The Recall Lawyers

In April, forty-three medical products underwent label revisions, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

In addition to Yaz, Yasmin, Beyaz and Tekturna, the following medications have been affected:

• Aceon
• Altace
• Atacand
• Sporanox
• Zortress
• Advicor
• Altoprev
• Amturnide
• Premarin
• TekAmlo
• Tekturna HCT
• Vagifem
• Valturna
• Viracept
• Cimzia
• Krystexxa
• Levaquin
• Levemir
• Neupro
• Nutropin
• Prandimet
• Safyral
• Sutent
• Synagis
• Tarceva
• Victoza 

• Votrient
• Xgeva
• Zegerid

The attorneys of JONES WARD PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you have any questions about one of the above prescription drugs and the ramifications of a drug label change, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Yaz and Yasmin lawsuits are still pending against Bayer, the manufacturer of the two drugs. In addition to failing to warn consumers of the drugs' dangerous side effects, Bayer must be held liable for engaging in extensive off-label promotion of Yaz and Yasmin for unapproved uses.

Drugs are regulated by the FDA based on their intended conditions of use and may not be promoted or marketed for non-approved or 'off-label' uses. It is a drug's 'intended use' that is reviewed and approved by the FDA. Thus, it is not the chemical compound that is approved, but a chemical compound for a specific disease or condition at a specific dose that FDA reviews and approves. 'Off-label' uses are those that the FDA has not determined to be safe or effective, either because the manufacturer did not submit an application requesting approval for such uses, or because the FDA did not approve an application that was submitted in support of such uses.

FDA regulations prohibit drug manufactures from promoting drugs for non-approved uses. All major pharmaceutical manufactures are well aware of these provisions, which have been in force for decades. Nonetheless, Bayer promoted Yaz and Yasmin off-label for unapproved uses. In an effort to increase sales and profits, Bayer induced thousands of women to take these drugs. Increased sales and consumption caused thousands of women to suffer serious injuries and recklessly exposed thousands more to the drugs harmful side effects. Bayer must be held accountable for such flagrant behavior and thus liable for the damages inflicted on innocent women.

Yaz and Yasmin were both FDA approved for the specific indication of oral contraception. Yasmin was approved in May 2001 and has not received FDA approval for any other indication. Yaz was approved for oral contraception in March 2006. In October 2006, Yaz received subsequent approval to treat "Premenstrual Dysphoric Disorder" (PMDD) and approved for "moderate acne vulgaris" in January 2007.

With the approval of Yaz in 2006, Bayer began a huge marketing campaign promoting the two drugs. Despite the limited and specific indications for which Yaz and Yasmin were approved, Bayer's campaign promoted the drugs for 'Premenstrual Syndrome' (PMS), "severe PMS," relief of the physical and emotional symptoms associated with the menstrual cycle, acne and skin benefits.

Neither Yaz nor Yasmin was ever approved for PMS, severe PMS or for relief of the physical and emotional symptoms associated with the menstrual cycle. While Yaz was approved for "moderate acne vulgaris" it was neither approved for acne, nor for general benefit to skin condition. Bayer's extensive off-label promotion of Yaz and Yasmin for these unapproved uses is a clear violation of FDA regulations.

Bayer's marketing campaign not only persuaded thousands of women to take these drugs but also misrepresented and omitted the dangers of blood clots, pulmonary embolisms and other serious side effects. Bayer's actions violate FDA regulations, are contrary to good industry practice, and place all consumers at serious risk. Bayer must be held responsible for such flagrant behavior and liable for the damages Yaz and Yasmin inflicted on innocent women.

Bayer, not the FDA, is primarily responsible for the safety of its products. Bayer and all drug manufacturers have the responsibility to study a drug for its intended uses and submit such data to the FDA for their approval before they may promote and market a drug for non-intended uses.

To date, more than 11,000 women have filed suit against Bayer for injures they suffered as a result of taking Yaz, Yasmin, and its generic version, Ocella. Their injuries include strokes, blood clots, deep vein thrombosis and pulmonary embolisms. Additionally, many healthy and young women with no other risk factors had their gallbladders removed. However, these women shared a common denominator: they all took a birth control pill in the Yaz-family.

The attorneys at JONES WARD PLC represent women from all over the country who have suffered blood clots, deep vein thrombosis, pulmonary embolisms, strokes and gallbladder problems after taking Yaz, Yasmin or Ocella. If you or someone you know has suffered any of these side effects because of these drugs, contact attorney Terrance Massey at JONES WARD PLC. You can reach him by phone at 502-882-6000 or by email at tj@jonesward.com.

