Recently in Products Liability / Dangerous Products Category

FDA Warns About Disease Caused By Contaminated Mattresses

May 21, 2013, by Benjamin J. Sansone

The U.S. Food and Drug Administration recently released an alert to nursing home providers across the country about the potential dangers posed by contaminated mattresses. Specifically, the alert referred to the risk of dangerous infections that can start when worn or damaged mattress covers allow blood and other bodily fluids to penetrate medical beds in nursing home facilities.

The FDA safety bulletin said that medical mattress covers are designed to protect the mattress itself from contaminated fluids. The problem is that due to overuse and simple old age, many of these covers can become worn. The wear and tear on mattress covers can cause leakage in places, allowing bodily fluids to penetrate to the inner layers of the mattress. This is possible even in covers that claim to be water-proof or which are coated in antibacterial substances designed to kill viruses and bacteria.

The FDA says that it believes damaged mattress covers are responsible for several potential infection outbreaks that have occurred across the country in nursing homes. Specifically, the FDA says that over the last two years it has received just under 500 reports associated with mattress covers that have failed to prevent bodily fluids from leaking into the mattress itself. Many of these reports have indicated that fluids from one patient penetrate a mattress and then later either leak out or come in contact with a new patient that has been placed on the same bed. This second patient is then at a high risk of developing infections which can spread throughout the rest of the facility.

The regulatory agency has said that problem is no small matter; instead, it believes that the issue of contaminated mattresses is widespread and seldom spotted by healthcare providers who are not trained to look out for such problems. To help combat the issue, the FDA has recommended that staff members at nursing facilities regularly check each mattress cover for visible signs of damage such as cracks, tears or pinholes which can allow fluids to leak inside the cover. Another vulnerable area in the covers is the zipper, which the FDA says can be the source of leaks. Staff members should also regularly remove the mattress cover and check inside for moisture. The mattresses should be checked for wet spots or stains, which can indicate that the cover is not functioning as it should. All damaged or soiled mattresses should be replaced immediately given the danger of an infection associated with such contaminated mattresses.

Illinois medical malpractice lawyer Ben Sansone is an experienced trial lawyer who routinely handles cases from simple car crashes to complex medical negligence cases. If you would like to discuss a potential case we are available for a free consultation to discuss your case. Call us at (314) 863-0500 or contact us online to arrange a free meeting.

Source: "FDA Warns That Damaged, Worn Covers for Medical Bed Mattresses Pose Risk," published at InfectionControlToday.com.

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FDA Reveals 13 Deaths Linked to 5-Hour Energy

November 29, 2012, by Benjamin J. Sansone

5 hour energy death cases.jpgAccording to a recent article by the New York Times, the Food and Drug Administration has launched an investigation after reports that the 5-Hour Energy product may be linked to some 13 deaths over the past several years. Potentially product liability wrongful death cases may follow.

The FDA confirmed that it has begun an investigation into the 13 deaths which all occurred within the last four years. The investigation is similar to the one involving Monster Energy Drink and the five deaths that were related to its use.

A report by the New York Times revealed that since 2009, 5-Hour Energy has been named in some 90 filings with the FDA including 30 that involved life-threatening incidents. These include incidents of heart attack, convulsions and, in one especially tragic case, a spontaneous abortion.

The company has responded by issuing a statement saying that the small shot of caffeine is safe when used as directed. The company, Living Essentials, says that no more than two of the 2-ounce shots should be consumed in a day and the two shots should not be consumed close together. Each tiny shot contains as much caffeine as a cup of coffee.

Consumer Reports recently studied the levels of caffeine in a wide array of energy drinks and found that the highest amount per serving was found in the 2-ounce, 5-Hour Energy Extra Strength which contained 242 milligrams of caffeine. This is many times more than the 35 milligrams of caffeine found in a 12-ounce can of Coke.

Though caffeine may not be a dangerous and regulated prescription medication, there's no doubt that that such high levels can cause serious harm. Seemingly safe ingredients in products we use and consume every day can cause great harm given the right set of circumstances. As an example of the harm they can cause, the Substance Abuse and Mental Health Services Administration said that more than 13,000 emergency room visits in 2009 were linked to energy drinks.

If you or someone you know has a loved one who has been seriously or fatally injured in any kind of accident due to the negligence of another party, you do have options to receive compensation for this loss. For information on how to protect your rights in a situation of negligence or wrongful death, please call one of the Missouri injury lawyers at 1-314-863-0500 or contact an attorney online today.

Source: "Caffeinated Drink Cited in Reports of 13 Deaths," by Barry Meier, published at NYTimes.com.

