Biomet, a medical device company specializing in orthodpedic devices, has agreed to settle a kickback case with the US Justice Department for $23.9 million. Biomet stands accused of attempting to bribe doctors in China, Argentina, and Brazil. The US Justice Department began investigating the firm’s international activities in 2007. The federal investigation has been ongoing since 2007. Biomet disclosed the probe just one month after it agreed to a $26.9 million settlement with government authorities, who alleged Biomet and its competitors were paying bribes to U.S. doctors.
The federal government has agreed to forestall prosecution of Biomet under the Foreign Corrupt Practices Act as long as Biomet adheres to the binding agreement for three years.
It’s not coincidental that two other large medical device companies were caught in the same investigation-Zimmer Holdings Inc. and DePuy Orthopaedics Inc both of which have also been mired in defective hip lawsuits recently.
Biomet faces similar defective hip lawsuits for their zirconia ceramic femoral heads that had been voluntarily recalled.
Monthly Archives: March 2012
Philly Abuse Trial Begins
“He paid lip service to children’s protection.” That’s one of the devastating lines from a Philadelphia Assistant District Attorney in the criminal priest abuse trial involving Monsignor William Lynn. The Philadelphia monsignor is on trial for criminal failure to protect children from sexual abuse while he was a top lieutenant for recently deceased Anthony Cardinal Bevilacqua. Lynn was in charge of priest personnel for the large Archdiocese and part of his duties as Bevilacqua’s Vicar included the evaluation, supervision, and assignment of priests who’d been accused of sexually abusing minors.
According to the Wall St. Journal, “Msgr. William Lynn is the highest-ranking member of the U.S. Catholic hierarchy to have his case reach trial on charges related to coverup allegations. He served as secretary for clergy in the Catholic Archdiocese of Philadelphia from 1992 to 2004, a job that included handling allegations of sexual abuse by priests. He is charged with conspiracy and endangering the welfare of children and has pleaded not guilty.”
Gotham’s Cowardly Lion
In my blog post yesterday, I set forth some reasons why it wouldn’t be a good idea for the nation’s Catholic bishops to attack SNAP. While I didn’t expect them to take my advice, I was surprised to learn of Cardinal Dolan’s latest blog post. The post is entitled “Catholic League Reports on SNAP Deposition”. Is the Cardinal now a cub reporter for a fledgling paper soon to rival the NY Times? Actually, that wouldn’t be nearly as bad as the truth.
The reality is that Cardinal Dolan wants to appear objective and merely report what the Catholic League is writing about SNAP. Dolan wants to appear as a third-party while behind the scenes pushing his pal Bill Donohue to center stage for the world to witness his vitriol. At least Donohue has the courage of his convictions even though they are hateful and inaccurate. Dolan doesn’t even make a comment in his blog post about the Catholic League article. Instead he re-prints a lengthy section of it with links to the entire article at the end. It’s important to note that in the linked article Donohue calls David Clohessy, a friend of mine and a man of integrity, a con man. He offers no proof of course, he just makes a personal attack. I’m not Catholic but I always thought that kind of behavior was considered sinful by Donohue’s church.
Making matters worse, this is the article Cardinal Dolan wants everyone to read. He wants to spread this attack on David Clohessy by highlighting it on his own blog. Of course, he doesn’t get his hands dirty by repeating the attack.(Remind you of any Biblical figure?) Pilate, err, Dolan maintains the plausible deniability of a coward. He doesn’t actually write it, he rather points in the direction of the one slinging the mud, encouraging others to read along. This is the President of the nation’s Conference of Bishops. He’s the one leading the crusade on moral issues. You can decide for yourselves what that makes him.
Attacking SNAP A Bad Move
The US Catholic published this morning a very good piece authored by Bryan Cones concerning the perception that the US bishops have decided to attack SNAP (Survivors of Those Abused by Priests). While the author correctly points out that this perception has been fueled by the combative head of the Catholic League, William Donohue’s recent comments on SNAP and his assertion that the US bishops have made a decision as a body to start fighting back against the non-profit group, media outlets such as the NY Times and the National Catholic Reporter have picked up on Donohue’s comments and written pieces on it.
Donohue’s comments come in the wake of two Missouri Catholic dioceses sending subpoenas for deposition testimony to David Clohessy, a SNAP founder and spokesperson. From reading the deposition transcripts of Clohessy’s testimony, it was evident that the lawyers were more interested in the internal finances and operation of SNAP rather than the sex abuse lawsuits that were purported to be the subject of the deposition.
Of course, the actions of these two dioceses does not make for a conspiracy of US bishops against SNAP. But, in case the bishops are entertaining such a notion, here’s why they shouldn’t do it: 1)SNAP’s mission is to serve and assist those who’ve been abused by priests, ministers, counselors and other authority figures, 2)they want to hold the Catholic Church and other institutions accountable for the actions and behavior of their ministers and priests, 3)as the article correctly points out, such a strategy would make the Catholic Church look like Goliath taking on David ie. it would be seen as a bullying tactic and an attempt to silence an organization that does much good, and finally, 4)SNAP wouldn’t exist or need to exist any longer if the Catholic bishops had done their job by taking care of those abused and reporting abuse to law enforcement.
It’s really as simple as that.
Citadel Sex Abuse Drew Warning from Police in 2001
The Citadel, a well-known military academy that also runs a youth camp, was warned by police in 2001 about inappropriate activity between young campers and camp counselors, according to The Charleston Post and Courier.
