Friday, December 31, 2010

Smith & Nephew Hip Manufacturing Problems Result in FDA Warning

 

What Types of damages are recovered in product liability suits

posted by the Rottenstein Law Group.

In a product liability case (such as when a defective drug or medical device has injured you), there are four types of damages (money award) you can potentially recover:
  1. Compensatory damages: This is money to cover your actual medical bills, lost wages (if you had to take time off from your job), and any property damage (not usual with medical products) that occurred because of the defective product.
  2. Pain and suffering: You might receive additional money for the pain caused to you by your injury that was a result of the defective product.
  3. Loss of consortium: If your relationship with your spouse suffers, “loss of consortium” damages might compensate you for this circumstance.
  4. Punitive damages: These damages are meant specifically to punish a wrongdoer (such as a company that is not merely negligent but intentionally causes harm). Note that if a court does order a blameworthy party to pay punitive damages, some or all of the money might go to charities, legal aid funds, or other public organizations. Punitive damages are not intended to reward the victim.

DePuy Hip Replacement Recall Results in Three Canadian Class Action Lawsuits

DePuy Orthopaedics recalled 93,000 hip replacements worldwide in the summer of 2010. Since then, lawsuits against the manufacturer of the defective ASR XL Acetabular Hip System and the ASR Hip Resurfacing System began mounting. The most recent news of these is in Canada, where three class action suits are pending against the Johnson & Johnson subsidiary.

In mid-December, 1,500 DePuy hip replacement recipients filed a class action lawsuit in courts all over Canada. They received their implants between 2006 and the time of hip replacement recall. Of the two other class actions, one was filed in Quebec Superior Court against DePuy in November. The third is a much more ambitious undertaking. Filed in Calgary, Alberta, Halifax, Nova Scotia, and Montreal, Quebec, it names DePuy for its ASR hip replacements, Zimmer Corp. for its Durom Cup and Stryker Corp. for its Trident Acetabular PSL Cup and Trident Hemispherical Cup.

DePuy initiated its hip replacement recall after foreign artificial replacement registries demonstrated that they failed 12 percent to 13 percent of the time after only 5 years, even though hip replacements are supposed to last for 15 years.

The resulting litigation in the United States has proceeded somewhat more quickly than in Canada. Here, the United States Judicial Panel on Multidistrict Litigation (MDL) assigned all the DePuy pretrial procedural matters to Judge David A. Katz of the U.S. District Court, Northern District of Ohio. Of the 115 cases consolidated into MDL, several are class action lawsuits. The rest are individual cases that will benefit from the more efficient pretrial process that MDL provides.

Recall notice sent by Depuy to the orthodpedic surgeons

Full text of the letter can be found here:
http://www.depuy.com/sites/default/files/DPYUS1%20Recall%20Notice.pdf

Excerpts:

 DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASR™ System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter).

 DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent and for the ASR™ XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patient.

 Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products.

 Do not implant the ASR devices.

 Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome.

For patients who are symptomatic or implanted with a cup angle greater than 45°, particularly where a small component has been implanted:
o Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scans
o If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
o If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.

Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery.

connie

Nice event timeline of the Depuy hip recall disaster beginning in 2005

http://www.hiprecalllaw.com/a-timeline-of-the-catastrophic-failure/  Reprinted from Rottenstein law group site (so this is the view of a time line of events by a plaintiff firm

