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.

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.

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.”

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.

Some research associated with hip implants, particularly metal-on-metal devices, has suggested the metal-on-metal hip implant devices may increase the risk of developing cancer. As the metal-on-metal hips are drawing increased regulatory scrutiny, some researchers have found that these types of artificial hip devices may lead to a systemic toxicity. We’ve blogged previously about the potential danger of metallosis, a condition in which the blood is infected by loose metallic particles flowing freely into the bloodstream from the rubbing of the metal-on-metal devices.
The latest of these devices, the Wright ProFemur Total Hip System has been found to fail at an alarmingly high rate. The Wright hips were approved by the FDA under the controversial 510(k) system by which similar medical devices (in this case the Wright ProFemur Total Hip System) is approved without much regulatory review or testing because they are deemed similar in design to those already approved by the FDA.

A Philadelphia Monsignor, facing a criminal trial involving child endangerment charges, filed papers in court stating that he had kept a list of Philadelphia Archdiocesan priests accused of sexually abusing minors but that Cardinal Anthony Bevilacqua ordered them destroyed.
Of course, we’ll never hear Bevilacqua’s side of the story since he’s now deceased. Monsignor Lynn has presented this evidence in an attempt to defend himself against these criminal charges. In so doing, he’s effectively accused the late Cardinal of obstruction of justice. There’s still an important question that Lynn hasn’t answered-why didn’t he take the information and give it to the police rather than give it to the Cardinal? That’s the real issue. From two Grand Jury inquiries, we already know that Cardinal Bevilacqua was not interested in pursuing justice for children. It’s convenient for Lynn that Bevilacqua can’t respond to his allegation. I don’t believe the new information absolves Lynn from the criminal charges. Yes, perhaps he was cast as a scapegoat for the Archdiocese. However, as a human being and a US citizen he had a duty to report the sexual molestation of children. He didn’t do that and that’s why he stands criminally charged with child endangerment. Apart from the morally repugnant nature of Bevilacqua’s alleged actions (shredding documents), Lynn should have called the police and protected children. It’s not any more complicated than that.

We are filing a new lawsuit concerning a defective hip replacement device that’s experienced unacceptably high failure rates. This lawsuit names Wright Medical Technology, Inc. and Wright Medical Group, Inc., the manufacturers of the Wright ProFemur Total Hip System, as defendants in the defective hip replacement lawsuit.
The Wright ProFemur Total Hip System is comprised of three separate components which are assembled during surgery: a femoral head, a modular neck and the femoral stem. Studies have shown and patients have experienced a design defect in the femoral implant that causes it to fracture just below the neck. The fracture causes Wright hip implant patients to experience tremendous pain. The femoral fracture requires immediate surgery that is extensive and complicated since the defective hip prosthetic must be extricated from the patient.
The hip lawsuit to be filed today points out that “studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter” “are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium.”
A 2009 report by the Australian Orthopaedic Association showed that the Wright ProFemur Z femoral stem had a high failure rate requiring approximately 11.2 percent of all patients receiving the implant to need revision surgery.
According to the complaint, in 2009, Wright Medical changed the material in the ProFemur Hip System Modular Necks from titanium to cobalt chrome alloy, but the company took “no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters.”
The first model of this hip device was cleared for market use in December 2000. Four years later, the Wright ProFemur hip system was given 510 (k) regulatory clearance. As early as 2007, the company knew or should have known from scientific research data that its ProFemur hip system was failing at an unacceptably high rate.

Just as Johnson & Johnson executives thought they were beginning to turn around their pharmaceutical division McNeil Consumer Healthcare, they have to announce another recall. This time, as in other recalls, its involves a type of Children’s Tylenol. The move Friday involved bottles of grape-flavored infants’ Tylenol, which had only just returned to shelves in November, one of the few recalled consumer products J&J had put back on the market.
According to the Wall St. Journal, “Since 2009, J&J has recalled millions of bottles of Tylenol, Benadryl, Motrin and Zyrtec as a result of such problems as metal shavings found in medicines, incorrect levels of an active ingredient and bad odors. The recalls prompted J&J to shut down a factory and have cost it more than $1 billion in lost sales.
With this new recall, J&J’s McNeil Consumer Healthcare unit said the popular over-the-counter cold and pain remedy was safe and that it hadn’t received any side-effect reports, but it acted after receiving a “small number of complaints” about a new bottle cap and dose syringe.”
This latest drug recall is perhaps more of a public relations problem than a safety problem, especially since no reports of injuries have been noted. Yet, it is a real problem for the pharmaceutical company. Pharmaceutical sales, especially pediatric pharmaceuticals, are driven by consumer confidence which is generated from the perception that the product is safe and effective in treating pediatric illnesses. Once that trust is eroded, most parents don’t venture back to give a product or a company a second try.
While pharmaceutical product safety has garnered much attention over the past 24 months, the more serious safety issue concerns medical devices and Johnson & Johnson is not immune from this either. J&J’s medical hip device unit, DePuy has suffered through one of the worst debacles in the company’s history with the DePuy Pinnacle and the DePuy ASR XL, both of which are now considered unsafe due to their high failure rates. Once thought to be on the leading edge of the evolving metal-on-metal hip market, the new hip devices have been linked to design defect issues that cause numerous health issues.
It’s not a good time for Johnson & Johnson. Their public relations problems stem from real safety concerns that need to be addressed sooner rather than later.

The first hearing concerning the consolidated Actos bladder cancer lawsuits has been scheduled by the presiding judge for March 22, 2012 in Louisiana. This first hearing is a status hearing where both sides will present to the court their case status as well as discuss possibilities for any potential Actos lawsuit settlement.
While the potential for substantive settlement discussions at this point is remote, the 150 Actos lawsuits consolidated in the U.S. District Court, for the Western District of Louisiana will be an important first step in the trial process.
The Actos bladder cancer lawsuits have named Takeda Pharmaceuticals, the manufacturer of Actos, as the defendant in the consolidated litigation.

The NY Times published an article today that claims Johnson & Johnson, the manufacturer of the DePuy ASR XL and DePuy Pinnacle hip devices, sold the unsafe hip devices overseas after the FDA found them to be experiencing a higher than acceptable failure rate among US patients.
According to the Times, “There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.”
That’s not really the issue, though. The issue is that the FDA has found safety issues with these hips based on thousands of consumer complaints and physician testimony that the hips aren’t working properly. That’s the issue. It may not be a legal issue but it is surely an ethical one.
Essentially, Johnson & Johnson was willing to sell what is considered in the United States a defective product based on its design (metal-on-metal configuration) in order to make a profit. Sales had been slipping prior to the hip recall and the medical device company saw an opportunity to bolster sales without any regard for the products’ safety.