Friday, July 31, 2015

Akttive High Performance Fat Burner Gold capsules recalled

783 bottles of Akttive High Performance Fat Burner Gold capsules weight loss supplements have been recalled. 

The product contains Sibutramine, desmethylsibutramine and Phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States. These undeclared ingredients make the product an unapproved new drug for which safety and efficacy have not been established.

No illnesses or injuries have been reported to the company to date in connection with this product.

The product, marketed as a dietary supplement for weight loss, is packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17.

Teva recalls Adrucil cancer drug for a second time

Teva has issued a voluntary recall for its intravenous cancer medicine Adrucil because of the potential presence of impurities.
As Philadelphia Business Journal reported, Teva recalled six lots of Adrucil because they may contain small amounts of silicone rubber pieces and fluorouracil crystals. In May, it recalled eight lots of the cancer medicine for the same reason.
No adverse events have been reported, but a company statement on the FDA website said “administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.”

Bexco recalls DaVinci brand cribs

Bexco recalled about 11,700 DaVinci brand cribs in the United States and Canada because a metal bracket that connects the mattress support to the crib can break, creating an uneven sleeping surface or a gap. If this occurs, a baby can become entrapped in the crib, fall, or suffer lacerations from the broken metal bracket.

The recall includes DaVinci brand full-size cribs including the Reagan crib (model #M2801), the Emily crib, (model #M4791), the Jamie crib (model #M7301), and the Jenny Lind crib (model #M7391) manufactured from May 2012 through December 2012.

The company has received 10 reports of the mattress support brackets detaching. No injuries have been reported. For more information, go to the U.S. Consumer Product Safety Commission websit


Monday, July 27, 2015

Bard IVC Filters and Potential Claims (July 2015)

Inferior vena cava (IVC) filters sold by Bard have been found to have a high failure rate in a study published in  the Archives of Internal Medicine.
IVC filters are implanted in patients to help prevent pulmonary embolism due to blood clots moving into the lungs. Patients who receive IVC filters such as the Bard Recovery and the G2 by Bard are often patients who are either unresponsive or unqualified due to other medical problems for anti-coagulant drugs.
The tiny vena cava filters are shaped similarly to a cone with legs that extend to catch blood clots. When these legs break off the pieces or the entire filter can migrate through the body to affect other body parts, perforate veins and even cause sudden death. The result of this study caused the FDA to take notice of the dangers involved in using IVC filters and issued a warning to physicians to monitor their patients and remove the filters once the risk of blood clotting has passed.  
The FDA issued a communication on this: 
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided. 
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.

If you have been harmed by one of these products, call us at 866.373.1800 and ask for Ms. Cragin.

Xarelto Trials Set for 2016

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Now, more than 500 Xarelto lawsuits have been consolidated and are currently pending in federal district court in the Eastern District of Louisiana, and District Court Judge Fallon recently announced that the first bellwether trial is scheduled for August 1, 2016.
Besides the Xarelto trial set for August 1, 2016, the court also scheduled three more bellwether trials for August 22, September 12, and October 17, 2016. The first two trials will take place in the Eastern District of Louisiana, the third will be held in the Southern District of Texas, and the fourth is scheduled for the Southern District of Mississippi.
You can also find the Order regarding case-specific discovery here: