A small mechanical heart pump manufactured by Thoratec Corporation has been recalled after 5 deaths were reported. The affected catalog numbers are 1355 and 102139. The heart pumps have been distributed to 153 hospitals throughout the country since the beginning of clinical studies in 2003.
The HeartMateII pump was approved in April for the temporary treatment of patients awaiting heart transplants. The recall was prompted by a failed electrical wire in the heart pump. The failure occurred in 27 of the 1,972 people who were using the heart pump device. In June 2007, Thoratec began using a stronger, more durable wire that has shown a lower failure rate.
Thoratec has recommended that patients using the heart pump device consult with their physician to determine the condition of the electrical wire.

Rev. Donald McGuire, the Chicago Jesuit priest who had served as spiritual director to Mother Teresa and her Daughters of Charity religious order has been found guilty on both counts in federal court in Chicago. His sentencing will be in December. McGuire has been dismissed from the priesthood.
McGuire’s victims were taken on trips out of state and witnessed the lavish lifestyle of a Jesuit priest. The sexual abuse consisted of massages (fondling), intercourse, and other vile acts. Well, the rooster has finally come home to roost.

The FDA has received more than 1,000 complaints of problems associated with a vaginal mesh used in surgeries to treat severe incontinence and a prolapsed uterus in women. The problems include erosion of the mesh through vaginal tissue, infection, pain and urinary problems. There has also been a recurrence of the original problem in the mesh surgeries. According to the FDA, it has received complaints from 9 separate manufacturers of the mesh.
According to the FDA, a pelvic organ prolapse occurs when a pelvic organ such as the bladder pushes against the vaginal wall. Other organs that can be involved in such a prolapse include the uterus, bowel, and the rectum. Symptoms of such a prolapse include pain or difficulties with the bladder or bladder. Problems with sexual activity may also by symptomatic.
The FDA lists sample questions one should ask their physicial before having such mesh surgery:
What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
What’s been your experience in dealing with the complications that might occur?
What can I expect to feel after surgery and for how long?
Are there any specific side effects I should let you know about after the surgery?
What if the mesh doesn’t correct my problem?
If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

A 45 year old teacher and mother of four has been arrested for having sex with a 17 year old student. Warner Christian Academy teacher Cynthia Horvath has been charged with unlawful sexual activity with a minor, a second-degree felony. Neither of the agencies’ investigations are complete. The sexual trysts occurred at least 25 times in seedy motels, under bridges, and in the teacher’s car.
You don’t even have to be a parent of a teenager to find this extremely disturbing and alarming. The private school was founded in 1971 and its mission is to help students develop “spiritually, academically, socially, and physically.” The school is affiliated with the White Chapel Church of God and serves the Halifax community in Volusia County.
The scourge of sexual abuse of minors is not something that is a bygone phenomenon. It’s happening right now and it’s taking place in our schools, youth groups, churches, and at times, our hospitals. If we’re going to protect our children from the horrors of sexual abuse we have to start with vigilance and education about the dangers of sexual abuse.

Eli Lilly took a calculated gamble when it decided to market its blockbuster drug Zyprexa for dementia and mild bipolar disorder. It hadn’t been approved for such purposes and the drug company was prohibited from marketing the drug for unapproved uses. Yet, Lilly decided to do it anyway. The cost of such a gamble: $1.4 billion. However, keep in mind that US sales of Zyprexa are over $2 billion so it was a calculated risk that made the company money, albeit illegally. The $1.4 billion will be charged off against company earnings and Eli Lilly will go on relatively unscathed.
That’s the problem with these huge pharmaceutical companies. They can afford to break the law because it’s still a lucrative thing to do. These practices won’t change in the pharmaceutical industry until the government and the court system decides to play hardball with them and hit them where it hurts-their pocketbook. As long as the consequences are minor, these companies can continue to act with impugnity. The situation will only deteriorate if they get what they want with potential federal pre-emption. This isn’t a good situation for the consumer who relies on the safety of these drugs. Ordinary people have to be able to trust these companies and believe that they are manufacturing safe and effective drugs. If not, our healthcare system is in real peril.

This time a letter was sent to the Cardiovascular Research Foundation about its financial ties to researchers. Congress, particularly Sen. Charles Grassley, is investigating the nonprofit group’s ties to drug manufacturers and medical device makers. The letter coincided with the Foundation’s annual conference. The conference, known as Transcatheter Cardiovascular Therapeutics, attracts doctors from around the world. At the conference medical device companies display their products in an exhibition hall.
Congress continues to press drug companies and medical device manufacturers for financial transparency so that the federal government as well as the general public know the relationship between such companies and the researchers who are paid by them. Senators Herbert Kohl and Charles Grassley authored the letter and are pushing for legislation to make the industry more transparent. In the letter, the Senators wrote, “As you are no doubt aware, there are divergent scientific opinions concerning such products, the safety and efficacy of which are a matter of dispute among cardiologists.”
According to a NY Times article, “At the same conference on Thursday, researchers released results of a new study indicating that a drug-coated stent called Endeavor, made by Medtronic, was linked to more heart attacks and deadly blood clots than the Cypher stent made by Johnson & Johnson. ”
This information along with greater financial transparency is urgently needed for an industry that often places profits before public safety.

