Thursday, November 17, 2016

Mazda to recall 70K RX-8 sports cars for fuel pump defect, fire risk.

Automotive News (11/15, 188K) says Mazada will be issuing a recall for “about 70,000 RX-8 sports cars from the 2004-08 model years...because of an issue with fuel pump sealing rings that may leak and catch fire.” On Tuesday, the National Highway Traffic Safety Administration posted on its website, “The affected vehicles have fuel pump sealing rings that may deteriorate due to exposure to heat from the engine or exhaust pipe...which in the presence of an ignition source can increase the risk of a fire.”
        Additional coverage is provided by Reuters (11/15), Car Connection (11/15, 86K), and Law360 (11/15, 23K).

Fiat Chrysler asks some owners to return to dealers after software upgrade fails to fix gearshifts.


The AP (11/16, Krisher) reports Fiat Chrysler has asked about 29,000 owners, including 13,000 in the US, to return their 2014-2015 Jeep Grand Cherokees and the 2012-2014 Dodge Charger and Chrysler 300 to the dealers after a software patch “designed to fix confusing gear shifters on 1.1 million Fiat Chrysler vehicles didn’t work” on their cars. The AP adds that “the problem, reported in a document released this week by the National Highway Traffic Safety Administration, was discovered in a Fiat Chrysler audit.” 

