NYTimes analysis: Volkswagen corporate culture enabled unlawful behavior.

The New York Times (12/14, Ewing, Bowley, Subscription Publication, 11.64M) reports Volkswagen’s “cutthroat and insular” corporate culture “is coming under scrutiny as potentially enabling...lawbreaking behavior,” according to experts and current and former employees. One high-level Volkswagen executive described management style as: “Be aggressive at all times.” The company stresses a lack of open criticism or admission of flaws and absolute obedience. The Times suggests that this aggressive corporate culture is in part responsible for the recent emissions fraud scandal.

        VW’s sales likely to decline for first time since 2014. The AP (12/11) reported that Volkswagen’s global sales declined 2.2 percent year over in November, from 852,900 vehicles in November 2014 to 833,700 last month, the company said on Friday. US sales dropped 15.2 percent to 45,300 units, and there were even bigger drop offs in Brazil and Russia, but sales were up 2.6 percent to 270,400 units in western Europe and up 5.5 percent to 329,000 in China. Group deliveries declined 1.7 percent to close to 9.1 million units over the first 11 months of 2014, compared to 9.26 million during the same period in 2014.

        Bloomberg News (12/11, Behrmann, 3.4M) reported that deliveries of the VW brand are declining for the first time since 2004, as consumers move away from the Passat sedans and Golf hatchbacks “tainted” by the emissions cheating scandal. Sales fell during the first 11 months of 2015 4.5 percent to 5.34 million vehicles, and Juergen Stackmann, the VW brand’s sales chief, doesn’t expect to be able to surpass last year’s 6.12 million automobiles. 

VW says emissions cheating began in 2005.

Coverage of the Volkswagen emissions scandal continues, with news of Volkswagen’s supervisory board chairman Hans-Dieter Pötsch’s revelations about the company’s internal investigation receiving significant coverage. In a lengthy article, the New York Times (12/11, Ewing, Subscription Publication, 11.64M) reports that Pötsch acknowledged Thursday that the decision to cheat on emissions tests began in 2005 because the company’s ambitions in the US conflicted with air quality rules that were more stringent than Europe’s. VW opted to install a technology called lean NOX traps over a more expensive technology called selective catalytic reduction (SCR), and even “sidelined” some of its executives who had argued for SCR. However, the lean NOX traps were less reliable at controlling emissions, so engineers introduced software that would lower emissions during testing after realizing that the diesel vehicles could not meet US standards. Pötsch said, “It proves not to have been a one-time error, but rather a chain of errors that were allowed to happen.” The Wall Street Journal (12/11, Boston, Varnholt, Sloat, Subscription Publication, 6.23M) reports that Pötsch added that the investigation showed the need for change in testing procedures in the engine development department, which allowed individuals who designed the procedures to sign off on the results without a second opinion. Despite Thursday’s admission, the Journal says VW failed to answer who ordered the software to be installed, when the order was made, and who was behind the long term cover-up. The company believes only a select few carried out the deception, and said that nine managers have been suspended in relation to the fraud, though it remains unclear whether they were actually involved in the wrongdoing. Fortune (12/10, 4.24M) contributor Geoffrey Smith similarly argues that the news conference was “a near-complete anti-climax” in which executives provided very little information and “refused to discuss who was responsible for hiding the true level of harmful emissions.”

        Washington (DC) Post (12/10, Rising, Sopke, 7.78M) adds that Pötsch also “did not say if any VW models from before 2009 had the cheating software in the United States,” nor would the EPA “comment on whether any more model years are under investigation.” Pötsch also reiterated that the investigation, which has “so far analyzed data from laptops, phones and other devices from 400 employees,” is ongoing but has so far turned up “no indications that board members were directly involved.” According to Reuters (12/10, Cremer, Prodhan, Potter), the company will work to improve oversight of software development in light of the findings and hopes to reach an agreement soon with US environmental regulators to begin recalling affected vehicles there. USA Today (12/10, Bomey, 5.56M) reports that Pötsch pledged that the company will partner with independent auditors for emissions certification in the future and create a new committee that will approve new emissions software. The AP (12/10), Ars Technica (12/10, Gitlin, 1.15M), Bloomberg News (12/10, Rauwald, 3.4M), the Los Angeles (CA) Times (12/10, Hirsch, Masunaga, 3.6M), and MarketWatch (12/10, Boston, 758K) offer similar coverage of Pötsch’s comments, while CNBC (12/10, 2.08M) and Reuters (12/10) provide video of the press conference.

