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

The writers obviously took exception to this. They had an issue with not being compensated for this huge new revenue stream, and they also took issue with episodes from older shows being made available (with advertising,) yet no compensation was offered to the writers who wrote those shows. For their part, the networks argued that this was the internet, which was “different,” and anyway, they weren’t being paid to write for the internet. They were being paid to write for television.  

Both sides eventually came to agreement on various points, and everybody went back to work. But what is remarkable about this situation was how the TV networks took it for granted that a minor change in medium (watching shows on the internet vs. watching shows on television) gave them a sudden exemption from long established rules.

This same sort of scenario has happened quite recently with big pharmaceutical companies, who thought that a change in medium (social networking sites) would allow them to skirt the rules that are in place regarding the advertising and marketing of pharmaceutical drugs:

The U.S. Food and Drug Administration (FDA) says that a Facebook Share button that Novartis Pharmaceuticals used to promote a cancer-fighting drug violated its requirements to disclose side effects or risks about such medications. The agency sent a letter to the company telling it that its promotion of Tasigna was "incomplete and misleading" - probably the first time FDA has issued a warning about using Facebook, according to Jeffrey Chester, a privacy advocate and executive director of the Center for Digital Democracy.

These share buttons are ubiquitous features on social media sites like Facebook. They essentially allow you to run your very own viral marketing scheme with anything you want. If you like a television show or a band or a brand of cheeseburger, you can create a “share” button declaring your liking of this product, which then let’s all of your friends know that you approve of…whatever it is. Your friends can then choose to share it on their pages, which will then be shown to all their friends, and so on and so on.

The problem is that the share button that Novartis created for its cancer fighting drug Tasigna was a clear violation of Food and Drug Administration marketing rules. When activated, the share button would post the following link and text:

• CML (Chronic Myeloid Leukemia)Treatment – Find out if Tasigna is Right for You | Tasigna (nilotinib)
  www.us.tasigna.com
  Tasigna (nilotinib) 200-mg capsules from Novartis is a next-generation treatment for Ph+ Chronic Myeloid Leukemia in adult patients in chronic or accelerated phase who are resistant to Gleevec.

This might not seem like a big deal, but what this Tasigna widget fails to do is list the potential dangers and side effects, which are considerable:

· feeling like you might pass out, fast or pounding heartbeat, seizure (convulsions);

· pale skin, weakness, feeling light-headed, rapid heart rate, trouble concentrating;

· easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· feeling short of breath, even with mild exertion;

· swelling, rapid weight gain;

· sudden headache, confusion, or problems with vision;

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· severe pain in your upper stomach spreading to your back; or

·cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

The Food and Drug Administration requires that any drug advertising or marketing information contains a list of side effects, which is why pharmaceutical companies often have to buy two pages in a magazine instead of one. You will notice that on the share button, Novartis mentioned none of these things.

There have been multiple instances of drug companies attempting to skirt federal regulations on advertising and marketing, and this is only the latest. Bayer was recently required to redo a whole marketing campaign over their line of birth control pills. The initial campaign made the claim that Yaz cured acne and prevented PMS, when in fact it did none of those things. But by the time the FDA finally acted and made Bayer change the advertising, Yaz, Yasmin and Ocella were all firmly entrenched in the minds of American women as the go-to choice for birth control pills, despite the fact that these pills have been shown to lead to strokes, heart attacks and pulmonary embolisms in otherwise perfectly healthy women.

Perhaps these pharmaceutical companies believe that any financial slaps on the wrist that they receive from the FDA for sneaking around marketing regulations are a small price to pay for the enormous amounts of money that they can make in sales.

Greenberg and Bederman is a personal injury law firm located in the Washington, D.C. area. We are currently offering legal help to those who have been injured by Yaz, Yasmin, Ocella, Avandia, and other dangerous pharmaceutical drugs. If you or a loved one in Maryland, Virginia or Washington, D.C. have been hurt or hospitalized due to side effects of pharmaceutical drugs, contact Greenberg and Bederman for a free legal consultation today.

These incidents led to studies by Swissmedic, which is the Swiss equivalent of the FDA, and by the British Medical Journal. Both of these studies concluded that women who use oral contraceptives with drospirenone experience a higher rate of blood clots than women who use other forms of hormone based oral contraceptives. Since Yaz, Yasmin and Ocella are the only pills that actually use drospirenone, it went without saying that the study was about these three birth control pills.  In its public relations defense, Bayer simply appropriated a line in both studies in which it was implied that the clotting side effects were “similar to those in other birth control pills,” but they neglected to mention that both the studies said that the risks were not only similar, but significantly higher as well.

As of last July (which was about the time that these birth control pills started to come under scrutiny,) the number of women worldwide who died as the result of complications from clotting (strokes, heart attacks or pulmonary embolisms) stood at around fifty. There have also been thousands of cases of non-fatal pulmonary embolisms, strokes and heart attacks, as well as some cases of gall bladder disease. Bayer hasn’t been forthcoming with the numbers  regarding deaths or injuries, but since they have not stopped marketing or selling these drugs, we have to assume that the numbers have only gone up.

As a result of all of these injuries and deaths, Bayer is facing an increasing number of lawsuits.  So far, there have been approximately 1,100 separate instances of litigation against Bayer over injuries and deaths that have occurred among users of Yaz and Yasmin.  All of the cases that have been filed in Federal court have been consolidated under multi district litigation so that there is consistency in pretrial discovery. To learn about Yaz lawsuits, read our article called “Understanding Yaz Class Action Lawsuits”.

