Canadian Yaz Study

Posted on November 18, 2011 by Greenberg & Bederman

 

The Food and Drug Administration recently released a study confirming what the British Medical Journal had already suggested in April. The FDA study found that birth control pills containing an ingredient called drospirenone put women at a greater risk of blood clotting than from other types of birth control pills.

The Canadian Medical Association Journal came to the same conclusion, stating that the risk for women taking pills with drospirenone is about 3 or 4 in 1,000. To put it in perspective, the risk from other pills is 1 in 1,000.

If there were only 1,000 women taking these pills, then 3 or 4 blood clotting episodes would be bad enough. But the pills that the BMJ, the CMAJ and the FDA are referring to are Yaz and Yasmin, which are birth control pills made by Bayer. Significantly more than 1,000 women are taking these pills. Hundreds of thousands of women all over the world are taking them, so the threat to the health of these women is much more wide spread.

It should also be mentioned that Bayer engaged in a particularly heavy advertising campaign which made quite a few misleading promises. The advertisements claimed that Yaz could prevent women from gaining weight, could cure acne and could prevent PMS. This wasn’t true. Some people who took the pill did not gain weight, but there isn’t much evidence that suggests that all women would experience the same thing. And some women did experience a clearing up of some pimples. But in the advertisements, they listed symptoms that are commonly associated with PMS, while what Yaz and Yasmin actually had an effect on were symptoms of Pre-Menstrual Dysphoric Disorder. PMDD is significantly different from PMS, and the ads implied that the two conditions were interchangeable.

 

These exaggerated claims caused Yaz and Yasmin to become one of the best selling birth control pills in the country, which led to more women unknowingly placing themselves in danger.

Normally when you think of blood clots (if you happen to think about them at all,) you would think of them as positive things. They are part of a naturally occurring mechanism that keeps us from bleeding to death. If you cut yourself, the blood in the area of the cut begins to thicken, making it easier for the flow of blood out of the body to stop. But the problem with drospirenone is that it is apparently creating blood clots where there is no reason for them. These clots generally form in the deep veins of the legs, which causes pain and swelling (deep vein thrombosis.) The real danger happens when these clots break into pieces, because then they are small enough to travel through the bloodstream. They can cause blockages in blood flow to the heart, which is what causes heart attacks, and they can cause blockages in blood flow to the brain, which is what causes strokes. They can also cause pulmonary embolisms, which are blockages in blood to the lungs.

Blood clotting has always been a concern with birth control pills, but the numbers weren’t that high. Our main concern is that Bayer put out a drug that elevates the risk of clotting, and engaged in misleading advertising in order to market it. The sheer number of women taking these pills makes Yaz and Yasmin a very real health risk.

Greenberg and Bederman are currently representing women in the Washington, D.C. area who were taking Yaz, Yasmin or Ocella, which is the generic version of the drug, and were injured or hospitalized as a result. Many of these health problems have effects that can last your whole life, and if the cause of the problems was a prescription drug that you took in good faith, then you shouldn’t have to bear the costs of your injury. If you live in Virginia, Maryland or Washington D.C. and you have been hurt due to Yaz, Yasmin or Ocella, contact Greenberg & Bederman for a free consultation today.
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Yaz Birth Control Injury Differences

Posted on March 11, 2010 by Greenberg & Bederman

DC Area Yaz Birth Control Injury Law Firm Greenberg and Bederman is Currently Offering Legal Assistance

As many of you probably know, the Bayer Corporation is facing a series of yaz lawsuits in various American states due to problems that users of their line of birth control pills are experiencing. If you don't know about yaz health problems, please read our page on yaz history.The difference between Bayer’s pills and most other oral contraceptives on the market is that Bayer’s birth control pills (which are marketed under the names Yaz, Yasmin, and a generic version called Ocella) all contain a synthetic variation of progestin called drispirenone. While the use of drispirenone has been marketed by Bayer as having some beneficial peripheral effects such as prevention of minor acne or helping to alleviate the symptoms of pre menstrual dysphoric disorder, Bayer failed to mention in either it’s marketing campaign or the warning labels used on the medication that drispirenone raises the risk of deep vein thrombosis, or blood clots in the deep arteries and veins of the legs. These blood clots can then break apart, and the pieces can travel through the bloodstream, which can cause strokes, heart attacks and pulmonary embolisms. The use of drispirenone has also lead to a higher than normal rate of gall bladder disease.

These side effects of yaz are not merely theoretical. There have been hundreds of women who have been seriously injured and hospitalized all over the country due to clot-based injuries. Otherwise perfectly healthy women have suffered from strokes, heart attacks, pulmonary embolisms and gall bladder disease, and there have even been more than fifty deaths.

 

As a result of these injuries and deaths, over 1100 lawsuits have been filed nationwide, with many of them falling under Multi District Litigation, which is a way to place cases with similar backgrounds against the same defendant under the same ground rules. A few class action suits (in which one group of attorneys represents multiple plaintiffs under the heading of one case) have also been filed.

