Earlier this week a new lawsuit was filed in Illinois State Court against Bayer and related entities alleging that Yaz caused a pulmonary embolism. This is the latest in a flurry of lawsuits that have been filed against the makers and distributors of Yaz, Yasmin and Ocella for serious side effects including blood clots, pulmonary embolism, stroke, deep vein thrombosis, gallbladder removal and other organ failures.
Other lawsuits have been filed in Pennsylvania and California state courts. In addition to the state court lawsuits, a number of lawsuits have been filed in federal courts around the country. As we mentioned earlier in this blog, plaintiffs have petitioned the Judicial Panel on Multidistrict Litigation to have the Yaz, Yasmin and Ocella federal lawsuits consolidated in a Multidistrict litigation (MDL). A hearing on that motion is set for September 24, 2009.
The Allen Law Firm will be filing suit on behalf of its Yaz, Yasmin and Ocella clients. If you or a loved one has been injured from taking one of these birth control pills, contact one of our attorneys for a free consultation.
Thursday, August 27, 2009
Yaz, Yasmin and Ocella linked to Gallbladder diseases and Gallstones
Yaz, Yasmin and Ocella have been linked to serious gall bladder problems including gallstones, infections, inflammation or obstructions.
The gallbladder stores and concentrates bile produced in the liver. The body uses bile to aid in the digestion of fats. If the flow of bile out of the gallbladder is slowed or obstructed, it may lead to gallbladder disease and possibly gallbladder removal.
Symptoms of gall bladder disease include abdominal pain, chest pain, chills, fever, heartburn, nausea and vomiting. In many cases the injuries caused by Yaz, Yasmin or Ocella lead to gallbladder removal surgery.
Lawsuits have been filed against Bayer and related entities by women who have suffered from gallstones, gallbladder disease and gallbladder removal.
If you or a loved one has been diagnosed with gallbladder disease or gallstones or had their gallbladder removed after using Yaz, Yasmin or Ocella, you may be entitled to legal compensation. Contact the Allen Law Firm to speak with an attorney today.
The gallbladder stores and concentrates bile produced in the liver. The body uses bile to aid in the digestion of fats. If the flow of bile out of the gallbladder is slowed or obstructed, it may lead to gallbladder disease and possibly gallbladder removal.
Symptoms of gall bladder disease include abdominal pain, chest pain, chills, fever, heartburn, nausea and vomiting. In many cases the injuries caused by Yaz, Yasmin or Ocella lead to gallbladder removal surgery.
Lawsuits have been filed against Bayer and related entities by women who have suffered from gallstones, gallbladder disease and gallbladder removal.
If you or a loved one has been diagnosed with gallbladder disease or gallstones or had their gallbladder removed after using Yaz, Yasmin or Ocella, you may be entitled to legal compensation. Contact the Allen Law Firm to speak with an attorney today.
Monday, August 17, 2009
New Article Questions Safety of Yasmin and Yaz
An article published August 13, 2009, questions the safety of birth control pills, like Yaz and Yasmin, that contain the progestin drospirenone. The article was based on a study completed in the Netherlands. The objective of the study was to assess the thrombotic risk associated with oral contraceptive use with a focus on dose of estrogen and type of progestin.
The authors concluded several things, including:
1. That all currently used oral contraceptives are equally effective in preventing pregnancy;
2. No major differences were found between oral contraceptives containing drospirenone and others containing levonorgestrel with regard to weight gain;
3. The effectiveness of alleviation of premenstrual symptoms by oral contraceptives containing drospirenone compared with other contraceptives or placebos has not been demonstrated; and
4. Available evidence suggests that for acne or weight gain there is no clear difference between most commonly used oral contraceptives.
Based on these findings, the authors advocated for the use of oral contraceptives with the smallest increase in side effects, such as risk of venous thrombosis. According to these authors, the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen.
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, A van Hylckama Vlieg, F M Helmerhorst, JP Vandenbroucke, C J M Doggen, F R Rosendaal, BMJ 2009;339:b2921.
