Attorneys at Schlichter, Bogard & Denton file Yasmin/Yaz lawsuit

Date Released: 07/24/2009 St. Louis, MO – The attorneys at Schlichter, Bogard & Denton, L.L.P. filed suit this week in Iowa federal court against Bayer alleging that Bayer’s oral contraceptives Yasmin and Yaz are defective and present an increased risk of injury to women. Their client represents her daughter who at the age of 23 died suddenly of multiple bilateral pulmonary embolisms after using Yaz for only 8 months. The client’s daughter was engaged to marry her high school sweetheart. She had also just graduated from college and was to start her first post-graduation position a scant three days after her sudden death. An avid swimmer, plaintiff’s daughter was named to an All American Swim Team three times and gave swim lessons through the American Red Cross. She is survived by her fiancé, parents, two siblings, grandparents, aunts, uncles and cousins.

The lawsuit alleges that Bayer failed to warn the client’s daughter and their physicians of the increased risk of injury, while over-promoting the benefits of the drugs. In October of 2008, the Food and Drug Administration (FDA) sent Bayer a warning letter objecting to its television ads claiming that Yaz has additional benefits compared to other oral contraceptives. The FDA’s letter warned that Yaz actually has additional risks because it contains the progestin drospirenone. The warning prompted an agreement for Bayer to spend $20 million on corrective ads.

Both Yasmin and Yaz have been associated with heart attacks, deep vein thrombosis, pulmonary embolism, stroke and even death in young women.

Schlichter, Bogard & Denton attorneys Roger Denton, Kris Kraft and Beth Wilkins are experienced in litigating dangerous birth control product liability cases. Mr. Denton, Ms. Kraft and Ms. Wilkins are also vigorously litigating suits against the makers of Ortho Evra and NurvaRing in addition to Yasmin/Yaz. Schlichter, Bogard & Denton are lead attorneys on the NuvaRing MDL.

Currently only a handful of Yasmin/Yaz cases across the country have been filed against the manufacturer. Not only are Mr. Denton, Ms. Kraft, and Ms. Wilkins pioneers in these suits across the country, they are also leading their firm’s Yasmin and Yaz litigation and expect to file additional lawsuits in the coming weeks.

Media Contact: Kristine Kraft Schlichter, Bogard & Denton, L.L.P. Phone: 314.621.6115 kkraft@uselaws.com www.uselaws.com

Labels: athlete, Bayer, bilateral pulmonary embolism, death, Deep Vein Thrombosis, DVT, heart attack, Iowa, stroke, YAZ

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.
Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.
The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.

For more information please see:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

Popular heart bypass technique may pose risk
A common method used in heart bypass surgery spares patients pain and problems upfront but seems to raise their risk of dying or suffering a heart attack over the next three years.

In heart bypass surgery, doctors remove a leg vein that moved to the chest to create detours around clogged heart arteries.

For decades, the leg vein was removed with a long incision — sometimes groin to toe. This technique referred to as "open harvesting" is painful, leaves big scars and often led to infections and longer hospital stays.

About 13 years ago, doctors began using a new way by making small "porthole" cuts and using a tiny scope and tools to tunnel along the vein and pull it out through the small openings. This technique, "endoscopic harvesting," is very popular. Of the approximately 450,000 bypass operations done each year in the US, 70 percent use the less invasive method.

However, the study recently published in the New England Journal of Medicine found that patients treated with the endoscopic harvesting method were significantly more likely to die, suffer a heart attack or need another artery-opening procedure in the following three years. The likely reason is that the vein suffers damage from being pulled out, so it doesn't hold up well over time.

The study involved 3,000 patients at more than 100 sites around the country who had been part of another study testing an experimental drug. Because its primary aim wasn't to evaluate the leg artery removal technique, the results on the endoscopic harvesting method are not definitive.

More than 9 percent of people whose veins were removed with the newer endoscopic harvesting method died or suffered a heart attack in the following three years, versus fewer than 8 percent of those who had the traditional big incision.

More research is needed to confirm the results, but doctors probably should use the technique more sparingly or handle the vein more carefully when they do pull it out.

For more information please see: New England Journal of Medicine Article

Labels: bypass sugery, doctor, endoscopic, heart attack, new england

The Food and Drug Administration approved a blood thinner from Eli Lilly, of Indianapolis, but the drug must have a black box warning of its risk of causing bleeding. The boxed warning is reserved for issues that can cause serious injury or death.

Lilly’s Effient is the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb.

A Lilly study of more than 13,000 patients found that thought Effient prevented more heart attacks than Plavix, it caused more internal bleeding. Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar.

The F.D.A. approval of Effient was 18 months long it weighed the drug’s benefits and risks.

Effient should not be taken by patients with a history of bleeding, stroke or who are undergoing an operation.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. Effient is approved only for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.

For more information please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Labels: angioplasty, approval, bleeding, blood thinner, Effient, FDA, heart attack, plavix

A federal investigation has revealed that heart attack survivors enrolled in a study using Chelation, which involves periodic infusions of the drug Disodium ETD, were not told enough about potential dangers from the drug, including death.

