NHSTA Investigating Potential Gas Tank Fire Hazard Affecting 3 Million Jeep Grand Cherokees

The National Highway Traffic Safety Administration (NHTSA) is investigating a potential design defect of the gas tank in about three million Jeep Grand Cherokee vehicles that could pose a fire danger in case of a collision.

In October 2009, the Center for Auto Safety (CAS) petitioned the NHTSA to open a defect investigation and recall model year 1993-2004 Jeep Grand Cherokees, alleging that the vehicle’s defective fuel tank storage systems present a fire hazard in crashes. In these models of the Jeep Grand Cherokee, the fuel tank is made of plastic and positioned behind the rear axle and below the rear bumper. CAS alleges that this design inadequately shields the gas tank from rupture or leakage from a rear-impact by another vehicle or from other external objects in the event of a crash.

CAS searched NHTSA’s data from the agency’s Fatality Analysis Reporting System (FARS) files and found that between 1992 and 2008, there were 172 fatal fire crashes with 254 fatalities involving these Jeep Grand Cherokee models. FARS showed 44 crashes and 64 fatalities where the most harmful event of the accident was the fire.

In comparison, NHTSA reported only 38 fire crashes resulting in 26 fire deaths for the infamous Ford Pinto when it issued its initial defect report in May 1978.

“The design is so bad that Chrysler frequently settles lawsuits without extensive discovery and subject to confidentiality agreements,” CAS wrote in the petition to the NHTSA.

CAS wrote that due to confidential settlements, the details of most lawsuits are not available. However, the petition did illustrate several crashes where people died, not from the impact of the crash, but from the fire resulting from the compromised gas tank.

There is no recall issued for these Jeep Grand Cherokee vehicles at this time, however if NHTSA investigators find that the gas tank design is defective, it may necessitate a recall.
"This is a terrible design," Clarence Ditlow, head of the Center for Auto Safety, told the Associated Press. Ditlow told the news source he planned to ask Chrysler to issue a voluntary recall of the Grand Cherokee.

The Center for Auto Safety (CAS) is a consumer advocacy group founded by the Consumers Union and Ralph Nader in 1970. The mission of CAS is to provide consumers with a voice for auto safety and quality in Washington. They list various accomplishments including: Lemon Laws in every state, recall of the Ford Pinto for exploding gas tanks, recall of the Firestone 500 tire for tread separation, exposing hazards of sidesaddle gas tanks on GM pickups as well as effecting government safety and highway standards and laws.

“While we design our vehicles to protect the greatest number of motorists in the greatest number of accidents, unfortunately accidents do occur, can be dangerous and, sadly, can sometimes cause injuries and even deaths,” The New York Times reports Chrysler spokesperson Mike Palese said in a statement. “Statistically, rear impacts that result in serious injury are rare occurrences. Chrysler Group is confident that a proper study which considered all factors in all collisions, including rear collisions with fire, would show that the 1993-2004 Jeep Grand Cherokees perform as well as or better than other vehicles in their class.”

When Chrysler reorganized under Chapter 11 bankruptcy earlier this year, the automaker asked the judge to give the company immunity from product liability lawsuits from vehicles sold before the bankruptcy. The judge agreed, however consumer advocacy groups spoke out and Chrysler reversed its position and agreed to be liable for future product liability claims.

New York Times Slams FDA for Failure to Act on Look-Alike Tubes Used in Hospitals

An article in the New York Times illustrates the dangerous consequences of mistakes involving look-alike tubing in medical applications and faults the U.S. Food and Drug Administration’s lax oversight of these medical devices.

Much of the clear plastic tubing used in hospitals for intravenous IV lines, feeding tubes, oxygen delivery and a wide range of other uses looks the same and is often interchangeable because of its small connector called a luer fitting. While the luer connection is cheap and universal, it contributes to misconnection mistakes that can cause serious or fatal results.

The article entitled U.S. Inaction Lets Look-Alike Tubes Kill Patients appeared online August 20, 2010 and printed in the August 21, 2010 New York edition.

The New York Times tells of a fatal mistake in which hospital staff connected a liquid food bag meant for a stomach tube to the IV line of a 24-year-old pregnant woman, introducing the food to directly to her bloodstream and comparing it to pouring concrete into a drain. Another pregnant woman died after a nurse accidentally put an epidural spinal anesthetic directly into a vein.

Incidences of tubing misconnections are not a new problem, reports of misconnections go back as far as the 1970’s and health professionals and advocacy groups have been trying to get manufacturers and government to differentiate the tubing or connections since 1996.

Yet millions of people in hospitals each year are at risk of injury from tubing misconnections.

