Posts Tagged ‘ Yaz ’

The Mass Tort Muser Ponders Yaz Lawsuits

October 26th, 2010. By Mass Tort Muser

Yaz (and its sib, Yasmin) has been under fire over the past couple of years. Hell hath no fury, right? And there are definitely some women out there feeling a bit scorned by big pharma on this one…

But talk about the pendulum swinging back in the opposite direction. It wasn’t all that long ago that we (women, that is) were ecstatic that finally, yes finally, there was a mere pill—such a teeny tiny helper!—that could save us from unwanted pregnancy and that God-forsaken monthly interruption—cramps and all. (Insert a “Right-on!” shout-out to Ms. Steinem, women’s lib and a few burnt bras…).

Fast-forward almost forty years…and the pill delivers zit relief, too—our cup runneth over! Breakout banisher is basically how Yaz positioned itself on center stage of the contraception market—and how it netted not only a whole new generation of pretty young things as groupies but also a wrist-slap from the FDA. Seems telling women about how clear their skin would be without telling them about potential little side effects like deep vein thrombosis or perhaps the need for gallbladder surgery wasn’t such a slick marketing move. At least they didn’t try to get shelf space next to Clearasil.

But you know all that. And here’s where the musing and pondering kick in…

Given what’s been going on with Yaz, you may be wondering why on earth there isn’t some big brouhaha going on—you know, one of those class actions. It seems whenever there’s a product—be it a lawnmower, Expedia.com’s hotel reservations, or Similac baby formula—that doesn’t do what it says it will do or causes undo harm, there’s a class action. So, what’s up with Yaz? Where the heck is my “opt in” claim form? Was I not invited?!?

Let’s look at how some of the details rack up: indeed, lots of women allege to have been harmed by Yaz—enough perhaps to even be considered a “class” or at least a sizeable cocktail party. And possible Yaz side effects are numerous—and not just your run of the mill “honey I’ve got a headache gonna lie down” type. No, these are biggies: gallbladder problems, deep vein thrombosis, pulmonary embolism, heart attack, stroke… Keep in mind, too, the women getting Yaz prescriptions filled are, obviously, within child-bearing age, so they’re younger—not the typical age-range for heart attack or stroke, for example.

So why not a Yaz class action? Why not a little “you may be part of a Yaz lawsuit” postcard in the mailbox or a full-page ad of legalese in People magazine? The answer is because Read the rest of this entry »

Tags: Mass Tort, Ocella, Yasmin, Yaz, Yaz lawsuit
Posted in Defective Products, Drugs/Medical, Emerging Issues, Personal Injury | No Comments »

Yaz by the Numbers: the Warning, the Recall, the Profit, the Lawsuits

May 12th, 2010. By Kristine B

As Bayer adds new warnings to its birth control pills in the wake of lawsuits regarding Yaz and Yasmin, we thought it would be a good idea to break Yasmin and Yaz down by the numbers. 

2001: The year Yasmin came on the market

2006: The year Yaz came on the market

2008: The year Bayer (maker of Yasmin and Yaz) received a warning from the FDA about overstating the pills’ effectiveness while minimizing their risks

2008: The year Ocella receives FDA approval; Ocella is the generic version of Yaz that is manufactured by Barr, which is owned by Teva

2009: The year Bayer launches new $20 million ad campaign to address the FDA’s warning

2009: The year the FDA issued a recall on certain lots of Yaz and Ocella for “Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.”

2010: The year Bayer added new warnings about the risks of blood clots linked to Yasmin and Yaz

1,100: Approximate number of lawsuits filed against Bayer regarding Yasmin and Yaz

$1.64 billion: Approximate profit Bayer reportedly made from Yasmin and Yaz during 2009

993: Number of reports the FDA received by November, 2009, of cases of pulmonary embolism linked to Yaz or Yasmin

487: Number of reports the FDA received of deep vein thrombosis

229: Number of reports the FDA received of other blood clots

800: Number of Canadians who have joined class-action lawsuits against Bayer

50: Number of women who reportedly died after taking Yaz, as of July, 2009

6.3: The number of times the risk of developing a blood clot is increased in women who take Yasmin or Yaz, according to a study in the British Medical Journal.

Note: Bayer has defended the birth control pills, saying they are safe and effective.

All stats taken from the FDA.gov, The New York Times, Los Angeles Times, Calgary Herald, BusinessWeek, The Bulletin (Philadelphia) and WISH tv, in addition to the British Medical Journal.

Tags: Birth Control, Contraceptive, Ocella, Yasmin, Yaz
Posted in Drugs/Medical | No Comments »

The Pill Turns 50 But Many Women aren’t Celebrating

May 7th, 2010. By janem

This week marks the 50^th anniversary of the birth control pill. We’ve come a long way baby! But some things haven’t changed: Even 35 years ago women were complaining about side effects, including blood clots.  Back in 1960, the pill was marketed as 100 percent safe, it would liberate women and it would even prevent divorce. Well, Bayer is still lying about its birth control pills Yasmin and Yaz, saying it is as safe as other oral contraceptives.

A few events regarding the pill have been announced this past month. On April 9, 2010 Bayer HealthCare Pharmaceuticals announced it would update its Yaz and Yasmin labels with a stronger warning, which has already happened in Europe. And Bayer has a dirty little secret: Did you know that 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product was recalled? You won’t find that recall on its website and you have to dig deep to find it on the FDA recall list.

