Fort Worth Injury Lawyers Blog

Recent reports have shown that the FDA is stepping up in strengthening the approval and research of post-approval drug safety. The administration has created a post market drug safety program that has shown to be extremely effective. The Center for Drug Evaluation and Research (CDER), the administration's program, focuses on further research and testing of drugs once they've hit the American market. CDER has come out with new technology and research methods that have proven to be a success for both the drug makers and the administration. The program is also benefitting the public by releasing potential drug safety information much earlier, hoping to avoid patients from unknown side effects or problems. According to the FDA, "in 2011, CDER issued 68 drug safety communications - up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge."

The FDA is pleased to see that this program has benefitted not only the public, but their program as a whole. The administration feels programs similar to CDER will continue to emerge and increase the quality and effectiveness of keeping patients safe and informed in a timely manner. Though the administration has received pressure from several sources about the time it takes to clear medical devices, the FDA hopes with programs like CDER, medical devices and medicines will be cleared at a faster and safer rate. (read full article)

Not being properly informed about potential side effects of certain medications or deciding on a surgery with a medical device that little research has been done on, can lead to severe life changing problems, sometimes even death. One can never be too careful when it comes to taking medicine or undergoing surgery. Our firm has seen many patients suffer from the results of negligence when dealing with failed medical devices and harmful prescriptions.

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The Texas Department of Transportation has launched a new campaign with hopes to decrease the amount of motorcycle accidents on the road. According to the department, "470 motorcycle riders and passengers died on Texas roads and highways just last year, 41 more deaths than in 2010. Officials reported that the drivers never saw the bike in half of all the motorcycle crashes." Based on these statistics, the department has named the campaign "Look Twice."

The Look Twice campaign will consist of new billboards along many Texas highways and will also include both English and Spanish public service announcements across the air, advocating drivers to look twice for motorcycles and blind spots. The campaign is pushing for all drivers, whether you're driving a motorcycle or car, to particularly look twice when changing lanes or making turns at intersections, where most motorcycle accidents occur. More than half of the 470 fatalities could have been avoided by simply looking twice. (read full article)

As most of us know, motorcycles already come with a high risk due to the lack of protection a bike has. According to the National Highway Traffic Safety Administration, there are over 4 million motorcycles registered in the U.S., making up two percent of all vehicles registered in U.S. However, even though motorcycles represent only two percent of all vehicles in the U.S., they also represent five percent of all highway fatalities each year. More than likely motorcycle accidents end in serious injury or fatality, compared to a car where 20 percent of accidents result in serious injury or fatality. Motorcycle drivers need to be aware of all safety precautions before heading out on the road. To read the most updated list of motorcycle safety tips click here.

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The FDA has recently been receiving a lot of attention for something other than a recall or warning; the health experts are facing pressure on approving medical devices at a faster rate. The majority of approvals can take years, and when life threatening or extremely painful health problems are at risk, that wait can be too long. However, other health experts and administrations fear that a faster approval rate of medical devices could also decrease the safety of the devices.

An article from the Huffington Post states the possible new agreement hopes to "double the user fees paid by device makers to the Food and Drug Administration; the fees help fund the agency's review of their products. In exchange, the industry wants to speed up the approval process, claiming that crucial devices to help treat suffering patients are being needlessly delayed in FDA bureaucracy." (read full article)

However, this agreement is not supported by all. Many health experts are arguing that administrations need to focus on the high number of medical device recalls just in 2011, the average number of recalls was doubled compared to previous years. Adjusting to a faster approval rate would only spike those numbers even more. Looking back at the thousands of DePuy Hip System recalls and the several vaginal mesh lawsuits, the idea that devices would be approved even quicker only frightens patients, lawyers and doctors. After thousands of patients suffered from severe pain and multiple revision surgeries due to failed medical devices, patients are very hesitant on devices being approved faster. Many of them believe health experts and administrations need to put more focus on approving the devices, rather than speeding up the process.

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Bayer, a world-wide pharmaceutical company headquartered in Leverkusen, Germany, has agreed to pay an average of $220,000 per case to settle close to 500 law suits involving Yaz and Yasmin. The once very popular contraceptive pills have now gained negative attention across the world. Yaz and Yasmin, unlike older birth controls, contain drospirenone, a synthetic version of the female hormone progesterone. All birth controls come with the risk of blood clots, however, pills containing drospirenone have shown to increase that risk. The FDA examined data on more than 830,000 women taking pills containing drospirenone, the results showed an increase in that risk by as much as three times the normal risk. After hundreds of women experienced severe blood clots with out proper warning or labeling, some ending with fatalities, close to 500 law suits against the pharmaceutical company piled up for failure to properly warn the public of these increased risks. Bayer is expected to pay close to $110 million in their Yaz and Yasmin cases.

