A medical device designed to monitor the breathing and heart rate of infants in hospitals and homes is being recalled for an alarm system failure. According to the FDA recall notice, the Smart Monitor 2 manufactured by Respironics, Inc. has failed to warn doctors, caregivers, and parents of a suddent change in an infant’s heart rate or breathing pattern. The model numbers involved in the recall are Models 4002 and 4003 with serial numbers 3000033364 through 3000038740. The product was made January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
The FDA has classified this as a Class I recall meaning use of these medical devices have a reasonable probability of serious injury or death if used.

The Justice Department in conjunction with more than a dozen states have accused the mammoth drug company Wyeth with Medicare fraud. The whistleblower lawsuits contend that Wyeth overcharged Medicare programs when they issued massive discounts to thousands of hospitals without offering the same discount to the state Medicare programs.
In offering the discounts, Wyeth was able to avoid paying rebated to state Medicare programs. The controversy involves the Wyeth stomach acid drug Protonix.
Wyeth, in the process of being taken over by Pfizer, is no stranger to controversy. In the late 1990’s Wyeth was involved in the fen-phen diet drug debacle that cost the company millions of dollars in lawsuits.
The states involved in the whistleblower lawsuits include California, Delaware, Florida, Illinois, Indiana, Louisiana, Massachusetts, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia and Wisconsin, as well as the District of Columbia.

Former Walter Reed Army Medical Center surgeon and Medtronic consultant Dr. Timothy Kuklo has come under fire for falsifying studies concerning Medtronic’s Infuse bone graft used in patients with broken legs.
According to the Walter Reed investigation, Kuklo forged other doctors’ signatures whom he claimed were co-authors in a study praising the effectiveness of Infuse. Kuklo has also been accused of inflating the number of patients treated with the Infuse bone graft.
This isn’t the first sign of trouble for the Infuse bone graft. In July, the FDA warned Medtronic of problems associated with off-label use of the graft. When the product was used in cervical spine surgeries, patients reported difficulty breathing, speaking and swallowing. Several patients required further surgeries including tracheotomies and the insertion of feeding tubes.
Medtronic is a leading medical device manufacturer that has run afoul of the FDA before the Infuse bone graft problems. Medtronic’s cardiac defibrillator leads have been found to be defective causing inconsistent electronic pulses to the heart.

This past week has provided those who follow the priest abuse scandal a revealing look inside the workings of the Catholic Church and how they’ve handled the priest abuse situation.
First, during an abuse trial in Seattle, Rev. Michael G. Ryan, who served as Chancellor under then Archbishop Raymond Hunthausen, testified that every diocese and archdiocese has a secret archives. In his testimony, Ryan noted that the archives is mandated by canon law. Ryan also admitted that covering up for priest abusers was viewed by church officials as service to the church. Ryan said, “(The secrecy) was to see that the church was well served.”
Fr. Ryan’s testimony is crucial since it goes to the heart of our priest abuse cases. In our lawsuits, we allege a cover up as well as a conspiracy to hide the truth from the public. I’ve taken deposition testimony regarding priest abuse lawsuits against the Diocese of Orlando and the Diocese of Gary where high ranking church officials have denied the existence of a secret archive. It seems odd to me that something mandated by the universal law of the church would be ignored by two different dioceses.
In the view of church officials, these sex abuse cases are an assault on the church. These priests and bishops who keep facts secret and hidden are, in their view, defending the church and serving her well.
In the other piece of revealing news related to the priest abuse scandal, retired Archbishop Rembert Weakland, OSB announced this week that he’ll be publishing his memoirs. “A Pilgrim in a Pilgrim Church” will address some aspects of the abuse scandal as well as the Archbishop’s own brush with controversy.
In 2002, Paul Marcoux appeared on Good Morning America to publicly reveal that Archbishop Weakland had paid Marcoux $450,000 to keep quiet about his his sexual affair with the prelate. In the interview, Marcoux described his relationship with Weakland as date rape. However, as the relationship waned, Weakland penned a love letter to Marcoux.
The same day that Marcoux spoke about his relationship with Weakland, the Milwaukee archbishop called the papal nunio, Garbriel Montalvo, to inform him of Marcoux’s revelation. According to the Archbishop, Montalvo’s first reaction was, “Of course you are going to deny it.”
Weakland remained steadfast in his denial of the date rape characterization but would not deny the relationship.
In Weakland’s interview with the NY Times published today, he explains Montalvo’s reaction as typical of the Vatican’s desire to cover up and hide potentially damage news. It’s called the Roman way of doing things.
It’s interesting to note that this week’s revelations don’t come from lawyers or survivor advocacy groups. They come from within the church itself. A chancellor and an archbishop publicly give us a glimpse of the inner church operation. These revelations will be tough to deny or dismiss.

The Chicago City Council voted unanimously yesterday to ban all products manufactured with the dangerous chemical bisphenol-A. Council members decided to tackle the issue themselves after complaining that the FDA was too slow in moving against the dangerous chemical.
Bisphenol-A, which is widely found in plastic containers such as baby bottles and cups, has been linked to cancer, heart disease and diabetes. The chemical is used to harden plastics but has been found to leak into the inside of the container posing a risk to those who use the plastic for human consumption.
According to the NY Times, Chicago is the first municipality to take such a step but it’s not the first government to wade into the controversy. Minnesota Governor Tim Pawlenty signed a measure last week prohibiting plastics that contain bisphenol-A.
While local governments act to protect consumers, the FDA continues to study the issue. If the FDA continues to drag its feet, more governmental bodies are sure to follow suit. It’s time the FDA did its job and protect the American public from a hazardous chemical. It shouldn’t take local governmental action to deal with the problem if the federal agency tasked with it does its job.