“More than 1200 times in the past 10 years, U.S. hospital workers have inadvertently connected tubes meant to link one device or system—an IV, a feeding tube, a catheter—into another device, frequently causing harm and sometimes death,” says a March 2009 article by the Medical Device and Diagnostic Industry (MDDI). “But these figures may represent just a fraction of the total incidents. That’s because they are based on voluntary, anonymous reports from only 15% of the country’s 5800 hospitals—the 875 facilities that participate in an error-sharing program created by U.S. Pharmacopeia, a pharmacy standards agency.”

The FDA regulates these tubes as a medical device. Although the agency has sent out notifications warning hospitals of the potential for tubing mix-ups, it has failed to define standards requiring different types of medical tubing to have different connectors.

“The regulators have been waiting for the manufacturers to come up with a solution, and the manufacturers won’t spend the money to design and produce something different until the regulators force them to,” Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego told the New York Times. “And now the international standards organization is taking forever to get the whole world onto the same page.”

In November 2008, the FDA sponsored a webcast entitled Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events to identify and educate about the potential of misconnections with the medical tubes.

Reported instances of tubing misconnections prompted the FDA release its 2009 Medical Device Safety Calendar depicting twelve different misconnection cases, one for each month, including:

• An infant in the pediatric intensive care unit died after medical personnel inadvertently placed the feeding tube into the trach tube and delivered milk into the infant’s lungs.
• An anesthetist and a midwife mistakenly connected an epidural set to the maternity patient’s IV tubing, causing the delivery of epidural medication into the IV and the death of the patient.
• Medical personnel inadvertently connected the IV tubing to the trach cuff port of a child in the pediatric intensive care unit, the IV fluid over-expanded the trach cuff to the point of breaking and continuous IV fluids entered the child’s lungs, killing the child.
• A patient’s oxygen tubing disconnected from his nebulizer and a staff member accidentally reattached it to his IV tubing Y-site, causing the patient to die from an air embolism even though the connection was broken within seconds.

To find out more about tubing misconnections, see these FDA resources or this issue of Safe Practices in Patient Care.

380 Million Eggs Recalled Nationwide, How to Keep Your Family Safe from Salmonella in Eggs

Hundreds of salmonella infection cases have prompted a nationwide recall of eggs and reminded us of some basic food safety rules.

After a four-fold increase in cases of Salmonella Enteritidis (SE) infections since May 2010, a joint investigation by the U.S. Food and Drug Administration (FDA), Centers for Disease Control (CDC), the U.S. Department of Agriculture and state public health and agriculture officials has linked the illnesses to eggs produced at the Wright County Egg, in Galt, IA.

In response, Wright County Egg has issued a nationwide voluntary recall of 380 million eggs shipped since May 19, 2010 to food wholesalers, distribution centers and foodservice companies in California, Illinois, Missouri, Colorado, Nebraska, Minnesota, Wisconsin and Iowa. These companies distribute eggs nationwide under a variety of brands.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis or arthritis.

Click here for a list of all brands of eggs affected by the recall. Consumers can identify the recalled eggs by the date and code stamped on the carton. Consumers who believe they may have purchased these shell eggs should not eat them but should return them to the store where purchased for a full refund.

According to an article in USA Today, Wright County Egg is part of the DeCoster family agribusiness operations, which has a long history of environmental, immigration and labor violations.

While 380 million eggs seems a huge number, it represents less than 1 percent of all eggs produced in the United States.

To reduce the potential for contracting Salmonella from eggs, the FDA recommends:

• Do not eat recalled eggs or products containing recalled eggs. Recalled eggs might still be in grocery stores, restaurants and consumers’ homes. Consumers who have recalled eggs should discard them or return them to their retailer for a refund. Individuals who think they might have become ill from eating recalled eggs should consult their health care providers.
• Keep shell eggs refrigerated at ≤45˚ F (≤7˚ C) at all times.    
• Discard cracked or dirty eggs. 
• Wash hands, cooking utensils and food preparation surfaces with soap and water after contact with raw eggs.  
• People preparing egg should cook them until both the white and the yolk are firm
• Eat eggs promptly after cooking.
• Do not keep eggs warm or at room temperature for more than 2 hours.   
• Refrigerate unused or leftover egg- containing foods promptly.  
• Avoid eating raw eggs.
• Avoid restaurant dishes made with raw or undercooked, unpasteurized eggs. Restaurants should use pasteurized eggs in any recipe (such as Hollandaise sauce or Caesar salad dressing) that calls for raw eggs.
• Young children, elderly persons and those with weakened immune systems or debilitating illness should especially avoid the consumption of raw or undercooked eggs.

