Monthly Archives: April 2009

Pat Buchanan’s World: Bed Bugs Tied to Illegal Immigration

I was watching MSNBC’s Hardball with Chris Matthews the other night and happened to catch conservative political commentator Pat Buchanan discuss the issue of swine flu. During his commentary, Buchanan linked swine flu with illegal immigration noting that the first cases of swine flu originated in Mexico. If you think that may be a stretch, wait for his next comment. Buchanan also attributed the growing problems with bed bugs on illegal immigration! I haven’t seen that the mainstream media or the blogosphere caught the comment but he actually argued for the connection.
Bed bugs have re-surfaced in this country as a result of a dearth of effective agents to kill the pesky insects. In addition, the bed bugs multiply rapidly and can go undetected until they start feeding on the blood of human beings. None of this has anything to do with the immigration issue. Bed bugs aren’t even restricted to the warmer weather climes of the border states. Bed bug problems have been noted in Chicago, New York, Boston and other northeastern cities.
As an attorney who handles bed bug cases, I thought it was suprising, almost comical to have Pat Buchanan trying to blame bed bugs on immigration.

Drug and Medical Device Manufacturers May Receive More Inspections from FDA

A bill introduced by Senators Chuck Grassley and Edward Kennedy would provide more funding for inspections of manufacturing plants that produce medical devices and pharmaceutical drugs. The proposal would give the FDA broad new powers in detaining questionable drugs or medical devices, allow the federal agency to issue subpoenas, and collect inspection fees from the company they are investigating.
The legislation comes in response to the contaminated Chines heparin as well as problems with manufacturing processes in medical device plants that make Stryker hip implants and Zimmer Durom Cup him implants.
While Congress has complained that the FDA has done a poor, ineffective job at regulating and inspecting medical devices and pharmaceutical drugs, the agency has argued that it is woefully understaffed and underfunded to complete the consumer safety tasks the federal government demands of the agency. This bill is widely seen as a corrective measure that would give the FDA the money and regulatory power to ensure better adherence to safety guidelines for both drugs and medical devices.

Medical Device Company Gets FDA Warning Letter

St. Jude Medical Inc. has received a warning letter from the FDA regarding its manufacturing practices at its Minnesota plant. The plant makes medical devices designed to correct atrial fibrillation disorders.
In its letter, the FDA made mention of St. Jude Medical’s Safire ablation catheter which is designed to disengage electrical signals that cause atrial fibrillation. The warning letter was issued as a result of a December FDA inspection of the Minnesota facility. Such a warning letter can result in the termination of production of the medical device in question if the company does not correct the problems cited in the warning letter.
Other medical device companies such as Stryker Corporation, Boston Scientific, and Johnson & Johnson have received similar warning letters in the recent past concerning other medical device products.

Sex Abuse Rocks Paraguayan President

The president of Paraguay Fernando Lugo was a Catholic bishop prior to his resignation in 2004 in order to run for the presidency of Paraguay. In the last few weeks, Lugo admitted fathering one child while he was a bishop. Now it seems that Lugo fathered more than one child while a Catholic bishop. A former episcopal colleague of his, Most Rev. Rogelio Livieres, spoke out yesterday. Bishop Livieres spoke to the media and revealed that when Lugo was confronted with two complaints of sexual activity in 2004, he didn’t deny the accusations. In fact, Lugo stated that at least in one instance the child was most likely his.
If you think this is bad, wait, it gets worse. The women who are now accusing the former bishop of fathering their children were minors at the time. According to Bishop Livieres, two of the women wrote letters in 2004 to the Vatican informing them of their allegations. Livieres claims “everyone” knew about Lugo’s sexual activity with the minors but it was covered up so as not to hinder his presidential chances.
So, once again, the church knew about sexual abuse and covered it up. It covered up this behavior by a bishop who was preying on poor women who looked to him for guidance, spiritual assistance, and fatherly love. Instead, he abused his authority and role as a bishop to sexually prey on these young women. When notified of the bishop’s behavior, the Vatican officials turned a blind eye to it. I guess they didn’t want to create scandal!

