Monday, April 30, 2012

Depositions In Federal DePuy ASR Litigation Continue Over Recalled Hip Replacement Implants

Bernstein Liebhard LLP reports that a series of depositions of DePuy Orthopaedic executives as well as one of the developers of the recalled hip replacement systems were recently noticed in In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio.* In addition to the deposition of Dr. Thomas Vail, who developed the recalled hip replacement, several company executives were noticed in the federal DePuy ASR litigation, including: the Senior Bioengineer; the Group Manager, Global Testing & Simulation; and the Product Director of Hip Marketing. These depositions are scheduled to take place during May and June 2012.

These upcoming depositions will cover a range of topics including: the design, sale, promotion and marketing of the ASR hip implants, as well as communications relating to complications, post market surveillance and recall of the devices. The DePuy executives have also been asked to produce documents, notes, outlines, presentation materials, testimonies and oral proposals prepared or given to them that reference or relate to the recalled hip replacement systems.

In addition to these upcoming depositions, a status conference in the federal DePuy ASR litigation has been scheduled for May 1, 2012, at 11:30 a.m. at the Paul G. Rogers Federal Building and United States Courthouse in West Palm Beach, Florida. Subsequently, an open court conference will commence at 12:30 p.m. on that same day.**

Developer Of Recalled Hip Replacement Expected To Testify On A Variety ASR Related Topics

In addition to being credited as one of the main designers and developers of the DePuy ASR hip implant, Dr. Thomas Vail also provided the company with a wide range of consulting services.*** According to Bloomberg Businessweek, he was paid $552,000 in royalty income for intellectual property and/or product development in 2009 and 2010. Bloomberg reported that in addition to receiving payments for product development, Dr. Vail attended DePuy meetings in support of the ASR products and actively promoted them to his peers. According to Bloomberg, Dr. Vail’s participation has resulted in him being a named defendant in patient lawsuits against DePuy, alleging that he assured “orthopedic surgeons during these meetings that the ASR System was safe, was the best product on the market, had an excellent track record and a low and acceptable failure rate.”

Sunday, April 29, 2012

Strange Reimbursement letter from the Insurance Company: Will you be liable if the insurance company doesn't submit your expenses for reimbursement?

I sure can tell you that these insurance companies never cease to amaze me. 

I have discussed this reimbursement issue with you in prior posts.  Depuy/Broadspire has always been cooperative in reimbursing my direct expenses.  Earlier this year, I decided to just send a block of expenses in from Blue Cross to Depuy so that all expenses would be reimbursed.  Strangely, I got the biggest run a round trying to get the Blue Cross people reimbursed for these expenses.  Blue Cross refused to submit all of the remaining $50,000 or so to Broadspire so I decided to do it myself.

I got this utterly stupid shocking note from the office of the CEO telling me the following:
  • "We can not continue to process claims in this manner."  What the heck?  Oh so you want your claims to accrue until you have no chance of getting reimbursed?  A very strange business practice in deed.  In effect, they told me to let the claims be and they would take care of them.

  • "As with any other claim, your providers must submit all of your hip related health care claims to Blue Cross.  The claims will then be processed according to your plan"  Well, I got news for you Blue Cross, I hope you know that many of my claims have been processed directly.  That is, the claims go into Blue cross and then I have the claim refused and sent to Depuy.  They have been doing that for a year.  Now you are finding out how your subrogation plan is really working in your company?

  • "Please contact Broadspire's customer service dept  with any questions regarding disbursement."  Well, I got news for you again, I reviewed all of this with Broadspire prior to attempting to help you get your money back for claims on my behalf.  All you had to do was submit the list of claims to Broadspire and they would have paid them.  What kind of insurance business would turn away the reimbursement of a claim through a subrogated right they had to get that money.  Essentially, what they did was turned away the ability to collect on a $50,000 receivable!  Who would be so stupid?

  • So the final phone conversation went like this:
    • Connie: Are you telling me that you don't want this money?
    • insurance company:  I am telling you that we have a process in place with 3rd party attorneys to collect this money.
    • Connie:  I was told you have collected no money from Broadspire on behalf of your clients
    • Insurance company: That is correct but we have a process in place to do so.
    • Connie:  but I can get that reimbursed now.
    • Insurance company:  Thank you but we don't need your help.
Good God.  This person was the assistant to the CEO of the Blues in my area.  I hope they don't promote him to any other function for the insureds sake!

The issue with this is that, Broadspire is paying all of these claims voluntarily and I think they  have been doing a good job. From my perspective, I don't want to be burdened with some lien in the future if these geniuses at the insurance company can't collect. I am going to send the CEO of the insurance company recapping what went on so that it is clear they are turning down the right to collect to get paid now in exchange for perhaps never getting reimbursed.


Now, if I were an insurance company, I would put a plan in place to subrogate those costs immediately as they are submitted for every case.  Why?   The better question is why not?  Who is to say that they will have enough set aside to honor these payments in the long term.  The $3 Billion is not going to scratch the surface in my mind.  Simple math will tell you that. 

Saturday, April 28, 2012

My Diagnosis

Metastatic Renal Cell Carcinoma. Diagnosis rendered on 4/27.

My mission is clear.
  • Define the disease and the cause or precipitant of it.
  • Eliminate the hip as being some kind of initial precipitant (ongoing/this will take time)
    • Review the three test results I have taken (I will share those with you as soon as I have them.)
      • metal testing on the biopsied results
      • path tests on the diagnostics
      • the cytogenetics tests on the DNA changes.
  • Select a treatment program.
I will  publish  one part of the investigation for this blog since the subject matter of this blog is hip related and will continue this blog as long as the potential link between the hip and cancer is resolved one way or another.

Here are the 3 key large short term patient metal on metal  studies that will prompt me to move forward and serve as my inspiration that there are no answers at this point...only questions. I also will commit to attempt to get some studies funded to move this research forward.


Cancer risk after hip replacement with metal implants: a population-based cohort study in Sweden.

     J Natl Cancer Inst. 1995 Jan 4;87(1):28-33.

                  CONCLUSION:  (40K patients)

•     In this study, the largest study to date to evaluate hip replacement and subsequent cancer risk, the overall cancer risk appears to be negligible from a public health perspective, and our results have not produced any strong evidence against the continued use of these devices. Nevertheless, the small but statistically significant increases in kidney and prostate cancers and the decrease in gastric cancer deserve further study.

      Nationwide study of cancer risk among hip replacement patients in Sweden.

    J Natl Cancer Inst. 2001 Sep 19;93(18):1405-10.

      CONCLUSIONS:  (116K patients)

•     In this 2nd study, the largest study to date, hip implant patients had similar rates of most types of cancer to those in the general population. Although the excesses of melanoma, multiple myeloma, and prostate and bladder cancers may be due to chance, confounding, or detection bias and should be interpreted cautiously, they warrant further investigation because of the ever-increasing use of hip implants at younger ages

The third study was just published
British Medical Journal
BMJ 2012;344:e2383 doi:  10,1136/bmj.e2383 published 4/3/12
Risk of cancer in the first seven years after the MOM hip replacement ...

