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US FDA issues Class I recall of St. Jude Medical, Inc.’s Riata ICD Lead

Houston medical device injury attorneys: U.S. FDA Class I recalls represent the most serious type of medical device recall. Class I recalls cover those defective medical devices that could lead to serious injury or death.

This Class I recall applies to the Riata and Riata ST Silicone Endocardial Defibrillation Leads manufactured by St. Jude Medical, Inc. The recall stems from premature insulation failure in the recalled implant able cardioverter defibrillator (ICD) leads. The insulation can erode prematurely around the electrical conductor wires.

Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICDs should detect life-threatening heart rhythms and deliver an electrical shock from the ICD to the heart through the ICD lead. ICD leads have layers of insulation to protect the electrical conductor wires inside the lead from corrosion and damage.

Our Houston medical device injury attorneys emphasize that this insulation failure defect can lead to ICD lead malfunctions. The ICD lead malfunctions might cause abnormal sensing or pacing, delivery of inappropriate shock therapy, or NO delivery of needed shock therapy. These insulation failure-related malfunctions could lead to serious adverse health consequences including death. The FDA estimates that almost 80,000 of the defective Riata ICD leads remain implanted within U.S. patients.

The average ICD lead should last about 10 years without erosion or insulation failure. But in the case of the recalled leads, the FDA has received numerous reports of premature failures as early as 4 years after implantation. The Riata ICD lead insulation failure may cause some of the electrical conductors inside the leads to migrate within or externalize outside of the outer lead insulation. These changes might sometimes be detectable on X-ray or fluoroscopic imaging. But imaging detection can sometimes be challenging.

Riata and Riata ST leads that show insulation abnormalities on imaging tests could be at greater risk of future electrical failure and harm to the patient. The FDA suggests that doctors closely monitor patients that have the recalled Riata or Riata ST leads implanted inside them. Patients should receive a recent evaluation and device interrogation to assess for any electrical abnormalities.

The FDA also recommends that doctors consider remote monitoring for patients with a recalled lead to better detect electrical abnormalities. The doctors could also consider performing fluoroscopy of the ICD lead when the generator is replaced in order to check on the condition of the ICD lead.

St. Jude Medical recommends reprogramming the recalled medical devices to increase the chances of detecting a dangerous abnormality in the Riata and Riata ST ICD leads. Our Houston medical device injury attorneys also note that the patient alert and remote monitoring alerts should also be turned on.

The U.S. FDA does NOT recommend replacement of the leads except in cases where the leads show abnormal electrical function and evidence of insulation failure in imaging tests. Removal of the leads is not recommended except where the benefits outweigh the patient risks due to the dangerous risks of explantation surgery on the ICD leads.

The FDA recommends that patients contact their cardiac physicians to find out if they have the recalled leads and to request additional information regarding care and monitoring. If you’ve received an injury from a defective medical device and you need legal advice regarding what to do to obtain fair compensation for the needless harm you’ve suffered, contact our experienced Houston medical device injury attorneys for a free and confidential legal consultation. You could reach us toll free or through our convenient online contact features. Our goal is to help you win the full financial recovery you deserve.

U.S. data on the incidence of jack failure injury accidents nationwide

Alarmed by a recent fatal jack collapse incident in our city, our Houston jack failure accident lawyers decided to take a look at data from across the country. The National Center for Statistics and Analysis, part of the U.S. NHTSA, complied detailed data on jack failure accidents in a special Research Note.

The NHTSA Research Note, put together using data from the U.S. CPSC’s National Electronic Injury Surveillance System (NEISS) examined data from 102 incidents of jack collapse injury across the nation.

The sample data was obtained from a specific group of hospitals. Our Houston jack failure accident lawyers point out that based upon the pattern of incidents, NEISS estimated that 4,822 people in the U.S. receive hospital emergency treatment in a single year for jack failure injuries. That’s almost 5,000 people injured by the simple act of jacking up a vehicle for repair.