Bayer has, of course, vowed to fight any and all yaz lawsuits regarding their line of birth control pills, and we certainly believe them. With profits of Yaz, Yasmin and Ocella reaching $1.7 billion dollars in 2009, Bayer can afford to wage as many court battles as they see fit. Even with all the justified bad publicity, Yaz is still Bayer’s top selling product.

The Bayer Corporation has already given some clues as to what they expect their defense to be. They recently made an attempt to allow past birth control history of the plaintiff’s to be used as evidence, which was quite rightly denied. And based on public statements by Bayer, we are expecting them to center their defenses on the warning label that is currently in place on the products themselves.

Bayer will probably wear the current label as a shield against any liability, with the premise being “Look, we have a warning label on the box, and the doctors who prescribe it have their warnings as well. If you didn’t read it, we can hardly be expected to be blamed for that.”

There are a few things wrong with that premise. In the first place, the warnings weren’t mentioned very prominently in the enormous and splashy advertising campaign that Bayer used for Yaz. The focus on these ads was all about what Yaz could do for you besides keep you from getting pregnant. In the second place, while the warning on the doctor’s labels does admit that there is a risk of hyperlykemia (elevated potassium levels,) it fails to mention that drispirenone has a higher risk of causing hyperlykemia than any other progestin based oral contraceptive on the market. Since hyperlykemia is a possibility with most other pills, this warning label basically makes it seem as if Yaz, Yasmin and Ocella are no different than any other pill on the market when it comes to risk, and this is simply not true.

An equivalent here would be if a gun manufacturer was selling a pistol that has a higher tendency to fire accidentally than any other gun on the market, but since there is a slight chance that many guns on the market will fire accidentally, their particular gun is no different than the others.

When you study the injuries associated with yaz Bayer’s warning labels should produce a list of conditions that should discourage you from taking any of their drispirenone based pills:

Yaz should not be used in women who have the following:

·         Renal insufficiency

·         Hepatic dysfunction

·         Adrenal Insufficiency

·         Thrombophlebitis or thromboembolic disorders

·         A past history of deep-vein thrombophlebitis or thromboembolic disorders

·         Cerebral-vascular or coronary-artery disease (current or history)

·         Valvular heart disease with thrombogenic complications

·         Severe hypertension

·         Diabetes with vascular involvement

·         Headaches with focal neurological symptoms

·         Major surgery with prolonged immobilization

·         Known or suspected carcinoma of the breast

·         Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

·         Undiagnosed abnormal genital bleeding

·         Cholestatic jaundice of pregnancy or jaundice with prior Pill use

·         Known or suspected pregnancy

·         Liver tumor (benign or malignant) or active liver disease

·         Heavy smoking (≥ 15 cigarettes per day) and over age 35

·         Hypersensitivity to any component of this product

This is all well and good, but that doesn’t explain the hundreds of women who are suffering from none of these symptoms who are still being injured and hospitalized. And aside from that obvious red flag, these symptoms all more or less appear as disqualifications on the warnings for practically every other birth control pill out there. This again makes it appear that Bayer’s line of birth control pills are just the same as every other oral contraceptive, when they are in fact not, and that is one of the major reasons for all of these yaz lawsuits.

The “read the warning label” argument doesn’t carry any water unless that warning label clearly states that drispirenone increases your chances of hyperlykemia, which increase your chances of DVT, which increases your chances of heart attacks, strokes, pulmonary embolisms and gall bladder disease. The increased chances aren’t mentioned in a clear manner at all. Bayer did not say “Here is a birth control pill that can prevent acne and the symptoms of PMDD, but it increases the odds that you will suffer from blood clots. Take it at your own risk.” They simply said “Here is a standard, run of the mill birth control pill, except it can prevent acne and the symptoms of PMDD!”

Greenberg and Bederman is currently offering legal assistance for people in the Washington D.C. area who have been injured due to the use of Yaz, Yasmin or Ocella. Our attorneys are working diligently to help women in Virginia, Maryland and the District who have been hospitalized due to Bayer’s line of birth control pills. If you or a loved one has been injured in this manner, contact Greenberg and Bederman for a free yaz legal consultation today.

To learn more about yaz birth control, please read our yaz lawyers website page, or watch our yaz video on Youtube.

 
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Yaz Lawsuits Filed in Indianapolis

Posted on February 16, 2010 by Greenberg & Bederman

Women in Indianapolis Latest to File Yaz Lawsuits

According to the Star Press, over fifty women have filed yaz lawsuits against the Bayer Corporation due to injuries that these women received due to the use of Bayer’s line of birth control pills.

According to the British Medical Journal Study of the women who take Yaz, Yasmin, or Oscella, 6% will experience dangerous adverse reactions ranging from blood clots, to DVT, to Gallbladder injury. Other birth control products have adverse reactions in about 1 % of patients who take birth control pills.

Bear in mind, we certainly don’t think that it’s “normal” for birth control pills to be dangerous to women. But considering that Bayer had no problem with producing, releasing and aggressively marketing a pill with an ingredient that they knew to be more dangerous than other forms of oral contraceptives, we have to assume that they think a five percent casualty rate for their products is “normal.”

