Monthly Archives: November 2010

Florida College Investigations

The Florida Attorney General’s Office has announced that it will expand its investigation from 5 to 8 for profit colleges operating in Florida. Initially, the AG’s office said it would investigate five schools including Everest University, Kaplan University, Medvance Institute, Argosy, and the University of Phoenix. The three new schools that will be investigated are Keiser University, Concorde Career Colleges, and Sanford-Brown Institute.
The Florida AG probe began after the federal government’s Government Accounting Office went undercover to investigate complaints about the schools’ marketing practices, financial aid packages, and their recruiting practices.
If any of the school’s are found to be in violation of Florida’s consumer protection laws, they face fines of up to $10,000 per infraction. In addition to the state fines, the schools face possible action concerning the student loans offered to students by the federal government. In one video excerpt of the GAO investigation, the recording reveals a Medvance Institute recruiter telling a prospective student not to worry about paying back the student loans. “It’s not like a car note, where if you don’t pay they’re gonna come after you,” the recruiter told the unsuspecting student.
The investigation may jeopardize the school’s ability to obtain federal and state grant money as well as offer student loans. According to the St. Pete Times, “At stake is billions of dollars in federal student aid — $20 billion in loans last year, plus another $4 billion in Pell grants for low-income students. That’s about a quarter of all federal aid to college students.
In Florida, for-profit schools also receive state money from students with Bright Futures scholarships. Last year, for-profits received $2.7 million through Bright Futures, with more than $571,000 going to the eight schools under investigation.”

Tylenol Recall Information

Last week the FDA released the results of a new inspection report of a Johnson & Johnson manufacturing facility in Puerto Rico that had failed quality control inspections in January 2010. Yesterday, November 26, 2010 an FDA spokesperson stated:
“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law”.
This statement by the FDA was about the Johnson & Johnson McNeil Consumer Healthcare unit that recalled millions of bottles of Tylenol and other over the counter drugs. However, this is the same company that recently recalled its DePuy ASR XL hip implants made by its DePuy division. It is apparent that Johnson & Johnson and DePuy had knowledge for several years that these hip implants were failing at an unacceptable rate and left them on the market.
Johnson & Johnson used to be a company with the highest standards for conduct. In fact, the Tylenol recall over two decades ago involving Tylenol on shelves that may have been tampered with is still taught in business schools around the country as the textbook example on how an ethical company should properly handle a recall.
Recently, with regard to the over the counter products, J & J was accused of a “stealth recall” in which they hired private firms to go to drug stores and purchase all the product off the shelves without disclosing a recall. This stealth recall involved children’s Motrin products as well as other popular Johnson & Johnson over-the-counter medicines.
There do not appear to be any injuries or deaths reported from the recalled over the counter products. The DePuy ASR XL hip implants, on the other hand, have subjected many hip implant patients to additional surgeries to remove the implants and exposure to cobalt and chromium poisoning that could have long lasting health effects.
It is apparent that the Johnson & Johnson Credo of quality which was like scripture within the company for so many years is not being followed by current management. Such repeated failures in the protection of public health by Johnson & Johnson would make the founders of the company roll over in their graves.
One wonders if the company suffers from a systemic failure in quality control as well as research and development. Johnson & Johnson is suffering from failures in both its medical device division as well as its pharmaceutical division. If this trend continues, consumers will start associating the brand with bad products and dangerous medical devices. No company can survive that reputation.

Darvocet Recall Attorney

Now that the FDA has recalled Darvon and Darvocet, manufactured with propoxyphene, an opiod painkiller, attention and criticism have been focused on the slow response of the governmental agency to remove the painkillers from the US marketplace. It’s well-documented that the advocacy group Public Citizen has been calling for the drugs’ removal from the marketplace since 1978. Other countries have removed the drugs much more quickly, including the entire European Union. Dr. Sidney Wolfe told the FDA that the drugs were relatively weak and weren’t effective especially given their potential serious adverse consequences which include fatal abnormal heart rhythms, arrhythmia, bradycardia, cardiac/respiratory arrest,congestive arrest, congestive heart failure (CHF),tachycardia,
and myocardial infarction (MI).
In response to the recall, Public Citizen released the following statement, “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the group said in a statement. “The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being ’caused’ by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.”
There is little doubt in the medical and scientific communities that these are dangerous drugs. Yet, because of the FDA’s inaction, thousands have been prescribed these painkillers in the United States. Little to no information is available as to what caused the years of inaction by the FDA. Because of this delay, consumer safety and consumer confidence have been dealt another blow.
Darvocet Recall

