Monday, January 31, 2011

Hezekiah Sistrunk Appointed to DePuy Hip Implant Discovery Committee

ATLANTA, Jan. 28, 2011 /PRNewswire/ -- The Cochran Firm - Atlanta attorney, Hezekiah Sistrunk, Jr., has been selected for a leadership position in the DePuy ASR Hip Implant mass tort multidistrict litigation.

Federal Judge David A. Katz appointed Mr. Sistrunk to the Discovery Committee which will be responsible for leading and directing the discovery efforts for all federal lawsuits related to the DePuy Orthopaedics ASR hip implant and ASR Hip Resurfacing System manufactured by Johnson and Johnson's orthopedic division, DePuy Orthopaedics, Inc. All federal lawsuits related to the DePuy ASR implants will rely on the evidence developed by the Plaintiffs' MDL Discovery Committee

Sunday, January 30, 2011

Continuing Medical Education Panel sponsored by the American Orthopedics Association for Surgeons: Total hip Atheroplasty: Is there a MOM bearings controversy? (Part Two of Five)

Part Two of Five/My notes:

Dr. John Cuckler MD:  Complications of MOM bearings   (Complications of total hip athroplasty with adverse tissue response in 11 patients.)
Initial experience over last 10 years
·         More than 1 million MOM couples in use today with patients
o   resurfacing and conventional
o   conventional hip replacements outnumber resurfacing by 4:1
·         Head size of implants have grown over the years
Known Issues (history):
·         Hypersensitivity (adverse tissue response/osteolysis/tissue necrosis)
o   Initially in 2005 seen as rare
o   No one knows what the prevalence of this occurrence is
o   As MOM implant use increased, so did the occurrence of this hypersensitivity in patients
o   Dr. Cuckler thought it was likely present in about 1 in every 1000 cases.
o   If you suspect osteolysis, might consider sending a frozen section to a pathologist and ask them to look for the lymphocytes. Look for the lymphoreticular response in the synovial fluid (aspirate the joint.)
o   Ask the patient if they have a history of metal allergies especially should look for women who complain that they can’t wear cheap jewelry due to rashes they get from it.  This is an important sign to look for.
o   If you postpone revision of the surgery, after having identified the osteolyis, this could degrade to tissue necrosis.
·         Tissue response to wear debris.
o   Pseudotumors initially associated mostly with resurfacing not total hip replacements
§  Present in MoM, Ceramics and Poly
§  Pseudotumor described as an aggressive response to rapid wear of the implant
·         Tests recommended:
o   Sedimentation rate (ERP)
o   CRP
o   Ultrasound if you can’t do the MARS MRI
o   Aspirate the joint
§  Culture and sensitivity
§  Cell count of more than 2500 per CC and cell block with more than 95% monocytes would indicate a hypersensitivity response.
·         Revision options:
o   Go to a non MOM articular couple
o   Going to CoCr on poly is generally acceptable
o   Should get frozen section path report
·         Results from revision:
o   Tissue necrosis (muscle damage) may be a severe challenge
o   Revise early if suspicious with a constrained component even if you suspect the tissue damage is  minor!
§  Permanent non-repairable tissue damage may occur if left as is.
§  Repairing soft tissue necrosis is very difficult
·         Indications for MOM:
o   Young, active , heavy male with no metal allergies
·         Contraindications for MOM
o   Female, small socket, high risk for renal failure, allergies

Saturday, January 29, 2011

Continuing Medical Education Panel sponsored by the American Orthopedics Association for Surgeons: Total hip Atheroplasty: Is there a MOM bearings controversy?

Part One of Five (my notes on the lectures)

Panelists:
Josh Jacobs MD:  Professor and Chairman of Rush Medical Center Orthopedics
Robert Barrack MD:  Professor of Orthopedics Washington University School of Medicine St Louis Mo
John Cuckler MD:   Professor at U of Alabama
Hollis Potter MD: Professor of Radiology at Cornell
Jerry Leiken MD:  Professor of Medicine and Pharmacology at Rush Medical Center and University of Chicago (Medical Toxicologist)

Poling questions for the audience of orthopedic surgeons attending this CME course:

1)      Do you use MOM bearings in your practice?
a.       2/3rds of the audience used MOM hips in their practice