        Jalopnik (12/10, 627K) contributor Jason Torchinsky asserts that the company is “enduring this colossal failure because its culture didn’t let employees fail enough before,” prompting them to fudge solutions when they were “unable meet the U.S. tough diesel emissions requirements.” Torchinsky condemns the “idea of not being ‘allowed’ to make mistakes” in corporate settings as “absurd” and criticizes VW for not embracing failure as opportunities to learn.

        VW CEO: No reason to sell assets. Bloomberg Business (12/10, Nichols, Rauwald, Reiter, 3.4M) reports that VW CEO Matthias Mueller said, “in his first television interview since the scandal broke in late September,” that the company has “no reason whatsoever to get rid of these assets” – referring to the company’s twelve brands – in the wake of the scandal. According to Bloomberg, Mueller’s comments suggest that the company “has the financial means to pull itself out” of the scandal without selling off assets. In Europe, the company is likely to face “6.7 billion euros in diesel recall costs,” plus “regulatory fines and potential damages from hundreds of lawsuits,” in addition to “as much as $9.4 billion” in recall costs in the US, according to Bloomberg Intelligence. Meuller also told CNBC (12/10, 2.08M) that the company is not prepared to reduce prices and discussed how the company intends to rebuild lost trust with customers. To that end, according to NPR (12/10, Ydstie, Greene, 1.78M), officials said the company plans to compensate vehicle owners for the lost resale value of the cars but declined to elaborate further. In a column for Bloomberg Business (12/10, 3.4M), Chris Bryant speculates about whether the company has surmounted the highest hurdles in the scandal, concluding that the company appears confident and “has resources to call on before bond investors would face any pain.”

        Consumer attorneys nominate Ken Feinberg as settlement master in VW suits. Bloomberg Business (12/10, Fisk, 3.4M) reports that Kenneth Feinberg, who “handled General Motors Co.’ ignition switch fund” and “compensation for victims of the Sept. 11, 2001 terrorist attacks and BP Plc’s 2010 Gulf of Mexico spill,” has been nominated as a special settlement master in the federal consumer lawsuits against VW after U.S. District Judge Charles Breyer requested suggestions for names on Wednesday. The request doesn’t necessarily mean that the case will be settled but is “likely a recognition that an experienced neutral should be able to facilitate a fair and just resolution of the claims whether that is early or at a more advanced stage of the litigation,” according to Blair Nicholas, a lawyer for the plaintiffs. 

NHTSA raises scrutiny of Jeep Wrangler electrical issue.

The Detroit News (12/8, Burke, 545K) reports that on Tuesday, NHTSA announced that it is “upgrading an investigation into nearly 630,000 Jeep Wrangler SUVs for an electrical wiring” issue, which may “cause air bags to not work properly.” According to the article, NHTSA said it is initiating an “engineering analysis” into the SUVs after launching a preliminary investigation earlier this year. 

Honda recall targets 145,000 motorcycles.

The AP (11/4) reports that Honda” is recalling over 145,000 motorcycles in the US to fix dragging rear brakes that can cause a fire or crash.” The NHTSA posted documents showing it’s the third recall for some of the motorcycles. 

Mercedes issues recall over airbag issue.

The AP (11/4) reports that Mercedes has issued a recall affecting more than 126,000 cars and SUVs in the US due to an issue that can cause its air bags to inflate without a crash. “The recall covers the C-300, C-350, and C-63 models from 2008 and 2009, and the GLK-350 4-Matic from 2010,” the article reports. In documents filed with the NHTSA Mercedes says no warning would be provided to the driver in the event of unintended deployment. Dealerships will replace defective units.

        The story was also covered by the New York Times (11/4, Jensen, Subscription Publication, 11.64M). 

Arbitration Everywhere, Stacking the Deck of Justice

The New York Times

“On Page 5 of a credit card contract used by American Express, beneath an explainer on interest rates and late fees, past the details about annual membership, is a clause that most customers probably miss. If cardholders have a problem with their account, American Express explains, the company “may elect to resolve any claim by individual arbitration.” Those nine words are at the center of a far-reaching power play orchestrated by American corporations, an investigation by The New York Times has found. By inserting individual arbitration clauses into a soaring number of consumer and employment contracts, companies like American Express devised a way to circumvent the courts and bar people from joining together in class-action lawsuits, realistically the only tool citizens have to fight illegal or deceitful business practices.”

