Botox or botulinum toxin (available as Botox and Myoboloc) has been linked by the FDA to severe adverse reactions including respiratory problems and death in some cases. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths. While the FDA has warned about the dangers of Botox it fell short in that it didn’t require doctors and healthcare professionals to warn patients about these potentially lethal effects.

Eli Lilly, the manufacturer of the schizophrenia drug Zyrexa, has settled a lawsuit with the State of Alaska for $15 million. Alaska had sued Lilly in order to recoup costs associated with treating Medicaid patients who experienced weight gain and the onset of diabetes as a result of taking the drug Zyprexa. In his statement from the bench, Anchorage Superior Court Judge Mark Rindner, stated that as a result of the state’s lawsuit problems associated with bad drugs was addressed. This is an important statement in the light of higher courts’ decisions to side with big pharma and medical device companies in shielding themselves from accountability for harmful drugs and defective medical devices. The civil justice system provides an avenue for consumers to hold companies accountable for harmful products that cause injury. It also forces manufacturers to make better and safer products for consumers.

Central American Produce, Inc. of Pompano Beach, FL announces a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras. The product was distributed nationwide and Canada. Based on current information, the cantaloupe grown, packed and shipped from Agropecuaria Montelibano appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.
In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Symptoms of food-borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.

The FDA has issued a warning to consumers against using dietary supplements Blue Steel and Hero because they are unapproved and contain an active ingredient that is similar to sildenafil found in Viagra which is regulated by the FDA. The dietary supplements may cause a dangerous increase in blood pressure. Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Ga.

Pope Benedict XVI is coming to visit the United States for the first time as Supreme Pontiff of the Catholic Church. No doubt, he’ll face criticism within the church as well as those not affiliated with the Catholic Church for his handling of the priest abuse scandal. Before he was Pope Benedict XVI, he was Joseph Cardinal Ratzinger, head of the Congregation for the Doctrine of the Faith and the Vatican point man for handling wayward priests who abused children. One of his lieutenants, Bishop Gianfranco Girotti characterized the priest abuse scandal as nothing more than media hype. I’m pretty sure he’ll be hearing quite a bit about that comment when he arrives on US soil. The last thing he needs right now is to have one of his lieutenants dismissing the sexual abuse of children as a mere media creation. It would be better for him and survivors if he dealt frankly and openly with the issue. This isn’t a matter of Catholic bashing by those who hate the church. Such loyal Catholics as the late William Buckley, Jr. and Peggy Noonan have decried the scandal as offensive and a blight on the church. As chief shepherd of the flock, Benedict needs to take the forefront and unequivocally condemn it for what it is.

While we’re hearing a lot about the budget constraints in Tallahassee and the continuous push for lower taxes, we’re not hearing enough about how these two forces impact our quality of life and the safety of the consumer. Both are directly tied to a sound infrasctructure. We still need good roads, safe bridges, quality teachers, top notch emergency responders, and a government that’s accountable to the community. If we don’t find the resources to support these vital aspects of our community, we all suffer. There will be more auto accidents, poorer response from emergency personnel, and a dearth of educational opportunities for our children. It’s not just about cutting taxes and a tight state budget.

In response to the Supreme Court’s ruling concerning pre-emption, Congressmen Henry Waxman (D-CA) and Frank Pallone (D-NJ) have drafted legislation to ensure federal law does not preempt state law when people harmed by medical devices sue devicemakers for liability.
The bill will be introduced next month, a spokesman for Pallone said.
The draft Medical Device Safety Act of 2008 was written because the lawmakers found the Supreme Court’s Feb. 20 decision in Riegel v. Medtronic “denies patients any legal recourse if they are a victim of a faulty medical device,” Pallone said.
The court held that the express preemption provision — section 360k of the Federal Food, Drug and Cosmetic Act (FDCA) — preempts state-law claims seeking damages for injuries caused by devices that have gone through the FDA’s premarket approval process.
The new law would amend the FDCA by adding the subsection “No Effect on Liability Under State Law,” which states, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”
This would essentially restore a consumer’s right to hold medical device makers accountable in a court of law for defective products that have caused serious, often debilitating injuries. It also would balance a flawed and one-sided court decision that clearly favors big business over the individual. Hopefully, this legislation will pass.

While the sexual abuse scandal in the Catholic Church has certainly grabbed the majority of headlines since 2002, a new abuse phenomenon is springing up: teachers who abuse their minor students. Since 2005, 10 teachers have been arrested on sex abuse charges in the Tampa Bay area alone. While these are not as significant to the priest abuse problems, the numbers should alarm any concerned parent. Parents must continue to keep a watchful eye on their children who are threatened by child sex predators in their classrooms, in their places of worship, at sporting events, and on the Internet. Monitoring of their activity is one key to prevention. Another important aspect of keeping our kids safe is talking to them so they are aware of potential dangers.

After only eight months, Cooper Tire has been forced to recall its tires again. This time, the defective tires have experienced a sidewall separation problem. The recall involves 48,000 Cooper tires. Tires under recall include:
* Cooper Discoverer ATR (sizes LT235/85R16 and LT265/75R16).
* Dean Wildcat Radial (size LT265/75R16).
* Mastercraft Courser A/T 2 (sizes LT235/85R16 and LT265/75R16).
* Mentor All Terrain Radial SXT (size LT265/75R16).
The tires were manufactured at Cooper’s Albany, Ga., factory during a 10-week period from December 2007 through February 2008. “All dealers affected have been informed about this recall and have been given instructions for returning the tires.”

The heparin contamination recall continues and has now spread to other European countries. Earlier this month, Germany recalled its heparin and now France, Denmark, and Italy are recalled batches of the contaminated heparin. The culprit appears to be the same as the one that sparked the recall of Chinese heparin imported by the United States. The contaminant in question is over-sulfated chondroitin sulfate. On Friday, France began recalling heparin manufactured by Rotexmedica GmbH. The recalls in Denmark and Italy were a result of the heparin’s raw ingredients coming from China. The European Union countries are working in conjunction with the US FDA in monitoring and testing the heparin.