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Recall Coverage
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Mylan Recalls 81,000 EpiPens Outside U.S. After Reports of Failure
Mar 23, 2017 | Reuters
Generic drugmaker Mylan NV (MYL, +1.01%) has recalled about 81,000 EpiPen devices in countries outside the United States, following two reports of the life-saving allergy shot failing to work in emergencies. -
Mylan recalls thousands of EpiPens over defect
Mar 22, 2017 | CBS News
By Alain Sherter
Mylan Pharmaceuticals (MYL) is recalling thousands of EpiPen anti-allergy injectors in overseas markets over concerns that a defective part could cause them to malfunction. -
Some EpiPen Injectors Recalled, But Not In The U.S.
Mar 21, 2017 | Consumerist
By Ashlee Kieler
Four batches of EpiPen auto-injectors have been recalled by the manufacturer over concerns that the devices may fail to work when needed. However, Mylan — the company behind the emergency allergy treatment — tells Consumerist that the potentially defective injectors were not distributed in the U.S. -
New EpiPen Recall Includes the US and EpiPen Jr.
Apr 1, 2017 | Gizmodo
Last week, the drug company Mylan issued a recall in seven countries for the EpiPen. The initial recall of the emergency allergy product didn’t include the US, but Mylan issued a new recall last night which not only includes EpiPens sold in the US, but also involves the children’s version, known as EpiPen Jr. -
Some EpiPens recalled, FDA says
Mar 31, 2017 | CNN
By Ralph Ellis
Thirteen lots of Mylan's EpiPen and EpiPen Jr. are being voluntarily recalled by the manufacturer, the US Food and Drug Administration said Friday. -
Two deaths spark recall of St. Jude heart devices
Oct 11, 2016 | Reuters
By Jim Finkle and Ransdell Pierson
St. Jude Medical Inc STJ.N on Tuesday said it would recall some of its 400,000 implanted heart devices due to risk of premature battery depletion, a condition linked to two deaths in Europe. -
St. Jude Warns Defibrillator Patients About Battery Risks
Oct 11, 2016 | Bloomberg
By Michelle Cortez
St. Jude Medical (STJ) is warning patients that the batteries on thousands of its implantable defibrillators can quickly and unexpectedly deplete in rare cases, leaving them vulnerable should they need a shock from the device to restart their faltering hearts. -
FDA Warns About Heart Defibrillators After Two People Die
Oct 11, 2016 | NBC News
By Maggie Fox
Two people have died after the batteries in two implanted heart defibrillators made by St. Jude Medical failed early, and now the company has issued warnings about 400,000 of the devices. -
St. Jude Medical Warns of Battery Problems With Heart Products
Oct 12, 2016 | Wall Street Journal
By Joseph Walker and Austen Hufford
St. Jude Medical Inc. warned Tuesday that a battery malfunction could cause hundreds of thousands of its implanted heart defibrillators to quickly lose power and stop functioning. -
Lawyers for U.S. vehicle owners have sued Honda Motor Co (7267.T), Nissan Motor Co (7201.T), BMW AG (BMWG.DE), Ford Motor Co (F.N), Mazda Motor Corp (7261.T), Toyota Motor Corp (7203.T) and other automakers, alleging they knew about the defective Takata i
May 19, 2015 | New York Times
By Danielle Ivory and Hiroko Tabuchi
For more than a decade, the Japanese company Takata, one of the largest suppliers of airbags, denied that its products were defective even as motorists were killed by exploding airbags and automakers around the world recalled millions of cars equipped with its products. -
3 Takata Executives Face Criminal Charges Over Exploding Airbags
Jan 13, 2017 | New York Times
By Hiroko Tabuchi and Neal E. Boudette
United States prosecutors said on Friday that they had charged three executives at Takata, the Japanese auto parts maker, with fabricating test data to mask a fatal airbag defect, a striking turn in a case that set off the largest automotive recall in United States history. -
Takata plea, compensation deal clears path to potential sale
Feb 27, 2017 | Reuters
Japan’s Takata Corp 7312.T removed a major obstacle to its potential sale or restructuring, pleading guilty on Monday in a U.S. federal court to a felony charge as part of a $1 billion settlement that included compensation funds for automakers and victims of its faulty airbag inflators. -
7 questions about the Takata air bag recall
Jun 26, 2017 | Associated Press
Takata has filed for bankruptcy protection in Japan and the U.S., leaving consumers to wonder about the status of the recall of about 70 million defective air bag inflators in the U.S. and another 30 million worldwide.
Epipen
St. Jude Medical Batteries
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Mylan Recalls 81,000 EpiPens Outside U.S. After Reports of Failure
Mar 23, 2017 | Reuters
Generic drugmaker Mylan NV (MYL, +1.01%) has recalled about 81,000 EpiPen devices in countries outside the United States, following two reports of the life-saving allergy shot failing to work in emergencies.
In both situations, patients were able to obtain treatment through the use of an alternate EpiPen, Mylan said on Wednesday.
The recall affects devices distributed in Australia, New Zealand, Europe and Japan only, according to the company.
Mylan said it is working with the regulatory authorities, where appropriate, to inform them about the recall.
The U.S. drugmaker, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the United States.
Mylan has also been heavily criticized for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programs.
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Mylan recalls thousands of EpiPens over defect
Mar 22, 2017 | CBS News
By Alain Sherter
Mylan Pharmaceuticals (MYL) is recalling thousands of EpiPen anti-allergy injectors in overseas markets over concerns that a defective part could cause them to malfunction.