        Honda to stop using Takata airbag inflators in new models. In a front-page story, the New York Times (11/4, A1, Tabuchi, Ivory, Subscription Publication, 11.64M) reports that on Tuesday, Honda announced that it was dropping “Takata as its airbag supplier,” saying that the manufacturer had “misrepresented and manipulated test data.” According to the article, Transportation Secretary Anthony Foxx “also said that Takata manipulated the test data.” The NHTSA is quoted as saying in its consent order that in several cases, “Takata produced testing reports that contained selective, incomplete, or inaccurate data.” Honda announced that it would not use front driver or passenger Takata airbag inflators in new vehicles under development.

        According to the Los Angeles Times (11/4, Puzzanghera, 3.6M), Honda said that “it is working with other suppliers to replace Takata inflators” already in its vehicles. 

Takata Fined $200M For Airbag Defect In Largest NHTSA Penalty Takata Corp. was hit Tuesday with $200 million in civil penalties — the largest imposed by the National Highway Traffic Safety Administration — of which it will pay $70 million as a part of a settlement over a defect in the Japanese auto parts maker's air bag inflator linked to eight deaths and the injuries of some 100 drivers and passengers.

New recalls raise questions for Takata.

The New York Times (11/2, Ivory, Tabuchi, Subscription Publication, 11.64M) reports the recalls for Takata airbags continue to widen. “Two automakers have recently announced recalls for 2015 and 2016 models,” the article reports, including Honda. The recall “came on the heels of a General Motors recall for 400 cars from the 2015 model year, initiated after side airbags failed in tests” only weeks after “regulators asked Volkswagen to provide information about the rupture of a Takata-made side airbag in a Tiguan from the 2015 model year,” the article adds. NHTSA spokesman Gordon Trowbridge said that the ruptures in newer-model vehicles “may be linked to manufacturing weakness in the inflater housing, rather than the degradation of propellant exposed to prolonged heat and humidity.” He added that the NHTSA had “included all Takata-made inflaters using ammonium nitrate propellant within the scope of its investigation in order to ensure that every American has safe airbags in their vehicle.” 

Volkswagen emissions investigation expands to Audi, Porsche models.

News broke on Monday that US regulators have charged that a six-cylinder Volkswagen diesel used in a number of vehicles also contain an emissions cheating software. A major theme is the impact on the new Volkswagen CEO could find himself in trouble, as he comes from Porsche, whose vehicles are implicated on the new charges.

        In a video segment, Bloomberg News (11/2, 3.4M) reports that US regulators have expanded their probe of the Volkswagen emissions scandal to include more models from Audi along with diesels from Porsche. International Business Times (11/3, Berger, 624K) reports US regulators issued a Clean Air Act violation notice on Monday that “applies to roughly 10,000 diesel passenger cars sold in the U.S. since model year 2014, as well as an unknown number of 2016 models.” In a letter posted on its website, the EPA “said it has determined that certain Audi, Porsche and VW models with 3.0 liter engines were rigged to pass pollution tests.” Mashable (11/2, Jaynes, 1.8M) reports that the California Air Resources Board also served VW group with a violation notice for its 3.0-liter V6 TDI diesel engines. The engine is used in a number of VW, Porsche and Audi vehicles for model years 2014-16.

        CBS News (11/3, 4.1M) reports that the EPA said on Monday that the software on the engines “has a timer that turns on pollution controls when testing begins, including fuel injection timing, exhaust gas recirculation rate and fuel injection pressure.” The Wall Street Journal (11/3, Spector, Subscription Publication, 6.23M) reports that the EPA’s Cynthia Giles said in a conference call, “VW has once again failed its obligation to comply with the law that protects clean air for all Americans.”

        The Los Angeles Times (11/2, Masunaga, 3.6M) reports that Volkswagen “replaced Winterkorn with Matthias Mueller, 62, the top manager of its Porsche subsidiary, making the inclusion of the Porsche Cayenne among the list all the more notable.” Bloomberg News (11/3, Welch, 3.4M) reports that Mueller’s appointment in September “was meant to signal a clean break from the group that oversaw the engineers who cheated and to usher in greater accountability.” But that “may be short-lived” with the new charges.

