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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