The Judicial Panel of Multidistrict Litigation assigned the Yasmin And Yaz MDL to Judge David R. Herndon of the Southern District of Illinois. The Yaz/Yasmin/Ocella MDL, docket number 2100 was created for the purposes of consolidating all federal Yaz/Yasmin lawsuits alleging personal injury and wrongful death. The cases are now under the heading IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation.

The Judicial Panel found the Southern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. U.S. District Court Judge David R. Herndon will preside over these Yaz and Yasmin cases for coordinated or consolidated pretrial proceedings. All consolidated actions share factual questions relating to at least one of the drospirenone-containing oral contraceptives Yaz and Yasmin, which are manufactured by Bayer. Plaintiffs in the products liability actions challenge the safety of those oral contraceptives and bring claims for personal injuries or wrongful death stemming from use of the drugs.

Yaz and Yasmin, as well as the generic Ocella, have been associated with various serious side effects, including Blood Clots, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, Cerebrovascular Accidents (CVA), Heart Attack, Myocardial Infarction, Gallbladder Disease / Injury, Gallbladder Removal (cholecystectomy), Kidney Failure or Renal Failure, Pancreatitis and even Death.

Labels: death, DVT, MDL, PE, yasmin, YAZ

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 public interest group, Judicial Watch, recently obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV). In 2007, there were just 19 deaths. The total number of Gardasil associated deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 adverse events in 2008, of which 1,061 were considered serious, and 142 considered life threatening.

Of the 47 reported deaths, 41 occurred within a month of receiving the vaccine and of those 17 were within two weeks or receiving the vaccine. In most of the deaths, the cause is still unknown.

Sixty-two developed genital warts after receiving the vaccine. Gardasil, which is designed to prevent two strains of genital warts, is not supposed to react with other HPV strains.

One woman developed full-blown cervical cancer within 15 months from the completion of the Gardasil vaccination. The patient now has the difficult choice of having a hysterectomy or receiving treatment in hopes that she may be able one day to conceive children.

Please report any adverse events associated with Gardasil to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.judicialwatch.org/news/2009/jun/new-fda-records-obtained-judicial-watch-indicate-28-deaths-related-gardasil-2008

Labels: death, FDA, Gardasil

The Food and Drug Administration said Friday, June 12, 2009, Krystexxa may successfully treat gout, despite evidence of potentially deadly side effects.

Krystexxa is manufactured by Savient Pharmaceuticals of New Jersey.

Krsytexxa’s new drug application has been under review since December. The FDA already has delayed a decision on the drug once.

Krystexxa is an injectable enzyme designed to lower the body's uric acid levels when administered either once or twice a month. Gout is a condition caused by a buildup of uric acid in the body. The drug appears to reduce gout’s symptoms such as relieving swollen joints and pain flare up. Gout affects about 8 million Americans and is most common in men over 40.

In a clinical study, about 24 percent of patients taking Krystexxa suffered a serious side effect, compared with 12 percent of patients taking a placebo pill. There were six deaths among patients taking the drug compared with three among patients taking placebo, though FDA noted many of them had pre-existing heart conditions.

"Because most of the patients developing the serious cardiovascular adverse events had other cardiovascular risk factors... there was uncertainty concerning whether the cardiovascular adverse events represent a genuine safety signal," states Dr. Bob Rappaport, FDA's director for rheumatology products, in a review posted to the agency's Web site.

The FDA is scheduled to ask a panel of outside arthritis experts next Tuesday to weigh in on the drugs risks and benefits. Though not required not required to follow the group's advice, the FDA generally adopts their recommendations. A final decision on Savient's drug is expected by the end of July.

It is possible that the FDA will consider whether additional studies are needed to evaluate Krystexxa's impact on the heart.

An analyst said the drug can likely win approval so long as the company agrees to limit its use to the target patient population and closely monitor negative side effects. The company is specifically seeking an indication for gout patients who are not receiving relief from other treatments.

For more information: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm155149.htm

Labels: death, drug application, enzyme, FDA, Gout, Krystexxa, savient, uric acid

On June 11, 2009, the FDA altered healthcare professionals a clinical trial suggests sirolimus may be associated with an increased morality rate. The study compared the mortality rate of stable liver transplant patients who converted from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune) to those who remained on a CNI regimen.