        Bloomberg News (11/2, Plungis, 3.4M) reports that unlike the original charges, Volkswagen has denied the new claim. The company said in an email, “VW stresses that no software has been installed in the 3-liter V6 diesel engines to change emission results in an inadmissible way. Volkswagen will fully cooperate with the EPA to clarify the matter unreservedly.” The New York Times (11/3, Mouawad, Subscription Publication, 11.64M) reports that Volkswagen “pledged in a short statement that it would cooperate with the E.P.A. ‘to clarify the matter in its entirety.’”

        A number of other news outlets covered the news, including Road and Track (11/3, Sorokanich, 4.37M), Reuters (11/2), CNBC (11/3, 2.08M), USA Today (11/3, Bomey, Woodyard, 5.56M), ABC News (11/3, 3.35M) and the AP (11/2). 

Study finds self-driving cars in more accidents.

USA Today (10/31, Woodyard, 5.56M) reported online that a University of Michigan study found that self-driving cars are involved in accidents at five times the rate of conventional cars. The article notes that the number of accidents for self-driving cars is extremely small, and that the study’s authors acknowledge that “their confidence levels could invalidate the overall finding.” The article also notes that the self-driving cars were never at fault for the accidents

Some 2016 CR-Vs recalled due to new Takata airbag flaw.

Bloomberg Business (10/31, 3.4M) reports that Honda is recalling 515 2016 CR-Vs because of a new defect in airbags created by Takata Corp. Takata has been under investigation from the NHTSA for airbag defects that have killed at least 8 people.

        The AP (11/1) reports that the problem is with the housing of airbag which could cause the bag inflator to rupture and “send metal fragments flying.”

        Bloomberg News (10/31, Plungis, 3.4M) reports that the NHTSA is considering using “its legal authority to compel manufacturers to speed up recall-related repairs, or get parts to vehicles at most risk more quickly” as part of its reaction the larger recall. 

NYTimes analysis: Forced arbitration becoming more prevalent.

The New York Times (11/1, A1, Silver-Greenberg, Gebeloff, Subscription Publication, 11.64M) reports on “a far-reaching power play orchestrated by American corporations.” By “inserting individual arbitration clauses into a soaring number of consumer and employment contracts, companies like American Express devised a way to circumvent the courts and bar people from joining together in class-action lawsuits, realistically the only tool citizens have to fight illegal or deceitful business practices.” The Times notes that “over the last few years, it has become increasingly difficult to apply for a credit card, use a cellphone, get cable or Internet service, or shop online without agreeing to private arbitration,” as well as “getting a job, renting a car or placing a relative in a nursing home.” According to the Times, “some state judges have called the class-action bans a ‘get out of jail free’ card, because it is nearly impossible for one individual to take on a corporation with vast resources.”

        Forced arbitration seen favoring corporations. The New York Times (11/2, A1, Silver-Greenberg, Corkery, Subscription Publication, 11.64M) reports that Deborah L. Pierce, an emergency room doctor in Philadelphia, “was optimistic when she brought a sex discrimination claim against the medical group that had dismissed her,” but “she began to worry, though, once she was blocked from court and forced into private arbitration,” where a corporate attorney who also handled arbitrations ultimately ruled against her. An investigation by the Times found that arbitration “often bears little resemblance to court,” and that “over the last 10 years, thousands of businesses across the country – from big corporations to storefront shops – have used arbitration to create an alternate system of justice.” Under arbitration, “rules tend to favor businesses, and judges and juries have been replaced by arbitrators who commonly consider the companies their clients, The Times found.” 

NTSB criticizes tire recall process.

Coverage of the NTSB’s special investigation report on tire safety continues garnering significant media coverage. Rubber News (10/28, Moore) reports the agency has 11 recommendations to address the tire recall process. “The current tire registration process has proven to be ineffective in enabling tire manufacturers to compile complete and accurate customer contact information, which is vital to ensuring the success of a tire recall,” the NTSB said in the conclusions in its report. “We cannot change what happened in the past, and we cannot bring back the 539 fathers, mothers, sons, daughters and friends who lost their lives due to tire causes in 2013,” NTSB Chairman Christopher Hart said. “But action on today’s recommendations can help bring those numbers down in future years,” he added. The NTSB’s recommendations to the NHTSA call for changes to standards, recall, and safety requirements.