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Lawsuit Says St. Louis Citizens Sprayed With Radioactive Chemicals in Secret Military Experiment

November 19, 2012, by Benjamin J. Sansone

According to a recent report by a professor at St. Louis Community College, the United States military conducted top-secret experiments on the citizens of St. Louis, Missouri for years, going so far as exposing them to radioactive compounds.

The researcher, Professor Lisa Martino-Taylor, said that while it has long been known that the government sprayed supposedly harmless zinc cadmium sulfide particles over St. Louis, she claims that a radioactive additive was also mixed with the compound.

Martino-Taylor says she has found detailed descriptions as well as photographs of the spraying which exposed the unwitting public, predominantly in low-income and minority communities, to radioactive particles. In her research, she found that the greatest concentration of spraying in St. Louis took place at the Pruitt-Igoe public housing complex, which was home to 10,000 low-income residents. She said that 70% of those residents were children under the age of 12.

Despite the extent of the experiment, local politicians were never notified about the chemical content of the testing. The people of St. Louis were instead only told that the Army was testing smoke screens to protect cities from a Russian attack.

Now that details have emerged of the chemical testing, a recent lawsuit filed in City Court says that the agriculture giant Monsanto and others conspired with the military to secretly poison residents of St. Louis with toxic chemicals.

The plaintiff, Benjamin Phillips Sr., claims defendants Monsanto, Parsons Government Services and SRI International participated in a study beginning in 1953 that lasted into the 1960s. Phillips claims the study, known as the "Involuntary Chemical Study on PI Residents", was conducted around the Pruitt-Igoe housing complex in St. Louis.

Phillips, who lived at Pruitt-Igoe at the time of the experiment, claims the chemicals caused emotional and psychological trauma and harm as well as unspecified personal injury. Phillips is seeking actual and punitive damages for public nuisance, liability, intentional infliction of emotional distress and battery.

If you or someone you know has a loved one who has been seriously or fatally injured in any kind of accident due to the negligence of another party, you do have options to receive compensation for this loss. For information on how to protect your rights in a situation of negligence or wrongful death, please call one of the St. Louis accident/wrongful death attorneys at 1-314-863-0500 today.

Source: "Army's secret chemical testing in St. Louis neighborhoods during Cold War raising new concerns," by, published at FoxNews.com.

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Second Major Drug Recall Related to Fungal Meningitis Outbreak

November 18, 2012, by Benjamin J. Sansone

A company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak is recalling all of its products after federal inspectors said it must improve its sterility testing process.

Officials with the FDA have said that a routine inspection turned up inadequate quality assurance related to Ameridose's sterile products. The FDA was quick to say that it has not discovered any infections linked to the recalled products from Ameridose. In a statement, Ameridose declared it issued the recall "out of an abundance of caution."

Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing fungal meningitis outbreak.

The FDA warned that six drugs produced by Ameridose were already on the FDA's list of drugs in short supply. According to the FDA, the Ameridose recall could exacerbate one or more of the shortages of these drugs. Given the shortages, the FDA is working with manufacturers of the six drugs, asking that they ramp up production if they are willing and able to do so.

According to the Centers for Disease Control and Prevention, there have been reports of 386 fungal meningitis cases throughout the country related to the NECC recall. The CDC also announced that there have been 28 deaths in the following states: Florida (3), Indiana (3), Maryland (1), North Carolina (1), Michigan (7), Tennessee (11) and Virginia (2).

Ameridose and the NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. According to Ameridose, it is a separate entity. However, Cadden, who was the lead pharmacist at NECC, has resigned from his role at Ameridose. In a bizarre bit of news, it was recently revealed that despite an internal investigation showing serious contamination problems at the lab, NECC has been sending customers report cards declaring how clean its facilities are.

Those who have suffered injuries at the hand of their doctor should be aware that legal remedies might be available to them. If you or a family member have suffered needless injury or death as a result of hospital or doctor neglect, please contact the experienced Missouri pharmacy malpractice lawyers at Sansone / Lauber by phone (314) 863-0500 or contact an accident attorney online.

Source: "Meningitis-Related Pharmacy Recall Worsens Drug Shortage," by Anna Edney, published at Businessweek.com.

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Monster Energy Drink Deaths

November 10, 2012, by Benjamin J. Sansone

monster drink death lawyer missouri.jpgThe Food and Drug Administration recently announced that the agency launched an investigation concerning five deaths and one non-fatal heart attack linked to consumption of the Monster Energy Drink. The Monster Energy Drink is a heavily caffeinated soda that has grown in popularity in recent years among those eager for a boost, especially young people.

Reports indicate that several people suffered adverse reactions after consuming the drink which contains a whopping 240 milligrams of caffeine. To put that number into some perspective, one Monster Energy Drink contains about seven times the caffeine in a typical 12-ounce can of soda.

