The Recall Lawyers

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 responsible 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.

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 other serious side effects after taking Yaz, Yasmin and 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.

At a legal conference I attended in April, a presenter described an incident that sounded like a scene straight out of a horror film. A woman taking the drug Pradaxa accidentally cut herself. When the bleeding would not stop, she called family members. The cut was minor, so she waited. The bleeding continued. When EMS was finally notified, they arrived at her house only to find that she had died. She had bled out, and her kitchen was covered in blood. Doctors and EMS workers were puzzled; they couldn't even find the cut that led to the bleeding. A small cut that medical professionals couldn't even identify had led to the death of an otherwise healthy patient.

The startling truth is that this story might not be that uncommon. A growing number of reports of dangerous and sometimes fatal bleeding continue to accumulate from the use of the blood thinner Pradaxa (generic name: dabigatran). Although Pradaxa was initially approved by the FDA in October 2010, these reports question whether the risks outweigh the benefits. The drug underwent a safety review by the FDA last December. Despite the fact that the FDA concluded Pradaxa provides an important health benefit when used as recommended, reports of uncontrollable bleeding continue to rise.

Pradaxa was first approved to prevent strokes and blot clots in patients with atrial fibrillation, the most common type of heart rhythm abnormality. It has been marketed as a substitute for the blood thinner Coumadin (generic name: warfarin). Coumadin requires constant blood monitoring. Since Pradaxa doesn't require frequent blood tests, it has been touted as the convenient alternative to Coumadin.

This may seem like a godsend to those patients who must undergo frequent and laborious blood tests. But the makers of Pradaxa neglected to emphasize one alarming detail: The blood-thinning agent of Pradaxa is irreversible, meaning even minor cuts can lead to uncontrollable bleeding and ultimately, death.

Although all blood thinners, including Pradaxa's competitor Coumadin, have a heightened risk of hemorrhaging (due to the simple fact that they are blood thinners), Pradaxa is the only one without an antidote. Coumadin bleed-outs may be battled with Vitamin K. That is not to say that Coumadin is always treatable. Anytime a patient is using a blood thinner, there is always a risk of bleeding out with any sustained trauma. However, the life-or-death difference lies with incidents of minor trauma, like cuts or scratches. With Coumadin, when a patient suffers minor trauma, they usually have time to get to the hospital where doctors have Vitamin K to jumpstart blood coagulation. With Pradaxa on the other hand, doctors may be helpless, regardless of the severity of the trauma, and the only life-saving procedure is extensive blood transfusion, which does not guarantee survival.

We first reported this startling drug property in February. You can read our initial blog post here. Since then, numerous reports and studies have accumulated with the very same findings. In September 2011, New Zealand authorities investigated the safety of Pradaxa after five reports of elderly patients dying from internal bleeding, and another 36 reports were received of near-fatal internal bleeding. By November 2011, the FDA had received at least 50 reports of fatal bleeding due to Pradaxa. This March the Journal of Neurosurgery published a case report of an elderly patient who died of a brain hemorrhage after a minor fall. A team of Cleveland Clinic researchers released a study this January that also links Pradaxa to an increased risk of heart attacks and symptoms of heart disease as compared with Coumadin or warfarin.

The risk of uncontrollable bleeding due to Pradaxa may be increased in the following groups of patients:

• Age: Patients over 75 years of age;
• Other Medications: Patients taking aspirin or non-steroidal anti-inflammatory drugs (NSAIDS);
• Kidney Problems: Patients with impaired renal function; and
• Other Health Issues: Patients with stomach ulcers and other gastrointestinal medical problems.

Part of the problem may be that a patient's cardiologist may prescribe Pradaxa as a safe and convenient alternative to Coumadin, without knowledge of its irreversible nature. It is the ER doctors who try to save a patient's life, often in vain, who have raised the alarm regarding Pradaxa's fatal qualities.

Although Pradaxa's warning label does warn of the risks of significant and sometimes fatal bleeding risks, many in the legal and medical community feel it is inadequate. And the fact that there is a viable alternative, Coumadin, which works just as well but may be inconvenient, makes the use of Pradaxa even more unjustified. As more information comes in, we will be sure to update you.

For more information, contact attorney A. Layne Stackhouse at layne@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.

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.