Though the FDA has ordered Bayer to emphasize the increased risk in blood clots while taking the birth control, the pharmaceutical company continues to suffer as more women file lawsuits. The new labels will state contraceptive pills containing drospirenone may triple your risk for blood clots. With Yaz and Yasmin being two of the most commonly used contraceptive pills among women from 2008 to 2011; Bayer is expecting additional lawsuits to come.

Continue reading "Bayer to Pay Close to $110 Million in Yaz/Yasmin Lawsuits" »

Yaz, Yasmin and several other newer birth controls will soon undergo important changes to their labeling. Last Tuesday the FDA announced the changes will take place immediately in order to properly inform the public about the slight increased risk in thromboembolism, the formation of blood clots, while taking the once-a-day contraceptive pills. The newer birth control pills, unlike older pills, contain drospirenone, a synthetic version of the female hormone progesterone. Several studies have shown drospirenone to be a leading factor in the increased risk for blood clots.

Many women continue to take birth control with out knowing the severity of the potential risk. Blood clots have the ability to travel all over your body, eventually leading to life changing problems and sometimes even death. Birth controls containing drospirenone have shown to increase the risk of their formation. Blood clots may form inside small veins near the surface of your skin, leaving swelling, redness and possible pain in that area. They also have the risk of forming inside larger, deeper veins, also known as deep vein thrombosis, possibly causing more critical problems. Deep vein thrombosis blood clots have a higher risk of breaking apart and traveling to other areas of the body, such as the lungs, heart and brain, potentially leading to stroke, heart attack or death.

Yaz, released on the market in 2006, was Bayer's top selling birth control pill. It appealed to millions of women due to its ability of helping with acne and PMS as well as being a contraceptive pill. By 2008, Yaz was the top selling birth control pill in the U.S. However, when several women began filing complaints, health experts began further research. As research increased, complaints quickly turned into law suits, studies found a connection with blood clots and drospirenone. Today, doctors and attorneys are advising all women taking birth control to talk to their physician about possible increased risks and side effects. They also advise all women to stay informed about any symptoms they might have that could be possible signs of blood clots.

Continue reading "FDA Orders Label Changes for Yaz, Yasmin, & Other Birth Controls Containing Drospirenone " »

Every year drivers are warned about the risks of driving, risks involving alcohol, drugs, texting and just about any distraction. Another risk that many drivers may think they don't need to worry about is driving while tired, also referred to as drowsy driving. However, a recent study done by an Australian research team has found that almost half of the 517 professional truck drivers that were tested had positive results for sleep apnea.

Sleep apnea is characterized as a sleeping disorder where a person may experience abnormal pauses in breathing during sleep. These pauses can range from a few seconds to minutes, they can occur anywhere between five to 30 times or more per hour, greatly affecting the energy level of the person the next day. The problem with the disorder is that many people who have it don't realize they have it, though one of the most common symptoms can be constant fatigue and exhaustion during the day. At the beginning of the study, the researchers asked all 517 drivers if any of them had been diagnosed with sleep apnea. 4.4 percent said they had been. After the tests, results showed 41 percent of those drivers actually had sleep apnea.

"Sleep apnea remains a significant and unrecognized problem in CMV drivers, who we found to have multiple health risks," the researchers wrote in the study. "Objective testing for this sleep disorder needs to be considered, as symptom reports and self-identification appear insufficient to accurately identify those at risk." Though this study was done in Australia, all truck drivers and other drivers as well need to be aware about the condition and risks it creates while driving. Sleep apnea can effect people all over the world. (read full story)

Trucking companies have continued to update their laws and tests in hopes to enforce a safe driving environment both for their truck drivers and other drivers on the road, however, drivers still need to be aware of any symptoms they might have of sleeping disorders. Truck News recently reported that the Federal Motor Carrier Safety Administration will most likely begin testing truck drivers for sleep apnea in order to prevent drowsy driving.

