California Injury Lawyer Blog

Qualitest Pharmaceuticals, which is an entity of Endo Pharmaceuticals Holdings Inc., has recalled more than a million packages of defectively packaged birth control pills. The voluntary recall, which takes effect immediately, was issued because of a packaging error that may inadvertently cause women to take the incorrect dose of birth control and consequently, put women at risk for an unplanned pregnancy. In a statement released by the U.S. Food and Drug Administration (FDA), multiple lots of birth control pill blister packs were rotated 180 degrees, which resulted in the reversal of the daily regimen. The rotation also hid the lot number and expiration date. According to the FDA, there are no immediate health risks associated with the error, but women taking the affected pills are being told to use a non-hormonal form of birth control immediately and consult a health care provider.

Qaulitest Pharmaceuticals spokesperson, Kevin Wiggins, told CNN the recall affects 1.4 million packages of oral contraceptives, including Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Orysthia, Gildess FE 1.5/30, Gildess FE 1/20, Previfem and Tri-Previfem. A detailed list of the affected pills can be found here. For additional information on the recall, contact Qualitest toll-free at (877) 300-6153.

Product Liability Lawyers

If you or someone you know suffered an unplanned pregnancy as a result of taking one of the affected Qualitest birth control pills, contact a California product liability lawyer at Estey Bomberger. We have more than 70 years collective experience helping victims obtain compensation for damages associated with the use of a dangerous or defective product. Victims may be able to collect financial compensation for medical expenses, lost wages due to time away from work and other various types of damages.

Continue reading "Birth Control Pill Packaging Error May Cause Unplanned Pregnancy" »

A wrongful death lawsuit has been settled following an Illinois woman's death from liver failure in 2004. Pamela Hoppe sought help from LA weight loss in 2004 and was given supplements that were not regulated or tested by the US Food and Drug Administration (FDA). She was diagnosed with liver failure caused by the supplements and died on August 29, 2004, about four months after beginning treatment at LA Weight Loss.

The FDA supervises the safety of food and drugs, including supplements and diet pills. However, dietary supplements are not regulated until after they have reached the market. Manufacturers are responsible for making sure their products are safe before putting them on the market. If products safe found to be harmful, the FDA may take action. Consumers injured by dangerous products may be entitled to compensation in a product liability claim.

If you or a loved one have suffered injury from a dietary supplement or dangerous diet pill, contact the attorneys at Estey Bomberger for a free consultation. You may be entitled to monetary compensation from the manufacturer of the supplement and other parties. The law firm of Estey Bomberger has successfully handled numerous dangerous product cases, including weight loss supplement injury claims.

As the number of Zicam lawsuits continue to rise, Matrixx Initiatives, the maker of Zicam, has introduced a new line of Zicam products - Cold Remedy Plus. The Cold Remedy Plus products, cherry-flavored Zavors and cherry-flavored Liqui-Loz, are a multi-ingredient formulation marketed to reduce the duration of the common cold and relieve symptoms of people with the common cold. Two mint flavors, available in a rapid melt and an oral mist, will launch this fall. Matrixx Initiatives will be spending $23 million to advertise the products across print, radio and television media formats.

FDA Warning Regarding Zicam

On June 15, 2009, after identifying at least 120 reports of people losing their sense of smell, the FDA issued a warning letter recommending consumers immediately stop using certain Zicam Cold Remedy products, including Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size. Very shortly thereafter, Matrixx Initiatives issued a recall of the Cold Remedy products. Matrixx has reportedly received more than 800 reports of loss of smell from consumers.

Zicam Injury Lawsuits

Matrixx Initiatives has twice requested the FDA retract their warning, but the FDA has twice refused. Zicam's manufacturer is now facing lawsuits alleging that they knew their Zicam products were dangerous but continued to advertise and sell them anyway. Zicam is also facing litigation from Matrixx investors alleging the over-the-counter healthcare manufacturer hid the complaints of smell loss from investors. The Securities and Exchange Commission is also investigating Matrixx Initiatives.

Continue reading "Zicam Introduces New Zicam Cold Remedy Plus Line " »

This week, the FDA issued a press release to both patients and health care providers about Avandia - the popular diabetes drug manufactured by GlaxoSmithKline. The FDA says it is "now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time." For several years now, the FDA has been working to determine (1) whether Avandia should remain on the market; and (2) whether Avandia causes heart attacks. A committee formed by the FDA in 2007 voted that the drug should stay on the market, but agreed that the drug did raise the risk of heart attack.

The announcement this week only confirms that the FDA is reviewing data and has no new conclusions. The FDA says that once it "completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes."

The RECORD Study

Results of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study were submitted to the FDA in August 2009. The 4,447 patients included in the RECORD Study were between the ages of 40 and 75, with a body-mass-index of more than 25, and had glycated hemoglobin level of more than 7.0% and less than or equal to 9.0% while receiving the maximum doses of a sulfonylurea or metformin. At a press briefing at the American Diabetes Association in June 2009, the chairman of the RECORD steering committee said that the RECORD study indicated no increased overall cardiovascular morbidity or mortality associated with Avandia, but there was twice the risk of heart failure and distal fracture in women. Critics of the RECORD trial say the trial was seriously flawed because the report does not reveal how many patients were actually still taking Avandia at the end of the clinical trial.

The TIDE Study

The TIDE study (Thiazolidinedione Intervention With Vitamin D Evaluation) is a double-blind direct comparison study comparing Avandia to Actos, a diabetes drug manufactured by Takeda Pharmaceuticals. The first issue the study addresses is the cardiovascular effects of long term treatment with rosiglitazone (Avandia) or pioglitazone (Actos), when "used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease." The second issue the study addresses is "the effects of long-term supplementation of vitamin D on death and cancer". The TIDE trial began in 2009 will not end until October 2015.

Continue reading "FDA Reviewing Results of Avandia Cardiovascular Risk Study" »

On Monday, opening statements will begin in the first Seroquel diabetes lawsuit trial to reach a jury. The case is being brought by Ted Baker, a Vietnam veteran who alleges that he developed diabetes after he was prescribed Seroquel to treat his post-traumatic stress disorder.

Seroquel is one of the best selling drugs for pharmaceutical giant AstraZeneca. It is used in the management of schizophrenia and bipolar depression, but is commonly prescribed "off-label" for treating obsessive dementia, obsessive compulsive disorders, anxiety, autism, alcoholism, tourette syndrome, and post-traumatic stress disorder. Seroquel is available in 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets. Annual sales for Seroquel are estimated to be $4.7 billion nationwide, and $2.7 billion in the United States. The drug has been used by more than 19 million people around the world.

One of the side effects of taking Seroquel is weight gain, and the heightened risk of diabetes. Taking Seroquel (quetiapine fumarate) can cause the patient's appetite to persist even after eating a meal.

Baker's lawsuit is one of an estimated 26,000 claims against AstraZeneca over the side effects of the drug. The lawsuits allege that AstraZeneca did not warn patients about the risks of weight gain and diabetes, pancreatitis, and tardive dyskinesia, a rare movement disorder. Court documents suggest that AstraZeneca knew of the possible weight-gain side effects of Seroquel, but continued to market the drug as "weight neutral," even after clinical trial evidence confirmed the drug could cause significant problems.