The NEISS data looked at motor vehicle jack failure accidents according to:

  • The action or situation that produced the accident;
  • The portion of the body most severely injured by the jack collapse;
  • The injury diagnosis and severity; and
  • The age and gender of the person injured in the jack failure incident.

First our Houston jack failure accident lawyers note that not one injured person from the sample of 102 cases was female. So extrapolating the sample, the NHTSA determined that the estimated 4,822 people injured across the U.S. annually were 100% male. But the agency also says that the limited size of the sample means that one can’t conclusively say that women never receive injuries from jack failure.

Additionally, 82% of those injured in jack collapses were between 15 and 45 years of age. Only 2% were below the age of 15. And the proportion of injured victims above 45 years of age declined significantly by the age of 54.

Of those injured in jack collapse accidents, the NEISS data indicated that 96% were treated in the emergency rooms and released. Only 4% were hospitalized. The data did not examine fatal jack failure incidents.

The range of injuries reported fell into the following categories:

  • 5% = amputations
  • 10% = strains or sprains
  • 15% = fractures
  • 18% = lacerations
  • 40% = contusions
  • 13% = other (dental injuries, avulsions, and internal organ injuries)

39% of the most severe injuries were to the hand, finger, or wrist. Another 17% of the most severe wounds were sustained on the upper trunk of the body, with another 15% to the head, neck, or face.

40% of the jack failures occurred when the jack was being used to lift the vehicle for a repair, and another 19% occurred while the victim was changing a tire. 74% of the accidents were tied to the jack or the vehicle slipping or falling, while 18% were linked to a loss of pressure in the jack so that the jack could no longer support the vehicle.

The NEISS data reveals that sudden collapse of a defective jack can lead to all kinds of injury, from amputations and disfigurement, to crushing of internal organs. As the tragic story out of Houston of a teen’s death under a Chevy that fell from a jack demonstrates, jack failure might even lead to fatal injury.

Our experienced Houston jack failure accident lawyers could help if you or a loved one have been injured in a jack collapse and you don’t know where to turn. We have been successfully handling complex product defect and injury cases on behalf of injured clients for almost 15 years.

Our Houston jack failure accident lawyers know the law, and understand the technical evidence required to prove your claim. Let us help you win the full financial recovery you deserve for your needless injury. Call us today, toll free, at 877-307-9500 or use our convenient online contact features to schedule your free in initial case evaluation consultation with us.

5-year-old killed in tire blowout rollover SUV crash on Eastex Freeway

The Houston rollover crash lawyers at Denena & Points have written several articles over the summer regarding the deadly dangers of tire failure from inherent defects, wear, age, heat and sun damage, and improper inflation. Crash statistics show that tire blowouts are particularly likely to lead to loss of vehicle control and rollover crashes. And SUVs, with their high centers of gravity on relatively narrow wheelbases, are especially prone to rollover crashes, even in these days of ESC (electronic stability control).

Sadly on Monday a Chevy Suburban SUV provided a fatal demonstration of the deadly danger of rollover crashes from tire blowouts. Young Trace Williams was in the rear of the SUV when it suffered a blowout in the 10100 block of U.S. 59 near Parker.

The Chevy Suburban left its intended trajectory and swerved to the left following the blowout. It then struck a center highway divider, rode up the barrier, and struck a light pole. The SUV then rolled and slid about 100 more feet down the Eastex Freeway. The 5-year-old in the back of the Suburban dies at the scene, and 4 other occupants of the SUV received transport to the hospital with serious injuries. (Source: khou.com, 7/31/2012)

Our Houston rollover crash lawyers reiterate the critical importance of taking the time to check the inflation, wear, and condition of your tires on a regular basis. Especially in the brutal heat and sun of a lengthy Texas summer, your tires could age unnaturally quickly. Tire rubber and polymers could dry, crash, and degrade. And the bonds between the treads and the steel belts could weaken and separate.