Bed Bugs More than a Nuisance

Infestations of bed bugs are causing quite a stir not only locally but in our nation’s capital. Last week, the EPA convened its first ever Bed Bug Summit to address the growing problem. These stubbon insects are found in homes, hotels, motels, college dorms, hospitals, and nursing homes. The recent growth in bed bugs complaints can be directly related to the decrase in effective agents on the market to remove the pesky creatures. After the effective chemical agent DDT (Dichloro-Diphenyl-Trichloroethane) was banned in 1972, the bed bugs became increasingly difficult to kill. The lack of effective agents coupled with the rapid pace at which bed bugs multiply has lead to what some have called a dire situation.
While there have been no known diseases spread by bed bug bites, I know, as a bed bug lawyer, the harm and discomfort these insects can cause. Some of my clients have permanent scars from their bed bug infestations. Others continue to experience “phantom itching” even after the bed bugs have been eradicated.
A common bed bug myth is that they are only found in unsanitary places. However, the truth isn’t so simple. Let me give an example. Suppose you and your family travel on vacation. You arrive at your hotel and you put your suitcase on one of the beds in your hotel room. Eager to unpack and start your vacation, you open the suitcase on the bed and unpack your clothes. If that bed is infested with bed bugs, chances are very good that you’ll be carrying these insects home with you. Now, you’re bringing them into your home. A simple remedy would be to inspect the beds in your hotel BEFORE placing your belongings on the bed. If you see brownish-reddish stains on the sheets or more likely the mattress, bed bugs are present.
Bed bugs are a nasty problem that cause pain and discomfort. From all I’ve read, the EPA Summit posed more questions than it actually answered. We don’t seem near a solution to this insect problem.

The Week That Was

In the past week, we’ve seen many news stories that affect us us one way or another. Some of the stories have a direct impact on us while others have a slightly less impact or one that will be subtle at best. Some of those news stories include:
Archbishop Timothy Dolan becomes the Archbishop of New York: Dolan’s appointment to the nation’s most prestigious See is a statement about how the Vatican views the church in the US. Dolan, a charismatic figure who holds a graduate degree in history, has been viewed by many as a conservative who holds fast to the Vatican line. Most importantly, he’s brushed off the sexual abuse scandal through charm and a relatively successful public relations campaign in Milwaukee. Unfortunately, there is little hope he’ll do anything differently in New York. He will in all likelihood support the Lopez bill before the NY State Legislature which will do little to help survivors of sexual abuse.
FDA Clamps Down on Medical Device Companies-this news is a long time in coming. For years now, the medical device manufacturers have made millions promoting device products that received scant attention from the FDA due to a loophole that allowed them to avoid rigorous clinical trials. The new FDA announcement will hopefully force them to comply with existing laws that compel them to demonstrate their device’s effectiveness and safety before they are marketed to the public.
Gadolinium Lawsuit Settlement– Bayer AG has settled a few of the lawsuits linked to Nehprogenic Systemic Fibrosis. These and other consumer justice lawsuits are an important check on the power and influence of pharmaceutical companies that market products that are dangerous and potentially lethal to the consumer.

Epilepsy Drug Taken During Pregancy May Affect IQ

Valproate, the epilepsy drug manufactured by Abbott, has been found to significantly lower a child’s IQ, according to a new study published in the New England Journal of Medicine. Valproate (Depakote) was found to lower a 3 year old’s IQ by 9 points in comparison to children whose mothers took other epilepsy drugs during pregnancy.
“We’ve known this drug is a bad actor for a long time,” said Dr. Lewis Holmes, director of the North American Antiepileptic Disease Pregnancy Registry, based at Massachusetts General Hospital in Boston.
Epilepsy is a brain disorder that can cause continual seizures.
The new study found that the higher the dosage of valproate taken during pregnancy the lower the child’s IQ. While the connection between epilepsy drugs and birth defects has been well documented the significant relationship between valproate and birth defects had not been determined prior to the latest study. Valproate use during pregnancy has been found to have a 2-4 times higher ratio of birth defects. Researchers still do not know the reason for the lower IQ in children who’ve been exposed to the epilepsy drug. The study did recommend that pregnant mothers avoid valproate as their first choice for epilepsy treatment.
If you are pregnant or may be pregnant and are epileptic, consult your physician for treatment options.

