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.
Advocates for victims of child sex abuse are calling on actor Billy Baldwin to change the locale of a film he plans to shoot. Originally, plans for the movie shoot were scheduled for “a Florida evangelical church that was scarred by a child molestation scandal.
Baldwin, 48, and the brother of actor Alec Baldwin, is set to shoot the film, “Blind Faith,” on the campus of Trinity Baptist Church in Jacksonville, where its founder, Robert “Bob” Gray Jr., was alleged to have molested more than 20 young children in the 1970s and 1980s.
Gray was arrested in 2006, but died at age 81 before he could be prosecuted. For 38 years, ending in 1992, when he fled the country, he led the church and its Trinity Christian Academy, where his accusers were elementary students or parishioners.”
Moving the location of the film would be an important acknowledgment of the suffering and trauma experienced by many Florida children who were preyed upon by this pastor.
Actos was a blockbuster drug for Takeda Pharmaceuticals in treating diabetes by decreasing insulin resistance. However, the Actos lawsuits allege that the drug’s manufacturer, Takeda, failed to warn doctors and consumers about the drug’s connection with bladder cancer. Actos is the single ingredient product containing pioglitazone. The medication is also sold in combination with metformin under the names Actosplus Met and Actosplus Met XR. Metformin is another diabetes medication that has a different mechanism of action. Pioglitazone is also sold in combination with glimepiride, a third diabetes medication, in a product called Duetact.
In spite of a 2010 FDA study alleging a link between bladder cancer and the long-term use of Actos, the drug company continued to tout the drug as effective and safe in treating diabetes. However, the FDA ordered an updated warning label to be placed on the drug noting the new findings.
Most likely some Vatican insiders cringed when Monsignor Charles Scicluna, the Vatican’s point man in investigating Catholic abuse allegations, used the term “omerta” to describe the Church’s silence in not dealing with the Catholic priest sex abuse scandal. Here’s an excerpt of what he said, “The teaching … that truth is at the basis of justice explains why a deadly culture of silence, or ‘omerta,’ is in itself wrong and unjust. . .Other enemies of the truth are the deliberate denial of known facts and the misplaced concern that the good name of the institution should somehow enjoy absolute priority to the detriment of disclosure. No strategy for the prevention of child abuse will ever work without commitment and accountability.”
The fact that he used the term “omerta” in describing the Church hierarchy’s response to the abuse saga speaks volumes. The word has a definitively negative connotation that conjures up images of the Mafia. As a powerful Vatican insider, it would be hard to deny that the Maltese Monsignor used the term thoughtlessly.
Now, whether this talk will translate into definitive action on the part of the Vatican remains to be seen. At least, someone from Rome has finally stated the obvious, the Emperor has no clothes!
A much publicized symposium on Catholic Church sex abuse is underway in Rome and the event has drawn much international media attention. According to John Allen of the National Catholic Reporter, 23 Americans including some bishops are attending the conference. Yesterday, attendees heard from Pope Benedict XVI who urged the Church to undergo a “renewal” so as to purge the Church of the abuse scandal. William Cardinal Levada, formerly archbishop of San Francisco and presently head of the Congregation for the Doctrine of the Faith, spoke about the Vatican’s engagement on the issue noting that it is actively investigating more than 4,000 abuse cases worldwide.
Yet, back on US soil, Archbishop Jerome Listecki, through his lawyers, has petitioned the court to dismiss 95% of sexual abuse cases filed against the Archdiocese. This in spite of the fact that Listecki himself promised that each and every one of the survivors of sexual abuse should and would be heard and compensated. The court filing on behalf of the Archdiocese has SNAP calling for the Archbishop to explain himself. Interestingly, SNAP is joined in this call by the current chancellor of the Archdiocese Fr. James Connell. Connell no doubt will pay for this “treason”. However, it’s high time priests stand on the side of abuse survivors instead of with the bishops.
Rather than holding symposia in Rome about abuse, let’s see some real action. I can only imagine what would happen if Catholic priests joined the SNAP civil rights movement on behalf of all survivors. I’d suspect the bishops would stand alone in their shallow and pitiful defense of corruption and cover-up. That would be real change. That would send a real message to the Roman chattering class.