Don’t become the victim of a needless rollover crash caused by tire failure. Check your tires’ condition and replace them if necessary. Learn more about what to check for and how to avoid tire failure in this article by our concerned Houston rollover crash lawyers.

Mazda Tribute recalled-same sticking accelerator defect as Ford Escape

Galveston auto defect injury lawyers remark that Mazda and the NHTSA have announced the recall of 2001 through 2006 and 2008 Tributes equipped with V6 3-liter engines and cruise control. The Mazda Tribute defect results from inadequate clearance space between the cruise control (speed control) cable connector and the engine cover.

When the accelerator pedal is fully or nearly fully depressed, this lack of clearance could cause the cruise control cable to get stuck under the engine cover, which means that your throttle would be stuck at high speed and you wouldn’t be able to slow down or stop. This dangerous risk exists whether or not you use your cruise control feature.

Our Galveston auto defect injury lawyers caution that if your throttle gets stuck in the open position because of the Mazda Tribute defect while you are traveling at high speed, you could experience a very serious or fatal crash. You might remember from our earlier recall warnings regarding the Ford Escape, that Ford warned owners of the affected vehicles to stop driving them immediately due to the high risk of injury from the sticking accelerator defect. And Ford built the Tribute for Mazda according to the same design specifications it used for the Escape. (That’s why the Ford Escape and the Mazda Tribute share this same dangerous defect.)

Mazda has said it will repair the defect free of charge by increasing engine cover clearance space as soon as parts are available. Until then, Mazda dealers will disconnect the cruise control cable to prevent it from getting stuck. Mazda Customer Assistance can be reached at 800-222-5500, option 6.

Our Galveston auto defect injury lawyers note that unlike Ford, Mazda has apparently not warned owners to stop driving their vehicles immediately, nor has it said it will pick up the Tribute from where you stop driving it to take it to the dealer for repair. The tragic death of a teenager that was directly linked to the sticking accelerator defect was in a Ford Escape, not a Ford Tribute.

But the Mazda Tribute defect s the same one as that which led to the teen girl’s death. So if you own one of the Tributes affected by the recall, you should have the dealer disconnect the speed control cable immediately and get the free repair of the engine cover made as soon as parts are available. Lives could depend upon quick action on this matter. Learn more about the Ford Escape defect and the crashes tied to it in this article by our Galveston auto defect injury lawyers.

Tire tread separation likely caused deadly Texas crash that killed 15

Our Houston injury attorneys have written multiple times on the dangers posed by sudden tire failure. We’ve described how a sudden tire tread separation or blowout while you’re on the highway can cause a deadly crash. And just recently we mentioned the additional toll that the scorching Texas heat and sun takes on your tires, aging and weakening them before their time.

News reports have been filled over the last few days with accounts of the mounting toll in lives taken by a single vehicle pickup truck crash on U.S. Highway 59 between Goliad and Beeville, TX. The pickup truck was jam packed with 23 illegal immigrants when it ran off the road on Sunday and crashed into a tree, apparently at high speed.

So far 15 of the people in that pickup truck have died, and 8 of them remain hospitalized. As overloaded as the truck was, a lot of the injuries and fatalities might have resulted when victims were forcibly ejected from the truck on impact. Investigators say the victims of the deadly Texas crash were from Mexico, Guatemala, and Honduras. The driver of the pickup truck, 22-year-old Ricardo Mendoza-Pineda, was among those killed in the crash near Goliad.

Officials are now saying that a front tire that came apart likely contributed to the crash. As yet, they have not mentioned the brand of the tire or whether the tread separation resulted from tire age and wear or from a manufacturing defect. Our Houston injury attorneys point out that either factor might cause a deadly tire tread separation crash. And things like heat, overloading a vehicle, over inflation of the tire, or under inflation can also precipitate a tire’s blowout and tread separation.