Findings from the investigation were revealed this week by the U.S. Office for Human Research Protections in a letter to the three medical centers leading the study, Mount Sinai Medical Center in Miami Beach, Florida; the University of Miami; and Duke University Medical Center in Durham, North Carolina.

The probe found that several doctors doing the study had been accused of poor practices by state medical boards or involved in insurance fruad, and that at least three are convicted felons. Federal officials recommended corrective steps to researchers, but have allowed to study to go on while the probe continues. This decision has angered critics. Arthur Caplan, Chief of Bioethics at the University of Pennsylvania stated, “This study should not be going on. It is incredibly unethical to subject anyone to these risks.”

Disodium ETD carries a risk of kidney failure, bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breath troubles, reported the American Heart Association.

For additional information see: http://www.msnbc.msn.com/id/31715589/ns/health-heart_health/

Labels: Duke University, heart attack, heart disease, insurance fraud, medical boards, Mount Sinai Medical Center

Those suffering from Type II diabetes, beware. The FDA has recently announced that they are issuing a new Black Box warning on the Type II diabetes medicines, Actos and Avandia. Both of these drugs have been connected with an increased risk for heart attacks and heart-related deaths. Anyone who has taken Actos or Avandia could potentially be at risk.

The warning urges physicians prescribing Actos and Avandia to watch their patients for signs of heart problems. Some symptoms of a heart problem are: shortness of breath, edema (retaining of fluid causing swelling of extremities), and excessive or rapid weight gain. Anyone experiencing any of these symptoms and taking Actos or Avandia should contact their doctor immediately.

Type II diabetes is a disorder that is characterized by high blood glucose due to an insulin deficiency. The insulin resistance is caused because the cells do not respond appropriately to insulin. Unlike Type I diabetes, Type II is a problem of cellular response to insulin rather then a problem with the production of insulin. The prevalence rate of diabetes have doubled from 1990-2005, causing the Center for Disease Control to declare it an epidemic.

For more information see:
The FDA warning: http://www.fda.gov/medwatch/SAFETY/2002/summary-actos-avandia.PDF
The American Diabetes Association Website: http://www.diabetes.org/

Labels: Actos, Avandia, diabetes, edema, heart attack, myocardial infarction, Type II

YAZ is the first birth control pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). Fourth generation progestin drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. YAZ was approved by the FDA in March 2006.
A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", regarding approval of the drug suggests cardiovascular events are not a concern when using YAZ. The press release states:
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
In YAZ’s current package insert, the warning above is bolded while serious cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke are not emphasized.
The FDA now has some concerns about an association between YAZ and DVT, PE, heart attack, and stroke as demonstrated in the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study.
WebMD even lists blood clots such as pulmonary embolism, stroke or heart attacks as rare but very serious side effects of using YAZ.
There are numerous reports of women suffering from a DVT or a PE while using YAZ pills.
The safety concerns surrounding YAZ are similar to the serious and at times fatal side effects of unsafe birth control like Ortho Evra and NuvaRing.
For more information please see: http://www.fda.gov/medwatch/SAFETY/2007/Jan_PI/Yaz_PI.pdf,
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf
http://www.medicalnewstoday.com/articles/39844.php, http://clinicaltrials.gov/ct2/show/NCT00335257,
http://www.webmd.com/drugs/mono-656-ETHINYL+ESTRADIOL%2FDROSPIRENONE+24%2F4+-+ORAL.aspx?drugid=95358&drugname=YAZ+28+Oral,

Labels: birth control, cardiovascular, death, Deep Vein Thrombosis, DVT, heart attack, PE, pulmonary embolism, stroke, YAZ

Biosite and FDA notified healthcare facilities and clinicians of the recall of Biosite® brand Triage Cardiac Panel
Biosite and the Food and Drug Administration have recently notified emergency room and hospital laboratory personnel of a Class 1 recall of the Biosite brand Triage Cardiac Panel. FDA defines a Class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. “
The Biosite ®Triage Cardiac Panel is a test used by hospitals and clinics to assist medical professionals in making the diagnosis of a heart attack. On April 27, 2009, the company sent an urgent recall notice to hospitals and clinics. Facilities were instructed to immediately stop using the tests, and to throw away all packages showing the recalled lot number. Using test kits from the defective lot may lead to false negative results in blood samples containing very low levels of the blood markers used to determine heart damage.
These inaccurate test results can possibly mean that heart attacks, especially in the early stages, were incorrectly diagnosed or missed completely as clinicians relied on incorrect test results as a part of making a correct diagnosis. The defective test kits might not have been sensitive enough to detect low levels of the blood markers to indicate that a person had a heart attack or other damage to the heart muscle.
Testing packets with the recalled lot number were sold to hospitals and clinics from January 24, 2009 through February 17, 2009. If you or a loved one has recently been treated for heart related chest pain or other heart related symptoms, and early signs of a heart attack were missed or incorrectly diagnosed, you may be entitled to compensation.
If you would like to view the complete recall notice, you may do so at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel

Labels: Biosite, cardiac, heart attack, javascript:void(0) class 1, misdiagnose, panel, recall, triage