        KXAN-TV Austin, TX (10/28, Ricke, 119K) reports that according to the NTSB, “close to two million tires could be too dangerous to be on the road right now, but the system for recalling those tires is broken.” Some 500 people are killed and 19,000 injured in the US each year in crashed involving faulty tire. T. Bella Dinh-Zarr, NTSB Vice Chairman asked “Why can’t be service tech tell me if my tires are recalled?” to which NTSB Highway Safety Investigator Robert Squire answered, “The main reason for that is there’s no easy way to do it.”

        Landline Magazine (10/28, Fisher, 607K) reports the NTSB found the registration and recall system for tires “ineffective” and the tire industry provides “insufficient guidance on tire aging.” In its report, NTSB also “found that manufacturers’ registration process was ineffective,” the article reports. The NTSB however found that “more than 75 percent of all recalled vehicles have been serviced,” yet “the rate specific to tire recalls can be as low as 20 percent,” the article adds. The NTSB called on the NHTSA to streamline the way it lists recalled tires as it confuses website users.

        The story was covered on local television by KOIN-TV Portland, OR (10/29, 5:25 p.m. PDT, 29K), WCSC-TV Charleston, SC (10/28, 7:12 p.m. EDT, 27K) and WVTM-TV Birmingham, AL (10/28, 4:46 p.m. CDT, 13K). 

After a Delay of Years, Mazda Recalls 4.9 Million Vehicles

The New York Times

"As attention to auto safety intensified after General Motors’ admission last year that it had failed for a decade to disclose a deadly defect in millions of cars, many automakers have scrambled to address lingering safety problems. This week, Mazda became the latest automaker to do so, revealing for the second time in three months that it had known about safety problems for years before alerting customers. In the latest case, Mazda announced that it was recalling 4.9 million vehicles worldwide, including 1.4 million in the United States, because too much grease in the ignition switch could cause a short circuit and possibly a fire. The automaker knew about the problem seven years ago, according to a filing submitted this week to the National Highway Traffic Safety Administration. It took action only after Japanese regulators opened an investigation this year."

Important FDA Safety Communication

Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication

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Date Issued: October 15, 2015

Audiences:

• Health Care Providers who use heater-cooler devices
• Hospital staff who are responsible for operating and maintaining devices
• Infection Control Practitioners
• Infectious Disease Specialists
• Surgeons
• Perfusionists
• Operating Room Managers, Directors and Staff
• Risk Managers

Medical Specialties: Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Intensive Care Physicians

Product: All heater-cooler devices. Heater-cooler devices provide heated and/or cooled water to 1) oxygenator heat exchangers, 2) cardioplegia (paralysis of the heart) heat exchangers, and/or 3) warming/cooling blankets.

Purpose:The FDA wants to heighten awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.

Summary of Problem and Scope:Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.

Through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.

Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015. Some reports describe NTM infections related to cardiothoracic surgeries, but other reports do not specify the procedure the patient was undergoing. Eight reports were related to 3 events describing patient infections occurring in U.S. health care facilities. The remaining 24 reports involved health care facilities outside the United States, most of these in Western Europe. In some cases, patients presented with infections several months to years after their surgical procedures. It is important to note that half of the 32 reports submitted to the FDA describe bacterial contamination of the heater-cooler device without known patient involvement or infection. The FDA is not aware of NTM infections acquired by hospital staff.

It is possible that some cases have not been reported to the FDA. It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use of or exposure to a particular medical device. The FDA continues to evaluate reports through follow up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.

Recommendations for Health Care Facilities and StaffIn addition to following standard precautions, the FDA recommends that facilities and staff using heater-cooler devices consider implementing the following measures to reduce risk to patients:

• Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s device labeling. Ensure you have the most current version of the manufacturers’ instructions for use readily available to promote adherence.
• Do not use tap water to rinse, fill, refill or top-off water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for patient cooling during surgical procedures use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.
• Direct the heater-cooler’s vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
• Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers’ instructions to minimize the risk of bacterial growth and subsequent patient infection.
• Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
• Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer.
• Consider performing environmental, air, and water sampling and monitoring if heater-cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.
• Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.
• Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect heater-cooler devices have led to patient infections.

