The US Food and Drug Administration will commence two days of hearings on issues relating to the safety and effectiveness of metal-on-metal hip replacement devices. The hearings come in the wake of numerous metal-on-metal hip replacement lawsuits that allege the medical devices suffer from faulty design and may lead to a serious medical condition known as metalosis where the metal parts of the replacement hip grind against each other and metal debris enter the bloodstream leading to metal poisoning.
According to an article in today’s NY Times, “Why were these devices implanted in 500,000 people without adequate testing?
“There was not enough data to support” their widespread use, said Dr. Henrik Malchau, an orthopedic surgeon at Massachusetts General Hospital in Boston.
Under F.D.A. rules, orthopedic implant makers did not have to run clinical trials of the hips before marketing them, nor were they required to follow patients afterward to see how they fared. Doctors embraced the implants without evidence they were better or more durable than existing ones.
Many doctors say they adopted the devices believing they would help reduce a complication of hip replacement — the possibility of implant dislocation.”
In May 2011, the FDA ordered five hip replacement makers to conduct studies on how patients who’d received the metal-on-metal hips were doing. Thus far, only the Biomet study plan has been accepted by the FDA. The federal agency has rejected plans from DePuy, a division of Johnson & Johnson as well as Zimmer, both of whom are considered leaders in the hip replacement industry.
According to court records, Johnson & Johnson continued to sell its defective vaginal mesh device even after the US FDA ordered them to stop marketing the product. Vaginal mesh sales continued unabated for nine months in spite of the FDA’s order to stop selling the medical device product.
According to Reuters, this is what the FDA told Johnson & Johnson, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
Reuters also noted that, “The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.”
This is egregious, reckless behavior on the part of Johnson & Johnson. As a result, countless thousands of women were exposed to serious health dangers. There have already been approximately 1,400 vaginal mesh lawsuits filed against Johnson & Johnson with more expected.
Fr. Murphy, a priest of the Archdiocese of Philadelphia, spoke to his parishioners this past weekend like a true shepherd. He didn’t gloss over the conviction of one of his fellow priests regarding the sexual abuse he allowed to continue. Rather, he asks the legitimate question-where are the bishops? Why have they not been held accountable. I’ve copied the full text of his message below:
This is a copy of my remarks made at Masses on the weekend of June 23-24:
“I would be remiss if I didn’t say something about the elephant in the room. Yes. As has been reported in the news, Msgr. Lynn was found guilty on Friday of child endangerment. For some, perhaps many, this verdict brings with it at least some small sense of justice rendered. No doubt, it makes clear that “I was just following orders,” is an unacceptable defense in the face of blatant evil.
Yet for many with whom I have spoken and with whom I agree, it is only a partial sense of justice. Because the other elephant in the room is the fact that those directly in charge, the bishops, have yet to claim or accept responsibility for their own horrific part in this painful scandal. Not a single bishop has acknowledged or apologized for his decision to put the image of the Church before the protection and care of sexual abuse victims of clergy. Nor have any bishops had the decency or courage to call their fellow bishops to accountability.
The result? Many Catholics, including fellow clerics, friends who are practicing Catholics and friends who have left a Church they find disingenuous, dismiss the bishops as inauthentic and unworthy of their attention.
Moreover, the bishops’ latest attempt to exert moral authority with their “Fortnight for Freedom” campaign rings hollow for many who wish the bishops had been at least as energetic and enthusiastic with their denunciation of their role in institutionalized evil in the Church concerning abuse, as they are with a perceived threat to religious freedom. Rather than appearing prophetic, to many Catholics this looks like a pathetic attempt to reclaim power and authority.
Now, while all these feelings and observations are completely legitimate, there is one thing left to say:
I preached this weekend on the need to “shut up” as Zechariah was forced to do in today’s gospel, so that we might have time and space and silence to “hear” the voice of God and discern the will of God. Well, in the aftermath of this verdict, I have been called to silence. And in the silence I have been thus far able to discern this much: all of the above may be true and legitimate. And it must be said lout and clear. “But be careful,” I hear God saying.
