Wednesday, November 30, 2011

More litigation questions

From one of our readers:

"I  want to know why we need to pay 40 percent of the settlement to a lawyer. If depuy offers a settlement, why do we need a lawyer? Is there another option? "

Well, as you all know, I am not a lawyer but I will give you my thoughts on this.  In short, I don't know the answer to your question because I have not really concentrated on the litigation but here are my thoughts .

1.  Someone has to underwrite the expensive discovery and expert witness process that is required to even to get to settlement.  There can be no settlement if someone doesn't advocate a case right?  Someone deserves to be paid for that process.  Further, most plaintiff lawyers in these situations front the money to do that.  That is, there is no cost incurred unless they are successfully in getting a settlement for the patient.  It is fair in that case that someone should be compensated right?

2.  However unfortunate it might be, I find most of the litigation stuff focused on "What did Depuy know and when did they know it?"  Now, granted, this is an important question but my guess is that even in the best case whereby they prove that
  •  Depuy knew the problem. 
  • Depuy ignored the problem. 
  • Depuy  knowingly deceived the public blah blah, the most I have ever seen awarded for this type of hip case is a couple hundred thousand bucks if you got a revision.

3.  I think the more important issue is to work on the issue that involves potential long term systemic issues like cancer because that is going to be a costly undertaking for a patient if it happens and no patient should be left without a chair when the music stops.  So, in order to pursue this, I would pick a law firm who is focused on this in their case.  I have found such a firm in NY but want to have the tests that I think I need to address on the systemic (long term ) effects of the case before I take my case in if I choose to do that and am convinced that the systemic issues will be addressed.

4.  I know there has been at least one settlement whereby the hip company reached out to the patients directly for a settlement (presumably those who were unrepresented at the time of the offer).  My hunch is that without some knowledge of what your case is worth vs what you would be offered, it might be hard to settle this without an attorney.

5.  The other key consideration to be aware of is that you must file something with the court somehow in order to avoid the statue of limitations.  I am unsure as to how you do that without an attorney albeit, I am sure there is a way.

I suppose we can provide a private site through this blog with patients who can express interest in "going direct" to Depuy but I would have to look into this for you.  I personally can't be involved with anything that  discloses the names of any patients for any reason whatsoever.  I can check in on this and put a sign up on a password protected site which is confidential and if enough patients are interested in this, I can look into it and e-mail you directly but I have to think about this first.

My first focus is the systemic issues and testing.  The legal stuff is secondary to me at this point until I get the testing which I feel I need as baselines to deal with the potential systemic issues.  My second focus will be to pursue having  Depuy  allocate some funding to looking at the long term systemic effects of this issue.  This should be part of any litigation settlement and if the lawyers are not including this a settlement, shame on them.  It would be at the top of my settlement list since the studies on the long term systemic effects are few and far between but there are some really good nuggets to follow up on.

Now for Depuy's perspective.  I would think Depuy or any manufacturer involved in a case like this would prefer to settle directly.    I have noted that the suits filed to date are about 3500 or so but many law firms have not filed the suits they have.  There is a strategy involved as to what suit gets filed where and for what venue (MDL, one suit at a time...etc.)  If Depuy had to settle one case at a time, I think it would be too costly.  If they had some kind of negotiated settlement with a large group, likely a different story. 

Depuy has been exceptional to me (through Broadspire) in paying everything I have needed to have reimbursed.  I am not sure I would approach them as an adversary given the fact that they have answered most of my questions and have paid every bill I have submitted to them.  My concern is not being caught without a chair when the music stops re the long term systemic issues and funding studies on the long term systemic effects.  Pain and suffering is what most patients concentrate on.  Hey, for some patients, this revision process has been hell.  Some more than others and those patients deserve to be compensated accordingly so I am not pooh pooing a pain and suffering claim.  I am merely putting that claim into perspective. 

While I didn't answer your question, perhaps some of these thoughts might cause you to think about some additional items you may not have considered previously.

One other thing, when I began down this path, I was hell bent on finding a lawyer immediately.  I have not hired anyone yet because my objectives can't be articulated  without some additional testing to satisfy my sense that the systemic issues will be dealt with adequately.

Every state  seems to have different prices and every law firm within that state has different ways of viewing the underwritng of these cases so the idea that 40% of something goes to you is somewhat a misnomer. 

let us know what you think.

Tuesday, November 29, 2011

What does the wound of a revision surgery look like?

This is a photo of my surgical wound before the staples were removed.  Pretty picture hugh?  this revision was no fun.  I am looking forward to having this heal.  The incision was 9 inches vs my minimally invasive surgery 5 years ago of 2 short incisions on the front and back of my leg.  Big difference this time!

Monday, November 28, 2011

Preliminary observations on possible premalignant changes in bone marrow adjacent to worn total hip arthroplasty implants


I must have missed this journal article in my past research. Thought it was worth publishing. 
Clin Orthop Relat Res. 1996 Aug;(329 Suppl):S269-79.

Case CP, Langkamer VG, Howell RT, Webb J, Standen G, Palmer M, Kemp A, Learmonth ID.

Source

Department of Histopathology, University of Bristol, United Kingdom.

Abstract

Previous epidemiologic studies have suggested that there may be a risk of malignancy, especially lymphoma and leukemia, after joint replacement, but the followup has been relatively short. This is a preliminary study to see if there is any biologic basis for such a risk. Blood and bone marrow samples from 71 patients at revision arthroplasty of a loose or worn prosthesis and 30 control patients at primary arthroplasty were analyzed with cytogenetic techniques and molecular biology. There was a higher chromosomal aberration rate in cells adjacent to the prosthesis at revision surgery compared with iliac crest marrow from the same patients or with femoral bone marrow at primary arthroplasty. Clonal expansion of lymphocytes without a serum paraprotein was seen in 2 of 21 patients at revision arthroplasty performed more than 10 years after primary arthroplasty. The results of this preliminary study suggest that future epidemiologic studies should concentrate on patients with longer postoperative intervals to see if there is any risk that would be pertinent to a young patient at primary arthroplasty.

[note that they are using cytogenic techniques here...likely the FISH techniques I spoke about in the FISH series.   see this post series of 6 articles. this is the first in the series but you can just follow them through:  http://www.mydepuyhiprecall.com/2011/10/what-are-cytognic-labs-and-why-might.html  My investigation will be complete by mid December on these tests, where to get them and what the benefits and downsides are of the tests.

The other thing that is important in this article is note that  it was written in 1996.  Can you guess how much work has been done on investigating the long term systemic effects of these chemicals on our body?  Guess? 

Do you See how important funding  studies are in any legal settlement?  While money might be important for some, a couple of hundred thousand dollars isn't  gonna do any good if you have some long term systemic disease like cancer to deal with.  Funding these studies is very important.  It is critical that they get funded now.]

Sunday, November 27, 2011

Follow-Up for Asymptomatic Patients (directives from the FDA web site)

I can't believe these OLD  recommendations listed below  are still posted on the FDA web site.  Had I followed these directives, I would still have that toxic devise inside me.  This is the first time I have used the word "toxic" to describe the damage that resulted from this hip.  You can have a look at my post op report which I posted a few weeks ago. (just type in post op report in the search index box.)

In my opinion, this FDA regulation should be revised in light of the findings from the asymptomatic revision surgeries (of which there are likely few due to these mindless recommendations which are guiding surgeons away from appropriate testing)  and the study the "Silent soft tissue pathology is common with metal on meal hip athroplasty" which was published this year with the specific recommendation:

"We recommend that  with this implant should be closely follwed up and undergo routien metal artifact reduction screening."



These recommendations from the FDA below are causing patients to not be tested which is not consistent with the recent literature.  IN MY OPINION, EVERY SINGLE PATIENT WHO HAS THIS HIP SHOULD BE TESTED PERIODICALLY WITH BOTH THE MRI AND THE CHROMIUM AND COBALT TESTING.  Every single solitary patient who has this hip implanted should be tested periodically for the rest of their lives.

