Posts Tagged ‘ Yasmin ’
Top 10 Drug Legal News Topics For 2012
December 24th, 2012. By AbiK
LawyersandSettlements.com recently shared its list of the hottest consumer-related pharmaceutical legal news stories during the last year. Of note is that while the top drug-related topic on the legal news website in 2011 had been Tylenol—prompted by concerns over a series of Tylenol recall notices as reported by The New York Times; for 2012, the most sought out pharmaceutical topics have shifted to women’s health.
Third-generation contraceptives such as Yasmin/Yaz, NuvaRing and Mirena top the list this year as numerous birth control lawsuits either settled, or began the process of consolidation into multi-district litigation (MDL).
Reader interest in Yaz/Yasmin rose in response to Yasmin lawsuit settlements that were announced in April (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois, East St. Louis). Bloomberg reported Bayer AG settled about 500 Yasmin lawsuits over claims of blood clots that had, in some cases, led to stroke or heart attack.
Along with Yaz, readers remained concerned about NuvaRing (etonogestrel/ethinyl estradiol) and blood clot risk even as a new study on non-oral hormonal contraception, published in the British Medical Journal (BMJ 2012;344:e2990), was presented at the annual meeting of the American College of Obstetricians and Gynecologists (May, 2012). The study, aimed at quantifying NuvaRing blood clot risk, indicated no significant difference in risk of venous thromboembolism when compared to oral contraceptives.
Still, NuvaRing lawsuits continue and have been consolidated into a federal MDL court in Missouri (In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri). As of September 5, 2012, according to the U.S. Panel on Multidistrict Litigation, more than 1,000 NuvaRing lawsuits have been filed.
Mirena IUD (levonorgestrel) saw an increase in reader interest after August 2012, as Bayer Healthcare Pharmaceuticals, Inc. submitted an Application for Centralized Management of Certain Cases involving Mirena. As FoxNews reported (11/11/12), the request seeks to create a multi-district litigation (MDL) for 16 pending Mirena lawsuits in NJ that allege Mirena caused uterine perforation, infection and hemorrhaging injuries.
After the top three women’s health-related drugs, Pradaxa (dabigatran), an alternative to warfarin, joined the list this year making the Top 5. In November 2012, the FDA issued a Drug Safety Communication regarding Pradaxa bleeding events which in turn helped drive reader interest.
Thousands of LawyersandSettlements.com monthly readers have followed the latest legal news and information on these topics, many of which have fallen from the radar of traditional media outlets.
“We believe these issues are of great importance to the public, mostly due to the life-changing impact they can have on an individual,” said Stephen King, CEO. “Some of our most interesting stories of the year related to pharmaceuticals. Many of them have pending lawsuits or have had substantial settlements related to their life-altering side effects and it’s important to get this information out to the public. While many pharmaceutical companies continue to earn significant profits, people are suffering. They may think they have no recourse but in many cases they do. By keeping these topics alive, LawyersandSettlements.com is helping people stay up-to-date on these important topics every day.”
The LawyersandSettlements.com Top 10 Pharmaceutical Topics of 2012, along with the potential side effects readers were seeking information on, are:
1. Yasmin/YAZ (gall bladder disease, blood clots, deep vein thrombosis, pulmonary embolism)
2. NuvaRing & Mirena (blood clots, infection, perforation of the uterus)
3. Pradaxa (uncontrollable bleeding, lack of an available antidote)
4. Granuflo (elevated bicarbonate levels, risk for metabolic alkalosis)
5. SSRIs (birth defects including heart defects, spina bifida, cleft palate, club foot, PPHN)
6. Actos (bladder cancer, heart failure, kidney failure, rhabdomyolysis)
7. Diethylstilbestrol/DES (cancer)
8. Crestor / Statins (diabetes, cardiomyopathy, rhabdomyolysis)
9. Fosamax (bone fractures, esophageal cancer)
10. Propecia (sexual dysfunction, erectile dysfunction, sterility, prostate cancer)
LawyersandSettlements.com readers are looking for the latest and most comprehensive legal news available. Those seeking legal help can request assistance by completing a form which is then distributed to attorneys specializing in these cases. Over two and a half million people visit the site yearly, and hundreds of thousands of request forms have been submitted by qualified readers looking for legal guidance.
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.
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 »
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.
The Pill Turns 50 But Many Women aren’t Celebrating
May 7th, 2010. By janem
This week marks the 50th 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 »
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