2)      What percent of hip replacements are MOM bearings in your practice?
a.       60% said under 20%
b.      13% said 21-40%
c.       7% said 41-60%
d.      7% said 61-80%
e.      6% said over 80%

3)      How many patients have you treated with adverse soft tissue damage with respect to MOM hips in the last year?
a.       69% said none
b.       27% said Under 5
c.       3% said 6-10
d.      1% said greater than 10

4)      Options (will come back and fill this in on the site later/course didn’t have the tally by percents of participants choosing each of the following statements prior to my publishing this post:)
a.      There is a definite  role for MOM hip replacements for definite indications
b.      There is a role but there needs to be additional research to define the indications
c.       There is no role for MOM in hip replacement
d.      The reported results and complications are design specific, so no generalizations can be made.
 Section 1: Robert Barrack MD-Indications for MOM hips
·     Incidence of occurrence of issues surrounding the MOM hips is “hotly debated.”
·     Given that selection and technique are both issues with this hip, there needs to be some clinical advantages to warrant the use of this MOM technique
o   Dislocation is lower
o   Less thigh pain
o   Higher level of functioning
·     Not much evidence for the above  advantages in the literature though given the limitation of prior studies
o   One study showed that 43% of patients had all of their expectations met with no limping being most important
o   Second study on ability to perform various functions after the “modern implants” were used (mom, ceramic/poly)


Standard Total hip replacement (under 32 MM head)
Large THR (greater than 36MM head)
Resurfacing
No limp last 30 days
46%
50%
70%
Able to walk greater than 1 hour
52%
62%
68%
Tried to run
74%
69%
94%
Run greater than 1 mile
9%
14%
25%
Run for exercise
27%
33%
47%


·         Not a lot of differences between the groups
·         Resurfacing on the whole was most successful
·         You lose about 8% bone density with Total Hip replacement vs resurfacing
·         Warrants continued exploration of the use of resurfacing
Who is the best candidate?
·         Best results obtained in young males
·         Data on age and gender is not definitive
·         Stronger evidence of the importance of component size and implant type
·         Osteo Arthritis as a diagnosis has the best results
·         Revision stats below after 4 years:


Resurface
Resurface
Conventional
Conventional
Age
Male %
Female %
Male %
Female %
Less than 55
1.9
3.9
2.2
3.2
56-64
2.2
6.4
2.2
2.7
65 and greater
4.0
11.0
2.2
2.3


Overall conclusions from Dr. Barrack:
·         There is data indicating the clinical advantage for MOM artheroplasty
·         The data is more compelling for resurfacing rather than total hip replacement
·         Major issues:  indication, surgical technique and informed consent.

You can buy this course on line at the association.  It is a 1.5 hour video and costs about $100.

 I will publish the next 4 sections wiover the next 4 days on the site.
Connie

Thursday, January 27, 2011

MDL Litigation Conference in Florida with Judge Katz on the 20th of January

A New York attorney reported that many topics were discussed at the plaintiff-lawyer-only conference which he attended , including strategy for the law firms that plan to steer the mass tort litigation. The specifics of the conference are confidential and cannot be discussed however.

Depuy Reports a $1Billion dollar Set aside for Potential Settlement Costs and Litigation

Johnson & Johnson announced its fourth quarter earnings this week, which included a charge of $922 million to cover litigation costs and potential settlements associated with a DePuy hip recall issued last year.

According to an earnings statement released on Tuesday, Johnson & Johnson reported net earnings of $1.94 billion, which was a 12 percent drop from the previous year. The net earnings were greatly affected by the DePuy ASR hip recall litigation set aside of nearly $1 billion, which will cover some of the company’s anticipated DePuy hip settlement costs, litigation defense expenses and other costs associated with the DePuy hip recall.

In addition to the DePuy ASR lawsuits, Johnson & Johnson also faces potential lawsuits over DePuy Pinnacle hip replacements. Although a recall for this other hip replacement has not been issued, a handful of DePuy Pinnacle hip lawsuits have already been filed by consumers who have experienced metallosis or other problems from the metal-on-metal hip replacement parts wearing down

