Yaz and Yasmin Lawsuit Information

Our Blog Has Moved

2009-12-07T12:21:00.000-06:00

Effective immediately, the Yaz and Yasmin Lawsuit Information Blog is changing addresses. Please follow our blog at our new location, http://www.theyazlawyers.com/Yaz-Blog.aspx

Bayer Continues Aggressive Advertising of Yaz

2009-11-19T12:50:00.001-06:00

Bayer is using Yaz as a pilot for the new Google sponsored links format proposed at FDA hearings last week. The new format was created in response to FDA warnings regarding the lack of safety information provided with sponsored link advertising on sites like Google. Bayer was on of 14 companies who received a letter from the FDA in April stating that their sponsored links violated FDA rules. The letter to Bayer said that "omission of risk information is particularly concerning as one of these products, Yaz, has a boxed warning." Bayer was also notified that its Levitra and Mirena sponsored links were in violation of FDA rules.

The FDA warnings in April caused search rates and sponsored link revenue to plummet. The drop in online advertising spurred the FDA to hold hearings on the future of prescription drug advertising on the internet and social media. At those hearings, Google proposed the new format that Bayer is now testing with Yaz. The new sponsored links contain a headline with a link to the drug's web site, then a line that says "Read important product info here" and a third line which reads "Click to see full safety and prescribing information, including boxed warning."

Given the recent health concerns with Yaz birth control pills, Bayer seems to be flying in the face of patient safety by using Yaz as a pilot for new online advertising. Or, maybe Bayer knows that the dangers of Yaz will lead to decreased popularity and they are hoping to squeeze the last bit of profit out of a dying franchise. Either way, Bayer's choice to feature Yaz in this pilot program is in bad taste to say the least.

New Jersey Courts seek Mass Tort Statuts for Yaz, Yasmin and Ocella Lawsuits

2009-11-09T13:39:00.000-06:00

New Jersey Judge Donald Volkert, Jr. made an application to the New Jersey judiciary to designate the 39 cases against drug companies Bayer and Teva over the birth control pills, Yaz, Yasmin and Ocella as a mass tort. The mass tort designation will allow the cases to be consolidated in one court in New Jersey, rather than in several jursidiction as is now the case. Judge Volkert, Jr. cited the following reasons to consolidate these cases:

large number of filings;
geographic disbursement of parties;
risk of redundancy and inconsistent filings by different judges, resulting in undue delay and expense;
increased efficiency by having one judge oversee the issues
common issues of law and fact, as found by the Judicial Panel on Multidistrict Litigation; and
consolidation of the federal court cases by the Judicial Panel on Multidistrict Litigation

According to Law.com, the chief of civil court programs also noted that consolidation of federal cases weighs in favor of a similar move for state litigation because judges hearing federal multidistrict cases tend to coordinate case management with state judges hearing similar cases.

Usually mass tort status requests are made by plaintiffs' counsel, but the rules permit judges to make requests as well. Since mass tort applications from lawyers typically request a specific venue, plaintiffs lawyers will probably express their preferences in comments to the court. However, the final venue decision will be decided based mainly on caseloads in various venues. The three counties being considered are Atlantic, Bergen and Middlesex.

Public comments on the application for mass tort status will be accepted until December 31, 2009 with a determination expected shortly thereafter.

Swissmedic Releases Report on Venous Thromboembolism Caused by Yaz and Yasmin

2009-10-27T21:29:00.003-05:00

October 22, 2009 - Swissmedic, the Swiss Agency for Therapeutic Products, released its report regarding the increased risk of thromboembolism for Yaz and Yasmin users. Swissmedic's Human Medicines Expert Committee analyzed recent data and studies on these risk factors. The agency took particular notice of two epidemiological studies released in August 2009. These studies reported an increased risk of pulmonary embolism, deep vein thrombosis, stroke and heart attack due to the progestin, drosperinone, in Yaz and Yasmin. The agency concluded that the risk of having a venous thromboembolism with a drosperinone-containing birth control pill is close to the risk with 3rd generation birth control pills. So called 2nd generation oral contraceptives remain the safest on the market.

