Dangerous Diet Pills

The FDA has issued a warning that some over-the-counter weight loss pills, being sold as dietary supplements, are actually dangerous, unapproved and misbranded drugs. 

Pure Edge Nutrition recently announced that it is recalling several of its products, after it was discovered the supplements contained undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein. Sibutramine, a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons. Phenolphthalein is used medicinally as a laxative and not approved for marketing in the United States.

Products containing sibutramine and phenolphthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.

These products may also interact in life threatening ways with other medications a consumer may be taking.

Click here to read the complete recall.

Different Regulations for Dietary Supplements

dietary supplements

Although dietary supplement manufacturers must register their facilities with FDA, the dietary supplements themselves are not subject to premarket testing or FDA approval. Additionally, manufacturers are not required to provide the FDA with any evidence that a supplement is safe or even effective.

According to agency’s website, this is because the FDA regulates dietary supplements under a different set of regulations than conventional drug products:

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of federal regulations.
  • The FDA is only responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. 

Misbranded – A dietary supplement is misbranded if its labeling is false or contains misleading information regarding nutrition and health claims, ingredients and quantities.

Adulterated – According to the Dietary Supplement Health Education Act (DSHEA) of 1994, adulteration of a dietary supplement occurs when it does any of the following:

  • Presents a significant or unreasonable risk of illness or injury when used in accordance with the suggested labeling or, if unlabeled, under ordinary conditions of use
  • Is a new entity and lacks adequate evidence or information to ensure its safety of use
  • Has been declared an imminent hazard by the Secretary of the Department of Health and Human Services
  • Contains a dietary ingredient that is present in sufficient quantity to render the product poisonous or deleterious to human health 

Before taking any dietary supplements, including diet pills, herbs, vitamins or minerals, you should speak to a qualified health care provider. He or she can help best determine the benefits and risks.

 

Source:Bella Vi, Super Fat Burner contain dangerous drugs: Tainted dietary supplements” by Brie Zeitner, The Plain Dealer, March 27, 2014.

Speed to Blame for Paul Walker Crash

California investigators have determined that unsafe driving, not mechanical problems caused the Porsche carrying “Fast & Furious” star Paul Walker to lose control and crash, killing the actor and the vehicle’s driver.

tire yaw mark

According to a report by the Los Angeles County Sheriff’s Department and California Highway Patrol, the men were travelling up to 94 mph when the driver, Roger Rodas, struck a pole. Both men died at the scene. Investigators were able to determine the vehicle’s speed based on a “yaw” mark left on the road. Tire yaw marks are created when the driver’s steering causes the vehicle to slide sideways while the wheels are still rolling forward.

Crash Reconstruction

If a motor vehicle accident resulted in death or serious injury, it is vitally important to contact an experienced personal injury lawyer. Remember, although police may secure the scene, take photographs and write a report, they may not have the time or resources to collect all the evidence required to perform an in-depth investigation. While building your case, your attorney should have a crash reconstruction expert conduct a thorough post-crash investigation as soon as possible.

Don’t Wait

Time is not your friend when investigating a crash scene. Evidence left on the road, such as skid marks, yaw marks, tire tracks, fluid stains, vehicle debris, and any paint marks left by the police indicating points of impact or final resting positions, will soon begin to disappear.

By waiting too long, evidence may also fade in areas away from the pavement. Gouges in the dirt, tree scars, as well as damage to poles, mailboxes, and other structures must be carefully documented and evaluated in a timely manner.

In addition to preserving evidence at the scene, investigators need to examine all vehicles involved in the incident. If too much time has passed, they may be difficult to find. Oftentimes, owners will move their vehicle to another location, sell it, or even scrap it for profit.

Read about automotive “black boxes.”

Road Defects and Design Flaws

An experienced accident reconstructionist can also help determine if roadway defects or design flaws contributed to the cause of the accident. It is crucial to have forensic experts who are knowledgeable about government regulations and industry standards.

You can count on Elk & Elk

If you have been seriously injured or lost someone you love in a motor vehicle accident, you can rely on us for help in your recovery. For information about how our Ohio lawyers can help you obtain compensation for your damages after an accident, call 1-800-ELK-OHIO or contact us online.

 

Source: Paul Walker car crash was caused by speed – not mechanical problems: investigatorsAP/New York Daily News, no author given, March 26, 2014.

