Posts Tagged ‘ Yaz lawsuit ’

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 | No Comments »

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 »