FDA Activities:The FDA is actively engaged with stakeholder groups to better understand the causes and risk factors for transmission of microbial agents associated with these devices and to develop strategies to minimize patient exposure. Our ongoing activities include:

• Working with health care facilities and professional medical societies to understand their experiences with heater-cooler devices.
• Evaluating information about documented and potential infections from multiple sources, including medical device adverse event reports submitted to the FDA, the medical literature, international public health agencies and federal partners.
• Collaborating with medical device manufacturers to review their existing cleaning and disinfection protocols provided in the instructions for use for currently marketed devices.

FDA continues to actively monitor this situation and will provide updates as appropriate.

Reporting Problems to the FDA:Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers’ instructions for use to the agency via the Medical Device Reporting (MDR) process. If a health care provider suspects bacterial contamination of the heater-cooler device following use, we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Additional Resources:
Centers for Disease Control and Prevention. Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices. Safety Alert. October 2015.

American Thoracic Society. An Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacterial Diseases: 2007.

European Centre for Disease Prevention and Control (ECDC). Rapid Risk Assessment: Invasive cardiovascular infection by Mycobacterium chimaera potentially associated with heater-cooler units used during cardiac surgery: April 30, 2015.

References:Kohler, P.; Kuster, SP.; Bloemberg, G. Healthcare-associated prosthetic heart valve, aortic vascular graft, and disseminated Mycobacterium chimaera infections subsequent to open heart surgery. Eur Heart J. 2015 Jul 17. (Abstract)

Sax, H.; Bloemberg, G.; Hasse, B.; et al. Prolonged outbreak of Mycobacterium chimaera infection after open chest heart surgery.  Clin Infect Dis. 2015 Mar 11.(Abstract)

Falkinham JO.; Pruden A.; Edwards M. Opportunistic Premise Plumbing Pathogens: Increasingly Important Pathogens in Drinking Water. Pathogens 2015;4(2):373-386.

Contact Information:If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

Fiat Chrysler issues recalls.

NBC News (10/28, 3.32M) reports that Fiat Chrysler Automobiles “said Tuesday it is recalling 86,046 Ram trucks and 93,895 Jeep Cherokee sport utility vehicles for two different safety issues.” FCA “said the recall of certain 2015-2016 Ram 1500 pickups produced between mid-June and late September this year is to inspect and replace rear axles,” the article reports. This comes after an internal investigation found axle shafts on some trucks could “overheat and trigger the anti-lock brake system warning light, leading to component fracture and possible wheel separation,” the article adds. Meanwhile, the recall targeting certain 2015 Jeep Cherokee SUVs “is to replace air-conditioning lines that may have been installed close to the engines’ exhaust manifolds, posing a fire risk,” the article continues.

        The Detroit News (10/27, Shepardson, 545K) reports that the automaker launched its investigation into the issue after two owners complained to the NHTSA, citing incidents involving smoke and fire. FCA “told NHTSA it has 31 reports of low-mileage failures in new Ram pickups,” the article reports. Earlier this year, “Fiat Chrysler agreed to a record setting $105 million, three-year consent decree with NHTSA for failing to properly carry out 23 recall campaigns covering more than 11 million vehicles,” the article adds.

        The story was also covered by the AP (10/27) and Reuters (10/27, Ajmera

General Motors announces third recall.

The CBS Evening News (10/27, story 10, 0:25, Pelley, 5.08M) reported, that after General Motors attempted two repairs that failed, it announced Tuesday a third recall of nearly 1.3 million 1997-2004 cars. “Oil leaks have started fires in more than 1300 of these cars after they were supposedly fixed by dealers,” CBS reported.

        ABC World News (10/27, story 11, 0:15, Muir, 5.84M) reported that GM is in fact recalling 1.4 million older vehicles, including “the Chevy Impala, Pontiac Grand Prix and more.”