From the FDA web site:

Follow-up of asymptomatic metal-on-metal (MoM) patients should occur periodically.

  • Patients, including the following, are at risk for increased device wear and/or adverse reactions to metal debris and should be monitored closely:
    • Female patients
    • Patients with increased activity
    • Patients with malpositioned components
    • Patients with bilateral implants
    • Patients with evidence of renal insufficiency
  • Patient follow-up visits should include:  
    • Careful exam which includes a functional assessment
    • Physical examination for asymptomatic local swelling or masses
    • Careful review of systems for general health changes and evidence of systemic effects (particularly as pertains to the cardiovascular, neurological, and thyroid systems)
  • At this time, the utility of routine screening of asymptomatic patients using diagnostic soft tissue imaging and/or blood metal ion testing has not been established. Moreover, findings of lesions on soft tissue imaging, or of elevated blood metal ions, in the absence of symptoms, though reported in a limited number of research studies for some MoM hip implant patients, are difficult to interpret because:
    • The exact incidence or prevalence of asymptomatic lesions and their natural history is not known
    • The correlation between elevated blood metal ions and development of future local or systemic system adverse reactions is not well established
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/
MetalonMetalHipImplants/ucm241667.htm
[All I can say about these uninformed recomendations is that I hope the FDA comes to thier senses and make it manditory that all patients get tested with at least 2 tests for the rest of thier lives.  While I happen to be a research oriented patient, I would never have undergone this surgery.  Preeminent surgeons and researchers in the field had strongly recomended my revision regardless of the fact that I was asymptomatic once they reviewd my test results.  They were right.  They told me if I left that hip in, in no uncertain terms, the deterioration they saw would continue until it became painful and a revision would ultimately become a necissity.   I am sure no one expected the deterioration we actually found during the revision.

It seems that the FDA continues to maintain the position " wait and see"  until the hip deterorates and the surgery becomes more complex before we suggest doing any tests.  Frankly, I find thier position outrageous.
Where is Depuy in all of this?  Why are they not making a strong recomendation to Surgeons to have all of thier patients tested?  Is this an expense issue on thier part?  Remember Depuy:  The recent study "Silent soft tissue pathology" studied 75 patients. 27 of the 75 patients had MRI detected metal debris related abnormalities of which 5 were mild, 18 moderate and 4 severe.  8 of those hips were revised with a mean time post surgery of 31 months!!!  So what this says is that 8 revisions occured with asymptomaic patients of 75 examined after 3 years.  That is a 10% revision rate in 3 years with Asymptomatic patients!

I think this testing is so important.  Look at my results, I had a hole the size of a golf ball in my ilium that required a bone graft to fix it in addition to necrotic tissue and inflamation with fluid accumulation.  It all had to be cleaned out.

I have no idea what would have happened had I did nothing.  We all agree that the surgery would have been much more complex had I waited longer. 





Saturday, November 26, 2011

Another medical device company is suing DePuy for patent infringement!

Some of the excerpts taken from Rottenstein Law Web site

Boy oh boy, this seems like a comedy of errors!  If I understand this correctly (I may not), another hip manufacturer wants to be paid on the patent infringement of the devices that are under recall and litigation for one of the deffective parts used in part, in the recalled hips?  I am unsure as to what the duralock system is and what specific Depuy devise it is related to but whatever patent these guys infringed on, the idea of irreperable harm should be reserved first for the patients that may have been harmed.

Three Manufacturers Named as Defendants

The plaintiff in this case is Howmedica Osteonics Corp., a subsidiary of Stryker, Inc., another medical device manufacturer. It alleges that DePuy Orthopaedics, Wright Medical Technology, Inc., and Zimmer, Inc. infringed on its 2002 patent for an acetabular cup device that uses a dual-locking mechanism. NorthJersey.com has the story. The three devices that supposedly infringed on the patent are: Lineage and Dynasty systems (Wright); Continuum system (Zimmer); and the Pinnacle and Duraloc systems (DePuy). The Pinnacle is also a metal-on-metal hip replacement system, and it too is the subject of hip replacement lawsuits.

The lawsuits, filed in U.S. District Court in Newark, accuse the three companies of causing Howmedica "irreparable harm" by selling products that infringe on the Howmedica patent.
According to the lawsuits, Howmedica received the patent for the surgical device, a cup that fits into the pelvis and features a dual-locking mechanism, in 2002. This device allows doctors more flexibility in the parts that can be used in hip replacements, Howmedica said. After a reexamination, the validity of the patent was confirmed in 2010, Homedica said.

Howmedica asked the courts to bar the other companies from marketing any product that infringes the patent, as well as for monetary damages.

Julie Tracy, a spokeswoman for Wright, declined to comment on the lawsuit. DePuy representatives were not available for comment, and representatives for Zimmer did not respond to requests for comment.

Duraloc® Acetabular Cup System by Depuy (48mm-66mm)
The DURALOC® Acetabular Cup System was introduced in 1990. Fixation of the DURALOC® metal shell is achieved with POROCOAT® Porous Coating. The cup has a patented sensor locking ring mechanism, which automatically conforms to variations of the polyethylene in vivo; this provides congruency between the liner and the shell while locking the liner within the shell. http://www.depuy.com/healthcare-professionals/product-details/duraloc-acetabular-cup-system-48mm-66mm

Gee, this sounds quite like the liner that went into my Pinnacle.

The Duraloc 36 mm Acetabular Liner is made from

Marathon Cross-linked Polyethylene. Marathon

Cross-linked Polyethylene reduces wear by 86 percent,

resists oxidation and exceeds minimum American

Standards and Testing Methods (ASTM) mechanical

standards.
1, 2, 3 These benefits, combined with standard

minimum polyethylene thickness, provide a design

format to address use of a larger 36 mm femoral head.

Australian Senate Demands For Health Authorities To Act On Depuy

By: Katherine Russel

Johnson & Johnsons trouble with the DePuy Articular Surface Replacement (ASR) hip systems is not only raging in the United States but also in Australia wherein its Senate committee has demanded for the urgent action of its health authorities against the implant manufacturer. The Senate community affairs references committee described as intolerable and unacceptable the suffering that the hip implant has caused to hundreds of patients. Facing a number of lawsuits in connection to its implants high failure rate, DePuy is also being sued by its rival over hip implant design.

According to DePuy, 93,000 patients worldwide have received its ASR hip device. Of that number, 5,500 are Australians and many of them needed one or more revision surgeries. Patients fitted with the metal-on-metal hip implants also reported serious and systemic health problems extending beyond the initial complications caused by the device.

The Senate committee has described the issue as a ''ticking time bomb'' facing many patients. The Department of Health and Ageing have been told to prioritize alerting doctors, patients and the public about the issues associated with the DePuy devices as well as options for treatment and the reporting of adverse outcomes. The department was also urged by the committee to consider the best ways to monitor the levels of cobalt, chromium and other toxic metals which have been recorded in patients who received the metal-on-metal hip implants."

Independent Senator Nick Xenophon, who had called for the inquiry into the DePuy implants, said the issue highlighted major flaws in the way the Therapeutic Goods Administration (TGA) dealt with information detailing problems with the devices. The senator added that the TGA had not been receptive to concerns raised about the devices until December 2009, more than a year after the concerns had been raised. Patients had suffered from pain, multiple surgeries, extended hospital stays, financial loss and personal anguish, said committee chairwoman Greens Senator Rachel Siewert.

It had taken three years for the product to be recalled after evidence came out that the implants had a high failure rate back in 2006 as pointed out by orthopaedic expert Stephen Graves at a Senate committee hearing last September. Anthony Bishop, the Australian head of Johnson & Johnson, had expressed the companys regrets over the incident before the Senate committee last September. Johnson & Johnson reimbursed more than $21 million in claims to more than 3,500 patients in Australia who had registered with the company's claim processor.

