Monthly Archives: October 2008

Bush Continues to Push Pre-Emption in Product Safety Cases

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 Manufacturing Plant Receives FDA Warning Letter

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

Sexual Abuse in Society

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.

Johnson & Johnson Has Paid $68 Million to Settle Ortho Evra Lawsuits

According to court records, pharmaceutical giant Johnson & Johnson has paid $68 million to settle lawsuits filed regarding the controversial birth control patch Ortho Evra. The lawsuits claim that the birth control patch cause a deep vein thrombosis, blood clots in the legs and lungs as well as heart attacks and strokes. At least 20 women have died as a result of complications from use of the Ortho Evra patch which releases a highly concentrated amount of estrogen into the blood stream. 5 million women have used the patch since its inception in 2002. The lawsuits argue that Johnson & Johnson hid or didn’t disclose data about the dangers of the birth control patch so that many users were unaware of its potential dangers until too late.
Once the problems began to surface, stronger warning labels were placed on the Ortho Evra boxes. Presently, the FDA warning label notes that those who use the patch may be exposing themselves to 60% more estrogen than the regular birth control pill. Along with the increase in estrogen comes the increase in risk for blood clots, heart attacks, and strokes.

Pfizer’s Internal Docs Suggest Drug Company Tactics

Court documents filed in a Pfizer Neurontin lawsuit allege that the pharmaceutical company tried to suppress data from a study showing that Neurontin was ineffective in alleviating nerve pain. The documents reveal Pfizer executives strategizing about how to silence a British researcher whose study found the negative Neurontin results. At the same time these inner dealings were going on inside the corporate world of Pfizer, the company’s marketing machine was engaged in an aggressive campaign to market the drug. The marketing campaign touted a smaller Neurontin study showing positive effects of the drug Neurontin.
The documents filed in court in anticipation of a potential class action lawsuit provide consumers and the courts with an insider’s view of how the large drug companies influence and manipulate the flow of data and information presented to doctors and their patients.
According to the Boston Globe, “a dozen researchers and physicians reviewed thousands of documents for the plaintiffs’ attorneys; their conclusions included that Pfizer controlled the information available to doctors and consumers by suppressing or delaying negative studies about Neurontin’s effectiveness for certain types of pain, migraine headaches, and bipolar illness, and by manipulating other studies before they were published to make the results look more positive.
“They created the illusion of Neurontin’s efficacy in the scientific literature,” said lead plaintiff attorney Thomas Greene of Boston. “Pfizer’s scientific misconduct and unethical behavior caused physicians to write tens of millions of ineffective prescriptions for serious and debilitating conditions resulting in billions of dollars in profit for Pfizer at the expense of patients and insurance companies.”
Once again, we see the importance of transparency with the documents of large corporations. Just like that other large corporation immersed in scandal because of its internal documents, the Catholic Church, drug companies like Pfizer have had a disturbing history of covering up information that is not beneficial to them or their bottom line. A new and urgent call for transparency is the way out of this public relations morass but neither the Catholic Church nor the large pharmaceutical companies want to come out of the shadows and be transparent.
It’s too bad for that’s the only way to restore public confidence.

Scranton’s Bishop Martino on Respect Life

This past weekend, Bishop Martino waded deep into the political maelstrom by ordering that his pastoral letter on abortion be read at all the masses in the Diocese of Scranton. As everyone knows, Scranton is a blue collar city in the swing state Pennsylvania. Joe Biden’s from there and Barack Obama is starting to show some real traction in the Keystone state.
In his letter Bishop Martino states emphatically, “Being ‘right’ on taxes, education, health care, immigration and the economy fails to make up for the error of disregarding the value of a human life. It is a tragic irony that ‘pro-choice’ candidates have come to support homicide — the gravest injustice a society can tolerate — in the name of ‘social justice.’ ”
Now, that’s a real whopper of a statement! Martino is linking elected officials and those who vote for them with homicide if they are considered “pro-choice”. Besides the glaring logical fallacies Martino makes by trying to make such a connection, his hypocrisy is beyond belief.
If he’s so concerned with pro-life issues where has he been when it comes to ministering to sexual abuse victims? I represent a dozen or so Catholics and former Catholics who were abused by Scranton priests. I’m talking about known abusers, the notorious ones, such as Robert Capparelli, Peter Crynes, Albert Liberatore, and Carlos Urrutigoity. Martino hasn’t lifted a finger to help sexual abuse victims in the Diocese of Scranton.
His recent letter on “abortion” is nothing more than a cheap political trick to keep a Republican in the White House. By the way, none of our previous Republican presidents have been successful in getting Roe v. Wade overturned.
If Bishop Martino wants to involve himself and his Diocese in presidential politics, he is certainly free to do so. However, he can’t have it both ways. If he’s going to continue to make political statements and tell Catholics for whom they can vote without risking going to hell, he shouldn’t keep his tax exempt status. Perhaps the IRS should look into this and revoke their status as a tax exempt organization.

