Dr. Thomas Joyce, a biomedical engineering professor at Newcastle University in the United Kingdom, will address conference attendees about the DePuy ASR XL hip replacement recall. In remarks leading up to the conference, Dr. Joyce termed the recall a “medical disaster.” He noted, “It is the biggest disaster in the history of orthopaedics.”
Dr. Joyce holds a Ph.D. in Biomedical Engineering from the University of Durham in the United Kingdom. He is also a member of the British Orthopaedic Society. In 2009, Dr. Joyce co-authored “Serum Cobalt Concentrations Post Hip Resurfacing Arthroplasty: Analysis of 585 Results”. He and his fellow co-authors were awarded a prize at the London Hip Meeting.
While the DePuy ASR XL hip replacement was recalled last August, issues and concerns with the DePuy metal-on-metal hip implant have been present as far back as 2007, according to international medical device registries. Of course, in this country we don’t have access to such a database because the United States doesn’t have such a registry.
In 2007 the Australian National Joint Replacement Registry began to notice problems with the DePuy hip replacements, noting that these hips were 4 to 5 times more likely to fail within the first 3 years of implantation. Joint registries in England and Wales determined the 5 year failure rate to be 12.5%, which is double the industry average.
If we had a national registry of medical devices, there would probably be fewer people suffering with the DePuy hips.
A grave concern for those patients who’ve received the recalled DePuy ASR XL hip implants concerns periprosthetic metallosis or metal poisoning that results from the wear of the metal-on-metal DePuy hip implant. The hip implants design allows metal to rub against metal which may lead to tiny metal particles falling into the bloodstream. Such metallosis can cause tissue and organ damage and makes any revision surgery very difficult.
According to Dr. John Tower whose study on this subject was published in the Journal of Bone and Joint Surgery, “A serum cobalt level of > 7 mg/L indicates possible periprosthetic metallosis. A normal serum cobalt level is .19 mg/L and 95% of those who are unexposed to cobalt have a value of <.41 mg/L. A serum cobalt level of > 1 mg/L indicates excessive cobalt exposure, and levels of >5 mg/L are considered toxic.”
A specific blood test must be administered in order to determine if the patient suffers from periprosthetic metallosis. While there are no clear warning signs, patients may experience tinnitus, vertigo, blindness, deafness, peripheral neuropathy, headaches, optic nerve atrophy, convulsions, cardiomyopathy, and or hypothyroidism.
More than 34,000 DePuy ASR XL hips have been implanted in the US. Patients who experience metallosis as a result of the metal-on-metal hip implant may suffer cardiac or neurological damage as well.
In an ironic sidebar to a scandal, Cardinal Justin Rigali’s driver was videotaped by Fox 29 in Philadelphia yesterday going the wrong way down a one-way street in order to avoid the media. Rigali it seems has been going the wrong way for quite some time in order to keep the sex abuse scandal out of the view of the general public.
Now that the Grand Jury Report has received widespread media attention and four Philadelphia priests have made their first appearance in court, there’s no more hiding and cover-up. It’s time to come clean and bring justice to survivors.
The DePuy MDL status conference originally scheduled for March 9, 2011 has been re-scheduled for April 5th in order to allow both parties to “complete their conference, commence with discovery, and present a comprehensive report to the Court.” The presiding judge over the DePuy MultiDistrict LItigation is Judge David A. Katz, US District Judge for the Northern District of Ohio, Western Division.
The conference will be held before Judge Katz on April 5, 2011 in the Paul G. Rogers Federal Building in West Palm Beach, Florida.
The scene was unprecedented in the history of the Catholic priest abuse scandal-a Catholic priest standing as a criminal defendant before a judge. He wasn’t there accused of performing the sexual abuse on minors. Rather, he was in a criminal courtroom for what he allowed to continue to happen to countless children during his tenure as one of the top ranking officials in the Archdiocese of Philadelphia. From 1992 until 2004, Monsignor William Lynn served as the Vicar for Clergy and was responsible for the handling of priests accused of sexually abusing minors. The recently released Grand Jury Report recommended that he be criminally indicted for endangering the welfare of children in the Archdiocese. If Lynn is found guilty, he could face up to 14 years in prison for the crimes.