The recalled replacement hips manufactured by Johnson & Johnson/DePuy Orthopaedics did not become defective overnight. The evidence suggests that J&J has known for years that the products were defective.
Key dates and events include the following:
2005: J&J/DePuy introduces the ASR hip replacement system in the United States after winning a “510(k) clearance” from the Food and Drug Administration (FDA). Such clearance meant that the product was given regulatory approval without having to go through clinical trials.
2008: A report to the Medicines and Healthcare products Regulatory Agency (MHRA; the British equivalent of the FDA) finds “evidence of genetic damage in patients with certain metal hip implants” (such as the ASR system).
2008: The FDA receives 400 complaints from or about patients who had ASR devices installed. 13% of ASR hip replacement patients require a second surgery to replace the device(s)—a much higher failure rate than the industry standard.
2009: DePuy voluntarily withdraws the ASR system from the Australian market.
2010: J&J/DePuy announces that it will phase out sales of the ASR hip replacement system by the end of the year. The companies send letters to doctors warning that data from the Australian Medical Device Registry show a higher than expected failure rate of the ASR system, especially in smaller patients or those with weak bones.
J&J/DePuy continue to sell the defective ASR even after being warned for years by surgeons of the device’s problems.
May 2010: The London Times reports that “[MHRA] announced an official review in April of some 40,000 hip replacements. Doctors are warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.”
March 10, 2010: The New York Times reports that DePuy has warned doctors that its ASR system was failing patients within a few years after the replacement surgery, when such implants should typically be expected to last 15 or more years. To some this was considered a “silent” recall
June 15, 2010: Kathleen Margunau, a Florida woman, files the first DePuy hip recall lawsuit for harm caused by the ASR system. The suit, filed in federal court in Fort Myers, claims that Ms. Margunau received a DePuy ASR acetabular cup in March 2008 and began experiencing “extreme weakness in her hip and quadriceps” following surgery. Less than one year later, she required a second surgery, during which doctors, after removal of the hip implant, found that the device had catastrophically failed.
July 17, 2010: The FDA notifies the public that DePuy is recalling its ASR hip implant cups (FDA recalls nos. Z-2031 through Z-2059-2010).
August 26, 2010: J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. The decision is the result of a determination that the failure rate for both systems was over 12%

US Drug Watchdog.com.- Humm…a consumer advocacy group?????

I recently saw this posted on line and decided to call this group to see what they were all about.  Contrary to the information in the comments below, this purported consumer group referred me to one law firm who could take on a hip case. When I asked the gentleman on the phone how this consumer group was funded, he got angry.  I was very skeptical about this referral given the person couldn’t give me one good reason why they were making a referral to this particular law firm in Florida.  Further, this person told me they were paid to run various drug campaigns by wall street.  I found this whole conversation quite objectionable.

I decided to post this because a few weeks ago, another firm was posing has a new National Hip Registry attempting to get hip replacement victims to call in.  It was really a lead generation firm providing leads to litigators.

I can find no information on this company that tells me how it is funded.  I would be leery of contacting any of these groups posing as companies who are going to help you with your hip litigation by posing as a  consumer group advocate.

Here are the comments that lead me to call them:

The US Drug Watchdog is also saying, "don't fall for the sympathetic cable TV ad, offering assistance for DePuy hip implants, or phoney Internet ads offering compensation for victims. More often than not these ads offer zero value to the victim, so call us & we will give you the names of the highest caliber actual law firms working on this horrible situation." For more information ASR DePuy hip implant victims, or their loved ones can call the US Drug Watchdog anytime at 866-714-6466, or they can contact the group via its web site at http://USDrugWatchdog.Com

 

Unfortunately, in this case, I did not buy into this story.  If someone were advocating for the consumer, they should have a list of law firms on the  recommended list and certainly be capable of communicating what criteria was used to qualify the one law firm on their “recommended list.”

Connie

ASR implants possbily approaching 30% in various practices in England

Recent reports indicate that that the revision rate in ASR implants in England are approaching 30%.  (This had been reported by Herbert Phillips MD JD who is a fellow with the American Academy of Orthopedic surgeons and a mal practice attorney in Ashville NC. http://www.usamedlaw.com/articles/curriculum-vitae.pdf)

connie

Thursday, December 30, 2010

Additional questions for an orthopedic surgeon

1.  Is metal wear induced by debris from the implant the only cause of Osteolysis (loss or dissolution of bone around the implant) that results in loosening of the implant?

2.  Is it correct to state that pseudotumors will keep reemerging until all metal is removed from the body which entails revision surgery to a non metal replacement?

3. Why are metal toxicity tests indicated for patients experiencing pain with a metal implant if there are limitations to the measurements since they only measure free circulating ions in the blood rather than total levels? 

4.  How can you measure the total body metal load which may indicate particles spreading to the lymph nodes, liver and spleen?

5.  Given the ASR system affixes itself to the bone and is designed so that the bone grows into the implant, how much bone is lost when you replace this implant?

6.  If MRIs are best means for detecting metal and other problems from the implant, why are patients not given this test in conjunction with the soft tissue scan?  What are the risk vs reward?

7.  It seems that the protocol for correctly administering an MRI for the purpose of detecting the issues surrounding the implant is complex.  Shouldn’t a radiologist be used who has considerable experience administering the test for detecting hip issues given the complexity of the protocal required to detect the problems?

