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.

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.

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.

Approximately 21,000 Kappa and Sigma pacemakers have been recalled by the FDA due to a wiring defect that could cause a severe heart injury or death.

Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences of death.

While the recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world, approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medronic Sigma pacemakers installed for more than five years are included in the recall. Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall. These devices were manufactured primarily between November 2000 and November 2002.

According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacment time.

Patients experiencing problems with a defective pacemaker may show signs of lightheadedness and fainting, and should contact their doctor if these signs occur.

Hundreds of deaths and thousands of injuries can be traced to defective medical devices each year.

The Heart Rhythm Society has said that defibrillator lead wires need better surveillance to detect defects, and has called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

The lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock, and in the worst case scenario, preventing a defibrillator from sending a necessary shock to the heart.

In 2007, Medtronic Inc.’s Sprint Fidelis lead was removed from the market following reports of 5 deaths due to lead fractures with another 13 deaths caused by “possible or likely contributing factor” of defective leads.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators, and around 150,000 people are still implanted with a Sprint Fidelis lead.

The Heart Rhythm Society used the Sprint Fidelis recall in its request for a surveillance system to track lead performance in order to spot defective devices earlier. The group also said hospitals need to train more doctors to remove faulty defibrillator leads.

During the Sprint Fidelis recall, four deaths occurred when doctors tried to remove defect leads from patients. The group said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

Finally, the group called on the FDA to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

If you or someone you love has been injured by a defective medical device, it’s important to seek out expert advice of an experienced defective drug attorney for valuable insight.

A new warning will be added to Botox according to the Food and Drug Administration (FDA).  The warning will be added to Botox A and B labels and patient information.

Botox is widely used throughout the U.S. to help children who have Cerebral Palsy, but the treatment has never been approved by the FDA for use in the doses that are required to affect spastic muscles.

The FDA released the following statement: Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), blepharospasm (abnormal tics and twitches of the eyelids), and primary axillary hyperhidrosis (severe underarm sweating).  For theses used, botulinum toxin is injected into the skin or into muscle tissue.

It has been recently reported from many people that the Botox injections spread beyond the target area and have injured or even killed the victims.  These are cases of botulism and include symptoms such as difficulty breathing, muscular weakness, and speech disorder.

If you or someone you know is seeing these signs up to three weeks after the injection, you are urged to contact your local hospital.

Yet another scandal involving the Walter Reed Army Medical Center has surfaced. Apparently Dr. Timothy R. Kuklo, a former surgeon at Walter Reed, may have falsified his study of Medtronic Inc.’s Infuse Bone Graft.

During his time at Walter Reed, Kuklo conducted, published, and promoted a study in which he claimed that soldiers’ leg injuries healed faster when Infuse was used.

However, major news agencies such as the Wall Street Journal and the New York Times have reported that Kuklo lied about the number of patients and injuries treated, did not obtain the Army’s permission to conduct the study and forged the signatures of his co-authors.

Kuklo is currently an associate professor at the Washington University medical school in St. Louis. He is a paid consultant for Medtronic and even gave speeches on Medtronic medical devices while at Walter Reed.

His position at Medtronic may cause legal problems for both of them since Kuklo employed an off-label use for Infuse in his study and pharmaceutical companies are forbidden from promoting off-label use of their products.

Women who develop lung cancer while undergoing hormone replacement therapy may be at a greater risk for death from the disease.

The Women’s Health Initiative was a federal study that studied the effects of combined hormone replacement therapy (pills containing estrogen and progestin) on almost 17,000 women. The study halted abruptly in 2002 when researchers noticed higher cancer rates in women taking the test pills and women on the fake pills.

Dr. Rowan Chlebowski of Harbor-UCLA Medical Center analyzed the results of this study and found that women taking the estrogen-progestin pills when they developed non-small cell lung cancer had twice the mortality rate of female lung cancer victims who were not taking hormone replacement pills at the time of their diagnosis.

However, Chlebowski’s findings are not definitive. Hormone replacement therapy has changed a lot in the few years since the study was conducted. For example, women in the study were usually in their early 60s when they started taking the estrogen-progestin pills and took them for more than 5 years. Now, most women start hormone replacement therapy in their early 50s and take the pills for only 2 years. Because of this, the risks Chlebowski identified may no longer be applicable.