        The New York Times (10/28, Jensen, Subscription Publication, 11.64M) reports that the recall is in fact the fourth for GM and is targeting 1.4 million vehicles, including about 1.3 million in the US. Alan Adler, a GM spokesman, said that associated malfunctions resulted in 19 minor injuries, as well as damage to some structures, such as garages. All models involved have a 3.8-liter V6 engine.” The models covered are the 1997-2004 Pontiac Grand Prix; 2000-4 Chevrolet Impala, 1998-99 Lumina and 1998-2004 Monte Carlo; 1998-99 Oldsmobile Intrigue; and 1997-2004 Buick Regal,” the article reports. The NHTSA received complaints from some customers, including the owner of a 2001 Buick Regal.

        The story was also covered by the AP (10/27, Krisher). 

York Hospital Patients May Have Been Exposed to Bacteria

WellSpan York Hospital is warning patients who had open-heart surgery at the hospital over a three-and-a-half-year period that they may have been exposed to bacteria.

The issue affects approximately 1,300 patients who had surgery at the hospital between Oct. 1, 2011 and July 24, 2015, according to WellSpan.

Defective air bags being sold online.

Bloomberg News (10/23, Plungis, 2.66M) reports that “an underground market is growing” online for unauthorized replacements for Takata’s recalled air bags. Jennifer Timian, chief of the NHTSA’s recall management division, said that the agency has “learned of defective air bags for sale on EBay Inc,” according to the article. She said that consumers should only buy replacement air bags from authorized dealers. Timian is quoted as saying, “Under no circumstances should a person purchase an air bag off the Internet, or from a salvage yard or any other unauthorized source.” 

Mazda recalling 1.36 million vehicles in the US over ignition switches.

The AP (10/22) reports that Mazda “is recalling 4.9 million older vehicles worldwide, including 1.36 million in the US, because ignition switches could overheat and catch fire.” The recall involved “the 1990-1996 323 and Protégé, the 1993-1998 626, the 1993-1995 929, the 1993-1997 MX-6, the 1989 to 1998 MPV and the 1992-1993 MX-3.” 

Toyota to recall 6.5 million cars over power window issue.

Reuters (10/21, Kim) reports that Toyota Motor Corp on Wednesday announced it will recall some 6.5 million vehicles globally over a defect in the power window switch in some models. In the US and North America, 2.7 million such vehicles will be subjected to repairs in a bid to fix the issue concerning the power windows. 

        GM recalls more than 3,000 trucks, SUVs for new ignition switch defect. USA Today (10/17, Gardner, 5.23M) reported online that General Motors announced Friday that it would be recalling “about 3,300 large pickup trucks and SUVs” due to newly discovered ignition switch defects. This comes but “a month after agreeing to pay $900 million to settle criminal charges” related to the earlier faulty switch problems. In this new case, some GM trucks “have ignition lock gears with an outer diameter that is larger than specifications, making them difficult to turn.” 

GM adds vehicles to Takata air bag recall.

USA Today (10/18, Snider, 5.23M) reports in continuing coverage on the addition of 395 General Motors vehicles to the Takata air bag defect recall. The problem, according to the NHTSA is that the air bags “may rupture when deployed, causing possible serious injury or death.”

        The AP (10/18, Krisher) reports that the global issue of “exploding Takata air bag inflators” has now “spread to newer vehicles, this time hitting a small number of 2015 General Motors cars and SUVs.” On Saturday, GM announced the recall of “more than 400 vehicles” due to potentially faulty side bag inflators that can “rupture and send shrapnel into drivers and passengers,” according to documents posted with NHTSA. As the AP points out, the Takata question “continues to widen with no end in sight.” NHTSA’s Gordon Trowbridge comments that “All Takata-made ammonium nitrate inflators are within the scope of our investigation,” adding that the agency “will take action” should it find “that additional recalls are necessary.”

        MLive (MI) (10/18, Al Hajal, 739K) reports that the number of recalled vehicles was “395 vehicles of six different models,” bringing the number of recalled vehicles with Takata airbags to “more than 19 million.”

        WIMS-AM South Shore, IN (10/17) also reported online. 

Medical malpractice rates “essentially flat” in 2015.

Medscape (10/7, Lowes, 232K) reports on a survey of medical malpractice rates by the Medical Liability Monitor finding that rates were “essentially flat” for 2015 in “three bellwether medical specialties” namely, obstetricians/gynecologists (up 0.6 percent), internists (up 0.5 percent), and general surgeons (down 0.2 percent). Rates fell in the Northeast, West, and Midwest, but were up 0.9 percent in southern states, with Texas, North Carolina, and Georgia having 5 percent increases. The report also found that 71 percent of rates were the same in 2015 as in 2014, 12 percent were lower, and 17 percent were increased. Decreases outnumbered increases in every year since 2006 until this year. 

