Dallas Fort Worth Injury Lawyer Blog

August 24, 2009

FDA: Safety Review of Weight Loss Drugs Orlistat, Xenical and Alli

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

August 24, 2009

Nuvaring Side Effects, Stroke and Pulmonary Embolism

by Dr. Shezad Malik

Lawsuits have been filed alleging death and serious injury associated with NuvaRing, a contraceptive product made by Organon.

NuvaRing birth control is a third generation contraceptive manufactured by Organon USA. Nuva Ring birth control is a flexible polyethylene ring that contains estrogen and a form of the progestin desogestrel. NuvaRing is considered a combination hormonal contraceptive.

Since Nuva Ring birth control is a relatively new form of contraceptive there are few studies regarding its safety and effectiveness. As early as 1995 studies had shown there was an increased risk of venous thrombosis (blood clots) in contraceptives containing desogestrel compared to second generation birth control that contained other types of progestins.

Venous thromboembolism (VTE) is a disease that includes deep vein thrombosis ( DVT) and pulmonary embolism (PE). A pulmonary embolism occurs when a segment of a thrombus (A clot within a blood vessel) within the deep venous system detaches from the vessel, travels to the lungs, and lodges within the pulmonary arteries.

August 23, 2009

Mis Diagnosis of Epidural Abscess Leads to Paralysis

by Dr. Shezad Malik

Sheila Matthews, a Naples mother of three, walked into NCH North Naples Hospital’s emergency room in March 2005 in extreme pain.

Over the years, the 55-year-old retired nurse had suffered from diabetes, peripheral neuropathy and bipolar disorder. On a scale of one to 10, she told doctors, this was a nine. The pain grew as doctors tried to determine what was wrong.

“She’s screaming, she’s in so much pain,” Matthews’ attorney, Nancy La Vista of West Palm Beach, told a Collier Circuit Court jury during opening statements Aug. 13.

Six days later, Matthews would become a quadriplegic.

August 23, 2009

Dallas Woman Sustained Brain, Knee Injuries in Slip-and-Fall Incident

by Dr. Shezad Malik

On April 5, 2005, plaintiff Liria Lopez, 49, a self-employed house cleaner, entered a Minyard Food Store on the corner of Abrams Road and Gaston Avenue in Dallas. It had rained that day and water had accumulated in the store’s foyer area. As Lopez exited, she slipped on the water.

Lopez sued Minyard Food Stores Inc., alleging premises liability. She claimed that other customers had fallen in the same area under reasonably similar conditions about 18 months earlier. She also maintained that on the day of her accident there there were no warning signs or mats placed in the foyer, nor were there any warnings from store employees prior to her fall.

Lopez’s walking surfaces/traction expert testified that the manner in which Minyard addressed the water issue in the foyer was below the standard of care. After looking at the records, he said Minyard did not adequately handle the continuing problem of a wet slick floor on rainy days.

August 23, 2009

Yaz Birth Control Dangers and Lawsuits

by Dr. Shezad Malik

The Yaz birth control pill has been on the market since 2006. Yaz is taken orally once daily to prevent pregnancy.

Yaz differs from other birth control methods because it contains a progestin hormone called drospirenone, which can increase potassium levels in the bloodstream. Yasmin, a birth control drug very similar to Yaz, has been on the market since 2001. It contains the same hormone as Yaz and is associated with the same health issues.

August 23, 2009

Yaz, Yasmin and Pulmonary Embolism, Stroke, Heart Attack

by Dr. Shezad Malik

Yaz and Yasmin manufacturers are now involved in multiple Federal and State lawsuits.

In October of 2008, a warning letter was sent by the Food and Drug Administration to Bayer HealthCare Pharmaceuticals, Inc., in response to claims the company had made for Yaz, a very popular and heavily promoted birth control pill.

The warning letter stated that Yaz has additional risks compared to other birth control pills because it contains drospirenone, a progestin hormone that can increase potassium levels.

Among the serious and debilitating injuries reported from the birth control pills are heart attacks, blood clots, strokes, pulmonary embolisms, deep vein thrombosis, gall bladder disease, and other serious injuries. Some deaths have even occurred.

August 23, 2009

Levaquin Side Effects and Lawsuits

by Dr. Shezad Malik

The antibiotic Levaquin has been associated with side effects that could increase risk of tendon ruptures and permanent damage of the tendon.

STATUS OF LEVAQUIN LITIGATION: All federal Levaquin lawsuits have been consolidated in an MDL before Judge John R. Tunheim in the U.S. District Court for the District of Minnesota. It has been suggested that the first cases could be trial ready by January 2010.

Throughout the country, Levaquin lawyers are continuing to review and investigate potential lawsuits for users of the antibiotic who have suffered a tendon rupture.

August 22, 2009

Popcorn Workers Lung – Bronchiolitis Obliterans

by Dr. Shezad Malik

Bronchiolitis Obliterans also known as Popcorn Workers Lung, is an obstructive lung disease in which the bronchioles of the lungs are blocked by the growth of fibrous tissue.

The moniker Popcorn Workers Lung has been given to Bronchiolitis Obliterans because workers in factories that make microwavable popcorn that uses diacetyl for the buttery flavoring are known to contract the disease. The disease is irreversible, and can become so severe that a lung transplant may be necessary. Popcorn Workers Lung is a rare disorder that is known to be caused by repeated exposure to toxic gases, namely diacetyl.

August 22, 2009

Yaz Lawsuit

by Dr. Shezad Malik

Yaz and Yasmin are popular and widely-used oral contraceptives targeting women with the promises of worry free contraception. But there is potentially life threatening Yasmin side effects and Yaz side effects.Yaz was recently targeted by the Food and Drug Administration (FDA) as a prescription drug that is more dangerous and less effective than advertised by Bayer Healthcare Pharmaceuticals.

In mid-August 2009, the results of two new studies of oral contraceptives, including Yaz and Yasmin, were released in the British Medical Journal Online. The studies showed that Yaz, Yasmin and the generic form of Yaz, Ocella, caused a six-fold increase in the risk of blood clots, which cause injuries such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

August 22, 2009

FDA Cracks Down on Ibuprofen Pain Relief Gels

by Dr. Shezad Malik

The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen.

Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.

“These companies have an obligation to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah Autor, director of FDA’s office of compliance.