John W. entered St. Mary’s Hospital in June 2004 for what was described as a routine operation to repair a ventral hernia using the large oval Composix Kugel Mesh. A year and a half later, John began experiencing severe abdominal pain with cramping and bowel difficulty. He returned to the surgeon who performed the hernia repair to be told that the Kugel Mesh hernia patch needed to be removed. When John complained of symptoms consistent with bowel obstruction, his surgeon decided to take x-rays of his abdomen. The surgeon concluded that the Kugel Mesh patch needed to be removed. His doctor, a well-respected general surgeon had read reports of problems with the Kugel Mesh patch. The next day, John went in for surgery to have the patch removed. Unfortunately, that was just the beginning of his problems. Since that time, John has had to endure the pain and suffering of three additional surgeries due to the complications and bowel perforations caused by the defective Kugel Mesh hernia patch. John had no idea that the patch used to repair the hernia had a defect that caused it to break when placed in the abdominal cavity. In fact, the Kugel Mesh hernia patch was later recalled. The recall was prompted by a problem with the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh patches. The recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This breakage can lead to bowl perforations and/or chronic intestinal fistulae.
John continues to suffer from what should have been a fairly routine procedure. Yet, this 50 year old man lives in constant pain with astronomical medical bills from four follow-up surgeries. His immune system and digestive system are still in a weakened state and he is unable to work and provide for his family. His young children wonder what happened to there once strong dad. His wife worries about the bills and the health and future of her husband whom she now has to care for.
John and his family continue to suffer because a medical device company didn’t disclose what it knew about the problems with its Kugel Mesh patch. Instead of taking responsibility for the defect, it blamed doctors and tried to argue that inexperience and poor surgical procedures resulted in problems with the patch. Yet, the truth is the Kugel Mesh hernia patch is a defective product that is dangerous and hurt many, many unsuspecting patients. Doctors are also the victims in this tragedy. They were never told of the medical device’s defects.

A new 2007 federal law that requires the federal government disclose its investigations into adverse events regarding drugs. Now for the first time the FDA has released the list of drugs that are under investigation for adverse effects. All of the reports on the list come from the FDA’s early-warning system for drugs already on the market. This Adverse Event Reporting System (AERS) collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might — or might not — be related to a medication.
Just because a drug is on the list doesn’t mean it isn’t safe — or even that it caused the suspected problem. Nobody should stop taking a drug just because it’s on the list, the FDA says.
“If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation,” Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.
However, the list is just that-a list and not an exhaustive discussion of the potential problems concerning the drug. The list also doesn’t say anything about the severity of the problem or how widespread it may be. In some instances, the drug listed has already received adverse publicity such as the antipsychotic drug Seroquel. The blood thinner drug Heparin is also on the list. Heparin received quite a bit of adverse attention earlier this year due to contaminaton issues.

We’re often conditioned to think that those who need implanted pacemakers or need implanted defibrillator leads are those of us who’ve lived a long life and are hoping to prolong that life for a few more years. If something goes awry, well, that person lived a long life. At least that’s what we tell ourselves.
What if it involves a kid, a 9 year old? A child isn’t the likeliest candidate for a Sprint Fidelis defibrillator lead or any other type of heart lead for that matter. Yet for his dad and mom, it doesn’t matter. They have a sick child whose life depends on that medical device. What if that child clings to life because of a heart defibrillator lead that doesn’t work. Imagine for a moment that is your child, what lengths would you go to protect the child? What if that child clung to life because of a heart defibrillator lead that didn’t work, how would you feel? That’s exactly what happened to one of my clients. Their precious child had a heart defect that required a defibrillator lead in order to live. It’s no longer a matter of legal arguments, it’s a matter of life and death. And, it’s your child. what would you do? The defibrillator lead, the Sprint Fidelis, doesn’t work, it has defects. In this particular case, the child’s heart had an irregular rhythm that required an electric shock to keep it in a normal rhythm. Yet the Sprint Fidelis cardiac defibrillator lead didn’t always send electric impulses when needed. As we now know, the Sprint Fidelis lead wire broke and therefore short-circuited so the parents took him back to the surgeon who decided to remove the implanted device. But they couldn’t remove it. He was flown to another city where specialists had to perform lengthy and delicate surgery to remove the defective lead replacing it with another medical device. The trauma of seeing their son suffer and cling to life has left both parents shaky. They try to sleep at night but can’t since their thoughts kept racing to what if this defibrillator lead doesn’t work? What if our son needs an electric shock but doesn’t receive it? What if? This is all the result of a medical device company continuing to sell a defective product. The surgeon who implanted the Sprint Fidelis lead didn’t know about the defect. The company, however, did know that the lead was prone to breakage. They just didn’t tell anyone about it. They didn’t want to hurt sales.
That’s often what it’s like practicing consumer justice law. People’s lives are in peril. You share in their pain. You suffer with them and you try to pursue justice.