How Do I Pay For My Personal Injury Case?

Ohio attorney Art Elk explains what a contingency fee is and how it affects you in your personal injury accident or medical malpractice case.

After an accident, it’s easy to become overwhelmed by all the decisions you are required to make. You may need to seek medical help, talk to insurance companies, get your car repaired and deal with not being able to work.

One of the last things on your mind may be bringing a lawsuit against the other driver to help compensate you for lost wages, medical bills and other costs from the accident.

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Most people think of attorneys as charging very high hourly rates—like the ones shown on television and in movies. However, personal injury attorneys work in an entirely different way. Accident lawyers work on a contingency fee basis. In this type of fee structure, you owe the attorney nothing unless a favorable outcome is reached.

The attorney will pay the upfront costs of your case, including investigation fees, getting your medical records and even hiring experts to testify in your case. They must put
together visual aids for court, set up depositions and cover court costs. As an injured victim, you pay no money upfront in your case.

This helps victims who would not ordinarily be able to afford such services, especially after an accident that may have left them in the hospital and out of work. Once you have won your claim, your attorney gets his costs and fees out the money you’re awarded. This allows you to bring a claim when you’ve been hurt but at no cost to you. If your attorney doesn’t win your case, you don’t have to pay a single dime. Since the attorney only receives compensation if there is an award, it gives your lawyer the incentive to make sure your lawsuit is successful.together visual aids for court, set up depositions and cover court costs. As an injured victim, you pay no money upfront in your case.

To learn more about personal injury law, I encourage you to watch the video above and to explore our educational website at www.elkandelk.com. If you have legal questions, please call us at 1-800-ELK-OHIO. I welcome your call.

Art Elk

 En Español

 

March of the Orange Barrels: Work Zone Safety

After the seemingly endless winter months under drab, grey skies with polar vortexes and even a “snowmageddon,” many Ohioans are giddy with delight when they see the familiar signs of spring: daffodils, robins and the NCAA Basketball playoffs.

Yesterday, the Ohio Department of Transportation heralded the long-awaited arrival of spring with this Throwback Thursday tweet:

 

Active construction season. The phrase sends shivers down my spine and conjures visions of that other, less-appreciated sign of spring – the orange barrel. Now, before the griping begins, don’t forget new rules require us to slow down and move over for workers.

New law to be enforced

Starting today, Ohio officials will begin enforcing the expanded “Move Over Law,” designed to protect workers in construction and maintenance crews. The law requires motorists to slow down and, as conditions permit, shift to an adjacent lane when approaching construction, maintenance and public utilities vehicles parked on the roadside with flashing, oscillating or rotating lights. Drivers found in violation of the new law can be cited with a minor misdemeanor.

Work Zone Safety Tips

At Elk & Elk, we encourage everyone to be attentive when driving, especially in work zones. While proper planning, design, and implementation are vital to a safe work zone, drivers must be attentive to changing conditions and exercise caution when approaching and travelling through a work zone.

Here are some important tips from the Federal Highway Administration to help make sure everyone gets home safely.

  1. Expect The Unexpected. Things may change overnight. Normal speed limits may be reduced, traffic lanes may be closed, narrowed, or shifted, and people may be working on or near the road.
  2. Don’t Speed. Obey the posted speed limit at all times, even when workers are not present.
  3. Don’t tailgate. Keep a safe distance between you and the car ahead of you and the construction workers and their equipment. Rear-end collisions account for 30% of work zone crashes.
  4. Obey Road Crew Flaggers and Pay Attention To The Signs. The flagger knows what is best for moving traffic safely in the work zone. The warning signs are there to help you and other drivers move safely through the work zone.
  5. Stay Alert And Minimize Distractions. Dedicate your full attention to the roadway and avoid changing radio stations or using cell phones and other electronic devices while approaching and driving in a work zone.
  6. Keep Up With The Traffic Flow. Do not slow down to “gawk” at road work.
  7. Know Before You Go. Check radio, TV and websites for traffic information and schedule enough time to drive safely. Expect delays and leave early so you can reach your destination on time. (In Ohio, check out www.ohgo.com/index for real time traffic updates.)
  8. Be Patient and Stay Calm. Work zones aren’t there to personally inconvenience you. Remember, the work zone crew members are working to improve the road and make your future drive better.
  9. Wear your seatbelt. It is your best defense in a crash.
  10. Remember – Dads, Moms, Sons, Daughters, Brothers, and Sisters Work HERE!

