Friday, October 21, 2016

NHTSA confirms 11th US fatality linked to Takata airbag inflators.

ABC World News Tonight (10/20, story 8, 0:20, Muir, 14.63M) reported US Federal highway officials have confirmed another fatality “linked to a Takata air bag inflator in a 2001 Honda Civic that had been recalled in 2008, but was never repaired.” NBC Nightly News (10/20, story 6, 0:25, Holt, 16.61M) reported the National Highway Traffic Safety Administration “says a 50-year-old woman died from injuries in a crash on September 30th,” which NBC notes is the “11th confirmed US fatality tied to ruptures of Takata air bag inflators.” MLive (MI) (10/20, 609K) mentions Transportation Secretary Anthony Foxx said in June, “With as high as a 50 percent chance of a dangerous air bag inflator rupture in a crash, these vehicles are unsafe and need to be repaired immediately,” and has continually encouraged motorists go “straight to a dealer to have them repaired immediately, free of charge.”

        Additional coverage is provided by the AP (10/20), Automotive News (10/20, Beene, 185K), Reuters (10/20), Bloomberg News (10/20, Lippert, 2.49M), the Huffington Post (10/20, 224K), Riverside (CA) Press Enterprise (10/20, Brooks, 328K), KCAL-TV Los Angeles (10/20, 176K), the Los Angeles (CA) Times (10/20, Press, 4.52M), and KABC-TV Los Angeles (10/20, 668K). 

Thursday, October 20, 2016

Self -Driving Cars and Crash Avoidance Systems: The Future of Car Crashes”.
                                                                                      Jaime D. Jackson
                                                                                      Atlee Hall, LLP

Crash Avoidance Systems (CAS) or Crash Avoidance Technology (CAT) is now becoming widely implemented in production vehicles. CAT has already had an impact on how car crash cases are litigated, and who the proper defendants may be, and will continue to have a more dramatic impact as this technology continues to be developed and implemented.  THIS IS NOT THE FUTURE THIS IS NOW!

The wide-spread implementation of  Crash Avoidance Systems (CAS) otherwise known as Crash Avoidance Technology (CAT)  will revolutionize the concept of driving. It could be the first step toward autonomous driving, perhaps along with the many currently-performing  driverless car projects, including Google and Uber, but more importantly it could be a huge step toward increased road safety if this technology is tested and implemented in the right way. All CAS and CAT  systems have a clear purpose of not only driver safety, but complete road safety. CAS is not just some idealized goal to be accomplished in the future, but it is happening right now. Although we might best classify CAS and CAT as within the first stage of implementation, automotive manufacturers and suppliers are moving quickly to get this technology on the road, and the industry push to driverless cars is on full force..

Automotive manufacturers and suppliers are moving quickly to get this technology on the road. It is expected there will be more that 100,000 autonomous cars on American highways by 2025. We are already seeing these ads on TV, as there is a push to be first to market or on the leading edge. Chevy put out new commercials about Forward Collision Warning (“FCW”) being “available” on its new Chevy Equinox.[1] These ads show focus groups being introduced to FCW on the Equinox. A focus group member says “Maybe Ford should try to keep up” after the moderator tells them that the Ford Edge does not have Forward Collision Warning. Think about “failure to equip cases” against auto manufacturers, as safety should not be an option.   Mercedes has a demolition derby ad for its 2014 M –Class where the announcer states, “Its almost as if it couldn’t crash even if it tried[2]

As the automotive industry has shown, flaws and defects in vehicles continue, For example, in May, Honda recalled some 2014-2015 Acura MDX 2WD and AWD, RLX and 2014 Acura RLX Hybrid vehicles, because its Collision Mitigation Braking System could incorrectly interpret certain roadside objects such as metal fences or metal guardrails as obstacles and unexpectedly apply the brakes. Over three miles of wiring, weighing more than 150 pounds, is in a modern car.  It, and its associated connectors, is reportedly the third heaviest component in a car, after the engine and transmission (Car & Driver, p. 34, December 2013