The drugmaker said Tuesday that its Australian subsidiary, AlphaPharm, has recalled four EpiPen batches, totaling 80,000 devices, after receiving two reports of the injectors failing to work properly. None of the injectors affected by the recall were distributed in the U.S., according to the company.
EpiPens are used to treat severe, and potentially lethal, allergic reactions.
“The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening,” Mylan said in a news release announcing the recall.
AlphaPharm said it was recalling the product, which was made by Meridian Medical Technologies in St. Louis, Missouri, as a precautionary measure.
Controversy over EpiPens erupted last year, as Mylan drew widespread condemnation for jacking up the price of the product more than 500 percent over seven years, from about $103 in 2009 to more than $608 in 2016. The issue prompted congressional hearings in which CEO Heather Bresch was grilled by lawmakers over the company’s pricing practices.
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Some EpiPen Injectors Recalled, But Not In The U.S.
Mar 21, 2017 | Consumerist
By Ashlee Kieler
Four batches of EpiPen auto-injectors have been recalled by the manufacturer over concerns that the devices may fail to work when needed. However, Mylan — the company behind the emergency allergy treatment — tells Consumerist that the potentially defective injectors were not distributed in the U.S.
Mylan’s Australian subsidiary AlphaPharm Pty. announced the recall yesterday, saying a manufacturing issue “may result in patients not receiving the required dose of adrenaline,” which can lead to the user’s symptoms getting worse, with potentially lethal results.
The company published this list of batch numbers and expiration dates for the four recalled batches:
This information can be found on the end of the carton containing EpiPen packs and printed on the label of each pen.
Mylan says it knows of two instances “world-wide” where the EpiPens from the recalled lot failed to activate. Since this implies that the recalled injectors were distributed internationally, we asked the company why it was not announcing the recall in the U.S.
“Mylan has issued a voluntary recall for one lot of EpiPen Auto-Injectors distributed in Australia, New Zealand, Europe, and Japan only,” said the company in an emailed response to Consumerist. “This lot was not distributed in the U.S.”
That said, it certainly can’t hurt to check your stash of EpiPens to make sure they aren’t somehow included in the recalled batches. We also have a number of readers outside of the U.S., so we’re posting this news as a service to any of them who may have some EpiPens waiting to (hopefully never) be used.
Pfizer’s Meridian Medicial subsidiary manufactured the EpiPens in the recalled lot. The company referred questions about the recall to Mylan.
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New EpiPen Recall Includes the US and EpiPen Jr.
Apr 1, 2017 | Gizmodo
Last week, the drug company Mylan issued a recall in seven countries for the EpiPen. The initial recall of the emergency allergy product didn’t include the US, but Mylan issued a new recall last night which not only includes EpiPens sold in the US, but also involves the children’s version, known as EpiPen Jr.
The EpiPens affected by the new recall were distributed between December 2015 and July 2016, but Mylan has not yet made clear precisely how many EpiPens are affected. Mylan’s new generic EpiPen is not part of the voluntary recall and has been deemed a suitable replacement for the potentially defective product.
Last week’s recall of EpiPens in countries like Norway, Denmark, Japan, and Australia was a direct response to complaints from two consumers whose EpiPens failed to work during their allergic reactions. Thankfully, both were able to receive medical attention and survived.
“The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America,” Mylan said in a statement. Curiously, Mylan hasn’t yet said which “additional markets” will be included yet.
Patients are being directed to Mylan.com/EpiPenRecall for replacement instructions, and the company is encouraging patients to keep their EpiPens handy even if they can’t immediately get a replacement.
Mylan’s business practices came under intense scrutiny last year after consumers started to notice that the price of the EpiPen was rising at a rapid rate. After Mylan bought the product in 2007 the drug company raised prices almost 600 percent over the course of the next decade. Ironically, Mylan defended the actions by insisting that quality control was one of many reasons for the price hikes.
Mylan CEO Heather Bresch was even called to testify in front of Congress last year, though she lied about things like how much the company was making on the product. There were no repercussions for her lies, though the company had to repay $465 million to the US government for scamming Medicare and Medicaid. The company was not forced to admit any wrongdoing in that case.
The list of EpiPens recalled in the US can be found below:
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg - Lot number: 5GN767 - Expiration: April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg - Lot number: 5GN773 - Expiration: April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 5GM631 - Expiration: April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 5GM640 - Expiration: May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg - Lot number: 6GN215 - Expiration: September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM082 - Expiration: September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM072 - Expiration: September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM081 - Expiration: September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM088 - Expiration: October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM199 - Expiration: October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM091 - Expiration: October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg - Lot number: 6GM198 - Expiration: October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg - Lot number: 6GM087 -Expiration: October 2017Photo of an EpiPen 2-Pak released by Mylan to show consumers where they can find the lot number and expiration date for products affected by the recall (Mylan)
It’s not yet clear why the initial recall didn’t include EpiPens sold in the United States, since the product is manufactured in St. Louis, Missouri. It’s also not clear why Mylan executives haven’t faced any real consequences for lying to Congress.
Anyone who has trouble with an existing EpiPen is encouraged by Mylan to contact the FDA. Anyone who has trouble accepting that Mylan can get away with this shit is encouraged by me to contact their Senator.
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Some EpiPens recalled, FDA says
Mar 31, 2017 | CNN
By Ralph Ellis
Thirteen lots of Mylan's EpiPen and EpiPen Jr. are being voluntarily recalled by the manufacturer, the US Food and Drug Administration said Friday.
