Since 2007, at least five people have died as a result of defective Sprint Fidelis defibrillator leads implanted in order to correct irregular heart rhythms. Since that time, thousands of patients and doctors have agonized over how to correct the problem. With certain medical devices, the simple solution of removing the offending device is the best option. However, with the Sprint Fidelis defibrillator leads, it’s not that simple, according to cardiology experts. The removal of such leads can cause death if not done properly and some health experts are complaining that the procedures are being performed by those who are not qualified to perform the extraction.
The anxiety for the patient who relies on the cardiac defibrillator is overwhelming. Imagine for a moment you or a loved one had one of these defibrillator leads implanted in order for your heart to function properly. Now you find out the leads are defective and may not work when your heart needs it most. This is a terrible situation for poor patients and a difficult dilemna for healthcare professionals.

Rep. Rick Kriseman (D-53) is an attorney with Saunders & Walker PA
Mikey, age 14, and his friend decided they wanted to go buy a Slurpee at the local convenience store. After telling his mom where he’s going, Mikey and his friend grabbed their bikes and headed off down the street to the local convenience store. When they got back home, Mikey’s mom was waiting at the front door for him. She was not happy. Mikey looked confused, unsure of why his mother was mad at him.
Then, Mikey’s mom reminded him of the law in the State of Florida, specifically Florida Statute 316.2065 3(d), which states that
“A bicycle rider or passenger who is under 16 years of age must wear a bicycle helmet that is properly fitted and is fastened securely upon the passenger’s head by a strap, and that meets the standards of the American National Standards Institute (ANSI Z 90.4 Bicycle Helmet Standards), the standards of the Snell Memorial Foundation (1984 Standard for Protective Headgear for Use in Bicycling), or any other nationally recognized standards for bicycle helmets adopted by the department. As used in this subsection, the term “passenger” includes a child who is riding in a trailer or semitrailer attached to a bicycle.”
Mikey’s mom was mad at him because neither he nor his friend wore their helmets when they rode their bikes to the store.
If HB169/SB68 passes the legislature this year, Mikey will also have to wear a helmet if he goes horseback riding. Under HB 169, any person under the age of 16 must wear a helmet when riding a horse on public lands unless they are competing or performing during a show or an event, or they are riding the horse on private property or engaged in an agricultural related activity. This bill further states that anyone renting a horse to be ridden by a person under the age of 16 must either provide the underage person with a helmet or verify that the underage person has their own helmet.
Therefore, if this bill passes and Mikey and his mom ever go horseback riding, he will have to wear a helmet before he is allowed out of the stables on the horse.
It is the hope of the sponsor that passage of this bill will prevent future head injuries from occurring.
Unfortunately, in the State of Florida, the concern over head injuries seems to cease when a person turns 21, as Florida law DOES NOT require a person over the age of 21 to wear a helmet which complies with Federal Motorcycle Vehicle Safety Standard 218 promulgated by the United States Department of Transportation, provided they carry an insurance policy providing for at least $10,000 in medical benefits for injuries which might be incurred as a result of a crash while operating or riding on a motorcycle. So when Mikey turns 21, the state no longer seems to care about him.
Not a very good example for Mikey, is it? Sure hope he learns of the importance of wearing it now.

In what the Wall St. Journal has reported as a first for the FDA, the federal agency has warned 14 big pharma companies about their misleading advertisements on the Internet. The ads were typically found as a result of Google searches and the ads were usually sponsored links meaning the drug companies paid for the ads as part of their “pay per click” marketing campaigns. Sponsored links are one way of attracting Google search engine traffic by targeting certain key words that a person surfing the web may be trying to find.
The ads typically overpromoted their benefits while completely ignoring their risks and side effects. The Wall St. Journal article cites one ad by Biogen Idec Inc. for its drug Tysabri which boldly but inaccurately state, “”A Multiple Sclerosis Treatment That’s Different from the Others” or “Satisfied with your MS Medication or Looking for Something Different?”
This is a good sign that the FDA is not only reviewing big pharma’s traditional marketing practices to mainstream media but is branching out and investigating drug companies’ behavior on the Internet.
According to the Wall St. Journal, the companies that received the warning include: Pfizer, Biogen Idec Inc., Sanofi Aventis, Johnson & Johnson, GlaxoSmithKline PLC, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was recently acquired by Roche.

Scientists have discovered trace amounts of perchlorate in various brands of powdered baby formula. The chemical is mixed with water that also contains perchlorate can exceed what the CDC considers safe for adults. The chemical is usually associated with defense and aerospace facilities. The scientists didn’t disclose which baby formulas were tested. Perchlorate has been tied to problems with thyroid function. However, the health effects to babies and adults is still undetermined at this point. Various municipalities’ drinking water supplies have been tested and shown to have amounts of the chemical in the drinking water.
While some states have already set acceptable limits of perchlorate in drinking water, the EPA is reviewing the issue. It did state earlier this year that the chemical’s presence in drinking water may pose a serious health risk and a top priority for the EPA.
The tests that found the chemical in the baby formula were not health related so no determination as to the risks associated with the chemical can be made at this time.

