FDA Alerts Blog

Update: More Persona Knee Recall Implant Information-Notice To Implanting Surgeons Issued

March 19th, 2015

We have recently learned more information on the Persona Knee Recall.  A Persona Knee Recall Notice was sent by Zimmer to medical facilities throughout the United States that implanted the Persona Knee Implant System, and specifically the Persona Trabecular Metal™ Tibial Plate (all sizes). Since the recall effects approximately 11,658 U.S. citizens, we wanted to alert you to this important information as quickly as possible.

To: Risk Managers and Surgeons

Subject: URGENT MEDICAL DEVICE RECALL

Affected Product: Persona Trabecular Metal™ Tibial Plate, all sizes (see Attachment 1 for a complete list)

Zimmer is initiating a voluntary recall of the Persona Trabecular Metal™ Tibial Plate as the current complaint rate (0.61%) for radiolucent lines and loosening is higher than Zimmer’s expectations and experience based on Zimmer’s similar devices. Affected product has been distributed from November 29, 2012 until January 23, 2015.

Out of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.

persona knee plate recall

 

Persona Trabecular Metal™ Tibial Plate, all sizes

Risks

Immediate health consequences (injuries or illness) that may result from use of or exposure to the device   issue. Most Probable Worst Case
None Implant does not have appropriate initial fixation causing patient pain
Long range health consequences (injuries or illness) that   may result from use of or exposure to the device issue. Most Probable Worst Case
None Implant never achieves appropriate   biological   fixation, leading to revision surgery

Your Responsibilities

1. Review the notification and ensure affected personnel are aware of the contents.

2. Assist your Zimmer sales representative with the quarantine of any affected product.

3. Your Zimmer sales representative will remove the recalled product from your facility.

Other Information

This voluntary recall will be reported to the U.S. Food and Drug Administration.

MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 Online:www.fda.gov/medwatch/report.htm

 Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

 Fax: 1-800-FDA-0178

Under 21 CFR Part 803, manufacturers are also required to report any serious injuries where a device has contributed to or may have contributed to the event. Please keep Zimmer informed of any adverse events associated with this device or any other Zimmer product. Adverse events may be reported to Zimmer at zimmer.per@zimmer.com.

 

ATTACHMENT   1  

 

Part   Number

 

 

Description  

42-5300-064-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size C, Left
42-5300-067-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size D, Left
42-5300-071-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size E, Left
42-5300-075-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size F, Left
42-5300-079-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size G, Left
42-5300-083-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size H, Left
42-5300-088-01 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size J, Left
42-5300-064-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size C, Right
42-5300-067-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size D, Right
42-5300-071-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size E, Right
42-5300-075-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size F, Right
42-5300-079-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size G, Right
42-5300-083-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size H, Right
42-5300-088-02 Persona   Two-Peg Trabecular Metal™ Tibia, TM Size J, Right

*Due to length and detail, some other information was omitted from the Notice to relevant medical providers by Zimmer.

Contact Us:

If you have questions about your Zimmer Persona knee implant, please call Childers, Schlueter & Smith, LLC to discuss your legal rights. Our Persona knee implant lawyers are standing by to answer all of your questions. All inquiries are kept completely confidential and all initial consults are free of charge. We can be reached at 1-800-641-0098

Tags: , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

FDA Recall: Zimmer Persona Knee-Trabecular Metal Tibial Plates

March 18th, 2015

On March 12, 2015 the Food & Drug Administration announced a Class 2 Recall of about 11,658 Zimmer Persona knee implant Tibial components parts because of premature loosening and radiolucent lines. These component parts are part of the Zimmer Persona Trabecular knee system. Distributed from 2012 through January 2015 due to the recall, the Persona knee was marketed as “The Personalized Knee System” by Zimmer Inc. Since its launch, the Persona has been linked to numerous failures and complications from patients all over the United States. This Class 2 Recall by the FDA relates to the following system components:

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.

persona knee lawsuit

According to the FDA: “An increase in complaints of loosening and radiolucent lines” was noted in the Persona knee system and has been investigated for device failures. As we have seen with many other devices, implant loosening can cause unbearable pain, discomfort and even lead to revision/repair surgeries.  tibial plate-persona

To date, we have received a number of inquiries from patients with the now recalled Zimmer Persona knee implant components and some have already had to have revision due to device failures. Investigations into this knee implant device are ongoing.

Persona Knee Xray

As further noted by the FDA:

Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately.

If you received the Zimmer Persona knee implant and have experienced complications with it, please call Childers, Schlueter & Smith, LLC to discuss your legal rights. Our Persona knee implant lawyers are standing by to answer all of your questions. All inquiries are kept completely confidential and all initial consults are free of charge.