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For those who have never heard of a program called SteerSmart, our firm would highly recommend everyone to look into it, especially those with young drivers. After seeing and dealing with several cases involving tragic accidents on the road, McGartland & Borchardt LLP wants all drivers to be reminded of the basic ways to stay safe behind the wheel. At times, it is easy to simply think you'll be fine with out your seat belt, or going 10 over on the high way is no big deal. However, after watching a presentation done by SteerSmart, you'll be reminded why those simple gestures can not only save your life, but other drivers and passenger's lives as well.

SteerSmart is a non-profit organization devoted to educating young drivers and parents about the risks and safety of driving. The program informs the public through presentations, literature and videos targeted to drivers, passenger and their parents. "The program helps drivers become more responsible and safer while helping their parents learn the real risks they face and how to better protect them." SteerSmart presentations cover topics ranging from speeding to texting to alcohol to overcorrecting. The program covers every risk you can think of, and how easily those risks can be avoided. SteerSmart was founded by Lauren Winborne. Winborne, a mother of six, began the program after hearing interviews with parents who had lost their children to accidents. Winborne has since strived to educate schools, associations and communities in hopes to help prevent accidents that take lives and leave others impaired.

(all images came from steersmart.org)

After attending a presentation, the program is guaranteed to leave an impact. SteerSmart presents students in the program who have been killed by making just one fatal decision and survivors from crashes discussing how easily their accidents could have been avoided. Accidents occur everyday across the U.S. Of all those accidents, 70 percent of them are avoidable accidents. SteerSmart shows their audience how to be in that 70 percent, the program focuses on the idea that no one wakes up and begins their day with the thought process of, "I could die this afternoon." When you think twice about that statement, you begin to realize all the small things you might do behind the wheel that only increase your chances of being involved in an accident. It makes you think twice about the risks of driving and how to prevent your children from making those dangerous decisions.

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Metal-on-metal hip replacement systems continue to receive criticism as experts across the world encourage doctors to stop using these defective systems. Due to the full metal design of these replacement systems, the implant is known to shed tiny pieces of metallic ions that lead to a high risk of causing permanent tissue, muscle and bone damage. Though all orthopedic implants shed debris after a few years, the metal-on-metal poses a much higher threat that can cause severe lifelong problems.

Recalls and lawsuits began piling up in August of 2010 after one of the most commonly used metal-on-metal hip replacement system was recalled. The DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting in several costly revision surgeries only a few years after the implant.

The decreasing use of metal-on-metal hip replacements has spread world wide. Recently, British experts at one of the world's largest artificial joint registry's have told doctors metal-on-metal hip replacements are prone to being fixed or replaced more often then other non metal-on-metal system. According to the Huffington Post, a recent study shows that "experts analyzed data for more than 400,000 hip replacements from the National Joint Registry of England and Wales between 2003 and 2011. More than 31,000 of those were metal-on-metal devices. After five years, about 6 percent of people with the metal-on-metal variety needed surgery to fix or replace them. That compares with just 1.7 to 2.3 percent of people who had ceramic or plastic joints." (read full story)

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When it comes to nursing homes, several difficult decisions must be made. Deciding when to move a loved one into a nursing home is a strenuous process, we all want the best for our family and need to consider several things when it comes to finding the right home. Unfortunately, one important area that needs to be considered when finding the right home is nursing home abuse and neglect. Sadly, it is much more common than we think. Several homes across the U.S. are deciding if they want cameras placed in all rooms of nursing homes, hoping to prevent any abuse or neglect.

In 2009, the public was informed about one of the largest nursing home abuse cases the U.S. has seen. In Arlington, Virginia, close to a dozen employees at the Potomac Center nursing home were indicted on multiple charges of abuse and neglect. Complaints ranged from un-changed diapers to never being fed. When one woman became aware of how her husband was being treated in the home, her attorney asked her if she would allow the FBI to put a surveillance camera in her husband's room at the center. After agreeing to add surveillance, solid evidence was caught on tape. With the addition of the surveillance camera, 11 employees were indicted on charges including neglect, forgery to assault, and battery, the most serious charge being a nurse holding a pillow over the patients face. (read full story)

After reviewing the case, attorneys and the public have stated this kind of behavior can be found at several nursing homes across the U.S., supporting the idea that all homes need to have surveillance cameras in order to keep their patients safe. Many cases of nursing home abuse and neglect go un-reported, leaving patients at risk for further abuse. Signs of abuse and neglect can vary among each patient differently; if you have a loved one in a nursing home, make sure to be aware of any signs or symptoms they may have that reflect abuse or neglect. To read about the obvious and less obvious signs of abuse or neglect click here.