Drug manufacturer Pfizer has announced its intention to settle lawsuits against the pharmaceutical company for its drugs Bextra and Celebrex. The amount of the settlement is $894 million with $745 million set aside to settle the personal injury lawsuits claiming that Bextra and Celebrex users suffered heart attacks or strokes as a result of using the painkiller drugs.
According to the Wall St. Journal, “Attorneys General in 33 states and the District of Columbia, who have filed suits relating to Pfizer’s promotion of Bextra, will receive $60 million of the settlement; the remainder, $89 million, will resolve class actions alleging fraud in connection with the promotion of Celebrex and Bextra.”
The settlement annoucement comes a year after Merck agreed to settle its Vioxx lawsuits. All three drugs are considered Cox-2 inhibitors which became popular for their painkilling ability as well as their gentleness on the stomach. However, the drugs have been linked to an increase in heart attacks and strokes and controversy remains concerning their overall painkilling effectiveness.

In the midst of a floundering economy, a mounting credit crisis, and two wars, George Bush is actively engaged in absolving large corporations from their duty to provide the consumer with safe products. In his last few months in office, the Bush administration is pushing hard to make it impossible for ordinary citizens who are injured by defective products to hold the makers of these products accountable for their actions.
The Wall St. Journal reports, “The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine. The latest changes cap a multiyear effort that could be one of the administration’s lasting legacies, depending in part on how the underlying principle of pre-emption fares in a case the Supreme Court will hear next month.”
It’s unbelievable that in the midst of a national economic crisis Bush focuses his attention on those who need his assistance the least. In the final analysis, this isn’t good for the economy or consumer safety. It only helps Bush’s well-heeled friends who’ll get richer as ordinary folks suffer. That’s not leadership.

Kugel Mesh Hernia Patch Recall Lawsuits
A Puerto Rican medical device manufacturing plant has received an FDA warning letter concerning its operating procedures. The plant, which manufacturers medical devices such as the Kugel Mesh hernia patch and the Vacora Biopsy Probe, was inspected by the FDA from November 2007 through February 2008. The Kugel Mesh hernia patch manufactured by Bard has been recalled due to defects in the memory recoil ring. This latest warning letter from the FDA spells more problems for C.R. Bard, Inc.
Kugel Mesh Hernia Patch Recall Lawsuits
The 11-page FDA warning letter cites numerous complaints concerning operating procedures at the plant. The FDA inspectors called the medical devices “adulterated” becuase “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820.”
The 11-page report specifically cites 8 complaints in particular but notes that these are not an exhaustive list of the defects concerning the plant. Here is the FDA’s summary of the 8 named complaints:
1)Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation
2)Failure to establish and maintain procedures to control product that does not conform to specified requirements
3)Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality issues. In addition, procedures addressing the identification of corrective and preventative actions were not implemented
4)Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems as required
5)Failure to retain all required records for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer as required
6)Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. In addition, failure to process all complaints in a uniform and timely manner
7)Failure to conduct quality audits in a timely manner to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required
8)Management with executive responsibility has failed to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of your organization as required
These 8 complaints, while not exhaustive, is a stinging indictment of operational procedures at the Puerto Rican plant that makes the defective Kugel Mesh hernia patch. The hernia patch maker has already come under fire from the FDA for not revealing quality issues in a timely fashion as well as not taking proper safety steps to correct medical device defects. This latest problem only adds to the Kugel Mesh hernia patch defect story.
Kugel Mesh Hernia Patch Recall Lawsuits

While I’ve spent the majority of my efforts on this blog discussing the various issues surrounding the priest abuse scandal that has rocked the Catholic Church, the ancient institution is not the only one affected by the scourge of sexual abuse. Recently, our office has received inquiries from people who’ve been abused at schools, hospitals, and in their own homes by service workers. It should be noted that there has been an alarming increase in reports of sexual abuse by teachers. Just last week, a police officer (school resource officer) resigned after admitting he had told a 13 year old girl that he was falling in love with her!
Parents and children’s advocates can no longer take for granted that their children are safe at school, church, synagogue, or hospital. Parents must be vigilant and look for the tell-tale signs of grooming that leads to abuse ie. an adult who takes an inordinate liking to a child, an adult who starts giving gifts to a child, etc. Now, in and of themselves, these may not be significant but given the present climate we must be aware of our child’s surroundings in order to assure their safety.