Archive for June, 2009

Drywall lawsuits move to New Orleans

Friday, June 26th, 2009

Several lawsuits from around the country involving defective Chinese drywall have been moved to a single federal court in New Orleans, Louisiana where they will be presided over by a panel of seven judges.

United States District Judge Eldon Fallon will be in charge of pre-trial procedures. The panel chose Fallon because he has had previous experience in overseeing litigation that started in multiple courts.

The biggest source of lawsuits against home builders, suppliers and manufacturers of the defective Chinese drywall is in New Orleans from Katrina survivors. Unfortunately, many of the houses built and paid for by the victims’ insurance companies contained drywall that secreted sulfuric smells, eroded appliances, and was accused of causing a variety of health problems.

Ten cases from Florida, Louisiana, and Ohio have been consolidated into this one court. In doing this, the government hopes to avoid inconsistent rulings that might occur if similar cases were dealt with by separate judges.

FDA device division review is high priority

Friday, June 19th, 2009

Margaret Hamburg, the new commissioner of the US Food and Drug Administration, has said that her first priority is to reinvigorate the troubled agency. Doing so, she said, will restore its credibility with the public and policy makers.

In an interview with The Wall Street Journal, the commissioner said that she is taking a “hard look” at the medical device division and a “fresh look” at the abbreviated framework it uses to approve many riskier and implantable products. “This is a high priority,” she said.

Scientists at the FDA’s Center for Devices and Radiological Health have sent letter to Congress and the White House alleging that political and corporate influence have trumped science at the division. The device industry is concerned that the FDA or Congress might toughen standards in applying the abbreviated approval process, called 510(k), to devices that would otherwise go through a lengthy review involving more clinical trials and safety data.

A government report in January said that the 510(k) process has been overused.

Dr. Hamburg said that a new transparency task force at the FDA is weighing the need to transmit emerging data about potential drug side effects against claims by corporations that want to keep commercial information confidential.

Recalls on Hand Lotions

Thursday, June 18th, 2009

A recall has been announced on hand sanitizers made by Clarcon Biological Chemistry Laboratory.  The Food and Drug Administration (FDA) reported that the products being recalled contain high levels of disease-causing bacteria.

“Serious deviations” were found in recent tests dealing with government required practices.  According to the statement the analysis, “revealed high levels of various bacteria, including some associated with unsanitary conditions.  Some of these bacteria can cause opportunistic infections of the skin and underlying tissues.  Such infections may need medical or surgical attention, and may result in permanent damage.”

Some of the products recalled include: Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty, and Total Skin Care Work.

The company located in Roy, Utah, has voluntarily recalled the products.  The FDA advises that anybody with these defective products should throw them away immediately.