Bayer Settles Some Gadolinium Contrast Dye Lawsuits

Bayer AG has settled approximately 40 of the 241 lawsuits concerning its gadolinium contrast dye product Magnevist. The lawsuits contend that the contrast dye has caused Nephrogenic Systemic Fibrosis (NSF) in those with pre-existing kidney disease. NSF can be a fatal disease marked by a hardening of the skin which can replicate in any organ but has been linked to gadolinium in those with kidney disease. Symptoms include hardening of the skin, high blood pressure, burning, and itching.
Bayer is not the only gadolinium contrast dye manufacturer. Other products include Omniscan by GE Healthcare, OptiMARK by Mallinckrodt/Tyco Healthcare, ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.
Gadolinium’s link to NSF led the FDA to ask the manufacturers of the gadoliniums contrast dye to add a black box warning to its label in September 2007.

Sex Abuse

When confronted with church documents dating back to the 1950’s, two priests vehemently disagree as to why the numerous warnings contained in the documents were ignored.
On the one hand, Monsignor Stephen Rossetti, president and CEO of St. Luke Institute, believes the bishops ignored Rev. Patrick Fitzgerald’s dire warnings about priest sex abusers, because they were coming from only one source and the pleas were emotional rather than scientific.
On the other hand, Rev. Thomas Doyle, OP, who had worked with the bishops in the 1970’s and 1980’s, saw it another way. Doyle believes the bishops ignored the warnings because they simply didn’t want to deal with it. Doyle issued a document to all the US bishops in 1985 warning them again about the growing problem of sexually abusive priests.
Msgr. Rossetti claims to have no knowlege of Fr. Fitzgerald in spite of the fact that Fitzgerald’s order, the Servant of the Paracletes was the primary institution bishops would send priests with problems of sexual abuse, alcoholism, and pedophilia. Since Rossetti is engaged in the same line of work that Fitzgerald had performed decades earlier, it’s hard to believe that he had never heard of Fitzgerald. It’s also similarly difficult to dismiss Fitzgerald as “emotional” since most bishops were indeed sending their sexual abuse priest problems to him for counseling.
The situation became so dire in the 1960’s that Fitzgerald told many bishops and even the Pope about the situation. He even spent $5,000 as a downpayment for an isolated island where he could send these priests.
Since the bishops have been saying that they never knew about the depth and extent of the priest abuse problem until recently, these recently released letters from Fr. Fitzgerald are extremely important. They do a great deal of damage to the credibility of bishops who still continue to pat themselves on the back for all they’ve done to protect children in spite of their past ignorance of the situation.
Facts and documents don’t lie. It’s hard to sidestep such proof in spite of all the slick public relations efforts of the Catholic Church. The Church has a credibility issue when its own bishops dismiss someone like Fr. Fitzgerald. It gets even worse when someone like Msgr. Rossetti attempts to diminish Fitzgerald’s work and his dire warnings.
That’s why courts are ordering dioceses to make such documents public. The public needs to know what happened and why if this crisis will ever come to an end.

Company Caught in Clinical Trial Sting

Coast IRB, LLC is supposed to supervise and approve safety methods for clients in clinical trials involving human subjects. However, the Colorado based company was caught in a Congressional sting and ordered to cease work in the clinical trials. An FDA spokesperson cited the federal agency’s serious concern that Coast IRB was not doing enough to protect human subjects.
According to a report in the Wall St. Journal, the work stoppage could affect 300 clinical trials and over 3,000 researchers in such fields as pharmaceutical, biotech, and medical devices.
Coast IRB’s deficient practices were uncovered during a Congressional sting operation begun last year. The GAO and congressional staff created a phantom medical study of a phantom product. It was during this phantom study that Coast’s deficient measures to protect humans was discovered.