According to Bishop, the company would not answer questions about its response to earlier advice of the product's failure and why it took so long to withdraw it due to legalities. The first country to withdraw the two DePuy hip implants is Australia back in December 2009. DePuy ASR lawsuit is not only rising in the United States but also in Australia after solicitors acting on behalf of people affected by the allegedly faulty hip implants filed an action against DePuy in the Federal Court last September seeking compensation for harm. Punitive Damages are also claimed by the claimants on the basis that DePuy, owned by the medical giant Johnson & Johnson, allowed the products to remain on the market despite sufficient evidence showing the devices were causing harm.


Read more: http://www.articlesnatch.com/Article/Australian-Senate-Demands-For-Health-Authorities-To-Act-On-Depuy-/3386510#ixzz1eow82XaP
Under Creative Commons License: Attribution No Derivatives

Friday, November 25, 2011

20 lawsuits filed daily against Depuy Orthopaedics

excerpts from KnupNet – The Health and Fitness Blog

Court documents showed that nearly 20 lawsuits are filed everyday against DePuy Orthopaedics Inc. and its mother company Johnson & Johnson over its Articular Surface Replacement (ASR) hip systems. The number of cases filed has already surpassed 2,600 and more is expected with an estimated 37,000 patients in the United States having received the devices before a worldwide recall was issued in August of 2010. In other countries, Johnson & Johnson has reimbursed thousands to Australians in recall claims.

Several lawsuits that have been filed were consolidated into a multidistrict litigation (MDL) under Judge David A. Katz of the U.S. District Court for the Northern District of Ohio who called for a status conference of the DePuy hip replacement lawsuit this month. The consolidated lawsuits alleged the following:

* That DePuy and Johnson & Johnson designed and sold a defective hip implant;
* That they failed to adequately warn both doctors and patients about the implants high failure rate;
* That they failed to inform the public that the implants put patients at an increased risk of metal poisoning caused by the cobalt and chromium particles which flake off from the device and accumulate in the soft tissue surrounding the implant area.

According to the report, there are approximately 3,500 pending ASR hip implant lawsuits following the DePuy hip replacement recall. Furthermore, Johnson & Johnson’s quarterly earnings report recorded $223 million in litigation expenses and additional DePuy ASR hip recall cost in the fiscal nine months of 2011.    

Thousands of Australian Recipients Reimbursed

excerpts from the Rottenstein Law Group posting

According to a WAtoday article titled, “Regulator Dithering Put Hundreds of Hip Patients at Risk,” the Australian government estimates that 5,570 people received a recalled DePuy hip replacement, and of them, 430 underwent revision procedures. That’s 7.7 percent of all recipients. More interestingly, it reports that J&J reimbursed more than 3,500 claimants with a total amount of $21 million Australian dollars. At the time of publication, that’s $21.6 million U.S. dollars, roughly the same amount. On a per capita basis, that’s around $6,000 each in either currency. Assumedly, those whose hip replacements were revised received a disproportionately greater reimbursement. It appears J&J has paid out money to around 62.8 percent of all its Australian recipients.

[I am not sure what this means though.  Does this mean that this payout was that which was used to cover the surgery and medical expenses or what?  Very small amont of money based on prior suits for what might be termed "pain and suffering."]

Thursday, November 24, 2011

Happy Thanksgiving to the readers of the Depuy hip Blog!

I had several invitations to Turkey dinner but I backed out at the last minute.  I couldn't figure out how I was going to use a low commode with no bars or handles to get off the commode!  Boy oh boy.  This was the first time in 58 years, I didn't have turkey with all of the fixens on Thanksgiving!

I had some friends drop by to take me outside for a walk as it was a beautiful day in Upstate NY today.

Hope your holiday was a good one!

Connie

FDA solicits feedback on an open web site re the Intsitute of Medicine report on the fast tracking of medical devices (501K process) for device approval

FORT WORTH (CBSDFW.COM)

A spokesperson with the FDA told CBS 11 News that the FDA is now considering all feedback on the IOM’s (Institute of Medicine)  recommendation in an open forum on the FDA’s website. The medical device makers and associations in favor of keeping the 510K rule in place argue that the 510K rule is needed because patients should not have to wait the normal five-to-ten years to get a product approved that has subtle differences to those on the market.

The depuy hip went through this approval process which of course they later recalled voluntarily.

The FDA is expected to make some decision regarding the status of this three-decade old procedure next year.

CLICK HERE to read the FDA’s public comments and an open forum on the IOM report.  There are about 50 comments from many in the medical community including insurance companies and medical groups.    The FDA commissioned this report from the IOM to comment on the overall approval process for allowing medical devices to come to market.  The IOM report came out with 8 recommendations for changing the system of approval which it seems, most concur with.

The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report.

More information can be found on a prior post here:  http://www.mydepuyhiprecall.com/2011/08/reivew-of-501k-clearance-process-at-35.html

Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years;” Request for Comments

http://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=FDA-2011-N-0556

Wednesday, November 23, 2011

Broadspire Redux

When I was in the hospital some of my fellow patients were told from their lawyers that Broadspire was trying to get them to postpone their surgeries, didn't want to reimburse some of them, didn't want them to take advantage of the physical therapy rehab.  Poppycock!

I know I have written before on how unusual all of these comments are especially in light of the fact that none of these patients have had any dealings whatsoever with Broadspire directly.  As I have said, if I were to grade the service I have personally have experienced with Broadspire,  I would give them an A+.  I have had numerous dealings with them directly.  In fact, in this revision which I had over the last few weeks, I had the opportunity yet again to see how responsive they are.

3 days following my surgery, I was uncomfortable going home without additional therapy given I live alone and was having a really difficult time moving around independently.  That hospital had a policy to ship all patients home on day 4.  Hospitals are all about payments.  The billing people told me I would have to underwrite the therapy if I were to transfer to the therapy wing.  Absurd.  I called my insurance company and Broadspire and within the hour, that stay was entirely covered because both companies worked together fast to get me into that transitional care unit for additional therapy so that I could function on my own.

I can't understand these negative  comments about broadspire.  They have been extremely responsive and couldn't do any more than they have to try and facilitate this revision process.

Frankly, the only complaints I hear are through lawyers who are continuously criticizing them for one thing or another.  Perhaps the patients should deal directly with Broadspire and experience thier service first hand.  I have never had one issue with reimbursement on any expense which I have submitted to them.  ZERO.

Keep up the good work Broadspire!  Nice Job and thank you for being so responsive to my needs in terms of making my revision process stress free in terms of the reimbursement and facilitating my testing and hospital stay.

If your lawyer is dealing with them and having difficulties, perhaps you should insist on dealing with them directly.  You do not need a lawyer to deal with Broadspire.  There is no presumption of non reimbursement with Broadspire.  They will do everything in their power to help you though this process and in my opinion, they have gone well beyond the call of duty.

Connie

Tuesday, November 22, 2011

Path report from my surgery 2 weeks ago

Hi guys,

Well, I can see the path report has provided no value add.  In order to have a meaningful path report, we have to ask for certain tests and the tests I would like to see  are NOT run  by most path labs.  Only the most sophisticated and specialized labs would have these tests.

No tests were completed on the hardware.  The only information on the report is:

-fragments of synovial and soft tissue with chronic inflammation. 
-Old Hemorrhage and Necrosis.  [how much necrosis? where?]
-No acute inflammation or malignancy identified. [This lab does not have the FISH tests which are the only tests that I am interested in as discussed previously.  Will have to contact Mayo Clinic and or Oxford for that.  I will report on those tests as I get the information.....I am looking for DNA baselines with our without abnormalities so I can measure this every 3 years or so.]

The two specimens submitted to the lab were:
-femoral head shell in two portions including the cup and ball
-synovum and capsule received in formalin as multiple pale yellow-tan to grey brown fragments of firm soft tissue all measuring in aggregate:  11.5 x 9 x 2 cm.

