Monthly Archives: May 2011

Fosamax Lawsuits Consolidatedin MDL

Fosamax lawsuits have been consolidated into a multidistrict litigation for purposes of streamlining discovery and judicial proceedings in the US District Court for the District of New Jersey. Fosamax, Merck’s osteoporosis drug is already facing numerous lawsuits in an MDL in New York for jaw necrosis. However, the new consolidated Fosamax lawsuits are concentrating on femur fractures in those who’ve taken Fosamax for osteoporosis.
Last year, the FDA asked all bisphosphonate drug makers to include an additional warning about atypical femur fractures associated with these drugs, including Fosamax.
The new MDL in New Jersey was requested because the drug’s manufacturer has its headquarters in the Garden State.

DePuy Pinnacle Hip Lawsuits Consolidated

DePuy Pinnacle hip replacement lawsuits will be consolidated in a multidistrict litigation in a Texas federal court. The MDL allows all claims to share discovery and streamline the discovery process as the lawsuits proceed through federal court.
Presently, there are about 57 DePuy Pinnacle hip lawsuits to be consolidated. Like the DePuy ASR XL lawsuits which are consolidated in federal court in northern Ohio, the Pinnacle hip replacements are failing at a higher than acceptable rate. As a metal-on-metal hip replacement similar to the DePuy ASR XL, the Pinnacle replacement hips may shed metal particles that flow into the bloodstream causing a potentially dangerous situation known as metallosis.
Recently, the FDA called on hip medical device manufacturers to submit data to the FDA as well as contact all hip implant patients in order to obtain information about failure rates, symptoms and problems with the hips, as well as information about which hips are failing and the causes relating to the failures.

Bishop Finn and Child Safety

It all began last December when Fr. Shawn Ratigan had a technician work on his laptop. The technician found image of child pornography on the laptop and promptly turned the computer over to officials at the Diocese of Kansas City-St. Joseph where Ratigan was incardinated. Ratigan’s bishop, Robert Finn acknowledged that he knew back in December about the images but he was told they weren’t pornographic. (This in spite of the fact that media reports note the image include “up skirt” photos of young girls under the age of 12 and one nude photo of a young girl’s genitalia).
Diocesan officials copied the images and returned the laptop to Ratigan’s family. Ratigan attempted suicide after he found out the Diocese knew about the images. At this time, it’s not clear who contacted a police officer. The officer was not shown the images but they were described to him. During this entire time, the Diocesan Review Board was never told about Ratigan or the images found on his laptop. Review Board members found out when Ratigan was arrested and charged with possessing child pornography.
Bishop Finn, who has promised transparency in all abuse matters, failed to tell his own Review Board about the pornography and appears to have been less than forthcoming with law enforcement about Ratigan. His inaction could have endangered more children since Ratigan continued to be around children until his arrest last week. Finn defended his actions by stating that he spoke with Ratigan and ordered him to stay away from children. That’s not good enough. Children could have been harmed and some may have been harmed by Shawn Ratigan because of Finn’s desire to keep it quiet.

Infuse Spine Device Linked to Male Sterility

A new study by a Stanford physician shows a possible connection between Medtronic Inc.’s spine device Infuse with male sterility. The study is significant since earlier studies funded by Medtronic showed no such correlation. Infuse is a bone growth protein that has been used in spinal fusions since 2002.
The NY Times quoted Dr. Eugene J. Carragee who performed the study, ““It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, who based his study on 240 patients he treated several years ago with Infuse or a bone graft.
The procedure in which Infuse is used is called an anterior lumbar fusion. There are approximately 80,000 such procedures performed each year.
The new Stanford study renews the debate concerning the accuracy and effectiveness of studies that are funded by the companies themselves. Two surgeons who published favorable Infuse results had financial arrangements with the maker of Infuse, Medtronic, Inc.
In publishing his findings, Dr. Carragee noted that his study was prompted by a complaint he received from a Croatian doctor. “Since 2006, an orthopedic surgeon in Croatia, Dr. Tomislav Smoljanovic, has written more than 35 letters to medical journals questioning the claims. In their 2002 report, Dr. Burkus and Dr. Zdeblick reported that a major clinical study involving Infuse had found no adverse effects with the product, including the sterility-related complication.”