Swissmedic will include the results and findings of their investigation in the patient information included with Yaz and Yasmin birth control pills. Doctors will be warned that they should be cautious when prescribing these pills to patients with any other risk factors for venous thromboembolism such as smoking, obesity and genetic predisposition.

Bayer has attempted to interpret Swissmedic's report in its favor. However, a careful reading of the report indicates that Yaz and Yasmin risks are more in line with those of 3rd generation oral contraceptives. It is well-documented that 3rd generation oral contraceptives carry a statistically significant increased risk of venous thromboembolism compared to other birth control pills.

Bayer now faces hundreds of lawsuits filed by women seriously injured by Yaz and Yasmin. Contact the attorneys at Jackson Allen Williams, LLP if you or a loved one was seriously injured by these birth control pills.

Jackson Allen Williams, LLP Announce Association With Lisa Blue Baron and Mike Kaeske

2009-10-23T00:05:00.002-05:00

The drug injury lawyers at Jackson Allen Williams, LLP are proud to announce their association with nationally prominent trial lawyers Lisa Blue Baron and Mike Kaeske to represent victims of serious injuries caused by the side effects of Yaz/Yasmin. Lisa and Mike are nationally known for their representation of victims of serious injuries in high profile cases, having obtained numerous significant jury verdicts.

Lisa Blue Baron of Baron and Blue in Dallas, Texas is both an attorney and a PhD. in Counseling Psychology. Lisa was formerly a partner at Baron & Budd, the largest environmental and toxic tort law firm in the United States. Her accomplishments in trial courts nationwide have been widely recognized, including being named one of the Top 50 Women Litigators in the U.S. by the National Law Journal, Trial Lawyer of the Year by the Texas Chapter of the American Board of Trial Advocates, as well as receiving the Honorary Barrister Award from the University of Texas Law School and the Distinguished Alumni Award from South Texas College of Law. Blue was named Trial Lawyer of the Year in 2006 by the Dallas Bar Association. In 2007, she received the Louise Raggio Women’s Legal Advocate Award from Legal Aid of Northwest Texas and was awarded the Ronald D. Secrest Outstanding Trial Lawyer Award from the Texas Bar Foundation in 2008. Ms. Blue was honored to accept the 2009 Rayburn Johnson Award posthumously on behalf of her husband, Fred Baron.

In addition to her legal practice, Lisa maintains a private consultancy as a forensic psychologist and is a nationally renowned expert in jury selection. With her unique background, she has been a commentator for several high-profile trials covered by Court TV and has co-authored numerous articles on jury selection. These include: “The Dos and Don’ts of Jury Questionnaires” (Texas Lawyer), “Make the Most of Your Jury Questionnaire” (Trial), “Profile of a Perfect Juror” (Trial Talk), “How to Pick a Winning Jury” (Champion), “Profile of a Perfect Juror” (Arizona Trial Lawyers Association Advocate), “Inside the Juror’s Mind” (Texas Bar Journal), “Profile of a Perfect Juror” (Advocate Magazine - Journal of Consumer Attorneys Associations for So. California), “Profile of a Perfect Juror” (South Texas Law Review), “In Defense of the Peremptory Challenge” (Voir Dire Magazine), and “Twelve Psychological Tips for Getting Re-elected Every Time” (In Chambers). Lisa has written two books: ATLA’s Blue’s Guide to Jury Selection, co-authored with Robert Hirschhorn in 2004 (published by West), and Dr. Blues’ Guide to Making Relationships Work: 50 Quick Tips that Will Save Your Relationship, co-authored with brother Rick Blue in 2006.