The trial was conducted by sirolimus’ manufacturer, Wyeth. After one year, the overall treatment failure rates were significantly higher for the patients converted to sirolimus compared to those that continued on CNIs. Treatment failure is measured by the occurrence of acute rejection or premature discontinuation for any reason. Patients on sirolimus discontinued its use due to an adverse event more often than CNI patients. Sirolimus’s most frequent adverse events were peripheral edema, stomatitis, rash, and mouth ulceration.

Currently, Sirolimus is approved for treating prophylaxis of organ rejection in patients aged 13 years or older receiving kidney transplants. The safety and efficacy of this drug in liver or lung transplant patients have not been established by the FDA.

The current Boxed Warning of sirolimus indicates that the use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death.

The FDA is examining this information and will make the appropriate recommendations. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy.

At this time, FDA has not made any changes to the professional label for sirolimus.
Any adverse events associated with Sirolimus should be reported to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787
For information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165015.htm

Labels: CNI, death, kidney failure, Liver, Rapamune, sirolimus, transplant, Wyeth

Propylthiouracil (PTU) treats hyperthyroidism (including Graves disease) by decreasing the amount of thyroid hormone produced by the thyroid gland. Its notable side effects include a risk of agranulocytosis. Agranulocytosis is a rare, drug-induced blood disorder that is characterized by a severe reduction in the number of white blood cells in the circulating blood.

Propylthiouracil is only available in the United States as a generic medication. Some manufacturers include Actavis Elizabeth, LLC of New Jersey and West-Ward Pharmaceutical Corp, also, of New Jersey.

Recently on June 3, 2009, the FDA alerted healthcare professionals of the seriousness of hepatic reactions related to PTU. It poses a risk of serious liver injury, including liver failure and death in adult and pediatric patients.

Reports to FDA’s Adverse Event Reporting System suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole. Metimazole is another treatment option for thyroid disorders. FDA has identified 32 cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and Metimazole are treatments of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months of treatment.

PTU should not be used in pediatric patients as a last resort. The FDA suggests that PTU only be used in pediatric patients who are allergic to or intolerant of Metimazole, and there are no other treatment options available.

West-Ward’s label from September 2007 does warn of agranulocytosis and of severe hepatic reactions. It is generally perceived the treatment of hyperthyroidism and not the disease itself causes these serious side effects.

Reports of adverse events associated with Propylthiouracil, including liver failure, should be reported to the FDA.


The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm

Labels: children, death, FDA, hepatic, Liver, PTU

The Food and Drug Administration is weighing whether patients’ course of treatment for the widely used cancer drug Rituxan should be changed. Rituxan may pose less of a risk of developing progressive multifocal leukoencephalitis (PML) if it is used for a shorter period or with breaks, according the FDA and the Wall Street Journal.

The drug is co-marketed by biotechnology companies Genentech Inc. of California and Biogen Idec Inc. of Massachusetts. Rituxan, which is used to treat lymphoma, a cancer of immune-system cells, had $2.6 billion in U.S. sales in 2008.

PML is a viral infection that affects the white matter of the brain. PML is caused by reactivated JC virus. Latent JC virus is present in about 80 percent of adults. Patients with PML exhibit neurological symptoms like confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. PML gets worse over time, and is usually fatal. There is no treatment or cure for the disease. It is often associated with drugs that suppress the immune system.

A study released in March in the medical journal, Blood linked Rituxan to 57 cases of PML between 1997 and 2008. Of 57, 51 died. The median time between their diagnosis and death was about two months.

The study’s researcher commented: "The potential contribution of Rituxan to the development of PML is unknown; however, it cannot be excluded."

While Rituxan has been linked to a higher number of PML cases, some are not calling for a recall of Rituxan because it is frequently the best option for patients with life-threatening cancer. It is questionable whether the drug should be used in patients who do not have life-threatening diseases. There are typically more options for patients with rheumatoid arthritis, another ailment which Rituxan is approved to treat.

Doctors say Rituxan is also used "off label" for conditions not approved by the FDA, including lupus and psoriasis. FDA officials said they are aware of some off-label uses, which are legal so long as the drug maker does not promote them. Genentech said it doesn't promote off-label use of Rituxan.