The FDA issued a statement saying that it was taking the reports of death seriously and will begin a thorough investigation to determine if any action should be taken. Although the FDA caps the amount of caffeine in soda at 0.02 percent, there is no such limit for energy drinks, something that may need to change in the future. Though a response from the regulatory agency is a good thing, the timing leaves something to be desired as reports first surfaced back in 2004. The agency says so far there's no proof that the drinks directly caused the deaths or injuries.

The FDA's announcement follows quickly on the heels of a report that a wrongful death suit was filed in California by parents of a 14-year-old girl who died after consuming two cans of the Monster Energy Drink in less than 24 hours. The child's parents argue that the soft drink company failed to properly warn consumers about the dangers associated with consuming its products.

An autopsy was conducted on the girl soon after her death which revealed that she died of cardiac arrhythmia due to caffeine toxicity. However, the medical examiner also announced that the girl had an inherited disorder that can cause weakened blood vessels.

For its part, Monster Beverage Corporation, says that it puts labels on its cans stating the drinks are not recommended for children and people who are sensitive to caffeine.

If you or someone you know has a loved one who has been seriously or fatally injured in any kind of accident due to the negligence of another party, you do have options to receive compensation for this loss. For information on how to protect your rights in a situation of negligence or wrongful death, please call one of the St. Louis accident/wrongful death attorneys at 1-314-863-0500 today.

Source: "Monster Energy Drink Linked to Five Deaths, FDA Investigates," by The Associated Press, published at FoxNews.com.

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Where do your drugs come from? Negligent Manufacture or Filling of Prescriptions

November 7, 2012, by Benjamin J. Sansone

The recent outbreak of fungal meningitis has many people asking questions about the safety of compounding pharmacies and the origins of many of the medicines we put into our systems everyday. Something that many may not realize is just how hard it can be to track down the source of the drugs that you take on a daily basis. If you believe you have been injured by dangerous drugs contact our Missouri pharmacy malpractice lawyers.

So far the Centers for Disease Control and Prevention has said that the fungal meningitis outbreak has made 344 people sick in 18 states and caused 25 deaths. The outbreak was linked to a batch of injectable steroids that have since been recalled by the New England Compounding Center, a compounding pharmacy in Massachusetts. The facility has announced that as many as 14,000 patients have been treated with the steroids and may be at risk.

Compounders have recently played an important role in the medical field given the increasing occurrence of drug shortages. The pharmacies have been able to step in and provide some much needed supplies when the big manufacturers are down. Compounders are also useful as cheaper alternatives to the big name brands.

The recent rash of cases has pointed out a gap in the current FDA inspection regime. Though the FDA regularly inspects large pharmaceutical factories, it keeps out of inspecting compounding pharmacies, instead allowing states to handle that.

It's hard to pin down exactly where medications come from. Learning the source of an injectable drug given in a hospital or clinic may be even harder. The fact is that many patients may not even know what a compounded drug is, let alone know where to begin to find out where it came from. Moreover, doctors aren't accustomed to providing answers as few if any patients ever bother to ask.

Even many medical professionals are unaware of where the drugs they prescribe come from. This is because most drugs are purchased in large quantities from a central provider then distributed as necessary. Middlemen act as barriers between doctors and the manufacturers, providing yet another impediment to discovering the origin of drugs. Experts say that doctors may not be able to answer the question unless the specific vial of drugs contains information about the origins of the product.

Another possible source of information for concerned patients is the hospital's procurement office or in-house pharmacy. Both departments are often in charge of ordering drugs and might have more contact with suppliers and other relevant information.

Despite the inconvenience, patients have a right to know where their medications come from and to refuse any compounded medications. Patients can ask to see a medication's FDA-approved drug label if they are curious and want to be sure about the medicine's safety. Something to watch for is that compounded drugs do not have to comply with the labeling requirements for a standard FDA-approved drug. This means that the risks of the drugs are typically not disclosed and instructions for safe use are usually not provided on compounded products.

While patients might not be able to inquire about their medications during an emergency operation, elective procedures, like the steroid injections in this case, allow patients plenty of time to find answers. Given the seriousness of the problem, there's no reason why patients should hesitate in asking for a background on the drugs they take.

Those who have suffered injuries at the hand of their doctor should be aware that legal remedies might be available to them. If you or a family member have suffered needless injury or death as a result of hospital or doctor neglect, please contact the experienced Missouri medical malpractice lawyers at Sansone / Lauber by phone (314) 863-0500 or contact an accident attorney online.

Source: "Patients have few ways to learn source of medications," by Liz Szabo, published at USAToday.com.