Will have to follow up with my surgeon on this but I do intend to aggressively pursue additional path tests as discussed in previous posts re the FISH testing.

The hip is being preserved for later processing. Make absolutely sure that all of the hip parts extracted from you during surgery are preserved by the lab.

Personally, I think the path reports are the most important part of this process but you have to have access to the right testing to make this process meaningful.

Make sure you ask for both the post op surgical report and the path report and then review the results with your surgeon in terms of what they mean.

Monday, November 21, 2011

DePuy Orthopaedics' International Sales Save 1.5% Decrease in US Sales

Written by Laura Miller | November 15, 2011
DePuy Orthopaedics experienced a 1.5 percent decrease in U.S. sales for the third quarter of 2011, according to a news release from DePuy's parent company, Johnson & Johnson.

The company reported $737 million in U.S. sales for the third quarter and approximately $1.4 billion in worldwide sales. Worldwide sales increased by 5.7 percent over the third quarter of last year. The 1.5 percent decrease in U.S. sales was offset by at 15.3 percent increase in international sales.

Johnson & Johnson's total expenses due to litigation matters was reported as $654 million during the third quarter, with additional costs of $109 million due to the recall of the DePuy ASR Hip, initiated in the summer of 2010. Johnson & Johnson also reported $214 million in costs associated with acquiring spine device company Synthes.

Progress from my revision sugery two weeks ago.

It has been 2 weeks since I had my surgery.  I was not able to come home until Friday of this past week.  I have a couple of observations.  By the way, I live alone.  If you have a companion, these activities might be a bit easier. :

1)  REVISION SURGERY IS NOT LIKE THE FIRST GO ROUND

2 weeks is not adequate time to plan for a recuperation from this type of surgery.  My plan was to be off for two weeks and based on my experience last time around, I was expecting to be back to work today.  Well, that is not going to happen.  While I can work from my computer at home intermittently, it was overly optimistic on my part to plan as I did. 

The PT told me yesterday that most of her hip patients are off 6 weeks from work!

2) Intensive PT work is required to recover from  properly

As mentioned previously, I was taking 3 sessions per day for over a week and that is not adequate.  Started on home care yesterday.  She took me out of the  house for a walk in the drive way and her observation was that "Connie, you are just beginning to recover from this surgery."

I am your classic Type A personality so I am ready for this recuperation to end.  I will not be back in the office this week.  I will have to continue out patient PT in order to recover from this operation, so says the PT.  Hopefully next Monday will be a better start date.

Don't let the hospital boot you out without appropriate course of PT.  I was told when I went in that I would be home in 3 days.  Well, perhaps superman could accommodate those goals but I found them to be completely unrealistic and dangerous in fact.   You can always request transfer to a rehab to prepare you for recovery  if you are unable to function.  NEVER AGREE TO BE SENT HOME WITHOUT YOU HAVING COMPLETE AND TOTAL CONFIDENCE IN YOUR ABILITY TO FUNCTION.  ITS TOO LATE ONCE YOU ARE HOME.

3) Driving/  it takes longer than last time to engage in driving

I am hoping to be driving (automatic car as my surgery was on my left leg) next Monday.  I sure hope that is not optimistic!  Of course you have to be off of all pain medications before you attempt that.  I discontinued all major narcotics as I choose to deal with the pain rather than sleep the days away from the drowsy side effects of the meds.  I found getting in and out of a car really hard this time around.

4) If you have no tools (fetcher, sock aid, hooks, sponges on a stick, raised commode etc) you will not be able to care for your self adequately.  Get the aids before you go home.  All of your normal everyday tasks are multiplied by a factor of 10 in terms of difficulty from the first surgery.  The aids help you stay within your hip protocols (no bending past 90 degrees is the most confining one.)

5) Pets: you will need an animal sitter for a while to feed them.  I just tried this morning to feed by 2 kitties and I spilled the food all over the floor.  There is no one around to clean it up.  I have to wait until someone gets here to help me.  Scraping out the Kitty litter becomes an issue.  My carpenter made me a tool with a long poll to do that.
Hope a few of these observations help some of you plan adequately for  your  revsion sugery.

Sunday, November 20, 2011

Question on Litigation settlement from our readers

 "I am curious if any of your readers have been through their revision and then settled with DePuy for some money without any legal help."  If anyone has any feedback on this, let us know.

Jeannie

Hi Jeannie,  I have written on this under the category on the landing page of the blog "litigation."  There have been settlements in prior recalls directly with the patients by the offending party but I am not sure what the circumstances were.

From various legal blogs I just searched/most of these are referring to out of court settlements through a lawyer rather than direct settlements made with the patient without a lawyer.:

(1)  Shay Morrigan | October 12th, 2011 | Posted in Depuy Hip Recall

Might a DePuy hip lawyer procure a settlement in MDL?

With so many people filing a DePuy ASR hip recall lawsuit, speculation has increased as to whether or not the orthopedics company may agree to out-of-court settlements before the cases start going to trial. Johnson & Johnson, parent company to DePuy, has already set aside millions to cover litigation costs, which may include settlements.

The first bellwether case in the DePuy ASR hip recall MDL has yet to be scheduled. An MDL has also been established in Texas for DePuy Pinnacle hip lawsuits.

(2) DePuy Hip Recall Settlement News

Richard Burke | May 24th, 2011 | Posted in Recent Settlements
 
As DePuy lawsuits mount in federal and state litigation, plaintiffs speculate about whether or not the orthopedic device manufacturer will soon offer a DePuy hip recall settlement.

So far, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, has only offered compensation to cover medical costs associated with treatment for problems caused by the defective ASR acetabular system.

(3) DePuy ASR Hip Replacement Recall Lawsuits  (Blizzard McCarthy)

What Should I Know Before I Have my Defective Implant Removed?
If you know that you have a defective DePuy hip replacement and are intending to have it replaced, there are two very important things to know before having the defective hip implant removed:
  • Don’t let yourself be intimidated by DePuy.*
    DePuy has been acting aggressively to protect its interests, approaching patients with recalled hip replacements and attempting to persuade them to forego lawsuits in exchange for payment of their medical expenses. DePuy is acting solely in their best interests, not yours. To protect yourself, do not speak with a DePuy representative without an attorney present.
xxxxxxx
*  I deal with the Broadspire  (depuy's claims agent  regularly and no one has ever approached me with any such offer.

(4)  Depuy Hip Recall blog Wednesday, June 29, 2011

Settlements have also been reached out of court, an ideal situation for defendant and plaintiff alike. When an out-of-court settlement is reached, defendants get to keep sensitive information like trade secrets under wraps, and the settlement amount is not disclosed. Plaintiffs get a speedy resolution to their case, while the money they win can help pay medical bills and lost wages on a more immediate basis.

xxxxx

I know there is a case whereby the orthopedics company went directly to the patients. I think I have written about it but I can't recall the case.  If you go to this link  :  http://www.mydepuyhiprecall.com/2011/09/other-hip-recalls-in-2008-stryker.html, you can see the 6 prior cases which I have published about.

I myself have asked the question many times about whether it is best to retain a law firm or just go direct.  I don't know the answer.

Anyone who has insight into this question, please let us know.

Connie

Thursday, November 17, 2011

Just passed our one year Anniversary For the MYDEPUYHIPRECALL Blog!

Thought it was note worthy to mention this as we have developed a pretty active community of readers at this point.

Just wanted to thank all of the readers for your contributions.  Blogs are communities that consist of both the writer or poster of the blog and the readers who review the content and then post their comments.  Blogs only work as communities and this one is pretty active for this small niche market sector.