The authors concluded several things, including:
1. That all currently used oral contraceptives are equally effective in preventing pregnancy;
2. No major differences were found between oral contraceptives containing drospirenone and others containing levonorgestrel with regard to weight gain;
3. The effectiveness of alleviation of premenstrual symptoms by oral contraceptives containing drospirenone compared with other contraceptives or placebos has not been demonstrated; and
4. Available evidence suggests that for acne or weight gain there is no clear difference between most commonly used oral contraceptives.
Based on these findings, the authors advocated for the use of oral contraceptives with the smallest increase in side effects, such as risk of venous thrombosis. According to these authors, the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen.
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, A van Hylckama Vlieg, F M Helmerhorst, JP Vandenbroucke, C J M Doggen, F R Rosendaal, BMJ 2009;339:b2921.
Monday, August 10, 2009
Would Hundreds of Women Have Been Saved by Legislation Limiting Direct-To-Consumer Advertising?
On the heels of the FDA's admonishment of Bayer Corporation regarding it's Yaz commercials, a handful of legislators are trying to limit direct-to-consumer advertising for pharmaceuticals. As I have discussed in previous posts, the FDA has taken an unusually harsh stance against Bayer's Yaz marketing resulting in Bayer agreeing to spend $20 million to correct its misleading ads. The problem with this corrective action is that the damage to hundreds, if not thousands of women, is already done. That's one reason legislators are seeking to limit direct-to-consumer advertising.
For instance, Representative Harry Waxman, Democrat of California, favors legislation that gives the FDA the power to bar direct-to-consumer advertising for new drugs for a period of time. Under this scenario, the FDA could limit advertising on new drugs for an initial period after approval. During that initial period following FDA approval, there will be more real world experience with the drugs, and the reasoning goes that drugs' warning labels can be modified to address any serious side effects that occur during that time.
Legislation like that suggested by Rep. Waxman may very well have saved many women from life-altering injuries following their use of Yaz and Yasmin. If you, or a loved one suffered serious injuries after using Yaz or Yasmin, I encourage you to contact your representative to show your support for limits on direct-to-consumer advertising of pharmaceuticals.
For instance, Representative Harry Waxman, Democrat of California, favors legislation that gives the FDA the power to bar direct-to-consumer advertising for new drugs for a period of time. Under this scenario, the FDA could limit advertising on new drugs for an initial period after approval. During that initial period following FDA approval, there will be more real world experience with the drugs, and the reasoning goes that drugs' warning labels can be modified to address any serious side effects that occur during that time.
Legislation like that suggested by Rep. Waxman may very well have saved many women from life-altering injuries following their use of Yaz and Yasmin. If you, or a loved one suffered serious injuries after using Yaz or Yasmin, I encourage you to contact your representative to show your support for limits on direct-to-consumer advertising of pharmaceuticals.
Wednesday, August 5, 2009
Basic facts about Yasmin and Yaz
In order to understand claims being asserted in the lawsuits against Bayer, as the manufacturer of Yaz and Yasmin, it is important to know a little more about the drugs themselves. The following is some basic information about Yasmin and Yaz and the harmful side effects they have.
Yasmin and Yaz are combination birth control pills that contain drospirenone and ethinyl estradiol. Yasmin, approved by the FDA in April 2001 and originally developed by Berlex Laboratories, Inc., contains 3mg of drosperinone and 0.03 mg of ethinyl estradiol per tablet. Yaz, approved by the FDA in 2006 and marketed by Bayer Corporation, contains 3mg of drospirenone and 0.02mg of ethinyl estradiol. Both pills are considered "fourth generation" oral contraceptives because of their use of the progestin, drospirenone. Drospirenone (DRSP) is not used in other combination oral contraceptives on the market in the United States.
