Tuesday, June 10, 2008
Attack of the Killer Tomatoes


When I pulled up to my favorite restaurant last night, I noticed a sign on the door, "We, like many other restaurants, will not be serving fresh tomatoes due to the salmonella outbreak." Now, I have heard about the outbreak in the news, but hadn't realized its scope until I got my favorite entrée sans tomatoes.

Since mid-April there have been nearly 150 cases of salmonellosis, a rare type of Salmonella Saintpaul posioning, linked to raw red plum, red Roma and/or round red tomatoes (according to the FDA, grape and cherry tomatoes as well as those still attached to the vine are still safe to eat). At least 23 have been hospitalized and illnesses have been reported across 17 states, making this the biggest food scare since the tainted spinach fiasco of '06. The source of the tomato contamination has yet to be identified.

In the wake of the FDA warning, restaurants and supermarkets across the country are pulling the summer staple trying to ensure the safety of their customers.

If you have any of these tomatoes at home, best advice is to toss them in the trash or take them back to the place where you purchased them. Salmonella is passed when human or animal fecal matter comes in contact with food. In case that visual isn't gross enough, the severe, flu-like symptoms that follow are enough to keep anyone away from these types of tomatoes. But, if you decide to go against the FDA's advice and all conventional wisdom by eating the tainted treats, remember to wash them thoroughly, remove the part that is attached to the plant and the button on the other side and cook them at a minimum of 145 degrees. No matter how much of a daredevil you are, don't try to eat them raw- its just not safe.

This latest breakdown of safety in our nation's food chain should serve as a good reminder to remain vigilant when dealing with food. Properly cooking meat, poultry and eggs, and washing produce are generally the best methods to prevent illness. Keep your hands and kitchen surfaces clean to prevent cross-contamination.

If even after you take these precautions, you get sick- report the illness to the FDA. This is a very important step to identifying the source of the sickness and preventing others from falling ill.

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posted by Munley Attorney @ 9:22 AM

Friday, June 6, 2008
FDA's Brain Drain


According to an article from the Associated Press, when Big Pharma has a job opening- the first place they look is the FDA.

The former stewards of public health are extremely valuable to drug companies, because of their crucial experience. But what is good for Big Pharma is not always good for America.

With the FDA coming under fire just about every week now and paychecks that pale in comparison to what the world's largest drug-makers can provide, some of the agency's top scientists are leaving for greener pastures.

The problem? The FDA is already stretched thin with the departure of many Baby-Boomers and increased competition for science graduates. Now that other top-level personnel are jumping ship to Big Pharma, the FDA is left with a leaner, less experienced and less-confident staff, and tasking them with keeping America safe. The scenario has been dubbed the "FDA brain drain."

Steve Brozak, an analyst with WBB Securities, told the AP, "What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely. This cannot have any positive effect whatsoever."

This is leaving the leadership of the agency scrambling to find bodies to fill the vacancies.

Those left behind are less confident about putting new drugs onto the market in light of more recent fiascoes like tainted heparin and Vioxx. And the dwindling numbers also mean that increase of the much-needed food and drug manufactures inspections are little more than a hoop dream.

To read more, click here.

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posted by Munley Attorney @ 12:30 PM

Thursday, June 5, 2008
Summer Time is Playground Safety Time


Well, it's that time of year again- school's are letting out and the lazy, hazy days of summer are finally in sight.

With time to waste, many kids are going to be hitting local playgrounds. While playgrounds offer kids a great opportunity to keep active and socialize, a poorly maintained playground could also be dangerous.

Before you unleash your kids at the local playground, make sure it lives up to your standard of safety. Just remember to play it S.A.F.E.!

S= Supervision

Supervision is a critical component to a child's safety, especially at playgrounds. By keeping a watchful eye over what the kids are up to, parents or supervising adults can help prevent injuries.

In some cases, children are seriously injured at the playground, but have no adults with them at the time! The National Program for Playground Safety urges parents and adults to follow the ABC's of Supervision- Anticipate preventable problems and hazardous situations. Behavior means being alert and attentive. Despite the type or Context of the play area, whenever children are on the playground, adults should be present.