"This recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate," the FDA said in a news
Epipens are used to give an emergency injection of epinephrine to treat life-threatening allergic reactions.
The 13 lots of recalled EpiPens were distributed between Dec. 17, 2015, and July 1, 2016, the FDA said. Lot numbers of the affected devices can be found on the FDA website.
Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions. Meridian Medical Technologies manufactured the devices, which were distributed by Mylan Specialty, the FDA said.
EpiPens not included in the recall do not need to be replaced before their expiration dates, the FDA said.Mylan came under criticism last year for jacking up the price of the EpiPen. In 2009, an EpiPen two-pack cost less than $100. By 2016, its sticker price rose to $609.
Amid accusations of price gouging, Mylan CEO Heather Bresch testified before Congress in September. And in October, the company agreed to pay the US government $465 million after it was accused of falsely classifying the EpiPen to overcharge the Medicaid system.
In response, Mylan started offering $300 savings cards for patients who have to pay full price and began developing its generic spinoff.
About 15 million people have food allergies in the U.S., and allergic reactions account for about 200,000 emergency room visits per year, according to Food Allergy Research & Education.
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Two deaths spark recall of St. Jude heart devices
Oct 11, 2016 | Reuters
By Jim Finkle and Ransdell Pierson
St. Jude Medical Inc STJ.N on Tuesday said it would recall some of its 400,000 implanted heart devices due to risk of premature battery depletion, a condition linked to two deaths in Europe.
The devices shock dangerously racing heartbeats back to their normal rhythm or to treat heart failure. All the devices, called ICDs and CRT-Ds, contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit.
“There have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion,” St. Jude’s vice president of quality control, Jeff Fecho, said in an advisory to physicians on Tuesday.
The devices were introduced in 2010 and are meant to last for seven years or longer, until their batteries are depleted, the company said. They are designed to vibrate at regular intervals once power is diminished, a signal to patients that they should visit their doctors for replacements within 90 days. In addition, a home monitoring unit wirelessly reads the battery level and other information and routinely sends details to doctors.
The company said one of the patients died after his vibration signal indicated low power, but a few days before his planned replacement.
The company said the recall is not expected to have a material financial impact on the company, although many patients are expected to visit their doctors and some could request early replacements.
St. Jude said 841 devices had been returned to the company for analysis due to premature battery depletion, traced to a build-up of lithium clusters in the batteries.
Mark Carlson, medical officer of St. Jude, said in an interview the company’s advisory board of physicians has strongly recommended that most patients not seek prophylactic replacements “because the risk associated with replacing the devices outweighs the low risk of a patient problem occurring.”
News of the issue surfaced late on Monday when short-selling firm Muddy Waters tweeted a copy of a physician advisory from St. Jude, which agreed in April to sell itself for $25 billion to Abbott Laboratories (ABT.N).
The letter said problems with the lithium batteries were rare and could be identified by patients using tools for monitoring battery levels at home.
Patients should seek immediate medical attention as soon as they get a low-battery alert from the monitoring devices, the U.S. Food and Drug Administration said, in announcing the recall.
“Hospitals should immediately remove any unused devices affected by this recall, and contact the manufacturer to receive corrected devices,” the FDA said.
Wedbush Securities analyst Tao Levy said the recall would likely cost St. Jude no more than “a few million dollars” because relatively few patients will need early replacements and devices now being sold have improved and reliable batteries.
St. Jude’s shares fell 3.5 percent, while Abbott’s declined 5.4 percent. Abbott said it still expects to close the St. Jude deal this year.
The recall comes as St. Jude is defending itself against unrelated allegations that its heart devices are riddled with defects that make them vulnerable to cyber hacks.
Those claims were made by Muddy Waters and research firm MedSec Holdings. St. Jude has denied the allegations and sued both firms.
The FDA said on Tuesday its investigation into the cyber security vulnerabilities of the devices, including the Merlin@Home monitoring system, was continuing.
“Despite the allegations, at this time, the FDA strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities,” the FDA said in a statement.
Battery-depletion recalls or advisories have been issued in the past two years by Boston Scientific Corp (BSX.N) and Medtronic Plc (MDT.N), with no visible impact on company businesses, according to Barclays analyst Matt Taylor.
Medtronic in November recalled three models of its InSync III pacemakers due to battery problems, but overall company pacer sales continued to grow sharply thanks to newer products, Taylor said.
Boston Scientific in September 2014 alerted doctors of potential battery-life problems with two ICDs, and recommended that patients upgrade their software.
St. Jude advised patients to check its website for details on which devices were affected by the battery issue. (www.sjm.com/batteryadvisory).
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St. Jude Warns Defibrillator Patients About Battery Risks
Oct 11, 2016 | Bloomberg
By Michelle Cortez
St. Jude Medical (STJ) is warning patients that the batteries on thousands of its implantable defibrillators can quickly and unexpectedly deplete in rare cases, leaving them vulnerable should they need a shock from the device to restart their faltering hearts.
The premature battery depletion has been seen in less than 1% of the devices, the company said in letters sent to doctors and patients. Two people died after their devices failed to work correctly because of the drained battery, while 47 others reported dizziness or fainting. The warning applies to devices made before May 2015, which are in use in about 350,000 people worldwide. The company's shares dropped in early trading.
