Monthly Archives: May 2011

FDA Wants Review of All Metal-On-Metal Hips

The FDA has ordered a comprehensive review of all metal-on-metal artificial hips, irrespective of the model or the manufacturer. The order was communicated in an FDA letter sent this past Friday to all hip device manufacturers including Stryker, Johnson & Johnson’s Depuy Orthopaedics, Biomet and Wright Medical, according to the NY Times.
The broad study comes in the wake of mounting concern that the problems with metal-on-metal hip implants is not isolated to a particular design or a particular manufacturer. The FDA is concerned that the problem may be much wider spread than previously thought. In the FDA letter, hip device manufacturers were told the FDA was invoking a federal rule requiring postmarket studies of each metal-on-metal hip implant device. Some analysts believe that such a postmarket study reflects a failure on the part of the FDA for allowing such metal-on-metal hip implants move to market without rigorous premarket testing.
The FDA order compels manufacturers to test their hip device products as well as conduct an extensive study of patients who’ve received these metal-on-metal artificial hips. The manufacturers will have to submit failure rates for their hip devices as well.
The patient study will focus on whether patients have experienced hip failure as well as whether the artificial metal hips are shedding high levels of cobalt into the bloodstream which can lead to a condition known as metallosis. The FDA is requiring hip device companies to provide blood tests to hip implant patients in order to determine the level of metallic debris in their bloodstream.
The NY Times interviewed Dr. William H. Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health. Maisel commented that “Our concern is the product, not about a manufacturer.” He acknowledged that the hip review is significant in that it marks the broadest review of any medical device after the device has already gone to market.
Until news of potential failure issues with the metal-on-metal hips began surfacing a few years ago, the metal hip devices had accounted for nearly one-third of the 250,000 hips implanted annually in the United States.
Unlike other countries, the United States has no medical device registry. This will make the FDA’s order more difficult for medical device manufacturers to track the hips and the patients who received them. The FDA has given the manufacturers 30 days in which to propose their review plan to the federal agency.
Some metal hips have been subject to scientific scrutiny as well as hip device lawsuits already. Johnson & Johnson’s subsidiary DePuy Orthopaedics is the subject of a class of lawsuits for which a multidistrict litigation has been formed in Ohio.
This past March, British Orthopaedic Association estimated that the DePuy ASR XL had a failure rate of 50% within the first six years of implantation. They also believe that other manufacturers of the metal-on-metal hip implants have a higher than expected and reported hip failure rate.
The metal-on-metal hip implants had been touted as an improvement over the older hip devices since they were purportedly able to offer more flexibility and resilience for those seeking to maintain an active lifestyle.

This is Going to Be Controversial. . . So Don’t Read It

The title of this blog post is a warning to all those who don’t want to read stories about Catholic bishops destroying documents. The National Catholic Reporter published a story about the Archbishop of Denver, Charles Chaput who recently visited an Australian diocese purportedly to report back to Rome about his findings. The bishop there, Charles Morris, has been fired for his opinions on clerical celibacy and women’s ordination. According to NCR, “NCR Editor at Large has been following the story and reports on today’s Web site that Morris, referring to a report written by Archbishop Charles Chaput, said to Roberts he knows it exists because Chaput sent him an e-mail ‘telling me that he’d sent an electronic copy as well as a hard copy to the dicastery for bishops, and then he did what he was supposed to do. He destroyed both the electronic copy and the hard copy, so he didn’t have a copy any more.”
Chaput, a loyal Roman foot soldier followed the instructions of a Roman dicastery which, in turn, follows the direct orders of the Pope, instructed Chaput to destroy the evidence.
The incident should be deeply disturbing to all of us. However, it’s revealing in that it shows the institutional culture that weeds out those whom the institutional protectors consider dangerous. If the Church acts in such a fashion in these matters, why would one think it wouldn’t do the same in matters involving clergy sex abuse?
In both instances, scandal is the primary thing to be avoided, and at all costs. Destruction of documents serves that end. Wouldn’t anyone who’s unswervingly loyal to the institution act in such a manner?

Vatican to Issue Child Sex Abuse Guidelines

Almost a decade after the latest sex abuse scandal cycle rocked the Catholic Church, the Vatican is finally getting around to issuing guidelines for sex abuse cases. It’s tardiness and the Church’s bad record on policing its own regarding the abuse of minors, has left many to ridicule the news of such guidelines. In many corners of the world, the Vatican’s announcement is a “little too late” to say the least. Such guidelines won’t help to alleviate the notion that the Catholic Church has done everything in its power to protect the institution rather than protecting children.

Merck Settles Drug Kickback Case

Merck Serono SA, one of the world’s largest pharmaceutical companies, has settled its drug kickback case with the US Justice Department by agreeing to pay $44.3 million. Federal prosecutors were pursuing charges against Merck that the drug maker illegally paid doctors to prescribe their multiple sclerosis drug Rebif to patients. The investigation concerned the company’s activities from 2002-2009. The Justice Department found that Merck paid doctors to go to training conferences and seminars at upscale, posh resorts in exchange for prescribing the MS drug.
“The health care of our seniors and other vulnerable citizens under the Medicare and Medicaid programs should be based upon sound medical decisions, not upon decisions tainted by influence and corruption,” said Tony West, assistant attorney for the Justice Department’s civil division.
Merck is not the only pharmaceutical company to have legal issues with the Justice Department. Both Eli Lilly and Pfizer have paid similar penalties for kickback schemes. Unfortunately, such financial penalties don’t deter such large companies from engaging in illegal activity. The profits the companies stand to make far outweighs the financial penalties they face if the federal government investigates them.

Dr. Reardon Sex Abuse Trial Goes to Jury

Lawyers for survivors of Dr. Reardon’s sexual abuse finished closing arguments yesterday. The trial is now in the hands of the jury. The survivors have contended that St. Francis Hospital and Medical Center failed to supervise and monitor so-called “growth” studies performed by Dr. George Reardon who has been accused of abusing hundreds of young boys under the guise of medical exams.
According to the Hartford Courant, “The jury began considering a verdict at about 4 p.m. Thursday, after the hourlong summations and after Superior Court Judge Dan Shaban, presiding over the trial’s fifth week, gave them instructions in applicable law.
Doe’s suit against the hospital contains two counts for the jury to consider. Both accuse St. Francis Hospital and Medical Center of negligence that contributed substantially to Reardon’s ability to abuse children.
The first contends that the hospital’s failure to apply generally accepted scientific standards of review to research by Reardon resulted in the abuse of Doe. It also claims that St. Francis failed in a special duty under state law to provide care to vulnerable children in its custody, including Doe.”

Okeechobee Elementary School Teacher Arrested for Sex Molestation

A 28 year old middle school teacher, Joel A. Huddleston, has been arrested on charges of lewd and lascivious molestation of a child. In addition to his teaching duties, Huddleston coaches the girls’ basketball team.
According to the local CBS affiliate, “Joel A. Huddleston, of 3844 NW 30 Ave., also is youth pastor at the Buckhead Ridge Christian Church, according to the Okeechobee County Sheriff’s Office.”

Canadian Catholic Bishop’s Porn Trial Starts Today

Disgraced Canadian Bishop Raymond Lahey will face criminal charges of having explicit images of young boys engaged in sex acts on his computer. Lahey was arrested in September 2009 after being detained for questioning at the Ottawa airport. Bishop Lahey later resigned his post as the bishop of Antigonish in Canada.
Besides the criminal trial, Lahey faces a civil suit from a man who says Lahey abused him when he was a young boy. At the time of the sexual abuse, Lahey was living at a Canadian orphanage notorious for the sexual abuse of minors.