Following a study that we first reported here, the FDA has announced that it is requiring all drospirenone-containing birth control pills to have stronger warning labels regarding the risk of strokes. The change comes from recent epidemiologic studies that compare the risk of blood clots associated with women taking drospirenone-containing birth control pills versus women who are taking other progestin-containing birth control pills. Drospirenone is a synthetic version of progesterone (progestis), and it is contained in Yaz, Yasmin, and the generic Ocella.

The label changes will require drug makers to inform users about the results of the studies, one of child reporter a three-fold increase in the risk of forming blood clots, which may cause stroke. The FDA recommends that women talk to their doctors about their individual risk for blood clots before selecting a birth control.

Continue reading "FDA Requiring Lable Change for Certain Birth Control Pills" »

The value and number of Yaz stroke lawsuits have increased after studies linked the birth control pills to such a serious medical condition. The birth control pills Yaz, Yasmin, and the generic Ocella, are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin that is unique to these pills. Studies have shown that drospirenone can elevate potassium levels, which increases the chance of a blood clot. While all combined oral contraceptives can increase the risk of blood clots, these studies have shown Yaz, Yasmin, and Ocella to double or triple theses risks.

The increased risk of blood clots has caused women to suffer numerous medical complications, including strokes. A stroke occurs when the blood supply to a portion of the brain stops, is severely reduced or interrupted. The loss of blood deprives brain tissue of oxygen and within minutes brain cells begin to die. Yaz, Yasmin, or Ocella are often linked to ischemic strokes. An ischemic stroke occurs when a blood clot blocks a vessel that supplies blood to the brain. If the clot forms in an artery that is already very narrow, the ischemic stroke is known as thrombotic. An embolic ischemic stroke occurs when a clot that formed in another area of the body breaks loose and travels to the brain.

Ischemic strokes are deadly and those victims lucky enough to survive are often left with numerous neurological side effects. The most common side effects of a stroke include:

• Impaired speech pattern (aphasia)
• Difficulty swallowing (dysphagia)
• Loss of writing ability
• Numbness, paralysis, or physical weakness on one side of the body
• Impaired hearing
• Decreased visual field loss

Clinical studies have found that Yaz, Yasmin and Ocella increase the chances of strokes in women. The connection between the ingestion of these drugs and such a serious medical condition has subjected Bayer, the manufacturer of Yaz, Yasmin and Ocella, to civil liability. In fact, thousands of women have filed suit for the injuries they suffered as a result of these drugs. These lawsuits allege that Bayer failed to adequately research the effects of these pills before placing them on the market and also failed to warn consumers about the potentially life threatening side effects. The aggressive marketing campaign for Yaz and Yasmin misrepresented and omitted the dangers of strokes, blood clots, pulmonary embolisms and other serious side effects.

Women who have experienced a stroke while taking Yaz, Yasmin or Ocella should consider seeking legal advice because they may be entitled to financial compensation. The attorneys at JONES WARD PLC represent hundreds of women from across the country that have been harmed by Yaz, Yasmin and Ocella. If you would like to speak with someone about a potential case, please call attorney Terrance Massey at JONES WARD PLC. He can be reached by phone at (502) 882-6000 or by email at tj@jonesward.com.

Bayer has acknowledged that it has reached settlements in 70 Yaz and Yasmin lawsuits as of February 13, 2012. In all 70 cases, the women alleged to have suffered blood clots, pulmonary embolisms, deep vein thrombosis, strokes and other catastrophic complications after taking Yaz or Yasmin. The settlement amounts and terms have not been released and thousands more cases are unresolved. However, the 70 confirmed settlements signals one main thing: women who suffered a deep vein thrombosis, pulmonary embolism or stoke after taking Yaz or Yasmin have a strong case.

Yasmin, Bayer's first drospirenone birth control pill, was developed and released in May 2001. With the approval of Yaz in 2006, Bayer began a huge and costly marketing campaign targeted at women's sense of freedom and individuality. It also directed Yaz and Yasmin for uses not FDA approved, including bloating, muscle fatigue, aches, and PMS. Then the problems surfaced. Women began having strokes, blood clots, deep vein thrombosis and pulmonary embolisms. Many healthy and young women with no other risk factors had their gallbladders removed. However, these women shared a common denominator: they all took a birth control pill in the Yaz-family.

To date, more than 11,000 women have filed suit against Bayer for injures they suffered as a result of taking Yaz, Yasmin, and its generic version, Ocella. Most of the cases have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, currently pending in the U.S. District Court for the Southern District of Illinois.

These lawsuits allege that Bayer failed to adequately research the effects of these pills before placing them on the market and also failed to warn women about the potentially life threatening side effects. The aggressive marketing campaign for Yaz and Yasmin misrepresented and omitted the dangers of blood clots, pulmonary embolisms and other serious side effects.

