Thursday, April 28, 2011

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

Acta Orthop. 2011 Apr 19. [Epub ahead of print]
The Centre for Hip Surgery, Wrightington Hospital , Lancashire.

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.

 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".

[ Comments by connie:

·         I have blogged extensively about the potential issues surrounding asymptomatic patients with MOM implants

·         I have suggested that anyone with a MOM implant request their orthopedic surgeon provide you with the orders to get  ion tested for Cr and CO levels as well as having an MRI Mars protocol done.

·         This article confirms my suspicions that we have only seen the tip of the iceberg with the hip issues related to Depuy.

·         The concept of “silent soft tissue pathology” is so telling…..

·          Results 27 of 75 hips (scanned 31 months post surgery) had MRI-detected metal debris-related abnormalities

·         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.

·          Don’t wait to see your orthopedic surgeon even if you have no symptoms!

If your Orthopedic surgeon is not interested in getting you tested, go for a second opinion!

Update on the Depuy multi district litigation (MDL) proceedings

On April 5, 2011, the court issued Amended Case Management Order No. 4, which requires each plaintiff to file a short-form complaint and DePuy to file a single master abbreviated or short-form answer.

Order No. 4 permits plaintiffs to claim damages under 23 specific causes of action in addition to whatever other ones they choose to assert. Here are some noteworthy examples:
    • Simple negligence
    • Strict products liability
    • Breach of warranty
    • Fraudulent misrepresentation
    • Malice
    • Violation of state consumer protection statutes
The order allows plaintiffs to claim the following types of damages, among others:
    • Injury to self
    • Wrongful death
    • Economic losses
    • Loss of services
    • Loss of consortium
Meanwhile, DePuy’s master answer may contain 32 individual defenses. Some of these originate from its responses to the first DePuy hip replacement lawsuits, particularly those portions addressing limitations of damages such as punitive damages. Here are a few examples of the defenses DePuy may assert against hip replacement plaintiffs:
    • Plaintiff assumed all risks associated with the use of his or her DePuy ASR device
    • Plaintiff was negligent, careless, and at fault and conducted himself or herself so as to contribute to alleged injuries
    • Plaintiff’s alleged damages are barred because of the plaintiff’s failure to mitigate them

http://www.hiprecalllaw.com/update-on-depuy-multidistrict-litigation-parties-must-file-complaints/  -excerpts from article from the Rottenstein group-

Tuesday, April 26, 2011

Early Markers of Nephrotoxicity[kidney toxicity] in Patients With Metal-on-metal Hip Arthroplasty.

Clin Orthop Relat Res. 2010 Nov 25. [Epub ahead of print]
Nephrology and Health Sciences, University of Parma, Parma, Italy.

Abstract

BACKGROUND:

Metal ions released from arthroplasty devices are largely cleared in urine, leading to high exposure in renal tissues. Validated early markers of renal damage are routinely used to monitor workers in heavy metal industries, and renal risk can be quantified in these industries. It is unclear if the ion levels in patients with metal-on-metal hips are sufficient to cause renal damage.

QUESTION:

Does metal-on-metal (MOM) bearing use over a 10-year period lead to elevation of early renal markers compared with the levels expected in subjects with no metal exposure?

METHODS:

We retrospectively reviewed 31 patients who underwent MOM hip resurfacings 10 years earlier. Whole blood specimens were collected for metal ion analysis, serum for creatinine estimation, and urine for timed metal ion output and renal markers. The renal marker levels of 30 age- and gender-matched subjects with no metal exposure and no known renal problems or diabetes mellitus were used as controls for renal markers.

RESULTS:

Median serum creatinine level in the MOM group was 1.1 mg/dL (interquartile range, 1.0-1.2 mg/dL) and median creatinine clearance was 79.2 mL/min. In this cohort, the number of patients with markers of renal damage above the reference range was comparable to the controls. None of the renal markers were associated with metal levels.

CONCLUSION:

The absence of elevation of renal markers in this cohort 10 years after MOM bearing implantation is reassuring. However, we believe surveillance through further longer-term, large-scale controlled trials are needed to monitor this arthroplasty-induced low-intensity (but long-term) trace element exposure to rule out potential nephrotoxicity.

LEVEL OF EVIDENCE:

Level III, retrospective comparative study. See Guidelines for Authors for a complete description of levels of evidence.

[comments from connie:
  • Interesting study
  • Small population
  • I would be interested in seeing some variation on this study such as what happens if you only have one kidney? What about patients with  minor renal impairment with a MOM hip?  does it get worse?  What about autopsies on hip patients...what do the renal biopsies look like?