"We are recommending that patients utilize remote monitoring, to enable their physicians to monitor their devices' performance over time," Chief Medical Officer Mark Carlson said in a telephone interview. "Physicians and patients can take specific measures to mitigate the risk, albeit small, that this can impact their health."
The warning comes at a sensitive time for the St. Paul, Minn.-based medical device manufacturer, which is in the midst of being purchased by Abbott Laboratories (ABT) for $25 billion. In August, short-seller Carson Block and his investment firm Muddy Waters Capital LLC issued a report saying St. Jude's heart devices are uniquely vulnerable to cybersecurity attacks, including a depletion of the battery.
The issue at hand had nothing to do with wireless communications, which are essential for doctors to closely monitor their patients, Carlson said. The problem stems from the lithium-powered batteries that run the devices.
St. Jude shares fell nearly 6% in premarket action, and ended the trading day down 3.5% to 78.41. The devices fall under St. Jude's cardiac rhythm unit, which had 27% of the company's $5.54 billion in sales last year.
There are safety measures to alert doctors and patients when the battery is losing power, the company said. It vibrates inside the patient's chest twice for 16 seconds, much like a restaurant's paging device buzzes when a customer's table is ready, then repeats the notification several times in 10-hour increments. In addition, a remote home monitoring network informs doctors when patients' batteries are low.
The rapid draining of the battery can happen in days, Carlson said. Those devices should be replaced immediately, and St. Jude said it will provide a replacement device at no cost. The issue doesn't affect pacemakers and doesn't lead to inappropriate shocks or other complications, he said.
St. Jude recommended only replacing devices whose batteries had failed, since the risks of surgery outweighed the risks from devices that were still working fine.
When the devices charge up, lithium clusters can form and move inside. If the clusters connect the positive and negative electrodes inside the battery, it creates a short circuit that drains the battery, sapping its power, Carlson said.
The company identified the issue based on an analysis of 841 devices, out of 398,740 sold worldwide, that were linked to premature depletion and returned. Lithium clusters and visible electrical shorting were seen on 46 of the devices. The number may be low since not all cases are recognized or reported.
The affected devices include the Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra. The company will set up a website, www.sjm.com/batteryadvisory, to allow patients to determine if their device may be affected by the battery depletion.
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FDA Warns About Heart Defibrillators After Two People Die
Oct 11, 2016 | NBC News
By Maggie Fox
Two people have died after the batteries in two implanted heart defibrillators made by St. Jude Medical failed early, and now the company has issued warnings about 400,000 of the devices.
While the company doesn’t recommend that doctors remove the devices from patients, it says doctors need to get in touch with users and check them out.
The problem is that the batteries die almost without warning, the Food and Drug Administration says. The device is supposed to give a warning called an Elective Replacement Indicator (ERI) alert three months before the battery in it is fully depleted.
The affected devices are St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device.
“If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death,” the FDA said.
“The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.”“If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.”
St. Jude has sold 398,740 of the devices worldwide, but the company claims fewer than one percent of them are faulty.
“Two deaths (one in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion,” the FDA said.
“Ten patients (nine in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
Another 37 got dizzy, the FDA said.
So far, the flaw has only affected devices made before May 2015.
"Pacemaker-dependent patients with a device that has reached Elective Replacement Indicator should be treated as a medical emergency," the FDA said.
St. Jude says most patients should be fine. "The likelihood that this will impact your health is low, as the vast majority of devices have not experienced premature battery depletion," it said in a statement.
"We have asked physicians to contact their patients with information about this advisory. Device replacement is not recommended unless the physician determines otherwise," St. Jude said.
“Patients can learn if their device is included in the advisory by visiting a dedicated webpage: www.sjm.com/batteryadvisory.”
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St. Jude Medical Warns of Battery Problems With Heart Products
Oct 12, 2016 | Wall Street Journal
By Joseph Walker and Austen Hufford
St. Jude Medical Inc. warned Tuesday that a battery malfunction could cause hundreds of thousands of its implanted heart defibrillators to quickly lose power and stop functioning.
Two patients died after batteries in their St. Jude-made defibrillators ran down prematurely and prevented the devices from providing needed shock therapy, the Food and Drug Administration said in a separate advisory on Tuesday.
St. Jude, based in St. Paul, Minn., is in the process of being acquired by Abbott Laboratories ABT 0.79% in a cash-and-stock deal initially valued at $25 billion. St. Jude doesn’t expect the medical advisory to have “a material financial impact,” a company spokeswoman said.
In 4 p.m. trading Tuesday, St. Jude shares were down 3.5% at $78.41, and Abbott shares fell 5.4% to $41.16.
“We continue to expect the transaction to close by the end of the year,” said Abbott Labs spokesman Scott Stoffel, in an email.
St. Jude said the battery problem is a “rare occurrence,” and that it was “working with regulators and physicians to communicate about this advisory and the resources we are providing to assist with patient management.”
Nearly 350,000 patients globally have the potentially affected devices, which are cardioverter defibrillators or cardiac resynchronization therapy defibrillators manufactured by St. Jude before May 2015, the FDA said.
The implanted devices provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. They alert patients that batteries are running low by vibrating.
When the devices are functioning normally, patients have three months to replace them after receiving the alert, the FDA said. But the devices involved in the recall could stop working within 24 hours to a few weeks of patients receiving the alert.
“If the battery runs out, the [devices] will be unable to deliver lifesaving pacing or shocks, which could lead to patient death,” the agency said in its warning. “The patients most at risk are those with a high likelihood of requiring lifesaving shocks and those who are pacemaker dependent,” it said.
