stellar image are being diminished in one fell swoop, each day a new revelation is made in the fiasco over safety issues. The Toyota Motor Corp. stock closed today at 76.01, a continued downward spiral.

In an effort to promote safety, we encourage all Toyota owners to contact their local Toyota dealer to find out if their vehicle is a part of the recall.  It will not hurt to take your car in to the shop, just to make sure. Safety and precaution go hand in hand.  You can also contact Toyota directly to see if your car is on the list. However, taking your car to a local Toyota Dealer for a check-up to be sure, can only help improve your chances of being safe in your Toyota.

Click on the following link to read more on the Bloomberg article: Regulators Hired by Toyota Helped Halt Investigations

• Email This
• Print
• Comments
• Trackbacks

As though it could not get any worse for the world's largest automaker, Toyota Motor Corp., a new report shows that former Toyota regulators helped ward off four U.S. investigations of unintended acceleration by company vehicles. The surprising news is that this was uncovered in recent court and government records.

Two people at the heart of this revelaton are: Christopher Tinto, vice president of regulatory affairs in Toyota's Washington office, and Christopher Santucci, who works for Tinto. Allegedly, these individuals encouraged the National Highway Traffic Safety Administration to discontinue looking into 2002-2003 Toyota Camrys and Solaras, court documents show. The most alarming revelation is that Tinto ans Santucci were former NHTSA employees before joining Toyota.

• Email This
• Print
• Comments
• Trackbacks

Toyota Motor Sales U.S.A., Inc. (TMS), announced today, that the company has developed a safe solution to the risk of sudden, unwanted acceleration. The Japanese automaker indicated that its engineers created and thoroughly tested the solution: a small steel pedal reinforcement assembly designed to eliminate excess friction. Toyota reports that it has commenced shipping the parts to dealers, and expects the millions of affected vehicles to undergo repair as soon as possible.

According to Toyota, this sticking occurred (or can occur) because of excess friction resulting from normal vehicle operation. The company indicates that the pedal reinforcement assembly will eliminate the excess friction that caused the accelerators to stick in rare instances.

At the end of January, the company recalled over 4 million cars from eight vehicle models due to the risk of sudden acceleration caused by the accelerator sticking in a partially open position. In an unprecedented move, the Japanese automaker also halted production to resolve the problem safely and effectively. With Toyota’s announcement comes an apology from top brass, and a hope that the solution will begin to restore customers’ faith in the brand.

Toyota Motor Sales (USA) president and Chief Operating Officer, Jim Lentz, commented on the situation:

“Nothing is more important to us than the safety and reliability of the vehicles our customers drive. We deeply regret the concern that our recalls have caused for our customers and we are doing everything we can – as fast as we can – to make things right.  Stopping production is never an easy decision, but we are 100% confident it was the right decision. We know what’s causing the sticking accelerator pedals, and we know what we have to do to fix it. We also know it is most important to fix this problem in the cars on the road.

The Toyota saga continues with the National Public Radio report Toyota Apologizes, Releases Details On Plan To Fix Gas Pedals.  In a continuing story, NPR's  All Things Considered, co-host Melissa Block spoke with Toyota's Jim Lentz this afternoon on how a driver should handle the situation, of a gas pedal getting stuck.

Lentz is quoted in the interview as giving listeners the following advice:

The Driver should put both feet on the break, press hard, shift the transmission into neutral, and pull off the road.

Click on the following link to hear the All Things Considered interview with Toyota President Jim Lentz
 
Click on the following link to view more from Toyota on the accelerator pedal recall issue.

Click on the following link to see the Toyota PSA on the accelerator issue given by Jim Lentz..

The Toyota vehicles involved in the recent accelerator recall include:

• 2009-2010 RAV4 (Certain models)
• 2009-2010 Corolla (Certain models)
• 2009-2010 Matrix
• 2005-2010 Avalon
• 2007-2010 Camry (Certain models)
• 2010 Highlander (Certain models)
• 2007-2010 Tundra
• 2008-2010 Sequoia

As we mentioned in a previous LaBovickInjuryLawBlog article on the Toyota accelerator recall, owners  and drivers of the above mentioned Toyota models to contact their local Toyota dealer or to contact Toyota directly, if they are having issues. Safety measures and precautions should be taken to avoid any serious car accident.

• Email This
• Print
• Comments
• Trackbacks

Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration (FDA) announced a Class I recall of certain infusion set needles used in the treatment of chronically ill patients and others. Products included in the recall are the following all manufactured by the Japan-based Nipro Medical Corporation for Exelint International Corporation.

Exel/Exelint Huber needles

Exel/Exelint Huber Infusion Sets

Exel/Exelint “Suretouch+ [plus.”