This particular sudden tire failure accident proved unusually deadly because the pickup truck was packed with so many people. This deadly Texas crash on U.S. Highway 59 near Goliad, TX provides a particularly saddening example of what can happen when a tire fails because of a hidden defect, age, or wear.

Tire failure accidents are notorious for causing rollovers and deadly vehicle ejections. The Ford Explorer-Firestone Tire combination that brought the issue of tire failure into the news some years ago was linked to hundreds of fatalities from deadly rollover crashes. We remind you that around 75% of victims ejected from a vehicle in a crash suffer fatal injuries.

Our Houston injury attorneys remind you to check your tires for age or wear on a regular basis. Make sure that the tires are properly inflated. And pay attention to the tire recall announcements that come out on a regular basis. You can sign up to receive notification of these recall notices on the NHTSA website. You, your passengers’ safety, and even your very lives could depend upon your care and attention to your tires.

Learn more about the dangers from sudden tire failure-related accidents and what you could do in the event of a serious crash in this article from our Houston injury attorneys.

Toyota wants you to blame unintended acceleration (UA) on the floor mats

Houston Toyota defect lawyers caution: Beware the dangerous floor mats. That appears to be Toyota’s message after issuing yet another recall on floor mats for about 154,000 2010 Lexus RX350 and RX450 models. Meanwhile, the company has done nothing to address the dangerous problem of unintended acceleration that has plagued its vehicles, including Lexus models, since the company introduced electronic throttle control systems in 2002.

Complaints about the problem of unintended acceleration (UA) events in Lexus and Toyotamodels have been coming in regularly since electronic throttle control was introduced. But various investigations into the complaints have failed to produce any significant results.

Toyota continues to blame the problem on floor mats and sticky accelerator pedals even though victims of the UA events have vehemently denied that either issue factored into their incidents. And mechanical investigations of vehicles involved in various UA incidents failed to turn up evidence of stuck pedals or floor mats.

But go ahead: fear the floor mat and ignore the real problem. Some feel that the problem may lie in a defect in the electronic throttle control systems used by Toyota. But the NHTSA stands squarely behind the Toyota assertion that the problem must be floor mats and sticky pedals. Our Houston Toyota defect lawyers are frankly a little disturbed by the NHTSA’s apparent willingness to abandon its position as watchdog of vehicle safety to echo an automaker’s denial.

Victim reports regarding the frightening UA events consistently state that the brake failure warning light came on in the dashboard once the UA took hold and that the brakes did indeed fail and would not respond. Quick-thinking drivers saved themselves from serious crashes by downshifting their vehicles into neutral, whereupon the vehicles finally slowed to stops.

You don’t have to be a certified Toyota mechanic to realize that a sticky accelerator pedal or a floor mat entrapping a pedal would not trigger a brake failure warning light. Indeed, our Houston Toyota defect lawyers point out that such events would not be able to trigger such a warning.

Rather, there must be some defect in the vehicles’ electronic control systems that link the UA event to disengagement of the brakes. You should know that electronic control systems are designed to detect events indicating that a vehicle is leaving the road or losing control and to correct the situation quickly, faster than a human driver could respond. When such systems work properly, they can save vehicle occupants from crashes that would occur because human drivers can’t always detect and react to errors or equipment failures quickly enough to save themselves.

But in the case of these Toyotas malfunctioning with UA, human drivers are required to react quickly to loss of control apparently caused by the very electronic control systems designed to prevent such things. Safety Research & Strategies, Inc., which has researched the issue and described specific UA incidents suffered by vehicle owners, detection and resolution of the exact source of the UA/brake failure problem in the Toyota/Lexus electronic control systems is probably years away.

In the meantime, concerned Lexus and Toyota owners may replace their floor mats, drive carefully, and hope for the best. Read more about the investigations into Toyota’ s UA problem in this previous posting on the subject by our Houston Toyota defect lawyers.