In order to better understand how crash avoidance systems and crash avoidance technology will effect car crash litigation, it is first important to gain an understanding of what this technology is, what its function is and how it effects the drivability of the car. This technology has an effect on how these cases are prosecuted, for instance what exactly are the negligence claims against the driver, may have a different flavor, for example failing to properly respond to the forward collision warning (FCW) or the Side View Assist (SVA). The distracted driver?  Technolgy will effect how these cases are defended, for example, a defense may be, “this rear end crash was not the driver’s fault because the car was equipped with Automatic Emergency Braking (AEB), that did not engage in time to avoid the crash. And perhaps most importantly, who is responsible for the crash? The driver? The automated vehicle that did not avoid the crash? Both? This is a whole somewhat new area of the law and litigation. One must also consider litigation against the auto manufacturers for failing to equip its vehicles with Crash Avoidance Technologies that have been available for years, and then if the technology fails or malfunctions, or does not perform properly due to software errors or defects, may subject the auto manufacturer to auto product liability claims.  

Current Crash Avoidance Technology (CAT)

The Insurance Institute for Highway Safety (IIHS) has created a program for evaluating the performance of front crash prevention systems to raise consumer awareness of safety options and encourage auto manufacturers to adopt and continue developing this technology. (see, The program ranks vehicles based on the availability and functionality of  crash avoidance systems. A higher ranking is given to vehicles that utilize crash avoidance technology.
Forward Collision Warning and Automatic Emergency Braking
Forward Collision Warning, (FCW) the most passive of the front crash avoidance technology, which uses camera, radar, and/or laser equipment for object recognition and speed detection, and alerts the driver via visual, audio, or haptic warning to apply the brakes when the relative speed between a vehicle and object in the road presents a risk of impending collision.

Automatic Emergency Braking, (AEB) the most active of the front crash avoidance technology, which automatically engages the full braking potential of a vehicle to either completely prevent a frontal collision or slow the vehicle down to mitigate severity when an imminent collision is detected. AEB is a camera-based or radar-based system that utilizes object recognition and speed detection to determine whether the relative speed between a vehicle and object in the road presents a risk of impending collision. A camera-based system uses a mounted camera with object recognition on the windshield behind the rearview mirror, and the radar-based system uses a 24 GHz medium-range sensor connected to a warning device.
In conjunction with FCW, the Automatic Emergency Braking System (AEBS) or Predictive Emergency Braking System (PEBS) activates automatically when the FCW system determines that the distance between the driver and a vehicle or object in road is becoming critically short. When a critical situation is detected, the system may alert the driver, may initiate partial braking, and may prepare the brakes for emergency stopping in such a way that the driver may engage full braking potential as soon as the slightest pressure is applied to the brake pedal.

On the other hand, something to consider is that while forward collision warning is intended to alert the driver to an impending collision it can also be distracting or create a false sense of security or in attentiveness because the driver believing the car will stop itself or avoid a crash.
Dynamic Brake Support

Other crash avoidance technologies include Dynamic Brake Support, a hybrid of passive and active front crash avoidance technology, which pre-conditions the brakes when a collision is detected so that full braking power is applied with even slight force to the brake pedal, to shorten the vehicle’s stopping distance.

Pedestrian Detection Systems

Some vehicle also include Pedestrian Detection systems which warn the driver or automatically engage emergency braking when pedestrians are detected either in the same lane as the vehicle or to be moving dangerously into this direction. BMW and Toyota are currently implementing this technology.

Crash or Injury Mitigation Systems

Apart from crash avoidance technology, suppliers and manufacturers are working on adaptive restraint systems and other pre-crash systems. TRW, for example, is producing the Active Control Retractor, a system that provides full or limited reversible belt retraction when dangerous situations are detected. Similarly, Mercedes has implemented a system called Pre-Safe into their latest line of production, a system which automatically engages when an imminent collision is detected and prepares the vehicle’s occupants by tightening the front seat belts, adjusting the front head restraints and passenger seats, and closing the windows and sunroof. It is important to know in whether your client’s vehicle was equipped with such safety systems when analyzing their injuries.