In light of the recent G-20 meeting in London, Pope Benedict XVI has called upon the world leaders to remember the poor when devising plans to aid the world economic situation. This is a laudable act considering a great many peoples still live below the poverty line.
However, poverty transcends the mere economic. Many live in poverty due to a lack of education, healthcare, and justice. In terms of the latter, many in this country are poor because they lack access to justice. I’m thinking in particular those who are poor because they lack access justice after they’ve experienced sexual abuse. This is a paralyzing poverty that often spills over into the educational, health, and economic spheres of life. Those who’ve been sexually abused and lack the proper recourse in a system of justice continue to suffer. The pope should’ve included those in his remarks as well. Very often, sexual abuse victims who’ve been abused by clergy are robbed of their relationship with God, a faith community, and their own human family. This is a justice issue and a life issue just as important as any other justice or life issues. When will we hear the church speak about that?

Rev. Gerald Fitzgerald, founder of the Catholic order Servants of the Paraclete, dedicated his life and his priestly ministry to stopping the sexual abuse of children at the hands of Catholic priests. He did so by writing numerous letters to at least 12 Catholic bishops and one pope warning them of the dangers of sexually abusive priests. Fitzgerald even attempted to buy a Caribbean island where he would send the problem priests. The letters, unsealed a few years ago but now becoming public, show Fitzgerald as a priest who consistently warned bishops about the danger of transferring sexually abusive priests. In some letters, he called for their removal from the priesthood.
These revelations contradict the Catholic bishops consistent defense over the years that they didn’t know the nature or the extent of the problem. Fitzgerald had been working with priest abusers since the 1940’s and had spoken with Pope Paul VI in 1962 about the issue. Some of the most notorious priests were sent to Fitzgerald’s retreat in Jemez Springs New Mexico for treatment and counseling. The strongly worded letters mince no words in depicting the priests as “vipers” and “devils”. In a 1957 letter to a bishop in New Mexico, Fitzgerald wrote, “These men, Your Excellency, are devils, and the wrath of God is upon them, and if I were a bishop I would tremble when I failed to report them to Rome for involuntary layization (sic).”
Fr. Fitzgerald’s prescient warnings went unheeded until the scandal broke wide open in 2002 after the Boston Globe uncovered years of conspiracy and coverup by the Archdiocese of Boston. Fitzgerald died in 1969 and his successors changed the tone and manner in which priests with sexual abuse problems were treated. Often, the change resulted in the priests being returned to ministry in different dioceses. Fitzgerald himself was the object of scorn from some bishops who considered his methods and warnings bizarre and alarmist.
The Catholic bishops of the United States can no longer pretend they didn’t know about the issue. Nor can they feign ignorance of the magnitude of the abuse. As early as the 1940’s they received warnings from Fr. Fitzgerald. In the 1980’s Fr. Tom Doyle took up the mantle and warned the entire group of bishops assembled for their annual meeting. Just like Fitzgerald, Doyle was dismissed and ostracized by the bishops.

State Rep. Rick Kriseman (D-53) is a lawyer with Saunders & Walker PA
Nancy Shopper heads to her favorite grocery store to purchase her groceries for the week. While walking down the aisle in the produce section, Nancy steps on a banana peel, slips and falls down, and injures her right shoulder. She contacts a lawyer to learn what her rights are in this type of case.
Had Nancy fallen in this store prior to the case of OWENS vs. PUBLIX SUPERMARKETS, INC. , (802 So.2d 315(Fla. 2001), she would have been obligated to prove that the store had actual or constructive knowledge of the dangerous condition and that the condition existed for such a length of time that in the “exercise of ordinary care, the premises owner should have known of it and taken action to remedy it”. Constructive knowledge can be established by circumstantial evidence. Under this factual scenario, if the banana Nancy slipped on was black, circumstantial evidence would have suggested that it had been on the floor for a long enough period of time to conclude that the store could have or should have known of its existence and taken action to remedy the condition.
In this instance, Nancy slipped AFTER the Owens decision was rendered. Because of the Court ruling in Owens, Nancy was not required to prove the store had actual or constructive knowledge of the condition. Instead, the burden was shifted to the grocery store, with the Court in Owens holding that the premises owner or operator “had to establish that it exercised reasonable care under the circumstances, eliminating the specific requirement that the customer establish that the store had constructive knowledge of its existence in order for the case to be presented to the jury.” (Owens at 331). The Owens case created a new standard, finding that “the existence of a foreign substance on the floor of a business premises that causes a customer to fall and be injured is not a safe condition, and the existence of that unsafe condition creates a rebuttable presumption that the premises owner did not maintain the premises in a reasonably safe condition”. (Owens at 331).
Because Nancy fell after the Owens decision, the store was presumed to be negligent in allowing the banana to be on its floor, and to rebut that presumption, had to prove that it exercised reasonable care in maintaining its floor under normal circumstances of running its business.
Because of the Owens case, in 2002, the Legislature adopted Florida Statute 768.0710. This statute shifted the burden of proof back to the claimant, but, changed the elements necessary to prove negligence. Under this statute, the claimant was required to prove that the business owed a duty to the claimant, that the business acted negligently by failing to exercise reasonable care, and that the failure to exercise reasonable care was the cause of the loss, injury or damage suffered by the claimant. In showing that the business acted negligently by failing to exercise reasonable care, the claimant does not have to show the business had actual or constructive notice of the object. So while this new statute shifted the burden of proof back to the claimant, doing away with the presumption of negligence, it lessened that burden on the claimant. Had Nancy fallen after the enactment of the 2002 statute, she would have had to prove that the store owed a duty of care to her, that the store failed to exercise reasonable care in maintaining its floors, and that she was injured because of the failure by the store.
Just when you thought the law could not get any more confusing, wait, there’s more. This year, Rep. Dave Murzin has filed HB 495. The effect of this bill is to change the law once again, this time bringing the law BACK to what was in 2001, before the decision of the Florida Supreme Court in Owen.
Whether this bill passes the full house and senate and get’s signed into law by the Governor remains to be seen. For now, the bill has passed its first committee stop, on a vote of 8 to 2. It has 2 more committee/council stops before reaching the floor of the house.