The ingredient in question is a synthetic variation of one of the two main ingredients found in almost every birth control pill on the market. Most pills contain a combination of progesterone and estrogen, which essentially fools the female body into thinking that it is already pregnant. In order to separate themselves from the pack, Bayer decided to use a synthetically produced variation of progesterone called drospirenone. With this ingredient firmly in place, Bayer began to trumpet the additional peripheral benefits of what their line of pills could supposedly do. Aside from helping to prevent pregnancy, Bayer claimed that Yaz and Yasmin both helped to prevent serious forms of acne and Pre Menstrual Dysphoric Disorder (PMDD.) They combined these claims with an expensive and flashy advertising campaign that was aimed at younger women. After all, what young woman wouldn’t want to avoid acne? What young woman wouldn’t wantto avoid the emotional instability that often comes with menstruation?

 

As predicted, Yaz, Yasmin and Ocella became Bayer’s top selling products. And this is exactly why the casualty rate is so high. It turns out that drospirenone does other things besides acne and PMDD prevention. It also dramatically raises the potassium levels in the bloodstreams of the women who use it. This condition (called hyperkalimia) does not lead to positive health benefits. High potassium levels in the bloodstream can and do lead to blood clots in the arteries or veins in the legs, which is called deep vein thrombosis. These clots then break apart and the pieces start to travel through the bloodstream, where they then block the regular flow of blood. This leads to pulmonary embolisms, strokes and heart attacks. This is not to mention gall bladder disease, which has also been linked to Yaz, Yasmin and Ocella.

As of right now, Bayer’s public defense has been presented in two ways. The first is to say that since they have a warning label on the box, and since they mentioned the possible side effects on both the warning labels and the commercials, then it couldn’t possibly be their fault if nobody read it. The second public defense is to release statements that say things like, “When taken properly, Yaz or Yasmin are effective and safe birth control pills,” which implies that it is somehow the fault of the person who was taking the drug rather than the drug manufacturers themselves.

We find a great deal wrong with both of these methods of defense. In the first place, considering that the only way you can get birth control pills in this country is through a prescription from a doctor, most patients are already assuming that the pills are safe. If your doctor prescribes you a medication, wouldn’t you assume without thinking about it that it won’t be harmful to your health? With that being the case, we have to make the assumption that Bayer did not tell the medical community everything that it needed to know.

Secondly, how can you possibly blame the patient for any illnesses or adverse medical conditions that develop? Birth control pills are relatively easy to deal with. It’s one pill a day. We find it hard to believe that any of the women who have been taking these pills have somehow stumbled across a magic formula to make an otherwise benign working birth control pill deadly.

If Bayer had come right out and said “This pill contains an ingredient that increases the likelihood of deep vein thrombosis, strokes, heart attacks, pulmonary embolisms and gall bladder disease,” then it could be said that their bases were covered. But they did not. They did not say such things on the labeling, they did not say such things in their multi-million dollar advertising campaign, and they certainly aren’t admitting it now that the casualty numbers are starting to come in.

The women filing the yaz lawsuit in Indianapolis are only a fraction of the number of women all over the world who have suffered real and provable damage from the use of these birth control pills. Women who, in good faith, took birth control pills that were dangerous to their health, and these women were hospitalized with painful or even fatal injuries.

Here in the Washington, D.C. area, Greenberg and Bederman has been leading the way in both informing women of the dangers of Bayer’s line of birth control pills and providing legal assistance for women who have been harmed by using these pills. We are currently representing several women who have been injured and hospitalized due to Yaz, Yasmin and Ocella.

If you or a loved one has been similarly injured, contact Greenberg and Bederman for a free yaz legal consultation today.

To learn more about our yaz lawyer, Andy Bederman, please read about Andy Bederman, or watch his yaz video onYoutube.
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Yaz Lawsuit Tedious Obstacles Removed

Posted on January 14, 2010 by Greenberg & Bederman

One of the reasons that scare people away from litigation is the amount of time that it takes for many cases to come to a conclusion. Many corporations and insurance companies make it a point to delay the litigation process as much as they can, solely in the hopes of wearing out the plaintiffs. In the midst of the judicial process, there are all sorts of opportunities for both sides to file motions about one aspect of the trial or another, and corporate defendants often take many of these opportunities. They are in a good position to do so. Most plaintiffs in injury cases are facing real financial hardship, like medical bills or an inability to go back to work due to injuries. Insurance companies or major corporations aren’t facing any such difficulties, and can more easily afford the legal costs of delaying a trial.

A product liability trial most often takes a long time; especially if there have been multiple victims from the same product. Fortunately for the victims of Bayer’s line of birth control pills, the process has been streamlined by the judicial system, so women who have suffered from strokes, heart attacks, gall bladder disease or pulmonary embolismshould not have to suffer as long from unnecessary delays.