Criminal investigations of high ranking church officials who conspired to hide sexual predators and keep their crimes from public view has been done before. It’s the actual indictments that are new. Prosecutors in Boston, Manchester, Cincinnati and Los Angeles have tried to charge church officials with similar crimes but were unsuccessful.
It’s unclear what transpired yesterday in court other than Lynn will not have the criminal charges summarily dismissed. He has two powerful criminal defense attorneys who are being paid by the Archdiocese. While four other priests were indicted along with Lynn, I’d suspect it’s Monsignor Lynn’s case that is drawing the attention and interest of the Archdiocese. They know they can ill afford a criminal conviction.
The five Archdiocese of Philadelphia priests who’ve been indicted on criminal charges relating to the sexual abuse of minors will appear in a Philadelphia courtroom today.
In related news, survivor advocates believe that since the most recent Grand Jury report indicated that the Archdiocese of Philadelphia had committed fraud in dealing with abuse victims, survivors may be able to seek justice in a civil court. The Grand Jury report concluded that the Archdiocesan Victim Assistance Office was little more than a way for the church’s lawyers to gain valuable information to defend themselves against priest abuse suits. If that’s proven, survivors very well may have an opportunity to face the predators and church officials who covered for them in a court of law.
Soon after DePuy Orthopaedics, Inc. recalled its DePuy ASR XL Acetabular hip systems, it was estimated that the failure rate would be around 12-13% of all 93,000 hip implants received by patients.
However, Bloomberg News is reporting that doctors in the United Kingdom believe the failure rate may be as high as 49%. That’s as disturbing as it is shocking.
According to Bloomberg, “The British Orthopaedic Association and the British Hip Society said in a statement this week that data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.
“It’s probably the best indicator so far of what the failure rate is likely to be,” John Skinner, an orthopedic surgeon and chairman of the groups’ expert advisory group on metal bearing hips, said in a telephone interview. “As far as I can tell, it’s reliable.” Skinner said the data haven’t undergone peer review required for publication.
That would mean close to 50,000 patients would have defective hips and in need of painful and complex revision surgery.
Fox 29 in Philadelphia first broke the news about a “smoking gun” document related to the Archdiocese’s priest abuse scandal. The document, dated 10/03, appears to have been drafted and promulgated for use in the Philadelphia Archdiocese almost a year after the so-called Dallas Charter was approved by the US bishops. The Dallas Charter mandated that all dioceses report allegations of sexual abuse to law enforcement and clearly inform sexual abuse survivors of their civil legal rights.
The newly released Philadelphia document clearly contradicts the the spirit and actual directives of the Dallas Charter. In part, the document reads, “I (name of individual) prohibit (name of official from the Archdiocese of Philadelphia) of the Archdiocese of Philadelphia from releasing to the appropriate law enforcement authorities of (location of law enforcement) any information I provide about alleged sexual abuse by an official or employee of the Archdiocese of Philadelphia unless I disclose information which is mandated to be reported.”
Interestingly, the month in which the document is dated corresponds to the same month that Cardinal Justin Rigali was installed as Archbishop of Philadelphia, succeeding Cardinal Anthony Bevilacqua.
The document is curious in that it states that “I understand that this is contrary to the policy of the Archdiocese.” It’s not entirely clear what “this” refers to. It’s sufficiently unclear so as to create doubt about the possible intent of the document. We’ve seen this before in church documents. Such ambiguity allows church officials the “wiggle room” needed to explain their way out of a delicate situation.
However, it’s clear from this morning’s Catholic media reaction that some see it as an unambiguous attempt at pressuring survivors of sexual abuse from contacting law enforcement. Michael Sean Winters writes in his National Catholic Reporter blog, “But, again, the problem in Philadelphia is not a problem of a one errant hierarch. The problem is a culture of clericalism.”
In a blow to Johnson & Johnson’s efforts to fix its public relations issues, the pharmaceutical manufacturer has turned over control of three of its manufacturing plants to the Food and Drug Administration. The transfer occurs in the wake of Tylenol product recalls as well as an ongoing criminal investigation concerning safety issues at the plant.
According to CNN, “McNeil, a division of Johnson & Johnson said it had agreed to put its plants — one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.”
Safety issues have not been limited Johnson & Johnson’s pharmaceutical divisions, however. DePuy, a subsidiary of Johnson & Johnson, has had to recall is DePuy ASR XL hip implant device for high failure rates and potential metallosis (metal poisoning) issues.