Friday, November 11, 2016

A TRUE AMERICAN HERO - RIP

Photo
Clarence M. Ditlow III, the head of the Center for Auto Safety, in his Washington office in 2009.CreditMichael Temchine for The New York Times
Clarence M. Ditlow III, widely regarded as America’s foremost advocate for automotive safety, who championed seatbelts, airbags, electronics to avert crashes and campaigns to force the recall of millions of dangerously flawed motor vehicles, died Thursday night in Washington. He was 72.
His death, at George Washington University Hospital, was caused by cancer, said Daniel Becker, a friend and associate.
As head of the Center for Auto Safety, based in Washington, for 40 years, Mr. Ditlow exposed hundreds of automotive defects. He was instrumental in forcing manufacturers to recall the Ford Pintos with infamous exploding gas tanks, Toyotas that suddenly accelerated out of control and General Motors pickup trucks with sidesaddle gas tanks that blew up in collisions, killing more than 1,000 people.
With a budget of less than half the cost of one G.M. Super Bowl commercial, Mr. Ditlow took on auto industry giants in lawsuits that tightened standards for ignition systems, airbags and fuel efficiency; lobbied government agencies to ban driving while texting or using cellphones; and achieved “lemon laws” in all 50 states that made it easier for buyers to return defective vehicles.
Continue reading the main story
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Mr. Ditlow, far right, appeared with Toyota executives at a 2010 Senate hearing concerning the recall of Toyota vehicles with acceleration problems. CreditMichael Reynolds/European Pressphoto Agency
An engineer and lawyer, Mr. Ditlow collaborated with Mr. Nader on “The Lemon Book” (1980), on “The Lemon Book: Auto Rights” (1990) and on many safety articles. He also wrote about the tendency of some vehicles to roll over, to jump from Park into Reverse gear and to power off with a loss of all controls and airbags while being driven.
“When regulators sleep and auto companies place profits over safety, safety defects pile up,” Mr. Ditlow and Mr. Nader wrote in an Op-Ed article in The New York Times in 2014. “A record number of vehicles — more than 50 million — have been recalled this year, a result of congressional hearings and Justice Department prosecutions, which exposed a mass of deadly defects that the auto industry had concealed.”
Mr. Ditlow never achieved the fame of Mr. Nader, whose landmark book, “Unsafe at Any Speed: The Designed-in Dangers of the American Automobile” (1965), accused car manufacturers of hiding defects at the cost of untold lives. The book also prompted Congress to create what became the National Highway Traffic Safety Administration to enforce safety standards and supervise recalls.
But Mr. Ditlow carried to fruition many of the initiatives that Mr. Nader began after he and Consumers Union jointly founded the Center for Auto Safety in 1970. Mr. Ditlow, who became the center’s executive director in 1976, was instrumental, for example, in long campaigns to require that all motor vehicles have seatbelts and airbags.
Over four decades, Mr. Ditlow badgered the traffic safety administration for more stringent standards, saying its leaders were often political appointees reluctant to move against the powerful auto industry.
He also became the industry’s fiercest critic, issuing scathing reports on defective vehicles and related problems ranging from child car-seat flaws to dangerously designed engine mounts. He testified at scores of congressional hearings on safety and warranty issues, consumer protection, air pollution and fuel economy.
And he successfully pushed for myriad recalls by the traffic safety administration: There were 60 million vehicle recalls in the last year, including 11 million for defective ignition switches and millions more for defective Takata airbags. In 2014, 1.4 million G.M. cars were recalled for engine and airbag shut-offs; in 2013, two million Jeeps for exploding gas tanks; in 2010, seven million Toyotas for sudden acceleration. In the 1970s, 6.7 million Chevrolets were recalled for defective engine mounts, and 1.5 million Ford Pintos — half of all those produced — for fuel-tank fires in rear-end collisions.
In addition to millions of other recalls in the ’80s and ’90s, Mr. Ditlow and his organization achieved lemon laws in all 50 states to protect consumers. Over the last 25 years, he also served on the boards of Consumers Union, the environmental group Friends of the Earth and the Canadian highway and the auto safety organization Automobile Protection Association.
Photo
At a news conference in 2014, Mr. Ditlow displayed a G.M. ignition switch similar to those linked to 13 deaths and dozens of crashes.CreditJ. Scott Applewhite/Associated Press
He often sought data under the Freedom of Information laws and sometimes found shocking unintended revelations. In 1978, he discovered a secret internal memo that raised questions about the safety of Firestone 500 steel-belted radial tires sold in the ’70s. A dozen deaths resulted from blowouts caused by tires that overheated. He pressed the issue, and 15 million tires were recalled.
“This year, 60 million vehicles are under recall,” Mr. Becker, director of the Safe Climate Campaign, a unit of the Center for Auto Safety, said in an interview in October. “The vast majority of the defects were discovered by Clarence and pursued by him to protect the driving public. Hundreds of thousands of people are alive today because of his work.”
Clarence Mintzer Ditlow III was born on Jan. 26, 1944, one of three children of Clarence Mintzer Ditlow Jr. and the former Myrtice Lamb, and grew up in Camp Hill, Pa. His father was a service manager at a Chevrolet dealership in Harrisburg, Pa.
He earned a bachelor’s degree in chemical engineering from Lehigh University in Pennsylvania in 1965. After working for five years as a patent examiner in the United States Patent Office, he received a juris doctorate from Georgetown University in 1970 and a master’s degree in law at Harvard in 1971.
Drawn by Mr. Nader’s crusading for consumers, Mr. Ditlow, in the late ’60s, joined what the press called “Nader’s Raiders,” young volunteers who investigated the Federal Trade Commission and in their reports found it to be “passive” and “ineffective.” A formal study by the American Bar Association then led to an overhaul that emphasized more aggressive consumer protections and antitrust enforcement.
Later, Mr. Ditlow joined another Nader spinoff, the Public Interest Research Group, which lobbied for consumer protections, environmental regulations and other progressive goals. He was a lawyer for the group until 1976, when, at Mr. Nader’s behest, he took over the Center for Auto Safety.
Mr. Ditlow, who lived in Washington, is survived by his wife, Marilyn J. Herman, and a sister.
He continued the fight into his last months. This year, he urged that auto executives who had concealed dangerous defects in their products be criminally prosecuted. And in a USA Today blog in August, he argued that the National Highway Traffic Safety Administration was endangering lives by not issuing standards on driverless vehicles.
“In its zeal to advance driverless vehicles, N.H.T.S.A. has forgotten its mission is to ensure safety, not promote gee-whiz vehicle technology to increase sales,” he wrote. “It is an inherent conflict of interest for any agency to both promote and regulate technology. N.H.T.S.A.’s deference to industry initiatives in lieu of safety standards represents an abdication of regulatory responsibilities that is unprecedented in the history of the agency.”