Mike Kaeske worked closely with Lisa Blue and Fred Baron at Baron & Budd where he trained as a courtroom trial lawyer. He picked juries as often as many lawyers attend hearings and his first verdict was an $8.5 million single-plaintiff victory. His last verdict for Baron & Budd was a radiation exposure case in Federal Court in Pittsburg, PA, and the jury returned a verdict of over $60 million for eight plaintiffs with leukemia and other cancers. That verdict led to Mike being nominated as Trial Lawyer of the Year from the Trial Lawyers for Public Justice. Mike’s primary emphasis is trial work. Because of his aggressive and effective courtroom techniques, he is called upon by lawyers across the country to try significant cases. He has obtained more than $450 million in settlements and verdicts since opening his own practice in 1999. The Kaeske Law Firm has a national practice based in Austin, Texas. Mike has devoted his professional life to the representing seriously injured victims and their families.

Jackson, Allen, Williams, LLP is located in Dallas, Texas and provides legal representation to injury victims nation wide.

Allen Law Firm is now Jackson Allen Williams, LLP

2009-10-22T22:39:00.004-05:00

Allen Law Firm is now Jackson Allen Williams, LLP. The dangerous drug lawyers at Jackson Allen Williams, LLP will continue to provide legal representation to injury victims nationwide including women injured by Yaz, Yasmin and Ocella and their families.

Germany's Federal Institute for Drugs and Medical Devices May Require Bayer to Add Stronger Warnings to Yaz Label

2009-10-22T19:30:00.004-05:00

An article on Deutsche Welle, a German news web site, the Federal Institute for Drugs and Medical Devices is looking into changing the product information for the Yasmin line of birth control pills. The changes may be made to reflect the new data coming from recent studies that show Yaz and Yasmin are twice as likely to cause blood clots - or thrombosis - than older pills. Ulrich Hagemann, head of the institute's department of drug safety said, "there is a need from my point of view to change the text" in the product information that accompanies the pills to reflect this increased risk.

A total of 130 cases of adverse drug reactions to the Yasmin line of contraceptives have been reported to Germany's Federal Institute for Drugs and Medical Devices. Felicitas Rohrer, a 25-year old German citizen, collapsed in July with three thromboses in her lung. "I got the first package in a nice little silver box with a mirror and make-up brush inside; it seemed very nice, so why shouldn't I take it? But I never heard that this pill has a much higher risk of pulmonary embolism than other pills," Felicitas Rohrer told Deutsche Welle.

The Allen Law Firm is representing women, like Felicitas, who have suffered strokes, pulmonary embolisms and deep vein thrombosis. If you or a loved one has suffered a serious injury after taking Yaz, Yasmin or Ocella, we'd love to hear from you.

Ten Lawsuits Filed Against Bayer Over Yaz and Yasmin in New Jersey

2009-10-08T12:42:00.004-05:00

According to NorthJersey.com, ten women from various states have filed lawsuits against Bayer Healthcare Pharmaceutical, Inc. of Wayne, New Jersey. The lawsuits allege that the women suffered deep vein thrombosis and pulmonary embolism as a result of taking Yaz, Yasmin and Ocella. Like the dozens of other lawsuits filed across the country, these cases allege that Bayer mislead consumers about the risks of these birth control pills.

Bayer has confirmed that they have lawsuits pending regarding Yaz and Yasmin. According to a written statement, Bayer admitted that as of September 24, 2009 the company had been served with 74 lawsuits involving and Yaz and Yasmin.

More Lawsuits Filed Against Bayer Over Yaz an Yasmin

2009-10-07T09:28:00.003-05:00

Bayer has been sued by two Pennsylvania pension funds and accused of misrepresenting the safety and effectiveness of the Yaz contraceptive to boost sales, according to a Bloomberg report. The lawsuit claims that Bayer unlawfully promoted Yaz and Yasmin from March 2006 to March 2009 by hiding the risks of the birth control pills. The risks that were concealed include blood clots, heart attacks, pulmonary embolisms and gallbladder disease. The complaint was filed by the Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund and the American Federation of State, County and Municipal Employees, District 47 Health and Welfare Fund. The suit was filed in the U.S. District Court, Eastern District of Pennsylvania (Philadelphia).

Yaz and Yasmin may be linked to Pancreatic Cancer

2009-10-06T18:00:00.003-05:00

The birth control pills, Yaz and Yasmin, that have been linked with other digestive organ problems such as gallstones, gallbladder disease, pancreatitis and kidney failure may now be linked to pancreatic cancer.