The use of Yaz or Yasmin is said to have a prothombotic effect which can result in pulmonary embolism, stroke or DVT. Thrombosis is the formation or presence of a blood clot (thrombus) in a blood vessel. If the thrombus breaks loose and travels through the bloodstream, it is a thromboembolism. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.
Experts believe the reason Yaz and Yasmin have a prothombotic effect is because drospirenone is a diuretic which can cause an increase in potassium. Unsafe levels of potassium in the blood, also known as hyperkalemia, can disrupt heart rhythms and slow the flow of blood. This can lead to blood clotting.
As early as April 2002, Yasmin was linked to venous thrombosis by the Dutch College of General Practitioners who recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin. And about a year later, Yasmin was linked to thromboembolism in a paper published in the British Medical Journal.
Yaz and Yasmin have also been linked to serious gallbladder damage. Because you use water due to the drosperinone's diuretic effect, you develop sludge or bile that injures the gallbladder. Numerous users of the pills have suffered gallbladder removal or sudden death.
Between 2004 and 2008, over 50 deaths of Yaz and Yasmin users were reported to the FDA. In addition, the number of adverse event reports made to the FDA by users of Yaz and Yasmin appear to disproportionately higher than reports for other birth control pills.
If you have taken Yaz or Yasmin and suffered a serious injury, we'd like to hear from you. Please feel free to post your comments to our blog or contact us here.
Yasmin and Yaz are combination birth control pills that contain drospirenone and ethinyl estradiol. Yasmin, approved by the FDA in April 2001 and originally developed by Berlex Laboratories, Inc., contains 3mg of drosperinone and 0.03 mg of ethinyl estradiol per tablet. Yaz, approved by the FDA in 2006 and marketed by Bayer Corporation, contains 3mg of drospirenone and 0.02mg of ethinyl estradiol. Both pills are considered "fourth generation" oral contraceptives because of their use of the progestin, drospirenone. Drospirenone (DRSP) is not used in other combination oral contraceptives on the market in the United States.
The use of Yaz or Yasmin is said to have a prothombotic effect which can result in pulmonary embolism, stroke or DVT. Thrombosis is the formation or presence of a blood clot (thrombus) in a blood vessel. If the thrombus breaks loose and travels through the bloodstream, it is a thromboembolism. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.
Experts believe the reason Yaz and Yasmin have a prothombotic effect is because drospirenone is a diuretic which can cause an increase in potassium. Unsafe levels of potassium in the blood, also known as hyperkalemia, can disrupt heart rhythms and slow the flow of blood. This can lead to blood clotting.
As early as April 2002, Yasmin was linked to venous thrombosis by the Dutch College of General Practitioners who recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin. And about a year later, Yasmin was linked to thromboembolism in a paper published in the British Medical Journal.
Yaz and Yasmin have also been linked to serious gallbladder damage. Because you use water due to the drosperinone's diuretic effect, you develop sludge or bile that injures the gallbladder. Numerous users of the pills have suffered gallbladder removal or sudden death.
Between 2004 and 2008, over 50 deaths of Yaz and Yasmin users were reported to the FDA. In addition, the number of adverse event reports made to the FDA by users of Yaz and Yasmin appear to disproportionately higher than reports for other birth control pills.
If you have taken Yaz or Yasmin and suffered a serious injury, we'd like to hear from you. Please feel free to post your comments to our blog or contact us here.
Monday, August 3, 2009
For Bayer $20 Million Corrective Ad Campaign is Just the Cost of Doing Business
Late last year Bayer Corporation agreed to spend $20 million on an advertising campaign to correct misleading ads for its birth control pill, Yaz. The agreement came after several warnings from the FDA and legal action taken by 27 states.
Yaz, a fourth generation oral contraceptive pill, is aimed at women in their 20s. It's slogan, "Beyond Birth Control", is intended to promote Yaz as a lifestyle drug and not just birth control. The two commercials that necessitated the corrective action depicted fashionably dressed young women and promoted Yaz as a "pill that goes beyond the rest".