Bayer’s birth control pills, which are marketed under the names of Yaz, Yasmin or Oscella, contain an ingredient called drospirenone, which is a synthetic variation of progestin. Bayer claims that this ingredient brings with it additional benefits, such as an easier time with premenstrual dysphoric disorder as well as a cure for acne. The trade off is that the levels of potassium in the blood go up, which can and has shown to cause blood clots. These  blood clots can break apart and travel, which causes blockages in the heart (cardiac arrests,) blockages in the brain (strokes,) and blockages in the lungs (pulmonary embolisms.)

The British Medical Journal recently released a study claiming that out of all the commercially available hormonal replacement birth control pills, women that take the brands that contain drospirenone have a 6.3 % greater chance of suffering from blood clotting. Concrete evidence of this study is currently manifesting itself among women all over the country, as more and more otherwise healthy women who use Yaz, Yasmin and Oscella are being hospitalized with pulmonary embolisms, heart attacks and strokes.

Since so many women are filing suit under similar circumstances, the U.S. Judicial Panel on Multidistrict Litigation ruled that suits involving Yaz, Yasmin and Oscella should be consolidated for pretrial discovery. What this means is that rather than have each individual victim of these birth control pills file an individual law suit, which would require them to provide what is essentially the same sort of evidence over and over again, and call the same witnesses over and over again, our court system has decided to determine what will be considered standard evidence so this won’t have to be determined again and again.

So far, the multi-district litigation has progressed somewhat smoothly, and Bayer has provided a million pages of documents as part of the discovery process. There has also been some give and take regarding how confidential information will be handled during the trial. This actually should work in both the favor of Bayer and the plaintiffs. Bayer does not want any trade secret information to be made available, and the plaintiffs don’t want any private information regarding sexual history or birth control history to be part of the evidence. It appears that both sides should be satisfied in that regard.

What is important about this consolidation of cases is that a great deal of time and necessity has been removed from the trial process. With so much of the evidence and testimony already established, women will be able to present their cases that much faster. In fact, there is already discussion between Bayer and some defendant’s attorneys about what are called “bellwether trials,” in which some cases will be selected early in order to determine how these trials can be expected to proceed with the established evidence.

We would hope that this state of affairs would remove some of the barriers that prevent otherwise victimized women from stepping forward and pursuing a case. There have been a few occasions where otherwise healthy women who have been injured and hospitalized due to the use of Yaz, Yasmin or Oscella have gotten in touch with us, but then they talked themselves out of taking any action whatsoever. They were afraid that the whole process would take too long, or they somehow convinced themselves that the blame fell squarely on them, or they were convinced that a trial would bring out embarrassing personal information.

This is precisely the wrong attitude to take. Bayer has released a birth control pill that is not only more harmful to women than any other similar product, but they also overstated the peripheral benefits of the pill, which persuaded more and more women to buy it, without being fully aware of the increased risks from the drospirenone in the birth control pill .

We can’t expect that going through the judicial process will be easy, because it almost never is. But we can tell you that, thanks to this multi-district litigation consolidation, quite a few of the more tedious obstacles have been removed.

Greenberg and Bederman is a personal injury law firm that offers legal assistance for injury victims in the Washington, D.C. area. We have helped thousands of Washingtonians receive fair compensation for car accidents, medical malpractice and Social Security disability. If you or a loved one has been injured due to the use of Yaz, Yasmin or Oscella, contact our yaz lawyer, Andrew Bederman, from Greenberg & Bederman for a free yaz legal consultation, or watch his yaz lawyer video on youtube.
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Yaz Birth Control Alternatives

Posted on December 30, 2009 by Greenberg & Bederman

As we have been reporting extensively over the past few months, Bayer’s line of birth control pills has been a source of major controversy over the past year or so. The pills (which are marketed under the names Yaz, Yasmin and Ocella) first came to the attention of the general public when the Food and Drug Administration ordered Bayer to remake an advertising campaign in October of 2008. The FDA’s problem with the campaign was that it overstated the supposed side benefits of Yaz (treatment for acne and depression,) while understating the increased dangers that the special ingredient posed towards the women who used the pill.

While the FDA was having problems with the advertising, the women who were actually using the products themselves were having serious problems of their own. The new ingredient that Bayer decided to use for these birth control pills is called drospirenone, which is a synthetic variation of progestin. Along with the supposed benefits of decreased acne and an easier time with premenstrual dysphoric disorder, this ingredient has also been shown to increase the odds of deep vein thrombosis (blood clots in the legs.) These blood clots have a tendency to break apart, and the pieces of the clots have a tendency to travel through the bloodstream. This can cause pulmonary embolisms, strokes and heart attacks among women who are otherwise healthy.

To be fair, there is a risk of deep vein thrombosis associated with most forms of oral contraceptives, but the problem with Bayer’s line of pills is that the drospirenone increases those odds pretty substantially. According to the British Medical Journal, there is a 6.3 fold increase of deep vein thrombosis among women who use birth control pills containing drospirenone. Bayer’s birth control pills are the only brands available that use drospirenone, so the BMJ’s study might as well just say “Yaz, Yasmin and Ocella.”

