As more DePuy ASR XL lawsuits are filed, both sides are gearing up for a complicated litigation process. Johnson & Johnson, the parent company of DePuy Orthopaedics, has already submitted 200,000 pages of documents regarding the failed DePuy ASR XL hip replacements, according to the Wall St. Journal. In the end, the medical device company is expected to have to submit 18,000,000 pages of documents. Thousands of hip lawsuits have already been filed with most being consolidated in the multidistrict litigation in northern Ohio.
Johnson & Johnson has told the Wall St. Journal that it has already fielded 27,000 calls from DePuy hip sufferers who’ve needed assistance with reimbursements or information about the recalled hip. The company estimates that there are approximately 37,000 DePuy hip patients in the United States and 93, 000 worldwide. Some of these patients have already undergone the expensive, complicated, and painful hip revision surgery in order to have the failed DePuy hip replaced.
Harvard Medical School and Massachusetts General Hospital have punished three psychiatrists for failing to disclose payments they received from companies in their industry. The three doctors, Joseph Biederman, Thomas Spencer, and Timothy Wilens received $4.2 million from drug companies for psychiatric research performed between 2002 and 2007. The income was never reported to either medical institution or the federal government.
It’s hard to fathom why doctors would continue to hide payments in such conflict of interest cases especially when the federal government has demonstrated a heightened concern over the issue as well as a willingness to investigate such matters.
The three doctors will be prohibited from receiving any payments for such research for one year as well as undergo conflict of interest training. In light of the potential harm such conflicts can generate, the penalty seems to be no more than a light slap on the wrist especially given some of the research they were doing.
According to National Public Radio, “The accusation carried more weight because Biederman is a leading proponent of the off-label use of antipsychotic drugs to treat bipolar illness in children. His work is widely seen as contributing to an explosive growth in such prescriptions, and much of his support came from companies that benefited from his research.
Biederman and the other two psychiatrists have also published extensively on the treatment of attention deficit hyperactivity disorder.”
A new Finnish study has linked the use of antidepressants Prozac and Paxil to cardiac birth defects in pregnant women who’ve taken the drugs. The study was published in the medical journal Obstetrics and Gynecology.
According to a media report “Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.”
Surgeons who were paid handsomely to test Medtronic’s Infuse bone graft medical device system never reported failures and complications in their research results, according to a new study published in the Spine Journal.
According to the Wall St. Journal breaking news report, Over the past decade, 15 of those surgeons have collectively received at least $62 million from the medical-device giant for unrelated work, according to a Wall Street Journal analysis of Medtronic documents and of recent disclosures made on the company’s website.
Last week, the Senate Finance Committee began investigating whether Medtronic’s large payments to the surgeons played a role in the fact they didn’t report the complications, after seeing an advance copy of the study. The product, called Infuse Bone Graft, has already been the subject of a series of inquiries by the Senate committee, as well as of an ongoing investigation by the Justice Department into its use beyond its official Food and Drug Administration indication. Infuse represents about $700 million in annual sales for Medtronic.”
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The failed results are serious according to the study-cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10% to 50% of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010.
The Diocese of Venice in Florida has had a rash (for them) of priest abuse cases in the news recently. First, there was the arrest of Carmelite priest Rev. William Wert for committing a sex offense against a minor. More charges against Wert were filed as we learned that Wert had been in trouble for similar sex abuse issues while stationed in Washington DC. Next, a Polish priest incardinated in the Diocese of Venice was arrested in a Sarasota park for exposing his genitals to an undercover officer as well as grabbing the officer’s genitals. Finally, this past week a former Catholic school teacher filed a civil lawsuit against Bishop Frank Dewane fired him after he blew the whistle on a Venice priest, Fr. Cory Mayer, for asking teenage girls inappropriate sexual questions during confession.
Dewayne denied responsibility in the Wert case since the priest is a religious order priest and not affiliated with the Venice diocese. In the matter concerning Fr. Chojnacki, the Diocese placed the priest on administrative leave but has said little about the matter. In the lawsuit concerning the teacher, the Diocese has yet to respond. Given Bishop Dewayne’s reputation as an authoritarian leader, it’s doubtful we’ll hear much about any of these matters.
In an unrelated matter, this past weekend Fr. Corapi, a popular televangelist priest announced he was quitting the priesthood after allegations surfaced that he had sexually abused a former female employee. Corapi cited the church’s own internal procedures for his resignation. Corapi’s popularity and his abrupt resignation will no doubt give rise to those who believe Catholic priests are being singled out and railroaded by those who make sexual allegations against them. These certainly aren’t new claims. We hear them regularly from the likes of William Donohue of the Catholic League. Of course, these same folks never mention the thousands of children who’ve been sexually abused and traumatized by priests and religious figures. The trauma and the damage is real but you’d never know it if all you heard was their proclamations.
After DePuy Orthopaedics has spent the last year fighting complaints about its metal-on-metal hips the DePuy ASR XL and the Pinnacle, the FDA has recently approved a new DePuy hip device. This new hip replacement is different from the failed hip devices in that it is the first of its kind-a ceramic on metal device that the company hopes will fare better than the ASR XL and the Pinnacle.
