The Recall Lawyers

The U.S. Food and Drug Administration (FDA) remains concerned about the potentially higher risk of blood clots in women taking newer forms of birth control pills, such as Yaz, Yasmin and Ocella. These "fourth generation" contraceptive drugs contain drospirenone, a new type of synthetic progestin.

An FDA-funded study indicates that women taking contraceptive drugs containing drospirenone have a 50 percent increased risk of blood clots. Earlier this year two other studies appearing in the British Medical Journal found double to triple the risk. An FDA advisory committee is scheduled to meet in December after which the full findings of the study will be released.

A deep vein thrombosis (DVT) is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. A pulmonary embolism (PE) is a potentially fatal condition where the clot breaks loose and travels to the lung blocking a lung artery. DVTs and PEs are also known as venous thromboembolic events, or VTEs.

Continue reading "FDA Warns Yaz, Yasmin and Ocella Contraceptives Could Increase Clot Risk " »

The Food and Drug Administration (FDA) recently issued a safety warning on a group of drugs called 5-alpha reductase inhibitors (5-ARI). The drugs finasteride and dutasteride are included in the 5-ARI class and are marketed under the trade names Propecia, Proscar, Avodart, and Jalyn. The FDA revised the Warning and Precautions section of the drug labels to include new safety information on the increased risk of developing an aggressive form of prostate cancer. The label revision is based on the FDA's review of two studies, which showed that these drugs boost the chances of developing "high-grade" prostate cancer.

Propecia is FDA approved to treat male pattern hair loss. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate glad. Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.

Merk manufactures Propecia and Proscar. GlaxoSmithKline manufactures Avodart and Jalyn. Earlier this year, both companies requested the FDA to approve these drugs for use in preventing prostate cancer. The FDA denied their requests citing the increased risk of high-grade prostate cancer.

Continue reading "Propecia Increases Risk of Prostate Cancer - FDA Changes Label" »

In June of this year, the FDA announced that use of the diabetes drug Actos may be associated with a greater risk of bladder cancer. Based on its findings from the first five years of a ten-year study, the FDA recommended that Actos not be prescribed in patients with a history of bladder cancer or with active bladder cancer.

Actos has been used to control type 2 diabetes in adults. In the first ten months of 2010 alone, 2.3 million patients filled prescriptions for Actos or other drugs containing pioglitazone. Takeda Pharmaceuticals Co. Ltd., the maker of Actos, is already facing hundreds of lawsuits over the drug.

Continue reading "Diabetes Drug Actos Linked to Bladder Cancer" »

Another turkey recall was announced today by Cargill, the company responsible for the recalled turkey earlier this year that caused death and illnesses in numerous states. We here at the recall lawyers blog highlighted this recall because it demonstrated the importance of communication and regulation over food safety. Many people say that regulation isn't necessary because companies have an incentive to produce quality food because the "market" would hurt them if they didn't.

Well, that's all well and good, unless turkey is sickening people and killing people for literally months and they won't say whose turkey it is. That not only hurts consumers, it hurts responsible businesses that don't have contaminated products consumers don't buy any turkey, not just the uncontaminated turkey.

Cargill originally traced the tainted turkey to one plant in Arkansas and resumed production a month ago. However, in a not-all-that-surprising turn of events, the sample that was tested after production resumed was positive for salmonella. It's easy to see the cozy relationship between the local regulators and inspectors and the plant, especially when the job market is so tough and the plant being offline likely hurt the workers and families of workers and the community where the plant was located.

Let's hope that Cargill spends the time and money necessary to produce safe, salmonella-free turkey. And that inspectors and regulators do their part, since the "market will prevent Cargill" fiction has been exposed again by Cargill not fixing the problem even after getting publicly shamed.

Following two days of meetings on transvaginal mesh, the FDA said it would require two makers of vaginal mesh, Johnson & Johnson and C.F. Bard Inc., to conduct clinical studies and present safety information on the use of mesh to treat Pelvic Organ Prolapse (POP).

The FDA had initially approved mesh under a summary proceeding requiring no preclinical testing. However, now at least seven deaths have been linked to its use. Problems caused by vaginal mesh have been described as extremely painful and include organ perforation, bleeding, and infection. Such complications may require corrective surgery.

Continue reading "FDA to Require Transvaginal Mesh Clinical Trials" »

The motorcycle handlebar clamp on all 2011 KTM and Husaberg off-road/competition can develop cracks during normal use that causes the handlebars to move from their set position. This can result in the rider losing control of the vehicle, which poses the threat of serious injury.