 Conclusions: (41K patients
  • The incidence of cancer was low after hip replacement  (1.25% at one year.)
  • There was no evidence that metal on metal bearings were associated with an increased risk of any cancer diagnosis after 7 years
  • There was no increase in the risk of malignant melanoma or haematological, prostrate and renal tract cancers. 
  • The 5 year incidence of all cancers for men aged 60 was approx 5%,  with resurfacing approx 6%,  with stemmed MOM 7%  and were lower with woman.
"These data are reassuring, but the findings are observations with short follow up,  The use of hospital episode statistics data might underestimate  cancer diagnoses and there is the possibility of confounding  by indication.  Furthermore, as some cancers have a long latency period , it is important that we study the longer term outcomes and continue to investigate the exposure to orthopedic metals.

[There are issues with all of this stuff.  How often do patients get hip operations that have been tested for Cancer?  Never? While the author does point this out,these studies need to be taken to the next step. For obvious reasons, they all underestimate the cancer risk but we don't really know that someone has cancer unless there is a reason to have discovered it.]


Friday, April 27, 2012

No word yet on my path tests but should hear today

Waiting is the worst isn't it?  I would rather have the news ( A quick yes; you have x) rather than a long maybe....

I think I will call the pathologist this morning.  By the way...while I may be  working outside the normal lines and boundaries with physicians, always remember that there are two people on your team whom you never see that are great information resources:  the pathologist and the radiologist.  These two sub specialties have loads of information beyond that which you may get from your physician.  You can always request their notes and often times may speak with them directly if you are dealing with a patient care centered hospital.   (Most hospitals, sadly, are not based on a patient centered care philosophy.) 

That  philosophy entails the  recognition that the patient is an integral part of the care team. That means, you have access to all information and are very much a part of the decision making process.  We are lucky to have a hospital run by a CEO (and physician) who does have that philosophy.  He   had a very bad accident that has left him a paraplegic (for now.)  He became a patient at his own medical center and as a result is  acutely aware of the interactions that the medical team has with the patients.  The point is that many things changed in that hospital.

I experienced first hand those changes last Friday when I underwent that surgery for tumor removal:
  • My surgeon called me the day before the surgery to find out if I had any remaining questions (who has ever heard of surgeon doing that?)
  • upon admission, every single person shook my hand and introduced themselves and welcomed me to the hospital.
  • At lunch, I was not too kean on the food and one of the nurses offered to share their lunch with me
  • After recovery, even though this robotic surgery was day surgery, they moved me to a private room when giving me the preliminary news that I had cancer.
  • As a result of us discussing the hip and its potential implications  requiring certain tests, the pathologist was brought into my room to discuss the testing with me.  She mentioned that she started a program to become more interactive with the patients.
  • On a prior trip to the sister hospital, I was able to make an appointment to meet with my radiologist went the medical team recommended working with an interventional radiologist to get some tumor samples from a tricky area.
  • When I was admitted to the  floor for an over nite stay post surgery (that stay was unplanned), I was taken to a private room with an introduction from the nurses telling me that I would not be awakened all nite for tests.  They had a "quite time" policy that precluded all of that. 
  • When the nursing shift changed, I was told I would be introduced by my current nurse to the new nurse.
I am really lucky to have such care.  My point is,  some time in the future, hospitals will have to change their ways to be more responsive to patients.  If you are hospitalized for that hip and you want to discuss your path results or radiology results with the physicians who rendered the service because you don't understand something, you have every right to access those professionals.

I feel the radiologist and the pathologist are key members of your medical team because they see the hip images (radiologist) and the tissue samples (pathologist) from the surgery.  At the very, very least, you should request the path notes and the radiology notes along with the notes from your surgery from your ortho. surgeon.

Thursday, April 26, 2012

J&J board faces growing dissent

April 26, 2012: 8:35 AM ET

As the healthcare company battles reputational issues, investors Are targeting its Directors.

 

By Mina Kimes, writer Fortune

FORTUNE -- Every year, shareholders at public companies vote on whether their board members deserve another term or not. It's typically a non-event; the average director of an S&P 500 company wins 96% of the vote, according to proxy advisory firm ISS. But the directors of healthcare giant Johnson & Johnson, which hosts its annual shareholders' meeting Thursday, may face a rockier path to reelection. Investors have begun to turn against the board, with a growing contingent of shareholders voting against J&J's nominees.

In 2011, the average J&J (JNJ) director won approval from just 88% of shareholders, down from 94% in 2009. That may not sound like a steep decline, but it's actually quite low for a large corporation, according to Charles Elson, director of the John L. Weinberg Center for Corporate Governance at the University of Delaware. "When you get into the 80s, that's a real problem," he says.

Two J&J directors -- Charles Prince, the former CEO of Citigroup (C), and Michael Johns, the chancellor of Emory University -- received support from about 80% of voters, which is well inside the "danger zone," according to Paul Hodgson, a senior research associate at GMI, a corporate governance ratings firm. "That's a very substantial proportion of shareholders," he says. "It should be enough to make a board sit up and take notice."

A spokesperson for J&J wrote in an email that the board will analyze voting results after its annual meeting, as it does every year.

Red flags: Disappointing financials, recalls
It's easy to see why J&J's shareholders are frustrated. In recent years, the company has been charged with several legal violations and endured a seemingly endless series of product recalls. Its reputation has taken a hit. Back in 2009, before the recalls began, J&J was ranked fifth on Fortune's World's Most Admired Companies list. In 2012, J&J's overall rank dropped to 12.

The company's financial results have also been underwhelming. J&J's stock has delivered a total return of 5.3% over the last two years, while the S&P 500 has returned 17.5%. Its net income declined in both 2009 and 2011, in part because the company lost more than $1 billion in sales because of recalls of over the counter drugs.

Investors are typically wary of punishing directors for individual missteps. But J&J's troubles have been widespread. Two years ago, the Department of Justice charged the company with paying kickbacks to Omnicare (OCR), the nursing home pharmacy operator. Last year, the company agreed to pay a $70 million settlement over allegations that it paid bribes overseas. An Arkansas judge recently ordered J&J to pay $1.2 billion in penalties for illegal marketing practices.

J&J has had to recall millions of bottles of over the counter drugs made by its McNeil subsidiary, citing issues such as bad odors and an excessive amount of active ingredients. After the initial spurt of recalls in 2009, J&J shut down the McNeil plant, promising to revamp its quality assurance practices in order to get production back on track. But recalls keep popping up. As recently as February 2012, the company had to recall more than 500,000 bottles of Tylenol. J&J now says it won't reopen the plant until late 2013.

A group of J&J shareholders, including the NECA-IBEW Welfare Trust Fund and the Hawaii Laborers Pension Fund, sued the board in 2010, arguing that directors had ignored red flags. A U.S. District judge dismissed the complaint, but noted in her opinion that the shareholders' allegations against the board were "troubling and pervasive."

In J&J's 2011 proxy statement, the board praised J&J's CEO, William Weldon, for his handling of the recalls. The statement said Weldon "generally met expectations" in 2010, adding, "Mr. Weldon's leadership and engagement with employees, legislators, regulators, investors and the news media enabled the company to deal with the issues."