“Be careful not to become smug and satisfied in your rightful calling to task of cowardly and self-serving bishops. Don’t stop there. Instead remember why you are a member of the Church: not because of the bishops, or the priests, but because of Jesus Christ–because you love Jesus Christ and you know in your bones that he is the Way and the Truth and the Life.’
So this is a time for all of us to commit ourselves ever more intensely to know Jesus even more, to love him even more. And then, above all to LIVE him, with all we have and are. All of us truly LIVING JESUS–that will be the transformation of the Church and of all the world.
Let the Church say, “Amen!”
In Christ’s love,
“In those days, it was very spontaneous and casual, and it did not seem really wrong. . .The only thing I can assure you of was that everything I did was in warmth and affection and not a power play,” he said. “I may have crossed societal boundaries. If I did, I am sorry.”
No, this isn’t a Jerry Sandusky confession. It’s from a former Horace Mann School teacher who’s quoted in today’s Sunday Times. Now 88 years old, the former Horace Mann English teacher thinks having sex with his teenaged students was not wrong, just perhaps a crossing of societal boundaries.
While most of us would strongly disagree with the English teacher, most pedophiles think this way. In their twisted, sick thinking it’s how they show love and affection. I’ve taken enough depositions of sexual abusers and those who covered up for them to know this is true. They’ve actually said similar words.
What is perhaps more disturbing is the confusion and pain caused to the survivors of sexual abuse who’ve been so traumatized by their abusers they are at times unable to recognize the severity of their own suffering. The NY Times article describes the reaction of three students who were sexually abused by the teacher-“All three students cited Mr. Lin as a positive influence in their lives, even today, and seemed reluctant to speak, not wanting to hurt the reputation of a man who had opened their eyes to philosophy and literature, and whose strict grammar rules they remembered today.”
Sadly, I’ve also encountered this same reluctance from survivors. While disturbing, the story provides ample evidence that the real damage done by sexual abuse is not physical. It’s emotional and spiritual because it damages and distorts one’s ability to relate to others as well as form a healthy view of self. These damages can last a lifetime and the suffering is still all too often done in silence.
Jerry Sandusky, the former assistant football coach whose sex abuse scandal eventually brought down legendary Coach Joe Paterno, has been convicted of 45 of 48 counts of sex abuse. Sandusky who faces stiff sentencing was convicted of abusing young, vulnerable boys in a 15 year period. Ultimately, the jury wasn’t convinced of his defense lawyers strategy to portray Sandusky as suffering from psychological illness.
The Sandusky verdict marks the second huge jury verdict for survivors of sexual abuse. Earlier today, Monsignor Will Lynn of the Archdiocese of Philadelphia was convicted on one count of child endangerment. This is perhaps a watershed day in the civil rights movement to protect children from sexual abuse.
Monsignor William Lynn, former Vicar for Clergy in the Archdiocese of Philadelphia, will spend tonight and perhaps the next 3-7 years incarcerated for his conviction on one count of child endangerment. One could legitimately ask, “Did they convict the wrong priest?” I’m not saying Lynn was innocent of what he stood accused. Rather, like so many other archdioceses and dioceses across the country, Lynn was carrying out the wishes of a “higher up”, a prince of the Church who conveniently (for him) died before this sordid mess truly played out in a courtroom. Lynn is clearly the fall guy for an institution that coddled and nurtured clerics far worse than him. Trial testimony is clear that Cardinal Bevilacqua was thoroughly in charge of the assignments and transfers of sexually abusive priests. Here’s how a Philly Associated Press story aptly describes his role, “Despite Lynn’s acquittal on the conspiracy charge, the trial exposed how deeply involved the late cardinal was in dealing with accused priests.Bevilacqua had the final say on what to do with priests accused of abuse, transferred many of them to new parishes and dressed down anyone who complained, according to testimony. He also ordered the shredding of a 1994 list that Lynn prepared, warning that the archdiocese had three diagnosed pedophiles, a dozen confirmed predators and another 20 possible abusers in its midst.Church lawyers turned over a surviving copy of the list days after Bevilacqua died.”