The FDA is investigating the connection between two recent deaths at a Delaware hospital and tainted heparin. Just last year, 80 people tied as a result of receiving contaminated heparin.
Heparin, sold by Baxter International, is widely used in the United States and around the world as a blood thinner. Last year, heparin was the subject of a massive recall after it had been determined that it had been tainted with oversulfated chondroitin sulfate by manufacturers in China.
This time, the FDA believes the heparin was manufactured in China. Additionally, these two deaths involved patients with intracranial bleeding, not the allergic reactions linked to the Chinese contaminated heparin.
The FDA is testing the heparin bags but they don’t believe the recent deaths are related to what happened a year ago. The FDA is trying to determine the exact nature of the heparin-related deaths in Delaware.

According to Public Citizen, a consumer watchdog group, there have been 72 diet drugs or weight loss supplements that have been spiked with the active ingredients from prescription drugs. And this is only in the past six months! The FDA continues its investigation of these diet drug companies and will issue stiffer penalties if the companies fail to respond or pull their dangerous products from the market.
According to the FDA, they’ve found at least 9 prescription drugs added to diet drugs including:
Sibutramine (MERIDIA)
Fenproporex
Fluoxetine (PROZAC, SERAFEM)
Bumetanide (BUMEX)
Furosemide (LASIX)
Rimonabant (ZIMULTI)
Cetilistat
Phenytoin (DILANTIN)
Phenolphthalein
Obviously, this is a huge public health hazard. Some of these drugs haven’t even been approved for use in the United States. Yet, these diet drug companies, fueled by the diet craze and huge profits, are willing to take the risk of an investigation by the FDA.

Medical device manufacturer, Synthes, has settled a conflict of interest inquiry with the New Jersey Attorney General. The inquiry was pursued to protect consumers from fraud involving doctors who are paid consultants to the medical device company while also paid to test and recommend these same medical devices for consumer use.
As part of the settlement agreement, Synthes, manufacturer of Pro Disk artificial spinal disk, may pay the AG’s office $236,000 for its investigation as welll as full disclosure of doctors who are on their payroll. The agreement calls for full disclosure of medical professionals who are testing medical devices for approval while at the same time being remunerated by the same company as consultants.
In her letter to the FDA and Congress, New Jersey Attorney General Ann Milgram was highly critical of the FDA for doing nothing to police and monitor these conflicts. She cited instances where doctors signed and dated disclosure forms but left the rest of the forms blank.
The FDA has to make this a priority. Too often doctors and other medical professionals are caught in serious financial conflicts with the medical device companies and pharmaceutical companies. When they are paid company consultants, it’s hard to imagine that their testing and recommendations will be negative if they stand to lose money if the device or drug is not approved. This is clearly not good for consumers who must rely on FDA approval as assurance that the particular drug or medical device is safe and effective.

According to an article in the NY Times, Amber Suriani had just turned 40 when she noticed she was experiencing urinary discharge. As an avid athlete, Suriani didn’t want these embarassing occurrences affecting her active lifestyle so she sought medical advice. Her doctor diagnosed the problem as stress urinary incontinence and recommended surgery to correct the problem. After being assured that it was a fairly minor procedure that would correct the problem, Suriani agreed to have a vaginal sling inserted under her urethra. The surgery was performed with no complications and Suriani returned to a normal lifestyle until a few months later she noticed bloody vaginal discharge. She was understandably concerned that she may have cancer so she went back to her doctor. Surgery was performed to remove part of the offending sling that, according to her doctor, was causing the problem. Unfortunately, Suriani’s difficulties only grew worse. The sling continued to cause problems and growing pain. Since then, she’s endured four more surgeries to remove the offending portions of the sling.
The vaginal sling, manufactured by ObTape (acquired by Johnson & Johnson), was designed to treat female urinary incontinence. It didn’t fix the problem in Suriani’s case. It exacerbated the problem to the point she decided to take legal action against the company. The medical device company stopped selling the device in 2006 but insists that it was a good device that helped thousands of women.
As the Times article points out, the problems encountered with this medical device bring more scrutiny upon the FDA’s guidelines and methods for allowing medical devices to be sold in this country. Unlike pharmaceutical drugs, the FDA “clears” medical devices rather than approves them. The criteria for clearance is minimal. The new device need only be similar in design and use as previously cleared medical devices. In other words, the medical device is never tested or approved as safe and effective, a standard by which drugs are approved.
This is a clear gap in the FDA’s regulatory process. Medical devices should be approved only after they are demonstrated to be safe, reliable, and effective. Hopefully, passage of the 2009 Medical Device Safety Act will spur agency action to toughen standards for medical devices.

I’ve just been informed by a reliable source that a special committee of the NY State Legislature will consider both the Markey bill and the Lopez bill. As I’ve written in previous posts, the Markey bill is pro-justice and pro-survivor. It allows survivors a one year window to pursue justice against sexual predators and the institutions that protected them. The Lopez bill is nothing more than a bill that protects predators, hurts victims, and insulates institutions from their bad behavior.
According to my source, the committee will hear from both Markey and Lopez and either recommend one bill move forward, seek compromise legislation, or kill the measures outright. If you were sexually abused in NY and seek justice, please urge your legislators in NY to do the right thing and vote for the Markey bill.