Monthly Archives: April 2011

Christian Brothers File Bankruptcy

Facing lawsuits in Washington state and Canada, the Congregation of Christian Brothers has filed for bankruptcy protection in New York state where they are headquartered. Scores of sexual abuse lawsuits have been filed against the Archdiocese of Seattle and the Christian Brothers concerning the sexual abuse of minor boys in boarding schools and orphanages run by the Christian Brothers within the territory of the Archdiocese of Seattle.
According to Reuters, 35 of the lawsuits stem from cases involving the now-defunct Briscoe Memorial School, an orphanage and boarding school jointly run by the archdiocese and Christian Brothers in Kent, Washington. According to lawyers handling these cases, the bankruptcy filing is nothing more than an attempt to protect the religious order’s assets.
While these sexual abuse cases occurred in the northwest, the Christian Brothers have been implicated in the horrible Irish sexual abuse scandal. Many of the cases involving schools and minor boys sexually abused by religious involved the Christian Brothers.

Judge Who Oversaw Philadelphia Grand Jury in Priest Abuse Cases Resigns

Judge Renee Cardwell Hughes, who oversaw the Philadelphia grand jury proceedings that led to the indictment of three Archdiocese of Philadelphia priests, has submitted her letter of resignation. No reason was given for her abrupt resignation. Judge Hughes was serving her second 10 year term on the Court of Common Pleas.
The Philadelphia grand jury which she oversaw resulted in the criminal indictments of Monsignor William Lynn, a high ranking Archdiocesan official. Lynn’s indictment marked the first time a Catholic Church official has been indicted for allowing the sexual abuse of minors in the United States.

Johnson & Johnson Will Add Synthes to DePuy Orthopaedics

Johnson & Johnson, the troubled medical device manufacturer, has decided to purchase the Swiss medical device company Synthes and add it to J&J’s subsidiary DePuy Orthopaedics, Inc. Synthes already does the bulk of its orthopedics business in the United States. It manufactures screws, plates, nails and other implantable medical devices to fix broken bones.
Synthes will join DePuy as DePuy struggles with hip implant lawsuits concerning its DePuy ASR XL hip implant and the DePuy Pinnacle hip replacement. The ASR XL has been recalled and faces mounting lawsuits which have been consolidated in a multidistrict litigation in Ohio. Pinnacle has not been recalled but is facing lawsuits for similar issues including metallosis, hip implant loosening, and hip failure within a short period of time after implant surgery. Many of those who’ve had DePuy hips implanted have had to endure painful and complicated revision surgeries to correct the problems caused by the defective hip implants.

Vatican Ordered to Release Some Priest Files

An Oregon federal judge has ordered the release of some Vatican documents concerning the sexual abuse of a survivor in the 1960’s. In his ruling, Judge Michael Mosman ordered the Vatican to release some documents relating to the issue of whether the priest accused of sexual molestation was an employee of the Vatican. The judge limited the discovery request to those document relating specifically to the priest accused of sexual molestation, Fr. Andrew Ronan, who died in 1992. The documents that should be made available per the judicial order concern Ronan’s interaction with certain Vatican departments such as the Congregation for the Doctrine of the Faith as well as the Sacred Congregation for the Clergy since these departments are the ones that would have most likely been involved in the priest’s sexual abuse allegations and the Vatican’s handling of the charges which include laicization or removal from the clerical state.
The Vatican has taken the position that it knew nothing about the priest until after the sexual abuse took place. However, Fr. Ronan is known to have abused a seminarian in Ireland prior to transferring to the United States where he continued to abuse minors. He was subsequently laicized in 1966.
The Ronan case is an interesting one since it is the first of its kind to involve a judicial order mandating the release of Vatican documents concerning a sexual abuse lawsuit.

Topamax Receives More Serious FDA Safety Warning

In response to research done by the North American Antiepileptic Drug Pregnancy Registry, the FDA has moved Topamax from category C to D which is the second highest warning rating. The FDA move comes in light of data that suggests pregnancies exposed in utero to the drug Topamax have a significantly increased risk of being born with birth defects such as a cleft palate or cleft lip.
The new FDA category means that Topamax has a significant potential for causing injury or harm to an unborn child. The Topamax related injuries are severe in that they can cause pain and are permanent.
Topamax, manufactured by a subsidiary of Johnson & Johnson, is an anti-seizure drug that may be associated with an increased risk of birth injuries when compared to other anti-seizure drugs.