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Fungal Meningitis Outbreak Reveals Trouble With Compounding Pharmacies

October 15, 2012, by Benjamin J. Sansone

Post #1 image.jpgThose who suffer from chronic pain often turn to steroid shots to help ease their discomfort. Normally, this is treatment is seen as safe and effective. (See Negligent Pain Injections) Sadly, that perception has now changed due to the 105 people sickened across nine states and the eight who have died from fungal meningitis. Now, reports indicate that as many as 13,000 patients may have been exposed to fungal meningitis - a fungus that attacks the brain and central nervous system - from tainted spinal steroid injections. See steroid injection malpractice settlement.

It appears that all of the victims who have been infected were given steroids that had been produced by one Massachusetts pharmacy that issued a recall of the drug and has since closed. This issue touches upon pharmaceutical malpractice and products liability/ dangerous products law The pharmacy that issued the recall is the New England Compounding Center. Given the outcry since the recall was announced some lawmakers have called for bringing certain specialized pharmacies such as the one at the center of this case under greater regulatory scrutiny.

Three lots of potentially contaminated steroid injections were sent by New England Compounding Center to 75 health facilities in 23 states from July to September, according to officials. Despite the wide reach of the facility, oversight falls under the powers of the state, not the FDA. This is because NECC is considered a pharmacy and not a manufacturer.

There are about 3,000 compounding pharmacies nationwide, and drugs made by the facilities represent as much as 3% of the roughly $300 billion in prescription drugs sold in the U.S. each year, according to the International Academy of Compounding Pharmacists.

The FDA has pushed to increase its regulatory authority over compounding pharmacies. Thus far it has been prevented by court opinions and a lack of legislative interest. The FDA issued a warning back in 2007 noting that compounded drugs "are not FDA-approved." The warning went on to say that there had been "devastating repercussions" from such drugs, including three patients dying of infections from a drug used to paralyze the heart during surgery and two patients at a veterans hospital who were blinded by a compounded product used in cataract surgery.

Authorities from across the country fear there may be many more infections, as previous instances are reported or new cases develop. The virus has an incubation period of as little as two days or as many as 28 days. Fortunately, this type of meningitis is not contagious like the viral and bacterial types, but it is obviously still dangerous and potentially deadly.

People who received steroid treatments in the last three months are being contacted and made aware of the situation. If you have received this type of treatment recently, please contact your doctor or the facility where the steroid treatment was given to determine whether you might be at risk.

Those who have suffered injuries at the hand of their doctor should be aware that legal remedies might be available to them. If you or a family member have suffered needless injury or death as a result of hospital or doctor neglect, please contact the experienced Missouri medical malpractice lawyers at Sansone / Lauber by phone (314) 863-0500 or contact an accident attorney online.

Source: "As Outbreak Spreads, Calls for Tighter Controls on Specialized Pharmacies," by Timothy Martin, published at WSJ.com.

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NTSB Says Dangerous Flaw Found in Popular Train Tanker

September 22, 2012, by Benjamin J. Sansone

railiroad track injury.jpgFor at least the last 20 years, one of the most commonly used types of rail tankers has been allowed to transport hazardous materials across the country, this despite the fact that transportation officials knew of a dangerous design defect. The design flaw all but guarantees that the rail car will tear apart in the event of an accident, thus spilling cargo that could catch fire, explode or harm surrounding residents.

One reason the issue has become more pressing is recent spike in accidents due to the greatly increased demand for ethanol, a highly flammable fuel typically transported by rail. One recent derailment triggered a massive chemical spill and explosion over the summer in Columbus, Ohio. One eyewitness said the resulting explosion was so intense that it looked like the sun had blown up.

The tanker, known as the DOT-111, has a soda-can shape and is one of the most commonly seen cars on rail freight routes. Though the car itself is not the cause of derailments, the National Transportation Safety Board (NTSB) notes that the steel shell is too thin to resist puncture in accidents. Furthermore, the ends of the car are especially vulnerable to tears and the unloading valves and other fittings can break off during rollovers.

The flaws are nothing new and have been noted since as far back as a 1991 safety study. Sadly, the potential for things to go wrong has also not been newly discovered. A report found that ethanol tankers have been punctured in at least 40 serious accidents since 2000. The human toll is also very real given that accident reports indicate that since 1996 at least two people have been killed by explosions from railroad accidents and dozens more suffered injuries.

The example of how things can go terribly wrong became a reality in 2009 in Rockford, Illinois. A Canadian National freight train moved through town carrying more than 2 million gallons of ethanol. The crew was unaware that just ahead, rain had washed away a portion of the track. When the tankers rolled over the damaged track, the engineers could tell the train was going to derail.

The cars began falling from the tracks and flying into the air one by one. A driver parked at a nearby railroad crossing sat helpless as the waves of explosions washed over him and his family. One of several cars parked at the crossing belonged to Jose Tellez whose wife, Zoila, was killed. A witness reported seeing Zoila run from the family van in flames before dying. Jose suffered severe burns while his adult daughter, who was five months pregnant, lost the baby she was carrying at the time.