Adaptive Cruise Control

Adaptive Cruise Control (ACC) technology is another area that will continue to flourish. These systems automatically engage the vehicle’s brakes and acceleration to control the distance between the driver and other vehicles or objects on the road. For example, when the cruise control is set on the highway and a slower moving car merges ahead, a vehicle will automatically engage the brakes to prevent or mitigate a collision. When that car merges back over, the ACC system will bring the vehicle back up to speed. TRW’s system utilizes a 24 GHz ISM frequency band radar sensor to detect relative speeds between a vehicle and object in the road. Bosch is also producing ACC systems, and manufacturers such as Infiniti, BMW, Opel, Cadillac, Jeep, Dodge, Ford, and Toyota have already designed their newest models with this safety feature.

A sub-system of the ACC technology, called the Stop-and-Go system by some manufacturers, is designed for use in traffic jams, and will automatically accelerate, steer within the same lane, and bring the vehicle to a stop. The driver’s vehicle will basically follow the vehicle in front of it as long as it is in the same lane. Accordingly, when the Stop & Go feature is engaged in a traffic jam and a vehicle ahead merges into a separate lane, your vehicle will begin to follow the next-in-line forward vehicle. The system developed by Bosch will automatically activate, when the ACC function is being used, at speeds below 20 mph. Bosch has stated that “[i]n the following years, the system will be enhanced to cover ever-faster speeds and more complex driving situations, including automatic lane change.” Manufacturers including VW, BMW and Jeep are currently utilizing this feature in their 2015 production line.

Lane Departure Assist Systems

Additionally, Lane Assist systems, including such technology as Lane Departure Warning (LDW), Lane Keeping Assist (LKA), and Lane Centering Assist (LCA), are all designed to promote lateral safety. LDW is a camera-based system that provides a driver with visual, audio, or haptic (involving a vibrating steering wheel or seat) warning when the driver’s vehicle unintentionally crosses a road lane marking or the edge of the road. LKA is also a camera-based system and is designed to utilize electronically powered steering to provide counter-steering torque to assist the driver in moving back into the center of the lane. LCA is essentially an LKA system, except that its purpose is to continually assist the driver in keeping the vehicle in the center of the lane. To prevent misuse of the system for autonomous driving, both the LKA and LCA employ hands-off detection systems. Furthermore, for safety reasons, both the LKA and LCA are designed to be easily overruled by the driver. Automotive suppliers producing this technology include TRW and HELLA. Manufacturers currently implementing Lane Assist technology include Infiniti, BMW, Opel, Mercedes, Cadillac, Jeep, Hyundai, Honda, Ford, and Toyota.

Similar to the Lane Assist systems, Side View Assist (SVA) systems promote lateral safety by continually monitoring a range of area alongside and diagonally to the rear of the vehicle through an ultrasonic sensor. When another vehicle is situated in the monitored area, a warning LED light may display in the driver’s side mirror. If the driver uses a turn signal while a vehicle is in the monitored area, an audible warning will activate. The SVA system is not activated by stationary roadside objects, such as guardrails, poles, or parked vehicles. Bosch is currently producing SVA systems, and manufacturers including Infiniti, Volvo, Mercedes, Cadillac, Jeep, Hyundai, Honda, GM  and Ford, have implemented similar technology into their current line of production.