As of the date of this post, not much is known about the potential link between Yaz, Yasmin and pancreatic cancer. We will post additional information on this blog as we learn more about this possible new risk related to Bayer's Yaz and Yasmin birth control pills.

Bayer faces more suits over its Yaz and Yasmin Birth Control

2009-10-06T16:24:00.003-05:00

Following the consolidation of the Yaz and Yasmin federal court cases last week, at least 13 new cases have been filed in the Southern District of Illinois. The new cases, which will be transferred to the MDL for pretrial proceedings, allege injuries including strokes, blood clots, pulmonary embolisms, heart attacks and gallbladder removal.

Its obvious from the number of lawsuits currently on file, at least 90, that women across the country believe that Yaz and Yasmin caused them to suffer catastrophic injuries or even death.

This blog will keep you apprised of any developments in the Federal Court MDL and the state court consolidations around the country. If you or a loved one has suffered a serious injury after taking Yaz, Yasmin or Ocella, talk to a lawyer about your legal rights.

Yaz | Yasmin | Ocella and Stroke

2009-10-05T12:22:00.004-05:00

Yaz, Yasmin and Ocella have been linked to the risk of blood clots which can cause strokes. Experts believe Yaz and Yasmin have a prothombotic effect due to the progestin drospirenone or drsp. Drsp is a potassium-sparing 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.

A blood clot in a blood vessel are called thrombus. 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.

The following symptoms may indicate that you are suffering from a stroke caused by Yaz, Yasmin or Ocella:

Trouble with walking - dizziness, loss of balance or coordination
Trouble with speaking - slurring or trouble coming up with words (aphasia)
Paralysis or numbness on one side of the body
Trouble with seeing - blurred, blackened or double vision
Sudden, severe headache

If you suffer from these symptoms, you should report them to your doctor immediately. Tests to determine if you are having or previously suffered a stroke include:

Carotid ultrasound
CT Scan
Arteriography
MRI
Echocardiography

Treatment for Stroke:

Prompt treatment of a stroke is important. The type of treatment you will receive depends on the type of stroke you suffered. If you suffer an ischemic stroke, doctors need to immediately restore blood flow to your brain. They may accomplish this with medication or surgery. If you suffer a hemorrhagic stroke, treatment is designed to keep you from suffering additional strokes. Treatment would usually include surgery--either aneurysm clipping or arteriovenous malformation (AVM) removal.

Risk Factors for Stroke:

Birth control pills are known risk factor for blood clotting disorders including Stroke . However, the risk is increased with the use of Yaz, Yasmin and Ocella due to the progestin drosperinone (drsp). Drsp functions as a diuretic with thickens the blood possibly causing heart rhythm disturbances and blood clots.

Women who have taken these birth control pills and suffered strokes are filing lawsuits against Bayer and related entities for their injuries. Most of the lawsuits are being consolidated in the federal court in Southern Illinois or in Pennsylvania and California state courts. The attorneys at the Allen Law Firm are evaluating claims on behalf of individuals throughout the United States who were prescribed Yaz, Yasmin or Ocella and suffered serious side effects including strokes or death. If you would like to know if you qualify to file a lawsuit from your Yaz, Yasmin or Ocella injury, contact an attorney today for a free consultation.

Yaz and Yasmin Cases Consolidated in MDL in Southern District of Illinois

2009-10-01T21:36:00.005-05:00

Today the Judicial Panel on Multidistrict litigation filed its order transferring all federal court Yaz/Yasmin lawsuits to the U.S. District Court for the Southern District of Illinois. MDL 2100 was assigned to Judge David R. Herndon. The pretrial proceedings for these cases will be handled under the title, IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation. The order comes after a hearing in front of the Judicial Panel on Multidistrict Litigation last week.

As we have discussed in this blog, the cases consolidated under the MDL involve allegations that Yaz, Yasmin and the generic, Ocella, are associated with increased risks of pulmonary embolism, deep vein thrombosis, stroke, heart attack and serious gallbladder disease. The cases will be consolidated for the purposes of discovery and pretrial motions. The MDL consolidation is different than a class action lawsuit. We explain the difference between MDLs and class action lawsuits in more detail here.

