Fort Worth Injury Lawyer Blog

Bayer Healthcare Begins Settling Yaz Lawsuits

Published on: March 7, 2012 | by The Borchardt Law Firm, PLLC

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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FDA Changes Labels On Statin Drugs

Published on: March 5, 2012 | by The Borchardt Law Firm, PLLC

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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Blood Thinning Drug Coumadin Shows To Be Fatal With Out Proper Monitoring

Published on: February 29, 2012 | by The Borchardt Law Firm, PLLC

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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Cars Recalled Due to Defective Airbags

Published on: February 22, 2012 | by The Borchardt Law Firm, PLLC

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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New Inhalable Caffeine Product Grabs the Attention of the FDA

Published on: February 20, 2012 | by The Borchardt Law Firm, PLLC

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.

AeroShot pic.jpg

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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FDA Focuses on New Studies to Determine Safety of Surgical Mesh Implants

Published on: February 13, 2012 | by The Borchardt Law Firm, PLLC

The FDA has continued to further pursue research and studies concerning the safety of all urogynecologic surgical mesh implants due to the increased number of complaints and litigations. Filed complaints continue to increase across the U.S. as the FDA looks more closely into research. Complaints began several years ago as women were experiencing severe side effects after having vaginal mesh surgically implanted to help treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Vaginal mesh has been on the market since 2002, having several pharmaceutical companies provide it. Within only two years, the FDA had received over 1,500 complaints filed by patients and doctors. Several women’s procedures resulted in multiple revision surgeries that still left them with unsatisfying results. In October 2008, the FDA issued the first Public Health Notification, warning patients about the possibility of the device failing and the potential side effects that they were not informed about. As complaints continued to pile up, in July 2011, the FDA issued their second safety warning to patients stating that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare, and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.” (read full article)

January 2012, the FDA met again to review new studies and undergo new measures of research. Based on Medical Device Reports, published literature and the 2011 Obstetrics-Gynecology Device Panel meeting, the FDA is debating whether or not urogynecologic surgical mesh used for transvaginal repair of POP be reclassified from Class II to Class III. They administration is going to continue to evaluate the safety and success of urogynecologic surgical mesh devices through new procedures and continue to inform the public of any safety warnings. (view full list of new procedures)

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Metal on Metal Replacement Systems Possibly Linked to Cancer

Published on: February 8, 2012 | by The Borchardt Law Firm, PLLC

A British study shows a possible link between several metal-on-metal replacement devices and an increased risk in cancer. The Sunday Telegraph, a British newspaper, disclosed results from a recent study that show the potential link. Over the past couple years, doctors and patients began second guessing the performance of metal-on-metal replacement systems. Several systems were failing within only a few year of surgery, causing multiple revision surgeries and still no improvement in pain.

In 2010, a leading manufacturer of an all metal-on-metal hip replacement system, DePuy Othaepedics, recalled more than 90,000 hip replacement systems due to an unusually high failure rate. Studies showed the metal-on-metal hip replacement systems were found to shed tiny pieces of metallic ions that led to a high risk of causing permanent tissue, muscle and bone damage. According to the Sunday Telegraph, “there are also concerns that metal traces in the blood could put major organs at risk of being slowly poisoned, and increase the chance of cancer – in particular in the kidneys and bladder.”

The article discusses results from a recent in-depth study that found genetic damage to the bladders of 17 out of the 72 patients tested, three of the 17 patients developed cancer. British regulators plan to continue further research and warn patients about continuous tests and to be aware of any signs or symptoms. (read full story)

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Women Panic After Pfizer Birth Control Recall

Published on: February 6, 2012 | by The Borchardt Law Firm, PLLC

Pfizer, the worlds largest research based pharmaceutical company, issued a voluntary recall of its contraceptive pills that were found to have a manufacturing issue. Lo/Ovral-28 and its generic brands were recalled in late December after the company found a key mistake that could lead to several unintended pregnancies.

https://www.youtube.com/watch?v=zcLIbeVHGgY

Each packet of the birth control contains 28 pills, including 21 active pills, pills that prevent pregnancy, followed by seven placebo pills, pills that allow the body to have a period. Most active and placebo pills are differentiated by the color, allowing women to keep track of when they are taking an active or placebo pill. In order for the birth control to work effectively, the pills must be taken properly. Women are suppose to take them in the correct order at the same time everyday. If a pill is missed, her chances of becoming pregnant increase.

After the company received a call from a woman stating she found an active pill in the middle of her placebo pills, completely altering the order of her packet, Pfizer reviewed the manufacturing company. They realized there were a handful of packets that were put together incorrectly, mixing the order of active pills with placebo pills. The company immediately fixed the problem and later sent out a warning to the public addressing the issue. Pfizer recalled 1 million packets of Lo/Ovral-28 and its generic brands, though they believe only about 30 packets were defective. Though Lo/Ovral-28 is not one of the most used birth controls, the warning sent many women into a panic.

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MS Drug Gilenya Under Review After 11 Deaths

Published on: February 1, 2012 | by The Borchardt Law Firm, PLLC

Reports raise concern for a multiple sclerosis drug after 11 deaths were reported, all in which the patients had recently begun taking the drug. Novartis International AG, one of the largest multinational pharmaceutical companies based in Switzerland, came out with one of the first oral drugs used to help treat symptoms for multiple sclerosis. Gilenya, the oral medication, was approved in the U.S. and in Europe in 2010, but now, the drug is undergoing further safety testing.

Recent reports show the drug may have severe side effects on the heart, possibly leading to death. At this point, nothing has been confirmed but both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are reviewing the medication. According to an article in Business Week, concerns were sparked last November after a patient who had recently begun taking Gilenya died within 24 hours of starting his treatment. The article states, “ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to the disruption of heart rhythm, the London-based EMA said.” (read full article)

Novartis estimated around 30,000 patients are still being treated with Gilenya, Novartis and both agencies are notifying doctors about the possible side effects and have recommended all doctors to increase monitoring of patients’ hearts before beginning treatment and for at least six hours immediatly after beginning treatment. Though the drug has warning labels about the possibility of a slow heart rate and atrioventricular conduction block during your first treatment, it is still unclear whether or not the drug is the main cause of these deaths; the EMA and FDA hope to find out more information soon from continuous studies.

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Type Two Diabetes Drug Bydureon Approved by FDA

Published on: January 30, 2012 | by The Borchardt Law Firm, PLLC

A new diabetes drug has made it to the market after a long delay by the Food and Drug Administration (FDA). The FDA approved Amylin Pharmacuetical’s drug Bydureon just a few days ago. Bydureon is a once a week injection medication created to improve glycemic control in adults with type 2 diabetes in multiple settings. In 2010, the FDA rejected the drugs approval twice, requesting more studies be done, but Bydureon has finally been approved. Amylin is hoping with the new drugs convenient once a week use, it will gain an advantage over competitors. The company plans to sell the new diabetes drug in both the U.S. and Europe, they are expected to hit $1 billion in annual sales. (read full article)

According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes; it affects millions of Americans every day. With type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin, and insulin is necessary for the body to be able to use glucose for energy. Untreated patients with type 2 diabetes may experience constant fatigue, weight loss, blurred vision, increased thirst and several other serious side effects. Over the past few years, pharmaceutical companies have tried to find alternative options for diabetic patients when it comes to injections or oral medication and as of now, Amylin’s Bydureon is the only type two diabetic medication for adults with a once a week dose. The company has tested the drug for any side effects and has clearly posted all possibilities on the label.

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