As the seventh of 11 children, Kerry Kennedy’s Catholic upbringing was a huge influence on her formation. She was afterall the daughter of Robert F. Kennedy. The family prayed the Rosary together, attended daily Mass after the assassination of their father. In fact, the 49-year old Kennedy remains a practicing Catholic, teaching religion in her home parish in New York.
However, as she grew older, she began to wrestle with some of the Church’s stances on hot button social issues of the day. The result of that struggle is her new book, “Being Catholic Now”. The book attempts to demonstrate the profound effect that Catholicism plays in those who grew up Catholic as well as the contradictions and tensions of an adult Catholic who is at times at odds with the institutional church. Kerry Kennedy interviews a wide variety of Catholics from Bill O’Reilly to Martin Sheen. Interestingly, Kennedy does not shy away from the priest sex abuse scandal. She even interviews Justice Anne M. Burke who was interim chair of the National Review Board for the US Conference of Catholic Bishops for two years. Burke is sharp in her criticism of two leading cardinals-Francis George and Edward Egan. In the interview with Kennedy, Burke states, “started having problems with individual cardinals and bishops who thought we were too aggressive,” and that “bishops got away with concealing crime,” and “just when you think these bishops are getting it, they turn around and do something that in any other enterprise would result in their own dismissal.”
Burke is highly critical of Chicago’s cardinal Francis George. She says he lied to her about an abusive priest, “the cardinal wasn’t honest with me. Perhaps he was not honest with himself.”
She also doesn’t let Egan off lightly, “Cardinal Edward Egan was offended by our insistence for independence,” she says. “I also think he was intimidated by the thoughts of fifty former FBI agents doing our questioning. His animosity reached an absurd level when he publicly uninvited us from attending the Cardinal’s Annual Gala in New York [an Order of Malta dinner].”
Both cardinals have already rejected Burke’s critiques. However, it’s hard to dispute the veracity and integrity of Justice Burke as well as former Governor Frank Keating, especially when the cardinals haven’t had the best track record in the truth telling department.

Over the last two decades, I’ve witnessed various responses to the priest abuse crisis by the American bishops. Initially, they flat out denied the crisis and attacked the “Catholic bashers”. From there, I saw the bishops say that they had no idea that such priest would continue to abuse. They didn’t have the psychological data to deal with the crisis. (This in spite of documents that have come to light from the Servants of the Paraclete in New Mexico stating otherwise.) Then they blamed the lawyers and told the faithful that the lawyers were going to bankrupt the Church and one diocese after another filed bankruptcy. The latest public relations message spun by the bishops is “the crisis is now over. What happened in the past, is the past, we’re ready to move forward.” Throughout all of these public relations permutations, we never heard about concern for the victims and survivors of sexual abuse. The majority of Catholic bishops in this country have never moved away from what they perceive as their first duty: protect the institution at all costs. Even Archbishop Wilton Gregory, whom many considered to be a reformer, has been caught in the web of coverup this past week by an Illinois jury. It’s disheartening to say the least to see that not much has changed.
Even with Pope Benedict’s pastoral visit to the United States earlier this year, the words were nice but talk is cheap. The bishops haven’t budged. It’s hard to know if Benedict’s words were just a “wink and a nod” to the public relations machine. Either the bishops have ignored him and his words or they knew something we didn’t. His words were hollow and nothing changes.
Priest Sex Abuse Advocate

The crux of last year’s $660 million settlement with the Archdiocese of Los Angeles was the church’s willingness to hand over to the public the internal documents concerning the priest abuse scandal within the Archdiocese. For many of the survivors, the most important aspect of the settlement was the revelation of these important documents. Yet, more than a year later, the documents still have not seen the light of day. In spite of the settlement agreement, the church’s lawyer is fighting to have the documents sealed. According to the Associated Press story today, “The priest personnel files in question contain letters, handwritten notes and reports from doctors and psychologists — and the district attorney has said he will inspect them for evidence of crimes once they are public.
When the Diocese of Orange released tens of thousands of pages of similar files in 2005, they showed that two officials who covered up for molester priests years ago remained in top church positions. Another 800 pages that came out in Wisconsin this year showed the church knew of credible molestation reports against a priest but didn’t remove him.”
The Catholic Church will stop at nothing, spare no expense, and impugn the intentions of survivors in order to keep these Church documents out of the public eye. That’s why the public must have access to them. From the documents that other dioceses have released such as Boston and Manchester, they are a treasure trove of criminal behavior, cover-up, duplicity, and bold face lies in order to protect the all important reputation of the Church. This is not a new modus operandi for the Catholic Church. They’ve been doing this for centuries.
Take as an example the Pontifical Secret. If this secret is deliberately divulged, the Church considers it a grave sin. It’s so important to the instituional church that it’s covered in Canon Law, the official law of the church. While the Pontifical Secret pertains to various matters deemed important by the Pope, issues of clerical sexual abuse may fall into this category. In layman’s terms this is tantamount to the Pope demanding secrecy concerning a civil crime!
Another example of such institutional secrecy concerns the oath cardinals take upon their installation. Here’s the text to which they swear:
[name and surname], Cardinal of the Holy Roman Church, promise and swear to be faithful henceforth and forever, while I live, to Christ and his Gospel, being constantly obedient to the Holy Roman Apostolic Church, to Blessed Peter in the person of the Supreme Pontiff Benedict XVI, and of his canonically elected Successors; to maintain communion with the Catholic Church always, in word and deed; not to reveal to any one what is confided to me in secret, nor to divulge what may bring harm or dishonor to Holy Church; to carry out with great diligence and faithfulness those tasks to which I am called by my service to the Church, in accord with the norms of the law.
So help me Almighty God
I’ve highlighted the relevant parts of the oath for purposes of demonstrating how such an oath can be construed by cardinals to keep secret crimes committed against children. As is obvious, these are strong words from which one can sense the mentality of those in positions of authority regarding their duty to “protect” the church.
Now, that the judge in Los Angeles who was charged with reviewing these church documents has quit, the dissemination of the church documents is in jeopary. The Associated Press story relates, “Under a settlement announced in July 2007, the Los Angeles archdiocese promised to release the priest personnel files to the court, which would then appoint retired state Supreme Court Justice Edward A. Panelli to review each one. Panelli, whose name was written into the settlement agreement as the mediator, would decide which documents could be released and which couldn’t — and none of his rulings could be appealed.
But Panelli suddenly recused himself this summer because he received an unspecified honor from the Roman Catholic church, plaintiff attorney Ray Boucher said. Panelli declined an interview request through his assistant and archdiocese attorney Michael Hennigan said he didn’t know why Panelli recused himself.”
This is a battle for which we must fight. It’s a battle about justice and truth. Unfortunately, the Catholic Church is on the wrong side of this one.