One of the commercials, to the song "We're Not Gonna Take It" by Twisted Sister, shows the women kicking or punching away floating signs with labels of "irritability" and "feeling anxious". The other commercial is set to the tune "Goodbye to You" by the Veronicas and shows balloons with the words "acne", "headaches", and "feeling anxious" floating away from women who have presumably taken Yaz.
Both commercials minimize the risk of the drug by presenting the serious risk disclosures by way of voice over while showing distracting visuals, numerous scene changes, and background music. According the FDA, "[t]hese complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed." The FDA goes on to state that this is particularly troubling given the seriousness of the risks being conveyed.
The problem with the ads is that they basically speak to a majority of menstruating women and not to the minority of women who suffer from Premenstrual Dysphoric Disorder (PMDD), the psychological problem for which Yaz is approved, according to Dr. Nada L. Stotland, a professor of psychiatry at Rush Medical Center in Chicago and the president of the American Psychiatric Association. If an individual suffers from the serious psychological disorder PMDD, then the risks of taking Yaz may be worth the drug's benefits in treating their PMDD. However, the Yaz commercials failed to emphasize this point, misleading so many young women about who should take Yaz.
This is not the first time governmental officials have attacked birth control commercials for being misleading. In fact, the FDA sent a warning letter to Berlex Laboratories regarding its ads for Yasmin, the predecessor of Yaz. The FDA faulted the ads for minimizing the risks of Yasmin in much the same way as the 2008 Yaz ads run by Bayer.
For Bayer who saw profits soar in 2008 from about $262 million to about $616 million, the cost to correct the ads is just the cost of doing business and is "chump change" to a company like Bayer according to Bruce L. Lambert, a professor of pharmacy administration at the University of Illinois at Chicago. Professor Lambert doesn't think this type of misleading advertising is likely to stop "unless there are more significant consequences."
Yaz, a fourth generation oral contraceptive pill, is aimed at women in their 20s. It's slogan, "Beyond Birth Control", is intended to promote Yaz as a lifestyle drug and not just birth control. The two commercials that necessitated the corrective action depicted fashionably dressed young women and promoted Yaz as a "pill that goes beyond the rest".
One of the commercials, to the song "We're Not Gonna Take It" by Twisted Sister, shows the women kicking or punching away floating signs with labels of "irritability" and "feeling anxious". The other commercial is set to the tune "Goodbye to You" by the Veronicas and shows balloons with the words "acne", "headaches", and "feeling anxious" floating away from women who have presumably taken Yaz.
Both commercials minimize the risk of the drug by presenting the serious risk disclosures by way of voice over while showing distracting visuals, numerous scene changes, and background music. According the FDA, "[t]hese complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed." The FDA goes on to state that this is particularly troubling given the seriousness of the risks being conveyed.
The problem with the ads is that they basically speak to a majority of menstruating women and not to the minority of women who suffer from Premenstrual Dysphoric Disorder (PMDD), the psychological problem for which Yaz is approved, according to Dr. Nada L. Stotland, a professor of psychiatry at Rush Medical Center in Chicago and the president of the American Psychiatric Association. If an individual suffers from the serious psychological disorder PMDD, then the risks of taking Yaz may be worth the drug's benefits in treating their PMDD. However, the Yaz commercials failed to emphasize this point, misleading so many young women about who should take Yaz.
This is not the first time governmental officials have attacked birth control commercials for being misleading. In fact, the FDA sent a warning letter to Berlex Laboratories regarding its ads for Yasmin, the predecessor of Yaz. The FDA faulted the ads for minimizing the risks of Yasmin in much the same way as the 2008 Yaz ads run by Bayer.
For Bayer who saw profits soar in 2008 from about $262 million to about $616 million, the cost to correct the ads is just the cost of doing business and is "chump change" to a company like Bayer according to Bruce L. Lambert, a professor of pharmacy administration at the University of Illinois at Chicago. Professor Lambert doesn't think this type of misleading advertising is likely to stop "unless there are more significant consequences."
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