The attorneys at JONES WARD PLC have well over 100 cases pending before the Illinois Court and will file roughly 80 more cases in the coming weeks. Our clients have suffered blood clots, deep vein thrombosis, pulmonary embolisms, strokes and gallbladder problems after taking Yaz, Yasmin or Ocella. If you or someone you know has suffered any of these side effects because of Yaz, Yasmin or Ocella, contact attorney Terrance Massey at JONES WARD PLC. You can reach him by phone at 502-882-6000 or by email at tj@jonesward.com.

The value of Yaz pulmonary embolism lawsuits have increased after studies linked the birth control pills to such a serious medical condition. The birth control pills Yaz, Yasmin, as well as the generic Ocella, are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin that is unique to these pills. Studies have shown that drospirenone can elevate potassium levels, which increases the chance of a blood clot. Pulmonary embolisms are a byproduct of a blood clot. Thus, the increased risk of a blood clot necessarily creates an increased risk of a pulmonary embolism.

A pulmonary embolism (PE) is a potentially fatal condition where a blood clot travels to the lung and blocks a lung artery. The blood clot typically forms somewhere else in the body (most often the legs). If the blood clot breaks loose it can travel through the blood stream and become lodged near the lung. This sudden blockage of a lung artery is known as a pulmonary embolism. Pulmonary embolisms are extremely serious and can be life threatening. In fact, some experts believe 15% of all sudden deaths are caused by a pulmonary embolism.

The most common signs and symptoms of a pulmonary embolism include:

• Sudden shortness of breath, while active or at rest
• Chest pain that may become worse when eating, breathing deeply or coughing
• Cough that may produce blood or blood-streaked sputum

Other signs and symptoms include:

• Wheezing
• Leg swelling
• Clammy or bluish skin
• Rapid or irregular heartbeat
• Weak pulse
• Excessive sweating
• Fainting or lightheadedness

Women with any of these signs or symptoms should seek immediate medical care.

Thousands of women have filed suit against Bayer, the manufacturer of Yaz, Yasmin and Ocella, for the injuries they suffered as a result of these drugs. These law suits allege that Bayer failed to adequately research the effects of these pills before placing them on the market and also failed to warn consumers about the potentially life threatening side effects. The aggressive marketing campaign for Yaz and Yasmin misrepresented and omitted the dangers of blood clots, pulmonary embolisms and other serious side effects.

Women who have experienced a pulmonary embolism while taking Yaz, Yasmin or Ocella should consider seeking legal advice. The attorneys at JONES WARD PLC represent hundreds of women from across the country that have been harmed by Yaz, Yasmin and Ocella. If you would like to speak with someone about a potential case, please call attorney Terrance Massey at JONES WARD PLC. He can be reached by phone at (502) 882-6000 or by email at tj@jonesward.com.

Lawsuits by women who experienced a DVT after taking Yaz are growing in numbers. A DVT (deep vein thrombosis) is one of the worst side effects of Yaz, Yasmin and the generic version, Ocella. Hundreds of women who have taken these drugs and experienced a DVT have filed suit against the drug manufacturer Bayer and are likely to receive a large settlement award.

A deep vein thrombosis is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. DVTs are also known as venous thromboembolic events, or VTEs.

The signs and symptoms of a DVT can appear in one or both legs and include:

• Pain or tenderness that may only occur while standing or walking
• Swelling
• Red, discolored or warm skin
• Leg fatigue
• Visible surface veins

DVTs can be life threatening and women experiencing symptoms of a DVT should seek immediate medical care.

Numerous studies have found a direct link between Yaz, Yasmin and Ocella and DVTs. The strong connection between the ingestion of these drugs and such a serious condition has subjected Bayer to civil liability. Women who experienced a DVT after taking these birth control pills may be entitled to financial compensation.

I strongly advise any patient who experienced a DVT while taking Yaz, Yasmin or Ocella to contact an attorney. The attorneys at JONES WARD PLC represent hundreds of women from across the country that have been harmed by Yaz, Yasmin and Ocella.

If you would like to speak with someone about a potential case, please call attorney Terrance Massey at JONES WARD PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

What's a gallbladder worth? This is the question that I've heard over and over and over again as it relates to the Yas, Yasmin and Ocella settlement discussions currently taking place across the country. Bayer (the maker of Yaz, Yasmin and Ocella) says a gallbladder is worth zero, nothing, nada, zip. Bayer says that the woman who lost their gallbladders were fat, out of shape, old, and generally unhealthy. Bayer says that they are not responsible for gallbladder losses because there are no epidemiological studies showing an increased risk of gallbladder disease in Yaz, Yasmin and Ocella users.

What do I say? Bring it on. A gallbladder removal is a very serious injury. I represent teenagers, as well as middle-aged women, in the Yaz, Yasmin and Ocella litigation. They aren't all fat or old or out of shape. Indeed, there are thousands of young woman (pretty, thin, and in shape) who have lost their gallbladders. These women had no prior health history that would suggest gallbladder disease. These women never knew that they were at risk. The women never knew that a Canadian Medical Association published a study that found that there was a "statistically significant" increase in gallbladder disease for Yaz, Yasmin and Ocella users when compared to other oral contraceptives.