Doctors at the FDA have been looking at the long-term uninterrupted use of Rituxan as a potential factor in PML. By suppressing the immune system, the drug may give free rein to the virus, normally under check, that causes the brain disease.

"We've had discussions at the FDA about whether drug holidays or limitations on the duration of therapy might reduce the risk of PML and other serious adverse effects of chronic immunosuppression," said John Jenkins, director of the FDA's drug approval section.

Drug holidays themselves can cause problems, though. "Sometimes [after a break from the drug], the disease recurs more severely and requires higher doses to bring the disease back under control," Dr. Jenkins said.

The FDA warned of the possible link between Rituxan and PML in 2006. Currently, Rituxan's label has a "black box" warning about PML, the strongest possible warning.



Reports of adverse events associated with Rituxan, including PML, should be reported to the FDA.



The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787



For more information please see:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109106.htm

http://online.wsj.com/article/SB124381351149970563.html

Labels: Air France crash update, cancer, death, FDA, national running day, PML, rituxan, Wall Street Journal

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

The FDA is investigating deaths of two Delaware hospital patients that may be linked to the use of the anti-coagulating drug heparin. The FDA is also investigating life-threatening complications in other patients of the same hospital. In total, 5 patients who were administered heparin suffered complications. An independent laboratory is conducting the investigation. The official cause of the complications is unknown.
Baxter International manufactures the commonly used blood thinner, which has had issues with its safety track record. Last year, Baxter issued a recall on heparin. Though not known at this time, company officials believe that the bulk materials used in the heparin involved in Delaware cases came from North American-based Pfizer, unlike the bulk materials involved the tainted heparin from 2008's recall, which came from China. Heparin’s composition is largely derived from pig intestines, which is why China is a large supplier, as it is a major pork producer. Baxter claims that the recall resulted from the use of an adulterated product, referred to as oversulfated chondroitin sulfate, which came from a Chinese supplier. Baxter is based in Deerfield,
The contaminant found in the heparin recalled in 2008 has not been found in the heparin used by the Delaware patients. Baxter’s vast 2008 recall involved a form of the drug distributed in vials and occurred after numerous complications were linked to it, including complications suffered by Dennis Quaid and Kimberly Buffington’s newborn twins. The heparin involved in the Delaware cases is distributed via a different method than the heparin involved in last year’s recall.
For more information please see: http://www.chicagotribune.com/business/chi-tc-biz-brf-heparin-0512may12,0,2613571.story

Labels: anti-coagulating, China, death, Delaware, Dennis Quaid, FDA, Heparin, Pfizer, recall

Dana Jenn began using the NuvaRing in June, 2005. She was a healthy, fit mother of four training to run a marathon. She died suddenly of a pulmonary embolism (a blood clot in the lung) only a month after starting to use the NuvaRing.

Dana's family has chosen to file a lawsuit against the maker of the NuvaRing. Her lawsuit was mentioned in April, 2008 by the Springfield, Missouri newspaper, the News Leader. Dana is represented by Schlichter, Bogard & Denton. Click here to read the article.

If you or someone you love has been hurt by the NuvaRing, you may be entitled to compensation. Contact the expert attorneys at Schlichter, Bogard and Denton for a free consultation.

nuvaring@uselaws.com
nationalinjuryattorneys@uselaws.com
314-621-6115

Labels: death, marathon, Nuva Ring, NuvaRing, pulmonary embolism

Hundreds of women throughout the country are the victims of serious injuries caused by the NuvaRing. They have suffered strokes and blood clots, and many of them died. 150 or more women or their families have filed lawsuits against Organon, the maker of the NuvaRing, for the injuries and deaths it has caused.

The NuvaRing is a vaginal contraceptive ring that provides monthly birth control by inserting it against the cervix. It uses a type of synthetic hormone that is different from the one used in traditional birth control pills and is more dangerous.

If you or someone you love has been hurt by the NuvaRing, you may be entitled to compensation. Contact the expert attorneys at Schlichter, Bogard & Denton for a free consultation.

nuvaring@uselaws.com
nationalinjuryattorneys@uselaws.com
314-621-6115

For more information, see the following links:

Woman warns others not to use NuvaRing

Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device

Wrongful Death Lawsuit Filed Over NuvaRing

Labels: attorney, birth control, blood clot, contraception, death, DVT, lawyer, Nuva Ring, NuvaRing, stroke, thrombosis