 

From here, it’s just a matter of arithmetic. A 6.3 fold increase might not seem like much, but if you consider the full on advertising blitz that Bayer put on in order to sell this drug, then it stands to reason that the number of women who take this drug without knowing about the additional risks will increase, which therefore increases the number of women who are suffering from adverse effects. And that’s been an obvious problem. Thousands of otherwise women all over the country are finding themselves hospitalized with strokes, heart attacks or pulmonary embolisms, and the only consistent factor among these women is that they have been taking Yaz, Yasmin or Ocella.

Considering the increased risk of health problems that drospirenone can bring with it, we would urge any woman considering taking an oral contraceptive to avoid Bayer’s line of birth control pills and to consider some of the many alternatives that are available on the market. While there is still a risk of blood clotting with most birth control pills that are based on hormone replacement, the risks are significantly lower with pills other than Yaz. In fact, some of the safest pills on the market are the so-called second generation pills that contain low doses of estrogen and variations on progesterone that are much safer than drospirenone.

Lybrel: This is a pill that contains a hormone called levonorgestrel, which has been shown in most studies to have the lowest risk of deep vein thrombosis (clots.)

Nordette: This is another low dose estrogen/levonorgestrel combination pill, and Nordette is in fact just one of the many brands that use this combination. And again, levonorgestrel has the lowest incident rate of deep vein thrombosis.

Seasonique: Another levonorgestrel pill, which comes with additional benefits in terms of regulation of menstruation.

The injury law firm of Greenberg and Bederman has taken an active role in the Washington, D.C. area in both warning women of the potential hazards of Bayer’s line of birth control pills and offering legal help for women who have already been injured because of them. We are currently representing women who have been hospitalized with pulmonary embolisms, strokes or heart attacks after using Yaz, Yasmin or Ocella. Thanks to recent actions by the federal courts, the process of getting your case through the legal system has been streamlined, which is making it that much easier for your case to be heard relatively quickly. Rulings have also been made that will safeguard your privacy throughout the process.

If you or a loved one in Baltimore, Maryland, Virginia or Washington, DC has been injured due to Yaz, Yasmin or Ocella, contact our yaz lawyer, Andy Bederman, for a free yaz legal consultation.
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Does FDA Ensure Safety of Yaz or Yasmin?

Posted on December 11, 2009 by Greenberg & Bederman

The Food and Drug Administration’s  (FDA)primary responsibility is to see that any food products and pharmaceuticals are safe for consumption or use, or at the very least they make sure that the benefits outweigh the risks. For instance, if you were to come up with an effective pain reliever using ingredients in your kitchen, you couldn’t mass produce and sell it as a pain reliever unless you had your product go through the FDA approval process.

This process actually takes years. After initial testing, the pharmaceutical companies have to send their testing results to the FDA’s Center for Drug Evaluation Research (CDER.) These results are then reviewed extensively by a team of doctors, statisticians, pharmacologists and other scientists. Aside from going over the testing results, they also see if the labeling proposed by the pharmaceutical company is accurate. In other words, if the CDER perceives a risk in the drug that isn’t mentioned in the labeling, or feels that the supposed benefits of a drug are overstated, it is their duty to inform the pharmaceutical company of their findings.

It is important to mention that the CDER doesn’t actually test the drugs themselves. They only go over the data provided to them by the pharmaceutical companies. That’s not to say that they do a poor job in analyzing the data, but what is to prevent the pharmaceutical companies from turning in half truths or incomplete information? What if the pharmaceutical companies fail to mention a possible side-effect because they view it to be “statistically unlikely?”

 

Another aspect of the CDER’s testing and safety process is that the same scientists, statisticians, doctors and pharmacologists who approve a drug as safe for consumption are the same ones who are in charge of handling safety concerns after the drug has been on the market. This has led to real problems in the past.

In 1999, the FDA approved a drug called Vioxx, which was developed and initially tested by Merck. Vioxx was marketed as a nonsteroidal anti-inflammatory drug (NSAID,) which was meant to provide non-narcotic pain relief for sufferers of arthritis. This pill was basically known as a “super-aspirin,” mainly because Merck claimed it was able to not only provide better pain relief than traditional over the counter analgesics, but was able to do so without causing upset stomachs, which is a common side effect of aspirin and acetaminophen.

The drug was a huge success, with an estimated 80 million people taking the drug worldwide. But almost immediately, there began to be some real problems. Within months, there were reports of people suffering severe heart attacks. However, the very nature of Vioxx actually provided Merck with some protection from FDA fallout. After all, Vioxx was a drug for the treatment of arthritis, and arthritis sufferers are generally elderly. The elderly are statistically more likely to have heart attacks than any other demographic. The fact that Vioxx was a common link with these victims was discounted by the FDA:

“There were 14 cardiovascular deaths, (nine and five in rofecoxib and naproxen groups,

respectively). Most of the cardiovascular deaths were in patients with known

cardiovascular risks.”

