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The New York Times Investigates Reported Side Effects of Yaz/Yasmin Birth Control Pills

On September 25, 2009, The New York Times published an article entitled Health Concerns Over Popular Contraceptives, exploring reported side effects associated with the popular birth control pills, Yaz and Yasmin.  Reported side effects of Yaz and Yasmin include blood clots (including deep vein thrombosis and pulmonary embolism), gallbladder disease, heart attack, stroke, kidney failure, liver failure or cardiac arrhythmia.  The primary concern with Yasmin and Yaz is that the active ingredient, drospirenone, increases potassium in the blood to dangerous levels. 

AA LLP represents women who have suffered one or more of the above-listed events after taking Yasmin or Yaz birth control.  For more information on the potential dangers of Yasmin and Yaz, or to have your case evaluated by an AA LLP attorney, please click here.

AA LLP’s Jennie Lee Anderson Among Faculty At Litigating Toxic Tort, Pharmaceutical and Medical Device Cases Seminar

On September 24-25, AA LLP partners Lori E. Andrus and Jennie Lee Anderson attended the American Association for Justice’s Litigating Toxic Tort, Pharmaceutical and Medical Device Cases Seminar in Las Vegas, Nevada.  On September 25, Ms. Anderson moderated the program, which included insightful presentations on a variety of pharmaceutical and medical product cases that AA LLP is actively litigating or investigating, including Avandia, Hydroxycut, Paxil Birth Defects and Gadolinium-based MRI contrast agents.  If you believe that you or a loved one has been injured in connection with use of a pharmaceutical or medical device, please click here to have your case reviewed by an AA LLP attorney.

Yasmin/Yaz Manufacturer Warned by FDA

The U.S. Food and Drug Administration (FDA) has warned the makers of Yasmin and Yaz birth control drugs about problems concerning the testing and quality of the pharmaceutical ingredients in the drugs.  This, after repeated warnings by the federal government to Bayer (and its predecessor Berlex) for improperly marketing its birth control drugs in a manner that overstates the drugs’ benefits and downplays the very serious, and potentially fatal, side effects of the drug.

In a letter released on September 15, 2009, the FDA warned Bayer about the quality control and testing problems relating to the key ingredient in Yasmin and Yaz, drospirenone.  Click here to view the letter.

The warning followed an inspection, conducted in March, of the Yasmin manufacturing plant in Berghamen, Germany that “revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile APIs [Active Pharmaceutical Ingredients].”  Bayer has thirty days to respond to the warning.

Andrus Anderson LLP is representing women who have been harmed by Yasmin and Yaz, including those who have suffered: gall bladder disease, heart attack, stroke, cardiac arrhythmias, pulmonary embolism (PE), deep vein thrombosis (DVT), liver failure and kidney failure.  The primary concern with Yasmin and Yaz is that the active ingredient, drospirenone, increases potassium in the blood to dangerous levels.  A prominent consumer advocacy group, Public Citizen, listed Yasmin as a “Do Not Use” drug in 2002, because:

*Yasmin side effects caused by drospirenone increase blood levels of potassium, which could result in heart problems and other health concerns; and

* There is no evidence that the drug is superior to old contraceptives or that the benefits outweigh the risk of Yasmin dangers.

For more information on the potential dangers of Yasmin and Yaz, or to speak to an attorney, please contact Andrus Anderson LLP by clicking here.

Andrus Anderson Achieves Nationwide Class Action Settlement In Connection With Honda and Michelin PAX System Litigation

Andrus Anderson LLP announces that on June 23, 2009, the Honorable Roger W. Titus entered an Order granting final approval of a nationwide settlement in a consumer class action, which was filed on behalf of Plaintiffs from various States against Defendants, American Honda Motor Co., Inc. (“Honda”) and Michelin North America, Inc. (“Michelin”). The litigation involves the marketing and sale of certain Honda and Acura Vehicles equipped with Run-Flat Tires (“Vehicles”).  The Settlement was negotiated over a number of months with the assistance of a nationally recognized mediator on behalf of Plaintiffs in all of the pending cases and on behalf of a proposed nationwide class with Honda and Michelin.  
 