Texans check your tires’ condition from the summer sun & heat

Texas tire blowout accident attorneys caution Texans to examine their tires’ condition this summer for safety. A fortuitous flat led this writer to discover that all 4 tires on my vehicle were in deplorable condition and in need of replacement. Specifically, the tire repair technician said they showed evidence of “dry rot.”

On the flat, nail-punctured tire he removed, the treads of the tire showed slight cracking and splitting, as well as that telltale dull gray of deformed and decaying rubber. Unlike after an earlier flat about two years ago, the tire rubber was no longer flexible or malleable. After removal, the tire remained in the ugly, deformed position it had taken on in the parking lot after the air left the tire.

Now these tires weren’t that old. They were only 5 years old. The tires were not recalled, nor were they among the least expensive types of tires.

You may recall from our Texas tire blowout accident attorneys’ earlier articles on tire safety that 6 years represents the manufacturers’ default position for tire replacement. And indeed I had an entry in my calendar for next year to buy new tires for my vehicle. The rubber industry often insists that tires will actually serve you well for many additional years past the recommended 6.

Not in the Texas summer heat and strong sunlight they won’t. Heat and sunlight are among your tires’ greatest enemies. In the absence of other wear and errant roofing nails, high temperatures and sunlight alone will degrade your tires. Sudden tread separations, blowouts, and catastrophic rollover accidents could follow.

My tires were ready to fail at any time. I consider myself lucky that a flat caused me to find out about my tires’ condition this year before I experienced tread separation or a catastrophic blowout. Waiting to replace the tires until after next summer clearly was not a good plan. Given our strong summer heat and sunlight conditions, our Texas tire blowout accident attorneys caution that Texans should be aware that they need to check their tires’ condition more frequently than those drivers living in states with cooler weather.

Another Chevy Cruze defect that could cause fire and injury dangers

Pearland engine defect lawyers remark that the U.S. NHTSA recently announced a recall related to a defect in the Chevy Cruze that could lead to a fire from leaking fuel in the event of a vehicle crash. That particular defect was the absence of necessary welds to help hold fuel tank brackets in place. So if the vehicle received sufficient jarring such as from an impact, the fuel tank could come loose and spill fuel. If the spilled fuel encountered an ignition source, as it just might during an unexpected wreck, that leaked fuel could ignite or explode.

The NHTSA has also announced another recall related to the Chevy Cruze. This recall affects more than 400,000 vehicles. The affected Chevy Cruze vehicles have manufacture dates from October 2, 2009 through May 31, 2012. That is almost three years of defective manufacture of that vehicle model.

This recall relates to the danger of spilled or dripping oil, such as you might experience after an oil change, collecting in the belly pan (engine shield). The engine shield sits near hot engine and exhaust system surfaces. The heat from those sources could cause the collected oil to ignite. The resulting fire could consume both the oil and the shielding, resulting in a dangerous engine compartment fire. A fire in your engine compartment could lead to injury and death among vehicle occupants.

General Motors Corporation has said that it will notify owners of affected vehicles. GM dealers will modify your Chevy Cruze engine shield so that fluid like spilled oil cannot contact the hot shielding. Dealers will also place protective tape on the electronic power steering wire harness. These repairs will be free of charge on affected vehicles. Concerned Chevy Cruze owners can reach GM through the Chevrolet Owners’ Center at 1-866-694-6546.

Note: Not all owners of affected Chevy Cruze vehicles will be currently registered with GM. If your vehicle has changed hands or if your contact information has changed since you bought the vehicle and you did not update it with GM, General Motors might not be able to reach you about the dangerous defect. You should check your Chevy Cruze’s manufacture date and contact the Chevy Owners’ Center with questions you might have. Your Pearland engine defect lawyers mention that your vehicle’s manufacture date can usually be obtained by contacting a deal with the VIN number, make, and model.