Yaz, Yasmin and Ocella and Pulmonary Embolisms

2009-09-30T17:38:00.003-05:00

Yaz, Yasmin and Ocella have been linked to the risk of blood clots which can cause pulmonary embolism. The types of blood clots caused by Yaz, Yasmin and Ocella are more formally known as thrombosis. 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.

The following symptoms may indicate that you may be suffering from pulmonary embolism caused by Yaz, Yasmin or Ocella:

Sudden shortness of breath
Chest pains that mimic heart attack
Cough that produces bloody or blood-streaked sputum
Rapid heartbeat (tachycardia)
Wheezing
Leg swelling
Clammy or bluish-colored skin
Excessive sweating
Anxiety
Weak pulse
Lightheadedness or fainting
Fever

If you suffer from these symptoms, you should report them to your doctor. Depending on how likely it is that you have a blood clot, the doctor may recommend a chest x-ray, lung scan CT Scan, and/or pulmonary angiogram to make a final diagnosis. Doctors may also conduct tests to determine if you have blood clots including a D-dimer blood test, ultrasound, MRI, and/or venography.

Treatment for Pulmonary Embolism
Prompt treatment of pulmonary embolism is essential to avoid serious complications or death. Pulmonary embolism is usually treated first with a fast-acting coagulant, usually heparin. If the pulmonary embolism is life-threatening doctors will often use clot-dissolving (thrombolytic) therapy and/or a vein filter.

Birth control pills are known risk factor for blood clotting disorders including Pulmonary Embolism (PE). However, the risk is increased with the use of Yaz, Yasmin and Ocella due to the progestin drosperinone (drsp). Drsp functions as a diuretic with thickens the blood possibly causing heart rhythm disturbances and blood clots.

If you want more information about the lawsuits involving pulmonary embolisms caused by Yaz, Yasmin and Ocella, contact the Allen Law Firm for a free case evaluation.

Yaz, Yasmin and Ocella Litigation - Consolidation not Class Action Lawsuit

2009-09-29T17:35:00.003-05:00

Many people think that class action lawsuits are the same thing as cases consolidated in one state court or in a federal court MDL (multidistrict litigation). However, the personal injury claims made in products liability claims like those involving Yaz, Yasmin and Ocella, are too unique to be handled in a class action lawsuit. Instead each plaintiff 's case must proceed based on their individual injuries caused by the dangerous drug.

As we have discussed before, a motion has been filed to consolidate the federal court Yaz, Yasmin and Ocella cases in an MDL in the Northern District of Ohio. The Judicial Panel on Multidistrict Litigation held a hearing on that motion last week. A decision on the consolidation is expected around the end of October.

In addition, numerous cases filed in Pennsylvania state court have been consolidated in the Philadelphia Court of Common Pleas.

Consolidation of the cases will eliminate duplicate discovery in the numerous cases and avoid inconsistent rulings from judges in courts across the country. Usually when cases are consolidated, the first trials conducted, also known as "bellwether" trials will proceed in the court where pretrial litigation is proceeding. The remaining cases will be returned back to their original courts for individual trials or settlement.

If you have suffered a serious injury such as stroke, pulmonary embolism, deep vein thrombosis or gallbladder disease after taking these birth control pills, contact a lawyer to discuss your legal rights. An experienced dangerous drug lawyer can explain the differences in case consolidation versus class action lawsuit status and evaluate your case for you.

Swiss Agency Investigates Death of Woman Using Yaz Birth Control

2009-09-28T13:46:00.002-05:00

September 25, 2009 - According to the Swissmedic agency, that agency along with an investigative judge are probing the death of a woman due to pulmonary embolism. The woman died suddenly within ten months of starting Yaz birth control pills. Bayer will conduct its own investigation according to a Bayer spokesman. Swissmedic is expected to release the results of its analysis in late-October of this year.