Vito Lopez (D-Brooklyn) says his alternative bill to help victims of sexual abuse levels the playing field by allowing sexual abuse victims to seek justice from both public and private institutions that allowed the abuse to occur. In fact, so does the much better legislation proposed by Rep. Margaret Markey (D-Maspeth). The crucial difference between the two bills is that Markey’s bill would provide a one year window during which sexual abuse victims could pursue justice irrespective of when they were abused. This is important because most of those who’ve been abused aren’t able to come forward about their abuse until many years later, if at all. The Markey legislation takes into account the particular circumstances of the constituency her bill is aimed to serve. It is an undisputed fact that victims of sexual abuse crimes are not able to go public at the time the abuse occurred due to the traumatic nature of the abuse as well as the position of authority the abuser holds. Lopez’ bill doesn’t take this important factor into account. By the way, the Catholic dioceses of New York are vigorously supporting the Lopez version. That should tell you all you need to know.

Medtronic Corporation had voluntarily recalled its BioGlide Ventricular Snap Shunt Catheter in February. However, the FDA has now classified the recall as Class I which means that the defective medical device has a reasonable probability to cause serious injury or death.
The Medtronic device is a brain catheter which is supposed to drain excess fluid away from the brain. However, the catheter tends to disconnect necessitating a revision medical procedure.
The specific models recalled were manufactured from October 2002 through December 2008 and concern the following lot numbers: 27782 (Innervision), 27708, and 27802.
The catheters are used to treat hydrocephalus-a condition where excess fluid builds up in the brain. The pressure caused by the excess fluid can cause brain damage and death, if left untreated.
For those who’ve had the Medtronic brain catheter inserted, symptoms of hydrocephalus include but are not limited to the following: a rapid increase in head size, a large soft spot on the top of the head, dizziness, blurry vision, vomiting, seizures, nausea, and sluggishness.
Symptoms vary due to age. It is imperative to contact your physician if you or a loved one show any such symptoms or signs.

As I read reports over various Catholic bishops and church organizations fomenting protest over President Obama’s invitation to the give the commencement address at Notre Dame University, I couldn’t help but think of the late Cardinal Joseph Bernardin’s plea for a consistent ethic of life ie. a “seamless garment” as he called it. The protests over the Notre Dame invitation concern President Obama’s stance on abortion and stem cell research.
This post has no intention of delving into the abortion/stem cell debate or President Obama’s postitions on either issue. However, I would like to take a moment and reflect on why the Catholic Church has been so vocal on these issues when another “life” issue ie. the treatment of those who’ve suffered sexual abuse continues to receive scant attention from the Church and the bishops. Some will say that the bishops have “fixed” the problem that resulted in the sexual abuse scandal. Others will say the church has made great strides to address the issue.
Yet, the manner in which these life issues, including the sexual abuse of children, is qualitatively different. However, if you re-examine Cardinal Bernardin’s theory of a consistent ethic of life, the sexual abuse of children should be no less worthy of church attention and action than say abortion or stem cells. How is it pro-life to protect a fetus while not doing the same for a young child? How is it pro-life to deny justice to those who’ve suffered due to the sexual abuse of a priest?
It seems to me that an aggressive implementation of this consistent ethic of life teaching would go a long way in restoring credibility to the bishops as well as the teaching authority of the church.