Here are some stats on the blog as of our anniversary this month:
  • Pageviews
    • Nov 14th 2010-first blog posted by me.
    • Jan of 2011 crossed the 1000 page views* per month
    • April of 2011 crossed the 2000 page views per month
    • July of 2011 crossed the 3000 page views per month
    • We might hit 4000 page views per month in November
  • The average time a visitor spends on site is about 2.5 minutes. (large standard deviation though so the time range is quite varied.)
  • 40-50% of our visitors are repeat visitors
  • A preponderance of readers are from the US however, we have a strong readership in Australia and the UK (countries who have been very involved early on in the Depuy hip issues.)
  • Most of our traffic comes from Google through organic search although we do see traffic from  Yahoo, Bing and Blogger.com.  Some from Twitter as I do automatically post on Twitter.
  • 60% of our readers come to the site via IE  browsers (Internet Explorer) and about 20% come Firefox browsers.
  • 80% of our readers are using windows operating system and 20% are using apple.
  • We have had over 100 comments posted by readers
  • I have posted about 334 times since we started so averaging about 1 per day.
  • On average a reader views about 2 pages per visit so the implication of that is that we have about 2000 visitors per month reading this blog.

 *A page view is the number of posts (pages) viewed cumulatively by our readers each month.

Wednesday, November 16, 2011

DePuy ASR Metal Hips: Tip of the Iceberg?

exerpts

Posted by Shezad Malik MD JD November 12, 2011 11:05 AM

There is an average of 20 new cases filed daily in the federal multidistrict litigation, In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation ("MDL No. 2197").

There are approximately 2,600 cases currently pending in the DePuy ASR MDL, in the U.S. District Court for the Northern District of Ohio. The Judicial Panel for Multi-District Litigation consolidated all federal cases arising from the DePuy ASR recall in December 2010.

There are over 1,000 related ASR hip cases pending in state courts. 37,000 Americans received the recalled ASR hip implants, and we predict that this litigation is likely to continue.

The U.S. Food and Drug Administration ("FDA") has received more than 5,000 complaints since January about metal-on-metal hip implants. According to the EDA, 75 percent of those complaints involved the recalled ASR XL Acetabular System and the ASR Hip Resurfacing System


Discovery Progressing In Federal ASR Hip Replacement Lawsuits

Given that the DePuy ASR MDL is not yet even a year old, and the rate at which new lawsuits are being filed, plaintiffs leading the litigation are devoting substantial time and resources in order to efficiently manage these lawsuits. For instance, discovery forms have been negotiated and standardized; protocol for the production and review of electronically-stored information has been established; experts have been retained; and depositions have begun.

Silent soft tissue pathology is common with a modern metal-on-metal hip arthroplasty.

I mentioned that I would reprint this journal article as my revision surgery is an exemplar case to illustrate  the issues and outcomes with metal on metal  patients who have no pain.  I had a revision based in part on the soft tissue damage identified by the MRI.  The post op report, certainly confirmed that I needed this operation for several reasons:
  • A hole the size of a golf ball was found in the ilium that was fixed with a bone graft.
    • "large cavetry leison" found  on my ilium and this defect was contained.
  • Significant amount of inflammatory fluid within the hip joint
    • all evacuated
  • Diffuse, hypertrophic, synovitic reaction within the joint itself
    • this was thoroughly debrided (cleansed.) 
There have been a number of reports in the literature describing  inflammatory masses around painful MoM atheroplasties that can  be grouped under a variety of headings such as:
  • ayseptic lymphocytic-dominated vasculitis (ALVAL)
  • pseudotumors
  • adverse reaction to metal debris (ARMD)

Although these "lesions" have been previously described in patients investigated for pain, there have been no studies of these lesions in unselectected series of patients including those with no or few symptoms as is the case with me.  "It is not known whether these lesions may occur in the absence of symptoms."

This study which was just undertaken early this year, confirms that these things can occur without pain symptoms and I believe my results confirm their observations as well.  I had no pain prior to surgery which might have served as a warning sign to the presence of these underlying issues.

I have not received the tissue path reports yet but I will get them soon. (It is like pulling teeth to get op reports in the hospital.  You must be very persistent.  I get the sense that these reports are guarded in some kind of shroud of secrecy.  No one should have an operation without reading the post op report.  Why would you pay thousands of dollars for an operation with no documentation on what was done????  Kinda crazy if you think about it.  Ditto for the path report.  These are your reports and by law, you are entitled to read them.)
Acta Orthop. 2011 Jun;82(3):301-7. Epub 2011 Apr 19.

Source

The Centre for Hip Surgery, Wrightington Hospital, Lancashire, UK. hwj@doctors.net.uk

Abstract

BACKGROUND AND PURPOSE:

Adverse reactions to metal debris have been reported to be a cause of pain in metal-on-metal hip arthroplasty. We assessed the incidence of both symptomatic and asymptomatic adverse reactions in a consecutive series of patients with a modern large-head metal-on-metal hip arthroplasty.

METHODS:

We studied the early clinical results and results of routine metal artifact-reduction MRI screening in a series of 79 large-head metal-on-metal hip arthroplasties (ASR; DePuy, Leeds, UK) in 68 patients. 75 hips were MRI scanned at mean 31 (12-52) months after surgery.

RESULTS:

27 of 75 hips had MRI-detected metal debris-related abnormalities, of which 5 were mild, 18 moderate, and 4 severe. 8 of these hips have been revised, 6 of which were revised for an adverse reaction to metal debris, diagnosed preoperatively with MRI and confirmed histologically. The mean Oxford hip score (OHS) for the whole cohort was 21. It was mean 23 for patients with no MRI-based evidence of adverse reactions and 19 for those with adverse reactions detected by MRI. 6 of 12 patients with a best possible OHS of 12 had MRI-based evidence of an adverse reaction. [12= best score and 60 is the worst score.]

INTERPRETATION:

We have found a high early revision rate with a modern, large-head metal-on-metal hip arthroplasty. MRI-detected adverse reactions to metal debris was common and often clinically "silent". We recommend that patients with this implant should be closely followed up and undergo routine metal artifact-reduction MRI screening.

Additional information from this study found in the discussion section  of the paper:

(1) "One of the most concerning findings in this was that MRI based evidence of an adverse reaction to metal debris does not appear to correlate with symptoms. 

(2) In fact, some of the highest levels of patient  satisfaction were in those patients with the worst MRI/MAR findings.

(3) One quarter of the patients with the best OHS (12) had MRI based evidence of ARMD.

(4) This suggests that even a policy of frequent clinical reviews would not detect patients developing soft tissue complications until extensive damage had occurred.

(5) It is unclear why there is no pain.

(6) We believe it is preferable to detect ARMD soft tissue damage and fluid filled cavities at an early stage before the damage becomes extensive and irreversible.

I will continue to address the  potential serious  nature of ignoring early testing with MoM implants even if there is no pain present.

Remember the title of this study which was just published this year:  "Silent Soft Tissue Pathology is common with modern metal-on-metal implants". 



Tuesday, November 15, 2011

Follow up with my ortho Surgeon this morning from revision last Monday

Sorry guys but not quite up to being able to publish everyday yet.  Very rigorous schedule in the hospital rehab which consists of at least three- 45 minute sessions per day at the rehab unit.  I am not quite ready to be released but do anticipate being released by Friday at the latest.

Wound is still oozing so staples can't come out quite yet.  I understand the time frame to remove them is 10-14 days poat surgery.

I asked the surgeon about this "large cavitary lesion involving the dome of the acetablulum"  which he wrote about in my  post op reports (and I posted on yesterday) and he said it was kinda hard to picture but if you conceptualized a hole the size of a golf ball in the ilium caused  by the metal, that would be a good representation of this issue.  He said he had another revision yesterday where there were no lesions but the joint had become loose.  (I think they said they conduct only one revision per week here in this hospital out of the 30-50 joint replacements-including knees they do each week.)
The thing that still amazes me is that this happened with not one stitch of  pain!  Also, I noted that even  with the resolution of the Mavrik MRI  protocol, this hole wasn't picked up.  So the most sophisticated scan didn't find this large hole.  I had one of the most renowned Radiologist run my scans. Very interesting what you can and can't see on these scans.