Continue reading "Over 6,000 Off-Road Motorcycles have been Recalled by KTM " »

The Food and Drug Administration plans to hold a subcommittee meeting to discuss "the safety and effectiveness of transvaginal surgical mesh for repair of pelvic organ prolapse" this week on September 8 and 9. This meeting comes at a time when consumer groups are calling for the widespread recall of surgical mesh due to severe complications.

Tranvaginal surgical mesh is used to treat Pelvic Organ Prolapse, a condition that occurs when the support in the vagina is lost which results in the dropping of the bladder, urethra and other pelvic organs. Vaginal mesh has also been used to treat Stress Urinary Incontinence, a condition that occurs due to weakening of the pelvic area muscles and causes short bouts of incontinence.

The FDA first warned of serious complications from transvaginal surgical mesh in October of 2008. It warned of erosion through vaginal epithelium--the wearing away of the thin lining covering the vaginal wall. Surgical mesh has also been linked to infection, pain, urinary problems, bowel, bladder or blood vessel perforations.

Continue reading "FDA to Hold Transvaginal Mesh Hearings This Week" »

After Toyota delayed its recall and got fined for it, car companies seem to be more responsive to potential defects and are being more proactive about recalls. For instance, today Honda announced it was recalling more than 962,000 vehicles beacuse of problems with the power windows and computer systems. The cars recalled include the Fit subcompact, CR-V crossover and Fit Aria in North America, Asia, Europe and Africa. The Fit is also called Jazz in some places, and the Aria in others.

The recall is because defects in the driver's-side power window switch units could melt and catch fire. The recall will also include 26,000 CR-Z compact hybrids because of computer problems with the engine control unit.

Continue reading "Honda Recalls CR-V, Fit - More than 900,000 Cars" »

King International LLC and the U.S. Food and Drug Administration (FDA) are recalling King International's Shoulderflex massager. The recall was initiated due to a report of a strangulation and death. According to the FDA's recall, the product warned never to wear a necklace while using the massager to avoid entanglement. Consumers and retailers alike are advised to stop using the massager immediately and safely dispose of them in the trash. The massager's components should be disposed of separately so that the massager cannot be reassembled. King International suggests disposing the power adapter and the massage fingers separate from the massager unit. Approximately 12,000 of the recalled massagers were sold in the U.S. between 2003 and 2011.

Recently, the U.S. Consumer Product Safety Commission and nine manufacturers and distributors issued a recall of an estimated 2 million units of pourable gel fuels due to serious risks of flash fire and burns. The gel fuel can unexpectedly ignite and splatter onto nearby people and objects when poured into a firepot that is still lit. According to the Commission, 65 incidents have been reported which include 2 fatalities and 34 cases of persons being hospitalized with second and third degree burns of the hands, chest, arms, legs and face. Due to the severity of these injuries, the Commission has issued an immediate recall of the pourable gel fuel.

The recall involves all pourable gel fuels manufactured or distributed by the following nine companies: Bond Manufacturing of Antioch, Calif.; Bird Brain Inc., of Ypsilanti, Mich.; Smart Solar Inc. of Oldsmar, Fla.; Lamplight Farms Inc of Menomonee Falls, Wis.; Pacific Décor Ltd. of Woodinwille, Wash.; Sunjel Company (2 Burn Inc.) of Milwaukee; Luminosities Inc (Windflame) of St. Paul, Minn.; Real Flame of Racine, Wis.; and Fuel Barons Inc. of Lake Tahoe, Nev. Consumers should stop using these products and not attempt to fashion homemade remedies or substitute the gel fuel with other flammable materials.

Honda has announced that it is recalling 1 million cars in the United States alone. The Honda recall involves the 2005-'10 Accord, 2007-'10 CR-V and 2005-'08 Element.

The National Highway Traffic Safety Administration said: "The outer race of the secondary shaft bearing (in the transmission) may be broken during certain driving styles. A broken outer race may cause abnormal noise, the malfunction indicator light to turn on, and allow contact between the transmission idle gear and an electronic sensor housing within the transmission."

Moreover, NHTSA added, "This could result in a short circuit causing the engine to stall. Additionally, broken pieces of the outer race or ball bearing from the secondary shaft may become lodged in the parking pawl, resulting in the vehicle rolling after the driver has placed the gear in the park position."

Honda is offering a free fix to the software that runs the transmission to help ease the transition between gears.