Obviously, Merck was not going to admit that there was anything wrong, considering that they had spent millions on both developing and marketing the drug, and they were making money hand over fist. And the problems and delays with the FDA were due to the fact that the people in charge of reviewing Vioxx complaints were the same people who approved the drug in the first place.

There were two things very wrong with this scenario. In the first place, if the same FDA workers who approved Vioxx came out publically and said that they were wrong to do so, that would essentially be admitting that they didn’t do their jobs properly. Secondly, aside from regular FDA workers reviewing the drug, it was also reviewed by what was called an “independent advisory board,” which wasn’t really “independent” at all.

In 2005, when it became clear that there was a severe problem with Vioxx that could no longer be ignored by the FDA, the advisory board met to discuss not only Vioxx, but also the similar NSAID drugs that were either on the market or were close to being put into production by all the other pharmaceutical companies. The advisory board voted to keep these drugs on the market, despite the estimated 27,000 deaths that had occurred since their introduction. A group called the Center for Science in the Public Interest looked into who was serving on this board, and found that of the 32 experts serving on the panel, 23 of them were either receiving consulting fees from the drug companies themselves or owned a considerable amount of stock in drug companies that were either marketing NSAID’s or were about to introduce one of their own.

So between rank and file FDA members who were hesitant to publically correct their own mistakes and outside advisory boards that were staffed with people who were practically pharmaceutical company employees, the environment for fast action on a dangerous drug did not exist.

To its credit, the FDA did in fact alter the rules of its advisory panels, so that in order to serve on one you couldn’t have a financial stake higher than $50,000. But the rules regarding in-house review of dangers at the FDA have not changed:

Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

This was one of the two major factors in Vioxx being allowed to stay on the market for so long, and this worries us because right now a popular drug is posing a serious danger to the health of women who have been using it.

Bayer’s line of birth control pills, which are marketed under the names Yaz, Yasmin and Oscella, have been linked to thousands of hospitalizations all over the world, and more than a few deaths. The active ingredient in these pills is a synthetic variation of progestin called Drispirenone, which has been shown to raise the potassium levels of women who use it. Elevated potassium levels can raise the risk of deep vein thrombosis, which is the formation of blood clots in the legs. These clots can break apart and travel, which can and does cause strokes, heart attacks, and pulmonary embolisms.

Bayer has been arguing that these dangerous side effects are not out of the statistical norm, and that the victims are mostly women who smoke or were over the age of thirty. But we and other attorneys like us have read about enough cases of perfectly healthy women ending up hospitalized after taking these pills disagree with Bayer.

With FDA culture being what it is, it isn’t very surprising that the only real problems they have had with Bayer so far is over their advertising. The rest of it, the strokes, the heart attacks, the elevated levels of potassium, well…that’s still under review. Perhaps by the exact same people who approved this drug in the first place?

Greenberg and Bederman is a Washington, D.C. area law firm that is currently offering legal help for women who have been injured due to the use of Yaz, Yasmin or Oscella. If you or a loved one has been injured or hospitalized due to the use of these birth control pills, contact our yaz stroke lawyer, Andy Bederman, for a free yaz legal consultation.
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Yaz or Yasmin Birth Control Side Effects

Posted on October 22, 2009 by Greenberg & Bederman

 Yaz birth control side effects

Whenever you think about birth control side effects, what comes to mind?

A little bit of weight gain? A minor swelling of the breasts, or maybe breast soreness? A lightening of the period, or spotting between periods? An occasional mood swing?

These are the sorts of birth control side effects that have occurred on a pretty regular basis since the birth control pill was placed on the market. Most women and medical professionals view these issues as more of a nuisance than a detriment. And quite often, even if they do occur, the benefits of the pill seem to far outweigh the negative aspects.

But there are other side effects to the pill that don’t even belong under that category. While breast soreness and weight gain can fall under the category of “birth control side effects,” strokes, heart attacks and pulmonary embolisms certainly can’t. These injuries can at the very least be considered “birth control complications,” but if the pharmaceutical industry were to be honest, they would call them “birth control dangers.”

After all, there is a big difference between coping with gaining five pounds and learning how to live your life after a massive stroke from a birth control with severe adverse side effects. And while weight gain or other minor inconveniences are far more likely than stroke, heart attacks or pulmonary embolisms with standard, run of the mill birth control pills, the odds of a “birth control danger” happening to users of a line of birth control pills manufactured by Bayer are much higher.

The birth control pills in question go under the names “Yaz,” “Yasmin” and “Oscella.” These pills were marketed by Bayer as not only birth control pills, but also as “lifestyle choices.” The pills were sold in flashy, chic advertising campaigns that showed successful women in expensive clubs and seemingly prestigious universities touting the big differences that these pills have made to their lives.

These birth control pills were marketed as a cure for acne, and as a cure for PMS, PMDD and mood swings. It was even marketed as a “light dose” pill, which gives one the impression that you could take it without having to worry about those minor “birth control side effects” that we mentioned earlier. And while that might be the case, we are quite sure that any user of Yaz, Yasmin or Oscella would choose breast soreness over a pulmonary embolism any day of the week.