In addition to the fatality, 11 people were injured in the derailment, making it the nation's single worst ethanol tanker accident. Nineteen of the 114 cars derailed. Thirteen released ethanol and caught fire. In the final accident report, the NTSB listed the "inadequate design" of the tanker cars as a factor contributing to the severity of the accident.

It is incidents like the one in Illinois that have some communities worried about the potential dangers associated with the continued presence of the flawed tankers on America's railways. According to recent reports, the railroad industry has so far agreed to change all cars built after October 2011 to a safer design. The improvements will mean thicker shells and shields on the ends of the tanks designed to prevent punctures. While this is certainly goods news, the 30,000 to 45,000 existing tankers that will remain unchanged present real concerns to innocent Americans in the path of the railroads.

For information on how to protect your legal rights if you or a loved one has been seriously injured in an accident, call one of our St. Louis Missouri accident attorneys today at 1-314-863-0500.

Source: "Common type of rail tanker has dangerous flaw that risks hazardous cargo spills," by The Associated Press, published at WashingtonPost.com.

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Study Shows Consumers Tune Out Recall Notices

August 10, 2012, by Benjamin J. Sansone

recall - dangerous product lawyer best missouri.jpgRecent figures from USA Today show that there is concern among manufacturers and regulators that consumers have grown tired of the constant recall notices arriving in their mailboxes. The increased numbers of recalls, while a good thing, is causing consumers to be exhausted and ignore some notices, possibly to their detriment. Last year alone there were some 2,363 product recalls in consumer products, medical devices, drugs and food. This number represents an increase of 14% from just a year before.

While the increased number of recalls is good in terms of notifying consumers of potential dangers, it creates a worry that consumers will tire of the repeated warnings, perhaps not taking them as seriously. One bit of good news is that the messages are increasingly reaching consumers, as regulators have been successful in spreading the word of product issues through social media and other forms of communication.

Regulators have had to be creative because if consumers aren't listening then they must come up with new ways to warn about dangerous. As a result, consumer protection agencies are trying to vary the methods that they are using to contact consumers. Social media sites like Twitter and Facebook are now being used by government agencies to get the word out about potential recalls rather than simply mailing notices which are more easily discarded as junk mail. Authorities are also not giving up on the more traditional means of contact like telephone calls.

USA Today found that most retailers believe that the existing national recall system is flawed and that the country would benefit from a more uniform system. The FDA and USDA have different standards for recalls, each with its own unique set of requirements. These variances make it difficult for manufacturers and retailers to fully comply with all the specific rules for each recall.

Product recalls should be of concern to all consumers as they can warn you of potentially life-threatening dangers lurking in your own home. Always pay careful attention to any notices you receive as they could save your life or the lives of those you love.

If you or someone you know has been injured because of a company's failure to provide a safe and healthy product, you need the help of a St. Louis products liability attorney experienced and ready to help protect your rights and recover damages for your injury. Contact products liability attorney Ben Sansone today for a free initial consultation at (314) 863-0500.

Source: "Surge in products being recalled may be numbing consumers," by Christopher Doering, published at USAToday.com.

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Man sues maker of Pradaxa after father's death

August 6, 2012, by Benjamin J. Sansone

A man has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa. The drug company is being sued by the man who claims his father died as a result of side effects he experienced while taking the blood-thinning drug. Melvin Giles, Jr. sued Boehringer Ingelheim in the U.S. District Court for the Middle District of Tennessee.

According to the suit, Giles' father was prescribed the drug as a blood thinner. The medication is usually used to reduce the chance of blood clots developing and leading to a stroke in patients who present special risks for such problems. Giles' father was given the medication in February of 2011 and in June of that same year suffered severe internal bleeding and died as a result. His son claims that the bleeding he suffered was the result of Pradaxa.

Giles claims that the drug maker either knew or should have known about the potential for the drug to cause such serious complications. The suit cites as proof the 932 incidents reported to the FDA between October 2010 and March 2011 related to side effects of the medication. Some 120 of these reports involved death from Pradaxa bleeding, and 500 were severe and life-threatening bleeding events related to the medication. These numbers have gone on to spike and according to a new report from the Institute for Safe Medicine Practices (ISMP), the U.S. Food & Drug Administration received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.

Pradaxa also led in reports of deaths (541), hemorrhage (2,367), kidney failure (291) and stroke (644), according to ISMP's most recent report. Pradaxa was also a suspected cause of 15 reports of liver injury made to the FDA.

The problems with Pradaxa began in 2011 when the drug became the subject of an investigation in New Zealand after as many as five elderly patients died as a result of internal bleeding. Another 36 patients reportedly suffered similar bouts of serious internal bleeding but managed to survive. These reports came on the heels of similar news in Japan that regulators asked Boehringer Ingelheim to notify doctors about potentially deadly bleeding associated with the drug.