A= Age-Appropriate Design

Not all play areas are built the same. Different equipment is built for kids of different age groups. Since younger children are less physically developed and adept than their older counterparts, make sure youngsters stick to the structures that are right for them.

Kids between 6-23 months should play in areas that have space to move and explore. Appropriate play areas for this group should provide places to crawl, stand, and walk without the risk of falling.

2-5 year olds should play in areas that include areas to crawl, low platforms with multiple access such as ramps and ladders, ramps with pieces attached for grasping, low tables for sand, water and manipulation of materials; tricycle paths with various textures, flexible spring rockers, sand areas with covers and slides no taller than 4 feet.

Depending on their abilities, kids between 5-12 are able to use the largest equipment on the playground, including the large slides, seesaws and monkey bars. However, parental supervision is still necessary!

F= Fall Surfacing

Kids fall, that's what they do. That's why it is so important that your playground be outfitted with a proper fall surface, in order to minimize the risk of serious injuries. Acceptable loose-fill materials are pea gravel, wood chips, sand and shredded rubber. Loose-fill should be at least 12 inches deep. Acceptable synthetic surfaces include rubber tiles, rubber mats and certain synthetic poured surfaces.

Playground surfaces, including the fall surfaces, are often exposed to direct sunlight. That means, depending on the climate where you live, they can reach 100-150 degrees. That much heat can cause serious burn injuries. To prevent injury, kids should always wear shoes and other protective clothing.

E= Equipment Maintenance

Before you let your kids hit the playground, go through and do a visual inspection of the equipment and fall surfacing. Make sure they are in good working order, meaning wooden structures are not splintered or fractured, metal equipment is free from rust and other deterioration and plastic structures should be crack-free. In addition, nothing should appear broken or in disrepair, there should be no large gaps or sharp objects in play equipment and garbage should be removed frequently.

To ensure your child's utmost safety, print out and follow this NPPS playground safety checklist.

Remember summer time is a fun time, and playgrounds are important places for children as they grow and develop. With a young child, the risk of injury is around every corner, but by empowering yourself with knowledge and following the above safety tips, you and your family will be able to enjoy the best of what summer has to offer!

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posted by Munley Attorney @ 9:06 AM

Friday, May 23, 2008
Aviation, Trucking Regulators Warned About Dangers of Pfizer Drug


Pfizer's new smoking cessation drug, Chantix, has hit a few bumps in the road since it received FDA approval in May 2006. The drug's sales have been stumbling since this the FDA announced new label warnings were necessary due to increasing evidence that drug triggers changes in behavior and suicidal tendencies in some patients. Now, other potentially dangerous side effects are coming to light, but you wouldn't know it from their adorable television commercials.

On Wednesday, a study was released by the not-for-profit organization, the Institute on Safe Medication Practices. It blasted the drug for adverse reactions such as "serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, abnormal muscle spasms/movements, visual disturbances, diabetes, sudden losses of consciousness, psychosis, aggression and suicide." The drug accounted for 988 reports of serious injuries in the 4th quarter of 2007, more than any other drug in that period. In fact, 35 other drugs made up all the remaining 100 reports for the quarter. The Institute recommended that the drug be banned in all settings "where a lapse in alertness or motor control could lead to massive, serious injury."

Hours after the ISMP's study was released, the Federal Aviation Administration announced they would ban the drug for all pilots and air traffic controllers. Yesterday, the agency that oversees the trucking and busing industries, the FMCSA, requested that medical examiners "not qualify anyone currently using this medication for commercial motor vehicle licenses."

The FDA has yet to announce any new action. Agency spokesperson, Susan Cruzan, said they would continue to focus on the drug's link with neuropsychiatric side effects. "The agency has chosen to focus its current safety reviews on issues relevant to psychiatric adverse events but will continue to review other ADEs [adverse drug events] over time," she told the press.

On Wednesday, drug-maker, Pfizer, minimized the information released in the ISMP's report, saying most of the events reported were "infrequent" or "rare." The company said the serious side effects are already listed on the drug's warning labels, and over 5.5 million Americans have used the drug. Granted, just because 20 million Americans used Vioxx, didn't make it safe.
Prescriptions of Chantix were last month by over 23% on last year. And sales estimates on the drug have been cut by more than 20% this year, 42% next year and at least 50% the following year.