NHTSA: Fiat Chrysler under-reported vehicular deaths.

The AP (9/30, Krisher) reports that the NHTSA on Tuesday said Fiat Chrysler failed to disclose “some deaths, injuries and other information to the agency as required by law.” Transportation Secretary Anthony Foxx “told reporters he will call a meeting in Washington with all auto industry CEOs to address a long list of failures to meet reporting requirements. In the past several years, the agency has fined Fiat Chrysler, Toyota, Honda, Hyundai, General Motors, Ford and others for failing to follow the law,” the article reports. “We need to have confidence the information we get is real and accurate information,” Foxx said. NHTSA “said its investigators found a discrepancy in reporting by Fiat Chrysler and notified the company in late July,” according to the article. “This represents a significant failure to meet a manufacturer’s safety responsibilities,” NHTSA Administrator Mark Rosekind said. “We’re still trying to uncover how deep the under-reporting is and how far back it goes,” Foxx said.

        CNN Money (9/29, Isidore, Marsh, 2.15M) reports that the Fiat Chrysler’s failure to notify the NHTSA resulted in fatal accidents not getting the attention they needed. “The news is obviously troubling,” Secretary Foxx said, adding, “NHTSA is still trying to uncover how far back this goes.” The article points to the TREAD Act, which “requires car companies to notify NHTSA every three months of accidents that caused injuries or deaths” and of mechanical problems. “NHTSA will take appropriate action after gathering additional information on the scope and causes of this failure,” said Rosekind. Fiat Chrysler for its part said it “takes this issue extremely seriously, and will continue to cooperate with NHTSA to resolve this matter and ensure these issues do not reoccur.”

        The New York Times (9/29, Vlasic, Subscription Publication, 11.82M) reports that Secretary Foxx said Fiat Chrysler’s admission is “troubling,” and “said it underscored the need for a meeting with automakers to emphasize the importance of safety reporting rules.” Foxx said, “We’re giving strong consideration to calling everybody in.” He explained, “There are a number of issues on the table right now that merit discussion across many of the manufacturers at this point.” New penalties could be levied against the company after it admitted to under-reporting, which was “discovered in an internal review tied to the company’s recent $105 million settlement over its handling of recalls.”

        The Detroit News (9/29, Shepardson, 493K) reports that Secretary Foxx on Tuesday said that “It’s time to bring everybody in here and have a deeper conversation about go-forwards.” He added, “There are a number of issues on the table right now that probably merit discussion across many of the manufacturers. And one of them is, ‘Look folks, we have millions of people who rely on what you make every day to get from everywhere from work to putting their most precious cargo — their kids — in cars, and we need to have confidence that the information that we get is real and accurate.’” Foxx said, “We’ve fined heavily where we can. We’ve also added in on top of that consent agreements that give us greater authorities to peer behind the veil.” He has called on Congress to increase “maximum fines for failing to recall vehicles to a maximum $300 million from the current $35 million,” the article reports. Foxx said he has yet to invite automakers.

        The AP (9/29) reports that Foxx said, “We need to have confidence the information we get is real and accurate information.”

        The Hill (9/30, Laing, 471K) reports that in light of the recent “revelations that German automaker Volkswagen has been cheating Federal pollution emission standards to trick regulators into believing their cars are more fuel efficient than they actually are.” Foxx “said Tuesday the Environmental Protection Agency (EPA), which made the allegations against Volkswagen, is taking the lead on punishing them for their violations, which VW has admitted,” the article reports. “Because it deals with emissions, the EPA is rightly in the lead on this,” he said, adding that the NHTSA is backing the EPA’s efforts. “We’re playing an assist role here and following the lead of the colleagues at the EPA,” Foxx continued.

        The story was also reported by the Wall Street Journal (9/29, Spector, Subscription Publication, 5.95M), USA Today (9/29, Bomey, 5.23M), USA Today (9/30, Jansen, 5.23M), the Rochester-Rochester Hills (MI) Patch (9/29, Dalbey), and Reuters (9/29, Morgan).