During a significant portion of 2010, though, Weldon avoided the press. When he first addressed the recalls, he said that they were isolated to the company's McNeil unit; not long after that, J&J issued recalls of hip implants made by its DePuy division. In April 2010, a J&J spokesperson said Weldon didn't think that cost cutting played a role in McNeil's problems. The following July, J&J released a report that conceded that the company's push to cut costs through layoffs had contributed to its quality woes.

The report also said that J&J's officers and directors had not breached their fiduciary duties, and pledged to create a new regulatory compliance committee. In an email, a J&J spokesperson wrote, "The Company's management takes the shareholder concerns and criticisms very seriously."

Excessive pay
Weldon's compensation is a sore spot for J&J investors, and may be the primary source of their growing dissatisfaction with the board. The directors on the compensation committee last year -- which, in addition to Prince and Johns, included former Xerox (XRX) CEO Anne Mulcahy and former Wm. Wrigley Jr. CEO William Perez -- were particularly unpopular with voters. Prince, who famously walked away from Citigroup with about $100 million, is the compensation committee's chairman.

ISS told its clients to vote against the company's pay policy, citing a "lack of negative discretion on CEO's pay magnitude despite ongoing reputational challenges." Weldon took home $23.4 million last year, according to research firm Equilar, making him the 13th highest paid leader of a large company (he received a 3% bump in his base salary). J&J recently disclosed that Weldon is set to receive more than $140 million worth of benefits and deferred compensation when he retires.

In 2011 -- the first year that the Dodd-Frank Act mandated "Say-on-Pay" votes -- 39% of J&J's shareholders voted against its compensation plan. The company responded by changing its program, focusing more on performance-based pay. But representatives from the American Federation of State, County and Municipal Employees (AFSCME) say Weldon's pay package was still excessive. "To the executives at J&J who deal with executive compensation, the changes they made were monumental. For shareholders, they just weren't enough," says Lisa Lindsley, the union's director of capital strategies.

AFSCME has also lobbied the company to institute an independent chairman, a proposal that has won support from ISS. Weldon, who recently stepped down as CEO, intends to stay on as chairman. J&J has argued that he should maintain that role, writing in a filing, "Our Board believes that in the context of the upcoming transition to a new CEO, it will be in the best interests of the company to have our former CEO remain as Chairman and work closely with our new CEO to ensure a seamless transition of leadership."

Lindsley says J&J's board needs independent leadership. "When a former CEO is the chair, they tend to protect their protégés," she says. "We just don't think that Mr. Weldon should have anything to do with the company."

Wednesday, April 25, 2012

Cancer and my post op path testing

I don't have my tests back yet but I would like to clarify something.  My objective in the path testing is not prove that my cancer is related to the hip.  I don't think there is any test I can take to prove that.  I am interested in trying to eliminate the hip metals as being contributory to my current condition. The causative comes investigation comes later  if there is a later. That is different than trying to prove  that my cancer was  caused by the hip.  I have had a prior occurrence of cancer.  Did this metal stuff work somehow to surface this again?  Who knows.

I am going to pick up on my past  series on the Immune system because I think there is a clear link between stress to the immune system (perhaps from metals), cancer and the issues that are seen with the hip.  I don't know the order of these nor do I know which comes first but I will begin this immune perspective in the next week.
The tests I have embarked on are tests  that might indicate that we should explore this relationship (between the hip and cancer) further.  Why bother? Because I believe there are some really smart Research physicians in the medical community who have questions about this link between metals and cancer.  I have listed the publications of these studies in numerous prior posts.

The types of things I am looking for in the path tests:
  • Are there any metal nanoparticles contained in the tumors, of which I have a number of them?  We are only on my first biopsy.
  • Do the translocation tests show any abnormalities in the t(14,19) that have shown up previously to occur in metal on metal patients? [having this abnormalities does not  mean cancer is inevitable.]
  • Are the remainder of these so called tumors/growths etc actually cancerous or are they granulomas?
  • If this is a kidney cancer, why did it take the path of growth it did which is atypical of kidney cancer?
  • Why did these growths all become apparent after the revision when one year prior there was no evidence of any growths via the CT scans? stay tuned.....
On the research side, I continue to connect the links that others may see as co incidental.....more on this later.

Once I have the path finding from last Fridays surgery, I will have one more data point.  Will I prove anything by the time these tests are ready?  Absolutely not. 
Its just  hard for me to buy into a cancer recurrence when I hear things from the medical team like:
  • This is not a recurrence of the primary renal cell carcinoma.
  • The tumor path this has taken is not typical of any kind of renal cell carcinoma.
  • Something else must be at play given none of these tumors were there a year ago.
  • How did they grow so fast?
  • Why aren't you experiencing any symptoms?
I am one to believe there are no mysteries in medicine.  It's just that the science has not caught up with the occurrence of certain things to explain them.  Researchers have yet to tie the pieces of the puzzle together..."ye"t being the operative word.

What I have learned from dealing with this situation is that sadly, the physicians often times do not know what causes a cancer and the cause doesn't seem to be an issue.   Once the diagnosis is made, the treatment is already predetermined regardless of the cause.  I will never understand this.  It makes no sense to me that the cause doesn't inform treatment. It will never make sense to me.

Tuesday, April 24, 2012

Multi-District Litigation vs the state court (pluses and minuses)

[This is a brief summary of the down side of multi district litigation...written by the Hip Recall Alliance which appears to be a group of law firms  who do not take part in the MDL process.  There is another side to this story but this thier perspective on signing on to the MDL process.]

Multidistrict Litigation takes all similar DePuy hip recall cases currently in federal court throughout the United States and transfers them to a single federal court where they go through pre-trial proceedings and discovery at one time.

Discovery is when a patient's attorneys have the opportunity to force Johnson & Johnson to turn over documents. Discovery helps determine what the company knew about problems with the DePuy ASR and when they knew it.

After the MDL is complete, your case is sent to a different federal court for trial.
Official Court Seal of the U.S. Judicial Panel on Multidistrict LItigation

WHAT IS THE LARGEST AND LONGEST LASTING MDL?

The largest and longest lasting MDL was created in 1991 in the Eastern District of Pennsylvania to handle asbestos injury cases. Now, 20 years later, there are still thousands of these cases pending in that multidistrict litigation procedure.

WHY THE MDL IS BAD FOR YOUR CASE:

  1. Your case is taken away from your attorney and handed over to a committee of plaintiff's attorneys who you have never met and didn't hire.
  2. Your lawyer is cut out of the process until your case is returned from the MDL for trial. At that point your attorney has to try your case with only the evidence given to him/her by the MDL. Effectively, your lawyer looses control of your case.
  3. For DePuy ASR Recall patients, federal court is almost always NOT considered the best venue for a plaintiff's medical product liability case. Many states have more favorable procedures and laws for patients in medical product liability cases. For example, federal courts will often restrict your side's experts from testifying and even dismiss your product liability case altogether based on technical evidentiary rulings. That means sometimes your product liability case won't even go to trial. In contrast, state courts tend to allow juries of fellow citizens to decide cases

HOW MULTIDISTRICT LITIGATION (MDL) BENEFITS DEPUY:

  1. Large corporations such as DePuy Orthopaedics, Inc. and Johnson & Johnson prefer the MDL because they only have to defend a single case.
  2. Johnson & Johnson and DePuy Orthopaedics, Inc. can then devote their armies of lawyers to the single case.
  3. If the MDL judge rules that Johnson and Johnson can keep a document secret, it remains a secret.
  4. In contrast, if there are multiple state court cases, when one judge rules that Johnson & Johnson can hide a document, another judge will likely require them to produce it.

WHAT HAPPENS IF MY STATE COURT CASE IS SENT TO THE MDL?

The Hip Recall Alliance believes there is little downside to filing your case in state court. This is the venue that is in YOUR best interests, not DePuy's. If DePuy succeeds in forcing your case into the MDL after all, then you will proceed just like thousands of other hip recall patients going through mulitdistrict litigation. The Hip Recall Alliance fights for your rights against these huge corporations as aggressively as the law will allow.

[If there are any lawyers from the MDL committee reading this, feel free to provide a responce and I will publish it.]

Monday, April 23, 2012

First DePuy ASR Hip Recall Trial in U.S. Has Date Set for this December

[This is all interesting because I have wondered how the direct trials in state court will be dealt with vs the MDL trials in federal court.  There seems to be an argument for going either way.  Tomorrow I will post something on the perspective of going the State court route which is not through the MDL (multidistrict litigation route.) Honestly, I don't know which route is better should you decide to pursue litigation.  There are surely multiple approaches to this litigation.]

\(April 18, 2012 – Las Vegas, Nevada) -- A Nevada judge set the first trial date involving Johnson & Johnson subsidiary DePuy Orthopaedics, Inc.'s recalled ASR hip to begin December 3rd. The trial will take place in a Las Vegas, Nevada state court. The trial involves three patients with recalled DePuy ASR hip devices. All three patients have had their ASR hip implants removed and replaced. A Las Vegas judge and jury will decide the outcome of the case.

"This is the first DePuy ASR hip trial scheduled in the United States" says Brian Franciskato of the Nash & Franciskato Law Firm, "but if Johnson & Johnson continues to refuse to compensate patients, I have no doubt that there will be many, many more."

Representing the patients in the Nevada trial is an alliance of law firms including Maglio Christopher & Toale, P.A., the Nash & Franciskato Law Firm, and the law firm of White & Wetherall, LLP. "Getting this case to trial is one of the reasons that we fought DePuy so hard when they tried to force us into federal court," stated Altom Maglio of the Maglio Christopher & Toale, P.A. Law Firm. "If DePuy had succeeded in forcing this case into federal court, our clients would be stuck in limbo, with no possibility of getting justice for years."

In addition, the second DePuy ASR Hip trial in the U.S. has been set by a Maryland judge to begin the following month in January 2013. The Maryland trial is also on behalf of three patients with recalled DePuy ASR hip implants that had to be replaced. The Maryland patients are also represented by the Maglio Christopher & Toale, P.A. and Nash & Franciskato law firms. The January trial will be held in a Prince George County, Maryland state court.

The December Nevada trial is in the case of Rundle, et al. v. Precision Orthopaedics, Inc. and DePuy Orthopaedics, Inc., case number A-11-636272-C, in the Eighth Judicial District Court of the State of Nevada. The January Maryland trial is in the case of Jackson, et al. v. Chesapeake Orthopaedics, Inc. and DePuy Orthopaedics, Inc., case number CAL10-32147, in the Circuit Court of Prince George's County, Maryland.

Sunday, April 22, 2012

DePuy ASR recall takes $271M from J&J's Q1 bottom line

MassDevice staff
Litigation expenses and recall costs related to Johnson & Johnson's recall of the DePuy ASR hip implant cost the health care conglomerate $271 million in profits during the 1st quarter.
Shares of Johnson & Johnson (NYSE:JNJ) closed up a hair yesterday after the company said it added 12.5% to its bottom line, ending the day at $64.22 per share after the J&J raised its earnings guidance for the year by a pair of pennies.

The New Brunswick, N.J.-based health care conglomerate said costs associated with the recall of its DePuy ASR metal-on-metal hip implant and with litigating the 100s of personal injury lawsuits filed over the device slashed $271 million from its quarterly profits.

J&J posted profits of $3.91 billion, or $1.41 per share, on sales of $16.14 billion for the quarter, for essentially flat sales compared with profits of $3.48 billion, or $1.25 EPS, on sales of $16.17 billion during Q1 2011.

Saturday, April 21, 2012

Post Op surgery

Well, I am one day post op after removal of the first tumor located on my left ovary near the hip implant.  I got a preliminary path report today which was diagnosed as a cancer.  They don't know what kind of cancer yet but will be testing for that this week.

Just wanted to let you know.  Should be back hip blogging by tomorrow.

Thanks for your notes!

Connie

Thursday, April 19, 2012

Surgery on Friday 4/20/12

Hello fellow readers,

As you know from prior posts, on Friday, I will be undergoing my first surgery to determine the nature of these "tumors/Growths" that have appeared in the last 12 months. 

Since December, there has been lots of discussion about the nature of these growths.  There are at least 4 growths that the surgeons have targeted as unknown in nature and of concern to my medical team.

The objective of the surgery is to determine the nature of the least problematic of the growths (in terms of accessibility)  to either biopsy or removal of the lymph node/granuloma or organ.  The first growth is either on or near the ovary (could be a lymph node and not the ovary itself.)  The ambiguity arises because the first growth is located right near my hip prosthesis and it is difficult to make out the exact nature of it.  (The hip shines on the films so it  makes it difficult to read.)

The surgery, while not complex, will be done with the Divinci robot laproscopically.  It is an important surgery which hopefully will result in some indication as to what the pathology is of this "tumor" and also provide an indication of the nature of  the other growths.

As stated in prior posts on this issue, there are a wide range of possibilities which may include but are not limited to cancer ( 5 years ago, I had a cancer in situ removed in one of my kidney's) and or granulomas, the latter likely a result of the hip revision.  The surgeon who performed the nephrectomy does not think this is a recurrence of the renal cell carcinoma.  The GYN onclogist does not believe it is ovarian cancer.  A renal pathologist does not believe these growths have a path that is indicative of kidney cancer.  My research has resulted in the possibility of Granuloma formation as a result of the hip revision. 
I have discussed the the need to get some metal histochemical staining on the tissue which is removed and have requested the  T(14;18) translocation test via the FISH test (flourensence in situ hybridization)  which is the one possible test for looking at early DNA alterations which could possibly have resulted from the metals in the hip over time.  The latter test is one which has not been exposed to the hip population at large.  I am wondering if it should be in a research setting?

The literature suggests a long term gestation period for metal induced cancer.  I don't know but by nature, I question everything.  DNA alterations are not things that happen quickly.  Most of the medical literature concludes that changes such as these take years not months to come about.

I have no clue at this point whether any of these growths are related to this hip.  What I can say,  and has been mentioned in previous posts re this subject, is that none of these growths were present one year prior to their discovery in December of last year.  One month post revision, we became aware of the growths which of course, does not mean there is a connection between the growths and the revision.  Maybe its all coincidental?

I will certainly post whatever I can as soon as I can re this investigation and my findings .

My first post on this issue re my condition:

http://www.mydepuyhiprecall.com/2012/02/connies-status-with-her-investigation.html

Granulomas Redux...What are they again?

Seeking information.......Granulomas, histiocytosis, type IV immune response.... (part 1 of x in this series)

So what is the cause of these pseudotumors after the second revision? (part 2 of x in this series)

Granulomas, necrotic pseudotumors post revision.....what is the story on this? (part 3 of x)

Background on Type IV Immune response (part 4 of x)

Background on Type IV Immune response (part 5 of x)

Background on Type IV Immune response (part 6 of x)

Connie's status with her investigation into tumor type growths (7 of x)

Granuloma journal articles provided to my medical Team related to the hip (8 of 8)
Wish me luck! Thanks for all of your support.  It's important to me.

Connie

Wednesday, April 18, 2012

Johnson & Johnson reports profits of $3.8 billion despite expenses tied to hip device recall and litigation

 

[Isn't it interesting that out of all of the articles printed today on the Johnson and Johnson 4th quater earning, that this is the only one that headlined the Depuy Hip recall....]

(Johnson & Johnson reported first quarter earnings of $3.8 billion, excluding special items related to its hip device recall and expenses tied to litigation.)
Published: Tuesday, April 17, 2012, 8:17 AM Updated: Tuesday, April 17, 2012, 8:25 AM



Pathology Findings on Femoral Heads.......discovered post surgery.

I don't recall reading this last year. The study is interesting because it highlights the issue pointed out in the recent article widely published earlier this month on the lack of evidence in demonstrating a link between cancer and hip replacements 7 years post op.  Here is that link: 
http://www.mydepuyhiprecall.com/2012/04/risk-of-cancer-in-first-seven-years.html

Now, at the time I wrote the preface for that study, I noted a few things below.

A couple of things that should be noted:

-"hip patients are not routinely screened for cancer. It is likely that a targeted screening programme would identify more patients with cancer than were identified here." [ yes, I agree.]

- while this article mentions that the results should "reassure patients", I am not reassured at all. there is too much research that has set the stage for the cancer issue to be dismissed even in the short term.

-"patients who have undergone joint replacement have a higher than normal incidence of DNA damage to blood lymphocytes. In concentrations found in the blood after hip replacement, cobalt and chromium have the ability to signal across intact barriers in the body and cause irreversible DNA changes to cells on the other side of the barrier

 So why am I raising this again?  It is not the banking of femoral heads for the purpose of bone grafting  that was of interest to me but the following :

 Our findings indicate that, even with a detailed medical history and careful physical examination, clinically important diseases including neoplasms and Paget's disease are observed in patients diagnosed with osteoarthritis prior to total hip arthroplasty...105 of 6161 femoral heads demonstrated abnormal or reactive histopathological features not reported prior to surgery. A retrospective review of the histopathological findings was conducted to evaluate and reclassify all previous observations of abnormalities.  Nineteen patients had a suspected neoplasm. Of these nineteen, eight cases of non-Hodgkin's lymphoma or chronic lymphocytic leukemia and one case of myelodysplastic syndrome were confirmed on further investigation. One subsequently confirmed malignancy was detected per 770 femoral heads examined.

Histological examination plays an integral role in quality assurance in femoral head banking, and it also represents a possible early diagnostic test for bone and bone-marrow-related diseases in patients undergoing total hip arthroplasty


As the  article  above in the link pointed out,  hip patients are not routinely screened for cancer. It is likely that a targeted screening programme would identify more patients with cancer than were identified here." 


J Bone Joint Surg Am. 2011 Aug 17;93(16):1500-9.

Histopathology of femoral head donations: a retrospective review of 6161 cases.


Source

M508 Centre for Orthopaedic Research, School of Surgery, QEII Medical Centre, University of Western Australia, Nedlands, Western Australia 6009, Australia.

Abstract

BACKGROUND:

Although total hip arthroplasty is one of the most common orthopaedic surgical procedures, it remains unclear whether histopathological examination of the excised femoral head adds to the quality of patient care. We propose that assessment of femoral heads resected during total hip arthroplasty and donated for allograft use may provide a profile of femoral head pathology that benefits total hip arthroplasty patients and bone donors.

METHODS:

We retrospectively analyzed the histological findings reported for 6161 femoral heads donated for allograft use between 1993 and 2006. Specimens obtained during total hip arthroplasty and specimens donated at death were reviewed. Follow-up investigations that resulted from abnormal histopathological findings were also reviewed. The Western Australian Cancer Registry was used to determine whether patients with a suspected neoplasm were subsequently diagnosed with such a disease. A retrospective review of the histopathological findings was conducted to evaluate and reclassify all previous observations of abnormalities.

RESULTS:

One hundred and five femoral heads demonstrated abnormal or reactive histopathological features not reported prior to surgery and were rejected for allograft use. A reactive lymphocytic infiltrate, most likely due to osteoarthritis, was the most commonly identified feature (forty-five cases). Other features observed in twenty-seven cases were also most likely due to the presence of severe osteoarthritis. Ten femoral heads demonstrated plasmacytosis, which may have been related to osteoarthritis. Two patients were diagnosed with Paget's disease, and two, with rheumatoid arthritis. Nineteen patients had a suspected neoplasm. Of these nineteen, eight cases of non-Hodgkin's lymphoma or chronic lymphocytic leukemia and one case of myelodysplastic syndrome were confirmed on further investigation. One subsequently confirmed malignancy was detected per 770 femoral heads examined.

CONCLUSIONS:

Our findings indicate that, even with a detailed medical history and careful physical examination, clinically important diseases including neoplasms and Paget's disease are observed in patients diagnosed with osteoarthritis prior to total hip arthroplasty. Histological examination plays an integral role in quality assurance in femoral head banking, and it also represents a possible early diagnostic test for bone and bone-marrow-related diseases in patients undergoing total hip arthroplasty.

Tuesday, April 17, 2012

MRI imaging of the post op hip

I printed this article abstract because patients seem to continue to recieve sonograms do detect issues with the hip rather than MRI's.  This study reaffirms the need for patients to speak to thier physcians about getting MRIs pre op and post op follow up.  Further, there are different protocals for MRIs, most notably the MARS and the MAVRIC MRI.  you should ask your surgeon about the protocal being used.  I have a number of publications about the Mavric protocal on this blog.  It is a preffered method when examining MoM hips.

http://www.mydepuyhiprecall.com/2011/08/mri-after-arthroplasty-comparison-of.html


J Magn Reson Imaging. 2012 May;35(5):1013-25. doi: 10.1002/jmri.23523.

Magnetic resonance imaging of the postoperative hip.

Source

Department of Radiology and Imaging, Hospital for Special Surgery, New York, NY, USA.