To learn more about prescription injuries, click here.

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posted by Munley Attorney @ 9:02 AM

Wednesday, May 21, 2008
Carseat 101


It is frightening to think that each day 5 children are killed in automobile accidents- and another 586 will suffer injuries. It is even scarier to consider 1700 kids die a year, almost half of which are unrestrained passengers.

By simply securing your child in a car safety seat, you can reduce the risk of fatal injury by 71% for infants under one, and 54% for toddlers between one and four years old.

For some, installing a child safety seat can be an arduous task. Perhaps that's why as many of 85% of car seats are installed incorrectly or are not the right size for the child. By following these simple guidelines, we can help you keep your family safe.

1. Always read & follow the instructions from the manufacturer of the seat.
2. Remember to send in the registration card- this will be important is the seat is recalled.
3. Children under 12 should sit in the backseat, doing so reduces the risk of serious injury by 40%.
4. Car seats for children under 20lbs should always face backwards.
5. Never place a backward facing seat in front of an airbag.
6. The shoulder straps of the car seat go in the lowest slots for infants riding backward, and the highest slots for children facing forward.
7. The retainer clip should be placed at arm pit level to keep harness straps on the shoulders.
8. Harness straps should be snug. So snug that you cannot fit more than one finger at the child's collarbone.
9. Check the owner's manual for your car to see if you need to use a locking clip or some additional piece of equipment to keep the safety seat secure.
10. When the car seat is installed, be sure it does not move side-to-side or toward the front of the car.

Remember to continually check your car seat for evidence of damage such as cracked plastic, frayed straps, stiff adjusters or broken buckles. Never use a car seat that has been in an accident, it is no longer safe. Don't be tempted to save money by buying a used car seat. There is no way to tell if the seat has been damaged in an accident. If you can't afford a car seat, contact the National Highway Traffic Safety Administration or the National SAFE KIDS campaign.


Every parent knows that you can't protect your child from everything, but when it comes to auto safety, there is something you can do. Keep them safe, buckle them up!


Throughout the year, the State Police offer inspections of child car seats. To find the next inspection near you, click here.

Wondering if your seat has been recalled? Call the U.S. Department of Transportation Auto Safety Hotline for an up-to-date list of recalled seats that need repair, 1-800-424-9393.

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posted by Munley Attorney @ 11:33 AM

Thursday, May 15, 2008
Mr. Quaid Goes to Washington


Actor Dennis Quaid testified before Congress yesterday about the terrifying ordeal that nearly killed his newborn twins last year. The infants were given an accidental overdose of the blood-thinning drug, Heparin (shortly thereafter, the drug made additional headlines when tainted batches from China killed dozens).

He and his wife are suing Baxter International, the maker of the drug, as they believe confusing labeling on the bottle caused the mix-up. They also argued that the drug should have been recalled after three other infants died, also of accidental overdoses. Baxter cited preemption in their motion to dismiss the Quaid's lawsuit.

Before Congress, he urged lawmakers to protect the rights of average citizens, saying " I believe that if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uniformed and uncompensated lab rats."

Here's some video of Quaid talking preventive medical negligence-

The FDA, under the Bush Administration, has advocated the preemption of lawsuits. FDA Deputy Commissioner Randall Lutter said, "[The] FDA believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not by second-guessed by state courts."

Rep. Henry Waxman, D-CA, disagreed, saying, "One of the most powerful incentives for safety - the threat of liability - would vanish."

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posted by Munley Attorney @ 11:38 AM

Monday, May 5, 2008
Recall Round-up


May is still a young month, but we've already seen a rash of recalls on everything from SUVs to meat.

This weekend Toyota announced a 90,000 car recall of their popular Highlander SUV. The vehicle was recalled so that the automaker can repair a defect in a third-row seatbelt. This affects all gasoline and hybrid models of the SUV and includes all vehicles produced between May 2007 and March 2008.

