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.

Congressional Democrats are urging their colleagues to investigate the safety of vaginal mesh medical devices after months of news reports and vaginal mesh lawsuits have circulated and called attention to the growing safety problem with the meshes.
Transvaginal or vaginal mesh devices were originally approved for use to treat urinary incontinence in women as well as female pelvic organ prolapse. However, the meshes have proven to be ineffective in treating either condition and they have serious safety problems as well.
According to one media report, “House Democrats called on congress to not only hold hearings on Lap-Band and transvaginal mesh, but also on brain stents and metal-on-metal hip implants, which they had previously requested on October 12, 2011. They also called on the Committee to request documents from various facilities regarding their marketing of Lap-band and to seek safety and procedural documents from vaginal mesh manufacturers.
The Lap-Band is a device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach. However according to the House Democrats’ correspondence, the device can pose serious risks including erosion of the band through the stomach wall, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.
Transvaginal mesh implants are permanently implanted in the vaginal wall to treat pelvic organ prolapse and urinary incontinence. These mesh devices were permitted on the market under the 510(k) clearance process, which fast-tracks medical devices onto the market without clinical testing. However, according to an FDA Safety Communication dated July 2011, these devices pose serious side effects such as vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, painful sexual intercourse (also called dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.”

Two start-up companies have taken on the important task of compiling and publicizing data that has been maintained by the Food and Drug Administration for years. The data concerns adverse effect reports concerning pharmaceutical drugs and medical devices. The latter is especially important for consumers since the United States still has no medical device registry system in place that tracks the history and performance of medical devices. This type of data is most useful in tracking medical devices such as failed artificial hip devices such as the DePuy ASR XL, the DePuy Pinnacle, and the Zimmer Durom Cup hip devices.
According to the Wall St. Journal, “A start-up company, AdverseEvents Inc., has streamlined the FDA’s often impenetrable database and made it easy to search the adverse-event reports for more than 4,500 drugs, free and online.
Another start-up, Clarimed LLC, has done the same for reports filed with the FDA on 130,000 medical devices, a far more complex group that runs the gamut from syringes to stents to tanning beds and diagnostic machines that could impact tens of thousands of lives.
Both companies, which launched in September, see their services as empowering patients, many of whom now comb Internet discussion boards for medical information. “If your doctor tells you to take a drug and it’s three times more likely to give you a heart attack than another drug, not having that information seems foolish,” says AdverseEvents President and co-founder Brian Overstreet.
While basic searches will remain free, AdverseEvents plans to charge consumers $10 a month for access to full drug reports starting Wednesday, and will offer health-care professionals and businesses more detailed information for additional fees. Clarimed may follow suit. Both websites offer a way to file reports to the FDA, but few visitors have done so.”

Notorious serial pedophile priest Oliver O’Grady is going back to prison, this time for three years after an Irish court found him guilty of possession of thousands of computer images of child pornography.
O’Grady had been a Catholic priest in California until he was sent to prison and was the subject of a myriad of sexual abuse lawsuits for molesting children during his 30 year tenure as a Catholic priest.
According to one media source, “The 66-year-old returned to live in Ireland and was flying from Amsterdam to Dublin in 2010 when he left a laptop on his flight containing graphic images of children.
Gardai traced him to a hostel in Dublin where they found thousands more photos, videos and audio of child porn stored on hard drives and USB keys.
The judge at Dublin District Court jailed O’Grady for 3 years saying the former priest – described as socially isolated – seemed to have a serious problem and his time in American prison had not rehabilitated him.”
Pedophiles like O’Grady will continue to prey on children unless they are permanently removed from society. Just because he was defrocked as a Catholic priest, he remains a pedophile and a danger to children. It’s surprising to me that he received only a 3 year sentence, given that he has already spent considerable time in prison for numerous child sex offenses.