Back Up Systems and Rear View Safety

We will also be seeing a big jump in rearview safety, as NHTSA has issued a rule under the Federal Motor Vehicle Safety Standards (FMVSS) that will require all new vehicles weighing less than 10,000 pounds to have rearview visibility systems giving the driver a 10-foot by 20-foot zone of vision directly behind the vehicle while backing up.[3] Although the rule does not explicitly mandate the use of cameras to achieve this goal, the most practically available means of compliance would require auto manufacturers to install rearview cameras. NHTSA has included a phase-in period to ease the burden on manufacturers. For new vehicles manufactured after May 1, 2016, but before May 1, 2017, 10% of all new vehicles must be in compliance; 40% new vehicles manufactured after May 1, 2017, and before May 1, 2108, must be in compliance; and, finally, for new vehicles manufactured after May 1, 2018, 100% of a manufacturer’s fleet must be in compliance with NHTSA’s rearview visibility requirements.[4] NHTSA estimates that 58 to 69 lives will be saved each year, not including injuries prevented, once the entire on-the-road vehicle fleet is equipped with rearview visibility systems that meet these requirements.[5]

Parking Assist Systems

Parking Assist systems, such as Parking  Assistant, Parking Aid, and Rear Cross Traffic Alert, are all designed to promote safe backing up techniques. The Rear View System complements a normal rear-view camera with an ultrasonic sensor, giving the driver the ability to see an image of what is behind the vehicle as well as the distances of objects behind the vehicle. Parking Assistant utilizes an ultrasonic sensor and calculates the best path into a parking spot. Once found, the system alerts the driver to press a button to park. The driver will still have to engage the gas and brakes, but the steering will be hands-free. Parking Aid gives the driver an alert when ultrasonic sensors in the front and rear of the vehicle detect an object within 250cm of the vehicle. The Rear Cross Traffic Alert system issues an audible or visual warning to the driver when the vehicle is backing out of a parking space and other vehicles are crossing to the right or left behind the driver’s vehicle.

First Licensed Autonomous Commercial Truck
On May 5, 2015, Nevada became the first state to license an autonomous commercial truck to operate on a US public highway.[6] The first-licensed Freightliner Inspiration Truck, manufactured by Daimler Trucks North America (DTNA), underwent over 10,000 miles of testing in Papenburg, Germany, before receiving a special operating license from the Nevada Department of Motor vehicles.[7] Although the truck is not completely autonomous, DTNA categorizes it as a Level 3 on NHTSA’s five-level (0 to 4) scale of autonomous vehicle operating systems.[8] “Vehicles at this level of automation enable the driver to cede full control of all safety-critical functions under certain traffic or environmental conditions and in those conditions to rely heavily on the vehicle to monitor for changes in those conditions requiring transition back to driver control.”[9] According to DTNA, autonomous vehicles will allow their drivers to work more efficiently by, for example, handling logistical tasks, including scheduling and routing.[10]

Advanced Lighting Systems

Intelligent Headlight Control systems utilize a video camera to measure ambient brightness and estimate the distance from vehicles in front and oncoming traffic. Bosch’s system includes three different functions: the driver may set the high beams to switch on or off automatically depending on whether other vehicles are detected; the driver may set the high beams to continually adjust between low and high beam levels depending on the distance between the driver’s vehicle and other vehicles; or the driver may set the high beams so that they automatically tilt either vertically or horizontally depending on where other vehicles are located.

Night vision systems utilize either an active infrared light invisible to humans or a thermographic camera to provide the driver on a video screen the ability to see greater distance than is possible with conventional low beam lights

Additional Features

Road Sign Recognition systems utilize a video camera to detect speed limit road signs and then display the speed limit in the form of a symbol in the cockpit of the vehicle. The driver has an option to employ an audible warning when the vehicle’s speed exceeds the speed limit.

Driver Drowsiness Detection is a system that identifies when a driver does not steer for a brief period of time and then makes an abrupt correction to the steering. The system analyzes the frequency and strength of the driver’s reactions, as well as other data such as vehicle speed, time of day and use of other indicators, to calculate a threshold for when to engage warning signals. Warning signals may be visual or audible to remind the driver of the danger of nodding off at the wheel.