Pradaxa was heavily marketed when it was first introduced as a safer alternative to traditional blood thinners such as warfarin. The benefit was that Pradaxa does not react with certain foods in the same way that warfarin does which can increase the likelihood of bleeding. The problem is that warfarin bleeding can be controlled and even stopped by administering vitamin K. The danger of Pradaxa is that there is currently no known antidote for Pradaxa-caused bleeding, making injuries associated with the product far more deadly.

If you or someone you know has been injured because of a company's failure to provide a safe and healthy product, you need the help of a St. Louis products liability attorney experienced and ready to help protect your rights and recover damages for your injury. Contact products liability attorney Ben Sansone today for a free initial consultation at (314) 863-0500.

Source: "Wrongful Death Suit Filed After Pradaxa Bleeding Death," by Elise Kramer, published at InjuryLawyer-News.com.

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FDA Agrees to Start Tracking Medical Devices

August 5, 2012, by Benjamin J. Sansone

The FDA made a major announcement earlier this month which will make medical devices a lot like mass-produced consumer devices such as cars and microwaves. The new rule currently under advisement would require that each medical device manufactured be given a unique code which will help with tracking and hopefully assist the agency in catching safety problems earlier.

While similar codes are already found in almost all consumer products, the barcodes have been noticeably absent from such critical medical devices. The rule says that device makers will begin by placing barcodes on their riskiest devices, like implants or pacemakers. Over-the-counter or incredibly low-risk devices, think bedpans, will not be given a tracking code.

The FDA will then place all the codes in a public database which they hope will allow doctors and regulators to detect problems more quickly and notify affects patients in much less time about any dangers. Companies and hospitals will be able to access the database and quickly pull products that are affected by recalls or other problems. The codes will also benefit the device makers by helping to prevent counterfeit or stolen products from entering the supply chain.

The plan is for the code to be printed on labels for the device and also to be found in the devices themselves. The FDA is projecting the program will cost U.S. companies approximately $500 million to implement the proposal over the next ten years.

The rollout has been much slower than anticipated, with this announcement coming some five years after Congress first instructed the FDA to introduce such codes. The agency said it took its time rolling out the rules by testing a pilot program and by coming up with standard international codes that would work with regulators abroad, including those in Canada, the European Union and Japan.

Currently the public will have 120 days to comment on the proposed rule and the FDA will consider the feedback before making a final ruling which will likely happen in the next six months.

If you or someone you know has been injured because of a company's failure to provide a safe and healthy product, you need the help of a St. Louis products liability attorney experienced and ready to help protect your rights and recover damages for your injury. Contact products liability attorney Ben Sansone today for a free initial consultation at (314) 863-0500.

Source: "FDA Proposes IDs To Track Medical Device Safety," published at HuffingtonPost.com.

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Missouri ATV accidents spike during summer

July 19, 2012, by Benjamin J. Sansone

atv injury lawyer.jpgThe U.S. Consumer Product Safety Commission (CPSC) recently announced that the number of people who die or are injured using ATVs each year is on the rise and put out a special request that riders stay safe on the trails this summer.

The summer is an incredibly dangerous time for ATV riders and statistics show death and injury rates skyrocket as the temperatures increase. On average for 2004 to 2006, the deaths of children younger than 16 rose a shocking 65% from March to April. Adult deaths rose 85% over the same period. The peak of ATV-related injuries occurs in July and the CPSC is trying to put the word out early that drivers must stay aware of their surroundings and practice safe ATV driving habits to avoid a similar rise this summer.

On average, each year from 2004 to 2010, there were nearly 700 ATV-related fatalities. Each year also saw close to 136,000 injuries that required emergency room visits. Though these thankfully did not result in death, many such injuries can be life altering.

This year alone the CPSC says that it has received reports of some 130 adults and 28 children under the age of 16 who have died in ATV-related incidents across the country. The busy summer holiday season sees a huge increase in the number of ATV accidents and this year is off to a bad start with the Memorial Day holiday weekend alone accounting for the deaths of 14 adults and 3 children. The government is urging caution while out on the trails as the July 4th holiday weekend is coming up.

Most of the deaths and injuries occur when an inexperienced driver loses control of an ATV, is thrown from an ATV, overturns the vehicle, or collides with a fixed object. Those drivers with more than on year of experience operating an ATV have dramatically lower risk of injury and death than brand new drivers. Practice really does help in the case of ATV accidents as drivers develop comfort behind the wheel and experience with how to properly operate the device. Off-road driving is very different than cruising down the street and, as such, it requires special training to understand how to best operate an ATV.

