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 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.”

FDA Warns Of Risk Of Complications From Transvaginal Placement of Surgical Mesh

If you or a loved one was treated for stress urinary incontinence or pelvic organ prolapse with surgery that involved the transvaginal placement of surgical mesh, you may be at risk of developing serious medical complications. An estimated 1,000 women in the United States have suffered serious injuries and complications following the surgical procedures in recent years, prompting the U.S. Food and Drug Administration to issue a public advisory about nine brands of surgical mesh.

Women who were injured by the use of transvaginal placement surgical mesh in surgeries to repair damage done by stress urinary incontinence or pelvic organ prolapse may have rights to financial compensation. Complications commonly associated with this type of surgical product include infection, pain, and perforation of the bowel, bladder, and blood vessels. The experienced attorneys at Andrus Anderson LLP are dedicated to fighting for victims of surgical mesh to receive the financial compensation to which they are entitled.

FDA Warning

In October 2008, the FDA issued a public health warning to warn consumers about the risks of complication from the transvaginal placement of surgical mesh. Although rare, the complications pose serious health risks to women. The FDA recommended that physicians receive additional training in the use of the products and give more information to patients about the mesh in an effort to reduce injuries and complications.

When is the Transvaginal Placement of Surgical Mesh Used?

The transvaginal placement of surgical mesh is most commonly used in surgical mesh used to treat stress urinary incontinence and pelvic organ prolapse. The mesh is placed along the vaginal wall to protect the area and is designed to be left permanently inside the body.

Vaginal Mesh Injuries

Women injured by the transvaginal placement of surgical mesh may suffer a wide range of injuries, including infection, bladder pain, urinary problems, and a recurrence of the condition for which the surgery was done. There have also been reports of bowel, bladder, and blood vessel perforation during insertion of the mesh and of vaginal scarring and mesh erosion.

New Report Shows How Drug Industry Immunity Would Endanger Women – U.S. Supreme Court to Decide Major Case Soon

New York – A new report released today by the national consumer rights group Center for
Justice & Democracy finds that many of this country’s dangerous government-approved drugs and devices have been marketed specifically for women. Many of these products were removed or made safer only after women filed lawsuits.

The release of the report, THE BITTEREST PILL – How Drug Companies Fail To Protect Women and How Lawsuits Save Their Lives, comes less than a week before the U.S. Supreme Court hears arguments in Wyeth v. Levine, widely considered to be one of the court’s most important decisions this term. The Court will hear arguments on November 3 whether to afford the drug industry unprecedented legal immunity for causing injuries or death, despite negligent or irresponsible behavior.
“This report tells the story of the hyped marketing to women of a disproportionate number of unsafe drugs and devices resulting in countless deaths and injuries,” said report co-author Joanne Doroshow, Executive Director of the Center for Justice & Democracy. “Many times, these dangers were only known, or in some cases products pulled from the market, after women and their families filed lawsuits. As a result, the lives of countless other women have been saved. Blanket immunity for drug companies would be devastating for American women of all ages.” “Women have been hurt many times over the years by FDA-approved drugs, whether because drug companies withheld information and lied about health risks, or because the FDA has lacked the resources or political will to keep dangerous products off the market,” said Cynthia Pearson,
Executive Director of the National Women’s Health Network. “This report from Center for Justice & Democracy documents the devastating consequences of these regulatory failures and shows how women who have been hurt by unsafe drugs have used lawsuits to bring critical information to light, protecting other women from suffering similar harm.”

THE BITTEREST PILL examines the history of a variety of products including many types of birth control methods and hormone therapies, as well as lactation and acne drugs. Said report coauthor Amanda Melpolder, “This report clearly shows how the health and safety of women have greatly benefited from lawsuits over these products. As new drugs and devices are developed and marketed, it is imperative that women have the safest and most effective products available. That means making sure corporations are held legally accountable for causing injuries.”

Get Out of Jail Free: How the Bush Administration Helps Corporations Escape Accountability

The United States Supreme Court and Congress are currently facing critical issues that—depending on how they are resolved—could provide negligent corporations complete immunity from lawsuits.

It’s called “federal preemption,” and it refers to situations in which federal regulation trumps state law. And, perhaps most surprising, Americans and many policymakers have never heard of it. When viewed through the context of unsafe products, preemption of state law means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans. The civil justice system offers corporations a powerful incentive to make their products safer. All people should have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations.

The American Assocation for Justice recently released a series of documents that detail how helping negligent corporations escape accountability has been a top priority for the Bush Administration. The documents were obtained through repeated Freedom of Information Act requests by AAJ and reveal how the Bush Administration has silently ordered federal agencies to usurp state law and consumer protections.

You can obtain a copy of the AAJ report (titled “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability”) by clicking here.