TIME magazine featured an article on the pill this month. Here is an excerpt:

“In 1954, John Rock, the doctor who was leading the research on the pill, expressed the breathless excitement shared by many of his colleagues: An oral contraceptive, he said, “would be the greatest aid ever discovered to the happiness and security of individual families – indeed, to mankind” because “the greatest menace to world peace and decent standards of life today is not atomic energy but sexual energy.”

Regarding pregnancy, the article says that ” 63 percent say they know little or nothing about Read the rest of this entry »

Tags: bayer-natazia-oral-contraceptive-adverse-events, Birth Control, Contraceptive, FDA, The Pill, Yasmin, Yaz
Posted in Drugs/Medical, Emerging Issues | No Comments »

Yaz, Yasmin Russian Roulette?

February 8th, 2010. By LucyC

No matter how frequently or strongly Bayer Healthcare Corp declares their oral contraceptives Yaz and Yasmin to be safe and effective—as long as they’re used according to the product labeling—it’s not preventing women from filing lawsuits against the pharmaceutical giant.

I read a news report recently that stated some 50 women in Indianapolis have filed Yaz/Yasmin lawsuits alleging their use of the contraceptive resulted in their experiencing blood clots and pulmonary embolisms in their lungs and legs, and apparently several of the women required surgery to remove their gallbladders. How did that happen, you ask? Because Yas/Yasmin—among its lengthy list of ‘side effects’ which include pancreatitis, liver and kidney failure, rapid heartbeat and arrhythmias—can also cause gall bladder disease.

What I want to know is how you avoid these serious adverse events—let’s call a spade a spade—if you take the pill according to the product labeling? How does that work? Your doctor prescribes the contraceptive presumably in the knowledge that you are a suitable candidate to take it—meaning you don’t have one of the many conditions that would preclude you from taking it including a history of heart, liver or kidney disease, and you’re not a pack-a-day gal, but you still end up in the hospital having suffered a stroke or embolism. How could you have avoided that?

Also, and this may be a fine point, if the contraceptive is known to be associated with serious adverse events—just what exactly can you do to avoid developing them?

It sounds like a game of Russian Roulette to me. Maybe you’ll develop a blood clot—maybe you won’t—no way to tell really—but take a chance anyway. Worst case scenario, there are treatments, if you don’t die—right?

In a recent newspaper report, Kimberly A. Johnson developed numerous blood clots in both her lungs, which has resulted in her taking blood thinners, which are no picnic, for the last two years. She is a 37-old mother of two. The only sign she had that something was wrong, apparently, was a severe shortness of breath—which was worse at night. She told the Indystar.com in an interview that she felt like she was having a heart attack when she lay down at night. Kimberly had only been taking the contraceptive for three months. “I thought I was going to die,” she said in her interview. I’m betting if she knew how to avoid that situation she would have.

To add insult to injury Yas/Yasmin were marketed as providing health benefits. (If it sounds like snake oil…) In 2008, the FDA actually ordered Bayer to run ads correcting an earlier advertising campaign that claimed (a bit too far) that Yas/Yasmin provided health benefits. That cost them $20 million. Although the spate of Yas/Yasmin lawsuits will likely cost Bayer a good deal more, it will not be as much as it’s already cost women like Kimberly. 

Tags: Birth Control, Yasmin, Yaz
Posted in Drugs/Medical | 1 Comment »

Did Yasmin Clinical Trials Lack Female Researchers?

December 27th, 2009. By janem

Historically, clinical trials have studied more males than females, and researchers–for several reasons–test mostly or exclusively men. The Yasmin manufacturer says the effectiveness and safety of Yasmin was established in large-scale clinical trials: it involved 2,629 women. This number may seem substantial, but Viagra was given to over 3,000 men (of course) during its clinical trials and the statin Lipitor (prescribed for both sexes) involved 16,066 patients!

Biomedical scientists and researchers have preferred studying male subjects for a number of reasons including:

• The outdated belief that women were just little men and that the only difference was in reproductive organs;
• Perceived costs and complexity of recruitment and inclusion of women in clinical trials;
• The desire both to protect a woman’s potential fetus (regardless of whether she is pregnant, uses contraceptives, or intendsto conceive) and to avoid legal liability from prenatal exposure.
• The potentially confounding effects of women’s hormonal changes.

Clearly, a drug that is taken daily by millions of women-such as Yasmin and Yaz-needs more exhaustive clinical trials. Perhaps the (predominantly male) researchers are biased: they won’t ever take a birth control pill but they might use Viagra or a cholesterol-lowering drug like Lipitor or Crestor, the most widely prescribed medications in the world.

In the recently published book The Push to Prescribe, the authors make it clear that the under-representation–or even complete lack–of women in pharmaceutical research is one reason why women should research a drug such as Yasmin beforehand, even though they trust their doctors.

“Women are at the brunt of bad prescribing practices,” says Alan Cassels, a drug policy researcher. “Historically, it goes back to the birth control pill…Women are the leading consumers of health products, not just for themselves but for their husbands and kids as well.”

The Push to Prescribe also points out that adverse reactions to drugs are a major issue of particular interest to women. The number of people exposed to drugs is much more once it has been approved, meaning that experiences other than those observed in clinical trials are likely to occur after a drug is on the market.

Tags: Yasmin, yasmin clinical trials, Yaz
Posted in Drugs/Medical | No Comments »