The devices have a low rate of battery failure, and most patients won’t need to have them replaced early unless they receive an alert, the agency said.
St. Jude is telling patients with the devices to monitor them closely and to contact their doctors if the device notifies them of a battery problem. The malfunction occurs when deposits of lithium form within the devices’ batteries and create abnormal electrical connections, leading to battery failure. The problem was identified by medical researchers as far back as 2014. St. Jude said it resolved the problem with a new battery design in 2015.
Avi Fischer, St. Jude’s vice president of global education and medical director, said in an interview that the two patient deaths associated with the battery malfunction occurred in 2014 and in the spring of 2016. He said the company began an analysis of the devices after the second patient death this year, which ultimately led to it issuing the medical advisory on Tuesday.
In addition to the two deaths, 10 patients have reported fainting from devices that didn’t provide pacing because of battery depletion, and 37 patients have reported dizziness, the FDA said. So far, 841 devices have been returned to St. Jude for analysis due to the battery problem.
In recent months, St. Jude has been fending off allegations that its devices are vulnerable to hacking and other cybersecurity threats. St. Jude has denied the allegations and sued a short seller who released the report accusing its devices of having security gaps.
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May 19, 2015 | New York Times
By Danielle Ivory and Hiroko Tabuchi
For more than a decade, the Japanese company Takata, one of the largest suppliers of airbags, denied that its products were defective even as motorists were killed by exploding airbags and automakers around the world recalled millions of cars equipped with its products.
But on Tuesday, in an about-face, Takata admitted that its airbags were defective and agreed to double the number of vehicles recalled in the United States, to nearly 34 million — or about one in seven of the more than 250 million vehicles on American roads — making it the largest automotive recall in American history. The airbags can explode violently when they deploy, sending shrapnel flying into a car’s passenger compartment. Six deaths and more than 100 injuries have been linked to the flaw.
“Up until now Takata has refused to acknowledge that their airbags are defective,” said Anthony Foxx, the transportation secretary. “That changes today.”
The announcement also indicated a shift for the National Highway Traffic Safety Administration, which for years had been criticized by lawmakers and safety advocates as being too lax on the industry it oversees. At one point, in 2009, the agency opened an investigation into Takata and its airbags, only to close it six months later, citing “insufficient evidence.”
But since the appointment of a new administrator, Mark R. Rosekind, the agency has shown greater assertiveness toward companies like Takata.
“From the very beginning, our goal has been simple: a safe airbag in every vehicle,” Mr. Rosekind said. “The steps we’re taking today represent significant progress toward that goal.”
Takata, in a statement, said that the announcement was the culmination of a year of work with automakers and the safety agency.
“We are committed to continuing to work closely with N.H.T.S.A. and our automaker customers to do everything we can to advance the safety of drivers,” said Shigehisa Takada, Takata’s chairman and chief executive.
Despite the sweeping nature of the announcement, the agency said it would not know exactly which models of cars would be recalled until it coordinated with automakers, which could be several days. The final number may change as more tests are performed, Mr. Rosekind said. Ten automakers, including Honda, Chrysler and Nissan, have recalled cars in the United States because of the defect.
Mr. Rosekind acknowledged that the repairs could take several years to complete, but he said that consumers could still drive their cars in the meantime.
“Yes, people need to drive their cars,” Mr. Rosekind said, adding that they should be checking with their dealers often to make sure the defective airbags were “replaced as soon as possible.”
Honda, the automaker that has been most affected by the Takata airbag recalls, said that it was reviewing the announcement to determine what fresh recall measures might be required. Honda already said that it was looking to other suppliers to provide replacement airbags.
Nissan, Chrysler, Toyota and BMW also said they needed to review the announcement before taking any further action. None of the automakers would say whether they expected to have access to enough replacement parts to repair all the cars potentially carrying defective airbags.
Officials at other affected automakers, including Ford, did not immediately respond to requests for comment. Even now, Takata and automakers continue to search for the root cause of the defect. But in new filings with the safety agency, Takata went beyond its previous statements that there had been some errors in manufacturing and admitted to flaws in the airbags’ design and components.
For example, Takata said that the propellant in the inflaters — the explosive material that generates the gases to inflate the airbag — could degrade over time if exposed to high humidity and changes in temperature, making it prone to “overaggressive combustion.”
Former Takata engineers told The New York Times last year that they had raised concerns over a decade ago that ammonium nitrate, the explosive material Takata uses, was sensitive to moisture and temperature swings. But those concerns went unheeded, they said.
And for the first time, Takata also acknowledged that its testing had uncovered leaks in some of its inflaters that could allow moisture to seep into them over time. When that happens, the propellant breaks down, making it more susceptible to exploding violently.
Last week, a former Takata consultant said that tests he carried out on prototype Takata airbags in the early 2000s revealed leaks, and that he had urged the company to use a different leak testing method, one that he had devised and was offering to sell to the company. His advice also went unheeded, he said.
But in a statement on Tuesday, Takata argued that under industry-mandated testing, it could not have been expected to spot such complex problems.
“The potential for this long-term phenomenon to occur was not within the scope of the testing specifications prescribed by the vehicle manufacturers,” the supplier said in a statement.
In the face of mounting evidence, federal safety regulators in February began to fine Takata $14,000 a day because it had not cooperated fully in the agency’s investigation. The company disputed the agency’s assertions. With the expansion of the recall, though, regulators said they would suspend that fine, which had reached more than $1 million. It is unclear if it will be collected.
