Posts Tagged ‘ Yasmin ’

Yaz Scandal? Doc’s Accusations v. Bayer Unsealed, Revealed

December 7th, 2011. By AbiK

Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.

Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.

What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).

According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”

Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.

That was the draft version.

The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”

Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.

According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.

The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.

Is a new warning label in the offing? Stay tuned.

Tags: Adverse Events, Bayer, Dr David Kessler, Drospirenone, DVT, FDA, VTE, Warning Label, Yasmin, Yaz, Yaz lawsuit, Yaz side effects
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | 9166No Comments »2011-12-07+15%3A13%3A50AbiK

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 | 5342No Comments »2010-10-26+17%3A42%3A00Mass+Tort+Muser

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

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 | 3596No Comments »2010-05-12+16%3A58%3A29Kristine+B

The Pill Turns 50 But Many Women aren’t Celebrating

May 7th, 2010. By janem

pill The Pill Turns 50 But Many Women arent Celebrating 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 | 3549No Comments »2010-05-07+18%3A34%3A22janem

Yaz, Yasmin Russian Roulette?

February 8th, 2010. By LucyC

roulette Yaz, Yasmin Russian Roulette? 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 | 26691 Comment »Yaz%2C+Yasmin+Russian+Roulette%3F2010-02-08+22%3A15%3A16LucyC