As we embrace the warmer months, remember to leave a little extra time before hitting the road when travelling through work zones. Men and women are hard at work fixing those car-swallowing potholes, paving new roads and other important projects.

Parking Brake Safety: Mom throws herself in front of car to save kids

Like many people who drive a car with an automatic transmission, I rarely use my parking brake.

Just throw into park, right?

Wrong.

Earlier this month, a Massachusetts mom found out why. According to reports, Mindy Tran had buckled her twin 2-year-old daughters in the back seat of her Honda Accord when she remembered she forgot to lock the front door of her house. Tran placed the car’s transmission into “park,” but as she exited the vehicle, it began to roll away, down the steep driveway, towards a busy highway. She scurried to stop the car, but the weight was more than the young mother could handle.

“I wasn’t going to be able to hold it any longer, so I laid down,” she said. “With the traffic, I knew I had to stop it.”

That’s right. She threw herself in front of the car.

While this mother’s quick and selfless actions are to be commended, this accident could have been prevented.

Always use your parking brake

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Regular use of the parking brake is a good idea because it reduces wear and tear on the parking pawl – a metal pin or lever that mechanically locks the transmission and prevents the wheels from turning. In fact, manufacturers frequently recommend setting the parking brake before shifting the transmission into “park.”

Remember that parking on any incline, no matter how steep, can put considerable pressure on the parking pawl. Never attempt to stop a moving vehicle by putting the transmission into the park position because the pawl can sheer off under pressure.

It’s the law

As in many states, here in Ohio, there are rules regarding unattended vehicles. In addition to setting the parking brake, section 4511.661 of the Ohio Revised Code provides:

No person driving or in charge of a motor vehicle shall permit it to stand unattended without first stopping the engine, locking the ignition, removing the key from the ignition, effectively setting the parking brake, and, when the motor vehicle is standing upon any grade, turning the front wheels to the curb or side of the highway.

Luckily for Mindy Tran, now dubbed the “human speed bump” by the press, a neighbor was on hand to assist her and the children in their time of need. When firefighters arrived, they were able to lift the car off her body by using an air bag. She was then airlifted to a nearby hospital.

While there are no indications that her car suffered from a damaged parking pawl, her story serves as a reminder how a few preventative measures can help avert a tragedy.

 

Source:

“Mass. mom saves children by throwing herself in front of runaway car” by Lori Grisham, USA TODAY Network, Detroit Free Press, March 19, 2014.

State Investigating Abuse, Neglect of Disabled Children

An Ohio care facility for disabled children and young adults is under investigation by state authorities amid allegations of neglect and abuse.

“It was once said that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life—the sick, the needy and the handicapped.”

Hubert H. Humphrey (1977)

Stories like this one are hard to hear. The thought of anyone abusing any child, let alone a young person with severe developmental disabilities, is disturbing, to say the least.

Photo of belts found in Rose-Mary Center.
Photo of belts found in
Rose-Mary Center.

According to The Plain Dealer, the Ohio Department of Developmental Disabilities has determined the Rose-Mary Center in Euclid, Ohio was non-compliant with state codes, and has ordered the facility not to accept any new residents.

The suspension of the facility, run by Catholic Charities, comes on the heels of a scathing 65-page report by Disability Rights Ohio. The advocacy group visited the center earlier this year after receiving a complaint. Their report cites numerous health and safety concerns, including 375 Unusual Incident Reports (UIRs) in the past 6 months, 250 of which involved physical injury to the youth.

The report states, “The UIRs also reflect a disturbing trend of injuries of ‘unknown origin.’…these reports are concerning because the youth have very limited communication skills (many are non-verbal) and thus are unable to report whether the cause of their injuries is physical abuse.”

More serious allegations were included in the facility’s Major Unusual Incidents (MUIs), including reports of staff members slapping, kicking, and even hitting residents with belts. Despite the presence of numerous belts hanging throughout the facility, most of these physical abuse allegations were determined to be “unsubstantiated due to insufficient evidence.”

A staff member from the from the Department of Developmental Disabilities  has been dispatched to Rose-Mary Center “to ensure the safety of the individuals we serve until a long-term plan that assures safety can be developed.”

 

Source:State investigating Rose-Mary Center over care of residents with disabilities” by John Caniglia, The Plain Dealer, March 18, 2014.