So what's it worth? I'm an experienced trial lawyer. I can try these cases. I can't imagine that a jury would not award six figure verdicts. So when Bayer comes knocking at my door, they better be ready to negotiate reasonable settlements. If not, I'll go to court and try my cases on behalf of my gallbladder clients. We don't plan on letting them get away with endangering our daughters, moms, aunts, and nieces who have used Yas, Yasmin and Ocella.

Evidence is mounting that Bayer's birth control pills are unreasonably dangerous, particularly in light of safer alternatives. Yasmin, Yaz, Beyaz and Safyral are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin. During the month of December, several FDA advisory groups met to review Bayer's warnings for these birth control pills.

Bayer's first drospirenone birth control pill, Yasmin, was developed and released in May 2001. With the approval of Yaz in 2006, Bayer's heavy marketing campaign took off. Bayer's advertisements targeted women's sense of freedom and individuality. It also directed Yaz and Yasmin for uses not FDA approved, including bloating, muscle fatigue, aches, and PMS. The campaign proved a huge success. In 2008 Bayer's Yaz and Yasmin profits were a staggering $998 million.

Then the problems surfaced. Women began having strokes and heart attacks due to venous thromboembolisms (blood clots) and pulmonary embolisms. Many healthy and young women with no other risk factors had their gallbladders removed. A significant number of studies and other evidence suggest a link between drospirenone and these gallbladder injuries. Additionally, these women share a common denominator: they all took a birth control pill in the Yaz-family. In response to the rising number of adverse events, the FDA ordered Bayer to spend $20 million on corrective advertising.

Continue reading "Yaz/Yasmin: FDA Reviews Bayer's Warnings" »

A U.S. Food and Drug Administration advisory committee recommended stronger warning labels for Bayer's birth control pills Yaz and Yasmin. By a 21 to 5 vote, the panel recommended changing the contraceptives' labels to reflect the possibility that the pills could lead to a higher risk for blood clots or deep vein thrombosis (DVT). Currently, the labels suggest the risk of blood clot is similar to those of other contraceptives that combine estrogens and progestins.

FDA spokeswoman Morgan Liscinsky said the panel acknowledged the conflicting data but "definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data." While some physicians do not believe this risk is enough to change their prescribing habits, others, including members of the FDA advisory committee, disagree. In an interview with the Wall Street Journal, committee member Sean Hennessy of the University of Pennsylvania stated physicians should use an abundance of caution because "these drugs ought to be rarely used."

Continue reading "FDA Panel Recommends Stronger Warning for Yaz and Yasmin" »

The U.S. Food and Drug Administration (FDA) remains concerned about the potentially higher risk of blood clots in women taking newer forms of birth control pills, such as Yaz, Yasmin and Ocella. These "fourth generation" contraceptive drugs contain drospirenone, a new type of synthetic progestin.

An FDA-funded study indicates that women taking contraceptive drugs containing drospirenone have a 50 percent increased risk of blood clots. Earlier this year two other studies appearing in the British Medical Journal found double to triple the risk. An FDA advisory committee is scheduled to meet in December after which the full findings of the study will be released.

A deep vein thrombosis (DVT) is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. A pulmonary embolism (PE) is a potentially fatal condition where the clot breaks loose and travels to the lung blocking a lung artery. DVTs and PEs are also known as venous thromboembolic events, or VTEs.

Continue reading "FDA Warns Yaz, Yasmin and Ocella Contraceptives Could Increase Clot Risk " »

Recent studies have confirmed that thousands of lawsuits regarding Yaz, Yasmine and Ocella over gallbladder disease, blood clots and heart related trouble have merit.

According to the Canadian Medical Association Journal, a survey of health databases show that the risk to women on Yaz and Yasmin is double that of other birth control drugs of having to have their gallbladder removed. Researchers analyzed a database of more than 2.7 million women who used birth control pills. The analysis showed that newer birth control brands had increased risk of gallbladder disease when compared to previous generations, but that the increased risk of Yaz and Yasmin for gallbladder removal and disease was twice as much as any other.

In addition, a recent study published in the British Medical Journal showed that the risk of blood clotting disorders was twice as much for users of Yaz and Yasmine than other drugs. To make that determination, researchers from the Boston Collaborative Drug Surveillance Program at the BU School of Medicine analyzed about 900 women on birth control since the year 2002. For women taking Yaz or Yasmin, the rate of blood clots was 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years.

Continue reading "Yaz, Yasmin Studies Show Double Gallbladder, Clot Risk" »