As early as 2001, customers filed complaints with the National Highway Traffic Safety Administration alluding to rupturing airbags in models that contained Takata products.
Gradually, awareness grew within the company. The New York Times reported last November that Takata had ordered tests on the airbags in 2004 and found signs of defects, but did not report the results to regulators. Takata has disputedthe report.
In November 2008, Honda recalled more than 4,000 cars with Takata airbags and then, six months later, after a teenager was killed by fragments from an exploding airbag, the company recalled an additional 510,000 vehicles.
As the number of cars under recall continued to expand, the safety agency started a second investigation into the airbags last June and, late last year, began to demand that automakers issue nationwide recalls in the United States.
Last week, Honda, Toyota and Nissan expanded their worldwide recall by 11.5 million cars.
Tuesday’s announcement drew praise from some lawmakers who have been critics of Takata. “Folks shouldn’t have to drive around wondering if their airbag is going to explode in their face or if their car is going to be on another recall list,” said Senator Bill Nelson of Florida, the top Democrat on the Senate Commerce Committee and a central figure in a congressional investigation into the defective airbags. “Let’s hope Takata’s admissions today tells us the whole story.”
But at least one victim is not applauding the announcement.
“I’d like to know why it took them till now,” said Corey Burdick, a 26-year-old from Eustis, Fla., who was blinded in one eye last year when a piece of metal shot out of the Takata airbag in his 2001 Honda Civic. “What’s different now from a year ago?”
Mr. Burdick, who supports a wife and two young sons, works in a warehouse loading pallets with a forklift. He has filed suit against Takata and Honda.
“It’s been a mix of emotions, like a roller coaster,” he said. “It’s depressing because this could happen to someone else.”
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3 Takata Executives Face Criminal Charges Over Exploding Airbags
Jan 13, 2017 | New York Times
By Hiroko Tabuchi and Neal E. Boudette
United States prosecutors said on Friday that they had charged three executives at Takata, the Japanese auto parts maker, with fabricating test data to mask a fatal airbag defect, a striking turn in a case that set off the largest automotive recall in United States history.
Prosecutors also announced that Takata had agreed to plead guilty to charges of wire fraud for providing the false data, a rare outcome for businesses accused of wrongdoing. The company, based in Tokyo, was also fined $1 billion.
The guilty plea and fine had been widely expected, but the charges against the executives intensified a scandal that has roiled regulators, led to congressional hearings and brought the Japanese manufacturer to the brink of bankruptcy. The airbags, which can rupture violently when they deploy, have been linked to at least 11 deaths and more than 180 injuries in the United States.
“They falsified and manipulated data because they wanted to make profits on their airbags, knowing they were creating risk for the end-users, who are soccer moms like me,” Barbara L. McQuade, a United States attorney for the Eastern District of Michigan, said at a news conference in Detroit.
“The risk they allowed is really reprehensible,” she said. “We want auto suppliers to know they have to put safety ahead of profits. Cheaters will not be allowed to gain a competitive advantage.”Continue reading the main story
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The indictments are the latest moves by the outgoing Obama administration to come down harder on white-collar crime, including guilty pleas from companies and charges against individual managers and executives. Federal prosecutors this week also charged six Volkswagen executives for their roles in an emissions-cheating scandal, and the automaker pleaded guilty to charges of conspiracy and other crimes.
The efforts are seen as a departure from the years following the 2008 financial crisis, when not a single top bank executive went to prison, fueling a public outcry over the perception that Wall Street giants were “too big to jail.”
Takata’s executives are accused of especially egregious conduct.
According to the indictment, the executives were at the center of efforts to manipulate airbag safety data that continued for as long as 15 years. They knew as early as 2000 that the airbags’ metal inflaters could explode, prosecutors said.
But over the years, they routinely discussed falsifying those test results, discarding damaging information, an action referred to internally at Takata as “XX-ing” the data, the indictment said.
The New York Times has reported extensively, since 2014, on Takata’s tampering with its test results, as well as its early failure, along with its largest client, Honda, to alert regulators to the deadly defect. The Times also quoted former Takata engineers as saying that cost considerations drove some risky decisions about the airbags.
“Ammonium nitrate was a highly combustible and unstable chemical compound,” the indictment said. “Takata, however, created and distributed its inflaters as a purportedly safe and stable variation.”
The executives, Shinichi Tanaka, Hideo Nakajima and Tsuneo Chikaraishi, were indicted by a grand jury in December. The accusations were unsealed on Friday. All three had worked for Takata in the United States and Japan until around 2015, prosecutors said.
In one email, dated June 2005, Mr. Nakajima explained to colleagues, including Mr. Tanaka and Mr. Chikaraishi, that they had no choice but to manipulate test data and that they needed to “cross the bridge together,” the indictment said.
“Takata will continue to cooperate fully with D.O.J. in connection with its ongoing investigation,” the company said in a statement, referring to the Justice Department.
The three executives could not be reached for comment, and it was unclear who was acting as their legal representative. Neither the Justice Department nor Takata would provide any contact information.
Mr. Nakajima’s name appears on various internal documents that have been unsealed as part of litigation against Takata, and he is often described as a liaison between Takata’s Japanese and American operations. He was formerly director of engineering at Takata’s research lab in Farmington Hills, Mich.
Mr. Tanaka, the highest ranking of the three men, was formerly listed as an executive officer at Takata headquarters and the company’s chief director of procurement, as well as executive vice president of Takata’s global inflater operations.