Abstract

Magnetic resonance imaging (MRI) is ideally suited to imaging the patient with painful hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities, and lack of ionizing radiation. MRI is the most accurate imaging modality in the assessment of periprosthetic osteolysis and wear-induced synovitis, and can also assess regional tendons and neurovascular structures. This article discusses the technical aspects of MRI around metallic implants as well as the appearance of potential complications following hip arthroplasty, including osteolysis, wear-induced synovitis, infection, hemarthrosis, fracture, loosening, component displacement, heterotopic ossification, tendinopathy, and neurovascular impingement. The specific complication of metal hypersensitivity following metal-on-metal prostheses is reviewed. J. Magn. Reson. Imaging 2012;35:1013-1025. © 2012 Wiley Periodicals, Inc.

Sunday, April 15, 2012

Bellwether Trials For Hip Replacement Lawsuits In DePuy ASR MDL On Horizon

 Excerpts from Bernstein Liebhard LLP

On March 5, 2012, Judge Katz vacated a DePuy ASR MDL status conference scheduled for March 15, 2012.** According to the order, the conference was vacated because "discovery is proceeding apace which negates the necessity." In lieu of the meeting, Judge Katz held a telephonic status conference on March 15, 2012. Given that discovery is moving without delay, during the telephonic status conference, Judge Katz requested that lead counsel meet and confer to discuss the issue of bellwether trials for the initial group of hip replacement lawsuits. The purpose of "bellwether" trials is to try cases that are representative of plaintiffs' claims generally and to determine the strength of plaintiffs' claims and the extent of defendants' potential liability. Judge Katz ordered lead counsel to submit a joint proposal of competing bellwether trial selection protocols by April 27, 2012. In the interim, key witnesses in the DePuy ASR MDL continue to be deposed. 

The law suits keep on comming for J and J, the parent of Depuy.

Johnson & Johnson Fined $1.2 Billion for Drug Labeling Failure
Posted by Pratap Chatterjee on April 12th, 2012
CorpWatch Blog
Dicarded Risperdal Receipt. Photo: Mindful One. Used under Creative Commons license
Johnson & Johnson has been fined $1.2 billion over sales of Risperdal, an antipsychotic drug. Tim Fox, a circuit judge in Arkansas, ruled that the company has to pay $5,000 for each of the 240,000 prescriptions that were paid for by the state’s Medicaid program. (The program provides health care for low-income citizens, financed by the taxpayer)

Risperdal was introduced in 1994 by Janssen Pharmaceuticals Inc., a subsidiary of New Jersey-based Johnson & Johnson. It is prescribed for treatment of schizophrenia and short term episodes of bipolar disorder (manic depression) as well as irritability connected to autism in children.



In 2004 the U.S. Food and Drug Administration (FDA) forced the company to put labels on the drug to warn that Risperdal places elderly patients with dementia at an increased risk of strokes, seizures, major weight gain, possible diabetes and fatally high blood sugar, as well as potential death.

Fletch Trammell, a Houston lawyer acting on behalf of Arkansas, told jurors that the company had previously sent out a letter saying the drug did not increase the risk of developing diabetes. Tramell noted that some patients gained 60 to 100 pounds (27 to 45 kilos) in weight as a result of taking the medication, which in turn increased the risk of diabetes.

"The law is broken once they tell a lie," Trammell said. "You have to ring the bell. You have to tell the public.” He noted that patients in rural Arkansas were not able to get up to date information from specialists.

Jurors in the Arkansas trial were also told that the company avoided such labels because of the potential impact on its share price, which could have reached $200 million.

But Johnson & Johnson says that Arkansas has no grounds to sue them because it did not pull the drug at the time. “They didn’t run off and sound the alarm at the time this suit was filed,” James Simpson, a lawyer for the companies, told the jury. He says Arkansas should have told patients: “Whoa, whoa, whoa, this stuff is dangerous.”

Dozens of states have sued the company. Last year, Johnson & Johnson and Janssen was fined $327 million in South Carolina and in January, Texas settled a lawsuit against the company for $158 million.

The Arkansas fine is the biggest so far. “Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people,” said Arkansas attorney general Dustin McDaniel.

The company has said it will appeal. "Janssen firmly believes it did not violate the Arkansas Medicaid Fraud False Claims Act or the Arkansas consumer fraud statute. ... It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules," the company said in a statement.

Johnson & Johnson is also facing lawsuits over its hip-replacement technology. DePuy, a division of Johnson & Johnson, recalled 93,000 XL Acetabular metal-on-metal hips in August 2010 after experiencing a 13 percent failure rate. Some 5,000 product liability lawsuits have since been filed against the company. An FDA advisory panel of experts is to examine this issue in late June.

William Weldon, the company’s outgoing CEO, was confident that the company's finances will recover from the string of lawsuits because of their target audience. “Populations in the developed world are ageing rapidly, and we consume more healthcare as we grow older,” Weldon said. “Our investments continue to be aligned with these market opportunities.”

xxxxx

From Bloomberg

At upcomming Q1 release of financial results to investors in J&J, aAnalysts likely will ask about liability in continued litigation over allegations J&J marketed former blockbuster schizophrenia drug Risperdal too aggressively, including for unapproved uses. On Wednesday, an Arkansas judge fined J&J more than $1.1 billion for downplaying and concealing Risperdal risks such as major weight gain and developing diabetes. That ruling, which will be appealed, could affect dozens of pending lawsuits over the drug, many by states seeking reimbursement for what their Medicaid programs spent on the drug.

WHY IT MATTERS: While J&J has gotten past a spate of generic competition that slashed sales of blockbuster drugs for infections and attention deficit disorder, it continues to lose hundreds of millions of dollars a year due to manufacturing quality problems. About 30 product recalls since September 2009 -- for faulty hip implants and contact lenses, a couple of prescription drugs and Tylenol and many other nonprescription medicines -- have kept products off the market for as long as two years. J&J is operating under increased government oversight and was forced to gut and rebuild a huge factory.

Friday, April 13, 2012

Another Hip joint replacement recalled from a Subsidiary of Depuy

Fri, 13 Apr 2012 8:34p.m. (new Zealand channel 3 news)
A metal hip implant used in 41 New Zealanders is being recalled internationally after the device was found to have a high failure rate after three years, Medsafe says.

The primary cause of failure in the MITCH THR implant is loosening and movement in part of the hip joint replacement, Medsafe group manager Dr Stewart Jessamine says.

The international recall came after data found there have been higher-than-expected failure rates in the metal-on-metal hip device three years after implantation.

Three people in New Zealand have had surgery after the implant failed.

"As a result of the increased failure rates, patients who have this implant will need to be followed up annually for the life span of the implant," Dr Jessamine said.

"The recall does not mean that patients with the implant will necessarily require revision surgery."
The company which distributed the implant, Stryker, is asking surgeons to contact 41 patients in New Zealand who received the implant.

New Zealand Orthopaedic Association and New Zealand joint registry were also working to ensure people affected knew they needed further follow-ups and were given information.

Anyone concerned they may have the implant should contact their doctor or surgeon, Medsafe says.
The implant was used in New Zealand between 2006 and 2010.