 

What makes Bayer’s line of birth contyrol pills yaz, yasmin, and ocella,more dangerous is the use of a synthetic variation of progestin called drispirenone. This variation is what is supposed to bring with it “freedom” from acne, PMS, etc. But what drispirenone is also apparently doing is raising the potassium levels in the bloodstream of women how have been taking Yaz, Yasmin or Oscella. This is not a harmless development. High potassium levels in the blood add to an already existing risk of blood clotting, which can and does lead to strokes, heart attacks and pulmonary embolisms. More and more women are coming forward with their stories of very painful episodes of hospitalization as the result of taking these birth control pills, and there have been some cases that almost defy description.

Consider Susan Galinis. She lives in San Francisco and is the mother of 3 year old twins. Ms. Galinis suffered from fairly severe menstrual pain, so her doctor recommended that she start taking Yaz. Exactly one month and one day after she began to take the pill, she suffered an enormous stroke. The swelling in her brain was so severe that surgeons had to remove a part of her skull.

Ms. Galinis’ stroke is not the sort from which one recovers. In her own words:

"My IQ has plummeted to 77, which I guess is borderline mentally retarded, from the stroke, from the brain damage, that's what they say it is…”

She was in the hospital for six months. She cannot drive and can barely take care of herself, let alone her two children. She has no capacity for short term memory. And according to her own doctors, what caused this catastrophic stroke was the use of Yaz birth control pills. So Ms. Galinis is quite rightly filed a lawsuit against Bayer not only for damages, but also to attempt to take the pills of the market altogether.

Bayer responded with the following:

"Patient safety is our top priority. Bayer's oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used according to the product labeling."

This response implies that Ms. Galinis has nobody to blame for her condition but herself. That she somehow bungled using the pills, or simply didn’t pay attention to any of the warnings. But bear in mind that Bayer themselves did a remarkably poor job warning the public of any complications that may occur. And it should also be noted that there are plenty of women who followed what warning there were to the letter, and still ended up hospitalized or worse from the adverse side effects of these birth control pills.

Greenberg and Bederman is a law firm that is currently offering assistance to women in the Washington, D.C. area who have suffered from serious side effect complications due to being prescribed Yaz, Yasmin or Oscella. If you or a loved one in the District, Northern Virginia, Maryland or Baltimore have suffered an injury or hospitalization due to the use of any of Bayer’s line of birth control pills, including yaz, yasmin, or oscella, contact Greenberg and Bederman for a free yaz injury legal consultation today.

 

 

 

To learn more about yaz side effects, please read our yaz page.  To learn more abour our yaz lawyer, Andy Bederman, please read yaz bio or watch his yaz lawyer video.

 

To learn more about yaz, yasmin, or oscella dangerous side effects, please vist our website and click on the yaz page, or go to our youtube site and watch our yaz attorney video.
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Yaz Side Effects - Lawyer Andy Bederman on Yaz

Posted on October 16, 2009 by Greenberg & Bederman

To learn more about yaz, yasmin, or oscella dangers, please vist our website and click on the yaz page, or go to our youtube site and watch our yaz attorney video.

 

To learn more about yaz side effects, please read our yaz page.  To learn more abour our yaz lawyer, Andy Bederman, please read yaz bio or watch his yaz lawyer video.

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Yaz and Yasmin Should be Recalled?

Posted on September 29, 2009 by Greenberg & Bederman

 Yaz Stroke Lawyers MD, DC, VA

One of the biggest selling products of the pharmaceutical company Bayer are a line of birth control pills that go by the names of Yaz and Yasmin. Key elements of the marketing strategy of these pills are what could be billed as peripheral benefits. Aside from the obvious purpose of the pill (avoiding pregnancy,) Bayer is also claiming that the pill helps prevent acne, and even helps users deal with some of the more emotionally charged aspects of the menstrual cycle:

“Can the pill be good for you? Can you feel OK when you're on it? Is it doing anything positive for you besides preventing an unwanted pregnancy? The answer to all these questions is yes! Discover it for yourself.”

If Yaz and Yasmine worked perfectly and had no potentially dangerous side effects, then we would have no problems whatsoever with Bayer touting these other aspects of the pill. But the fact is that there have been some quite serious allegations of very real danger to the users of these pills, and ignoring these while touting other minor aspects of the products to increase the customer base strikes us as the height of irresponsibility.

It also strikes us as very sadly familiar. There is a long history of corporate irresponsibility when it comes to women and birth control, and the Yaz line of pills are simply the latest examples.

In the early 1970’s, a company named A.H. Robbins began an aggressive marketing campaign for a new product called the Dalkon Shield. The Shield was an intra-uterine device (IUD) that was presented as the safest and most effective way for women to avoid getting pregnant. There wasn’t a pill that you had to take every day. There wasn’t anything that you had to remember to do. In fact, the strongest marketing aspect for this device was that a woman could simply have it inserted and then could practically forget it was there.