8.  What is the size of the cup used in your surgery?
  • cups with a smaller size fail at a higher rate
  • femoral head sizes less than 44 mm have  more than 5x the risk for failure over femoral componenets greater than 55 mm.
9.  What kind of clearance is there between the cup and the femoral head?
  • wear could be reduced up to 80% with clearances ranging from 70-100 micron clearance but other implants on the market have clearances between 200 to 400 microns
  • If the cup has been placed exactly at the 45 degree angle you might have low ware but few physcians seem to be able to excute that placement.  It is important that the xray confirms the 45 degree angle placement.  If it is off, the chance of having  metal fragments appear increases significantly.
10.  What does this mean?  What is a poorly performing hip?  Is it x-rays alone that demonstrate metal debris or is it xrays accompanied by symptoms?
 Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome (taken from the recall notice to orthodpedic surgeons on 8/24/10.)

connie

Metal Sensitivity (from Wikkipedia)

Although little is known about the short and long term pharmacodynamics and bioavailability of circulating metal degradation products in vivo, there have been many reports of immunologic type responses temporally associated with implantation of metal components. Individual case reports link hypersensitivity immune reactions with adverse performance of metallic clinical cardiovascular, orthopedic and plastic surgical and dental implants. [9]

By 2010 reports in the orthopaedic literature have increasingly cited the problem of early failure of metal on metal prostheses in a small percentage of patients.[10] Failures may relate to release of minute metallic particles or metal ions from wear of the implants, causing pain and disability severe enough to require revision surgery in 1–3% of patients.[11] Design deficits of some prosthetic models, especially with heat-treated alloys and a lack of special surgical experience accounts for most of the failures. Surgeons at leading medical centers such as the Mayo Clinic have reported reducing by 80 percent their use of metal-on-metal implants over the last year in favor of those made from other materials, like combinations of metal and plastic.[12] The cause of these failures remain controversial, and may include both design factors, technique factors, and factors related to patient immune responses (allergy type reactions).

In the United Kingdom the Medicines and Healthcare products Regulatory Agency commenced an annual monitoring regime for metal-on-metal hip replacement patients from May 2010.[13] Data which is shown in The Australian Orthopaedic Association's 2008 National Joint Replacement Registry, a record of nearly every hip implanted in that country over the previous 10 years, tracked 6,773 BHR (Birmingham Hip Resurfacing) Hips and found that less than one-third of one percent may have been revised due to the patient's reaction to the metal component.[14] Other similar metal-on-metal designs have not fared as well, where some reports show 76% to 100% of the people with these metal-on-metal implants and have aseptic implant failures requiring revision also have evidence of histological inflammation accompanied by extensive lymphocyte infiltrates, characteristic of delayed type hypersensitivity responses. [15] It is not clear to what extent this phenomenon negatively affects orthopedic patients. However for patients presenting with signs of an allergic reactions, evaluation for sensitivity should be conducted

Connie

Claims by presenters re Depuy behavior at the HarrisMartin Litigation conference materials I found of interest:

  • Depuy OrthoPedics was charged with conspiring to violate antitrust kickback statute in 2007.
In September of 2007, Depuy Orthopedics was charged with conspiring to violate antikickback statute by using financial incentives to encourage surgeons to use their specific devices.  DePuy avoided prosecution by agreeing to new corporate compliance procedures and federal monitoring..[This is indicative of inappropriate behavior evidenced by Depuy but is not directly related to the ASR system per say.]

  • The ASR system (the recalled item) was approved by the FDA for THR (total hip replacement) although it appeared that this system was NOT designed for THR (total hip replacement.)
ASR was purportedly meant for hip resurfacing not total hip replacement. Instead of being completely replaced with a new head and cup, the femoral head is reshaped and a cap is placed over it.  There is NO stem involved.  The femoral neck is resurfaced only and glides against a cup implanted in the socket.

In order to use the ASR system for resurfacing surgery, DePuy would have had to conduct clinical trials to prove the safety and efficacy of this device.  The FDA never approved this device for resurfacing in the US but as discussed in other posts on this blog, the FDA approved the use for a THR based on the 501k process whereby Depuy claimed it was "substantially equivalent" to other devices that were previously on the market.

The ASR XL Acetabular Head System was advertized as a high performance hip replacement and also as an alternative to THR AND Resurfacing.  The XL System was marketed next to hip resurfacing while highlighting the advantages of ASR THR over Resurfacing.  The latter again, was not approved in the US for sale by the FDA.