The police investigated a sexual abuse allegation at the camp in 2001 and found that counselors were using alcohol, tobacco and having kids sleep with them during the camp events.
“These are the most serious findings that were brought to my attention during my investigation,” then-Sgt. Dale Middleton wrote to The Citadel’s commandant. “I am sure these activities will be addressed and corrected in the future.”
No one from the Citadel respond to the police sergeant’s letter.
The previously unknown warning letter surfaced as a result of a Freedom of Information Act request related to the court martial of former Marine Capt. Michael Arpaio, now a convicted sex offender.
Vaginal Mesh Lawsuits: What Every Woman Should Know
Vaginal meshes are not new medical devices. However, in the last three years, the tranvaginal mesh devices or vaginal meshes have been in the news for the medical complications they’ve caused countless women who’ve been diagnosed with urinary incontinence or pelvic organ prolapse. In fact, the FDA has received more than 3,000 vaginal mesh complaints and many of these complaints have turned into vaginal mesh lawsuits.
The vaginal meshes have been used to treat these two female medical conditions for nearly three decades now and since the 1990’s the mesh device has become the treatment of choice for many physicians who are treating women with either pelvic organ prolapse or urinary incontinence.
The problems began when these mesh devices began to fail and patients had to undergo difficult and often painful surgery to have the mesh devices removed. Some female patients have reported that they’ve undergone repeated corrective surgeries to correct the tissue damage caused by the vaginal mesh.
Catholic Bishops Offensive in Sex Abuse Cases
For about a year now it’s clear to those of us working to protect children from sexual abuse that the nation’s Catholic bishops have decided to go on the offensive. While they know they can’t attack the survivors of sexual abuse (they already tried that and it backfired), they’ve decided to attack a non-profit organization with three employees. The Catholic bishops have decided to take on, or perhaps more accurately, take down the Survivors of Those Abused by Priests (SNAP). Why? It’s simple. SNAP has done an excellent job advocating for survivors and getting them the assistance they need. They are also very good community organizers (seems like the gentleman living on Pennsylvania Avenue is not the only community organizer the Catholic bishops disdain).
Late last year, one of the founders of SNAP David Clohessy was served with a subpoena to give his deposition in a priest abuse case in the Diocese of Kansas City-St. Joseph. The church lawyers contended that Clohessy had knowledge about the case and was subject to a deposition. The transcript of the six hour deposition was just released and it’s clear that the church lawyers were not interested in the Kansas City-St. Joseph case but the inner workings of SNAP. Essentially, the Church has decided to silence SNAP by engaging them in a legal war of attrition, knowing full well that the non-profit doesn’t have sufficient resources to defend itself in court.
Of course, for the church lawyers to engage in these tactics they would to have had at least tacit approval of the bishops. It’s a shrewd and calculating move on the part of the Catholic bishops but it’s ultimately a very cynical one that will most likely backfire as badly as their earlier strategy of attacking survivors. The Catholic bishops are playing a dangerous game and they may end up the ultimate losers with their own faithful. Catholics expect their bishops to be men of God, shepherds of the Gospel not dons hiding behind their lawyers.
Medical Device Regulator Wants More Authority to Ban Dangerous Medical Devices
The Food and Drug Administration’s top medical device regulator is supporting federal legislation that would make it easier for the FDA to step in and ban dangerous medical devices that fail and harm unwitting patients. The statement of support comes in the wake of the recent spate of artificial hip devices and the vaginal mesh device that have failed and are the subject of numerous medical device lawsuits.
According to Bloomberg News, “The debate centers on the agency’s 510(k) program, the system used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them “substantially equivalent” to previously approved versions, known as predicates.”
This loophole has allowed many medical devices to be used without the proper safety protocols and has led to voluntary recalls and lawsuits. If the FDA is allowed to reject such devices and close the loophole created by the 510(k) process, medical devices would take longer to reach the marketplace but would ultimately be safer and less prone to recalls. Safety advocates have called for such action for years but have been stymied in their efforts by the medical device industry and their lobbyists who argue that the 510(k) process allows life-saving medical devices to reach the market quicker and at a substantially lower cost. Of course, those who advocate such an approach never mention the fact that the 510(k) process boosts device company profits often at the expense of consumer safety.
That’s why Jeffrey Shuren,director of the FDA’s Center for Devices and Radiological Health, is supporting legislation sponsored by House Democrats that would essentially close this medical device loophole. “It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market,” Shuren said by telephone. “The challenge now is if there’s a problem, it can get replicated” through future generations of devices.”
Bloomberg News reports, “The legislation, HR3847, was introduced Feb. 1 by four Democrats led by Representative Edward Markey of Massachusetts. Besides giving the FDA more power to reject devices, it would require manufacturers to submit information about recalls of predicates used in an application. The agency also would be required to review previously cleared products to see if any have safety issues in their “device lineage.”
Tampa Bay “Teacher of the Year” Accused of Molesting 12 Year Old
A Mango Florida teacher who last year was named the school’s teacher of the year has been arrested and charged with sexually molesting a 12-year-old boy. Ethel Anderson, a 29-year-old fifth grade teacher was arrested yesterday by the Hillsoborough County Sheriff’s Office and charged with 5 counts of sexual batter on a minor.
According to Hillsborough County deputies, Anderson engaged in sexual acts with the child in her home from December 2011 until the present when the child’s mother became suspicious of the relationship.