 

That’s what A.H. Robbins said, anyway. What was not mentioned in the marketing campaign was that this device was, like many pharmaceutical products before and since, tested in a rushed and slipshod manner and put on the market before they realized that something was going very, very wrong. The only real test that was performed on the Shield was one that determined whether or not it prevented pregnancy. Any other side effects were not considered or tested for.

The Dalkon Shield caused severe pelvic infections in over 200,000 American women, with the worst cases resulting in infertility and even death. What made the episode even more shameful was that A.H. Robbins fought tooth and nail for each and every case that was filed against them for damages, to the point that it was close to twenty years before any victims or their families received any compensation.

The Dalkon Shield is considered a watershed case because it caused both government agencies and manufacturers of pharmaceuticals and medical devices to seriously overhaul the way that they tested and marketed their products. As a result of this infamous IUD, products involving the reproductive functions of women have improved dramatically with regards to safety.

But as much as birth control products and devices have improved, there are still very real dangers involved in some of the products out there. In 2002, Johnson and Johnson released the Ortho Evra Birth Control Patch, which is a transdermal device that is meant to be worn for a week at a time. While both the patch and standard birth control pills work the same way (using the hormones progestin and estrogen to prevent eggs from being released from the ovaries for fertilization,) the main difference is that the hormones in pills are filtered and diluted through the digestive system, while the hormones in the patch are administered through the skin directly to the bloodstream. As a result, your average patch user is carrying 60% more estrogen in her bloodstream than the average user of a pill.

The problem here is that heightened levels of estrogen in the blood stream can lead to thromboembolism, which is the formation of blood clots in the legs. Blood clots can and will travel throughout the bloodstream, where they can end up in the lungs or the heart.

The first high profile victim of a pulmonary embolism was a perfectly healthy 18 year old girl named Zakiya Kennedy, who collapsed on a subway platform in Manhattan and died on the way to the hospital in April of 2004. Johnson and Johnson’s response was to deny everything, despite the fact that a CBS News story revealed that:

“…the company's own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.”

What followed was the inevitable incredibly lengthy bureaucratic ping pong match between Johnson and Johnson and the FDA, in which the FDA made the suggestion that perhaps Johnson and Johnson should include the dangers of blood clotting on the label, and Johnson and Johnson was given a lengthy opportunity to explain why they didn’t think it was necessary, and the FDA took a very long time to consider Johnson and Johnson’s explanations, all while more than a few of the users of this patch were not only suffering from serious adverse effects, but were also quietly receiving cash settlements, as reported in The New York Post in April of 2006:

"Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson & Johnson, has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending."

Finally, in January of 2008, the FDA ordered Johnson and Johnson to mention prominently the potential dangers of using this product. But all this really did was provide Johnson and Johnson with the opportunity to say to anyone who got hurt “Look, we told you this might happen. The warning is right there on the box.” The Ortho Evra birth control patch is still available for sale to this day.

You would think that with such a high profile product failure to use as an example, other pharmaceutical companies would stay well away from any sort of birth control that utilizes elevated levels of hormones and their accompanying dangers of blood clots, but Bayer apparently had no compunction whatsoever.

Which brings us to the Yaz line of birth control pills.

The culprit here is a variation on progestin called drospirenone, which is not used by any other birth control pill on the market. And again, we seem to be having the same problems with clotting that we had with the birth control patch, along with a host of others, including kidney failure, strokes, heart attacks, and, unfortunately, deaths:

“Over 50 reports of Yasmin or Yaz deaths were received by the FDA between the first quarter of 2004 and the third quarter of 2008, according to some of the complaints filed in the United States. The deaths involved women as young as 17 and included cardiac arrests, pulmonary embolisms and strokes, with elevated levels of potassium in the blood frequently reported.”

We would like to make the suggestion that perhaps simply making a bigger and bolder label on the box is not the solution here. While it is true that the percentage of Yaz users who suffer severe injuries is comparatively small, we have to wonder what sort of twisted arithmetic is going on over at Bayer when they can consider even a few of their customers dying or suffering from strokes as an acceptable outcome. Under no circumstances should any product be on the market where regular use has the potential to kill you, no matter how remote the outcome.

Recent studies published in the British Medical Journal reveal that women who use Yaz™ or Yasmin™ oral contraceptives are more than twice as likely to suffer serious health complications than women using other oral contraceptives. Yaz™ and Yasmin™ have been linked with the following serious health complications:

    • heart attack
    • stroke
    • organ failure
    • gall bladder disease
    • blood clots/deep vein thrombosis
    • pulmonary embolism

 

Greenberg and Bederman is currently accepting clients who have suffered serious adverse affects from the use of either Yaz or Yasmin birth control pills. If you or a loved one have suffered from the use of Yaz or Yasmin contact Greenberg and Bederman for a free legal consultation today from a Yaz or Yasmin lawyer.

 

To learn more about yaz, yasmin, or oscella dangers, please vist our website and click on the yaz page, or go to our youtube site and watch our yaz attorney video.

To learn more about yaz side effects, please read our yaz page.  To learn more abour our yaz lawyer, Andy Bederman, please read yaz bio or watch his yaz lawyer video.

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