For settlement purposes, the Court certified a nationwide class consisting of all person or entities who currently own or lease, or previously owned or leased, a Honda Odyssey Touring edition model or Acura RL model equipped with the “Technology Package,” which included Michelin’s PAX® Tire and Wheel Assembly in the United States. Excluded from the class are Defendants, Defendants’ employees, officers and directors, and the Judge to whom this Action is or has been assigned. For a copy of the Court’s Order Preliminarily Approving the Settlement and the Settlement Agreement, please click on the appropriate links below.  A detailed explanation of the relief under the Settlement can be found in the Class Notice. To view a copy of the Class Notice, please click here.  To submit a claim in connection with this settlement, click here to down load a copy of the claim form which should be submitted by mail as directed.

Lori Andrus Elected Secretary of the Women Trial Lawyers’ Caucus, American Association for Justice

July 28, 2009 -

Attorney Lori Andrus was elected Secretary of the American Association for Justice’s Women Trial Lawyers’ Caucus.  In this position, Ms. Andrus will continue to pave the way for female law students to join the ranks of the plaintiffs’ bar.  Ms. Andrus and the leadership of the Women’s Caucus are also committed to their continued fundraising efforts for the Women for Justice Education Fund, which Ms. Andrus helped found in 2008.

This year, the Women’s Caucus awarded two scholarships from the Women for Justice Education Fund, named after a primary benefactor, Mike Eidson.  Each year, the Mike Eidson Scholarship is awarded to a third-year female law student who commits to plaintiffs’ practice.  This year’s recipients, Samika Boyd and Christine Dunphy, both women of color, boast impressive academic acheivements, particularly in light of the obstacles they each faced growing up in poverty.  Ms. Andrus is pleased to support Ms. Boyd and Ms. Dunphy in their academic endeavors and as they enter the world of public service and trial law.

The mission of the American Association for Justice (formerly ATLA) is to promote a fair and effective justice system—and to support the work of attorneys in their efforts to ensure that any person who is injured by the misconduct or negligence of others can obtain justice in America’s courtrooms, even when taking on the most powerful interests.

Cal State ESL Teachers Represented by Andrus Anderson LLP

Andrus Anderson represents California State University-East Bay (Cal State) English as a second language (ESL) teachers in a class action in Alameda County Superior Court.  The lawsuit, Nelson et al., v. California State University, East Bay Foundation, Inc., was filed on March 23, 2009 (Case No. RG09442869).

ESL Teachers Allege Violations of Labor Laws, Back Pay Owed

In their complaint, current and former ESL teachers allege that Cal State has not paid them for all hours worked, as required under California’s labor laws.  Specifically, the teachers claim that Cal State’s refusal to pay for all time worked outside of the classroom (including preparation time, grading time and time spent meeting with students), violates California Wage Order 4-2001 and California’s Business & Professions Code § 17200.  Additionally, the lawsuit alleges breach of contract, failure to pay waiting time penalties to former teachers, and failure to maintain accurate time keeping records.

The ESL teachers seek certification of a class of ESL teachers who have not been paid for all hours worked since March 23, 2005, and, among other things, seek back pay with interest, restitution, and civil penalties.

Contact Andrus Anderson

If you are an ESL teacher and have been denied pay for time spent outside of the classroom, we would like to learn more about your experience as part of our investigation.  Please click here to submit your complaint.

Andrus Anderson Investigating Hydroxycut Injuries

Andrus Anderson LLP is investigating potential cases involving users of Hydroxycut® products who have experienced health problems that may include Rhabdomyolysis (muscle damage that can lead to kidney failure and other health problems), death, cardiovascular symptoms, hypertension, elevated liver enzymes (that can indicate liver failure), kidney failure and seizures.

If you would like to discuss Hydroxycut® cases, associate with us or refer cases to us, please contact attorney Lori Andrus at lori@andrusanderson.com.

Supplement Recall

On May 1, 2009, the FDA issued a consumer advisory that warned consumers to stop using Hydroxycut® products immediately, citing 23 reports of serious health problems and one reported death associated with use of Hydroxycut® products.  Reports of liver damage involved individuals taking the label’s recommended dosage.  Hydroxycut® products are distributed by Iovate Health Sciences USA Inc.  Iovate initiated a voluntary recall when it became aware that the FDA’s safety assessment differed from its own analysis.