Mr. Chikaraishi also held various executive positions, including chief of airbag inflater operations for Japan and Asia. His name appears on numerous patent applications related to airbag technology filed in the United States.
Ms. McQuade stressed that investigations were still underway.
“We will continue to investigate and if we are able to identify additional individuals, we will charge them as well,” she said.
In recent months, Takata has cooperated with the investigation, Ms. McQuade said, including identifying culpable individuals. Prosecutors took that cooperation into account in pursuing penalties, she said.
Prosecutors said the three indicted executives were thought to live in Japan. If so, it is unclear whether they will face a court in the United States. Japan has an extradition treaty with the United States, but in practice the Japanese government has discretion over whether to comply with any extradition requests from the United States.
Takata, however, has previously cooperated with authorities in this regard.
In 2013, three other Takata executives agreed to plead guilty for their roles in a conspiracy to fix the prices of seatbelts sold in the United States. The executives also agreed to serve time in a United States prison.
Pointing to that precedent, Ms. McQuade said she thought that the chances for an extradition were “pretty good.” She added, “It’s not an automatic, but we’re going to work hard at it in this case.”
Even with the current administration’s newfound interest in going after corporate executives, criminal charges against individuals in a case involving automotive safety defects are rare.
Prosecutors can struggle to surmount high legal standards and gaps in the oversight of carmakers — gaps that stem from nearly five decades of hard lobbying from the auto industry to beat back efforts to strengthen criminal penalties. These gaps do not exist in some other industries like pharmaceuticals or food.
Senators Richard Blumenthal of Connecticut and Edward J. Markey of Massachusetts, Democrats who led congressional efforts to investigate Takata, called the Justice Department’s effort to hold executives accountable overdue. They also urged regulators to speed up efforts to fix affected cars.
“The effort to protect drivers from Takata’s wrongdoing does not stop here,” they said in a joint statement. “We must recall every single vehicle with a Takata airbag,” they said, and the National Highway Traffic Safety Administration “must accelerate the recall of these dangerous airbags to prevent yet another unnecessary and tragic death.”
Transportation Secretary Anthony Foxx said regulators would “keep the pressure on Takata and the auto industry” to make sure recalls were carried out “quickly and efficiently as possible.”
Takata’s airbag recall in the United States has affected nearly 70 million airbags in 42 million vehicles. Takata also faces a class-action lawsuit filed by owners of cars fitted with Takata airbags, among other litigation.
“It’s about time somebody is being held accountable,” said Corey Burdick, 28, a Florida father of two who was injured in an airbag explosion in a Honda Civic in 2014.
He had been driving to his job as a forklift operator when he collided with another car, triggering his airbag, which exploded and sent a metal shard into his right eye. Mr. Burdick was left blind in that eye. He settled with Takata and Honda a year ago for an undisclosed sum.
He questioned, however, why only Takata was taking the fall for a defect the car companies also knew about years ago.
“I bought my car from Honda,” he said. “But I’m not going to be too harsh and hasty in my judgment. I’m just trying to live life the best that I can.”
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Takata plea, compensation deal clears path to potential sale
Feb 27, 2017 | Reuters
Japan’s Takata Corp 7312.T removed a major obstacle to its potential sale or restructuring, pleading guilty on Monday in a U.S. federal court to a felony charge as part of a $1 billion settlement that included compensation funds for automakers and victims of its faulty airbag inflators.
U.S. District Court Judge George Steeh approved the previously agreed settlement, despite objections from lawyers for victims of Takata inflator explosions that the criminal settlement identified automakers as victims of fraudulent activity.
Steeh said automakers could be victims of Takata’s decisions to hide evidence over 15 years that its inflators were defective and still be subject to civil litigation for harm done to individuals.
With the criminal settlement and penalties set in the United States, where the majority of air bag-related fatalities and injuries have occurred, Takata is expected to continue its search for a buyer or financial backer, a process which has dragged on for a year.
“Achieving a plea bargain in the United States shows some progress, and could help to revive stagnated talks in Japan,” SBI Securities senior analyst Koji Endo said in Tokyo.
Any deal will require agreement with its automaker clients over whether Takata’s restructuring should be managed privately, or through the courts, a sensitive issue for the founding Takada family, which holds a majority stake in the company.
Steeh said he considered imposing a stiffer sentence, noting federal guidelines allowed for up to $1.5 billion in fines. But the judge said he approved the settlement because Takata could otherwise be pushed into bankruptcy, delaying efforts to replace millions of potentially deadly inflators still on the road.
“Destruction of the corporation would probably have been a fair outcome in this case,” Steeh said, adding he had been involved in a separate case in which Takata had admitted to price fixing.
Lawyers for U.S. vehicle owners have sued Honda Motor Co (7267.T), Nissan Motor Co (7201.T), BMW AG (BMWG.DE), Ford Motor Co (F.N), Mazda Motor Corp (7261.T), Toyota Motor Corp (7203.T) and other automakers, alleging they knew about the defective Takata inflators for years but kept using them.
Lawyers for vehicle owners said in a court filing on Monday in Florida that automakers acted “recklessly” because “they were focused on the low price of Takata’s inflators and concerned that if they stopped using Takata’s inflators, they might not have a sufficient supply.”
Honda said in a statement the filing was “misleading”, adding that “the suggestion that Honda chose to use Takata airbag inflators - despite knowing of the risk of rupture - because they were less expensive than other inflators is categorically false.”