The CPSC offers the following tips to help riders have a fun and safe riding experience this summer:

• All ATV drivers, whether young or old, should take a hands-on ATV safety course from a certified instructor.
• Always, and this can't be stressed enough, always wear protective gear, especially a helmet.
• Do not put more people on an ATV than is recommended. If you're driving a single-rider ATV do not carry a passenger.
• Do not drive ATVs on paved roads. Though this may seem like odd advice, ATVs have solid rear axles, which makes turning on paved surfaces difficult and dangerous. Driving on paved roads actually increases the chance that the ATV will overturn.
• Do not allow children younger than 16 years old to drive or ride on adult ATVs. Children younger than 16 years old lack the skills to safely drive such a vehicle and more than 90% of all injuries to children occur from their presence on an adult ATV.
• Finally, children younger than 6 should not be on an ATV at all.

For information on how to protect your legal rights if you or a loved one has been seriously injured in an accident, call one of our St. Louis Missouri accident attorneys today at 1-314-863-0500.

Source: "Annual Rise in Summer ATV Deaths Prompts CPSC to Urge Safety on the Trails," published at CPSC.gov.

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Product Liability and Potentially Dangerous Toys: Magnets represent real danger to unsuspecting children

Firework Safety Month: Avoid the dangers of bright lights

July 12, 2012, by Benjamin J. Sansone

Given that June is National Fireworks Safety Month and many are looking forward to a July 4th break and the ensuing fireworks displays, now's a good time to discuss the many dangers the flashy products present. Though there are many kinds of fireworks which are legal to possess, this does not mean they are risk free. According to one study by the U.S. Fire Administration, at least 92% of all fireworks-related injuries each year are caused by legally purchased fireworks.

Those at most risk for injury are, not surprisingly, young children. Children under age 15 are at the highest risk for fireworks injuries. Their love of the bright lights attracts them but they are often too young to understand they danger they present. Even seemingly safe hand-held fireworks can cause serious burns as some sparklers can reach temperatures of 2,000 degrees Fahrenheit while burning, hot enough to melt copper. For children under the age of five, sparklers accounted for the largest number of estimated injuries, 36 percent of the total injuries in that age group.

During the 30 days surrounding July 4, fireworks sent about 1,900 injured consumers to emergency rooms. The Consumer Product Safety Commission's statistics show that in 2010 about 8,600 consumers ended up in hospital emergency rooms due to injuries involving legal and illegal fireworks. In 2011, 9,600 people were treated in emergency departments for firework-related injuries, an increase of 1,000 injuries in only one year. The CPSC's annual death and injury report on fireworks also indicates that approximately 40% of estimated injuries occurred to children younger than 15 years of age. In addition, CPSC received reports of three fatalities related to fireworks.

The part of the body most often injured were hands and fingers (estimated 2,900 injuries), eyes (1,100 injuries), head, face, and ears (1,100 injuries), and legs (700 injuries). The products that cause the most harm include sparklers (1,100), firecrackers (800), and bottle rockets (300). The major causes of injuries are due to delayed or early fireworks explosions, bottle rockets that go off course, falling debris from exploding fireworks and mishandling sparklers.

The Consumer Product Safety Commission recommends the following tips to ensure you and your family stay safe this holiday season:

• Never permit young children to play with or light fireworks.
• Avoid buying fireworks that are in brown paper which is a sign that they were designed for professional displays and could present special danger to your family.
• Always have an adult supervise fireworks activities.
• Never place any part of your body directly over a fireworks device when lighting the fuse. Once a device has been lit, make sure to back up a safe distance.
• Never try to re-light or look at fireworks that have not ignited fully.
• Never point fireworks at another person.
• After fireworks have been lit and exploded, pour plenty of water on them before throwing away to prevent a possible trash fire.

If you or someone you love has been injured by fireworks this year, don't hesitate to call one of our Missouri personal injury attorneys today at 1-314-863-0500.

Source: "Dangers of back yard fireworks: Safety tips," by Kim Wendel, published at WKYC.com.

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Product Liability and Potentially Dangerous Toys: Magnets represent real danger to unsuspecting children

June 13, 2012, by Benjamin J. Sansone

dangerous-child-magnets-x-ray-story-top.jpgPossible dangers of toys are not obvious, that is why there are legal requirements that the manufacturer test the toys. Additionally, enforcement of product liability injury laws help police the industry. On example of an unsuspected defect was a few months back; one unfortunate couple made a purchase they'll likely regret for the rest of their lives, magnets. They were shopping near their hometown and came across a bag of high-powered magnets that could be used to form various shapes and chose to buy them for a little amusement. When they arrived back at their house they made sure to put the toys away on an upper shelf. Apparently it wasn't high enough to keep their young son, 2-year-old Braylon, away. He found the bag of magnets and ended up swallowing eight of them.

