Injury Law Blog and News » Health – women

FDA Advisory Panel to Discuss Safety of Transvaginal Mesh

admin — Wed, 07 Sep 2011 23:56:47 +0000

Bloomberg reports that transvaginal mesh lawsuits are on the rise, and that a two-day hearing on their safety and effectiveness will begin tomorrow. An advisory panel “won’t take any formal votes,” but the “FDA will poll the panel of researchers and physicians on whether to reclassify the devices and gather thoughts on how to conduct clinical studies.”

Transvaginal mesh was approved as a moderate risk device under the FDA’s controversial 510(k) process. The FDA’s 510(k) process allows for a medical device to be approved for market without clinical data if it is deemed “substantially equivalent” to products already on the market. This “substantially equivalent” approval condition has been criticized as overly lax and responsible for public health nightmares such as DePuy’s recalled ASR hip implant.

Transvaginal mesh failures were cited in the U.S. Institute of Medicine’s July review of the FDA’s medical device approval and their recommendation that the process be replaced with a stricter system. Opponents of transvaginal mesh allege that the mesh products, currently classified as moderate risk devices, expose patients to higher risks than non-mesh products, and ask that transvaginal mesh be recalled and reclassified as a high risk device.

Previously reported in Bloomberg, the FDA issued a transvaginal mesh safety warning in July 2011, stating that it has received “1,503 reports of complication associated with the material from January 2008 to December 2010.” It is in response to these widespread reports of complications that the FDA is considering a change in risk classification.

College Student Who Died From Prescribed Yaz Profiled by CBS Early Show

admin — Wed, 06 Jul 2011 09:48:51 +0000

The CBS Early Show interviewed Joan Cummins, the mother of Michelle Pfleger who died last year while walking to her morning class at college. Cummins has filed a lawsuit against Bayer charging that its birth control drug Yaz, which Michelle was prescribed for the treatment of acne, caused the blood clot that killed her.

Photo: Yaz Birth Control

Click here to watch the TV report: http://www.cbsnews.com/video/watch/?id=7368159n

The symptoms of blood clots include persistent leg pain, severe chest pain, or sudden shortness of breath. The FDA advises that patients contact their healthcare professional immediately if they develop any of these symptoms. Furthermore, if you smoke and are over 35 years of age, the FDA advises that not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Contact Lieff Cabraser

If you or a family member have suffered a serious injury or a loved one died after taking Yaz, or similar drugs Yasmin and Ocella, please read Lieff Cabraser’s Yaz birth control side effects FAQ webpage to learn more about your legal rights and submit a complaint.

Trademark Notice

Yaz and Yasmin are registered trademarks of Bayer Schering Pharma Aktiengesellschaft. Ocella is a registered trademark of Barr Laboratories, Inc. The use of these trademarks is solely for informational and product identification purposes.

FDA Expands Safety Review of Yaz, Gianvi, Yasmin, Ocella and other Birth Control Drugs

admin — Tue, 31 May 2011 22:05:43 +0000

As part of its ongoing safety assessment of birth control pills, the Food and Drug Administration (FDA) announced on May 31, 2011, that is reviewing two newly published studies on the risk of blood clots in women who use birth control pills that contain drospirenone. The brand names of drospirenone-containing oral contraceptives include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.

Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones–estrogen and progestin.

While all birth control pills pose a risk of blood clots, the new studies found that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel found in earlier generation oral contraceptives. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills.

Video: Attorney Wendy Fleishman Discusses Birth Control Side Effects & Litigation

Contact Lieff Cabraser

Trademark Notice

Yaz Birth Control Pill Dangers: Death of 18-year College Student Leads to Yaz Lawsuit

admin — Tue, 10 May 2011 21:44:28 +0000

Last September, Michelle Pfleger was walking to her morning class at Elon University in North Carolina when she suddenly collapsed. Michelle was taken to a nearby hospital, but despite the efforts of the medical professionals, she died. The autopsy report showed that Michelle died from cardiac arrest triggered by a pulmonary emboli, which is a blood clot in the lungs that can lead to abnormally low blood pressure and sudden death. Michelle was prescribed Yaz for the treatment of acne.

