The FDA just completed its review of various studies and has concluded that women taking drospirenone-containing birth control pills (such as Yaz, Yasmin or Ocella) may have a higher risk of developing blood clots (such as deep vein thrombosis and/or pulmonary embolisms) than women taking progestin-containing birth control pills….as much as THREE TIMES THE RISK.

Click on this link to read the actual FDA warning: FDA Warning Regarding Drospirenone-containing Birth Control

What is Drospirenone?

Drospirenone is a synthetic version of progesterone (also known as progestin), which is a female hormone.  In combination with ethinyl estradiol, it is used as contraception, to treat moderate acne, and to treat premenstrual dysphoric disorder.

Required Label Change

The FDA is now requiring manufacturers of drospirenone-containing birth control pills to revise their labels to include the fact that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, as opposed to birth control pills that contain levonorgestrel or some other progestins. The labels will also state, however, that some of the studies showed no increased risk of blood clots with drospirenone-containing products. 

If you have taken Yaz, Yasmin or Ocella and have developed blood clots, call Kogan & Associates immediately at 800-876-2303 to discuss potential compensation.

Lawyers throughout the nation who represent women who have been injured after taking Yaz/Yasmin birth control are currently being contacted by Bayer (the makers of Yaz/Yasmin) to possibly reach settlements for their clients with pulmonary embolism and/or deep vein thrombosis (DVT) claims.

Since February of 2012, approximately 11,300 lawsuits have been filed by attorneys representing Yaz victims, according to Bayer’s 2011 Annual Report. So far approximately 70 of these cases have been settled, and Bayer is continuing settlement discussions on a case-by-case basis with attorneys nationwide. Bayer is only focusing right now on injuries involving pulmonary embolism and deep vein thrombosis. Gall bladder injuries are not yet being reviewed.

Pradaxa is a blood thinner used to prevent strokes and blood clots in patients with atrial fibrillation.  The FDA is currently reviewing Pradaxa’s safety, after numerous reports of increased side effects.  The first three Pradaxa lawsuits (based on “failure to warn”) have been filed against the drug maker Boehringer Ingelheim in Louisiana, Tennessee, and Kentucky federal courts.  The Pradaxa lawsuits claim that Boehringer Ingelheim failed to warn about the risk of fatal bleeding. 

• Lege et al. vs. Boehringer Ingelheim Pharmaceuticals Inc., et al. (filed in the U.S. District Court for the Western District of Louisiana)
• Bivens et al. vs. Boehringer Ingelheim Pharmaceuticals Inc., et al. (filed in the U.S. District Court for the Eastern District of Tennessee, Northern Division)
• Hawkins et al. vs. Boehringer Ingelheim Pharmaceuticals Inc., et al. (filed in the U.S. District Court for the Eastern District of Kentucky, London Division)

On January 5, 2012, The St. Clair Record reported that mothers who believe that their infants suffered from serious birth defects due to the fact that the women were taking Zoloft during their pregnancies have joined a Zoloft lawsuit against Pfizer (the maker of Zoloft).  The litigation reportedly claims that pregnant women were prescribed Zoloft even though it has a risk of Zoloft side effects.  The Zoloft lawsuit alleges that babies were born with heart defects (among other types of defects) due to the fact that their mothers were taking Zoloft while pregnant.

It is alleged that Pfizer knew, or should have known, about the increased birth defect risks caused by taking Zoloft during pregnancy, but chose not to adequately warn women of this increased risk.

Pfizer has been accused of negligence, fraud, and breach of implied warranties due to the fact that they did not adequately disclose the risk of birth defects caused by taking Zoloft during a mother’s pregnancy.  

One interesting study reported by ABC News on January 12, 2012 shows that about one in one thousand infants born in the general population are born with pulmonary hypertension.  However, researchers have found that incidences of pulmonary hypertension doubled in women who took SSRI anti-depressants during their pregnancies.

Kogan & Associates is currently interested in speaking with women who were taking Zoloft during their pregnancies, and subsequently gave birth to a baby with a heart defect.  Please call our Zoloft attorneys immediately to discuss the Zoloft litigation at 800-876-2303.

Yaz and Yasmin are birth control contraceptives which contain the hormone drospirenone.  These contraceptives, manufactured by Bayer (Germany’s largest drugmaker), have been the focus of regulators due to potential safety issues, including potential increase risks of deep vein thrombosis, pulmonary embolisms, and gall bladder disease.  There are currently over 10,000 lawsuits alleging injuries due to Yaz and Yasmin.

A series of important trials had been scheduled to begin this year accusing Bayer of misleading women regarding Yasmin and Yaz’s health risks.  These trials would have served as so called “bellwether trials” (which are often used to indicate future trends in a given litigation) on the Yaz/Yasmin litigation.  However, U.S. District Judge David Herndon in Illinois postponed the Jan. 9th trial last week, and ordered the two sides to work with  a mediator, Stephen Saltzburg.  Saltzburg is a George Washington University law professor who will work with both sides to look into the possibility of settlement.

