NHTSA Investigating Steering Defect in Ford Sedans

The National Highway Traffic Safety Administration (NHTSA) has launched a preliminary investigation into safety issues related to the steering systems of Ford sedans. The issue was raised after concerns over safety issues regarding steering shafts on about 500,000 Ford vehicles.

Ford Crown Victoria, Grand Marquis, and Marauder sedans from model years 2004 through 2007 may be affected by these steering issues. The steering problems are related to degrading heat shields on these Fords. According to NHSTA, the heat shields may rust and impede proper steering as time passes. NHTSA was made aware of the issue after five customer complaints were submitted about steering concerns.

So far, there is no formal recall, but one may be issued if the investigation determines that this problem is a wide concern. Ford has thus far said that it will cooperate with NHTSA investigation and has declined further comment.

Rust Problems with Ford Sedans

The inciting incident for this investigation occurred in April, 2014. A 2004 Crown Victoria rolled over after the steering locked. The resulting accident in the Detroit area caused neck and lower back injuries to the driver. According to the driver, the heat shield was found underneath the car after the accident, and it had apparently rusted off. The problem was attributed to salt corrosion.

In the other complaints received by NHTSA, drivers stated that steering had become very difficult to control, to the point that “bodily force” was required to turn the steering wheel. These problems may also be attributed to rusting problems.

In the agency’s official announcement of the preliminary investigation, NHTSA voiced worries over a “separation of the lower steering column shaft from the upper steering column shaft resulting in a loss of steering control.” The investigation will look into how big of a problem this may be, and if the defect is attributable to design flaws or simple wear and tear in less than optimal conditions.

This is not the first rust-related problem reported for these vehicles. Over 300,000 Crown Victoria and Grand Marquis sedans were recalled in August 2013 in states where salt was heavily used on roads. A defect in these vehicles could corrode the lower intermediate shaft. This eventually could cause a collapse of the upper intermediate steering shaft at a serious risk to the driver. This recall was a result of another NHTSA investigation sparked by 22 customer complaints to the agency.

NHTSA is now conducting an independent engineering analysis to determine if there is a harmful defect. In several months, NHTSA should make recommendations based on the outcome of the analysis or possibly issue a recall.

Source:

http://www.latimes.com/business/autos/la-fi-hy-nhtsa-investigating-ford-steering-defect-20140715-story.html?track=rss&cid=dlvr.it&dlvrit=52116

The Dangers of Gas Cans

Almost every home has gas cans. We keep them in our garages and sheds to fill up lawnmowers and other devices. These red, plastic canisters are about as ubiquitous as any other home accessory. For this reason, we never really think about the dangers posed by them.

Investigation has revealed many examples of horrific accidents related to children knocking over gas cans with tricycles, fathers filling up chainsaws or lawnmowers, or people just walking by a can that explodes. Just a small spark from static electricity or a water heater’s pilot light can cause the gas can to combust.

Blitz USA Defective Gas Cans

About 95% of all gas cans sold in the United States are made of plastic. According to the Consumer Product Safety Commission, about 19 million gas cans are purchased by consumers every year. About 75% of these plastic cans bought in the United States are sold by Blitz USA. The company chose not to use flame arresters in its design of plastic gas cans, which makes their cans especially prone to explosions as time passes.

Flame arresters have been used in metal gas cans for 100 years and they have effectively prevented explosions. Blitz USA even used them on their own metal gas cans. However, they chose not to include the simple metal device in their cheaper plastic models. Many plastic bottles containing flammable liquids and gases already include flame arresters, including lighter fluid. Although including flame arresters would minimally increase the cost of manufacturing the gas cans, the tiny cost is well worth the investment in safety.

Flame arresters are standard in most industries. In fact, workplace standard 1926.155(l) on fire protection and prevention from the Occupational Safety and Health Care Administration requires that all gas cans have flame arresters. The same standards of protection should be applied to consumers who have gas cans in their homes.

While Blitz has recently gone out of business, its successors, including Kinderhook, should be held to the highest standards. Safety should be the number one concern when it comes to manufacturing products that can be so dangerous. Legislation requiring flame arresters on every gas can is a top priority for consumer advocacy groups for the upcoming legislative session.

Source:

http://www.takejusticeback.com/node/60

FDA Rejects Citizen Petition to Ban Transvaginal Mesh

Regulators at the Food and Drug Administration (FDA) have rejected a petition to ban United States sales of nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). The petition was filed in 2011 by the consumer advocacy group Public Citizen.

The FDA issued a letter to Dr. Michael Carome, then deputy director of Public Citizen’s Health Research Group expressing sympathy for the petitioner’s concerns and even some level of agreement. However, the FDA did not agree with the proposed remedies, nor that a total ban and recall was necessary.

While the FDA acknowledged worries that transvaginal mesh products pose safety risks to women, it stated that it was already taking steps to counter those concerns. According to the FDA in its response, “There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all nonabsorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death.”

The Future of Pelvic Mesh Products

While the outright ban of nonabsorbable pelvic mesh products is not going to happen, there will be changes in the way the FDA treats these devices in the future. The FDA issued a tentative reclassification order to upgrade transvaginal mesh products to Class III. This would require premarket approval for all related devices.

Furthermore, the FDA has made safety communications about the risks posed by transvaginal mesh required before use and has increased post-market scrutiny. The FDA even stated that there was some evidence that there were measurable benefits to using surgical mesh when transvaginally repairing pelvic organ prolapse.

