Monthly Archives: October 2010

Defective DePuy Hips May Lead to Metal Poisoning

The metal-on-metal artificial hips such as the recalled DePuy ASR hip replacement systems may lead to severe pain, difficulty walking, tissue inflammation, and joint damage. Metallosis, commonly known as metal poisoning, may result as an adverse consequence of wear and tear of the metal-on-metal hip replacement.
The metal-on-metal hip has lead to cases where the grinding metal releases small particles of metal into the body. This can eventually lead to bone loss and necessitate the painful and arduous process of a revision surgery where the defective DePuy hip is replaced and a new hip inserted. These types of revision surgeries are far more complicated than the original hip replacement because the metal-on-metal hip parts have caused damage to the surrounding tissue and bone.
When DePuy, a subsidiary of Johnson & Johnson first announced that it was halting sales of its DePuy ASR hip, the company said it was due to declining sales. Months later, investigations have determined that numerous complaints about the hip have surfaced. It’s estimated that close to 13% of the DePuy hips have failed, some of which have had to be replaced.
Special blood tests may be performed to determine the level of metallic components such as cobalt and chromium in the blood stream. Certain levels of such metals in the blood may lead to metallosis which in turn can lead to aseptic fibrosis, local necrosis (bone death), and increase the chances of further hip replacement surgery.

San Diego Diocese Turns Over Priest Files

It’s the largest collection of priest abuse documents from any diocese in California that have been turned over to the public after a judge ordered diocesan officials to do so. The Diocese of San Diego settled a number of priest abuse cases in 2007 for $200 million and a promise to divulge all the documents relating to priests who abused minors. Finally, the Diocese complied with the settlement agreement and the judge’s order. When the settlement was finalized in 2007, it was agreed that a judge would inspect the San Diego priest documents and decide which documents should be made public. The judge has now reviewed the documents and released 10,000 pages of documents.
In any priest abuse case, the documents are the most important aspect of the case. As in Boston, the San Diego documents reveals patterns of abuse by priest predators as well as the cover-up, mismanagement, and secrecy of the diocesan officials, including bishops who either ignored abuse reports or simply transferred the offending priest. The San Diego documents also reveal the international character of the priest sexual abuse crisis. In this particular instance, priests were allowed to move not only from diocese to diocese but from one country to another in spite of known allegations of the sexual abuse of minors. Very often, the diocese that received the predator priest was unaware of the priest’s past criminal behavior and didn’t bother checking his background for fear of what may be discovered.
The public revelation of the San Diego documents is a victory for truth and justice. More importantly, it’s a victory for all the survivors who suffered the sexual abuse perpetrated by trusted Catholic priests. It’s also a victory for all children in the future.

Orlando Gets New Bishop

Catholics in the Diocese of Orlando woke up this morning to discover they had a new bishop. He’s Bishop John Noonan, the auxiliary bishop of Miami. Noonan, a native of Ireland, will take responsibility for the Orlando Diocese in December, a few weeks before Christmas.
Prior to becoming an auxiliary bishop in Miami, Noonan served in various parishes in the Archdiocese as well as the Dean of Men and rector at St. John Vianney College Seminary in Miami. Noonan has a reputation as a parish priest with a pastoral heart.
As a member of the US Conference of Catholic Bishops, Noonan serves on the Bishops’ Conference Committee on the Protection of Children and Young People.

Zimmer Hip Replacement Study

Related: Zimmer Hip Replacement Recall
New Medical Study on Zimmer Durom Cup shows 11.1% Failure Rate
Doctors at the University of Wisconsin released a study in September 2010 documenting for the first time the unusually high failure rate of the Zimmer Durom Cup Hip Implant. Lawsuits have been pending for several years alleging that the Durom Cup has a high failure rate. A number of orthopaedic surgeons have also expressed concerns about having to redo surgeries involving the Durom Cup. However, there has never before been a statistical analysis done to prove that the failure rate of the Durom Cup was higher that a background rate of failures of hip implants that can and do occur for unknown reasons.
The analysis done comparing hip implants was published in a well respected peer reviewed journal entitled The Journal of Arthroplasty. This is a Journal that is read by orthopaedic surgeons specializing in hip implant surgery. I expect this article will be used by doctors testifying in the pending lawsuits against Zimmer because it supports the case that the Durom Cup does not perform as expected and that a defect in the product has been the cause of many hip implant failures.
Zimmer Durom Hip Replacement Study PDF

