Topamax, manufactured by Johnson & Johnson, is being recalled for an “uncharacteristic odor”. The recall involves100 milligram tablets in 57,000 bottles of the epilepsy and migraine drug. Johnson & Johnson spokesman Mark Wolfe has stated that the odor is caused by TBA, a compound used to treat wooden pallets.
The company says in a statement that the two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012.
This is not the first issues concerning Topamax safety. Women who’ve taken Topamax during pregnancy have experienced an increased risk in giving birth to a child with a cleft palate or cleft lip.
On March 4, 2011, the FDA warned healthcare professionals of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. The FDA requested a label change for Topamax and its generic equivalent which has been on the market since 2006.
According to the FDA, “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.”

The Government Accountability Office has criticized the FDA for its lax oversight of medical devices, particularly artificial hips. The Senate Special Committee on Aging will hear testimony from industry experts and safety advocates concerning the FDA’s regulatory process in approving such medical devices today. Testimony will include an examination of the now recalled DePuy ASR XL hip which was approved for use without rigorous clinical trials because of a regulatory loophole. The Senate hearing will also examine why DePuy Orthopedics continued to market and sell the DePuy ASR XL after doctors complained about unacceptably high failure rates.
According to the NY Times, “The F.D.A. has two separate procedures for approving medical devices.
For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.
But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.”

The Justice Department is widening its criminal probe into the marketing practices of Medtronic, Inc. in relation to its spinal fusion device Infuse, according to a published report in the NY Times. The criminal probe could prove to be a financial burden for Medtronic since Infuse accounts for a majority of biologic product sales.
The Infuse investigation is not new. In 2008, a 2008 Army report found that Dr. Timothy R. Kuklo had overstated the benefits of Infuse. Kuklo who became a Medtronic consultant, had forged the signatures of co-authors on an Infuse study that had been submitted to a medical journal. That same year, the FDA issues a warning about such devices as Infuse, citing the potential for life-threatening injuries when Infuse and similar products are used to treat neck pain.
Most recently, the FDA denied Medtronic’s application for approval concerning a high-strength version of Infuse known as Amplify. The FDA found that clinical studies of Amplify raised questions about a higher rate of cancers associated with the use of the new bone fusion device.

The 2010 Annual Report on the Implementation of the Charter for the Protection of Children and Young People has been made public. The 93 page document is a self congratulatory document whose goal is to show how much the US bishops have done to protect children. However, if you read the document carefully, you’ll notice there are some troubling setbacks noted in the report: allowing clergy barred from ministry to lead public prayers, not monitoring parishes, not keeping track of the “safe environment training” required of priests, and failing to enforce other measures intended to end abuse. While these failures are mentioned in the report, it will take the discerning eyes of a knowledgeable reader to pick up on this as a disturbing trend.
The failures mentioned are central tenets in providing safety and security to children. These failures are not harmless clerical oversights but real failures in protecting children. Perhaps more disturbing, the failures have increased in comparison to last year. Auditors sent warning letters to 55 participating dioceses in 2010 compared to 23 in 2009.
Finally, it’s important to note that this report is based on the bishops’ self-reporting of data in their own diocese. Secondly, the Archdiocese of Philadelphia passed the audit! That should give us all pause.

The Catholic League for Religious and Civil Rights took out a full-page ad in the NY Times today. The ad is entitled “Straight Talk About the Catholic Church”. Bill Donohue, the League’s pugnacious president apparently authored the piece.
While the ad purports to be “straight talk” about the Catholic Church, most of the arguments offered are tired re-treads of what the Catholic bishops have been saying for years. In one instance, Donohue states, “The refrain that child rape is a reality in the Church is twice wrong: let’s get it straight-they weren’t children and they weren’t raped. We know from the John Jay study that most of the victims have been adolescents, and that the most common abuse has been inappropriate touching (inexcusable though this is, it is not rape).”
So, Donohue’s group is now splitting hairs and talking about “adolescents” rather than “children” which gives one the impression that it’s not as bad if an adolescent is sexually abused. That is just the type of reasoning that has caused such a problem for the Catholic Church. An adolescent boy or girl should never, ever be touched “inappropriately” by any adult. Furthermore, we’ve found that the euphemism “inappropriate touching” has been used in the Church documents as code for what any normal adult call sexual abuse.
In the same paragraph, Donohue concludes that the “issue is homosexuality, not pedophilia.” Really? Homosexuality is an attraction to a member of the same sex. It also implies that if the attraction is consensual, it’s a homosexual relationship. However, when an adult authority figure such as a priest makes unwanted sexual advances on an adolescent, that’s a crime. An adolescent isn’t capable of consenting to such a relationship. Donohue should know better.
Donohue also targets the grand jury process which he views as unfairly targeting Catholic priests. However, he fails to mention that the latest grand jury convened in Philadelphia was done so by a district attorney who is an active, devout Catholic. Unlike Donohue, he is able to distinguish between his Catholic faith and the criminal actions of priests who abuse minors and those in positions of authority who cover up for them.
Donohue’s NY Times’ ad didn’t do any favors for the Catholic Church. The public is tired of these lame excuses. They want corrective action. They want what we all want-our children to be safe and protected from sexual predators.