Archbishop Seeks Payment from Abuse Victim

Archbishop John John Nienstedt of the Catholic Archdiocese of Minneapolis-St. Paul has asked the judge in a recently dismissed priest abuse lawsuit for $64,000 in legal fees. The lawsuit was dismissed on the judge’s determination that the suit was not filed in a timely manner. Nienstedt’s attorneys want to recoup their legal fees from the survivor which a legal maneuver normally sought in frivolous lawsuit cases. Is it the position of the Archbishop that this survivor’s claims are frivolous and without merit? This is a tough argument to make since the priest in question, Fr. Thomas Adamson has been accused before and admitted as early as 1980 to sexually abusing minors.
The local Survivors Network of Those Abused by Priests has protested the Archbishop’s action and has released the following statement: “We in SNAP believe it’s immoral for a bishop to exploit legal technicalities and hide behind an archaic and predator-friendly statute of limitations,” said David Clohessy, director of SNAP, referring to Archbishop John Nienstedt. “A profit-making secular businessman might do this. But it’s just wrong for a professed spiritual figure to do so.” While it may not be moral, the Archbishop must view it as an effective means of intimidating other sexual abuse survivors from coming forward and seeking justice through a sexual abuse lawsuit.
The suit was not dismissed because the victim’s allegations were found not to be credible. The suit was dismissed because of the restrictive statute of limitations which prevents many victims from pursuing justice. If this is the Archdiocese’s idea of good pastoral practice, all of us should be alarmed.
One has to wonder if other dioceses and archdioceses around the world will soon follow the lead of this Archdiocese. I doubt if this is an isolated, aggressive strategy to deal with sexual abuse victims only within the Archdiocese of Minneapolis-St. Paul. It would be interesting to ask the newly appointed president of the US Conference of Catholic Bishops Archbishop Timothy Dolan his thoughts concerning this hardball tactic. His own handling of sexual abuse survivors in the Archdiocese of Milwaukee left much to be desired. However, Dolan seems to be sensitive to the potential adverse public relations consequences of these aggressive tactics. According to most press reports, Dolan’s ability to deal with the press (the NY Times a notable exception) was one of the principal reasons he was elected over Bishop Gerald Kicanas, a former Chicagoan who was felled by his mishandling of Chicago pedophile priest Rev. Daniel McCormack.
Perhaps the NY Times will ask Archbishop Dolan about his fellow archbishop’s actions toward a priest abuse survivor. It would be interesting to see what he says.

Darvocet Recall

The FDA Darvocet recall and Darvon recall was long overdue. These drugs have been on the market for over 50 years. The FDA memorandum dated November 19, 2010 on the darvocet recall sets forth some science on Darvocet that should be helpful in understanding the dangers of this drug.
First, Darvocet is cardiotoxic when used as directed on the label. That means that when used as directed Darvocet causes chemical changes in the heart that affect its electrical system. These changes in the heart’s electrical system can cause heart arrythmias. In some cases these unnatural heart rhythms can cause ventricular fibrillation. This means that your heart stops pumping blood. This can and does frequently result in sudden cardiac death. This is probably the cause of most of the deaths from Darvocet aside from overdoses. A disruption of the heart’s electrical system from Darvocet could also cause atrial fibrillation which could trigger a stroke or heart attack from a blood clot. An electrocardiogram or EKG is the test that is used to detect heart rhythm malfunctions.
The FDA report points out that elderly people or people with reduced kidney or renal function are most likely at risk for propoxyphene-induced cardiotoxicity. Individuals with pre-existing arrthymias would also be at increased risk. That is because those individuals are less able to naturally clear the toxic substances from their bodies. However, the most recent study shows that even healthy individuals taking normal doese were at risk of heart failure and sudden death from Darvocet.
The good news for Darvocet patients is that the medical literature does not indicate that Darvocet has a latent effect after the drug is discontinued. The FDA also observed that there does not appear to be a cumulative effect on the heart after the person stops taking the drug. There has not been much study of this question because most of the scientific reports and literature on Darvocet and Darvon have focused on treatment of overdose in emergency rooms. Since Darvocet and Darvon are opiates and are addictive many deaths may have been attributed to opiate overdoses causing respiratory failure and may not have been closely investigated.
I expect that most of the individual lawsuits and class action lawsuits that are being filed will involve sudden cardiac death cases. A cardiac arrythymia caused by Darvocet or Darvon should be treatable most of the time without permanent damage in most cases. However, it is possible that heart malfunction for a temporary period could cause health damage of other types. For example, lack of blood to the brain or other organs during the period of heart dysfunction could cause significant permanent problems. This would be the basis of a negligence or product liability lawsuit against the manufacturer of the drug.
I would be happy to discuss the science or legal issues with anyone that would like to comment or email or telephone me.
Darvocet Recall

Car Accident Lawyer

Auto accidents remain the leading cause of death for Americans under the age of 34. Each year, 40,000 people lose their lives in auto crashes. The resulting psychological, economic, and physical toll places tremendous strain on families and individuals alike. If the accident is not stressful enough, the aftermath can be a nightmare dealing with issues such as medical treatment, car repairs, mounting hospital bills, lost time from work, and lost wages. Yet, the decisions you make during this stressful period can have lasting impact upon you and your family.
If you’re involved in an accident what should you do?
Call the Police immediately
Fill out an accident report thoroughly
Obtain names and phone numbers of witnesses
Seek medical treatment even if you feel ok at the scene (your adrenaline may mask a serious injury)
Florida Accident Lawyer