“One day she was a freshman at college so full of hope and promise and the next she was gone,” said Michelle’s mother, Joan Cummins on the date she filed a wrongful death lawsuit against Bayer, the manufacturer of Yaz. “I can only hope that by publicizing what happened to Michelle, I can keep another family from having to go through this.”

Photo: Michelle Pfleger

The lawsuit follows the publication in the British Medical Journal in April 2011 of two studies finding that women taking oral contraceptives with the hormone drospirenone, which includes Bayer’s Yaz and Yasmin, have a three-fold or two-fold increased risk of developing serious blood clots than women taking earlier-generation oral contraceptives that do not contain drospirenone. In one study, the risk of blood clots in the veins and the lungs was more than three times greater for women prescribed contraceptives containing drospirenone.

Contact Lieff Cabraser

If you or a family member have suffered a serious injury or a loved one died after taking Yaz, or similar drugs Yasmin and Ocella, please read Lieff Cabraser’s Yaz side effects FAQ webpage to learn more about your legal rights and submit a complaint.

Photo: Yaz Birth Control

Update June 2, 2011

The CBS Early Show interviewed Joan Cummins and profiled the risks of Yaz.

Trademark Notice

Yaz, Yasmin: Medical Evidence of Greater Danger of Blood Clots Mounts

admin — Sat, 23 Apr 2011 05:56:03 +0000

Two new studies show that women who take birth control pills with the newer hormone drospirenone, including Bayer HealthCare Pharmaceuticals Inc.’s Yasmin and Yaz, have a higher risk of developing potentially serious blood clots than women who take oral contraceptives containing the older hormone levonorgestrel.

In one study, women who took the oral contraceptives Yasmin, Ocella, Gianvi, and Zarah (all of which contain drospirenone) had a threefold increased risk of non-fatal venous thromboembolisms (blood clots in the veins and the lungs) compared to women who took the oral contraceptives Jolessa, LoSeasonique, Quasense, Seasonale, and Seasonique (which do not contain drospirenone and are earlier-generation birth control pills).

The studies were published in the extremely well-respected British Medical Journal and involved U.S. and U.K. women who used oral contraceptives.

“These findings contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism [blood clots] than do formulations containing levonorgestrel,” the authors of the studies said.

Lieff Cabraser represents women across America who developed blood clots, and the families of loved ones who died. Learn more about Yaz lawsuits and read our answers to frequently asked questions on Yaz side effects.

Long-Term Use of Osteoporosis Drugs and Increased Risk of Fractures

admin — Wed, 23 Feb 2011 20:24:14 +0000

On February 23, 2011, the Journal of the American Medical Association published a study finding that long-term treatment with a class of drugs known as bisphosphonates to treat osteoporosis actually increases the risk of rare femur fractures by three times compared to women prescribed the bone drug for less than 100 days. Long-term treatment in the study was defined as continuous use for more than five years.

The researchers concluded:

In summary, our findings provide strong evidence that prolonged bisphosphonate therapy is associated with an increased risk of subtrochanteric or femoral shaft fracture, although the absolute risk of these fractures is low. These findings also highlight the need for a thoughtful assessment of individual risk of fracture when considering extended bisphosphonate therapy and that long-term use of these drugs may warrant reconsideration, especially in patients at relatively low risk of fracture. It may be appropriate to consider a drug holiday for selected patients, particularly as the cumulative duration of bisphosphonate therapy surpasses 5 years.

Last year, the Food and Drug Administration warned patients that bisphosphonates approved for osteoporosis treatment may pose the risk of a rare type of thigh bone (femur) fracture, particularly with patients who have taken Fosamax and/or other bisphosphonates for several years.

The FDA warning applies to:

oral bisphosphonates such as Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D, and their generic products; and
injectable bisphosphonates such as Boniva and Reclast and their generic products.

Lieff Cabraser represents patients injured by prescription drugs with dangerous undisclosed side effects. Learn more about bone drug (including Fosamax) lawsuits.