The Consumer Products Safety Comission has announced three recalls so far this month. In cooperation with QVC, the agency recalled SoleusAir Space Heaters which sold in QVC's Studio employee and retail stores from December 2007 through March 2008 for between $65 and $80. The unit poses the danger of overheating. QVC reported 9 incidents of flames shooting out of the 1500 watt unit, and 70 additional reports of it smoking, overheating, sparking, melting, and/or emitting burning odors.

The CPSC also announced the recall of a Children's Storage Bin sold at Lowe's. The bin was recalled due to a violation of the lead paint standard, which is potentially harmful to children. The recalled bins are wooden with scalloped edges, came with the item numbers 226782 (green storage bin) or 226781 (pink storage bin). They were sold nationwide at Lowe's between March 2007 and February 2008.

Just this morning the CSPS announced its third recall of the month, for 4,800 Broil King Gas Grills. The grills were recalled because the bottom of the cook box can melt or crack as a result of a grease fire, posing a serious burn hazard to users.

In other recall news, the Queens, NY-based Gourmet Boutique voluntarily recalled more than 30 fresh and frozen food items that had been sent to food service and retail establishments nationwide due to the presence of Listeria.

The products included chicken salad, sandwiches, frozen wraps and burritos sold under the names Gourmet Boutique, Jan's and Archer Farms.

Target, which sells Archer Farms brand food items, announced the affected products were only sold in SuperTarget locations.


The contaminated fresh items were produced between April 19 and 24, 2008, and the frozen items were produced between Oct. 23, 2007 and April 23, 2008. Read more here.

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posted by Munley Attorney @ 11:31 AM

Tuesday, April 29, 2008
Sick of Spinach


According to a House committee report, since 2001, almost half all the nation's spinach-packing facilities had "serious" sanitation issues; however, the FDA failed to make "meaningful" actions to address the violations. Read the government report here.

FDA inspections noted that 67 facilities lacked adequate restroom sanitation, had piles of garbage and potentially hazardous indoor condensation issues. Reports have shown some buildings were found to be vulnerable to rodent infestation and facility-workers displayed poor hygiene and went without hairnets and other sanitary garb.

Since 1995, there have been 20 serious outbreaks of E.Coli linked with tainted spinach and lettuce. One of the most notable was the 2006 poison spinach scandal that sickened hundreds and killed three. The outbreak was linked to a supplier for California's Natural Selection Foods. It is believed waste from cows and/or feral pigs contaminated the spinach crop. However, years before this outbreak, the FDA identified problems with several Natural Selection facilities. According to the authors of the House report, the "FDA at no time required the firm to correct these conditions at any of its facilities, even after laboratory tests indicated the presence of microbial contamination at the exact site later implicated in the 2006 outbreak."

Shortly after the episode, FDA officials admitted to lapses in food safety efforts. The House report revealed that Natural Selection facilities and other problem factories were being inspected every 2.4 years, rather than annually as required by federal guidelines.

Despite the identification of serious safety violations, the FDA did not report any of the problem facilities to its internal enforce authorities, and failed to take any serious efforts in correcting the potentially life-threatening problems. Authors of the House Committee report explained their investigation raised "serious questions about the ability of FDA to protect the safety of fresh spinach and other fresh produce."

FDA spokeswoman Kimberly Rawlings said in an e-mail that "despite recent concerns, the food supply in the U.S. continues to be one of the safest in the world and this includes fresh produce." I wonder if she still eats bagged spinach.

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posted by Munley Attorney @ 11:11 AM

Wednesday, April 23, 2008
8 Companies Pay $320K For Defective Kids' Clothing


Eight companies have agreed to settle allegations that they knowing sold defective children's apparel without notifying the U.S. Consumer Product Safety Commission, as required by federal law. Each firm will pay between $25,000 and 50,000 for their actions; however, in doing so, they deny CPSC's allegations that they knowingly violated the law. All together, the government agency will collect $320,000 for the violations.

The stores reportedly sold hooded sweatshirts and jackets with drawstring necks determined to be a strangulation hazard. The apparel was recalled.

The companies involved in the CPSC's actions are Life is Good, Inc., True Religion Apparel, Inc., The Cayre Group Ltd., DollarDays International LLC, Kohl's Department Stores Inc., Seena International Inc., Neiman Marcus Group Inc. and Glidan Activewear SRL.