Rather than just simply passing the round balls, they magnets fused together and, in the process, wreaked havoc inside the little boy. The high-powered magnets attached to each other and, in doing so, twisted and ultimately perforated the boy's intestinal tract.

Since the terrible accident the child has been in the hospital, coming up on two months now. Most of the time was spent in the ICU given the severity of his injuries. Braylon has had six surgeries, developed a blood infection and had to be fully sedated for three weeks. He's thankfully supposed to leave the hospital soon, but will have to return for more surgeries. He's scheduled to get an intestinal transplant given the amount of tissue that had to be removed during all his surgeries.

Shockingly, given the horrible damage inflicted on Braylon and other's just like him, there not yet been a thorough study of the impact of magnets ingested by children. The Consumer Products Safety Commission (CPSC) has said that since 2008 it has received some 200 reports of similar incidents involving children and high-powered magnets. As a result, one of the doctors that worked with Braylon, Dr. Adam Noel, decided to conduct a survey of his own. He asked a group of pediatric gastroenterologists for their thoughts on the issue. The 33 physicians who responded to Dr. Noel's survey said that they have seen a total of 82 young patients who have swallowed magnets. Sadly, the vast majority of these children suffered bowel perforations, just like Braylon.

Dr. Noel and a group of other concerned doctors will be meeting with officials from the CPSC to discuss ways to ensure that additional children don't suffer from similar accidents. The companies that make the toys insist that their products are perfectly safe if used per the instructions. Treat them like any dangerous item in a house, like a stove, and the children can be perfectly safe from the danger they present.

Doctors disagree, pointing out that the products often contain hundreds of individual magnets, making it impossible for parents to know if a few went missing. Children can then easily get ahold of the magnets and, possibly mistaking them for candy, swallow them; unaware of the danger they are placing themselves in. For information on how to protect your legal rights if you or a loved one has been seriously injured in an accident, call one of our Missouri personal injury attorneys today at 1-314-863-0500.

Source: "Powerful magnets in toys raise risks from swallowing," by Elizabeth Cohen, published at CNN.com.

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Major National Retailer Under Fire For Unsafe Products

May 31, 2012, by Benjamin J. Sansone

drugs and dangerous products accidents death.jpgSee also, Missouri Dangerous Products cases. Most Missourians believe that when they purchase products from a major national retailer they don't need to worry about the safety of what they've bought. We expect the retailer will be trustworthy with their labeling and that they will ensure what they sell is safe. Sadly this is not always the case. As the Huffington Post recently reported, the well-known sports and nutrition retailer, GNC, is under fire for selling unsafe products, and may possibly be liable for fraud as well as negligence relating to a major products liability claim.

The lawsuit against GNC was brought by Lynette Bates, a Southern California woman who bought a pre-exercise drink powder called C4 Extreme last summer. The drink promised users "explosive workouts." According to her suit filed at the Los Angeles Federal Court, the drink contained a substance that was originally used as an over the counter decongestant. The compound, 1,3-dimethylamylamine, also known as DMAA, is "illegal and dangerous," according to the complaint. The lawsuit went on to say that "experts in the industry have become concerned that this potent stimulant drug will lead to serious health issues and even death."

Bates sued the retailer, GNC, and Cellucor Sports Nutrition, the manufacturer, for "making false and unsubstantiated representations concerning the efficacy, safety and legality of C4 Extreme." Cellucor's parent company, Woodbolt International, is also named in the suit.

According to recent reports C4 Extreme is no longer being manufactured with DMAA. However, this doesn't mean consumers can rest easy, the substance can still be found in a plethora of products including "Jack3d" and "OxyELITE Pro."

Medical experts say there are potential health risks from consuming DMAA. Dr. Pieter Cohem, an assistant professor at Harvard Medical School, says "What we've seen is that DMAA in supplements has been connected to situations where the heart has gone suddenly into failure due to excessive stress."

For its part GNC declined to comment on the pending suit with Bates, but in a statement corporate spokesman Greg Miller was willing to say "despite the media hype surrounding DMAA, GNC is unaware of any scientific or medical evidence which calls the safety of DMAA into question. To the contrary, GNC is aware of a number of published, peer-reviewed studies that show that DMAA is perfectly safe when taken as directed."

The fact that DMAA remains in products on store shelves illustrates the real need for stronger oversight of dietary and sports supplements by the FDA. If you or someone you know has been injured because of a company's failure to provide a safe and healthy product, you need the help of a St. Louis products liability attorney experienced and ready to help protect your rights and recover damages for your injury. Contact products liability attorney Ben Sansone today for a free initial consultation at (314) 863-0500.

Source: "GNC Supplements: Lawsuit Claims Weight Loss & Sports Supplements Have Unsafe Ingredient," by Bernice Yeung, published at HuffingtonPost.com.

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