Priest Sex Abuse

Four days ago and one day after the $1.8 million John Jay study on the root causes of priest sex abuse, a Catholic priest of the Diocese of Kansas City-St. Joseph, Fr. Shawn Ratigan, was arrested for possession of child pornography on his computer.
Incredibly, that’s not the disturbing part of the story. According to the Kansas City Star, diocesan officials, including the bishop, knew about the computer pornography since last December but failed to tell anyone. Of course, he was transferred (that’s the protocol). The information wasn’t shared with the Diocesan Review Board or the parish where the priest had been assigned prior to his transfer.
“We haven’t been presented the case; we haven’t been asked to look at the case,” said Jim Caccamo, who serves on the board and said he first learned of the allegations against Ratigan after hearing news reports of his arrest.
“There’s nothing normal about this,” Caccamo said, referring to the delay between when the diocese first learned of Ratigan’s possession of child pornography and the priest’s arrest.
“My question will be: Why did it take five months?”
Bishop Robert Finn apologized for his behavior only after getting caught. His response to distraught and angry parishioners: “Trust our Lord Jesus Christ. Trust his church.” Isn’t he supposed to be representing Christ to Catholics whose faith has been shaken once again? His response isn’t good enough. This behavior can’t continue to be tolerated.
Review Boards and expensive reports don’t mean much when the bishops themselves remain the sole arbiters in priest abuse cases. In spite of all the talk and public relations spin, the bishop still gets to decide who stays and who goes when an allegation is made about the sexual abuse of a child. Perhaps, bishops should be held criminally liable for such actions. Perhaps, that would force much needed change.

Episcopal Reflux

After enduring withering criticism to its John Jay study on the root causes of sexual abuse by Catholic clergy, some bishops and members of the John Jay study have come out publicly to try to stem the tide against the findings of the study.
However, their responses have been a regurgitation of the same tired explanations and responses previously offered, leaving the public and some Catholic faithful to wonder when the Church will finally respond in a transparent, forthright manner to a crisis that’s overwhelmed the life of the Catholic Church.
In 2002, when the crisis bubbled to the surface, it was thought by Church insiders that this was a uniquely American problem. In the past year, that premise has been soundly defeated as abuse scandals erupted in South America, Germany, Ireland, and Africa. It’s indeed a catholic (universal) problem.
While the scandal has proven to be parochial, the Church’s response has been parochial and flat-footed.

Avandia to be Removed from the Market

After years of complaints about the dangers of Avandia, the FDA has decided to remove it from the marketplace, except in special circumstances beginning in November 2011. Avandia use has been associated with increased risk for heart attacks and other cardiovascular problems.
The FDA decision is widely viewed as a compromise position between doing nothing and removing the diabetes altogether. Avandia will remain available for those who’ve shown a demonstrable benefit from use of the drug.
First introduced in 1998, Avandia came under increased scrutiny after a 2007 New England Journal of Medicine highlighted the potential dangers of the drug.

Why Were the Metal-on-Metal Hip Replacements Fast Tracked?

Recently, the FDA has issued a letter to the manufacturers of metal-on-metal hip replacements. The letter states that the FDA will require the medical device companies to report hip replacement failures as well as test the level of metal in hip replacement patients, among other things.
The letter was issued because so many of these types of hips such as the DePuy ASR XL, the DePuy Pinnacle, Smith & Nephew’s Birmingham hip replacement to name a few, were fast tracked to the marketplace without having to undergo rigorous pre-market screening and testing. The logic behind the decision was that these metal-on-metal hips were substantially similar to previously approved hip replacements. Obviously, that logic was flawed and as a result many metal-on-metal patients will have to undergo painful and complicated revision surgeries.
Hip replacement patients have to rely on their doctors for guidance as to the type of hip replacement they receive. Doctors, in turn, rely on agencies such as the FDA to know which hips are appropriate for the individual hip replacement candidate. When the system breaks down as it has in this case, doctors are left in the dark and the patients suffer.
Hip replacement manufacturers want to make a profit and the faster they receive approval to move a product to market, the better. However, such short-sightedness comes at a cost, a cost borne by the patient and the medical community. It’s time that all such medical devices undergo rigorous and thorough scientific review PRIOR to their approval for market. Patients deserve it and so does the medical community.