It is always a combination of test results that will lead your surgeon to make a recommendation to revise.  There is no one piece of information that the decision to revise should be based on.  Our decision to revise was based on (1)  the very high metal levels,  (2) the preliminary MRIs that showed some soft tissue damage developing and (3)  a very, very strong opinion to "revise this hip now" by one of my leading 2nd opinion consults who has studied this issue and published extensively on it over the years.  His opinion  was that it (damage shown in the MRI) would only get worse.

This is why you can't rely on pain as a primary indicator for  some kind of problem developing with these metal on metal hips.  Just get tested if you have one of these metal on metal implants.  I love this
Nike (sneaker)  quote "just do it."!!
One final note, I asked my surgeon this morning about the path reports he ordered.   (Results not contained in the post op report.)  Those should be in today. I will report on those in a subsequent post once I have them.  I also pointed out one error to him in the post op report which he agreed was an error.  He had stated that "patient presents with significant left hip pain."  He immediately agreed this was a mistake and he would dictate and addendum to the op report that this get amended. He mentioned that initial op reports can not be changed.  Only addendums added.

I would assume that is still very rare for a surgeon to be conducting a revision on an a patient asymptomatic of pain.

 I have a tremendous amount of confidence in my surgeon. Other than the fact that  I think he is really bright and has a stellar surgical record in the community, he tells me immediately when he doesn't know something. He is also open to exploring new ideas and approaches to reviewing the implications of this problem.   He did his studies at Columbia and Penn.  His undergraduate was in genetics so he is a perfect person to work with in my forthcoming studies on measuring  the effects of the chemicals on your DNA long term...establishing baselines and following them over time.  I will be sharing those investigations with you as they progress.

Feeling much, much better today so hope to back to my daily posts.

Connie

Saturday, November 12, 2011

Preliminary Post Op Report for Connie

Hello my friends.  I so appreciated your kind notes.  Thank you from the bottom of my heart.

Who would  project that I would be down for 4 days with the surgery but it is what it is. Summary of  my post op reports follow.  BTW/ always request a copy of the post op report. It is a detail overview of what happened in the surgery authored by your surgeon.  You should review it with your surgeon.  If you have not done so, make an appointment to do it.

My revision surgery took place on Monday Nov 7th and ran for about 1.5 hours.

Overall Reaction to the revision vs the initial implant:
  •  My first reaction to this surgery is that it was much more involved than I anticipated.  In the first surgery, there were several  things that stood out:
    •  minimally invasive surgery which involved only 2 incisions of about 2-3 inches each.  One on the front of the thigh and one on the rear buttocks
    • minimal pain medications which I discontinued in a few days.
    •  only a few days in the hospital
    • 5 days of rehab to learn to cope with the restrictions post hip 
    • up on my computer 2 days after surgery
    • no real  pain post surgery
    • up and walking the day following surgery
    • working from home full time in the second week
    • back to work and driving in 2 weeks
  • The revision:
    • large incision (10 inches or more I would guess-haven't measured it.)
    • Remain on continuous pain meds for the last 4 days...lots of trial and error on that...Dilauded (hydromorphone), Tramidol (opiate), Perkocet (oxycodine.)  I have found it very difficult to get some kind of balance between  pain reduction while maintaining some ability to  partake in physical therapy. 
    • I was just  transferred out of the hospital on wed  to the rehab center.  Not sure how long I will be here. You can be sure I will be out of here as fast as I can be.
    • Large incision resulted in  daily  bandage changing with an oozing wound....Amazing to me that someone has not invented a tape that can be used in wound care that enables painless bandage changes. 
    • Staples will not be removed for 10 days.  Appears I may have 30 or 40..... so says the PA.
    • Friday is the first day I  spent  on my computer.
    • Undergoing 3 PT sessions per day to work my way out of this thing. 
    • Thursday is really the first day that I have been functioning with  partially assisted  (vs fully assisted )for activities such as  bathing, clothing, using a bathroom. Prior to this day, I required fully assisted support staff to do most anything. 
    • considerable swelling in my feet and on the wound
    • lots of water retention.
    • sick (vomiting) for a few days post surgery.
Operative findings for an asymptomatic patient (no pain presenting prior to surgery):  I have included most of the information but have not investigated the implications thereof.

Questions in Red:
  • significant amount of inflammatory fluid within the hip joint
    • all evacuated  (Why?)
  • diffuse, hypertrophic*, synovitic reaction* within the joint itself
    • this was thoroughly debrided (cleansed.)  (Why?)
[definitions added by Connie
Hypertrophy*  is the increase in the volume of an organ or tissue due to the enlargement of its component cells
 *synovial joint


Typical Joint
A Synovial joint, also known as a diarthrosis, is the most common and most movable type of joint in the body of a mammal. As with most other joints, synovial joints achieve movement at the point of contact of the articulating bones.

Structural and functional differences distinguish synovial joints from cartilaginous joints (synchondroses and symphyses) and fibrous joints (Sutures, gomphoses, and syndesmoses). The main structural differences between synovial and fibrous joints are the existence of capsules surrounding the articulating surfaces of a synovial joint and the presence of lubricating synovial fluid within those capsules (synovial cavities).

Synovial membrane (or synovium)[1] is the soft tissue found between the articular capsule (joint capsule) and the joint cavity of synovial joints. [2]
The word "synovium" is related to the word "synovia" (synovial fluid), which is the clear, viscid, lubricating fluid secreted by synovial membranes. The word "synvovia" or "sinovia" was coined by Paracelsus,[3] and may have been derived from the Greek word "syn" ("with") and the Latin word "ovum" ("egg") because the synovial fluid in joints that have a cavity between the bearing surfaces is similar to egg white.]


  • Some metallic staining in the soft tissues (What are implications of this?)
  • capsular, ligament and muscular attachments around the hip were all in good condition [interesting given the MRI showed something else.] This was thoroughly debrided (cleansed.)  Why if everything was fine? 
  • Acetabular implant itself was removed without difficulty
    • There was a very large cavitary leison involving the dome of the acetablum extending somewhat into the anterior and posterior column.
    • the defect was entirely contained  (What is the implication of all of this?)
  • The columns remained intact along with the remainder of the acetabular anatomy.
  • The femoral component was assessed and found to be in good position and was very stable within the bone.
  • Reconstruction was accomplished with a  Pinnacle size 60MM acetabular component screwed with 2 screws to the ilium, a 36 mm Pinnacle marathon acetabular liner, 36 mm femoral head with 8.5 neck length [ceramic I presume since that is what we discussed].
    • The acetabular defect described above was grafted (bone graph) with deminarlized bone matrix. (it was noted that the patient tolerated this proceedure well.) (What is the issue with this?  seems like there was a question about the ability to tolerate this....why?)
Points in the description of the Operation:
  • The acetabular component was removed without bone loss (good news) and was stable.
  • There was a large cavitary leision involving the dome of the acetablulum and extending aneriorly and posteriorly.  The defect was entirely contained and was debrinded of all osteolytic dbirs down to a bleeding bone surface throughout.
  • Following this, the acetabular bed was then reamed.
  • Special note was made of the trunion as I requested he review this based on the MRI observations.  The trunion was in good condition with minimal  corrosive changes. (So I gather there was corrosion but it was not enough to necessitate changing out  the full femur?)
Missing: 
  • What labs were sent to  pathology?  Surgeon likely ordered some tissue biopsies and I would like  to see the lab results on all of them.
 I have no idea what all of this means just yet (need to reveiw with my surgeon), but my sense is that it is a great case study for asymptomatic patients.  This case should demonstrate that if you are a party to a hip recall, get tested even if you are exhibiting no pain.   Why?  You have no basis upon which to make a decision to not act  without the base tests. The three tests to discuss with your orthopedic surgeon:
  • Chromium and cobalt levels
  • Soft tissue scan  (ultra sound)
  • MRI conducted by a skilled orthopedic radiologist.  No, a normal MRI is not sufficient.  If you want more information on these procedures, type the words into the search box on the blog and it will take you to these topics reviewed in various posts.
The most important issue is the long term effect of these chemicals in your body.  This blog will continue until two things have happened:
  •  The medical equipment manufactures involved with these hip recalls (voluntary or ordered by FDA)  have been directed  (by court settlement) to set aside adequate dollars to fund research into the long term systemic effects of these chemicals.
  •  Adequate information is disseminated by the manufacturer to the orthopedic surgeons changing the standards which have been set for requiring patient testing.  Let's see, there are 93,000 insertions world wide.  Expensive testing?  Yes!  Necessary in order to determine the levels of silent pathologies?  You Betcha!
Short of that, this blog has just started. I will be reviewing the following in the next few posts now with a new perspective:

1) The key points in the journal article: SILENT soft tissue pathology is common with modern metal atheroplasty. 