Find out more about safe handling and usage of egg products at http://www.foodsafety.gov/keep/types/eggs/index.html

Defective Safety Belts Prompt Huge Recall of GM Vehicles

General Motors Corp., of Detroit, MI, announced today that the company is voluntarily recalling 2009-2010 models of the Chevrolet Traverse, Buick Enclave, GMC Acadia and Saturn Outlook to inspect second-row safety belts for damage that may cause them to latch improperly.

According to the National Highway Traffic Safety Administration (NHTSA) Recall Campaign, the second row seat side trim shield restricts the upward rotation of the safety belt buckle when a user returns the seat back from a folded flat position to a seating position. If the buckle contacts the seat frame, additional effort is required to return the seat to a seating position. If sufficient force is applied, the user may push the buckle cover down the strap, exposing and partially depressing the red release button.

If this damage occurs, the buckle may not latch or unlatch and may appear to be jammed. In some instances, the buckle may appear to latch when the latch mechanism actually does not fully engage. Under these conditions, the safety belt may not restrain the occupant as intended during a crash, increasing the risk of injury to the seat occupant.

“Because of the potential for a false-latch condition, we want customers to return their vehicles to have the recall repair performed as soon as possible,” said Jeff Boyer, GM executive director of safety in a statement.

GM engineers have been investigating the root cause of damaged safety belt buckles since January 2010, but are unaware of any crash injuries related to the defective part.
The recall affects 243,403 GM vehicles worldwide, with 207,210 of those in the United States.

GM will notify owners of the recalled vehicles by letters mailed August 31, 2010. Owners must take the vehicle to their GM dealer, where the dealer will modify the second row seat side trim shields and inspect the belt buckle for damage, replacing it free of charge if necessary.

Defective Safety Belts Prompt Huge Recall of GM Vehicles

General Motors Corp., of Detroit, MI, announced today that the company is voluntarily recalling 2009-2010 models of the Chevrolet Traverse, Buick Enclave, GMC Acadia and Saturn Outlook to inspect second-row safety belts for damage that may cause them to latch improperly.

According to the National Highway Traffic Safety Administration (NHTSA) Recall Campaign, the second row seat side trim shield restricts the upward rotation of the safety belt buckle when a user returns the seat back from a folded flat position to a seating position. If the buckle contacts the seat frame, additional effort is required to return the seat to a seating position. If sufficient force is applied, the user may push the buckle cover down the strap, exposing and partially depressing the red release button.

If this damage occurs, the buckle may not latch or unlatch and may appear to be jammed. In some instances, the buckle may appear to latch when the latch mechanism actually does not fully engage. Under these conditions, the safety belt may not restrain the occupant as intended during a crash, increasing the risk of injury to the seat occupant.

“Because of the potential for a false-latch condition, we want customers to return their vehicles to have the recall repair performed as soon as possible,” said Jeff Boyer, GM executive director of safety in a statement.

GM engineers have been investigating the root cause of damaged safety belt buckles since January 2010, but are unaware of any crash injuries related to the defective part.
The recall affects 243,403 GM vehicles worldwide, with 207,210 of those in the United States.

GM will notify owners of the recalled vehicles by letters mailed August 31, 2010. Owners must take the vehicle to their GM dealer, where the dealer will modify the second row seat side trim shields and inspect the belt buckle for damage, replacing it free of charge if necessary.

Study Shows #1 Selling ED Supplement Causes Potentially Fatal Changes in Heartbeat

Researchers have found that men who take Enzyte, a popular dietary supplement sold for male enhancement, are placing themselves at risk for dangerous and potentially fatal heart arrhythmia.

For the study, researchers performed an electrocardiogram (EKG) at one, three and five hours after administering healthy young men either a placebo or Enzyte.

Results showed that study participants given Enzyte had a prolonged QT interval, a measurement of time in the heart’s electrical cycle. A prolonged QT interval is a risk factor for arrhythmia and sudden death.

"Enzyte appears to have some of the properties of some of the most powerful heart rhythm controlling medications that we give by prescription," study author Dr. Brian F. McBride told Reuters.

The study entitled “Effect of Enzyte on QT and QTc Intervals” appears in the August 9, 2010 issue of Archives of Internal Medicine.

According to Vianda, the maker of Enzyte, the product is the #1 selling supplement for male enhancement with five million men worldwide using the product to achieve stronger, firmer, easier to achieve erections. Because erectile dysfunction is an embarrassing condition, some men take such dietary supplements as a treatment rather than seek advice from a physician and are less likely to report adverse effects encountered with these products.