Toyota and Nissan declined to comment on the filing.
At least 16 deaths have been linked to exploding Takata inflators. The defects have led 10 automakers to recall more than 31 million cars worldwide since 2008. All but one of the deaths have occurred in Honda vehicles.
The automakers could face costs to replace all the defective airbags “that would be 5, 6 or 9 times the $850 million” set aside in the fund, Steeh said, indicating the total replacement cost could be more than $7.6 billion. The Takata airbag recall is the largest ever for the auto industry.
In January, Takata agreed to establish two independently administered restitution funds: one for $850 million to compensate automakers for recalls, and a $125 million fund for individuals physically injured by Takata’s airbags who have not already reached a settlement with the company.
U.S. senators called for more compensation for victims and voiced their opposition to automakers receiving any payments, arguing that Monday’s filing in Florida raised the possibility of their “possible complicity in Takata’s fraud”.
“No automaker should receive a single dollar until we fully understand their involvement in this fraud and how they so massively failed to protect their customers,” they said in a statement.
“While today’s guilty plea from Takata is welcome news, this is not nearly the end of this sad saga.”
Automakers in the United States are set to continue recalling defective inflators through 2020. U.S. safety regulators have said automakers are responsible for replacing defective airbags no matter what happens to Takata.TURNAROUND EFFORT
Takata is seeking financial backers as it faces potentially billions of dollars in recall-associated costs. It has not identified what company has been selected by a steering committee leading that process.
Key Safety Systems (KSS), a Chinese-owned auto supplier, is the leading candidate, people familiar with the process said in early February. A person briefed on the matter told Reuters on Monday a decision may be reached by the end of March.
Takata has denied investor speculation that it would have to seek some form of bankruptcy protection in the United States or Japan. However, during the court hearing, Judge Steeh and lawyers for the Justice Department alluded to the potential for Takata to collapse if it could not find a buyer.
As part of the agreement with U.S. authorities, Takata has agreed to pay a $25 million fine and has 30 days to pay the $125 million for victim compensation.
Takata has up to a year to deliver the remaining $850 million for automaker compensation. If a financial backer takes control of Takata, however, the money for the automakers must be delivered within five days. Reuters had reported in November that Takata may file for bankruptcy as part of a restructuring.
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7 questions about the Takata air bag recall
Jun 26, 2017 | Associated Press
Takata has filed for bankruptcy protection in Japan and the U.S., leaving consumers to wonder about the status of the recall of about 70 million defective air bag inflators in the U.S. and another 30 million worldwide.
The inflators, which fill up air bags in the event of a crash, can explode with too much force and spew metal shrapnel. At least 16 deaths worldwide and more than 180 injuries are blamed on the inflators.
The U.S. government says about 38 percent of the recalled inflators have been replaced. Takata says in Japan the figure is closer to 70 percent. Data for other countries wasn't available.
What car owners need to know about the massive recall:Will the recalls continue?
Yes. Automakers are ultimately responsible for the safety of their vehicles, and they have been funding the recalls.
Takata's assets are expected to be sold for $1.6 billion to a rival company, Key Safety Systems, and part of Takata will remain under a different name to make replacement inflators for the recalls. Money from the sale will go to pay claims against Takata, including a court-ordered $850 million that will reimburse automakers for their recall expenses.How can I find out if my car has been recalled?
The National Highway Traffic Safety Administration released a complete list of models covered by current and future Takata recalls. The full list can be found on the agency's website. The government's website also allows drivers to search for open recalls. Owners should input the car's vehicle identification number, or VIN, which can be found on the title or registration card, or on the driver's side dash or door jamb. The VIN check page will be updated as automakers announce more recalls.
Cars and trucks made by 19 companies are included in the recall.What's wrong with these air bags?
Three independent reports concluded that the chemical Takata uses to inflate its air bags -- ammonium nitrate -- can degrade after long-term exposure to environmental moisture and high temperatures. If the ammonium nitrate degrades substantially, it can cause the inflators to become overpressurized and rupture during air bag deployment.
In the air bags being recalled, Takata didn't use a chemical desiccant, a drying agent that can counteract the effects of moisture.Which cars are most at risk?
The government says vehicles younger than six years old aren't currently at risk of an air bag inflator rupture even if they're in a high humidity region, because it takes time for the ammonium nitrate to degrade. But the risk grows as the vehicle ages.How long will I have to wait for a replacement?
That varies by model, age of the car and manufacturer. For many models, dealers have ample parts in stock. Yet only about 16 million of the 69 million inflators had been replaced as of the end of April.
Parts aren't yet available for some models, and other models haven't been recalled yet. More recalls are coming as more parts are made. Some Takata replacement inflators will have to be replaced again because they don't have the drying agent. Other manufacturers are also supplying replacement air bags.
Remaining recalls are being phased in through the end of 2020. The phases are based on the age of the vehicles and exposure to high humidity and high temperatures. Owners will be notified when a remedy is available and should get the repair immediately.
Some automakers are offering loaner cars until replacement parts are available.How can I see if a used car has had the recall repair?
Dealers can legally sell used cars without notifying customers about open recalls. The government's VIN search goes back 15 years, so check the NHTSA website. Carfax, which sells vehicle history reports, also lets people check open recalls for free.Should I disable my air bag while I'm waiting for a repair?
No. If you're in a crash, it's far more likely that the air bag will protect you than hurt you. The National Highway Traffic Safety Administration estimates that front air bags have saved 43,000 lives since they were required in the 1990s.
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