Darvocet Recall Attorney

Drug safety advocates have been calling on the FDA to recall Darvocet since 1978. Finally, they’ve called for the recall of Darvocet and Darvon from the markeplace. These drugs, found to be less effective than other pain killing drugs, have been recalled for their potentially deadly consequences.
Darvocet is cardiotoxic when used as directed on the label. That means that when used as directed Darvocet causes chemical changes in the heart that affect its electrical system. These changes in the heart’s electrical system can cause heart arrythmias. In some cases these unnatural heart rhythms can cause ventricular fibrillation. This means that your heart stops pumping blood. This can and does frequently result in sudden cardiac death from heart attack. This is probably the cause of most of the deaths from Darvocet aside from overdoses. A disruption of the heart’s electrical system from Darvocet could also cause atrial fibrillation which could trigger a stroke or heart attack from a blood clot. An electrocardiogram or EKG is the test that is used to detect heart rhythm malfunctions.

Pope Benedict why Condoms Instead of Child Abuse?

Pope Benedict XVI has received a lot of ink this week about his thoughts on condom use. The thoughts come from a book length interview he gave to journalist Peter Seewald. Unfortunately, the condom issue has received the bulk of the news headlines rather than the ongoing problem of priest sexual abuse. The sexual abuse of our children can’t be tucked neatly in a corner and forgotten. It’s an ongoing crisis that darkens the cavernous walls of the Catholic Church even as some hierarchs attempt to move beyond it. It’s not going away and we still have no message from the Church that they are willing to deal with it in a substantive, worldwide fashion. No words can sufficiently assuage the suffering of countless children who’ve suffered at the hands of Catholic priests, brothers, and sisters who’ve abused them. It’s time for action. Pope Benedict needs to act rather than issue apologies to those who’ve endured these criminal acts. The time is now.

Depuy Hip Recall

The first major hearing on the individual lawsuits and class action lawsuits against Johnson & Johnson for the recall of the DePuy ASR XL hip implants took place in Durham, North Carolina on Thursday, November 18, 2010. The federal judges on the U.S. Judicial Panel for Multidistrict Litigation heard arguments from lawyers for Johnson and Johnson as well as lawyers for consumers who were injured or who are affected by the recall. The hearing was to determine whether all the lawsuits should be coordinated before one federal judge for pretrial management, and if so, which judge should be assigned to handle the cases.
Depuy Hip Recall
Lawyers from across the country attended the hearing. Many consumer trial lawyers also met privately with each other to share information that had been accumulated about the recall and to determine how to best represent injured consumers.
It is clear from evidence shared among attorneys in Durham that Johnson & Johnson had known about an unacceptably high failure rate for the DePuy ASR for several years prior to the recall and that the product should have been recalled much sooner. The Australian National Joint Replacement Registry had shown unacceptably high failure rates for the DePuy ASR for several years.
Depuy Hip Implant Recall
The most seroius health risk from the DePuy ASR is the exposure of patients to high levels of chromium and cobalt metal debris from the implants. The poor design of the ASR XL causes too much pressure on the edges of the cup causing excessive wear which releases metal debris into the patients hip. Chromium and cobalt occur naturally in the body at very low levels. However, the high levels released by the DePuy ASR are toxic to the tissues in the hip. These toxic metals can also damage other organs of the body. Medical studies of chromium and cobalt exposure in industrial setting have show that these metals are toxic to the liver, kidneys, and brain. This has not yet been proven with respect to the DePuy hip but it is a possible risk. Chromium has been shown to be a human lung carcinogen in industrial settings but no studies have yet been done with regard to the DePuy ASR failures.
Depuy Hip Replacement Recall
Consumer trial lawyers, including myself, and Johnson & Johnson are recommending blood testing of DePuy ASR patients for the presence of these toxic metals to determine the amounts of exposure and help physicans made medical decisions about whether and additional surgery is needed to replace the DePuy ASR with another hip implant of a different kind.
I think any DePuy ASR patient should get legal and medical advice immediately even if there are no symptoms because there is a risk of toxic exposure to from the metal debris that can be created by the hip implant. Health damage from the toxic metal exposure may not show up for long periods of time.
There are strict time limits for filing claims against Johnson & Johnson and DePuy that will bar claims that are late. These time periods for filing vary by states and circumstances so I can’t give a specific deadline in this article. Each case needs an individual analysis by an attorney experienced in medical product liability cases to determine the required filing date. I am happy to provide individual case analysis at no fee, cost, or obligation.
Depuy Hip Recall Lawsuit