"This creates a relatively anonymous patient population at an elevated risk for drug-induced sudden death," study authors said.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Generally, manufacturers do not need to register their products with U.S. Food and Drug Administration (FDA) nor get FDA approval before producing or selling dietary supplements. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

“Dietary supplements represent a distinct class of biologically active compounds which, unlike prescription and over-the-counter products, have been available to the public without regulatory oversight for nearly 15 years and are responsible for more than 13 000 adverse events annually,” study authors said.

Ingredients in Enzyte include Niacin, Zinc, Copper, Korean red ginseng root extract, Ginkgo biloba leaf standardized extract, Pine bark standardized extract, Tribulus terrestris extract, L-arginine HCI, Avena sativa extract, Horny goat weed standardized extract, Maca root, Muira puama extract, Octacosanol, Saw palmetto berry , Swedish flower pollen extract.

Indeed, it makes no biological or medical sense to believe that any combination of supplements, vitamins or herbs can increase penile size," Dr. Abraham Morgentaler, AOL Health’s men’s health expert said in an AOL article. "There is nothing in the listed ingredients for Enzyte that is known to affect erection quality. It is a scam."

Acetaminophen (Tylenol) Linked to Asthma, Nasal Allergies and Eczema in Teens

A new study released today has found a link between acetaminophen use in teenagers and increased risk of asthma, allergic nasal conditions and eczema, a skin disorder.

The study entitled “Acetaminophen Use and Risk of Asthma, Rhino conjunctivitis and Eczema in Adolescents: ISAAC Phase Three” was published online ahead of print on August 13, 2010 by the American Journal of Respiratory and Critical Care Medicine (AJRCCM).

Researchers of the International Study of Asthma and Allergies in Childhood (ISAAC) from New Zealand, China, Malta and Germany performed an international study of more than 320,000 adolescent children aged 13 and 14 year olds in 50 countries around the world. Participants completed written and video questionnaires reporting current symptoms of asthma, rhino conjunctivitis and eczema. They also completed a written environmental questionnaire for risk factors including acetaminophen use in the past 12 months.

"This study has identified that the reported use of acetaminophen in 13- and 14-year-old adolescent children was associated with an exposure-dependent increased risk of asthma symptoms," said study author Richard W. Beasley, MD, professor of medicine at the Medical Research Institute of New Zealand in Wellington, in a news release.

Study researchers found that teens using acetaminophen just once a year had a 43% increase in asthma risk, while monthly users had 2.5 times the asthma risk as nonusers, reports HealthDay. Those study participants who reported using acetaminophen once a month also reported more severe symptoms of asthma.

Both yearly and monthly acetaminophen users had increased risk of rhino conjunctivitis and eczema.

"We cannot assume causation, but the association was found in widely different communities, with widely different patterns of illness and lifestyles," Dr. Beasley told HealthDay. "When you put it together with all of the other studies, clearly there is [cause for concern].”

he Los Angeles Times reports that McNeil Consumer Healthcare, the manufacturer of Tylenol, said that the drug "has over 50 years of clinical history to support its safety and effectiveness" and that no clinical trial has demonstrated that the drug causes asthma. The drug "is the preferred pain reliever for asthma sufferers," the company said.

Honda Recalls 384,220 Vehicles after Woman Nearly Ran Over by Her Own Car

The National Highway Traffic Safety Administration (NHTSA) announced today that Honda is recalling 384,220 Accord, Civic and Element models in the United States due to a defect that can allow the vehicle to roll away unexpectedly.

Under certain conditions, the interlock lever of the ignition switch in these vehicles may unexpectedly deform, allowing the interlock function of automatic transmission vehicles to fail if the driver does not shift the gear selector to the Park position before rotating the ignition key to the off position. If the driver removes the ignition key without shifting the gear selector into the Park position, the defective interlock lever can allow the vehicle to roll away, increasing the risk of a crash.

Affected by the recall are approximately 197,000 Honda Accord and 117,000 Honda Civic of the 2003 model year, and 69,000 Honda Element model year 2003-2004 vehicles.

According to The Detroit News, Honda has recalled 1.4 million vehicles for various ignition defects since 2003. The news source reports that as of January 2009, the NHTSA had received 36 complaints attributed to the defective interlock lever, 17 instances resulting in crashes. In one instance, a woman reported that her own car nearly ran her over.

To remedy the defect, dealers will replace the interlock pin and lever within the ignition switch free of charge by sending letters to notify Honda owners beginning on or about September 29, 2010. Owners may contact Honda at 1-800-999-1009.