Wednesday, January 26, 2011

Interview with Dr. Stephen Graves, Director of the Australian Joint Registry

While the reason for the market withdrawal quoted in Depuy’s hip recall press release was adverse data from the British National Joint registry[more recent data], Depuy had long been well aware of the problem with the problems surround the hip from the Australian Joint Registry.  The registry records a high percentage of joint replacements in Australia with the objective of watching how they perform to avoid unnecessary revision surgeries.  While the interview was longer,   I reported the questions and answers that were appropriate for the topics discussed in this blog.
Reporter:  Were you surprised by the [US] recall of the Depuy hip?
Dr. Graves:  No not surprised at all.
Reporter:  Why is that?
Dr. Graves:  The Australian joint registry has identified for a number of years that the ASR prosthesis had a high rate of revision.
Reporter:  How did the Depuy hip perform relative to other devices of a similar class?
 Dr. Graves:  In 2008, we knew that the resurfacing procedure and the ASR device both had higher rates of revision.  After 3 years, these devices were 4-5 x the revision rate compared to other devices.
Reporter:  But in the Depuy press release, they stated that according to other international joint replacement registries, the Depuy hip was performing in line with other devices of similar kind.
Dr. Graves:  Yes I noticed  that comment in the Depuy press release and I couldn’t quite understand it because that simply is not correct because Depuy was fully aware of the Australian registry data so I’m not quite sure why they said that because it is simply not true.
Reporter:  Then why did the surgeons in Australia continue to use it given the public data on the registry?
Dr. Graves:  In Australia, the surgeons didn’t continue to use it once the problem was identified and in fact, Depuy removed the device from the Australian market last year [2009].
Reporter:  So what’s the bigger story here?  Are there other hips that are nonperforming that should not be on the market?
Dr. Graves: If the risk of revision is 2x compared to other devices, this is not considered to be an acceptable standard.  The results are reported annually and normally when we do that, the surgeons reduce the use of the device considerably.  In 2009 we identified 50 devices that were not acceptable.  Many of the devices are no longer being used but a significant number are.  Publishing these rates enables the [regulators]  to review each of these devices and determines what should be done with them.
Reporter:  What has the joint registry done for Australia?
Dr. Graves:  The rate of revision surgeries has been dramatic over each year which is to say,  1500 less revisions have occured each year with high complication rates.

Connie

Tuesday, January 25, 2011

Acute and chronic systemic chromium toxicity

Shayne C. Gada
aG.D. Searle & Co., 4901 Searle Parkway, Skokie, IL 60077, U.S.A.
 

Abstract

Although chromium and compounds containing it have been recognized as having potential severe adverse effects on health for more than 160 years, understanding of the systemic toxicology and true hazard of these compounds is still not complete. A review of the current state of knowledge is attempted in this paper, with appropriate attention given to the complications of multiple valence states and solubility.

Selected chromium compounds, particularly hexavalent ones, are carcinogens, corrosives, delayed contact sensitizers, and have the kidney as their primary target organ. But chromium is also an essential element for humans. The body clearly possesses some effective detoxification mechanisms for some degree of exposure to hexavalent chrome compounds. The significant features of acute and chronic chromium toxicity are presented in view of these considerations.

I will get the paper and review the points in it next week.

Connie

Systemic distribution of wear debris after hip replacement. A cause for concern?

 

VG Langkamer, CP Case, P Heap, A Taylor, C Collins, M Pearse, and L Solomon
Bristol Royal Infirmary, England.

The production of particulate wear debris is a recognised complication of joint arthroplasty, but interest has concentrated on local tissue reactions and a possible association with implant loosening. The fate of wear products in the body remains unknown, although some of the metals used in the construction of orthopaedic implants are known to have toxic and oncogenic properties. We report histological and electron-microscopic evidence from two cases which shows that metallic debris can be identified in the lymphoreticular tissues of the body distant from the hip some years after joint replacement. The increase in the use of total arthroplasty in younger patients, the development of new alloys and the use of porous coatings must raise concern for the long-term effects of the accumulation of wear debris in the body.

MDL hearing on Jan 20th with Judge Katz

Has anyone head what transpired in the conference with Judge Katz and the Depuy lawyers on the 20th of January?  I have not seen nor heard anything?  Please post any information you have.
Thanks
Connie

Sunday, January 23, 2011

Points made in the Video from the CEO of Depuy with his senior staff

(1.1 hour video from the Depuy site.. http://accordent02.origindigital.net/dmn/ASRrecallinfoOct28/main.htm)
I had not heard the President of Depuy, David Floyd and his senior staff comments on this recall prior to listening to the video.  Found the following points of interest:
·         They seemed to recommend the MARS (metal artifact reduction sequence) MRI as the best means to detect soft tissue damage from the implant. [My surgeon did not recommend this initially.  He advised that we first look at the blood levels and the ultra sound and then determine if the MRI was indicated.]