Learn more about the other dangerous defect affecting more than 50,000 Chevy Cruze vehicles in our Pearland engine defect lawyers’ news article.

Over 50,000 2012 Honda Civics Recalled for Dangerous Driveshaft Defect

Pearland auto defect lawyers pass along news of another vehicle recall announced recently by the NHTSA (National Highway Transportation Safety Administration). More than 50,000 2012 Honda Civics are affected by recall in the U.S. The recall relates to the driveshaft portion of the driveline in the vehicle’s powertrain.

 You probably know that the powertrain is the most important part of your vehicle – the part that makes it run. Much of your ability to control your vehicle depends upon reliable operation of your car’s driveshaft.

 In the affected Civics, the required process for seating the driver’s side driveshaft and setting the retaining clip was not completed during assembly. Therefore, this driveshaft could separate from the central powertrain. If this happens, the affected Honda Civic will experience a loss of drive power and crash.

 And if the parking brake has not been set when the gear selector is in “Park,” the car could roll away and injure you and other nearby pedestrians or bicyclists, and damage nearby property (until the vehicle strikes something that will stop its roll).

 Honda has said it will notify owners of affected vehicles of the dangerous driveshaft defect. And Honda dealers will inspect the driver’s side driveshaft and replace it with a new one, if necessary, free of charge. Concerned Honda Civic owners can reach Honda Customer Service at 1-800-999-1009.

 The injury and possible fatality dangers presented by a driveshaft that suddenly separates from the main powertrain are clear. Our Pearland auto defect lawyers remind you that over time, multiple fatal injuries have occurred when supposedly stopped or parked vehicles rolled forwards or backwards unexpectedly. Learn what to do if you experience serious injury because of a defective automobile by downloading our Pearland auto defect lawyers’ free book on the steps you could follow to make a successful car injury claim. It’s available at your convenience on this web page.

Certain 2012 buses of Blue Bird, major school bus maker, recalled

Houston bus accident lawyers mention a recent recall announced by the U.S. NHTSA. Therecall affects some buses from the 2012 model year that were manufactured by Blue Bird, one of the major manufacturers of school buses. You might remember the blue bird logo on school buses from your school years.

 The recalled buses were manufactured from May 20, 2011 through October 20, 2011. All the recalled buses were from Blue Bird’s “All American” and “Vision” lines. These recalled buses were equipped with SMI (Specialty Manufacturing Inc.) Prolo roof hatches intended for use as escape hatches in the event of emergency. But increased friction between the rear plate assemblies (numbered P/No. 009327) and the nylon rear pop-up supports (numbered P/No. 008956) could result in an opening force on these roof hatches that exceeds federal safety requirements.

 In other words, applying the force necessary to open the resisting hatch could result in a strong force upon hatch opening that could injure you. And, in the event of an emergency, our Houston bus injury lawyers caution that the extra friction, potentially causing injury to the bus occupants, could also hinder exit from the bus by the emergency hatchway.

 The defective hatchway does not conform to the federal motor vehicle standard (No. 217) governing bus emergency exits and window retention and release. If you have one of the recalled buses, your defective emergency exit hatchway could cause its own emergencies. Blue Bird has said that it will notify owners of the defective vehicles. And SMI will provide service kits along with repair instructions to dealers and owners free of charge.

 If your vehicle is subject to the recall, take advantage of the free repair. A bus with a useless or dangerous escape hatch could present dangers of injury or even fatality in the event of a serious bus emergency. If you’ve been injured in a bus accident or because of a defective vehicle part, please contact us at your convenience for a free legal consultation to discuss your accident and evaluate your options for making a full financial recovery for your needless injuries.

 For more than 12 years, our dedicated Houston bus accident lawyers have been helping the injured victims of serious accidents of all types to successfully obtain the monetary compensation they’re due from those whose carelessness caused their injuries. Call us toll free at 877-307-9500 or use our convenient online contact features to schedule your free consultation.