Continue reading

Florida For Profit Schools Target of AG Investigation

Five for profit universities operating in the state of Florida will be investigated by the state Attorney General’s office. The schools include Kaplan Inc., the University of Phoenix, MedVance Institute, Argosy University and Everest University. The investigation was prompted after the Attorney General’s office received numerous complaints concerning the schools’ marketing practices, deceptive financial aid packages, promises concerning job placement, and accreditation.
According to the Sun Sentinel, “Hearings from the Senate Health, Education, Labor and Pensions committee, as well as an investigation by the Government Accountability Office, found misleading and questionable practices at 15 schools during an undercover investigation. The office identified potential fraud at campuses of two companies McCollum is investigating: Kaplan College in Pembroke Pines, which has suspended enrollment of new students, and MedVance in Miami.”
The for profit universities have become increasingly popular as the economy continues to struggle and under-employed or unemployed people decide to go back to school to obtain a degree. Enrollment at these schools has skyrocketed in the past few years from 365,000 to 1.8 million students.
Federal investigators discovered school recruiters were deceptive in their recruitment practices by telling students not to worry about paying back student loans and that the for profit schools had the same accreditation as schools like Harvard

Drug Companies Paying Doctors to Promote Their Products

A recent study by consumer groups and media outlets has discovered that large pharmaceutical companies are paying doctors handsome sums of money to promote their drugs, some of them for so-called off-label uses which are not approved by the FDA. Doctors may prescribe medications for off-label use but such off-label uses can’t be promoted. The study is limited in scope in that only 7 pharmaceutical companies AstraZeneca, Cephalon, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Merck and Pfizer were part of the study. In all likelihood, this means there are more doctors being paid by other pharmaceutical companies to promote their drugs to other doctors.
“Tens of thousands of U.S. physicians are paid to spread the word about pharma’s favored pills and to advise the companies about research and marketing,” the group says in its report.
The report notes that 380 doctors were paid more than $100,000 in 2009-10 to promote the drugs. ProPublica, a journalism group that took part in the study, noted that 250 of the doctors who took money from the pharmaceutical companies had been sanctioned by state medical boards for inappropriately prescribing drugs or having sex with patients.

Chinese Drywall Settlement

A significant development in the Chinese drywall cases involving Defendant Knauf Plasterboard Tianjin (KPT) occurred this week in New Orleans, site of the MDL (multi-district litigation).
An agreement was reached between attorneys for KPT and the PSC (Plaintiff’s steering committee). This agreement will create a pilot program involving several hundred Plaintiffs located in four states – Florida, Mississippi, Alabama, and Louisiana.
Because the terms of the pilot program are confidential, I cannot discuss them in great detail. However, I can provide a general frame work of the program and its impact on those who currently are Plaintiffs in the MDL and those who have yet to join this lawsuit.
Currently, Knauf has agreed to have approximately 300 Plaintiffs participate in the program. By participating in the program, the Plaintiffs will be agreeing to waive their rights, now and in the future, to bring any additional causes of action against their contractor/builder, drywall installer, supplier and importer, and obviously, against Knauf or any entity associated with Knauf. In exchange for agreeing to this waiver, Knauf will retain a contractor to perform remediation of their property. In addition, Knauf will pay for other related expenses, attorney fees and court costs.
For the more than 2000 Plaintiffs who are already members of the MDL, the window of opportunity to be one of the 300 chosen for the pilot program is closing fast. As such, if you are not yet a Plaintiff in the MDL, your opportunity to be a member of this pilot program is even more limited and time crunched. If you are a Plaintiff in the MDL, you can expect to be hearing from your attorney to describe what has happened and the status of your case.
If Knauf was not the manufacturer of your drywall, you will not be able to participate in this pilot program. However, it is the expectation of Judge Fallon, the Federal Court Judge assigned to the MDL case, that if the pilot program works as hoped, other Defendant manufacturers, insurers, builders, suppliers, etc. involved in the MDL will agree to a similar resolution with those Plaintiffs who have filed suit against them in an Omnibus complaint in the MDL.
One final point that is very important – Judge Fallon, in comments made to counsel for Plaintiffs and Defendants, indicated that Plaintiffs in the MDL stand the greatest chance of recovering the most from Chinese manufacturers like Knauf. Those who choose to go it, so to speak, alone, will have the toughest time obtaining a judgment against those defendants they pursue, and even if a judgment is obtained, collecting that judgment from the Defendants.
Therefore, for anyone reading this blog who has been sitting on the sidelines trying to figure out what to do, you might want to make up your mind pretty quickly, as your failure to decide how to proceed could cost you your opportunity to recover your losses.