The Catholic Church has managed to survive for more than 2,000 years now. The institution knows a thing or two about self-preservation and defending itself from attacks from within as well as outside the church. Unfortunately, part of that self preservation involves protecting the institution at all costs and I mean at all costs. The church has learned that scandal can be very damaging to its image and may cause the faithful to wander away from the church. This has never been more evident in the recent sexual abuse scandal that has rocked the church the last decade or so. Similar to any great scandal such as Watergate or Iran Contra, the church sex abuse scandal is remarkable for two things: secrecy and cover-up.
In order to preserve the reputation of the institutional church, the clergy, especially the bishops and cardinals, kept secrets and covered their tracks as to how they dealt with sexually wayward priests. They developed a Morse code like language to talk about these priests. They would often be deemed alcoholic or immature. They would be sent away “for further study” or be determined to be “absent on leave”. When the notion of sexual acting out was mentioned, the bishops and cardinals spoke in terms of “particular friendship”.
In my next blog post on this subject, I’ll continue discussing this subject of secrecy and coverup by examining such items as the “Pontifical Secret” and the oath of secrecy each cardinal swears upon receiving the red hat of a cardinal. Then we’ll take a look at how individual bishops have attempted to cover up priest abuse and their efforts at secrecy.

The FDA approved Zetia and Vytorin in 2002 as drugs that would lower cholesterol and reduce the risk of heart attacks. The drugs have been heavily marketed and doctors have prescribed them aggressively ever since they came on the market. Yet the evidence as to their effectiveness is still not clear. In fact, Vytorin failed to clinic trials which were conducted to prove its benefits. Some doctors now believe the drugs shouldn’t be used outside of clinical trials since the evidence against using the drugs is mounting. Adding to these concerns is a potential link to cancer. According to one prominent cardiologist, the FDA set the initial standard for approval too low. “The F.D.A. set the bar too low on the initial approval,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic. “It would have been a lot better if the agency had said, ‘Show us that you do more than lower LDL a little bit, show us evidence of effectiveness.’ ”

Strkyer Corporation has filed a lawsuit against the federal government and HHS over a subpoena they received concerning their marketing practices. The lawsuit contends that Stryker should not have to comply with the subpoena because they had negotiated a settlement with the government regarding medical device company kickbacks whereby the company would pay doctors to use their knee and hip implant devices.
Stryker Corporation has been sued for the faulty design of its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. These devices have been recalled by the company.

Pfizer’s cholesterol drug Lipitor has a new ad and a new pitchman. The old ad and pitchman were taken off the air last year after Dr. Robert Jarvik’s expertise were called into question. Critics panned the old ad as misleading since Jarvik has never been a practicing physician. His fame is the result of developing the artificial heart.
The new ad emphasizes experience over notoriety by using an ordinary baby boomer pitchman who actually has had a heart attack and was supposedly told by his physician that he should have been doing more prior to his heart attack to lower his cholesterol. In one part of the ad the ptichman states, “I trust my heart to Lipitor.”
Lipitor, the world’s best-selling prescription drug, is a so-called statin drug that is typically taken once daily to block an enzyme in the liver that helps make cholesterol. The U.S. Food and Drug Administration approved Lipitor 12 years ago.
The potential side effects of LIpitor is presented subtlely in a voiceover. The ad shows the ordinary man with his family in active scenes. Of course, the ad is a direct to consumer marketing piece that still plays on the emotions rather than science.