More information can be found on bloomberg.com:  http://www.bloomberg.com/news/2012-01-05/bayer-judge-postpones-first-yaz-trial-orders-birth-control-cases-mediated.html

Here is a good article about IVC filters that I ran across and wanted to share it.  It was posted on ArticleTom.com:

An inferior vena cava or IVC filter is a medical device which helps prevent the existence of a condition known as pulmonary embolism. This is implanted into the inferior vena cava using a catheter, often performed on an outpatient basis. The procedure is done either by vascular surgeons or interventional radiologists.

Made out of very thin metal wires, its mesh-like design makes it look like a small umbrella. Its structure enables it to trap clots in the blood stream coming from the body’s lower portions, so they’re kept from getting to the lungs or heart. There are models which are designed in such a way that they may be left in their places permanently. Some, however, are designed to be retrievable after some time of being in the vein.

There are various reasons why an individual has to be implanted with the device. One is when anticoagulants fail to work. Anticoagulants are medications which thin the blood and prevent it from clotting. Likewise, it can also dissolve clots. Another reason is when intake of anticoagulants isn’t recommendable, such as when certain conditions are around.

Anticoagulants may have trouble dissolving large clots. Individuals who are detected with such are usually advised to get the device implanted in them. A person who has recently undergone an injury like a head trauma or fracture in the pelvis may require it. Those who are susceptible to having pulmonary embolism or have had deep vein thrombosis before may also be advised by a doctor to get the device.

Blood clots should be kept out of the lungs. When pulmonary embolism takes place, a clot blocks the supply of blood in some parts of the lungs. Someone who has it may experience troubled breathing, chest pain and dizziness. Bluish skin color is also observed on the individual due to oxygen deprivation. In some instances, it can also cause death.

The device is placed into the inferior vena cava through some large veins in the body. They include the femoral (groin), jugular (neck) and basilic (arm) veins. Inserted into any of these is a catheter, a thin rubber tube. The device is pushed into this catheter, guided by the use of a Doppler ultrasound. Fluoroscopic guidance, or x-ray, may also be used when contrast dye is injected before the procedure.

Originally it was through surgical means that such procedure is done. But thanks to design changes, vascular surgeons or interventional radiologists can put it in place via a catheter. Usually, local anesthesia is used, although it’s possible that the individual may also be given drugs to relieve anxiety. Sometimes, general anesthesia may be used instead.

As mentioned earlier, an IVC filter may permanent or temporary, depending on the design. What makes a temporary model different from a permanent one is the presence of a small hook or knob on one end. Likewise, it also has a collapsible structure. This allows the device to be pulled out safely of the inferior vena cava through a catheter. However, it may also be left in place for good, just like a permanent model.

Propecia Side Effects

In addition to the sexual dysfunction side effects that many people are talking about today, users of Propecia who decide to stop taking the medication noted losing the hair that was grown while on the drug.  Therefore, in order to maintain growth and thickness, finasteride (Propecia) needs to be taken for the long term….increasing the rise of Propecia side effects.

Users of Propecia also experienced hormone level fluctuations, which caused breast tenderness.  The drug also affects the Prostate Specific Angtigen (PSA) which is used to detect prostate cancer in routine screenings.  Using Propecia can make it more difficult to detect this form of cancer, which can be a very serious issue.

Even though the FDA has approved this drug for use, and required a number of stringent tests, clinical trials, and full reports, the agency admits it does not fully know the long term side effects and conditions that may result from using Propecia.

Since many young men take this drug to ward off male pattern baldness and to maintain their current level of hair, many could end up taking it for a number of years, and could cause side effects that can be potentially devastating.  The possibility of taking the medication for decades without knowing the full effect is something that should be considered carefully.

If you have been taking Propecia (finasteride) and are suffering from side effects, call Kogan & Associates immediately to discuss a potential claim against Merck. 800-876-2303.

American Venous Forum Launches IVC Filter Module of American Venous Registry

Improving Tomorrow’s Outcomes With Today’s Data

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The IVC Filter Module is launching at an extremely appropriate time as the FDA, doctors and patients are struggling with critical questions…

Beverly, MA (PRWEB) June 16, 2011

Today the American Venous Forum (AVF) is launching the Inferior Vena Cava (IVC) Filter Module for its American Venous Registry (AVR). According to Uchenna Onyeachom, the AVR Administrator, this is the first and only national registry of IVC filters placed and retrieved in the United States.

The AVR, launched in February of this year, standardizes the collaborative collection and analysis of clinical information about venous disease. By identifying practice patterns for venous disease diagnosis and treatment across the U.S. and across varied specialties, the Registry will facilitate the assessment of functional outcomes and comparative analyses of different clinical approaches to venous disease management. This makes it a powerful tool for the development of treatment guidelines, evidence-based modification of public policy, and re-direction of health care resources.