Common Causes of Plane Crashes

by Arthur M. Elk

When people think of plane crashes, it usually involves big accidents on commercial airliners. These accidents, such as the missing Malaysia Airlines plane, are front page news that hit on many individuals’ underlying fear of flying. However, many accidents also occur on small private or charter airplanes. Regardless of the type of plane on which one sustains an injury or fatality, it is key to have an accident lawyer who can professionally and knowledgeably address the specific needs of your case.

Compared to other methods of transportation, air travel is quite safe and well regulated to protect its passengers. Nonetheless, crashes continue to occur resulting in incredible tragedy, like that experienced at the Dayton Air Show in 2013. In Ohio alone, the National Transportation Safety Board has recorded over 300 plane crashes since 2005, with 50 of them resulting in fatalities.

There are two primary reasons for aviation accidents: human error and structural failure. Bad weather, errors by Air Traffic Control, negligent maintenance work, and birds can also cause aviation accidents. According to Boeing, crashes occur most often during the landing. When building a case in the aftermath of an crash, a qualified accident lawyer will investigate the cause of the accident and tailor their arguments accordingly.

Aviation law poses a unique set of challenges and complexities and requires extensive investigation that can only be properly handled by an accident lawyer experienced in this field. A skilled lawyer can construct the best case to help you and your family receive the highest compensation possible.

Cochlear Implant Shocks Patients’ Brains

For many families, cochlear implants are a modern miracle, restoring the hearing of a deaf loved one. Sadly, for hundreds of recipients of one cochlear implant, the dream of hearing birds sing or someone say “I love you” has turned into a nightmare.

Reports indicate that over 1500 HiRes 90k cochlear implants have failed due a leak that causes the build-up of excess moisture. This moisture caused some patients to experience severe electrical shocks, causing convulsions, vomiting, and other adverse effects.

Manufactured by Advanced Bionics, the device consists of two main parts: an internal component, which doctors surgically implant in the skull and an external component that sits outside the ear. These two parts are connected by the “feedthru,” which must remain waterproof.

According to an investigation by NBC News, Advanced Bionics knew as early as 2003 that the feedthru “may be vulnerable for a potential leak.” The device was recalled in 2004, but was quickly returned to the market later that same year. In 2005, the FDA sent a warning letter to Advance Bionics and in 2006 a second recall was issued, affecting more than 4,000 recipients of the device.

Despite a myriad of reports detailing device failure and other warning signs, such as internal Advanced Bionics memos, patients — including children — continued to receive implants during 2005 and into 2006.

“I think those human beings made a terrible decision,” said Dr. Arun Gadre, a professor of otolaryngology and head and neck surgery at the University of Louisville. “When you start putting profits before people, because that’s the only way I can interpret this, if you start putting profits before people it never comes to a good end. There’s no way that could ever come to a good end.”

A third recall was announced in 2010, after recipients experienced severe pain, overly loud sounds and shocking sensations shortly after the initial activation of their device.

In March 2013, a jury awarded more than $7.2 million, including nearly $6.3 million in punitive damages to the parents of a West Virginia girl who had been severely shocked by the HiRes 90k.

The jury in the lawsuit, filed in the U.S. District Court for Western Kentucky, found that Advanced Bionics did not properly test the implant before it hit the market and never told the FDA that it had switched the manufacturer of a key component to a different vendor.

 

Source:Defective cochlear implants shocked kids — even though company had been warned” by Michael Kosnar and Lisa Myers, NBC News, March 14, 2014.

Surgical Tools Left Inside Patients

Ohio medical malpractice attorney Craig McLaughlin explains how he helped a client that was injured when a surgical team left a towel inside his body after he had an operation.

Any time you go in for a medical treatment or surgery, you expect the doctor and hospital staff to be professional and fully aware of safety protocols.

Unfortunately, that’s not always the case. Whether it’s poor training or lack of attention to detail, medical staff can cause serious injuries and harm patients in the process. It is their duty to make sure that you are well cared for and not harmed in the process. However, there are times when medical mistakes occur, and few are graver than those that are made while in the operating room.

Surgical mistakes can come in many forms, from anesthetic errors, to operating on the wrong body part, to leaving surgical tools within the body. Some of the most common instruments left inside include scalpels, forceps, clamps, tweezers, sponges and syringes. Doctors may also leave scissors, scopes, tubing and measuring devices within a patient’s body as well.