Tags: , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Johnson & Johnson Still Unable to Expand Use of Xarelto

March 16th, 2015

The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal.

Xarelto is approved as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary xareltoembolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems.

Johnson & Johnson was hoping to expand the drug’s use to include patients who have had previous heart attacks or other complications due to acute coronary syndrome (ACS). An application by J & J for the expanded approval of Xarelto to reduce the risk of stent thrombosis, a rare condition in which a blood clot forms on a stent, was also rejected by the FDA.

Why Won’t the FDA Expand its Approval of Xarelto? 

Johnson & Johnson first tried to obtain expanded approval of Xarelto for use in patients with ACS in 2011, and last February’s rejections marked the third time the company’s application has been rejected for expanded use in ACS patients, and the second rejection for those with stent thrombosis.

xarelto 2In February 2014, an FDA advisory panel said that a large amount of data was missing from one of the company’s late stage trials in patients with ACS, making the information flawed and unreliable. In August 2014, Johnson & Johnson and Bayer AG announced plans to launch more clinical trials against three new diseases.

Johnson & Johnson isn’t the first company to try to replace warfarin, another anti-clotting drug – Britol-Myers Squibb Co., Pfizer Inc., and Boehringer Ingelheim GmbH all have similar medications currently in development. But while the new blood thinners are generally easier to take than warfarin, there have been numerous concerns voiced that dangerous bleeding episodes linked to the use of those drugs, including Xarelto, may be harder to control.

 

Get Help

If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.

Consultations are free and without obligation.

 

Tags: , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Declining Testosterone Levels Does Not Always Mean You Need Low-T Treatment

March 13th, 2015

Prescription medications for low testosterone levels, also known as “Low T” have been heavily advertised to U.S. men in recent years, and as a result, the sale of testosterone replacement treatments have risen substantially during the last 10 years.

What is Testosterone?

Testosterone is a hormone that helps build a man’s muscles, deepens his voice, boosts the size of his penis and testes, puts hair on his chest, and is the force behind his sex drive. As a man ages, testosterone helps keep his muscles and bones strong and maintains his interest in sex, but after age 30, most men begin to experience a slight and gradual decline in testosterone. The bottom of a man’s normal total testosterone range is about 300 nanograms per deciliter (ng/dL), while the upper limits are 1,000 to 1,200 mg/dL.

Although it is natural for testosterone levels to decline as men age, a 2014 study published in the Journal of Clinical Endocrinology & Metabolism suggested that many American men with normal testosterone levels were being prescribed testosterone treatments, sometimes after only a single test. Variations in testosterone levels can be triggered by many different factors, including:

  • Weight gain
  • Illness
  • Time of day
  • Quality of sleep
  • Diet

Men are being bombarded with media campaigns advertising low testosterone treatments, and as a result, testosterone treatment sales generated about $324 million in 2002, but by 2012, nearly $2 billion in annual sales were reported.

Treatments for low testosterone levels are commonly provided through a gel, cream, injection, pill, or pellet through a variety of Low-T products including:

  • AndroGel
  • AndroDerm
  • Axiron
  • Bio-T Gel
  • Delatestryl
  • Depo-Testosterone
  • Foresta
  • Testim
  • Testopel
  • Striant

Although low testosterone medications are meant to improve a man’s quality of life, recent research has found that the side effects of testosterone therapy may actually increase the risk of serious and potentially life-threatening health conditions in some men, including heart attack, stroke, pulmonary embolism, deep vein thrombosis (DVT), blood clots, and even death.

Seek Legal Help

If you or a loved one has suffered cardiac complications as a result of taking testosterone therapy, consult with one of our Georgia testosterone supplement attorneys at Childers, Schlueter & Smith to explore your legal rights. Our attorneys are committed to holding these drug manufacturers accountable and fighting for compensation for your injuries. We have a solid record of achieving success for victims like you.

Contact us today for a free consultation. There is no obligation.

Tags: , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Johnson & Johnson on the Losing Side of First Risperdal Trial-$2.5 Million to Plaintiff

March 11th, 2015

On February 25, 2015, a Philadelphia jury ordered drugmaker Johnson & Johnson to pay $2.5 million to a 20-year-old autistic man from Alabama who had developed 46 DD breasts as a young teenager – a condition known as gynecomastia.

In 2013, the company paid $2.2 billion to settle federal and state charges related to illegal marketing of Risperdal, but individual lawsuits continue to be brought in various states, including Pennsylvania, California, and Missouri.