The investigation by Swissmedic is the latest in a series of health concerns raised over Yaz, Yasmin and the generic, Ocella. As previously reported in this blog, Bayer has come under fire from the FDA over its advertising practices and its manufacturing practices.

Yaz, Yasmin and Ocella MDL Hearing Today

2009-09-24T09:38:00.004-05:00

Today the Judicial Panel on Multi-District Litigation will hear arguments on a petition to consolidate the Yaz, Yasmin and Ocella product liability cases. The Petition seeks to have the litigation consolidated in the U.S. District Court for the Northern District of Ohio. The hearing will be held in Richmond, Virginia. A decision by the MDL Judicial Panel is expected two to four weeks after the hearing.

The Yaz, Yasmin and Ocella litigation at issue involves lawsuits filed in federal courts across the country by women who have been seriously injured by these birth control pills. The lawsuits allege that the progestin in Yaz, Yasmin and Ocella called drosperinone or drsp is unique to these products and carries a greater risk of venous thromboembolism (deep vein thrombosis, stroke, pulmonary embolism) than other oral contraceptives. Some of the lawsuits also involve women who suffered severe gallbladder disease requiring gallbladder removal.

The Allen Law Firm would be happy to answer any questions you may have about the Yaz, Yamin and Ocella lawsuits and provide a free case evaluation for anyone who has suffered stroke, pulmonary embolism, deep vein thrombosis, heart attack, gallbladder removal or pancreatitis after using these birth control pills. Visit our web site or call us toll free 888-345-LAW1 (5291).

Philadelphia the Center of Pennsylvania State Court Yaz Cases

2009-09-22T11:31:00.003-05:00

Judge Sandra Mazer Moses of the Philadelphia Court of Common Pleas consolidated all Yaz and Yasmin lawsuits filed in Pennsylvania last week. So far about 20 suits have been included in the consolidated litigation with many more expected in the coming weeks and months.

A hearing is scheduled for September 24, 2009 on consolidating the federal court Yaz and Yasmin cases. Plaintiffs have filed a motion requesting that the Yaz and Yasmin cases be transferred to an MDL in the U.S. District Court for the Northern District of Ohio.

The lawsuits allege that the popular birth control pills, Yaz, Yasmin and the generic, Ocella, contain the progestin drospirenone that has been connected to increased thromboembolic events (blood clots) and organ failure, especially affecting the gallbladder. The blood closts caused by Yaz and Yasmin can lead to Deep Vein Thrombosis, Stroke and Pulmonary Embolism. These blood clots are sometimes fatal. Women are also experiencing in an increased risk of gall stones so severe that they must have their gallbladders removed, leaving them with compromised digestive systems.

The Allen Law Firm is representing women who have suffered severe injury and death after taking Yaz, Yasmin or Ocella. If you or a loved one has been injured or died following the use of these birth control pills, contact a lawyer today to discuss your legal options.

Letter to the Editor: Yasmin May Not Be As Safe As Previously Thought

2009-09-17T12:39:00.004-05:00

A letter to the editor in the September 2009 issue of the Southern Medical Journal associates Yasmin, and more specifically drospirenone, with Deep Vein Thrombosis. Dr. Thein Oo, M.D. of St. Elizabeth's Medical Center and Tufts University School of Medicine describes a case of a 28-year old woman with no family history of thrombophilia who suffered deep vein thrombosis. The woman had been taking Yasmin for about two years. Dr. Oo warns that the association of Yasmin with a lower risk of VTE has not been proven by research. He concludes that Yasmin may not be as safe as previously thought, due to the progestin drospirenone.

Dr. Oo's letter is just the latest in a serious of letters and articles written concerning the relative risk of thromboembolism in birth control pills containing drospirenone as compared to pills that contain other progestins.

If you have taken Yaz, Yasmin, or Ocella and would like more information regarding your legal rights, contact the lawyers at the Allen Law Firm today.

