Monthly Archives: March 2008

FDA Warns Against Blue Steel and Hero Supplements

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.

The Pope’s Impending US Visit

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.

Tallahassee Budget Crunch and Consumer Safety

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.

Congressmen Introduce Pre-Emption Amendment

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.

Teacher Sex Abuse Arrests on the Rise

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.

Cooper Tires Faces Another Tire Recall

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.”

Heparin Recalled in France, Italy, and Denmark

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.

Priest Abuse Lawyer Sex-abuse case against religious order settled

A Wilmington man who said he was sexually abused over a nine-year period by a former Salesianum School principal received a written apology, a vow his abuser will never work with children and an undisclosed amount of money in a settlement announced Monday.
Eric Eden, 40, settled with Salesianum, the Oblates of Saint Francis deSales and various Oblate officials, his attorney, Thomas S. Neuberger, said in a statement released after the parties met with Superior Court Judge Calvin L. Scott Jr. on Monday morning.
“I now hope to obtain the medical help necessary to begin addressing the many problems I have suffered since childhood,” Eden said in the statement. “This money will be placed in trust for the benefit of my wife and children.”
Eden’s suit against the sole remaining defendant, the Catholic Diocese of Wilmington, is scheduled for trial in October. Eden — formerly Eric Mazzetti — claims the diocese conspired to cover up the abuse.
“The case remains on track,” diocese attorney Tony Flynn said, adding the diocese knew “zero” about the abuse.
Eden filed his lawsuit in 2004 accusing the Rev. James W. O’Neill, a member of the Oblates of St. Francis de Sales, of sexually abusing him starting in 1976, when he was 8 years old and O’Neill was principal of the school.
According to the lawsuit, O’Neill was at the Mazzetti home to tutor the boy, but instead would have the boy sit on his lap so he could fondle him. Eden alleges that O’Neill also molested him during family vacations, at the priest’s residence and in the school office.
After leaving Salesianum in 1986, O’Neill was assigned to serve as principal of a Philadelphia-area school and pastor of a North Carolina parish. He was removed from the pastorate in April 2002, shortly after Eden reported to the Delaware Attorney General’s Office that O’Neill had molested him on a weekly basis over a nine-year period.
At that time, he was assigned to live at the Oblates’ retirement community in Childs, Md.
But he then became executive director of the Oblates’ Chablais Mission Fund, a job that involved frequent international travel to evaluate the needs of various missions. As recently as last year, O’Neill was “on assignment” in the Diocese of Upington-Keimos in South Africa, filling in for a priest who had to leave the field.
As part of Monday’s settlement, the Rev. Kevin Nadolski, director of communications of the Oblates, said O’Neill has been permanently removed from the ministry. Nadolski said O’Neill again will live and work at the Oblates’ retirement community in Childs.
Nadolski also released a statement apologizing to Eden, his parents and to the local Catholic and Salesianum communities.
“Today’s action is an important step in healing the pain and suffering that James O’Neill caused Eric Eden … ” the Rev. James J. Greenfield, Provincial of the Oblates, said Monday.
Priest Abuse Lawyer

Heparin Recall and Consumer Safety

In a reversal of sorts, the Chinese drug safety officials have now decided to take responsibility for the oversight and supervision of their blood thinnning product, heparin. Initially, the Chinese had stated that it was the exporters responsibility for safety oversight of the product they were exporting. In the wake of US identification of the heparin contaminant, they reversed course and stated they would indeed order new oversight procedures for the manufacture of heparin. This is good news but it doesn’t ensure consumer safety. Two other important safety measures must be utilized to make sure the public is safe from contaminated drugs. First, the US has to play a major role in the monitoring and evaluation of imported drugs, including heparin. We can’t just take another’s word that they are in compliance. We must trust but verify. The third major component concerns the tort system in the United States. The consumer’s ability and right to hold someone accountable in a court of law accomplishes two things: 1)it makes the manufacturer or supplier aware that defective products or harmful drugs will not be tolerated, 2)it provides the consumer an avenue for redress of wrongdoing. If the consumer is injured by a harmful drug such as the 19 people who died as a result of the contaminated heparin, they can seek justice in the courts. These three measures are really nothing more than a system of checks and balances that has worked for our country since its inception.