FDA Admits It Shouldn’t Have Approved a Knee Device

In an unprecedented move, the FDA has admitted that it should have never approved a medical device but succumbed to outside influence in approving the Menaflex knee patch manufactured by ReGen Biologics. The pressure came from NJ elected officials including Senators Frank R. Lautenberg, Robert Menendez, Reps. Frank Pallone, Jr. and Rep. Stephen R. Rothman.
Controversy began to swirl around the medical device last year when FDA officials complained that politics had unduly influenced the approval of Menaflex. FDA scientists released a detailed report showing that FDA scientists had found the device not worthy of FDA approval but were overruled by FDA managers who had come under the sway of the New Jersey politicians in whose state the device is manufactured.
According to an article in the NY Times, “Dr. Robert Smith, a former F.D.A. device reviewer who was among those who complained to Senator Grassley, said in an interview that the agency had yet to discipline the managers responsible for the ReGen decision. Some of those managers have since left the agency.
“There was serious managerial wrongdoing during the clearance of the device, and that needs to be investigated, and the managers involved need to be held accountable,” Dr. Smith said.
The controversy and potential improper conduct includes the FDA commissioner who is cited in the report for inappropriate involvement in the approval process.
The four NJ elected officials who pressured the FDA had received significant campaign contributions from ReGen headquartered in Hackensack New Jersey.

Medtronic Agrees to Settle Sprint Fidelis Leads Lawsuits for $268 Million

Metronic, Inc. has announced that it has agreed to settle lawsuits regarding its Sprint Fidelis defibrillator leads (Models: 6930,6931, 6948, and 6949) for $268 million. Many of the Sprint Fidelis lawsuits had arisen from the October 2007 Sprint lead recall that had been prompted by reports that the defibrillator leads were fracturing. The fractures caused the leads to malfunction. Many of those who had implanted Sprint Fidelis defibrillator leads had to undergo explantation of the leads as a result of the fractured leads. The fractured leads caused the defibrillators to short and not transmit proper electric impulses to the heart.
According to a Medtronic press release, the parties will file joint requests to terminate the Multi-District Litigation which had been set up to handle all of the Sprint Fidelis lawsuits.

DePuy Hip Recall Lawsuits Mount

The DePuy artificial hips that were recalled in August are facing mounting lawsuits as news about the hips’ defects and the device maker’s failure to notify the FDA and the public about what they knew about the problems continues to surface. There are widespread reports that DePuy officials knew the metal-on-metal artificial hip implants were failing at an alarming rate but those same officials didn’t disclose the problems until this past August.
According to DePuy, the company sold approximately 93,000 of the SR Hip Resurfacing Systems and ASR XL Acetabular Systems and that these devices have suffered a 12% failure rate requiring revision surgery within the first five years of implantation.
Any revision surgery is painful, subject to further failure and may lead to other complications. The metal-on-metal devices can cause metal debris which can lead to inflammation, loss of bone and tissue, and groin pain.

Page 1 of 212