Self Driving or Autonomous Vehicles

The crash avoidance technology outlined above are the fundamental building blocks to driverless cars. While perhaps we have seen in movies or on television, “self driving cars” for years now, this technology already exists and has existed for some time. Google and major car manufacturers are currently test-driving and developing driverless cars. It is expected there will be more that 100,000 autonomous cars on American highways by 2025. This will greatly impact liability and the law of car crashes moving forward.  Law Schools are  already teaching  courses on the law of autonomous driving. In preparation for the widespread use of self-driving cars, states are beginning to pass autonomous vehicle laws. The National Highway Traffic Safety Administration (NHTSA) is currently researching autonomous vehicle technology to develop appropriate regulations.

Generally speaking autonomous, in otherwords, self driving vehicles utilize technologies that navigates, detects traffic, and measures and analyzes the surroundings through the use of radar sensors, laser rangefinders, video cameras, global positioning systems (GPSs), and maps. The laser rangefinders map out the driving environment, the cameras and vehicle radars . . . detect potential obstacles, and the GPS determines the location of the vehicle to help it stay on the correct path.

Governments New Highly Automated Vehicle Guidelines Fail to Protect the American Public
The recent guidelines published by the National Highway Traffic Safety Administration NHTSA abdicate its mandate which would have resulted in thoughtful, thorough, national regulations that ensure, transparency, safety, and accountability, instead they are simply deffering to the industry to regulate itself and passing the buck down to the states. The guidelines clearly lack legally enforceable regulations and may allow the possibility of states  weakening  existing liability laws that protect consumers  and  permit manufacturers of unsafe and malfunctioning  vehicles to escape responsibility for harm caused when a highly automated vehicle (HAV)  crashes.
NHTSA must not delegate its regulatory responsibilities to the states. NHTSA must issue a minimum federal performance standard for Highly Automated Vehicles (HAV’s), and make clear there is no preemption. Designers and manufacturers must be held accountable for any harm HAVs cause.

This announcement should not be seen as an alternative to comprehensive safety standards, thorough oversight and strong enforcement. The promising benefits of HAVs are great, but the potential problems are too serious and the public safety risks are too momentous to be left to industry alone. Recent incidents involving the recall of tens of millions of vehicles and needless deaths and injuries due to faulty General Motors’ ignition switches, dangerous Takata airbags and cheating emissions systems in Volkswagen vehicles highlight how the industry easily conceals problems from both the public and the government.
The Department of Transportation (DOT) must use its federal regulatory authority to assure the American public of the safety of HAVs. Safety performance standards encourage competition among automotive companies because they help to assure a market for the real innovators and suppliers. The manufacturers always complain about new federal protections, but HAVs are a whole new technology with great promise but also with the potential for serious public harm.
The advent of this new technology and its release is happening so quickly that the NHTSA claims it is not ready to issue minimum regulatory performance standards. NHTSA has surrendered its Congressional mandate to manufacturers and the States. This is abhorrent of the National Traffic Safety Act. In doing so, it appears that we’re heading toward a hodge-podge of state regulations or no regulation whatsoever.
The addition of HAVs to the marketplace  represents a brand new area in which vehicle manufacturers will compete for sales.  There are billions of dollars of profits at stake. The more “autonomous” features that are offered, the greater the marketing opportunities. This certainly explains the frenzy of car companies to market each feature and to be the “first” with the “most” automated features.

Those who would market and profit from this technology – vehicle manufacturers and their suppliers – have organized major lobbying efforts suggesting that laws should be passed granting them immunity and shielding them from liability when injuries and deaths happen because of the failure of this new technology. They want taxpayers and state health care systems to fund their mistakes. That's not fair!

If corporations are confident that their highly automated vehicles will work properly and safely, why do they want immunity? Why should this industry get blanket protection?  Why should they even be worried about having to accept responsibility if their technology fails? Because history has proven that vehicle design changes, and especially those involving new technology, can cause injuries and deaths.