Thursday, November 10, 2016

Mayo Clinic Warns Heart-Surgery Patients of New Infection Risk

Consumer Reports
The Mayo Clinic is notifying 17,000 heart-surgery patients across the country about a rare but serious infection risk related to a common surgical device (called a heater-cooler) used in open-chest operations. The hospital—which has major campuses in Arizona, Florida, and Minnesota—has identified one such infection in a heart-surgery patient at its St. Mary's Hospital in Rochester, Minn., and has since found many of its heater-coolers contaminated with the microbe.
Consumer Reports learned of the Mayo Clinic's actions, which have not been previously reported, when a patient shared a letter from the hospital with us.
The Food and Drug Administration says that 16 U.S. hospitals, across 10 states, have reported similar heater-cooler incidents. But the agency has not named those hospitals or said which states they're located in, and just a handful have publicly acknowledged the problem.
The Mayo Clinic's letter tells patients that they should contact their primary care doctor if they have questions or experience any symptoms linked to the infection, including night sweats, substantial weight loss over several months, and a persistent, unexplained fever. It also says patients can call a Mayo Clinic nurse at 800-951-3836.
The hospital's decision to send that letter to every patient exposed to its heater-coolers was made following guidelines issued in October 2016 by the Food and Drug Administration and the Centers for Disease Control and Prevention for addressing the problem, which first emerged in 2015.
Heater-coolers help regulate a patient’s body temperature during surgery. But owing to a design flaw, the machines can spray deadly bacteria—most often a bacteria called non-tuberculosis mycobacteria (NTM), but also other bacteria that grow in water—through their exhaust fans and into patients’ open chest cavities during surgery.

That risk is very rare. But the machines are ubiquitous, the confirmed cases are mounting, and the CDC recently linked several separate NTM outbreaks to the same source of contamination: a manufacturing facility owned by the European company LivaNova, which produces 60 percent of all heater-coolers used in the U.S.

Like previous advisories, the October guidelines call on hospitals to take steps to reduce the risk of infection from the devices. Unlike those earlier alerts, the new ones also advise hospitals that use the LivaNova brand heater-coolers to test their machines for contamination and to develop protocols for alerting patients if a device is found to be contaminated or if an outbreak occurs.

What Heart Surgery Patients Need to Know

  • If you are undergoing open chest surgery, ask your physician whether a heater-cooler device, or HCD, will be used for the operations, and if so, whether it has been tested for contamination or implicated in any outbreaks.
  • If you’ve already had heart surgery, you and your primary-care doctor should be on the lookout for signs of infection, including irritation around the surgical incision, and unexplained fevers, night sweats, muscle aches, or weight loss, which can emerge as long as four years after surgery.

Alerting Patients

The Mayo Clinic has been using the LivaNova devices since 2012. The hospital convened an emergency meeting at 6:30 a.m. the day after the FDA advisory. Ultimately doctors there decided that, based on the one confirmed case, every patient who had ever been exposed to a heater-cooler at any Mayo hospital should be notified of the risk.
“We just felt strongly that every patient that had had cardiac surgery that could have been exposed to this bacteria should know about it,” says Brad Narr, M.D., Mayo’s chief of anesthesiology and chair of its Surgical and Procedural Committee.
That decision stands out because experts have been divided over when—or even whether—to warn patients about the problem. The machines are used in hundreds of thousands of operations each year, and some doctors argue that notifying all patients would be overly expensive and could create needless panic.
But others point out that unless patients are alerted, they won’t know what symptoms to watch out for—and that lack of awareness could delay treatment and cause worse, potentially devastating, outcomes.
At a meeting in June, doctors from both sides of the issue debated what number of confirmed NTM infections should count as an “outbreak,” and thus trigger a response from health officials. Some said one infection, and others said two.
"The Mayo Clinic's response is in line with what we'd like to see all hospitals do," says Lisa McGiffert, director of Consumer Reports' Safe Patient Project. "Health officials have not acted quickly or aggressively enough on this issue, and as a result, too many patients are still being exposed to risk without their knowledge or consent."

Heater-Cooler Alternatives

Hospitals everywhere are struggling to address the heater-cooler concern. Some have taken extreme measures to remove the devices from their operating rooms by drilling holes in the walls and creating separate containment areas that can be connected to the larger surgical theater through a hose.
For now, the Mayo Clinic has resorted to using older, more primitive heater-cooler devices—but only to replace those LivaNova machines that test positive for contamination. The older devices are messier and less efficient, Narr says, in part because they require the use of additional non-sterile equipment, including ice machines, which can introduce additional contamination risks. What’s more, the Mayo Clinic had just six of them in storage.
System-wide, Narr says that Mayo has about 23 or 24 LivaNova heater-coolers, which it uses not only for open-chest surgery but also for some patients on life support in its intensive care units. “We can’t take all the [LivaNova devices] out of practice immediately, because there’s nothing on the market that can respond to our volume,” Narr says.
Eventually, the hospital does plan to replace all of its LivaNova heater-coolers with a different brand. But as Narr acknowledged, even that move may not resolve the problem. All modern heater-coolers have the same basic design, and thus are vulnerable to the same device contamination.
“That’s absolutely something we’ve discussed,” Narr says. “Is it a problem with this device or with this technology? And are we deluding ourselves in thinking that if we spend this amount of money going forward we can fix it?” The answer, he says, remains to be seen.  