The Food and Drug Administration (FDA) has been addressing these concerns at its usual pace, which is maddeningly slow. The closest they have come to even sanctioning Bayer was to force them to re-do their controversial marketing campaign because they believed it to be both misleading and contrary to the FDA approved labeling that Yaz and Yasmin have as part of their packaging. While you can certainly make the argument that the FDA’s actions here were important, they are inadequate  when you think of the things that could be done.

And that’s one of the more frustrating elements of this whole scenario. A pharmaceutical company puts out a product that carries a significantly higher risk of use than any of the similar products on the market, but the pharmaceutical company fails to mention this higher risk in any of its advertising, marketing or labeling. This leads to injuries and deaths due to consumers not being properly informed. And after years of delays the FDA decides to simply allow Bayer to put the following “new label” on Yaz and Yasmin:

WASHINGTON - Bayer HealthCare said Friday it has added new information about the risks of blood clots to its contraceptive pills Yaz and Yasmin. In cooperation with the Food and Drug Administration, the company said it added new labeling stating that the risks of blood clots with Yaz and Yasmin are similar to those with other oral contraceptives. The statements are based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K.

What this means is that Bayer is simply saying that Yaz and Yasmin are risky, but so is every other birth control pill on the market. This is incredibly disingenuous. What should be on the label is the truth, which is that Yaz and Yasmin are significantly more dangerous than any other form of oral contraceptive.

We fail to understand why the FDA would crack down on Bayer for misleading advertising but not do so on misleading labeling. If two major studies claim that Yaz and Yasmin are more dangerous, then why would the FDA allow Bayer to claim that the pills are no different?

Greenberg and Bederman is currently offering legal help to women in the Washington, D.C. area who have been injured and hospitalized due to complications from Yaz, Yasmin or Ocella. Since the Food and Drug Administration is hesitant to take substantive action, it is up to the victims to take action. By taking your injury case to court, you could not only receive compensation for your injuries and medical bills, but you could also let Bayer know that there are consequences to selling and marketing dangerous products. You could tell them that there are actual people being affected by their decisions, and that there is more to running a business than the balance sheet at the end of the fiscal quarter.

Greenberg and Bederman has been helping injury victims in Maryland, Virginia and Washington, D.C. for twenty five years, and that includes people who have been injured by faulty or dangerous pharmaceutical drugs. If you or a loved one has been injured from taking Yaz or Yasmin,contact our yaz lawyer, Andy Bederman, for a free yaz legal consultation today.

The FDA is currently investigating these pills, which unfortunately is a process that can take months. In the meantime, there have been a slew of lawsuits filed against Bayer all over the United States, so much so to the point that many of them have been consolidated under what is called “multi-district litigation.” To understand multi-district litigation please read our article on Understanding Yaz Class Action Lawsuits. This is when tort cases that are similar in nature are essentially placed under the same ground rules in terms of evidence and witness testimony.

The premise of many of the yaz lawsuits is that not only did Bayer release and aggressively market a drug that is hazardous to women who use it, but that they did so while knowing that the use of dropserinone made it more dangerous than other birth control pills on the market. Many lawsuits are also alleging that Bayer used misleading marketing to increase sales, implying in their advertisements that Yaz could clear up all forms of acne or help women get past the negative emotional experiences of PMS.

And it isn’t just in the United States that these lawsuits are taking place. Our neighbors to the north are experiencing the same problems with Yaz, Yasmin and Ocella. There were 2 million prescriptions of Yaz and Yasmin in Canada in 2009.

In an article on CTV Edmonton, some women who have been taking these birth control pills are experiencing similar if not identical problems. One woman from Nova Scotia experienced a racing heart beat and dizziness after only taking Yaz for a short period of time. After being told by her doctors that she was essentially fine, she suffered what is called a transient ischemic attack, or a “mini stroke.” It left her paralyzed on the left side of her body and she was unable to communicate with anyone for an extended period of time.

Another woman from Halifax switched from Yasmin to Yaz due to some initial discomfort, but after 18 months on the pill she began to experience severe abdominal pains. Upon being examined by doctors, they determined that she had severe gallstones and that her gall bladder would have to be removed. The use of Yaz and gall bladder problems are not unrelated either.

 Bayer is steadfastly denying that they acted inappropriately or even that there is anything wrong with its Yaz birth control pills:

Bayer contends its oral contraceptives "have been and continue to be extensively studied worldwide and are safe and effective when used according to the product labeling."

"Bayer reaffirms and stands behind the safety of its drospirenone-containing oral contraceptives," the company said in a response to CTV News.

As for the lawsuits, Bayer said it is "in the process of gathering information on these cases, but the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours. Bayer will defend itself vigorously against these lawsuits."

The judicial process in Canada is somewhat different from ours, but what we do have in common is that the Canadian courts recognize the rights of citizens to seek damages from those who are responsible for their injuries. We believe that Bayer released and aggressively marketed a pill that is dangerous to women, and that they did so with the knowledge of the risks. As a result of this, women who have been injured or hospitalized due to the use of Yaz, Yasmin or Ocella are entitled to compensation for their medical bills, pain and suffering and lost income.

Greenberg and Bederman is a Washington, D.C. based injury law firm, and we are currently offering legal assistance to women who have been injured due to the use of Bayer’s line of birth control pills. If you or a loved one in Maryland, Virginia or Washington, D.C. has been hospitalized due to the use of Yaz, Yasmin or Ocella, contact Greenberg and Bederman for a free legal consultation today.

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.