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posted by Munley Attorney @ 3:21 PM

Tuesday, April 22, 2008
House Committee to Review FDA's Overseas Inspections


In just a few minutes from now, lawmakers will examine whether or not FDA inspectors could have prevented contaminated heparin from reaching the U.S. market. Watch it live, here.

Yesterday, Chinese and U.S. officials battled over whether or not a containment in the drug caused severe allergic reactions that killed 81 Americans. Previous reports put the number of dead at 20. They also argued the source of the contamination, with China suggesting it occurred in the U.S. The contaminated drug has been discovered in 11 countries across the globe.

The House and Energy Sub-Committee will be grilling FDA Chairman, Andrew von Eschenbach, who is expected to discuss the agency's plan to open a Chinese office next month. Lawmakers will also hear from FDA advisers who are requesting an additional $375 million to repair its poorly staffed and underfunded inspection process. CNN reports that the Bush Administration has requested $54 million for the FDA in the 2009 fiscal budget, a number that is under fire from both Democrats and Republicans in Congress.

Describing the heparin contamination as a world-wide problem, Dr. Janet Woodcock told U.S. Officials that the FDA's Center for Drug Evaluation and Research has "now established a mechanism by which we think this contaminant could cause these adverse events." To read more about the on-going heparin saga, click here.

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posted by Munley Attorney @ 9:49 AM

Wednesday, April 16, 2008
Merck's Questionable Ethics Explored


Two new reports in the Journal of the American Medical Association have raised concerns that Merck employed questionable ethics in pushing their dangerous drug, Vioxx, onto the market. You're shocked, I'm sure.

The reports were based on court documents discovered throughout the course of the 4.85 billion settlement involving 47,000 patients injured by the drug.

The first report alleges (read about it) that Merck was well-aware of the fact patients taking Vioxx in clinical trials were three times as likely to die as those taking placebo. Instead, Merck reported the drug was "well-tolerated," failing to report the findings of their study to the FDA and the public in a timely fashion. Vioxx was eventually withdrawn from the market in 2004.

The second report (as described here) indicates that Merck used company-hired individuals to write their studies, then paid well-respected academic scientists to take credit for them. The Journal indicated that this is common, but questionable practice in today's medicine, and urged reform.

Merck denies the reports, saying they were "false and misleading." And they know all about false and misleading!

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posted by Munley Attorney @ 2:22 PM

Are Plastic Bottles Safe?


New concerns are being raised about the safety of hard plastics containing BHA (bisphenol A), a chemical found in water bottles, baby bottles and in the lining of cans containing food and infant formula. BHA is used to strengthen plastics, making them shatter proof.

According to a brief by Department of Health and Human Services' National Toxicology Program, the chemical is believed to be linked to health problems such as prostate cancer, breast cancer and early-onset puberty. Others worry that exposure to the chemical can have neural and behavioral effects on fetuses, infants and children.

However, the FDA and food industry experts maintain the safety of the chemical. The question is can we believe them?

According to this Reuters article, Rep. John Dingell, the chairman of the House of Representatives Energy and Commerce Committee, said this report should cast doubt on the FDA's position that BPA was safe.

"I hope the FDA is willing to reconsider their position on BPA for the safety of our infants and children," he said.

Read more about BHP and the U.S Government's report on its safety here.

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posted by Munley Attorney @ 8:59 AM

Friday, April 11, 2008
Hillbilly Teeth Recalled


The U.S. Consumer Product Safety Commission along with the Huston firm, FUNTASTIC, are recalling 26,000 "Hillbilly Teeth" due to a violation of lead standard. To me, this seems extremely troublesome as these lead-riddled toys were specifically designed to go in kids' mouths.

The Chinese-made toys (surprise, surprise) were sold at grocery, drug and convenience stores as well as mass retailers from March 2005 through March 2008. They sold in a 2-pack with item # 2657for about $2.

Caregivers, please keep these dangerous toys away from your children and return them to the store of purchase for a refund.

For more information, call FUNTASTIC at (800) 434-5207 or visit the company's Web site.

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posted by Munley Attorney @ 12:07 PM

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