It was manufactured by a UK company, Finsbury Orthopaedics Ltd, acquired by DePuy Orthopaedics in 2009.

DePuy, a division of Johnson and Johnson, recalled another hip implant in 2010, after tiny metal fragments were found to be breaking off the implant, leaking into the blood and poisoning it.
About 500 New Zealanders may have that implant and a group of them are taking legal action against the company, seeking compensation for pain, suffering and financial loss.

Thursday, April 12, 2012

Histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties

AS

J Clin Pathol. 2012 Mar 15. [Epub ahead of print]


Source


Department of Pathology, University hospital of North Tees and Hartlepool NHS Foundation Trust, UK.

Abstract


AimTo describe the histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties. The nature of aseptic lymphocytic vasculitis associated lesion (ALVAL) is investigated.Methods Periprosthetic soft tissues biopsied at time of revision from failed MoM hip arthroplasties from January 2007 to March 2011 were analysed. The inflammatory cell response was categorised into perivascular lymphocytic cuffing (ALVAL), lymphoid aggregate formation with or without germinal centres, metallosis characterised by sheets of macrophages with intracytoplasmic metallic debris and well-defined granulomas. Results123 patient samples were analysed, 36 males (29.2%) and 87 females (70.8%). Three cases showing complete tissue necrosis were excluded. Patients were reviewed between 3.27 to 69.6 months postarthroplasty, with an average of 30.92 months. 103 cases (85.8%) showed ALVAL, 18 cases also showed well-defined granulomas. Of the 103 cases with ALVAL, 60 cases also showed a diffuse chronic lymphocytic synovitis, and 40 cases showed lymphoid aggregates with germinal centres. 17 cases (14.2%) showed pure metallosis. Small vessels showing ALVAL expressed peripheral node addressin.ConclusionsARMD is a spectrum of changes comprising of pure metallosis, ALVAL and granulomatous inflammation. ALVAL, a distinctive inflammatory response seen in ARMD, is a precursor of lymphoid neogenesis. Lymphoid neogenesis documented in a variety of chronic inflammatory conditions most probably contributes to tissue necrosis and prosthetic failure seen in MoM hip arthroplasties. The role of vascular changes in contributing to necrosis is unclear at this stage.

xxxx

[15% showed Granulomas

85% showed AVAL (of those that showed AVAL)

  • 17 cases showed metallosis
  • 60 cases showed chronic lymphocytic sinovitis***
  • 40 cases showed lymphoid aggregates* with germinal centers**

*Lymphoid aggregates appear as slightly elevated nodules that may be normal in color or more red than the surrounding tissue. Sometimes they can look like small polyps. This is a harmless, non- cancerous condition.

**Germinal centers (or germinal centres; GC) are sites within lymph nodes (also within lymph nodules in peripheral lymph tissues) where mature B lymphocytes rapidly proliferate, differentiate, mutate their antibodies (through somatic hypermutation), and class switch their antibodies during a normal immune response to an infection.

***Synovitis is the medical term for inflammation of the synovial membrane. This membrane lines joints which possess cavities, known as synovial joints. The condition is usually painful, particularly when the joint is moved. The joint usually swells due to synovial fluid collection


Wednesday, April 11, 2012

Severe cobalt intoxication following hip replacement revision: Clinical features and outcome.

Clin Toxicol (Phila). 2012 Apr;50(4):262-5.

Source

Toxicological Information Centre, Department of Occupational Medicine, Charles University, Prague and General University Hospital , Czech Republic.

Abstract

Context. Cobalt intoxication has become more frequent due to the wide use of metal hip implants. Case details. A 56-year-old male patient underwent total hip prosthesis, with a ceramics-on-ceramics implant. Almost 3 years later, it was replaced by metal implant containing cobalt, chromium, and titanium. He developed weight loss, heart, thyroid, and neurological toxicity, with severe hearing loss. He was treated with 2,3-dimercaptopropane-1-sulfonate (DMPS), and cobalt excretion increased. Clinical symptoms apart from deafness gradually resolved. Conclusion. We report significant cobalt poisoning from a damaged hip replacement with cobalt containing implant and a slow abrasion of the metal by residual ceramic particles. Chelation therapy resulted in apparent benefit.

xxxxx

[Chelation therapy:  (medicine) the process of removing a heavy metal from the bloodstream by means of a chelate as in treating lead or mercury poisoning.

I was told that this therapy only helps after immediate exposure to Metals.  I can find only one other article in Pub Med where Chelation was used to remove either chromium or coblat from the blood stream as associated with hip replacments or revisions.  the other reference was with Cobalt in 1986.

Tuesday, April 10, 2012

What are the 6 reasons why Depuy may not reimburse your revision claim?

I saw this on a news broadcast that noted it was on the Depuy web site.  I see this no where on the Depuy web site.  Perhaps it was there once and removed?  Anyway, I don't get this list at all.  Maybe someone else understands the  nature of this list? 

Perhaps the readers can comment?

1.  The revision was not legally caused by the product at issue.

2.  Allergic Reaction

3.  Idiosyncratic reaction: 

(pharmacy, medicine) A reaction to a medication that is unusual and unpredictable, specific to a particular person. Unlike allergy, it can occur on first exposure to the medication, unlike a side effect, it affects only very few individuals.

4. Idiopathic reaction

Of, relating to, or designating a disease having no known cause.

5. Unforeseeable accident

6.  Preexisting condition

Anyone else get this?  comments?

Monday, April 9, 2012

Union Fights Hefty Compensation Pay For Exiting J&J CEO

Posted from Drug Watch

For the second consecutive year, a union is urging Johnson & Johnson shareholders to vote against an executive compensation proposal. At issue again is the pay for Chief Executive Officer Bill Weldon, who is expected to step down this month.

The American Federation of State, County and Municipal Employees, which owns about 20,000 Johnson & Johnson shares, says shareholders need to use their Say on Pay option to vote down compensation that is out of line with other executives’ pay — especially with all the trouble Johnson & Johnson faced during Weldon’s 10 years at the helm.

“The JNJ Board needs to get its hearing checked. After almost 40 percent of its shareholders voted against CEO pay last year, they are still not listening,” said AFSCME President Gerald W. McEntee.
Weldon’s total compensation in 2011 fell to $26.8 million from $28.7 million the previous year. This is largely due to the company’s struggles with recalls. Still, Weldon received a $3.1 million annual bonus for 2011, which is a 55 percent increase from 2010.

Johnson & Johnson has faced more than two dozen product recalls since September 2009, ranging from contaminated drugs to dangerously defective medical devices, such as the DePuy Orthpaedics’ hip implants and vaginal mesh implants. Most recently, the company recalled more than a half million bottles of infants’ Tylenol because of defective dosing system was too difficult to use.

AFSCME President Gerald McEntee
AFSCME President Gerald McEntee
And the problems that have plagued Johnson & Johnson under Weldon’s watch aren’t just recalls. The U.S. Food and Drug Administration (FDA) warned the company about false claims it made about its Listerine mouthwash in September 2010, saying it has not been proven to be effective in removing plaque or preventing gum disease. In April 2011, the SEC charged Johnson & Johnson with bribing doctors to prescribe its drugs and medical devices.