Although the reports of serious health problems do not apply to all Hydroxycut® products, Iovate has issued a recall for the following 14 items:

*    Hydroxycut Regular Rapid Release Caplets
*    Hydroxycut Caffeine-Free Rapid Release Caplets
*    Hydroxycut Hardcore Liquid Caplets
*    Hydroxycut Max Liquid Caplets
*    Hydroxycut Regular Drink Packets
*    Hydroxycut Caffeine-Free Drink Packets
*    Hydroxycut Hardcore Drink Packets (Ignition Stix)
*    Hydroxycut Max Drink Packets
*    Hydroxycut Liquid Shots
*    Hydroxycut Hardcore RTDs (Ready-to-Drink)
*    Hydroxycut Max Aqua Shed
*    Hydroxycut 24
*    Hydroxycut Carb Control
*    Hydroxycut Natural

Supplement History

Hydroxycut® products are heavily advertised dietary supplements, energy enhancers and fat burners that are widely distributed and, according to the FDA, sold more than 9 million items in 2008.  Although Hydroxycut® products contain a variety of ingredients and herbal extracts, the FDA has not identified the ingredients, dosages or other health-related factors that may be associated with an increased risk of liver damage and other health problems.

Related Injuries

Symptoms of liver damage and other health problems associated with Hydroxycut® use may include:

*    Jaundice (yellowing of skin or whites of the eyes)
*    Brown urine
*    Light-colored stools
*    Nausea or vomiting
*    Excessive fatigue and weakness
*    Stomach or abdominal pain
*    Itching
*    Loss of appetite

As the manufacturer of dietary supplements, Iovate is required by the Dietary Supplement Health and Education Act of 1994 to ensure product safety before placing it on the market, but the product does not undergo FDA approval.  Once a product is on the market, the manufacturer must report adverse events to the FDA within 15 days.

F.D.A. Urges Consumers To Immediately Stop Using Hydroxycut

The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc., of Oakville, Ontario and distributed by Iovate Health Sciences U.S.A., Inc. of Blasdell, NY.  Hydroxycut products are associated with a number of serious liver injuries.  To see the FDA’s statement on Hydroxycut click here.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplants.  One death due to liver failure has been reported to FDA.  Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Genentech Pulls Psoriasis Drug Raptiva Due To Risk of Fatal Brain Infection

Today, Genentech and the U.S. Food & Drug Administration (FDA) announced a voluntary withdrawal of the drug Raptiva (efalizumab).  According to the statement issued by the FDA, “The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.”

Prescribers are being asked not to initiate Raptiva treatment for any new patients.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches of skin. On Oct. 16, 2008, the FDA updated the labeling for Raptiva to warn of the risk of life-threatening infections, including PML. Then, on Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva’s labeling regarding PML.

Supreme Court Rules In favor Of Diana Levine

The U.S. Supreme Court in a 6-3 decision upheld a Vermont’s jury decision that Diana Levine, the plaintiff in the case Wyeth v. Levine could hold the drug manufacturer accountable for the injuries she suffered — which included the loss of her arm — after taking one of Wyeth’s medicines.

Writing the Supreme Court’s majority opinion, Justice John Paul Stevens said Food & Drug Administration oversight of drug labeling doesn’t prevent the filing of state-level consumer liability lawsuits against drug companies.  Joining Stevens in the majority were Supreme Court Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer, and Clarence Thomas.

The following is a statement from American Association for Justice President Les Weisbrod:

“The Supreme Court reaffirmed the principle that state lawsuits perform a valuable and important function in ensuring accountability in uncovering drug hazards.  Also, the Supreme Court rejected the FDA’s attempts to use the preamble in drug regulations to provide complete immunity to drug manufacturers.

It is clear consumers retained their remedy under law when drug companies have failed to provide adequate warnings for the safe use of their drugs.

Today’s decision in favor of Diana Levine proved that even if you are just one person, you can fight for justice and hold your wrongdoer accountable.”