DePuy ASR XL Judge Issues Preservation Order

Judge David A. Katz, the federal judge in charge of the multidistrict litigation for the consolidated DePuy ASR XL hip lawsuits has issued an order to preserve all hip replacement parts so that they may be used as evidence in the hip trials. The preservation order handed down on April 6th instructs those who are responsible for the custody of the hip replacement parts to preserve them in such a manner that no additional damage or alteration be made to the DePuy hip parts.
The multidistrict litigation has been consolidated in the US District Court for the Northern District of Ohio.

Topamax Side Effects Recall and Birth Injuries

Topamax, manufactured by Johnson & Johnson, is being recalled for an “uncharacteristic odor”. The recall involves100 milligram tablets in 57,000 bottles of the epilepsy and migraine drug. Johnson & Johnson spokesman Mark Wolfe has stated that the odor is caused by TBA, a compound used to treat wooden pallets.
The company says in a statement that the two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012.
This is not the first issues concerning Topamax safety. Women who’ve taken Topamax during pregnancy have experienced an increased risk in giving birth to a child with a cleft palate or cleft lip.
On March 4, 2011, the FDA warned healthcare professionals of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. The FDA requested a label change for Topamax and its generic equivalent which has been on the market since 2006.
According to the FDA, “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.”

GAO Criticizes FDA For Lax Medical Device Oversight

The Government Accountability Office has criticized the FDA for its lax oversight of medical devices, particularly artificial hips. The Senate Special Committee on Aging will hear testimony from industry experts and safety advocates concerning the FDA’s regulatory process in approving such medical devices today. Testimony will include an examination of the now recalled DePuy ASR XL hip which was approved for use without rigorous clinical trials because of a regulatory loophole. The Senate hearing will also examine why DePuy Orthopedics continued to market and sell the DePuy ASR XL after doctors complained about unacceptably high failure rates.
According to the NY Times, “The F.D.A. has two separate procedures for approving medical devices.
For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.
But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.”

Medtronic’s Bone Growth Device Subject to Widening Criminal Probe

The Justice Department is widening its criminal probe into the marketing practices of Medtronic, Inc. in relation to its spinal fusion device Infuse, according to a published report in the NY Times. The criminal probe could prove to be a financial burden for Medtronic since Infuse accounts for a majority of biologic product sales.
The Infuse investigation is not new. In 2008, a 2008 Army report found that Dr. Timothy R. Kuklo had overstated the benefits of Infuse. Kuklo who became a Medtronic consultant, had forged the signatures of co-authors on an Infuse study that had been submitted to a medical journal. That same year, the FDA issues a warning about such devices as Infuse, citing the potential for life-threatening injuries when Infuse and similar products are used to treat neck pain.
Most recently, the FDA denied Medtronic’s application for approval concerning a high-strength version of Infuse known as Amplify. The FDA found that clinical studies of Amplify raised questions about a higher rate of cancers associated with the use of the new bone fusion device.

Bishop’s Abuse Report Released

The 2010 Annual Report on the Implementation of the Charter for the Protection of Children and Young People has been made public. The 93 page document is a self congratulatory document whose goal is to show how much the US bishops have done to protect children. However, if you read the document carefully, you’ll notice there are some troubling setbacks noted in the report: allowing clergy barred from ministry to lead public prayers, not monitoring parishes, not keeping track of the “safe environment training” required of priests, and failing to enforce other measures intended to end abuse. While these failures are mentioned in the report, it will take the discerning eyes of a knowledgeable reader to pick up on this as a disturbing trend.
The failures mentioned are central tenets in providing safety and security to children. These failures are not harmless clerical oversights but real failures in protecting children. Perhaps more disturbing, the failures have increased in comparison to last year. Auditors sent warning letters to 55 participating dioceses in 2010 compared to 23 in 2009.
Finally, it’s important to note that this report is based on the bishops’ self-reporting of data in their own diocese. Secondly, the Archdiocese of Philadelphia passed the audit! That should give us all pause.