When a foreign object is left inside a patient’s body, it can result in serious bodily injuries. These tools can pierce into organs and cause internal bleeding. Other items can cause infections, pain and lots of discomfort. Some tools can actually imbed themselves inside the body with tissue growing around them. If you notice pain or discomfort near your surgery site, it’s important to talk to your treating doctor immediately so that your matter can be checked.

If you are injured due to a surgical mistake or any type of medical malpractice, you should speak to an experienced medical malpractice attorney. Doctors, nurses and other medical staff are responsible to ensure that your surgery is safe and keeps you out of harm’s way. There are protocols in place to protect you as a patient and if you’re injured, you may need to bring a claim against those who harmed you in order to recover from the costs of your pain and suffering.

To learn more about personal injury law, I encourage you to watch the video above and to explore our website for details. If you have legal questions, please call us at 1-800-ELK-OHIO. I welcome your call.

R. Craig McLaughlin

Death of 2 Children Renews Storage Chest Concerns

Officials warn of dangers associated with storage, cedar, hope and toy chests

It seems you can’t go more than a few days without hearing about the recall of a car, toy, or other product, and it may be a bit overwhelming. However, here at Elk & Elk, we post news of numerous recalls in our blog and through social media accounts like Facebook and Twitter to help keep you safe and warn the public about dangerous products – and for good reason.

Lane chest dangers
Lane Cedar Chest – photo courtesy of CPSC

The deaths of two young children have reignited decades-old concerns about product that was first recalled nearly 30 years ago. The Boston Globe reports that 8-year-old Lexi Munroe died due to suffocation along with her brother, Sean, 7, in January 2014 – their small bodies found inside a common storage chest.

Following the deaths of these siblings in Massachusetts, the U.S. Consumer Product Safety Commission (CPSC) is renewing its warning to consumers about the dangers associated with storage, cedar, hope and toy chests. Lids on millions of storage chests and trunks can automatically latch shut, locking children inside and suffocating them. In addition, the lid supports on older toy chests can fail to prevent the lid from closing suddenly, entrapping or strangling children by the head or neck.

Lane Cedar Chest Recall

In 1996, Lane Furniture issued the first recall of 12 million of its popular “Lane” and “Virginia Maid”-brand cedar storage chests, made between 1912 and 1987. Since the chests latch automatically when the lid is closed, young children playing in the chest can become trapped inside and suffocate. Between 1977 and 1994, six children died inside Lane cedar chests. The recall was re-announced four years later, with the company calling for a renewed search for the affected cedar chests to replace the locking mechanism.

Lane and Virginia Made Labels
“Virginia Maid” and “Lane” Brand Name Logos

Now, once again, Lane Furniture is asking the public to search their homes for these chests and is offering a free, easy to install, latch replacement kit.

Although dozens of companies have taken action to correct more than 14 million toy and storage chests that posed a risk to children, the Consumer Product Safety Commission (CPSC) has received reports of 34 deaths since 1996 involving children.

If you have a storage chest in your home, follow these important steps to protect your family

  • Consumers should remove the latch from the recalled Lane and Virginia Maid brand cedar chest made between 1912 and 1987 and contact Lane for free replacement hardware.
  • For all other chests that have not been recalled but have an automatic latch/lock, disable or remove the lock and check with the chest manufacturer to see if the manufacturer is offering replacement hardware.
  • If the lid support does not keep the lid open in every position, you should remove the lid’s support or replace it with a spring-loaded lid support that will keep the lid open in any position. Remove or replace an unsafe adjustable lid support on these toy chests.
  • All toy chests should have ventilation holes that are not blocked by the floor or against the wall.

The Consumer Product Safety Commission said in a press release that it is working with the National Association of Resale Thrift Shops (NARTS), Goodwill Industries, and the Salvation Army to take steps to ensure that resale store managers and staff do not accept or sell chests that have been recalled or pose a danger to children. Do not purchase or sell any recalled chest that has not been repaired.

To obtain a replacement latch, contact Lane Furniture at (800) 327-6944, Monday to Friday from 7 a.m. to 6 p.m. CT, or access their web site at http://www.lanefurniture.com

 

Source: “Two Franklin children die after being trapped inside hope chest while playing” by Peter Schworm and John R. Ellement/Globe Staff, The Boston Globe, January 13, 2014.