In their rush to introduce as many computer driven safety features as possible, and reap the profits of increased sales, car manufacturers must not put vehicles on our highways unless each feature has been properly designed and fully tested to be certain of their effectiveness.  To fail to do so would surely expose the motoring public to new and unidentifiable risks of injury and death.

Without well thought out regulations, the marketplace must  demand that each company that participates in the design, manufacture or sale of highly automated vehicles commit – publicly – to take full responsibility, including accepting legal liability – for collisions and their consequences when such features fail.

Given the extensive deference the NHTSA has shown to the industry when it comes to the safety of HAVs, the industry must chose to accept responsibility and accountability for the self-driving vehicles it puts on America’s highways and to which American citizens entrust the lives of our families. As companies work to develop HAVs and  collision avoidance technology (CAT) such as “lane departure warnings,” “lane departure steering control,” “auto brake features,” “frontal object detection,” “rearward object detection,” and “auto pilot,” it has become increasingly clear that consumers are totally reliant on manufacturer’s skills and willingness to provide the safest available systems. While the industries’ efforts, as well as the voluntary guidelines promulgated by NHTSA, are a good first step, countless safety concerns remain when it comes to HAVs and CAT that could expose consumers to unnecessary harm if they are not properly designed and fully tested. Recognizing this, every manufacturer should follow the lead of Volvo Cars, whose chief executive officer recently stated his company’s commitment:
Manufacturers should be held responsible if their autonomous technology causes car accidents. We are the suppliers of this technology and we are liable for everything the car is doing in autonomous mode.” –President and CEO Hakan Samuelsson, October, 2015.

          As HAVs become a reality, with the singular goal of making highway travel safer, it is vital that American consumers be able to trust that each manufacturer has made its vehicles safe and reliable. To this end,  every other vehicle and component manufacturer must join with Volvo Cars and make a public pledge to accept responsibility for harm and injury resulting from a collision that occurs because of the failure of an autonomous feature or when one of its automated systems either malfunctions or fails to perform as intended.  Absent such a pledge how can the NHTSA, the states and the American Public trust the safety of their families to these highly automated vehicles?

The guidelines do appear to indicate  DOT is planning to address these issues and seeking public comment for this new system of transportation; but it must not shy away from assuring public safety with minimum federal vehicle safety standards and means to hold manufactures responsible and accountable. It should not rely on mere guidance, deference to the industry and each individual state. NHTSA must not delegate its regulatory responsibilities to the states. NHTSA must issue a minimum federal performance standard for Highly Automated Vehicles (HAV’s), and make clear there is no preemption. Designers and manufacturers must  be held responsible and accountable for any caused when an HAV does not perform as intended or malfunctions.

Moving Forward

This technology will have a dramatic effect on how car crash cases are litigated and we need to be prepared for it. It will greatly impact insurance rates and insurance premiums as this technology is implemented the number and severity of crashes will no doubt decrease. It also raises the question as the whether the driver or the vehicle is responsible for the crash? Or both?  Despite what the manufacturers have told us, CAT technology will fail and crashes will be out there. While we hope the opposite is true, we must continue to be on the lookout for cases involving defective CAT technology. And we must be just as eagerly monitoring for the “failure to equip” cases, in other words not having this technology as standard equipment on all vehicles, including commercial vehicles. Safety is not an option. Other cases may involve the technology simply not performing as intended or expected, such as the problems noted above with the Acura Collision Mitigation Braking System incorrectly interpreting certain roadside objects like metal fences or metal guardrails as obstacles and unexpectedly applying the brakes.

The legal profession, as it has always done, will play a critical role in protecting the American public, and holding the automotive industry accountable when their vehicles fail and harm the public.

[1] See Math Problems and Think Fast, (last visited Nov. 30, 2015).

[2] See Demolition Derby 2014 Mercedes Benz M Class, (last visited Nov. 30, 2015). Such ads may be useful to show drivers are entitled to rely on this technology.

