Maryland Injury and Disability Law : Washington DC Metro Injury & Disability Lawyer & Attorney : Greenberg & Bederman : Accidents, Falls, Medical Malpractice : Maryland, DC, Virginia

The FDA had been keeping an eye on this line of drugs, initially for valid reasons but reasons that overlooked the real dangers of the drug. The FDA’s first problem with Yaz was not the clotting dangers of drospirenone, but rather the advertising campaign that Bayer attached to the product. The advertisements inferred that Yaz would help women lose weight, would cure their acne and would cure all the symptoms of PMS. This was a gross overstatement of what Yaz can do for some users. In the first place, it doesn’t help all women lose weight. Some women reported that they lost weight, but some also reported that they simply didn’t gain any weight, while some women reported that they did in fact gain a pound or two. If you ran a survey of practically every woman who was on birth control pills you would probably get the same results.

Secondly, while Yaz provided some relief of severe acne, it didn’t do much for minor to moderate acne. Nor would it “cure” PMS. Instead users who were suffering from Pre-Menstrual Dysphoric Disorder (PMDD) reported experiencing some relief, but it should be mentioned that there is a big difference between PMS and PMDD. It’s the equivalent of the difference between a mild headache and a crippling migraine. It was disingenuous at best for Bayer to advertise that these pills would simply take care of conditions that women find troubling as well as providing them with contraception.

Disingenuous or not, the campaign worked. Yaz became the #1 selling birth control pill in the United States, which became alarming considering the damaging and potentially deadly side effects of this birth control pill. The FDA is finally getting around to considering what to do regarding pills with drospirenone, but in the meantime the product is still on the shelves, and is still being prescribed at an alarming rate.

At Greenberg and Bederman, we have been providing legal counsel for several victims of Yaz, Yasmin or Ocella, and are still offering legal services for women who have been adversely affected by Bayer’s birth control pills. But we are still concerned about this rogue ingredient drospirenone, which Bayer doubled down on in the new pill called Beyaz, and has been picked up by other manufacturers of birth control pills. This includes the brand names Syeda and Loryna, as well as Zarah. We would urge any woman in the D.C. area who has been prescribed these pills to please re-think your prescription and ask for a different method of birth control, preferably one that does not contain drospirenone.

If you or a loved one in Virginia, Maryland or Washington, D.C. has been injured or hospitalized due to injuries suffered from Yaz, Yasmin, Ocella, Syeda, Loryna, Zarah, or any other form of birth control with drospirenone, contact Greenberg & Bederman for a free consultation today.

In all criminal prosecutions, the accused shall enjoy the right to a speedy and public trial, by an impartial jury of the State and district wherein the crime shall have been committed, which district shall have been previously ascertained by law, and to be informed of the nature and cause of the accusation; to be confronted with the witnesses against him; to have compulsory process for obtaining witnesses in his favor, and to have the Assistance of Counsel for his defence.

This is a good thing to have if you happen to find yourself accused of a crime, but for those of you who are pursuing a civil remedy to a personal injury or a breach of a contract, there is no real time line for your case to get to court. You will get there eventually. But quite often, it benefits the defense to drag out the process as long as possible.

Here is an example: We have been discussing the serious health problems that have occurred with women who have been using Bayer’s line of birth control pills for about two years now. The issues with Yaz, Yasmin and Ocella have been going on for a lot longer than two years. It has been pretty well established that otherwise healthy women have been hospitalized with pulmonary embolisms, deep vein thrombosis, strokes, heart attacks and gall bladder disease, and the one major thing these women had in common was that they were taking Bayer’s line of birth control pills, each of which contain a synthetic variation of progestin called drospirenone. This ingredient can cause an increase in potassium levels in the bloodstream, which leads to a more active clotting mechanism. Clots form in the bloodstream, and then they start to travel, which leads to blockages in the bloodstream. This is where the pulmonary embolisms, strokes and heart attacks come from. The contention of the majority of these lawsuits is that Bayer failed to adequately research the effects that this new ingredient would have on the women who used their birth control pills.

As we said before, we have been discussing this for over two years now. In fact, we have a few clients who have been injured due to what we believe are these defective yaz birth control pills, and thousands of other women all over the country have filed suit for identical reasons. A few of these cases have finally been scheduled for October of next year:

 “The first trial dates for any Yaz lawsuits, Yasmin lawsuit or Ocella lawsuit pending in New Jersey state court will begin in the fall of 2012, with at least two cases to be selected as test cases out of hundreds of claims pending in the state.”

If this were a criminal case, the delay wouldn’t nearly be this long.

In many respects, defendants in injury cases use this delay to their advantage. The longer it takes for an injury victim to get to court, the more likely it is that this person will either accept a settlement that is much less than they can deserve, or will give up the case entirely.

For instance, let’s say you get hit by a car and have to spend six weeks in the hospital. During these six weeks, you aren’t working. You have no source of income. This does not matter one bit to the utilities, the bank that holds your mortgage, and the credit card companies. They expect to get paid. The insurance company of the driver that hit you has no such financial worries. Ultimately, they have you at a disadvantage, and many insurance companies will offer you much less than you will need to support yourself. If you refuse that offer, they have all the time in the world. They can request delays in the court proceedings, and often do. In the meantime, your financial situation gets more precarious with each passing day. All of a sudden, that initial lowball settlement offer starts to look pretty good.

One of the major problems with the Sixth Amendment is that it does nothing to address the delay that injury victims have to face to get their cases heard. While having an experienced attorney to help you navigate the legal process in your injury claim ensures your rights are protected, there is unfortunately, no such thing as a “speedy trial” for injury victims.

Greenberg and Bederman is a personal injury law firm located in the Washington, D.C. area. We are currently offering legal assistance to those who have been injured due to no fault of their own, and that includes car accidents, medical malpractice, defective drugs, and pedestrian or bicycle accidents. If you or a loved one has been injured due to someone else, contact Greenberg & Bederman for a free consultation.

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.

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.

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.