2) Re-review the current standards for testing .  Early detection should be strongly encouraged by Depuy, FDA and every medical organization associated with these chemicals. 

3)  The outlook  for progressive deterioration if the silent pathology is not addressed.  Patients who have these hips and are walking around with potential time bombs in thier bodies for which they are unawareof any potential consequences due to the nature of the announcements that were sent out to the patients re the recall.

What percent of patients need to be tested ?  Who knows?  The oversease countries who have quite a bit more experience  with this feel that 50% of these hips will become problematic.  If you had a one in two chance of encountering this type of pathology in your hip, do you think the odds are good to run these tests for which I see ....no downside.

Will resume with the "testing" posts as soon as I complete these next few posts.  sorry that line of thought was disrupted.

    Monday, November 7, 2011

    My revsion surgery is scheduled today

    Hi Fellow  patients,

    I will be off line for a few days (presumably) for my revision.  Should be back up by wed.

    Thanks for your well wishes.

    connie

    Saturday, November 5, 2011

    California Technology Assessment Forum (CTAF) Requested to Reveiw Evidence for MoM resurfacing systems

    CTAF was requested to review evidence for metal on metal hip resurfacing as an alternative to total hip replacement. Below are excerpts from that report

    • In the 50's, the concept of resurfacing the arthritic socket as well as the femoral head emerged but the materials used (first Teflon and then acrylic cement) and the design flaws led to numerous device failures and adverse events.
    •  The third generation of hip resurfacing emerged in the 90's in England and while there are 10 different commercially available hip resurfacing systems [one of them by depuy- but not approved in the US for sale] only three are approved by the FDA:
      • Cormet
      • Conserve plus
      • Birmingham
    • All three use a metal on metal Chromium-cobalt articulation
    • The potential advantages of resurfacing over total hip replacement is that it preserves the femoral head and only replaces the joint. Thus it can be a less complex surgery.
    • In 2007, CTAF concluded that all peer reviewed literature had not kept pace with the changes in hip resurfacing technology.  That is, there were no randomized controls.
    • The 2010 assessment was conducted to review the peer-reviewed literature on the 3 FDA approved MoM approved systems.
    • In August 2010, Depuy issued a voluntary recall of their ASR hip resurfacing system as they were undergoing clinical trials in the US.
    • There were 5 criteria judged by the committee to be required to provide assurances of safety of these systems:
      • technology must have final approval from the appropriate govt regulatory bodies. 
        • All 3  systems passed the FDA that were being actively being marketed.
      • Scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes.
        • All three systems passed this criterion
      • Technology must improve health outcomes
        • Most of the studies and tests conducted found no difference in patient outcome and substantially more revisions.
        • Although resurfacing has some benefits for younger patients, the risks are higher revision rates and elevated MoM levels are of concern.
        • Test Criteria 3 was not met
      • Technology must be as beneficial as any established alternatives
        • Because the 3rd criteria was not met, the 4th criteria cannot be met since the primary alternative is total hip replacement and there have been no significant studies to demonstrate this procedure works as well.
      • The improvement must be attainable outside of the investigational setting.
        • Since criterion 3 and 4 were not met, the 5th criteria can't be met.
    So the big conclusion is that "It is not possible to conclude from the current peer reviewed literature that the currently approved hip resurfacing systems in the US improve health outcomes comparably with the current standard of care, total hip replacement.  Further, the report concluded that the current metal on metal on metal resurfacing systems on the market which have been approved by the FDA do not meet 3 of the 5 criteria for safety and improvement in health outcomes for patients as an alternative to hip replacement therapy.

    Thursday, November 3, 2011

    Complaints of Adverse Events Skyrocket For Pinnacle Hip Implant

     

    I reprinted this in response to the blog post yesterday as it is an updated chart of the FDA complaints.  I like to present the other side of this story.  You would think I would be panicked by this given my surgeon chose the Pinnacle for my revision on monday.  REMEMBER, it is my belief and my surgeon's belief that these complaints are likely related to the metal on metal Pinnacle hip.

    It would be great if Depuy would come out and confirm or deny this.  In my surgery, we will be using one which has the following configuration:

    • titanium head
    • poly liner
    • ceramic ball.
    Nevertheless, I think it is important to know this data.  Likely there are many patients out there with the metal on metal Pinnacle.  Also, these comments below are not ones which I agree with but it is fair game  to acknowledge that there may be other opinions!

    by Brian Devine on October 9, 2011
    Our office just finished reviewing updated complaint data reported by the FDA about the DePuy Pinnacle hip implant. The results continue to alarm us. Based on complaint data reported through September 24, 2011, it is clear that that complaints about the Pinnacle hip implant are increasing rapidly.

    Over 700 adverse event reports were filed with the FDA in just the last three months (July-September 2011.) This compares to 556 adverse event reports that were filed in the previous six months (January – June 2011) and 556 reports that were filed in all of 2010.

    It is perplexing to us why the Food and Drug Administration has not yet recalled the Pinnacle hip implant. Over 2,500 adverse event reports have been filed with the FDA regarding the Pinnacle hip implant. To put this into perspective, in August 2010 when the FDA announced the DePuy ASR hip replacement recall, half the number of adverse event reports had been filed for the ASR (1,195) as have now been reported for the Pinnacle (2,500.)

    The following chart shows the history of adverse event reports for the Pinnacle hip implant:
    Many of these reports are similar to the complaints that were reported for the DePuy ASR hip implant, which led to a massive hip replacement recall. For example, many doctors have reported that Pinnacle hip implants are failing due to a large amount of metal degrading from the implant. The problems with all metal-on-metal implant has recently been addressed by the media, including NBC Nightly News and The New York Times.

    Despite the rapidly rising number of complaints, the FDA still has not forced DePuy to recall the Pinnacle hip implant. DePuy continues to sell the Pinnacle hip implant to unsuspecting patients who likely are not being told about the number of adverse events reports that have been filed with the FDA.
    Brian Devine, a former insider at an orthopedic company who now represents victims of DePuy’s hip implants, is concerned that the FDA may be allowing a defective hip implant to remain on the market. Brian Devine filed the first lawsuit involving the Pinnacle hip implant six months ago in October 2010. Since then, more than 500 lawsuits have been filed across the country.

    Wednesday, November 2, 2011

    Follow up with my surgeon-selected the hip for revision

    This is a follow up from my post yesterday.  Today I received an amazing letter from my surgeon in response to my final questions prior to surgery.  Here were  the highlights of that note:

    (1)  He strongly preferred the Depuy Pinnacle for the revision.  Why?
    •  He had personally placed over 1000 Pinnacle cups in his practice
    • He had a very small revision number due to infection but none due to loosening, excessive wear, liner issue or metal debris.
    • He does not use metal on metal in that line
    • His recommendation:
      • Pinnacle Cup (made of titanium...see post from yesterday where I address this metal.
      • Marathon poly liner.
      • Ceramic head
    (2) He reiterated his belief that the Pinnacle issues (surge of both FDA complaints and the law suit filings-see post yesterday for those details) were the metal on metal versions.  I had that hunch but I really had no evidence.  Nor did he get any.  His suspicion only.