[3] 49 C.F.R. § 571.111 (2014).

[4] 49 C.F.R. § 571.111 (2014).

[5] Rule Document on Rear Visibility,!documentDetail;D=NHTSA-2010-0162-0256 (last visited Nov. 30, 2015).

[6] Freightliner Inspiration Truck Receives Autonomous Vehicle Licensing from Nevada DMV, PRNewswire (May 5, 2015),
[7] Freightliner Inspiration Truck – the first licensed autonomous driving truck in the US, Daimler (May 5, 2015),
[8] Freightliner Inspiration Truck Unveiled at Hoover Dam, Freightliner (May 5, 2015),
[9] NHTSA Preliminary Statement of Policy Concerning Automated Vehicles, (last viewed May 18, 2015).
[10] Freightliner Inspiration Truck Unveiled, supra note 16.

Friday, October 14, 2016

Bacterial infection in heart patients linked to surgical device, CDC says.
The Washington Post (10/13, Sun, 10.14M) reports that “more than half a million patients who had open-heart surgery in the United States since 2012 could be at risk for a deadly bacterial infection linked to a device used during their operations...said” the CDC yesterday. The Post adds that “in US hospitals where the infection has been identified, officials say the risk remains low – between 1 in 100 and 1 in 1,000, according to Mike Bell, CDC deputy director of health care quality promotion.”
        The New York Times (10/13, Tavernise, Subscription Publication, 13.42M) reports a heater-cooler machine “that infected at least 12 patients at a Pennsylvania hospital last year was probably tainted at the plant in Germany where it was made,” according to an investigation by the Centers for Disease Control and Prevention and the Pennsylvania Health Department. Investigators took samples from multiple patients and devices connected to the infection outbreak and found that they all matched suggesting they came from a single source.
        The AP (10/13, Stobbe) reports that “the contamination has been tied to 28 cases in the US, including at least four who died.” According to the AP, “The outbreaks have been tracked to certain heater-cooler devices, which are used...during some heart operations.” However, “officials think hundreds or thousands of other patients” may have also “been infected.”
        The Wall Street Journal (10/13, Winslow, Subscription Publication, 6.37M) reports that the device is called the Stöckert 3T. Dr. Bell said, “We definitely have a multistate outbreak related to this one machine.”
        STAT (10/13, Boodman) reports that in a statement, the CDC said, “Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.” The data were published in the CDC’s Morbidity and Mortality Weekly Report.
        Reuters (10/13, Jain) reports that the CDC “released an advisory” yesterday “to help hospitals and healthcare providers identify and inform patients who might have been put at risk.”
        The Seattle Times (10/13, Aleccia, 1.18M) points out that “officials with the CDC and the” FDA “issued alerts about potential infections linked to the heater-cooler units in 2015.”
        MedPage Today (10/13, Lou, 132K) reports, “After further investigating Myocobacterium chimaera infections associated with the Sorin/LivaNova Stöckert 3T Heater-Cooler System used for temperature control during cardiothoracic surgery, the FDA updated the safety warning.” MedPage Today adds, “Facilities should immediately stop using any 3T device or accessory that has tested positive for M. chimaera or has interacted with an infected patient, the agency recommended.”
        Also covering the story are the Newark (NJ) Star-Ledger (10/13, O'Brien, 438K), the Greenville (SC) News (10/13, Osby, 189K), Medscape (10/13, Hand, 327K), HealthDay (10/13, Preidt, 24K), and Forbes

Thursday, October 13, 2016

Samsung officially announces expanded recall.