Due to all the problems with metal-on-metal hips, the FDA has insisted that this new hip will undergo a post-market study to monitor failure rates as well as patient complaints. The post-market study was a condition for the approval of the new DePuy hip.
The new DePuy hip will consist of a ceramic ball that fits into a metal socket.
The United States Catholic bishops have concluded their summer session in Bellevue Washington by upholding their own Charter for the Protection of Children and Young People, a document that’s supposed to protect minors from priests who sexually abuse them. While some minor revisions were approved, the Charter remains essentially the same as it did prior to the bishops’ meeting.
This has left most child abuse advocates angry and even more disillusioned with the bishops-if that’s possible. It doesn’t help when the bishop in charge of the task announces, “The charter has served the church well.” In making that statement, Bishop Blaise Cupich seems to ignore what happened with the grand jury in Philadelphia, the pornography and sex abuse scandal involving the diocese of Kansas City-St. Joseph, and their own audit that, according to Whispers in the Loggia’s own Rocco Palmo, “found over a quarter of the nation’s 197 dioceses, their identities undisclosed, were sent warnings after the USCCB’s designated auditors found the 55 local churches lacking in their enforcement of one or another aspect of the Dallas protocols. (Despite the “management letters,” the auditors found every diocese surveyed — Philadelphia, Kansas City and Gallup included — in compliance with the Charter for 2010.)
In other words, the Charter clearly hasn’t “served the Church well.” In the last few months there have been three glaring instances in which the Charter or its implementation failed miserably. This isn’t my assessment, Rocco Palmo, an influential blogger and faithful Catholic writing from Philadelphia came to the same conclusions.
Essentially, the Charter fails not because of its content. It fails because those charged with implementing it may pick and choose how it is implemented. Some bishops, notably Fabian Bruskewitz of Nebraska, has chosen to flaunt the document and nothing can or will be done.
The bishops of the United States failed children, their flock, and themselves in not having the moral courage to stand up and admit their efforts have failed. Of course, such courage would have compelled them to turn over their efforts to an independent civil authority to enforce child protection laws. Some bishops complained that they don’t have the authority to force their fellow bishops to do the right thing. They are right. But, they are bishops. They are their community’s moral leaders. They should have made the difficult decision to change that. Then and only then could they have left the Bellevue Hilton with their heads held high and not with their miters between their legs.
In responding to the growing number of complaints concerning metal-on-metal hip replacements, the FDA has responded in a two-fold manner. A few months ago, the governmental agency ordered all metal-on-metal hip replacement manufacturers to provide them with failure data and required them to contact patients who’ve received such hip replacements. Now, the FDA has published new information on its website concerning symptoms and signs of metallosis, a condition where metal fragments from the hip device enter the bloodstream. These metal fragments are loosened and fragment due to the wear and tear of the metal-on-metal friction caused by joint motion.
The new information should prove very helpful for patients who have a metal-on-metal hip replacement but don’t know if they are susceptible to metallosis or hip failure. In publishing the new information and making it accessible to the general public, the FDA has provided a real benefit to those who are concerned about their hip replacement. Here’s what they say in a nutshell:
Among the warning signs of such systemic reactions, according to the FDA:
• Chest pain
• Shortness of breath
• Visual or hearing disturbance
• Weight gain
• Abnormal feelings of cold
• Urinary trouble
Patients with suspected adverse reactions should receive blood tests — to check for cobalt or chromium ions.
If you have a metal-on-metal hip replacement or aren’t sure what type of hip you have and are experiencing any of the symptoms or conditions mentioned above, check with your doctor and refer him to the FDA website.
If US District Judge Eldon Fallon of New Orleans approves, Florida homeowners who’ve been plagued with the contaminated Chinese drywall will by paid $55 million by Banner Supply Company. The proposed settlement won’t be final until the Judge approves it and will only settle claims against Banner Supply, not the other Chinese Drywall manufacturers.
According to the Associated Press, “As many as 36,000 homes in Florida may have the Chinese-made drywall. Nationwide, the number may be as high as 60,000 to 100,000. The Environmental Protection Agency released a report in May 2009 confirming health risks in the drywall.”
It’s not clear how many citizens would be eligible to share in the settlement funds. Chinese drywall litigation will continue against the other manufacturers but this is perhaps a hopeful sign.
The US Catholic bishops will gather in Seattle this Wednesday for their three day summer gathering. The summer conference is usually shorter than the one held in November with a correspondingly lighter agenda. However, what makes this year’s summer gathering noteworthy is one particular item on the episcopal agenda. In the wake of the Philadelphia Grand Jury report and the Diocese of Kansas City-St. Joseph mishandling of a current abusive priest, the bishops will discuss how to rejuvenate the Dallas Charter originally passed and implemented in 2002. Because of this agenda item, media will likely converge on the meeting and hopefully ask the prelates some tough questions.
In my opinion, not much will come from the meeting. Those who are doing the talking are the same ones largely responsible for the priest abuse scandal in the first place. In nearly a decade of priest abuse cases surfacing all over the country, the bishops themselves have shown little resolve to fix the problem. They are essentially the problem.
In secular society, a community that is confronted with a high crime rate doesn’t look toward the criminals to fix the problem. An outside group must come in and re-establish order and the rule of law. Truthfully, that’s what needs to happen in the Catholic Church. But, don’t hold your breath.