    The one comment that was completely utterly fascinating is this one:  "The literature suggests that when wear debris is generated from contemporary metal on metal bearings, some hexavlaent chromium is generated, but it is quickly reduced inside the body's cells to trivalent."

    I definitely need to pursue this  comment post surgery...  You know why?  I have spent considerable time looking at this very issue (see prior posts by typing hexavalent or trivalent chromium in the search box or type in chromium 3 or chromium 6.)  If this is correct, we need to explore the relevancy of  "quickly reduced to trivalent".

    (1) Is this an acknowledgement  that chromium  6 (the carcinogenic chromium) is in fact present in the  the hip?...something I have suspected for a very long time.  If you ask any surgeon what Chromium version is in the hip, the answer will always be Chromium 3, the alleged non carcinogenic form. Chromium 3 can generate carcinogenic chromosomes but not to the extent that chromium 6 can.

    (2) Does it matter how long the the Chromium 6 is in your body before it oxidizes to chromium 3?  I don't know. Kinda sounds like an "almost pregnant" analogy.  By that I mean, pregnancy is binary.  You either are or you are not.  I think the same is true for oxidation.  It either happened and changed the chromosomes  or it didn't.  This is something I will definitely look at.  My understanding is that you can get abnormal cells generated  merely from  the oxidation process (having 6 turn to 3.)  I could be wrong but I want to know this.  Abnormal chromosomes (in number or size) have the possibility of becoming carcinogenic.  This statement above suggests that generating abnormal chromosomes is not binary but progressive or something???

      Here is a copy of the pertinent information from an earlier blog post I wrote:

    Oxidative Damage / exerpts from Acta Orthopaedica 2008 79 (6) 734-747 University of Oxford
    //Metal-induced intracellular effects

    1. Reactions with metal ions can lead to generation of free radicals: reactive oxygen species (ROS) and reactive nitrogen species (RNS) which in , cause cellular dysfunction.

    2. Inside the cells, Cr 6 is oxidized to Cr 3 in a series of steps that generate free radicals.

    3. Free radicals catalyze the oxidation of protein and phospholipids.

    4. That process leads to the formation of malondialdeyde which can react with DNA bases to form DNA protein cross links

    5. Permanet modification of genetic material resulting from this oxidative damage represents the first step in mutagenesis and carcinogenesis.

    6. Direct binding of Cr 3 to DNA is well documented.

    7. In cells , two main processes exist to correct DNA aberrations to restore the integrity of the genome.

    8. Under stimulation by Cobalt 2 and Chromium 6, both of these mechanisms are inhibited.

    9. Landon (2004) investigated changes in metal ion levels and chromosome aberrations in patients within two years of receiving metal on metal atheroplasties.

    10 The authors noted an increase in chromosome translocations and aneuploidy in peripheral blood lymphocytes at 6, 12, 24 months after surgery.


    • Aneuploidy is an abnormal number of chromosomes, and is a type of chromosome abnormality. Some cancer cells have abnormal numbers of chromosomes.[1] Aneuploidy occurs during cell division when the chromosomes do not separate properly between the two cells...The question is what is the relationship between the metal on metal hip and long term systemic effects with things like cancer?



    • In genetics, a chromosome translocation is a chromosome abnormality caused by rearrangement of parts between nonhomologous chromosomes. A gene fusion may be created when the translocation joins two otherwise separated genes, the occurrence of which is common in cancer.

    11. The authors noted the changes were progressive.

    12. The authors didn't find any statistically significant correlations over those short time frames between chromosomal translocations and Co and Cr concentrations in the whole blood.

    following are some summary steps of this oxidation process. A bit technical but helpful:


    • Different pathways are used by metal ions to enter the cells
    • Chromium 6 can cross the cell membrane
    • Chromium 6 undergoes rapid metabolic reduction to form Chromium 5, chromium 4 and then chromium 3.
    • At each step of the Cr 6 reduction, ROS and RNS are generated (see above for definition of these terms)
    • Cr 3 can cross the cell membrane and participate in alteration of DNA.
    So my question remains, did we start with Chromium 6 which was oxidized to Chromium 3 in our body? Yes or No? If yes, and the oxidation process is a known cause of DNA damage and is the first step in carcinogenesis and mutagenesis, is this not a problem?

    so...... pretty interesting hugh?

    In any event, my surgeon's note was quite helpful to me and provided me with peace of mind which is all I was interested in hearing.

    connie

    Tuesday, November 1, 2011

    Anyone have experience with the Zimmer Trilogy hip in revision surgery or the Pinnacles for that matter?

    My surgery is scheduled for Monday and have been provided with two options:  Pinnacle (by Depuy) and the Trilogy (Zimmer.)

    I will have the ball, head and liner replaced.  My preference is to have a ceramic ball, poly liner and titanium head.

    I am not interested in any more chromium and cobalt which is what is contained in the Depuy ASR system which now needs to be replaced.

    The most common metallic sensitizers that are used in orthopaedic alloys are nickel, cobalt, and chromium. Orthopaedic grades of stainless steel and cobalt-chromium alloys both contain these materials while titanium and titanium alloys do not. The excellent biocompatibility of titanium and its alloys, such as Ti-6Al-4V alloy, is well documented. Persons with a history of allergies, including sensitivities to cobalt, chromium, or nickel, generally do not exhibit or develop sensitivity to titanium or other constituents of Ti-6Al-4V alloy.

    I have not found any litigation surrounding the Trilogy system in process now.  This system was recalled  at one point but I see no current recall notices associated with this hip.

    I have looked at the Pinnacle previously in this blog.

    1) Below, you can see the cumulative conventional hip revisions as a percent of total vs the Depuy ASR which has a high cumulative revision rate (taken from the Australian 2010 Joint registry data.)


    1 year
    3 years
    5 years
    7 years
    9 years
    Depuy ASR
    1.8%
    5.9%
    9.3%


    Total conventional hip revisions
    1.5%
    2.6%
    3.4%
    4.3%
    5.3%

    2. Below are the revision rates at 5 years for the Pinnacle with different Femurs

    <><><> <><><>

    Revision rates @5 years from the 2009 report
    Revision rates @5 years from the 2010 report
    Depuy Corail** Pinnacle*
    2.6%
    2.9%
    Depuy S-Rom Pinnacle
    3.7%
    3.7%
    Depuy Summit Pinnacle
    1.6%
    2.0
    Depuy Summit ASR (FYI)

    7.1%
    * acetabular component.
    ** femoral component
    So it looks to me as though the revision rates for the Pinnacles above are well within normal revision rates. What I don't know for certain is whether the acetabular metal on metal component in question is the same component as those above in the chart. As I understand it, Pinnacle provides three choices:

    metal-on-metal,

    ceramic-on polyethylene

    or metal-on-polyethylene

    So which components above are combined to reflect Metal on metal in the chart? I don't know.
    Also, I can't account for the recent surge in both litigation filings and FDA complaints about the Pinnacle.  These complaints may be associated with the MoM version of these hips.  I just don't know.

    There have been 1300 adverse reports filed with the FDA for the pinnacles since 2001 however over 50% of these occurred in 2010 with an expectation that these rates will be higher in 2011.  Also, there are about 500 current outstanding litigation filings on the Pinnacles but I don't know which configuration the suits are filed on.  Likely Metal on Metal but i don't know the answer to that. 

    Without getting clarification from the surgeon on this, I would not be comfortable with the Pinnacles.  Perhaps I will get clarification to this in the next few days. 

    If there are any revision patients who have used the Trilogy, I would be interested in hearing from you.