Mayo Clinic Warns Heart-Surgery Patients of New Infection Risk

Consumer Reports
The Mayo Clinic is notifying 17,000 heart-surgery patients across the country about a rare but serious infection risk related to a common surgical device (called a heater-cooler) used in open-chest operations. The hospital—which has major campuses in Arizona, Florida, and Minnesota—has identified one such infection in a heart-surgery patient at its St. Mary's Hospital in Rochester, Minn., and has since found many of its heater-coolers contaminated with the microbe.
Consumer Reports learned of the Mayo Clinic's actions, which have not been previously reported, when a patient shared a letter from the hospital with us.
The Food and Drug Administration says that 16 U.S. hospitals, across 10 states, have reported similar heater-cooler incidents. But the agency has not named those hospitals or said which states they're located in, and just a handful have publicly acknowledged the problem.
The Mayo Clinic's letter tells patients that they should contact their primary care doctor if they have questions or experience any symptoms linked to the infection, including night sweats, substantial weight loss over several months, and a persistent, unexplained fever. It also says patients can call a Mayo Clinic nurse at 800-951-3836.
The hospital's decision to send that letter to every patient exposed to its heater-coolers was made following guidelines issued in October 2016 by the Food and Drug Administration and the Centers for Disease Control and Prevention for addressing the problem, which first emerged in 2015.
Heater-coolers help regulate a patient’s body temperature during surgery. But owing to a design flaw, the machines can spray deadly bacteria—most often a bacteria called non-tuberculosis mycobacteria (NTM), but also other bacteria that grow in water—through their exhaust fans and into patients’ open chest cavities during surgery.

That risk is very rare. But the machines are ubiquitous, the confirmed cases are mounting, and the CDC recently linked several separate NTM outbreaks to the same source of contamination: a manufacturing facility owned by the European company LivaNova, which produces 60 percent of all heater-coolers used in the U.S.

Like previous advisories, the October guidelines call on hospitals to take steps to reduce the risk of infection from the devices. Unlike those earlier alerts, the new ones also advise hospitals that use the LivaNova brand heater-coolers to test their machines for contamination and to develop protocols for alerting patients if a device is found to be contaminated or if an outbreak occurs.

What Heart Surgery Patients Need to Know

  • If you are undergoing open chest surgery, ask your physician whether a heater-cooler device, or HCD, will be used for the operations, and if so, whether it has been tested for contamination or implicated in any outbreaks.
  • If you’ve already had heart surgery, you and your primary-care doctor should be on the lookout for signs of infection, including irritation around the surgical incision, and unexplained fevers, night sweats, muscle aches, or weight loss, which can emerge as long as four years after surgery.

Alerting Patients

The Mayo Clinic has been using the LivaNova devices since 2012. The hospital convened an emergency meeting at 6:30 a.m. the day after the FDA advisory. Ultimately doctors there decided that, based on the one confirmed case, every patient who had ever been exposed to a heater-cooler at any Mayo hospital should be notified of the risk.
“We just felt strongly that every patient that had had cardiac surgery that could have been exposed to this bacteria should know about it,” says Brad Narr, M.D., Mayo’s chief of anesthesiology and chair of its Surgical and Procedural Committee.
That decision stands out because experts have been divided over when—or even whether—to warn patients about the problem. The machines are used in hundreds of thousands of operations each year, and some doctors argue that notifying all patients would be overly expensive and could create needless panic.
But others point out that unless patients are alerted, they won’t know what symptoms to watch out for—and that lack of awareness could delay treatment and cause worse, potentially devastating, outcomes.
At a meeting in June, doctors from both sides of the issue debated what number of confirmed NTM infections should count as an “outbreak,” and thus trigger a response from health officials. Some said one infection, and others said two.
"The Mayo Clinic's response is in line with what we'd like to see all hospitals do," says Lisa McGiffert, director of Consumer Reports' Safe Patient Project. "Health officials have not acted quickly or aggressively enough on this issue, and as a result, too many patients are still being exposed to risk without their knowledge or consent."