What is Risperdal?Risperdal 1

Risperdal is an anti-psychotic drug first approved by the U.S. Food and Drug Administration in 1993 to treat adults with schizophrenia. It was not until late 2006 that it was approved for any use in adolescents and children. In 2006 and 2007, the FDA approved additional uses for Risperdal, including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children, and certain behavioral symptoms in children with autism.

Risperdal and Dopamine

Risperdal works as an antipsychotic to block the activity of dopamine in certain areas of the brain; however, blocking dopamine also has an effect on the pituitary gland, causing a number of metabolic disruptions and results in the release of a hormone known as prolactin.  Increased prolactin levels in young males has had unfortunate permanent effects.

Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women, and for causing gynecomastia in adolescent males and in children as young as four. Gynecomastia can occur in one or both breasts and will not usually go away, even if the drug is discontinued. In mild cases, liposuction may be used to remove the tissue, but in more extensive cases, breast reduction surgery or a mastectomy may be indicated.

Despite initial rejection for use in pediatric patients, Janssen and Johnson & Johnson allegedly have illegally marketed the medication for use in children and for unapproved uses such as ADHD, pharmaceutical restraint, and dementia in elderly people. Though drug companies cannot officially promote drugs for unapproved uses, doctors are free to prescribe them as they see fit.

Contact Us

The defective drug attorneys at Childers, Schlueter & Smith are currently reviewing Risperdal cases in which a patient has been diagnosed with gynecomastia. If you have questions or concerns, contact one of our Risperdal lawyers today for a free evaluation. All inquires are completely confidential.

Tags: , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

DePuy ASR Hip Implant Settlement Update-Round 2 Settlements Announced

February 27th, 2015

On Friday, February 20, 2015, DePuy/ Johnson & Johnson agreed to pay approximately $420 million more to resolve approximately 1400 additional DePuy ASR lawsuits. The order came from the Court extending the settlement offer to Plaintiffs who had revision surgery after August 31, 2013 up through January 31, 2015.  hip

From the beginning of this litigation, almost five years ago, our goal at Childers, Schlueter & Smith has been to prosecute cases aggressively until DePuy accepted responsibility for its actions and offered to settle viable cases, or until viable cases were tried before a jury.  While we are pleased that DePuy has proposed a second round of settlements now for certain plaintiffs.

There are a number of very important issues we want all ASR patients to be aware of given this recent proposal:

1)      This is not a blanket, one-size-fits-all settlement proposal. DePuy’s proposal set outs specific terms which determine the individual settlement amounts for each person’s case (see below). As we have always maintained, all ASR cases are different.  Because of the differences in each case, the proposed settlement amounts for all claimants will be different.

2)      The settlement proposal is just that – a proposal – which you are not required to accept.  Individual claimants in any case can accept or reject any settlement offer.  At CSS, we evaluate each case and determine, as precisely as possible, the amount of compensation you would likely receive under the proposed settlement and whether it makes sense to continue under the program. For most it does, for a few select others it may not.

DePuy ASRWhat are the terms of the settlement?

DePuy is offering the proposed settlement to citizens and residents of the United State who: 1) had an ASR hip implanted in the U.S.: and 2) whose ASR hip was revised between August 31, 2013 and January 31, 2015. DePuy is only making the settlement proposal to patients who received an ASR hip. The proposal does not cover any other hip implant device manufactured by DePuy.

DePuy’s settlement proposal lists a number of factors which will determine the value of a settlement offer, such as whether you suffered a loss of income, whether you required another surgery after the revision of the ASR hip, your age, smoking history, and/or obesity.  As noted above, we are in the process of determining how these factors apply to our client’s cases right now and can do the same on new cases if you act fast.

Payment of Liens

If you choose to accept DePuy’s proposed settlement, they have also agreed to pay any liens that may be asserted by your medical providers or health insurance companies.  Liens are monies owed to repay your insurance company for the funds they paid relating to your ASR hip implant, or monies still owed to your medical providers for services they provided that relate to your ASR hip implant.  Ordinarily, such liens would be paid by you out of the settlement proceeds you receive.  In light of the fact that you have had revision surgery, the liens associated with your case could be significant.  We believe DePuy’s agreement to pay your liens is a benefit to anyone who chooses to accept DePuy’s proposed settlement.

Broadspire benefits

The Broadspire benefits that have been provided so far have been of great benefit to most of our ASR clients that are uninsured.  These benefits have been limited. In anticipation of the program potentially stopping, we urge you to provide us with documentation of all out of pocket expenses and lost wages that you have not already provided us, so we can submit them to Broadspire for processing if they were incurred prior to January 31, 2015.

What is the timeframe to decide to accept or reject DePuy’s proposed settlement?