IVC filters are placed in patients who have a history of, or who are at risk of, developing blood clots in the legs. The purpose of the filter is to trap large clot fragments and prevent them from traveling through the vena cava vein to the lungs, where they could cause severe complications or even death.

The filter is placed in the inferior vena cava, the large vein in the abdomen that returns blood from the lower body to the heart. Until recently, IVC filters were available only as permanently implanted devices. Now, there are newer filters, that may be left in place permanently or have the option to be removed from the blood vessel later.

The IVC Filter Module will enable physicians to enter and track the indications for which they are placing filters, the types of filters they are using, how frequently they are retrieving filters and any complications. They will be able to compare this information from their patients with the national aggregate.

“By tracking specific aspects of the IVC filter practice nationally, physicians will get a better idea of how IVC filters are being used, determine their complications and filter retrieval rates, and compare these aspects of their practices to the experience of other physicians,” says John Rectenwald, MD, Assistant Professor of Vascular Surgery, University of Michigan Health System, and Chair of the IVC Filter Module of the AVR.

“The IVC Filter Module is launching at an extremely appropriate time as the FDA, doctors and patients are struggling with critical questions about who should get filters, how many retrievable filters are actually getting retrieved, and which filter designs are associated with complications,” said Brajesh K. Lal, MD, Chairman of the AVR, and Associate Professor and Chief of Vascular Surgery, Physiology & Bioengineering, University of Maryland, Baltimore.

Vein Disease

Despite the medical advances of the past two decades, venous disease remains understudied and is severely underestimated for its effects on public health. Experts believe that at least 25 percent of the U.S. and worldwide population suffer from venous disease. In fact, chronic venous diseases affect more than 20 percent of the adult population and are more prevalent than coronary, carotid and peripheral artery diseases combined. Additionally, acute venous thromboembolism is the cause of more than 100,000 deaths in the U.S. each year. Still, the care for these conditions is not standardized.

“Despite venous disease affecting such a large segment of our population, there has been no platform available to collaboratively evaluate our procedures and outcomes using common language. The AVR fills that important need” said Dr Lal.

About the American Venous Forum and the American Venous Registry

The American Venous Forum (AVF) is an international consortium of venous and lymphatic specialists dedicated to improving patient care. Its mission is to promote venous and lymphatic health through innovative research, education and technology. The AVF created the American Venous Registry to:

• Standardize the collection and analysis of clinical information on venous disease
• Identify practice patterns for venous disease diagnosis and treatment nationwide
• Answer research questions prioritized by the AVF
• Provide a real-time clinical practice tool to assist the practices of individual participating physicians

The Registry will be comprised of five modules; two have been launched and three are under development. Each module focuses on one particular aspect of venous disease and offers several clinical practice tools and the ability to run specific benchmarking queries in real time. The modules are:

• Varicose vein module, which was launched in February 2011
• IVC filter module, which is launching today
• Stent module, which is scheduled to launch in the Fall of 2011
• DVT thrombectomy/lysis module
• Upper Extremity DVT module

For more information about the American Venous Forum, log on to http://www.veinforum.org

For more information about the American Venous Registry, log on to http://www.venousregistry.org

If your case is settled, or won in court, you will be entitled to compensation, and the attorney representing you will receive his/her compensation from this compensation.  Most contingency fees are somewhere between 33% to 40% of whatever compensation is received.  If you decide to work with a personal injury lawyer, you will be asked to sign what is called a Contingency Fee Retainer Agreement.  Once the agreement is signed and submitted, the attorney will begin working on the case.  If the attorney is unable to negotiate a fair and reasonable settlement with the company you are claiming is responsible for your injuries, the case will most likely move to litigation and be presented in court.  Once an attorney begins representing a client, the exact time and steps involved in obtaining proper compensation will be different for every claim.

The Food and Drug Administration recently warned women of childbearing age and expectant mothers against the use of anti-convulsant drug, Topamax, as is poses rick of development of cleft lips or cleft palate deformities in newborn babies.  According to the FDA’s research data, newborns of women who take Topamax during their first trimester of pregnancy are 20% more likely to develop cleft lips than those taking other anti-convulsant drugs.

Topamax was developed originally to treat people with epilepsy, and later, to help prevent migraine headaches.  The FDA has warned doctors to caution their patients against the use of Topamax to prevent their newborns from developing oral birth defects and deformities.  The FDA issued a warning against the use of the drug during the first three months of pregnancy, which is a time that many women do not even realize that they are pregnant.  This has lead to many women giving birth to babies with oral birth defects and deformities.  If you or someone you love was taking Topamax during your first three months of pregnancy and gave birth to a child with birth defects, it is important for you to call an attorney to discuss any legal rights to which you may be entitled.