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A recent study suggests a possible link between an increased risk in cancer or even death with the use of sleeping pills. Statistics show that an estimated six to ten percent of Americans currently take sleeping pills, a number that continues to increase as the public is provided with numerous options and constant advertising about the potentially harmful drugs.

The study evaluated data on 34,205 adults, with an average age of 54, including 10,531 of those adults prescribed sleeping pills. The study incorporated several different brands of pills, including Ambien, Lunesta, Restoril and Sonata. According to the Washington Post, the results showed, "people who were prescribed 18 or fewer sleeping pills a year were 3.6 times as likely to die as those who took none of the drugs; risk was 4.3 times as high for those prescribed 18 to 132 doses and 5.3 times as high for those taking more than 132 pills a year. Also, people taking the highest doses were 35 percent more likely to have developed a major cancer, not including melanoma, during that period." (read full article)

The study shows a potential connection between the problems and pills but has yet to reach a conclusion on an absolute cause and effect. Patients should be aware of any possible risks they might face while taking sleeping pills. It is always best to consult with your doctor about any effects you may be concerned with.

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Just recently Bayer Healthcare has reported the pharmaceutical company has reached agreements to settle all Yaz and Yasmin lawsuits brought by at least 70 women. In 2006, Bayer launched the very popular Yaz birth control, a once a day contraceptive pill that also helped women with acne and PMS symptoms. By 2008, Yaz was Bayer's number one selling birth control pill and the top birth control in the U.S.

Yaz, unlike many other contraceptive pills, contains drospirenone, an anti-androgenic synthetic progestin, an ingredient that research has found to be far more dangerous than others. Though all birth controls come with risks, birth controls containing drospirenone have shown to enhance those risks, particularly the risk of deep vein thrombosis and pulmonary embolism (blood clots). Blood clots can be a common factor in stroke, heart attack or even death. By 2009, Bayer's sales for Yaz quickly began to decrease as more and more women filed complaints that Yaz was the leading factor in their blood clots, and that they were not properly warned about this risk. Since 2009 Yaz sales have decreased by almost 80 percent, creating a much higher threat of concern and a significant increase in lawsuits. Today, the pharmaceutical company faces more than 6,000 lawsuits.

The majority of lawsuits are suing Bayer alleging the pharmaceutical company inadequately warned patients about the serious side effects drospirenone. In September 2011, the FDA released a statement warning women taking birth control containing drospirenone that there may be a possible link between the ingredient and deep vein thrombosis and pulmonary embolism. Since then, several studies have shown a consistent link. A bellwether trial has been scheduled for June 2012.

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The food and drug administration (FDA) is adding new safety warnings about possible risks while taking statins, a class of drugs mainly used to help lower cholesterol levels. Increased cholesterol levels are commonly associated with heart problems, leading to several statins to be used in the prevention of cardiovascular diseases. However, research has shown a number of statins being linked to risks of memory loss and elevated blood sugar. Though none of the side effects have been reported as severe, several drugs will undergo label changes, including Lipitor, Crestor, and Zocor, all medication used to prevent heart-related problems associated with cholesterol.

The new labels will warn of these potential risks and will also include a warning about elevated blood sugar associated with diabetes. Studies show the risk between statins and type 2 diabetes is small, but should still be carefully monitored. Doctors want to continue to inform patients that though the benefits of statins still outweigh the risks, it is best to be cautious and double check with your doctor to see if the medications are best for your conditions. Doctors are encouraging all patients to talk to their doctor to discuss any possible side effects they may be affected by.

As the FDA takes a closer look into the potential risks of statins, they have also decided to remove a different warning on the medications labels. Statins previously had labels warning of liver damage and recommended routine testing of the liver enzymes, but will now change the recommendation to a single test when patients first begin taking the drug. The FDA has found that severe liver damage is rare, and continuous testing of the liver enzymes does not show to be efficient in finding liver damage.

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An anticoagulant drug proves to be fatal with out proper monitoring of the medication. Coumadin, also known as Warfarin, is a blood thinning prescription used in patients to prevent blood clots, heart attack and stroke. Coumadin is mostly prescribed to patients with an artificial heart valve, atrial fibrillation (an irregular heart beat), deep venous thrombosis (blood clots in the deep veins), and pulmonary embolism (blood clots in the veins). However, when the drug is not properly monitored it can lead to devastating results.