Maker of Yaz Warned by FDA about Quality Control Issues at German Plant

2009-09-17T09:22:00.008-05:00

The FDA posted a warning letter online this week stating that its inspectors uncovered testing problems at Bayer's plant in Berghamen, Germany. The Berghamen factory makes the key ingredient in Yaz and Yasmin, drospirenone. Yaz and Yasmin were Bayer's top-selling pharmaceuticals last year with global sales of $1.8 billion.

According to the warning letter, Bayer was measuring the quality of its drug ingredients using the wrong method. The FDA requires that individual test results of the quality of ingredients be reported. Bayer had been reporting quality based on an average of several samples instead. The FDA expressly stated that this method of reporting is not permissible.

Eight drug batches from the plant were shipped to the U.S including drospirenone, the progestin used in the birth control pills Yaz and Yasmin.

Bayer denies that there are any safety or efficacy issues with these drug shipments. However, the FDA has asked Bayer to provide a list of all shipments from the Berghamen plant to the U.S. and a plan to prevent the problem from happening again. The FDA said it will consider delaying imports from the plant until Bayer adequately addresses the warning letter.

Bayer has been warned by the FDA about other issues with its popular birth control pills, Yaz and Yasmin. In 2008, Bayer was warned about its Yaz direct-to-consumer advertising. Following that warning, Bayer agreed to a $20 million ad campaign to correct the misinformation contained in its previous marketing.

More Yaz/Yasmin Lawsuits Filed

2009-08-27T13:41:00.005-05:00

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.

Yaz, Yasmin and Ocella linked to Gallbladder diseases and Gallstones

2009-08-27T11:18:00.003-05:00

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.

New Article Questions Safety of Yasmin and Yaz

2009-08-17T16:57:00.004-05:00

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.

Would Hundreds of Women Have Been Saved by Legislation Limiting Direct-To-Consumer Advertising?

2009-08-10T14:49:00.006-05:00

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.

Basic facts about Yasmin and Yaz

2009-08-05T16:54:00.016-05:00

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.

For Bayer $20 Million Corrective Ad Campaign is Just the Cost of Doing Business

2009-08-03T10:20:00.009-05:00

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."

Motion to Consolidate Yaz/Yasmin Lawsuits Filed

2009-07-27T17:49:00.000-05:00

A petition was filed on July 24, 2009 to consolidate the Yasmin/Yaz lawsuits into an MDL in the United States District Court for the Northern District of Ohio. The motion was filed with the Judicial Panel on Multidistrict Litigation in Washington, D.C.

The Yasmin/Yaz lawsuits involve Plaintiffs who have suffered injuries, including deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, kidney failure, seizures, gall bladder injuries, and death after using the birth control pills.

Allen Law Firm to Represent Women Injured by Yaz/Yasmin

2009-07-23T13:46:00.006-05:00

The defective drug lawyers at the Allen Law Firm are are evaluating claims on behalf of individuals throughout the United States who were prescribed Yaz or Yasmin and suffered serious side effects including blood clots, strokes, deep vein thrombosis, pulmonary embolism or death.

The manufacturers of Yaz and Yasmin have put profits over safety in marketing these birth control pills. The advertising campaigns for Yaz/Yasmin in the last three years have consistently minimized the serious risks of these oral contraceptives while exaggerating the benefits. The direct-to-consumer advertising has even raised red flags with the FDA prompting Bayer to be required to run new ads clarifying the serious health risks of Yaz and Yasmin. Sadly, the corrections are too late for many women who have already suffered heart attacks, strokes, deep vein thrombosis, pulmonary embolism, or even death.

If you or a loved one has suffered serious injury or death after using Yaz or Yasmin, contact the lawyers at the Allen Law Firm now for a free consultation.

Yaz Lawsuit Filed in Ohio

2009-07-22T11:54:00.003-05:00

May 26, 2009 - A lawsuit was filed today by a woman and her husband against the makers of the combination hormonal oral contraceptive Yaz. The lawsuit seeks damages for injuries sustained as a result of taking the contraceptive Yaz. The Plaintiff suffered a pulmonary embolism that was allegedly caused by Yaz. The lawsuit was filed against the drug's manufacturer, Bayer Corporation, and related companies.