Medtronic Drug Pump Recalled by FDA

Initially, the FDA issued a safety alert regarding Medtronic’s implantable drug pump but now the federal agency has classifed it as a Class I recall. The Class I status means that there is a reasonable probability that use of the product will cause serious adverse health consequences including death. Thus far one death has been attributed to the implantable drug pump with 83 adverse reaction cases reported. The problem concerns improper connections between the pump and the catheter which can lead to an overdose of pain medication, withdrawal symptoms or a recurrence of symptoms if the drug isn’t administered properly due to the catheter connection problem.
The pump is used in patients suffering from spasticity related to cystic fybrosis. The affected pumps are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. According to Medtronic, approximately 25, 000 pumps have been sold since 2007.

Glaxo Settles Paxil Lawsuit for $40 Million

Glaxo Smith-Kline has settled a lawsuit concerning Paxil and the manner in which it was marketed as safe and effective to minors. The class action lawsuit was settled for $40 million and the money will be used to reimburse health plans that paid for children’s Paxil use. While Glaxo Smith-Kline denies any liability in settling the lawsuit in which the company was charged with promoting the drug to children while at the same time withholding dangerous side effects, the settlement is a victory for consumer advocates who’ve been alleging that pharmaceutical companies regularly overpromote their drugs to consumers. Hopefully, this will curb pharmaceutical companies from illegally marketing their drugs for purposes which the drugs have not been approved. The drug companies market their drugs in this fashion because in their cost-benefit analysis it is worth it. If they continue to get penalized with lawsuits and federal fines they may re-think their cost-benefit analysis.
In the end, this is a good thing for consumers and children who don’t deserve to be victimized by big pharma trying to make huge profits.

Paxil Consultant Fails to Disclose Payments

An Emory University psychiatrist failed to disclose fees he received as a result of his consulting work for Glaxo Smith-Kline regarding their controversial drug Paxil. The payments were not a forgettable amount either-$500,000. Charles Nemeroff, chair of Emory University’s psychiatry department, was compensated handsomely for making Paxil presentations to doctors on behalf of Glaxo Smith-Kline.
According to a federal inquiry, Emory University was unaware of the conflict or the payments. In fact, according to Emory University officials, Nemeroff was specifically instructed not to take more than $10,000 for the work.
Any federally funded research is supposed to be free of these types of conflicts of interest as well as the egregious behavior of tenured faculty members. Their behavior and greed put the reputation of the entire university on the line when they behave in such a fashion. This isn’t the first scandal that clouds Dr. Nemeroff. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn’t disclose he was a paid consultant to its maker, Cyberonics Inc.
This is bad for the university, the integrity of research projects in general, and most importantly the health and welfare of the public who receive treatment from doctors who’ve been bamboozled by people like Nemeroff. Good for Chuck Grassley, keep up the good work in the Senate!

Medtronic Questioned Over Doc Payments

The federal government is scrutinizing Medtronic’s relationship with Infuse Bone Graft physicians who are being paid for their consultative services by Medtronic. Further complicating the situation is the fact that Infuse Bone Graft is linked to potentially life-threatening complications when the graft is used in off-label, unapproved instances. The complications involve dangerous swelling in the neck area. The graft is a manufactured version of a naturally-occurring protein that promotes bone growth. It is approved by the U.S. Food and Drug Administration for use in the lower back, but surgeons say it is used widely off-label in other parts of the spine.
According to a Wall St. Journal report, “Doctors with financial ties to Medtronic have been among those promoting the off-label use of Infuse. Former employees have alleged the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties, and handing out lucrative consulting contracts that required little work.”
In their letters, Sen. Kohl said the allegations by former employees are “highly disturbing.” Sen. Grassley called them “troubling.”