Monday, April 25, 2011

Nine-Year Incidence of Kidney Disease in Patients Who Have had Total Hip Arthroplasty.

Just published!!!!

Chandran SE, Giori NJJ Arthroplasty. 2011 Apr 18. [Epub ahead of print]
Department of Orthopedic Surgery, Stanford University, Stanford, California.

Abstract

Metal-metal total hip arthroplasty (THA) is contraindicated in patients with impaired renal function due to increased metal ion output relative to other bearings and renal excretion of metal ions. Although one can avoid a metal-metal THA in a patient with renal disease, a patient may be destined to develop renal disease later in life. In this study, we sought to determine the incidence of newly diagnosed renal disease in the 9 years after THA. Using the Department of Veterans Affairs national database, we identified 1709 patients who had a primary THA in 2000 without preexisting renal disease. We found the 9-year risk of developing chronic renal disease after primary THA to be 14% and severe or end-stage renal disease to be 6%.

[Interesting study.  Here is the question. What constitutes imparted renal function?  I think there may be two ways to look at this question:
·         Does one kidney constitute impaired renal function?  Or
·         Do impaired creatinine levels alone constitute impaired renal function? (You can have normal creatinine levels in the 80’s with one kidney.)
I recall having one of my consults asking me why I had a MOM hip inserted to begin  with when I only had one kidney.  My guess is the orthopedic surgeon would say that my creatinine levels were not impaired at the time ???]

Hip-replacement hospital re-admissions rise

A study published in the Journal of American Medical Association found that hospital readmission rates rose significantly in recent years for patients who underwent total hip replacement surgery. The study’s authors analyzed data on 1.45 million Medicare recipients who had total hip replacements from 1991 to 2008 and approximately 328,000 Medicare patients who required a second hip-replacement “revision” surgery.

From 2007 to 2008, 8.5 percent of total-hip-surgery patients were readmitted to the hospital within 30 days of being discharged, a rise of more than 2.5 percent in previous years. Although the study does not offer specific explanations for the increase, it does find shorter hospital stays (earlier discharges after hip-replacement surgery) occurred during the same time. Lead author Peter Cram told Bloomberg that he didn’t look at whether DePuy’s recalled hips contributed to the recent rise in early readmission, but said studying a possible link would be “a really good area for future research.”

Sunday, April 24, 2011

Johnson and Johnson excerpts form Quarterly earnings call:

DePuy franchise had operational growth of 1.7% when compared to the same period in 2010, with the U.S. down 0.4% and the business outside the U.S. growing by 4.2% operationally…….
 (Depuy CfO)  In recent weeks, we also announced several developments that I would like to comment on. In March, our McNeil Consumer Healthcare business finalized the terms of Consent Decree with the U.S. Food and Drug Administration for three manufacturing facilities. We have previously included in our guidance for 2011, an impact of approximately $0.06 per share from the ongoing remediation efforts of McNeil.

Now that we have finalized the terms of the Consent Decree, we estimate that that impact will be twice that amount. These results from both the slowdown in sales reflecting the impact on production volumes, as we implement the additional quality steps outlined in the Decree as well as additional investments required in the remediation process.

In April, we announced the settlement with the U.S. Department of Justice, the U.S. Securities and Exchange Commission and the U.K. (Securities) Fraud Office for matters related to Foreign Corrupt Practices Act, investigations and the United Nation's Oil for Food Program. We will pay nearly $80 million in connections with these matters and amount that was previously reserved for.
Details on these matters have been widely reported and we've accepted full responsibility for the short comings in our McNeil Consumer manufacturing operations and for the actions related to these other investigations. We are confident that these matters are not representative of the vast majority of the Johnson & Johnson employees around the world………

Michael Weinstein - JPMorgan: I'll actually pick up (where Rick left off) and just talk for just a minute about DePuy. Louise, if I heard you right, and so first correct me if I didn't, I think you said that U.S. hips and knees were both down 6% year-over-year. Is that right?

Louise Mehrotra - VP, IR: In the U.S., yes. On an operational basis, yes.

Michael Weinstein - JPMorgan: Then just to recognize, the comparison is still tough in the first quarter but that's probably, I think at least certainly on the knee side below (the street's) expectations. So any commentary you have about the environment for DePuy would be appreciated. If you could also maybe just compare that to the performances you saw in your other surgical businesses for Ethicon, Ethicon Endo?

Louise Mehrotra - VP, IR: Mike, on a sequential basis in the U.S., the hips are actually up 4% and the knees are up 1%. So, the knee market is still soft in the U.S., but on a sequential basis you are seeing it in a positive trend rate…..