The recall comes in response to inspections of Japanese Nipro facilities carried out in October 2009. These inspections found that the needles, used to access under skin ports designed for repeated access to veins, “cored” in approximately 60 to 72 percent of tests. According to the FDA, coring means that the silicone cores (or silvers) of the needles were cutting and dislodging the under skin ports when inserted, causing the ports to leak in certain cases.

In a news release about the recall, the FDA stated that:

“At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”

Needles involved in the recall were manufactured between January 2007 and August 2009. According to the FDA, this recall includes more than 2 million units in distribution nationwide.

The affected needles have lot numbers beginning with the following, along with a catalogue number of product code:

“07”

“08”

“09”

 For more information, please read the following articles on the Class I FDA recall for Needles

FDA’s New Release about Recall: FDA Announces Class I Recall of Certain Infusion Set Needles
 

CNN Health Article  on Recall: FDA recalls more than 2 million needles used in port implants

• Email This
• Print
• Comments
• Trackbacks

Honda Motor Corporation (Honda) issued a global recall of roughly 646,000 units of the models Fit/Jazz and City. The announcement came today and and includes 140,000 Honda Fit units in the United States.

According to Honda, the recall was to correct a faulty master power window switch, which could allow water to enter the switch and cause a fire. New York Times reports that three cases of fire due to the defective master switch were reported, including two in the U.S. and one in South Africa.

A statement released by Honda about the recall indicated that:

"Under some severe operating conditions, water, rain, or other liquid may enter the driver's window and reach the master power window switch, resulting in impaired function of the switch.” The statement went on to add that, "An overheating switch may cause smoke, melting or, potentially, fire."

Honda’s recall involves models sold around the world, including North America, South America, South Africa, and Asia. However, a Honda spokesperson indicated that the recall does not include Fit/Jazz and City units sold in Japan. Honda’s Fit is the company’s best-selling car in that country.

This latest recall by Honda comes just days after rival automaker Toyota halted sales and recalled millions of vehicles worldwide due to the threat of unintentional acceleration.

We strongly recommend all Honda Fit/Jazz or City vehicle owners to contact their dealer, or call Honda Automotive Customer Service at 1-800-999-1009.

For more information on the latest Honda recall, please click on one of the following links:

NY Times Article:  Honda Recalls Cars, Citing Defect

Wall Street Journal article: Honda Announces Worldwide Recall Of 646,000 Fit Cars

Honda South Africa’s Press Release about the recall:

• Email This
• Print
• Comments
• Trackbacks

Toyota Motor Sales, U.S.A., Inc. (Toyota) announced the temporary suspension of the sale of eight models, including the popular Corolla and Camry lines. The suspension comes after the Toyota recall on January 21 of 2.3 million cars due to the threat of unintentional acceleration. Toyota is instructing dealers to halt sales of certain vehicles in connection with the ongoing recall until a “remedy is finalized.”

Toyota anticipates stopping North American vehicle production lines for the week of February 1 to “assess and coordinate activities.” This production halt will affect Toyota manufacturing facilities in Kentucky, Indiana, Texas, and Canada.

The accelerator pedal recall and sales suspension affects eight models, including:
 

• 2009-2010 Corolla
• 2009-2010 Matrix
• Certain 2007-2010 Camry
• 2005-2010 Avalon
• 2009-2010 RAV4
• 2010 Highlander
• 2008-2010 Sequoia
• 2007-2010 Tundra

Bob Carter, Toyota Division General Manager and Group Vice President  stated the following:

"Helping ensure the safety of our customers and restoring confidence in Toyota are very important to our company. This action is necessary until a remedy is finalized. We’re making every effort to address this situation for our customers as quickly as possible.”

It is important to note that this recall is in addition to the carmaker’s ongoing recall of certain Toyota and Lexus vehicle lines due to the threat of pedal entrapment caused by “incorrect or out of place accessory floor mats.”

A Toyoya spokesperson reported that no confirmed deaths could be traced to the defect. However, Toyota’s stunning decision to halt sales and production are a clear indication of the serious nature of the situation.

For more information on the most recent Toyota recall click on the following links: Toyota, Washingtonpost,  CNNMoney.com and The New York Times.

We encourage Toyota vehicle owners with the affected models to contact their local Toyota Dealer or to contact Toyota directly at 800-331-4331.

• Email This
• Print
• Comments
• Trackbacks

Toyota Motor Sales, U.S.A., has recalled approximately 2.3 million vehicles to correct sticking accelerator pedals on specific Toyota Division models. This action is not related to the on-going recall of approximately 4.2 million Toyota and Lexus vehicles to reduce the risk of pedal entrapment by incorrect or out of place accessory floor mats. Approximately 1.7 million Toyota Division vehicles are subject to both separate recall actions.

• Email This
• Print
• Comments
• Trackbacks