To be eligible, you must register your case with DePuy by the stated deadline. Following that registration period, there will be a final enrollment date for all eligible claims where all the applicable medical records and settlement materials have to be properly submitted. We are currently waiting on the announcement of the enrollment deadline date. Once we have that date and the documents are made available, we will prepare settlement packets for our clients review and signature. We also have the capacity to do this on any new claims submitted to our office in the very near future.

DePuy’s walk away option

DePuy will have a walk away option. The percentage of enrollment is still to be announced. If enrollment is less than the target percentage, DePuy can choose to walk away and not pay you any settlement at this time.  DePuy can also choose, however, to continue with the settlement if less than the target percentage of people accept it, but they do not have to do so.  If less than target percentage of the eligible people agrees to the proposed settlement, DePuy must decide whether to continue with or withdraw the proposal by a date that will be published shortly.

Our next steps

As noted above, the law firm of Childers, Schlueter & Smith continues to investigate and take on new DePuy ASR clients that need assistance with their potential claims. We are evaluating all cases under the terms of the proposed settlement, and we will take all steps needed to ensure your rights are protected. As time is limited, you must act now if you want to put our firm’s experience to work for you. As always, if you have any questions, please can contact our office for more information on the Round 2 DePuy ASR Hip Implant Settlement. All calls are confidential and all initial consultations are free of charge.

Tags: , , , , , , , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

MDL Consolidates Xarelto Lawsuits Filed in Federal Court

February 20th, 2015

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary currently face nearly 90 product liability lawsuits over their new-generation coagulant, Xarelto. Late in 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) announced that all nationwide Xarelto lawsuits filed in federal courts would be consolidated in the Eastern District of Louisiana before U.S. District Judge Eldon E. Fallon. Experts estimate that eventually several thousand cases will be transferred into the MDL.xarelto

An MDL typically streamlines the litigation process, helps avoid repetitive discovery and conflicting pre-trial motions, and allow bellwether trials to be set to determine the strength of the plaintiffs’ claims.

What is Xarelto?

Xarelto was developed by Bayer and Janssen Pharmaceuticals in 2011 as a new generation anticoagulant meant to be a superior alternative to Coumadin (warfarin) in terms of better prevention of strokes and non-central nervous system embolism and the absence of a requirement for regular blood monitoring, making use more convenient.

Although all blood thinners, including Xarelto and Coumadin, have side effects and increase the risk of bleeding problems, Xarelto has been associated with a high number of adverse reports involving injuries associated with uncontrollable bleeding. While the effects of warfarin can be quickly reversed in case of an emergency through the use of vitamin K and blood transfusions, there is no approved antidote available for those using Xarelto, and side effects from the drug have resulted in catastrophic outcomes when doctors were unable to control the bleeding.

Xarelto Lawsuits

All the Xarelto lawsuits make basically the same allegations: drug manufacturers failed to warn consumers and medical professionals about the potentially dangerous side effects of Xarelto, which include uncontrollable bleeding, the need for blood transfusions, and death in severe cases. According to court documents, severe injuries and deaths could have been avoided had the pharmaceutical companies not provided misleading information about the blood monitoring, and if stronger warnings had been issued concerning the lack of a reversal agent or antidote.

Get Help

If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.

Consultations are free and without obligation.

 

Tags: , , ,
Posted in FDA Alerts Blog, News & Results, News Blog | No Comments »

Chantix Lawsuits Settled for $300 Million

December 9th, 2014

All of the nearly 2,900 lawsuits against the smoking cessation drug Chantix have been settled for approximately $300 million, and a federal judge in Alabama ruled earlier this month that the nationwide litigation should be dismissed.

More than 10 million smokers in the U.S. have been prescribed Chantix to help them stop smoking. The drug is highly effective as an aid to smoking cessation, but it has been blamed for triggering suicidal thoughts, behavioral changes, hostility, agitation, depression, and other psychological problems in patients.

In September, the U.S. Food and Drug Administration updated the warnings and precautions section on Chantix to include information from some new studies that have found that the drug’s psychological effects may not be as bad as originally thought, but an FDA advisory panel voted overwhelmingly on October 16 to retain the most serious warnings. Pfizer Inc., the manufacturer of Chantix, had been seeking to have the Black Box warning removed, but only one advisory panel member voted in favor of removal, while 11 voted to maintain the warning, and six voted to strengthen the labeling to include references to sleep disturbances.

The panel also recommended that any further changes to the Black Box warnings should not be considered until after Pfizer completes a post-marketing study anticipated in the third quarter of 2015. Had the Black Box warning been removed, it would have been difficult to have it reinstated later, even if the post-marketing study showed negative findings, what some experts consider to be a motivating factor in the company’s urging to have the warnings removed.