[comment from connie: so bottom line the hip business is down at Depuy on YoY basis (year over year) however, on a sequential basis in the US (progress since last quarter) hip sales are up...kind of interesting isn;t it?  Typically, CFOs don't comment on results in LOB (lines of business), I surely wonder where the increase in sales comes from in the hip business.  I recall my surgeon wanted to replace my problem depuy MOM implant with an alternate material from depuy.] 

Johnson & Johnson Q1 Profit Drops On Charges; Lifts Full-year

(RTTNews) - Health care giant Johnson & Johnson (JNJ: News ) on Tuesday reported a 23 percent decline in profit for the first quarter, hurt by charges due to litigation and additional recall costs. However, adjusted earnings per share increased from last year particularly due to sales growth internationally. The company also raised its full-year 2011 earnings outlook citing recent developments in the business.
The latest quarter's results include after-tax charges of $271 million due to litigation and additional DePuy ASR Hip recall costs. The year-ago quarter's results include an after-tax gain of $910 million representing the net impact of litigation matters.

Worldwide sales grew 3.5 percent in the quarter to $16.17 billion from $15.63 billion a year ago and topped analysts' consensus estimate of $15.83 billion.

Domestic sales declined 0.6 percent year-over-year to $7.61 billion, while international sales rose 7.3 percent to $8.57 billion.

The company operates in three segments - Consumer Health Care, Pharmaceutical and Medical Devices & Diagnostics

Saturday, April 23, 2011

What questions should you ask these Litigators before you Retain one?

As I mentioned yesterday in my post, I will begin thinking about this question. There is no magic list of questions. Given the research that I have done on this subject, it is likely that new patients in the process may have different basic questions than I may have.

The attorneys all have web sites and I have been through all of the 14 web sites of the attorneys on the MDL list which I published yesterday. 

Each site contains:
·        a bio on the lead attorney, as well as all of the attorney’s in that firm

·        A list of the monetary awards  they have been successful in procuring for their clients-not sure why that matters given most patients are first interested in having their medical issues covered for any eventuality that may occur for the rest of their lives right! Further, it’s kinda hard to judge those awards out of context.  Not sure what they all mean.

 
·        A list of rankings by something called “super lawyers” and I haven’t a clue as to what that indicates (maybe I should look at that definition)…I wonder if it’s like that “whos who in American women” a list I seem to be on each year but have no clue as to why I am on it?

·        The firm’s philosophy…all pretty predictable….client comes first stuff…


·        What about size of the legal staff (attorneys and support staff)?  I’m not sure how much this matters but what I can tell you is that this case is very complicated. I think it is more important that your team have experience dealing with complex, mass tort cases with medical devices or related issues in the medical field with companies like J and J and that the head litigator has  served in a leadership role in these cases before.

I’ve got to say, I didn’t get any real sense of compelling differentiators (why your firm vs another) on the sites other than one thing:  I did find it impressive if I could see the number of times the attorney who spearheads the case has been selected by a judge to serve on a steering committee for a complex litigation case.  That is the only thing that I found worth considering on those sites.  That selection to me implies:
·        Leadership
·        Good judgment
-         Can be a decsion influencer on the case
·        Convincing with a track record likely understood better by a judge in some context.

The most important thing to me is to understand how that litigator thinks about issues which they have to deal with on that case.  That means you have to ask questions. Here are some of things that interest me:
·        How are they thinking of identifying expert witnesses in dealing with the systemic issues?
·        How familiar are they with the key published influencers in this case
·        Are they disparaging of their colleagues…if they have to make their case by making another attorney look bad, I would pass on them.
·        What do they think about the consults you have used?
·        Listen to the questions they ask you.

·        How difficult it is to access the key lawyer?  I found that many of these firms seem to want to send you out a packet to “sign up” without ever speaking to an attorney…pass on those firms….You must talk to someone on the legal team who is not simply the administrative para legal. They are not lawyers. You generally have to be assertive to get past the para legal.

·        Ask them how they are paid. You should never have any out of pocket costs.  These lawyers work on contingency…that means, they fund the case and if they win, they take some percentage off the top for expenses and split the rest with you.  It appears that states differ in the rules set for remuneration in  contingency cases. If this monetary award matters, ask them to explain it to you.  This does not happen to be my primary concern.  My primary reason for considering a lawyer is to ensure that any damage done as a result of this hip will result in the ability to have those injuries covered by Depuy for the rest of my life.  This requires filing before the statue of limitations runs out.

What questions do you guys have?  Perhaps I can find some kind of criteria to help hone in on the legal selection in some reasonable way. One of the attorneys said something interesting:  at the end of the day, you simply have to feel comfortable with working with that attorney. That’s good advice.