Consequently, consumer confidence has dropped and sales have suffered. The recalls have cost well over $1 billion in lost sales and triggered Senate and regulatory investigations.

“Bill Weldon does not deserve pay far above his peers after Johnson & Johnson’s reputation has been damaged and shareholder value destroyed on his watch,” said McEntee. “Excessive pay is a disease, and the prescription for investors is to just Vote No.”

Johnson & Johnson’s board defends its decision in a recent filing with the U.S Securities and Exchange Commission (SEC): “We significantly changed the architecture of the long-term incentive program – the largest component of compensation for our named executive officers; discontinued the use of cash-based long-term incentives that have been in place for over 60 years; and introduced Performance Share Units with payouts contingent on achievement of sales, earnings per share and total shareholder return goal.”

Shareholders will decide when they vote April 26.

Saturday, April 7, 2012

Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics

Just published.  This study was designed to look at the incidence of cancer during the first 7 years after MOM hips were implanted.  The results showed pretty much the same information as did the Swedish studies; not much activity in this short term.
 
The conclusion basically warns that this is only short term data and it is important that we study the longer term outcomes and continue to investigate this issue.
 
A couple of things that should be noted:
-"hip patients are not routinely screened for cancer.  It is likely that a targeted screening programme would identify more patients with cancer than were identified here."  [ yes, I agree.]
 
- while this article mentions that the results should "reassure patients", I am not reassured at all.  there is too much research that has set the stage for the cancer issue to be dismissed even in the short term.
 
-"patients who have undergone joint replacement have a higher than normal incidence of DNA damage to blood lymphocytes.  In concentrations found in the blood after hip replacement, cobalt and chromium have the ability to signal across intact barriers in the body and cause irreversible DNA changes to cells on the other side of the barrier."
 
If you want more information on this research, here are some links:  http://www.mydepuyhiprecall.com/2012/03/response-to-british-orthodpedic.html
 
 
 
 
BMJ 2012; 344 doi: 10.1136/bmj.e2383 (Published 3 April 2012)
Cite this as: BMJ 2012;344:e2383
 

Abstract

Objective To determine whether use of metal-on-metal bearing surfaces is associated with an increased risk of a diagnosis of cancer in the early years after total hip replacement and specifically with an increase in malignant melanoma and haematological, prostate, and renal tract cancers.

Design Linkage study with multivariable competing risks flexible parametric survival model to examine the incidence of new diagnoses of cancer in patients with metal-on-metal hip replacement compared with those with alternative bearings and to compare the observed incidence of diagnoses in patients undergoing hip replacement with that predicted by national incidence rates in the general population.

Setting National Joint Registry of England and Wales (NJR) linked to NHS hospital episode statistics data.

Participants 40 576 patients with hip replacement with metal-on-metal bearing surfaces and 248 995 with alternative bearings.

Main outcome measures Incidence of all cancers and incidence of malignant melanoma and prostate, renal tract, and haematological cancers.

Results The incidence of new diagnoses of cancer was low after hip replacement (1.25% at one year, 95% confidence interval 1.21% to 1.30%) and lower than that predicted from the age and sex matched normal population (1.65%, 1.60% to 1.70%). Compared with alternative bearings, there was no evidence that metal-on-metal bearing surfaces were associated with an increased risk of any cancer diagnosis in the seven years after surgery (mean follow-up of three years, 23% (n=67 361) of patients observed for five years or more). Similarly, there was no increase in the risk of malignant melanoma or haematological, prostate, and renal tract cancers. The adjusted five year incidence of all cancers for men aged 60 was 4.8% (4.4% to 5.3%) with resurfacing, 6.2% (5.7% to 6.7%) with stemmed metal-on-metal, and 6.7% (6.5% to 7.0%) for other bearing surfaces. Equivalent rates for women aged 60 were lower: 3.1% (2.8% to 3.4%) with resurfacing, 4.0% (3.7% to 4.3%) with stemmed metal-on-metal, and 4.4% (4.2% to 4.5%) with other bearings.

Conclusions These data are reassuring, but the findings are observational with short follow-up. The use of hospital episode statistics data might underestimate cancer diagnoses, and there is the possibility of confounding by indication. Furthermore, as some cancers have a long latency period it is important that we study the longer term outcomes and continue to investigate the effects of exposure to orthopaedic metals.

Thursday, April 5, 2012

Looking at blood, urine and plasma levels of Cr and Co metals post artheroplasty

Fascinating study of different ways to look at Chromium and cobalt levels.  The conclusion:  make sure when you are doing blood level readings that you are comparing apples and apples over time.  I noted sometimes I have received levels for three different things:
  • Blood levels
  • plasma levels
  • urine levels
As you can see in this study, you will get different results using these methods on the measurement of different metals which is why i look at all of them and compare all of them in a time series.  You can see my chart here:  http://www.mydepuyhiprecall.com/2012/03/chromium-and-cobalt-levels-4-months.html   (my recent levels were based on blood levels.  If you look at the urine levels, they look exceptionally high.)



J Orthop Res. 2012 Mar 23. doi: 10.1002/jor.22107. [Epub ahead of print]

Differential distribution of cobalt, chromium, and nickel between whole blood, plasma and urine in patients after metal-on-metal (mom) hip arthroplasty.

Source

Department of Clinical Biochemistry and Metabolic Medicine, Royal Liverpool University Hospital, University of Liverpool, Prescot Street, Liverpool L7 8XP, United Kingdom. a.w.newton@liverpool.ac.uk.

Abstract

Evidence shows that raised cobalt (Co), chromium (Cr), and nickel (Ni) whole blood concentrations correlate with poor device outcome in patients following metal-on-metal (MoM) hip arthroplasty. To understand the local and systemic pathological effects of these raised metal concentrations it is important to define their distribution between whole blood, plasma, and urine. The metals were measured by Inductively Coupled Plasma Mass Spectrometry (ICPMS). Two hundred and five plasma, 199 whole blood, and 24 sets of urine samples were analyzed from 202 patients with Cr-chromium alloy MoM hip prostheses implanted between 8 months to 12 years (mean 6.0 years) prior to analysis. Plasma Co (median 39.1 nmol/L) showed significantly positive 1:1 correlation with whole blood Co (median 45.9 nmol/L; R(2)  = 0.98, p < 0.001, slope = 1.0). Plasma Cr (median 53.8 nmol/L) and whole blood Cr (median 40.3 nmol/L) were also correlated; however, concentrations were significantly higher in plasma indicating relatively little blood cell uptake (R(2)  = 0.96, p < 0.001, slope = 1.6). Urinary Co was up to threefold higher than Cr (median 334.0 vs. 97.3 nmol/L respectively). Nickel concentrations in whole blood, plasma, and urine were low relative to Co and Cr. The analysis shows fundamental differences in the physiological handling of these metals: Co is distributed approximately equally between blood cells and plasma, whereas Cr is mainly in plasma, despite which, Cr had far less renal excretion than Co. © 2012 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res.