Soon after Chantix was approved for use in 2006, the drug has been associated with reports of suicide and violence. Sales fell to $648 million in 2013 from $846 million in 2008, and Pfizer has spent hundreds of millions of dollars to settle the lawsuits.

Tags: , , , , ,
Posted in FDA Alerts Blog, News & Results, Uncategorized | No Comments »

Complications Linked to DePuy Pinnacle Hip Replacement System

December 4th, 2014

If you have experienced problems or complications after receiving a hip replacement utilizing the DePuy Pinnacle metal-on-metal hip implant system, legal recourse may be available to you.

hipThe DePuy Pinnacle is similar in many respects to the recalled DePuy ASR hip system, which was taken off the market in August 2010 because of a higher than anticipated failure rate, which is likely related to the design of the artificial hip.

The Pinnacle system was designed to accommodate younger hip replacement patients by providing more flexibility and range of motion than existing hip replacement products, but the metal-on-metal feature of the system, which was created to help lower failure rates, instead has resulted in more serious problems. 

 

 

Problems with the DePuy Pinnacle System

Some individuals who have received DePuy Hip Replacement systems are reporting debilitating symptoms such as:

  • Unexplained hip pain
  • Problems standing or walking
  • Reduced or lost mobility
  • Dislocation of the hip implant
  • Infection
  • Early hip replacement failure
  • Need for additional hip revision surgery

The metal-on-metal components of the DePuy Pinnacle system has been found to result in metallosis, biologic toxicity and a high failure rate due to microscopic metal particles that are shed when the parts rub against one another. Placement of the system is extremely difficult, even for the most talented surgeons, and without perfect placement, problem results may be intensified.

FDA approval for the DePuy Pinnacle artificial hip system was given to Johnson & Johnson and their DePuy Orthopaedics subsidiary in 2000 under the 510(k) approval process, which does not require rigorous premarket approval testing. Instead, the system was approved as a substantial equivalent to older hip replacement devices.

Doctors who are tracking groups of patients who received the Pinnacle estimate that more than 10 percent of the devices will likely fail in the next two or three years, according to sources.

Contact Us

If you or a loved one received a hip implant and have experienced complications or had to undergo revision surgery as a result, contact our metal-on-metal hip implant lawyers today for a free case evaluation and learn about your legal options. There is no obligation. Our attorneys will work closely with you to seek justice and fight for compensation for your injuries.

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
Posted in FDA Alerts Blog, News & Results, Uncategorized | No Comments »

Takata Air Bag Recall-Should It Have Been Done In 2004?

December 3rd, 2014

Former Takata employees have charged that the Japanese airbag manufacturer conducted secret tests in 2004 on 50 airbags retrieved from scrapyards, saying that tests were performed after work hours, on weekends, and holidays during the summer of 2004 at the company’s American headquarters in Auburn Hills, Michigan. Takata denies the allegations.

According to the employees who came forward on the condition of anonymity, when the tests exposed defects in the steel inflators of two of the airbags, instead of alerting federal safety regulators to the potential danger, company executives discounted the results and ordered technicians to delete the testing data from computers and dispose of the faulty airbag inflaters in the trash.

The secret tests, not previously disclosed, were conducted four years before Takata admitted in regulatory filings that it had conducted tests on the problematic airbags. Later tests led to the first airbag recall four years later, in 2008. Takata blames manufacturing problems and exposure to moisture by cars in humid regions for the defect, which caused the propellant to degrade and burn too strongly when the airbag deployed, rupturing the inflater.

Currently, eleven automakers have recalled more than 14 million vehicles worldwide because of Takata airbag rupture risks. So far there have been four deaths and more than 30 injuries linked to the defect, which causes the airbag’s steel canister to crack and explode into pieces when deployed in a crash, spewing metal debris into the vehicle’s interior, severely injuring drivers and passengers. But complaints have been received by regulators blaming Takata airbags for a minimum of 139 injuries, including 37 individuals who said that the airbags ruptured or spewed out metal fragments or chemicals.

Takata is one of the world’s largest suppliers of airbags, with a global market share of about 20 percent. Although Takata has said the problems with the airbags were corrected in the early 2000s, the National Highway Traffic Safety Administration has reopened an earlier investigation into four deaths in Hondas related to Takata airbags since 2008, and the company is also the subject of a U.S. criminal investigation over the defective airbags.

For more information on the expanded air bag recall click here.

Tags: , , , , ,
Posted in FDA Alerts Blog, News & Results | No Comments »

Call us toll-free at (800) 641-0098