While I’m pleased for Philadelphia survivors that they received a modicum of justice today, it’s precisely that, just a sliver. True justice was not served. True justice would have demanded Bevilacqua and perhaps Cardinals Rigali and Krol as well would have gone to jail. They are the criminals who allowed children to be terrorized and sexually abused by sick priests for fifty years or more in the Archdiocese of Philadelphia.
Yes, the prosecutors did a good job. They got their man but even they must know the big fish got away unscathed.
It’s as if “Uncle Tony” Bevilacqua has come back from the grave and penned this one-so devoid of any type of human emotion for survivors and even for one of its own priests who tonight will spend the first of possibly many nights behind bars. The cold, calculating manner evident in this Release is consistent with the way in which this whole human tragedy in Philadelphia, Boston, Los Angeles and around the world has been handled. Perhaps it’s the tip of the iceberg of evil that is the sexual abuse of children. . .
June 22, 2012
ARCHDIOCESE REACTS TO VERDICT
IN TRIAL OF MONSIGNOR WILLIAM LYNN
This has been a difficult time for all Catholics, especially victims of sexual abuse. The lessons of the last year have made our Church a more vigilant guardian of our people’s safety. The Archdiocese of Philadelphia is on a journey of reform and renewal that requires honesty and hope. We are committed to providing support and assistance to parishioners as they and the Church seek to more deeply understand sexual violence, and to create an environment that is safe and welcoming to all, including past victims.
The Archdiocese of Philadelphia offers a heartfelt apology to all victims of clergy sexual abuse. Now and in the future, the Church will continue to take vigorous steps to ensure safe church environments for all the faithful in Philadelphia.
Archdiocese of Philadelphia Catholic priest has been found guilty of one count of child endangerment. The more difficult count, involving conspiracy, the Philadelphia jury acquitted Lynn on conspiring with Fr. Brennan in conspiring to abuse and cover-up abuse of children.
Breaking News: According to Rocco Palmo: Lynn acquitted of one count of conspiring with former priest Brennan of endangering children. Lynn found guilty on one count.
After 12 days of jury deliberations,Monsignor William Lynn, one of former Cardinal Anthony Bevilacqua’s top lieutenants in the Archdiocese of Philadelphia, knows his future. A Philadlephia jury
Lynn had been charged with two counts of endangering the welfare of a child by allowing dangerous priests to continue in the ministry in roles in which they had access to children, and one count of conspiracy to protect a priest accused of abuse. The difficulty with which the jury appeared to have in determining Monsignor Lynn’s guilt reflects the unprecedented nature of the criminal charges. The Lynn case marks the first time a US Catholic priest faced criminal charges for endangering children, not by physically or sexually abusing children but rather, allowing it to happen and conspiring to cover-up for those priests who did sexually abuse children.
According to Philly.com, “On Wednesday, jurors declared they were deadlocked on all but one count. Common Pleas Court Judge M. Teresa Sarmina instructed them to keep talking.
Lynn, 61, was the first church official nationwide to be tried for enabling or covering up clergy-sex abuse. He was accused of recommending that Brennan and another priest, Edward Avery, be allowed to live or work in parishes in the 1990s despite signs that they might abuse minors.”
Takeda Pharmaceuticals, Inc. diabetes drug Actos has already been linked to an increased risk of bladder cancer. Now, there’s a report in the Archives of Internal Medicine that has shown a connection between Actos and vision loss. Actos, the brand name for pioglitazone,is prescribed to treat Type 2 diabetes (a condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood).
A little less than a year ago, the FDA issued a health warning concerning Actos. The FDA warning noted that diabetes patients who’ve taken Actos for more than a year are at an increased risk of bladder cancer. Two days prior to the FDA warning, Actos was banned in two European countries.
There is already an established Actos MDL (multidistrict litigation)which will handle the numerous Actos side effects lawsuits that have been filed as well as those new Actos lawsuits to be filed in the future. A recent MDL court ruling will allow new Actos lawsuits to be consolidated in the Actos MDL in a quicker, more efficient fashion.