Heater-Cooler Alternatives

Hospitals everywhere are struggling to address the heater-cooler concern. Some have taken extreme measures to remove the devices from their operating rooms by drilling holes in the walls and creating separate containment areas that can be connected to the larger surgical theater through a hose.
For now, the Mayo Clinic has resorted to using older, more primitive heater-cooler devices—but only to replace those LivaNova machines that test positive for contamination. The older devices are messier and less efficient, Narr says, in part because they require the use of additional non-sterile equipment, including ice machines, which can introduce additional contamination risks. What’s more, the Mayo Clinic had just six of them in storage.
System-wide, Narr says that Mayo has about 23 or 24 LivaNova heater-coolers, which it uses not only for open-chest surgery but also for some patients on life support in its intensive care units. “We can’t take all the [LivaNova devices] out of practice immediately, because there’s nothing on the market that can respond to our volume,” Narr says.
Eventually, the hospital does plan to replace all of its LivaNova heater-coolers with a different brand. But as Narr acknowledged, even that move may not resolve the problem. All modern heater-coolers have the same basic design, and thus are vulnerable to the same device contamination.
“That’s absolutely something we’ve discussed,” Narr says. “Is it a problem with this device or with this technology? And are we deluding ourselves in thinking that if we spend this amount of money going forward we can fix it?” The answer, he says, remains to be seen.  

Monday, October 31, 2016

Jury awards $70 million in talcum powder lawsuit against J&J.


ABC World News Tonight (10/28, story 10, 0:25, Muir, 14.63M) reported that a jury in St. Louis awarded a woman $70 million “after she sued Johnson & Johnson, alleging that years of using the company’s iconic baby powder had caused ovarian cancer.” According to NBC Nightly News, (10/28, story 8, 2:15, Holt, 16.61M) this is the “fourth time” a jury has held “that Johnson & Johnson failed to inform the public about a possible link between ovarian cancer” and talcum powder. Johnson & Johnson “is appealing three decisions, including nearly $200 million in damages.” USA Today (10/28, Yu, 6.42M) reported that while “some studies suggest a link between talcum powder and ovarian cancer,” most scientists “say it’s not clear yet whether products containing talc can cause the disease.” Additional coverage is provided by the AP (10/28) and the NBC News (10/28, 5.08M) website. 

Friday, October 28, 2016

Amtrak agrees to $265 million settlement for fatal Philadelphia crash.

The New York (NY) Times (10/27, Mele, Subscription Publication, 13.42M) reports that on Thursday, Amtrak agreed to pay $265 million to settle claims regarding a train accident that resulted in the deaths of eight passengers and injuries to more than 200 people. The Times explains the crash occurred in May 2015 when the train took a tight curve at 106 miles-per-hour, which was twice the speed limit. The Times says lawyers believe the figure is the largest settlement in a railroad disaster in US history.
        The Wall Street Journal (10/27, Calvert, Subscription Publication, 6.37M) reports David C. Cook, one of the plaintiffs’ lawyers, said that if the damages exceed $265 million, all of the individual claims will be proportionately lowered. The Journal says the large award was possible because Congress voted to increase the federal damages cap for railway accidents to $295 million from its previous level at $200 million. The piece explains the $265 million figure is the present value of $295 million in 2.5 years, the minimum length lawyers believe will be needed to sort through the individual claims. The Philadelphia Inquirer (10/27, Mondics, 586K) reports the settlement was “reached with unusual speed,” and another of the plaintiffs’ lawyers, Robert Mongeluzzi, called the speed with which an agreement was reached, “historic.”
        The AP (10/27, Dale) reports the crash occurred because engineer Brandon Bostain “didn’t realize where he was and accelerated full-throttle to 106 mph instead of slowing down for the curve’s 50 mph speed limit.” Bostain was said to be distracted by reports that “a nearby train had been hit by a rock.” New Jersey Local News (10/27, Gallo, 747K) reports the National Transportation Safety Board also faulted a lack of Positive Train Control as contributing to the accident.

        Reuters (10/27, Kearney) reports Amtrak Spokesman Craig Schulz said in a statement, “Amtrak appreciates the guidance and involvement of the Court in this matter.” He added, “Because of the ongoing nature of the litigation Amtrak will have no further comment at this time.”