Monthly Archives: March 2013

Pope Francis Catholic Church Sexual Abuse

Pope Francis I Catholic Church Sexual Abuse
Cardinal Jose Maria Bergoglio of Argentina has been elected by the College of Cardinals as the next pope. It was announced from the balcony of St. Peter’s Basilica Wednesday evening. He will take the name of Francis and is the 266th pontiff of the Catholic Church.
Bergolio’s selection came at the end of the first full day of the conclave and was sealed on only the fifth ballot. It would indicate that the College of Cardinals was in agreement but came as a surprise to many outsiders. Going into the conclave Bergoglio wasn’t considered to be one of the favorites, in spite of being the rumored as the runner-up in the 2005 conclave that elected Pope Benedict.
Formally the Bishop of Buenos Aires, Bergoglio will be the first non-European pope and seen as a nod to the growing significance of the church in the global south. In 2001 Archbishop Bergolio was elevated to Cardinal by Pope John Paul II, and began serving as an administrator of the Roman Curia – the administrative apparatus of the entire Catholic Church – which operates out of the Vatican.
The new pope inherits a Catholic Church mired in turmoil, much of it made worse by his predecessor pope Benedict. One of the first things Pope Francis must face is a sexual abuse crisis that has undermined the church’s moral authority around the globe.
As the College of Cardinals convened there were charges being brought against pedophile priests on every continent the Catholic Church operates. While the Vatican continues to downplay the crisis, new allegations emerge almost daily. Even during the conclave Cardinal Keith O’Brien, the archbishop of Scotland, was forced to resign amidst allegations of improper sexual relations going back 30 years.
On the same day Pope Francis was named, Cardinal Roger Mahoney of Los Angeles was receiving fresh attention for his role in the cover-up of sexual abuse by priests. The Archdiocese of Los Angeles agreed to pay a total of nearly $10 million to settle four child sex abuse cases brought against them. There is stark evidence that while he was bishop there, Mahoney helped a confessed pedophile priest evade law enforcement by sending him out of state to a church-run treatment center, then placing the priest back in the Los Angeles ministry.
Surveys of American Catholics reveal that they see sex abuse as the biggest problem facing the Catholic Church. Under Benedict the Church’s handling of the sex abuse scandals was cloaked in secrecy, and the impact was disastrous. In Europe, South America, and in the United States thousands of young men and women were victimized, and millions of dollars have been paid in settlements. This great tragedy is far from over.
As Cardinal, Bergoglio gave only three interviews, as Pope Francis he will be forced into the public spotlight. Until now the church’s reaction to the scandal has been entirely reactionary and relied on downplaying accusations or by using religion to bludgeon critics.
It is a pivotal moment for the church. The new pope must speak publically about the issue if he is serious about changing the church and putting an end to this epidemic of sexual abuse. Remaining dedicated to the Church’s current conservative principles will ignore the suffering of the victims and only allow this horrible tragedy to continue.