Blame it on the 60’s

The NY Times has published a story this morning about the US Catholic bishops 5-year study on the root causes of the priest sex abuse scandal. The John Jay College of Criminal Justice conducted the study and concluded that the abuse scandal can neither be blamed on celibacy or homosexuals. Rather, the study concluded, the tumultuous period of the 1960’s and 1970’s contributed to the overall social upheaval that led to the priest abuse scandal.
This conclusion neither angers the traditional crowd who oppose any loosening of the celibacy requirements for priests nor the homosexual community who perceive themselves as unjustly targeted by those who want to blame somebody for the priest abuse scandal.
It’s a cynical stroke of genius. Once again, the Catholic Church gets to show us all how concerned they are by issuing a comprehensive report that took five years to compile. They also get to blame a decade (not a person or institution) for causing the scandal.
Just like those who want to blame drugs and sex on the 60’s, the Catholic bishops get to heap their woes on the decade of “peace and love”.
However, it’s simply not true. The 60’s didn’t cause or create the pederast priests to terrorize children. A closer inspection of the US Catholic Church in the 1960’s reveals a Church still celebrating the sacraments in Latin. The Second Vatican Council didn’t end until 1965. Nuns were still, for the most part, wearing their traditional habits. Nothing had changed culturally in US Catholicism in the 1960’s. The Church, apart from a courageous lot who participated in the Civil Rights Movements, looked no different in 1965 than it did in 1945. Sorry, but you can’t blame this on the 60’s. That decade deserves much better.
I would have been hopeful if the John Jay study had actually examined the insular culture of the institution that preferred to protect predatory priests than children. I would have been interested in a study that examined the mindset of bishops who colluded with these abusive priests by transferring them and covering for them. Finally, I would have liked to have seen a study that looked at a Church that stubbornly refused to report crimes to law enforcement.
We didn’t get such a report and we many never receive such from a Church sponsored study. The John Jay study is another ecclesial exercise in navel gazing with its sole purpose to deflect blame and criticism. They still don’t get it.

Vatican Issues Child Sex Abuse Guidelines

The Congregation for the Doctrine of the Faith, the Vatican department presently in charge of priest sex abuse cases, has issued a circular letter to all the bishops of the world with its suggestions for dealing with the worldwide crisis of sexual abuse. The letter focuses its suggestions on five specific areas of concern to the Vatican. Here they are:
* Listening to the victims of abuse and offering “spiritual and psychological assistance”.
* Creating “safe environment” programs to prevent future abuse.
* Promoting “a healthy human and spiritual formation” of future priests, including “an appreciation of chastity and celibacy.” The guidelines also call for “an exchange of information” when candidates transfer from one seminary to another, or between dioceses or religious orders.
* Upholding the presumption of innocence when a priest is accused, yet conforming that a bishop or religious superior “is always able to limit the exercise of the cleric’s ministry” while the case is investigated.
* Stressing that “the prescriptions of civil law regarding the reporting of such crimes to the designated authority should always be followed.”
The letter is widely available on the web and anyone who reads it will be puzzled by its publication and not clear as to what the Vatican hopes to accomplish. There is nothing new in the letter as far as the Church’s rhetoric. The fact that they really don’t say anything new leads one to believe the Vatican has still not come to grips with the depths of the problem or the severity of the suffering of the survivors.
Ultimate authority remains with the bishops who have acted in the view of many as the keystone cops. (Others may apply more sinister analogies especially after the Philadelphia debacle.) There is still no universal reporting requirement and there’s nary a mention of what to do with priests who move from one diocese to another after being accused of sexual abuse.
All in all, this isn’t news at all. It’s a weak and tardy response to a critical problem that needs radical measures. So far, the Church hierarchy is unwilling to consider such moves. That’s why civil authorities must continue to drag the Church to justice and accountability.