·         They emphasized that there is an “Art” to getting this MRI sequencing right.  Need someone with experience conducting these tests who is equipped to deal with musculoskeletal imaging if you choose to just rely on the ultra sound alone. [You can refer to the video on their site on the MARS MRI, which is also contained on their site.]

·         They cleared up some confusion regarding the reading on the toxicity tests.  I had this confusion as well.  Levels that are reported in parts/billion can be equated to micrograms/liter.  7 parts per billion =1 microgram per liter. They also mentioned that they added a metal toxicity video to clear up the many conflicting issues on that topic for the physicians but I couldn’t locate the video on their site.

·         There was one question on the video from one of the physicians about what level of Cr and Co indicate revision surgery.
o   Depuy answered this by stating they don’t know what chemical levels should indicate revision but they are using the levels recommended by the British Orthopedic Association and British Hip Society which is 7 parts per billion.

·         Depuy wants to retrieve all implants and will send the implant to an independent lab and send a report to the surgeon only at the surgeon’s request but the patient has to agree and sign for this.  [I intend to have the sample reviewed by a lab of our choice.]

·         Three points on the medical reimbursement process that  I found interesting and in conflict with what I have been told by my surgeon and by the Depuy claims people:

o   Depuy’s senior staff is advising they cannot reimburse claims without the patient signing the authorization forms for the medical records.  I have not signed any form and was advised that I was not required to sign any form but the payment process would take longer.

o   If you use the Depuy approved lab for the toxicology tests to measure the Cr and Co;  Lab Corp (they are negotiating with Quest now), the lab results will be sent DIRECTLY TO DEPUY in addition to your surgeon.  I don’t get this in light of the HIPPA regulations.  I have not provided a release to have my records sent anywhere.

o   All insurance claims should be sent directly to your current insurer and they will submit them to Broadspire, the Depuy claims agents.  I was told by the claims agent to send the bills to Broadspire.

Connie

Saturday, January 22, 2011

When should you retain a lawyer?

This is my first post on this subject because I have prioritized the medical issues first.  I have postponed this due to the fact that I have not had surgery yet.  Certainly my family and close friends have advised that I retain a lawyer given it is likely that I will have to replace the hip.
The obvious questions:
·         Should I retain one before I get the replacement
·         Should I retain one even if I don’t choose to get the replacement?
·         Should I retain one prior to signing any papers from Depuy in order to get my costs reimbursed for merely evaluating my options with the physician.
My thoughts:
·         If you have been harmed (however that is defined) and you intend to bring a claim, you  will need an attorney to do so and you should be aware of the statue of limitations in your state with respect to filing a suit.  I believe in a case like this, it is 2 years in NY from the date you knew you were harmed. I believe each state has different rules on filing.  Following is a general URL you can use to look up the statue of limitations in your state:  http://www.edgarsnyder.com/statute-limitations/
·         If you ask any of the personal injury lawyers who seem to be available in hordes to file a suit against Depuy, they will tell you to retain one before you do anything (including processing claims) with Depuy.  Personally, I don’t think that is necessary.  You do not have to sign anything with Depuy before they begin reimbursing you for your claims when consulting with your doctor.  Depuy (via Broadspire-thier claims agent) is paying my claims and I have signed nothing.    They do not require you sign anything to start the process.  The claim that have been discussed on the web requiring that you must  “sign your rights away” before dealing with Depuy/Broadspire is incorrect.  I have not found the depuy claims agents to be anything but helpful.
·         If you don’t get a replacement and want to retain an attorney, you are going to need to prove you have been harmed.
·         It is important that you do have procedures in place to have the extracted hip sent to an independent lab for analysis if you are intending on filing a suit. plaintiff lawyers who deal with product recall suits in the medical arena will advise on that procedure.  If you have questions on this prior to visiting a lawyer, I can publish something on that procedure.
Insofar as my interaction with attorneys, I have had none to date.  Once I understand and qualify the harm that has occured-if there is any, I will speak to an attorney.   Replacing a hip is certainly enough to warrant visiting a medical product liability plaintiff lawyer.
I will publish some of the questions I have for them in a subsequent post.
connie