These actions have not totally placated concerns by consumer organizations who are worried about the side effects of transvaginal mesh, including vaginal scarring, shrinkage, and pelvic pain.

Public Citizen has stated that actions taken by the FDA are “backward” in the case of this product. Furthermore, they believe that while the higher regulatory scrutiny will be good for consumers, the FDA is undercutting its effectiveness in two ways. First, they believe that the FDA’s allowance of 510(k) clearance for transvaginal mesh products goes against purposes of the intensive premarket approval process. Secondly, they worry that the length of time for the installment of the reclassification will hurt women in the meantime.

Despite this fact, many organizations view these actions by the FDA as a step in the right direction. With added oversight, there is hope that the true health risks and benefits of transvaginal mesh can be known.

This response by the FDA does not preclude it from issuing a recall later. Many manufacturers of transvaginal mesh have been sued by patients who have been treated with nonabsorbable pelvic mesh, and researches on the products are still being conducted.

In the end, the FDA has a responsibility to take any accusations of patient risk seriously, so this is not the end of investigations regarding transvaginal mesh products.

Source:

http://www.fiercemedicaldevices.com/story/fda-rejects-petition-ban-transvaginal-mesh/2014-07-16

FDA to Decide If Testosterone Meds Boost Heart Attack Risks

The Food and Drug Administration (FDA) has decided to hold a special advisory committee meeting to discuss the potential cardiovascular risks posed by testosterone products. This meeting, to be held on September 17, 2014, will be spent examining two recently released trials that indicate that testosterone products may increase the risk of heart attacks in men.

At this advisory meeting, the FDA Bone, Reproductive, and Urologic Drugs panel and the Drug Safety and Risk Management committee will jointly discuss what implications these studies have for consumers and the general safety of testosterone products.

This safety reassessment is the culmination of a months-long investigation by the FDA. The agency has been researching claims made in the testosterone market and the safety of such products. The FDA has already put a warning on all testosterone drugs about blood-clot risks posed by these products. Depending on the outcome of these hearings, the market may be more tightly regulated or some products could even be banned.

Concerns about Testosterone Medications

In recent years, men have been buying testosterone medications in increasing amounts. The drugs for low testosterone count, or hypogonadism, are intended to increase sex drive, improve mood, and strengthen muscle tone. While testosterone medications have been advertised as a panacea for any male problem, the medications for “Low T” may pose serious risks. As the testosterone market is currently valued at $1.6 billion and is expected to grow to $5 billion by 2017, it is important for the FDA to take an active role in determining the health impact of these drugs.

A study of 55,000 men taking prescribed testosterone medications in the United States found that in the first 90 days using testosterone drugs, 1 in 167 men aged 65 or older could suffer a heart attack. These risks increased to 1 in 100 men under 65 for those with pre-existing heart conditions. These risks are more than double the normal risk for men in this age bracket. There were nearly doubled risks for younger men with previous risk factors for cardiovascular problems.

Many doctors have expressed concerns about these medications, and the FDA is taking these concerns seriously. However, the risk may be mitigated by other factors. The solution to make these drugs safer may be in requiring more stringent patient testing before starting the medication.
Source:

http://www.fiercepharma.com/story/do-testosterone-meds-boost-heart-attack-risks-fda-asks-advisory-panels-weig/2014-07-22?utm_medium=nl&utm_source=internal

2014 Breaks Auto Recall Records Halfway through the Year

By the beginning of July of 2014, the country has already broken records to have more automobile recalls than any other year in history. The National Highway Traffic Safety Administration (NHTSA) lists 37.5 million cars recalled so far this year in the most recent preliminary data available on the agency’s website. This tops the previous 30.8 million car recall record set in 2004.

While the number of cars recalled so far this year is already staggering, it is likely to grow over the course of the rest of the year. Faulty airbags made by the Takata Corporation have already sparked several recalls this year. As soon as Japan’s three largest carmakers finish an evaluation of their models, more recalls are likely.

The official recall numbers for 2014 from the NHTSA will not be available until 2015, but it is clear that the total number of recalled vehicles is going to far exceed traditional averages. According to the NHTSA database, recalls historically range from 10 to 20 million cars in the United States each year. In 2013, just fewer than 22 million vehicles were recalled and in 2012, 16.4 million vehicles were recalled. Besides the previous record-setting year in 2004, the total number of recalls passed 30 million only in one other year, which was 1981.

The Biggest Auto Recalls in 2014

General Motors vehicles account for about two-thirds of the total number of vehicles recalled so far in 2014. This year’s record-breaking auto recall started when GM recalled 2.59 million cars in February to fix a faulty ignition switch. This design problem has already been linked to at least 13 deaths in car crashes.

As it was revealed that the company had known about problems with the ignition switch for over ten years, congressional investigations into GM’s actions began. The company has since been issued a $35 million civil fine, and the Department of Justice has even begun a criminal investigation into the actions of executives.

This controversy and the fallout that followed led GM to investigate the safety of all of its models. GM ended up recalling 25.7 million vehicles for issues ranging from faulty ignition switches to ineffective door wiring to dangerous seatbelt retractors. This massive number of recalls constitutes 40% of the company’s models currently on the roads in the United States.

The other issue that has led to recalls is related to Takata airbags. While this is not nearly on the same scale as the GM recalls, it will continue to add numbers to this year’s total. What is clear, however, is that after all of the recalls this year, people will be actively looking out for any car defects in the future.

Source:
http://www.chicagotribune.com/classified/automotive/sns-wp-blm-news-bc-autos-recall08-20140708,0,4002137.story