DePuy ASR Hip Implant Lawsuit Settlement

DePuy ASR Settlement
Today in Los Angeles a jury awarded $8.3 million to a former prison guard who accused Johnson & Johnson’s DePuy Orthopedics subsidiary of knowingly marketing a faulty hip implant that it later recalled.
In the first of over 10,000 lawsuits filed against DePuy, jurors found that the now-recalled ASR implant had caused Loren Kransky, 65, to suffer from metal poisoning and other health problems after he underwent hip-replacement surgery in 2007.
Since DePuy introduced the ASR, almost 93,000 patients have received the implant. Roughly one-third of those recipients were in the United States. From the beginning there were complaints from patients and doctors about the device. The joint failed at an unacceptable rate and doctors discovered tissue damage caused by metal debris from the implant. Common complaints from patients with an ASR included pain- and joint-dislocations, infections and bone fractures. This led Johnson & Johnson to recall the device in 2010.
This suit came to trial first under a California statute that allows for cases involving plaintiffs with terminal diseases to be expedited. Kransky, a retired Montana prison guard, suffers from kidney cancer and other ailments. Jurors were able to see past these health problems and recognize the intense pain and suffering caused solely by the defective ASR joint. This sets a strong precedent as the other suits prepare to go forward.
In spite of the decisive verdict, Loire Gawreluk, a DePuy spokeswoman, said the company plans to appeal.
The trial’s evidence was overwhelming that DePuy had long known of problems with the ASR. Internal documents from DePuy showed that the company had concerns about the ASR joint long before 2010. It was aware of abnormally high failure rates with the device yet it continued to market it aggressively in the United States. Company head Andrew Ekdahl was told by consultants to DePuy as early as 2008 that the device was faulty and failing at alarming rates.
DePuy continues to deny it knew early on the device was defective. It claimed in the trial that ASR failure was entirely the result of surgeons implanting the device improperly.
The jury rebuked that argument completely and, despite the promise of an appeal, the verdict will set a starting price for other plaintiffs in settlement discussions.
Johnson & Johnson has set aside more than $3 billion to cover the ASR recall. Yet rather than settle the almost 11,000 law suits filed against it, the company intends to proceed on a case-by-case basis. This initial verdict in Los Angeles calls this strategy into question.
In closing arguments, Kransky’s attorney Michael Kelly said, “This is not an imperfect hip, this is a public health disaster. Somebody needs to tell them, ‘Build these things right. Don’t let this happen again.’ ”
While Johnson & Johnson continue to resist a settlement, analysts predicted that the decision will begin to make the company reconsider. Continued litigation will be onerous and expensive and the company will be forced to offer a national settlement under which thousands of hip plaintiffs would likely take what is offered rather than face years of litigation and appeals.
The ASR represents only a part of the biggest medical device failure in decades. Since its recall in 2010, the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination, but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.
The verdict in favor of Loren Kransky vindicates the thousands who suffer as a result of having ASR implants. DePuy will continue to insist it acted appropriately. But this trial refutes executives’ claims. Instead the evidence showed a corporation that placed profits above the health of its patients, the welfare of the corporation above the people it served.

New Jersey Jury adds $7.76 Million in Punitive Damages to $3.35 Million Ethicon Prolift Vaginal Mesh Verdict

New Jersey Jury adds $7.76 Million in Punitive Damages to $3.35 Million Ethicon Prolift Vaginal Mesh Verdict
Today the Atlantic City jury in Linda Gross v. Ethicon found that Johnson & Johnson and its Ethicon Division was guilty of culpable negligence in disregarding health of patients in pursuit of profits in the marketing of the Ethicon Gynecare Prolift transvaginal mesh implant. This verdict sends a message to medical product manufacturers that jurors will not tolerate a company that puts corporate greed above the safety of the public. The $7.76 million in damages to punish the company was in addition to the $3.35. million that the jury awarded Monday to compensate for the injuries that were caused by the mesh.
Linda Gross had suffered horrible pain and injuries when the transvaginal mesh that was implanted in her moved and shrank damaging her body. She has endured multiple painful surgeries to try to remove the mesh and fix the damage done to her body. The Gynecare Prolift mesh was marketed as safe and effective to treat pelvic organ prolapse but had never been clinically tested before the marketing campaign to doctors. The evidence at the trial demonstrated that Ethicon mislead doctors about the degree of testing that had been done and that Ethicon concealed emerging evidence that the Prolift product was unsafe. The Prolift was finally recalled last year after the FDA ordered the manufacturers to conduct a proper study on the safety of the device.
There are thousands of other lawsuits pending around the United States involving the Ethicon Prolift as well as other transvaginal mesh products (TVM) manufactured by Bard, Boston Scientific, American Medical Supply (AMS) and Coloplast. The FDA has ordered all of these companies to conduct safety studies on their TVM products.
All of these TVM products were marketed under the 510(k) loophole in the FDA regulations that allow manufacturers to “grandfather in” a new product because it is similar to a product already on the market. This is so even though the products already on the market have never been proven to be safe or effective. This is the same loop hole that allowed the widespread sale of metal on metal hips such as the DePuy ASR, Zimmer Durom Cup, Wright Converse, Stryker Rejuvenate ABG II, and Biomet Magnum without any clinical testing. There are thousands of lawsuits pending by hip implant patients with failed hip implants with these products as well.