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Hip Implant Recall Depuy Lawsuit
Belgian Cardinal Godfried Danneels has been caught on tape urging a victim of sexual abuse to keep quiet about abuse he suffered from his uncle a Belgian bishop until the bishop retired.
“The bishop will resign next year, so actually it would be better for you to wait, the cardinal told the victim. “I don’t think you’d do yourself or him a favor by shouting this from the rooftops.”
Before his retirement, Danneels was a leading church figure whom some considered papabile or pope material. Danneels was an influential cardinal in the Church for the past 40 years and has been investigated for the cover-up of sexual abuse by Catholic priests in Belgium.
The abuse victim had been abused by his uncle Bishop Robert Vangeluwe for 13 years from the time he was 5 until he was 18 years old.
According to the NY Times,
“The fact of the April meeting had been reported by The International Herald Tribune and The New York Times in July after an interview with the victim, who said he had sought to alert the church about the molestation by his uncle for many years. He did not mention then that he had made a tape of that meeting and another one of another meeting.
The tapes, which were published on Saturday in the Flemish dailies De Standaard and Het Nieuwsblad, display the tactics the church used to try to hush up the scandal and placate the victim by appealing to his feelings for his family and the larger church. ”
DePuy hip lawsuits will be likely as a result of defects in the Johnson & Johnson DePuy ASR XL Hip Replacement System. They are expected to result in hundreds of additional surgeries to replace the hip implants in the U.S. The DePuy worldwide recall announced last week involved 93,000 of two types of hip implants. One of the recalled Hip implant devices is the the DePuy ASR XL acetabular system and the other recalled hip implant is the DePuy ASR Hip Resurfacing System.
Of the 93,000 recalled hips worldwide 37,834 were sold in the U.S Only one of the recalled hip implant devices was approved for sale in the U.S. and that is the ASR XL acetabular system. The DePuy ASR Hip Resurfacing System was not approved for sale in the U.S. So in analyzing the U.S. recall and the consequences, we only need to consider the ASR XL acetabular system. The worldwide recall is based upon failure rates reported in the United Kingdom. Since we do not yet have a nationwide medical device registry in the United States we have to rely on data from countries such as the United Kingdom that have better systems of tracking failures of medical devices than we do in the United States. DePuy is claiming that they did not realize that their hip implants were failing until recently. What DePuy knew and when they knew it will probably be the subject of lawsuits that are beginning to be filed.
The New York Times ran a story on March 3, 2010 raising questions about problems with metal on metal hip implants such as the DePuy ASR systems. On March 6, 2010, DePuy sent a warning letter to doctors in the U.S. advising them of high failure rates in Australia. On March 9, 2010 the New York Times ran an article raising concerns about the ASR hip implants.
The DePuy ASR XL Hip Implant Systems were first sold in the U.S. in 2006. Since 2008 there have been more than 400 adverse events reported to the FDA. The ASR implants are metal on metal which means that there is a metal ball in a metal socket. DePuy is not disclosing why they think the devices are failing but it is likely to be related to metal debris being generated from the metal on metal wear especially if the cup is not properly aligned in the socket. Some surgeons have suggested that the shallow cup used in the ASR may be more difficult to install with a proper alignment causing the excessive wear between the metal parts.
This metal debris or a loose cup can cause pain, swelling, inflamation, and problems walking. The debris can also cause an allergic reaction to the metal debris in the person’s hip. Many of the patients with these symptoms will have to have another surgery called a revision surgery to have a new hip implant installed. As hip implant patients know, hip implant surgery is major surgery with many risks and a difficult recovery period. Patients who had implants after DePuy had knowledge that they were having a problem with these devices will certainly have a legitimate complaint against the company.
Johnson & Johnson, the parent company of DePuy, has recalled two types of DePuy hips today. DePuy Orthopaedics is replacing one hip system for a faulty ball and another for a faulty socket after new data shows one in 8 DePuy patients need revision surgery after receiving DePuy hip replacements.
The DePuy hip replacements were being phased out this year to be replaced by “Next Generation” artificial hip devices. It is not clear how many patients have received the DePuy hips at this point.
The Irish Times is reporting this morning on a new book by Professor Colin Barr who claims that Irish Cardinal Paul Cullen used mental reservation to lie to a civil jury in a case in the 1870′s. The claim is made in Professor Barr’s new book The European Culture Wars in Ireland – The Callan Schools Affair, 1868-81 , which describes a schism in the Catholic Church in the late 19th century.
More importantly for those following the priest abuse scandal, it’s an acknowledgment from a reputable scholar and associate professor at Ave Maria University in Florida, that church officials did employ mental reservation in conflicts between the church and state.
Mental reservation is not church doctrine but a concept from moral theology that allows someone to mislead others without lying. The classic example of mental reservation concerns Nazis hunting for Jews during World War II. If someone was indeed harboring Jews in their home and a Nazi official asked if they were Jews in their home, the person could employ mental reservation to evade the truth.
Unfortunately, the concept of mental reservation has been suspected in cases of priest abuse to protect the institution of the church and the reputation of a priest who has abused children.