Coumadin, similar to other drugs, must be carefully monitored almost everyday during a patients first month on the drug. Since the drug is a blood thinner, doctors must be extremely cautious in watching how thin the blood gets. When blood becomes too thin, it could eventually cause a patient to bleed to death, whether or not they have open wounds. If the blood does not thin, a patient could suffer from blood clots, possibly leading to a heart attack, stroke or even death. Once blood clots have formed, there is very little doctors can do in order to stop them, which is why patients taking Coumadin need to be carefully monitored.

During a patients first month on the drug, every day they should undergo either a prothrombin time (PT) test or an international normalized ratio (INR) test. Both tests are blood tests that measure how long it takes for the patient's blood to clot. The tests also check for bleeding problems and determine how well the blood thinning medicine is working. The only difference between the tests is the INR test is a way of standardizing the results of the PT tests, allowing doctors to understand results even if they come from different testing methods or different labs. The PT and INR tests are crucial for doctors, nurses, hospitals, nursing homes and care providers to maintain in order to monitor the safety and effectiveness of the medicine.

As all medicines do, Coumadin affects each patient differently. Age and health backgrounds may alter the performance and side effects of the drug for each person. Those responsible for the testing, whether it is the primary care doctor, hospital or nursing home, should know the risks and warnings that come with the drug.

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More than 2,700 vehicles have recently been recalled due to a problem with the vehicles side air bags. Federal safety regulators and The National Highway Traffic Safety Administration (NHTSA) have been investigating the problem they believe to be caused from defective parts. According to the investigation, "the recalled vehicles could have an ineffective mixture of the gas that inflates the side curtain air bags in a crash. That mix could mean air bags on one or both sides of the cars won't inflate, increasing the risk of injury." As of now, no one has been hurt but several companies have issued recalls. Regulators first noticed the problem at the end of January during a production parts tests at minus-22 degrees Fahrenheit, after further testing, results showed malfunctions at low temperatures.

The inflators were made by the Swedish Autoliv Inc, who stated to have shipped around 10,500 defective inflators to automakers and to two other air bag manufacturers. The recall includes Toyota, Honda, Subaru, and Nissan vehicles but more may be recalled soon. Other than the companies who have already recalled their vehicles, Chrysler Group LLC, Ford Motor Co., General Motors Co., Kia Motors America and Suzuki Motor Corp. also received the defective parts but have not yet recalled any vehicles. For a detailed list of the recalled vehicles, please click on the following link - recalled vehicles.

The NHTSA is continuing to look closely into the investigation in order to keep all drivers safe. As we all know, it is critical to have air bags in cars, they can save lives. With the advancement of technology and the improvement of safety features in cars, fortunately, we have seen a slight decrease in the number of fatal accidents on the road. According to records provided by NHTSA, in 2008 Texas had 3,476 fatalities due to traffic accidents. The number of fatal accidents decreased by 12 percent in 2009, resulting in 3,071 fatalities. Traffic fatalities have dropped by 10 percent from 2008 to 2009 for the nation as a whole. We hope to continue to see a decrease in the number of fatal accidents.

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A new inhalable caffeine product attracts the attention of the Food and Drug Administration (FDA). The FDA plans to commence a new safety investigation of AeroShot, a product of Breathable Foods Inc. AeroShot is a lipstick-sized canister that contains 100 milligrams of caffeine powder plus a number of B vitamins. Consumers are able to place one end of the canister in their mouth and breathe in, when breathing in a fine powder is released and quickly dissolves. The ingredients in each canister are almost equivalent to one large cup of coffee.

According to ABC News, Dr. Bruce Goldberger stated, "you could easily overdose or succumb to toxicity associated with the caffeine ingestion. You could mix it with alcohol in a social setting and also I'm troubled by its availability, potentially at home where young children can get a hold of it." The FDA worries that due to the canisters packaging, brightly colored and a sleek look, AeroShot will attract mostly kids and teens, a target audience that is most vulnerable to overusing such products.

AeroShot was first released on the market last month in Massachusetts, New York and France. The product never required FDA review before being released on the market in the U.S. because it was sold as a dietary supplement. The FDA recently released a statement that the safety review will not only focus on whether the product is safe for consumption but also, will review if the product legally qualifies as a dietary supplement.
David Edwards, inventor of AeroShot, claims the product is safe and does not contain common additives used to boost the caffeine effect in most energy drinks. As we have seen over the years, energy drinks can have severe side effects and at times can cause fatal accidents. After the release of Four Loko, the FDA and the public are very cautious about products used to boost energy, especially if they are being mixed with alcohol.

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