The AP (10/13, Lee) reports Samsung announced an “expanded recall of Galaxy Not 7 smartphones in the U.S” on Thursday, adding replacement Note 7s to the original recall. The Consumer Product Safety Commission said there were 1.9 million handsets “subject to the expanded recall,” noting there have been 96 incidents of overheating batteries in the US, “including 23 new reports since the first recall announcement.” In an effort to “retain customers,” Samsung will give a $100 credit to any Note 7 owner who decides to “switch to another Samsung phone.” Bloomberg News (10/13, Levin, Lee, 2.49M) also reports.
        The New York Times (10/12, Sang-Hun, Subscription Publication, 13.42M) reports in continuing coverage that Samsung cut its “third-quarter profit estimate by a third on Wednesday” following its decision to end production of its Galaxy Note 7. The Times notes Samsung’s revised guidance was $2.3 billion (2.6 trillion won) lower than previous estimates, a drop of about a third. The company also revised its revenue downward by 2 trillion won, to 47 trillion won.
        Writing at Bloomberg Business (10/12, 2.49M), Tim Culpan says the profit adjustment is “welcome news” as it shows “executives have signaled their willingness to quickly recognize the massive scale and sope of the costs.”
        Reuters (10/12) reports Smasung’s new 2016 Q3 profit estimate would fall “30 percent below its third-quarter 2015’s operating profit.” HDC Asset Management fund manager Park Jung-hoon predicts fourth quarter profits could also be cut “but it likely won’t be as large as the third quarter.” Reuters adds that Samsung’s stock price decline of 10% so far this week puts it on track for its largest “weekly decline since May 2012.” Reuters notes Park also thinks a share buyback could “mollify shareholders whose nerves have been jangled.” Reuters adds that some analysts are predictiong the company will make a push to “get the latest version of its premium S-series smartphones to market as soon as possible.”
        CNN Money (10/12, Mullen, 3.7M) reports that Nomura Securities expects a total sales hit of $9.5 billion and a profit decline of $5.1 billion through the end of 2017.

        USA Today (10/12, Lee, Bailey, 6.42M) reports the problem with the replacement Note 7 phones is “still unidentified,” according to South Korea’s safety agency. Oh Yu-cheon of the Korean Agency for Technology and Standards said, “The improved product does not have the same defect. That’s why we think there is a new defect.” Jackdaw Research’s Jan Dawson said the company will need “to come up with a convincing story and a set of actions that will reassure customers that when they buy an S8, it’s going to be safe” by the time it is expected to launch in late winter to minimize total fallout. 

Tuesday, October 11, 2016

Volkswagen, Audi issue North America recalls due to fuel leaks.

Reuters (10/7) reports that Volkswagen and Audi are recalling around 334,000 vehicles in Canada and the US under three separate recalls. Each of the recalls is related to fuel leaks, but the three have differing causes. Model years and types vary and range from Audi Q5 and Q7 SUVs to Audi A6 and A7 sedans and VW Golf and SportWagen vehicles. Some of the affected vehicles are as old as the 2009 model year. 

Study shows J&J’s Xarelto may cause more serious bleeding than Pradaxa.

Fierce Pharma (10/7, Helfand, 3K) reported on a study published in JAMA showing that Johnson & Johnson and Bayer’s Xarelto (rivaroxaban) may cause more serious bleeding than Boehringer Ingelheim’s Pradaxa (dabigatran). According to the study, Xarelto “was associated with significant increases in intracerebral hemorrhage and major extracranial bleeding.” The researchers also found that Xarelto was used up to three times more often than Pradaxa among American afib patients because “prescriber misperceptions about bleeding risks with dabigatran, arising from U.S. Food and Drug Administration receipt of a large number of postmarketing case reports following its approval.” 

Wednesday, September 28, 2016

Volkswagen recalls Audi Q7 for seat back defect.

The Automotive Fleet (9/27, 62K) reports the National Highway Traffic Safety Administration has announced that Volkswagen “is recalling 19,205 2017-MY Audi Q7 SUVs because the third-row seat backs may not remain in position during a crash.” According to NHTSA, “the third-row seat backs may move forward under load in certain situations, such as during a frontal collision,” and increase the risk of injury to a passenger.

        Additional coverage is provided by Consumerist (9/27, 61K) and Car Connection (9/27, 144K).