Mental reservation may be a theological concept which allows one to evade the truth in church circles. In a court of law, there is no evasion of the truth. If asked a question under oath, the whole truth is expected and demanded.
In spite of the judge denying Christopher and Laura Thorpe’s motion for punitive damages in the 2nd bellwether Kugel mesh trial, a jury awarded the North Carolina couple $1.5 million. The Kugel lawsuit was brought by the Thorpes and alleged that the Composix Kugel hernia mesh patch was defective and caused Christopher Thorpe internal injuries including sepsis. The jury sided with the plaintiffs and ruled that the manufacturers of the Kugel hernia mesh patch has failed to properly warn healthcare professionals and prospective patients of the Kugel patch design defect that made it prone to fail when inserted into the abdominal cavity.
Like many Kugel mesh patch victims, Christopher Thorpe suffered through numerous revision surgeries after the failed patch caused infections and other internal injuries. While the judge ruled against his punitive damages motion, the plaintiff was prepared to prove the following in regard to the Kugel manufacturers willful and wanton conduct:
” * While Bard and Davol were “formally investigating” the cause of ring breaks in Kugel patches in June 2005, the manufacturers were simultaneously making a strong push for territory managers to sell the devices to new hospitals as part of a summer sales contest that generated $4,472,971 in new accounts, including over $1.5 million of growth in ventral hernia repair product sales.
* The manufacturers continued to market and sell Composix Kugel hernia patch products while breaks were occurring for an allegedly unknown reason.
* The Kugel hernia patch recall was issued three months too late because Davol and Bard failed to follow their own procedures.”
While this was the second bellwether Kugel trial in the federal multidistrict litigation, there are more to come. These trials are designed to give both sides a sense of how juries will react to the Kugel lawsuits and trials. These trials may also provide the forum to discuss Kugel settlements in lieu of further litigation.
Reuters is reporting today that Matrixx Initiatives, Inc., the manufacturer of Zicam Nasal Spray and Swab cold remedies, has settled a consumer class action lawsuit concerning the company’s marketing of Zicam. The class action settlement has no relation or effect on the Zicam injury lawsuits filed as a result of Zicam users losing their ability to smell (anosmia). The Zicam injury lawsuits are continuing to move forward. Zicam was removed from the marketplace in June 2009 after an FDA warning letter raised concerns about Zicam’s active ingredient zinc gluconate and its relation to reports of anosmia or the loss of smell in Zicam users.
The priest, Stephen Kiesle, has been removed form from the priesthood and the Diocese of Oakland has already settled a number of of priest abuse cases involving Kiesle. So why is this a story? Perhaps because it contradicts what the bishops like to say when commenting on the priest abuse scandal-”that was a long time ago. We’ve moved beyond that and fixed the problem.” That’s convenient, it’s just not true. The Kiesle cases point to that fact. One of the latest Kiesle victims was abused as recently as 2001.
Time Magazine’s most recent investigation into the behavior of big pharma GlaxoSmithKline and their diabetes drug Avandia may have lead to further investigations by the FDA. Time’s investigation found that GSK officials weren’t entirely truthful when they told FDA officials that research on Avandia was inconclusive regarding an elevated risk of myocardial ischemic attacks. They revealed this five days before an article linking Avandia to a 43% increased risk of heart attacks compared to its competitors was to be published in 2007 by the New England Journal of Medicine. According to Time, “What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies “strengthens the [cardiac-risk] signal observed in the [previous] analysis.” Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an “increased risk of ischemic event ranging from 30% to 43%!” Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.”
This misdirection allowed GSK to continue to make huge profits at the expense of unsuspecting patients. Time estimates that the lack of full disclosure made the company billions in added revenue while putting millions at further risk of an increased risk of heart attacks.
The reaction to the soon to be dismissed lawsuit against the Vatican was very instructive as to how the Vatican and Church officials view the sex abuse crisis. Yesterday, we heard from the Vatican’s chief spokesman Fr. Federico Lombardi and the Vatican’s US lawyer Jeffrey Lena. We also heard from the Catholic League’s rabble rousing, pugnacious Bill Donohue. Interestingly, none of them feigned interest in the welfare of those who’ve been victimized by the sexual abuse of priests. Not one of them mentioned the human tragedy behind the lawsuits. Not one of these religious men seemed to care how their reaction would further hurt and alienate survivors of sexual abuse. Let’s take a look back and review what we heard from these men yesterday- Jeffrey Lena: the lawsuit always “lacked merit. The theory crafted by the plaintiffs’ lawyers six years ago misled the American public.” Fr. Lombardi called the voluntary dismissal of the lawsuit “good news”. How can the cover-up and secrecy surrounding child rape be termed “good news”? Finally, in a statement devoid of any grace or class, Catholic League bloviator released a statement which in part noted, “That’s right—once they got their check, they cashed out.” Donohue was referring to the survivors of sexual abuse. In another part of his remarks he refers to some abuse as “trivial”.
If the Bishops were smart, they’d distance themselves from Donohue and call for a public apology to the survivors of sexual abuse. Donohue, in his outlandish attempt at protecting the institution of the church, has boorishly stepped outside the bounds of propriety and decent behavior.