I do have one question in retrospect:  If the Depuy case is likely to settle in the MDL process (pre trial), does the selection of a lawyer really matter? That is, given the MDL process, isn't the only role of the lawyer to file the complaint  with the court?  I think there are levels of settlement in this case according to the “damage” or “injury”. If it settles pre trail and you are on the list with a certain type of categorized injury, you’re done!  I suppose you can’t assume that it will settle so you have to retain a lawyer based on the fact that your case may end up in a trial which has to be litigated by someone however unlikely that may be.

I will offer more feedback on this as I complete the process of speaking with these lawyers.

Friday, April 22, 2011

List of the 14 lawyers appointed to serve on the plaintiff steering committee for Depuy hip litigation (MDL)

I published this list back when this group was appointed but given the plethora of lawyers purporting to be experts in this area, I intend to continue to remind patients that this is in effect a prescreened list of competent counsel appointed by the Judge who is responsible for consolidating these Depuy cases.

There are hundreds of law firms dealing with these Depuy hip cases.  I think this group of attorneys below is likely to be the most familiar with the issues on this case as they were all appointed by Judge Katz (the Judge in charge of the MDL hearings on the Depuy hip). These lawyers were selected as experienced litigators in matters of this sort.

I began phoning them in the last few days and have been impressed with all of those with whom I have spoken.  You can choose any lawyer you wish however, coming up to speed on this kind of complex litigation is a steep learning curve.

The chart below contains their contact information.  I am not recommending any one of them imparticular but I feel certain that a judge would likely appoint only those lawyers who have experience in large complex litigation and are familiar with medical device plaintiff litigation.

A bit of background on MDL (multi district litigation)  

In the United States, multidistrict litigation (MDL) refers to a special federal legal procedure designed to speed the process of handling complex cases such as air disaster litigation or complex product liability suits. Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States.

MDL cases are "civil actions involving one or more common questions of fact are pending in different districts."[1] In order to efficiently process cases that could involve hundreds (or thousands) of plaintiffs in dozens of different federal courts which all share common issues, the Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL and where to transfer the cases. Cases subject to MDL are sent from one court, known as the transferor, to another, known as the transferee, for all pretrial proceedings and discovery. If a case is not settled or dismissed in the transferee court, it is remanded (i.e., sent back) to the transferor court for trial.

The Plaintiff's Steering Committee will conduct all pretrial discovery, appear as counsel at all pretrial hearings, submit and oppose all motions, and explore settlements, among other legal actions.

(apologies that the chart goes outside of the page bounds but if you scroll to the right, the firm size (number of lawyers is listed as well.)



Law firm
URL to firm site
Practice Area
State
Phone number
# attorneys in firm
Esther Berezofsky
Williams Cuker Berezofsky

Class action /mass tort
NJ  (cherry hill) and PA (phila)
856-667-0500
13
Ed Blizzard
Blizzard, McCarthy & Nabers
http://www.blizzardlaw.com/
Pharma litigation
Houston Tx
(713) 844-3750
6
Jane Conroy
Hanly Conroy Bierstein Sheridan Fisher & Hayes LLP 
Mass tort/class action
NY
212 784 6400
8
Leonard Davis
Herman, Herman, Katz & Cotlar, L.L.P
Nationwide plaintiff practice
New Orleans LA
504 581 4892
17
Wendy Fleschman
Lieff Cabraser Heimann & Bernstein, LLP
Class action
San Francisco  CA
NY and
Nashville Tenn
212.355.9500
60
Lawrence Gornick
Levin Simes Kaiser & Gornick LLP
877 575 4529
Product liability
San Fran, CA
(888yyy
15
Seth Katz
Burg Simpson
Mass tort/class action
Co, Oh, Wy,   Az
1-888-895-2080
38
Mark Lanier
Lanier law firm
Civil trial litigation
Houston  New York  Los Angeles  Palo Alto
713-659-5200 main (Houston)
60
Michael London
Douglas & London, P.C
Plaintiff litigation
NY
212 566 7500
12
Donald Migliori
Motley Rice
Plaintiff litigation
800 768 4026
60
Nava Ward
http://www.beasleyallen.com/about/
Mass tort
Montgomery Ala
(800) 898-2034
60
Peter Polos
Panish Shea & Boyle LLP
http://www.psandb.com/about-us.html
Mass tort and product liability
LA
877-800 1700
11
*Ellen Relkin
Wietz and Luxenberg LLP 
Defective medical devices
NY
212-558-5500
63
*Steven Skikos
Crawford Skikos Joseph & Millican
Mass Tort and defective medical
San Francisco, Laguna Beach CA and Cleveland OH

9

*Co lead counsels of the plaintiff  steering committee