Bayer Healthcare To Launch New Birth Control Pill Amid Controversy Over Yaz Oral Contraceptive

admin — Tue, 24 Aug 2010 23:22:32 +0000

NPR reported[link] this week that Bayer is planning to release its latest birth control pill called Natazia. The new drug contains a form of estrogen never before used as an oral contraceptive. In addition to the drug itself, the dosing schedule is also new: women will take four combinations and doses of hormones each month instead of one pill a day.

Bayer is the leading manufacturer of birth control pills, and their development of a new contraceptive pill comes at a time when Bayer is still dealing with the fall out from alleged serious side effects from its previous birth control drug Yaz.

Across the U.S., almost 3,000 women are suing Bayer alleging serious injuries related to the use of the drug. Side effects may include blood clots, deep vein thrombosis, strokes, heart attacks, gall bladder damage, and kidney problems. In certain cases, women have died suddenly. Learn more about dangerous Yaz side effects and Yaz lawsuits.

Yaz side effects and Yaz lawsuits

Bayer Healthcare Pharmaceuticals Inc. to Update Yaz & Yasmin Warning Label

admin — Wed, 14 Apr 2010 23:41:31 +0000

According to press reports, Bayer Healthcare Pharmaceuticals has agreed to change its warning labels on their oral contraceptive drugs Yaz and Yasmin to alert users to the risks of developing blood clots while using Yaz and Yasmin. The newly updated labels will now state that the risk of using these two birth control products is “comparable” to that of other oral contraceptives. However, as alleged in complaints against Bayer by injured patients and the families of loved ones, who have died, Yaz and Yasmin are dangerous drugs, posing a greater risk of blood clots and serious injuries than earlier generations of birth control pills that are available for use in the U.S. and worldwide.

The decision to update the labels came after two studies that were commissioned by Bayer showed that the risk of Yaz and Yasmin was comparable to that of other oral contraceptives on the market, according to press reports.

Click here to learn more about the risks associated with Yaz and Yasmin.

Mother Charges Yaz Birth Control Pill Killed Her College Student Daughter

admin — Thu, 18 Feb 2010 01:49:18 +0000

In January 2010, Leah Mayfield was rushed to the hospital after passing out in the shower. Less than an hour later she was dead. The official cause of death was a pulmonary embolism (a blood clot in the lungs). At the emergency room, a doctor informed Traci Mayfield that Yaz, a prescription birth control pill Leah had been taking, could have caused the blood clot.

In a report by the CBS affiliate TV station in Nashville, Tennessee, Traci Mayfield spoke of her love for her 20-year old daughter Leah, “We were more than mother/daughter, we were best friends. She blossomed into a beautiful young lady [in college].”

Leah and Traci Mayfield

Traci Mayfield has filed a lawsuit against Bayer, the manufacturer of Yaz, for death of her daughter, and is warning others of the dangers of Yaz. (Ms. Mayfield is represented by Lieff Cabraser Heimann & Bernstein, LLP). Watch the news report.

If you or a loved one have been injured or died as a result of taking Yaz or Yasmin, please visit Lieff Cabraser’s Yaz/Yasmin legal information page or call us toll-free at 1-800-541-7358. Our personal injury attorneys and legal nurse consultants will promptly review your case for no charge or obligation on your part.

Breast Cancer and Link to Hormone-Replacement Therapy Drugs: Trial Updates

admin — Tue, 24 Nov 2009 17:01:45 +0000

A Philadelphia jury returned a $28 million punitive damages verdict Monday against two drugmakers over the drugmakers’ hormone-replacement therapy drugs that the jury found caused a plaintiff’s breast cancer. And a $75 million punitive damages verdict from the end of October in another hormone-replacement therapy, or HRT, mass tort case was unsealed by court order after the other jury verdict was rendered around 2 p.m. Monday.

On Friday, the jury in Kendall v. Wyeth awarded more than $6 million in compensatory damages to plaintiffs Donna Kendall and John Kendall Jr., their attorneys said. In the punitive damages part of the case decided Monday, the jury awarded $16 million against Wyeth, which is now owned by Pfizer, and $12 million against Pharmacia & Upjohn, which also is now owned by Pfizer. The total verdict adds up to more than $34 million.

Read the full article on law.com.