“When Honda identifies concerns of this nature, nothing is more important to the company than fulfilling our obligation and responsibility to alert our customers,” American Honda Motor Co., Inc. said in a statement today.

The Detroit News reports that at a July 29, 2010 meeting with the NHTSA, the carmaker admitted the defect existed but did not initially feel that the issue warranted a recall and agreed only after the NHTSA said it was a “serious enough issue.”

Infant Death Prompts Recall of Nap Nanny Child Recliners

Baby Matters LLC, of Berwyn, PA, has announced a voluntary recall of 30,000 Nap Nanny® portable baby recliners due to a reported infant death, according to a release by the U.S. Consumer Product Safety Commission (CPSC).

The Nap Nanny® is a portable recliner designed for sleeping, resting and playing. The recliner includes a foam base with an inclined indentation for the infant to sit in, a fitted fabric cover and a three-point harness.

The CPSC and Baby Matters, LLC received 22 reports of infants, primarily younger than 5-months-old, hanging or falling out over the side of the Nap Nanny® despite use of the harness on most of the infants. One infant received a bruise from hanging over the side of the product.
Another infant sustained a cut to the forehead when the infant fell over the side of the Nap Nanny®, despite being harnessed in, and was caught between the baby recliner and the side of the crib.

In the case of the infant death while using the Nap Nanny, preliminary reports show the infant was in her harness and found hanging over the side of the product, caught between the Nap Nanny® and the crib bumper.

The CPSC warns that if the consumer places the Nap Nanny inside a crib, play yard or other confined area, which is not a recommended use, the infant can fall or hang over of the side of the Nap Nanny and become entrapped between the crib side and the product and suffocate. The agency also warns that consumers should use the product only on the floor and not place it on a table, countertop or other elevated surface and a child falls over the side, it poses a risk of serious head injury.

Consumers can identify first generation model of the Nap Nanny® by the absence of "D"-rings in the foam base. Consumers with first generation Nap Nanny® models, without "D"-rings, should stop using the recalled baby recliners immediately and contact the firm to receive an $80 coupon towards the purchase of a new Nap Nanny® with free shipping.

In second-generation models, the harness system has "D"-rings in the foam base and Velcro™ straps inside the fitted fabric cover. Consumers with second-generation Nap Nanny® models with "D"-rings, should immediately stop using the product until they are able to visit the firm’s website to obtain new product instructions and warnings.

The company said in a news release that 25,000 of the 30,000 are safe for continued use when used properly.

“As mothers ourselves, we were deeply saddened to learn of an infant death in a crib associated with the use of the Nap Nanny®,” Baby Matters said in a statement. “Safe sleep is of the utmost importance, and we have worked closely with the Consumer Product Safety Commission to implement this voluntary recall, to help ensure that the Nap Nanny® is used properly and only on the floor.”

For more information, contact Baby Matters toll-free at (888) 240-4282 or visit http://www.napnannyrecall.com

Toy and children’s retail stores nationwide and online, including at www.napnanny.com, sold the product January 2009 through July 2010 for about $130.

Clinical Trials Funded by Pharmaceutical Industry more likely to Report Positive Results

A study of clinical drug trials found that those funded by the pharmaceutical industry were more likely to report positive outcomes than were trials funded by other sources.

Researchers examined 546 clinical drug trials conducted between 2000 and 2006 listed in the registry at www.ClinicalTrials.gov. Their analysis showed that industry funded trials reported a favorable outcome 85% of the time, compared to 50% favorable outcomes for government-funded trials and 72% favorable outcomes for trials funded by nonprofits or non-federal organizations.

Of nonprofits and non-federal studies, nearly half were the recipients of drug industry contributions and reported positive outcomes 85% of the time, while those without any such contributions reported favorable results only 61% of the time.

"While we cannot specifically point to which factors contribute to the association between funding source and positive result reporting, our findings speak to the need for more disclosure of all elements of a study," said Florence Bourgeois, MD, MPH, of Children’s Hospital Boston in a news release. "Publication bias is likely a contributing factor, but there may be many more, including biases in study design, patient selection, data analysis and results reporting."

The clinical trial review entitled “Outcome Reporting among Drug Trials Registered in ClinicalTrials.gov” by Florence T. Bourgeois, MD, MPH; Srinivas Murthy, MD; and Kenneth D. Mandl, MD, MPH appears in the August 3, 2010 issue of the Annals of Internal Medicine.
Researchers also found that drug trials funded by pharmaceutical industry were less likely to be published within 2 years of study completion.
The National Institute of Child Health and Human Development and National Library of Medicine funded the study.

The U.S Food and Drug Administration (FDA) uses results of clinical drug trials in the approval process and regulation of drugs.