Johnson & Johnson has agreed to pay $70 million to avoid criminal prosecution of bribery-related charges in the United Kingdom and the United States. The charges stemmed from an investigation of J&J business practices that found company officials offered bribes in return for the purchase of their medical device products. According to the Wall St. Journal, “As part of the settlement, J&J acknowledged responsibility for the actions of its units, employees and agents who made “various improper payments to publicly-employed health care providers in Greece, Poland and Romania in order to induce the purchase of medical devices and pharmaceuticals manufactured by J&J subsidiaries,” according to the Justice Department.
J&J also acknowledged that kickbacks were paid on behalf of J&J units to the former government of Iraq under the United Nations Oil for Food Program in order to secure contracts to provide humanitarian supplies. A UN-commissioned report had alleged more than 2,000 companies acquiesced to Iraqi government demands between 2001 and 2003 that they pay a 10% fee as a condition of importing humanitarian goods into the country. The U.S. invasion of Iraq in 2003 toppled Hussein’s government. J&J had informed U.S. authorities of possible violations of anti-foreign bribery laws in February 2007, a development that led to the departure of the head of the company’s medical device and diagnostics unit, Michael Dormer. The Foreign Corrupt Practices Act bars U.S. companies from paying foreign government officials to obtain or retain business.”
The news could not come at a worse time for Johnson & Johnson or its subisidiary DePuy Orthopaedics Inc. DePuy is facing multidstrict litigation lawsuits for its failed DePuy ASR XL hip devices and possible multidistrict lawsuits for its DePuy Pinnacle hips which have not been recalled but have been the subject of widespread complaints of similar failures.

A motion has been filed to consolidate all DePuy Pinnacle hip lawsuits in MultiDistrict Litigation either as part of the already consolidated DePuy ASR XL litigation or as a separate MDL. The motion was filed as lawsuits begin to mount concerning problems with the DePuy Pinnacle hip replacement.
If the motion is successful, lawsuits would be consolidated so that the discovery process and pre-trial proceedings are able to proceed in a coordinated fashion. Normally, such motions are successful if the court finds that factual issues among the various hip lawsuits are similar.
While the DePuy ASR XL has been recalled and removed from the market after numerous reports of hip failures, the DePuy Pinnacle has not been recalled. However, the Pinnacle metal-on-metal design has been reported to have similar failures and design flaws as the ASR XL. These include hip replacement patients reporting difficulty walking, pain in the joint area, swelling, and a general loss of mobility. As in the DePuy ASR XL models, there are some reports that the Pinnacle hips may lead to metallosis, metal poisoning resulting from the wear and tear of the metal-on-metal components rubbing against each other.

A new study shows that 45% of teens surveyed didn’t see any problem with consuming five alcoholic drinks on a daily basis. The survey, part of a study released today by The Partnership at drugfree.org, shows a troubling lack of awareness concerning the potential adverse effects of heavy drinking among teenagers.
While the news article filed by the Associated Press didn’t discuss the report’s findings and its relation to auto safety, there is a clear link between teenage drinking and an increase in auto accidents among this demographic. Impaired driving, whether through alcohol or popular teen drugs such as Ecstasy, clearly lead to an increase in serious, often fatal car accidents.
Any impaired driver loses motor coordination and critical thinking skills necessary to safety operate a motor vehicle. The report should be a clear warning signal to all of us who are concerned with driving safety and our teenagers.

The first of 93 civil sex abuse lawsuits begins today against St. Francis Hospital in Hartford Connecticut. The abuse lawsuits stem from Dr. George Reardon’s sexual abuse of hundreds of minor boys for decades as Reardon served as chief endocrinologist at St. Francis Hospital. The majority of the abuse occurred during a sham growth study Reardon used to lure the boys into his predatory abuse.
Reardon worked at the hospital from 1963 until he was forced to leave in 1993 after a brother and sister tracked him down at the hospital. They complained to the Department of Health that Reardon had abused the two of them while a medical student in the late 1950’s and early 1960’s.
One of the first witnesses expected to testify at trial is a police captain who found pornographic images and movies of the young boys who were supposed to be part of the growth study.
According to the Hartford Courant, “When Reardon saw children in his examining room, he was separated by two, locked metal doors from waiting parents in his office reception area, according to pretrial evidence presented in the case. John Doe 2 said in a deposition that Reardon sometimes wore a pistol in a shoulder holster beneath his lab coat during so-called examinations.”

In November 2005, Lance Corporal Cody Perkins was serving his country as a Marine stationed in Iraq when he and his fellow Marines hit a roadside bomb. The explosion threw Perkins out of his Humvee. Perkins broke his femur and was sent stateside to have surgery to implant screws to hold the femur together. According to Bloomberg Businessweek which chronicled Perkins’ plight as part of its spotlight on problems with the DePuy hip implant, Perkins needed further surgery and a surgeon recommended a metal-on-metal prosthetic hip. According to the surgeon, Dr. Keith Holley, the metal-on-metal would allow the young Marine to resume an active lifestyle in the Marine Corps.
What happened after the DePuy hip implant surgery is a nightmare all too familiar to patients who’ve had the DePuy ASR XL hip implant. Perkins suffered pain, difficulty walking, and trouble sleeping at night. For Perkins, the pain is constant. When Perkins consulted another doctor about his pain, he was told that the failed DePuy ASR XL would have to be removed and a new hip implanted in its place. The revision surgery would be complicated, difficult, and promised no improvement in mobility.
Because of the failed hip, Lance Corporal Perkins, a decorated veteran who has received two Purple Hearts, will most likely have to leave his beloved Marine Corps prematurely. “I wanted to retire out of the Marine Corps,” says Perkins, who has earned two Purple Hearts. “But there’s no way that can happen … not a chance.”
While the Bloomberg article highlighted the tragic story of one individual affected by the DePuy ASR XL debacle, there are thousands more who have suffered similarly. To make matters worse, DePuy, a subisidiary of Johnson & Johnson, knew about the DePuy failures and continued to market it anyway.
Lance Cpl. Perkins and all the other people who’ve suffered as a result of the DePuy hips deserve better than this.