In the packet describing the ASR System, the following claims are made:
   -preserving bone
   -reducing wear
   -affixes itself to the thigh bone (all of which-as it turns out, are reasons why the implant is    being removed in patients.)
    -product has a strong clinical history

·         On August 19th, 2010, the FDA warned Depuy that it was illegally marketing two products for uses that were NOT approved by FDA, neither related to the recalled hip replacement system. [This is indicative again of inappropriate behavior by Depuy but is not directly related to the Depuy ASR system per say.]

Sunday, December 26, 2010

Rottenstein Law Group Warns DePuy ASR Hip Recall Victims About Misleading Web Sites Soliciting Information for “Joint Registry”

Apparently prompted by news of current efforts to create in the United States institutions similar to joint replacement registries such as the ones in Australia and the United Kingdom, at least one law firm here has sponsored a Web site that was evidently designed specifically to give the impression that it was being operated by a governmental entity (the non-existent “National Hip Recall Registry”). To the contrary, however, the site, which was publicized in press releases purportedly coming from Washington, D.C., was a private site maintained by a “lead-generation” company for the sole purpose of identifying potential clients for the sponsoring law firm. RLG determined that this particular misleading site, which has since been taken down, was sponsored by a White Plains, New York personal injury lawyer.
Prompted in large part by the recall of DePuy’s ASR hip replacement devices in August, the American Academy of Orthopaedic Surgeons is initiating a pilot program, the American Joint Replacement Registry (AJRR), in 15 hospitals to track recipients’ basic information and data on their doctors and implants. The federal government is also creating a registry, the National Orthopaedic Outcome Registry (NOOR). The hope is that these registries will help implant recipients avoid the problems being faced currently by those with faulty DePuy devices

http://www.rotlaw.com/blog/rottenstein-law-group-warns-depuy-asr-hip-recall-victims-about-misleading-web-sites-soliciting-information-for-joint-registry/

Part Two of Two: How was it designed? Excerpts from the HarrisMartin Conference (www.HarrisMartin.com) on the issues surrounding the Depuy hip recall held in November

I think this first section Part One: Development of the Product/How it was designed,  is nicely presented in language that is easy to follow. The course is worth purchasing for those of you who want to study the different implications and ramifications of the hip recall issues.

1.       The Depuy ASR hip has an “open back” design which means the acetabular component is designed to fit snugly without the use of screws or adhesive (cement.)  The outer surface of the hip cup is rough and porous allowing for the patient’s bone to grow into the back of the cup and secure it in place.
·         This feature is supposed to have the advantage of being a very strong and secure bond when the surface combines with the bone.
2.       One of the designers of the hip allegedly stated that the hip design of the Depuy hip which  was based on the Birmingham hip replacement (BHR), did not have the same characteristics as the Depuy hip.  The Depuy hip turned out to have a SMALLER acetabular cup so the suction tool used to place them was ineffective in implanting them. 
3.       A new tool had to be designed to put this piece in place but in order to accommodate this new tool, Depuy reportedly decided to reduce the rim size of the cup by about 5 degrees, making the ASR less forgiving for implanting surgeons and thus more prone to failure.
4.       The ASR design may be flawed because it uses the lowest tolerances in the industry.
·         The ASR design contains a size difference between the ball and cup of 80 and 120 microns vs the other MoM implants which have tolerances between 100 and 240 microns.
5.       When the size difference between the ball and cup becomes too small, the edge of the femoral ball purportedly wears against the edge of the cup because the fluid film barrier that provides the lubrication to the two surfaces is too thin.
6.       One of the inventors on the design team for the hip (Dr. Schmalzried) stated in an interview in Feb of 2010 in the NY Times article that he and the Depuy officials realized within the last two years, the ASR cup might be more challenging to implant properly than the competing cup.
7.       Dr. Schmalzried received $3.4 million in payments for his design and related fees between 2008-2010.
8.       In a study conducted by Schmalzried in 2005, he and another investigator asserted that metal ion levels are well within safe levels laid down by toxicologists.  They did admit that there are limitations to the measurement of these levels since the tests measure the free circulating ions in the blood rather than the total ion levels.
·         Metal particles have been shown to spread through the reticuloendothelial system (lymph nodes, liver, spleen) in patients with MOM implants.
·         If the implants were not positioned properly however, the ware rates can increase significantly and the metal levels can exceed the normal limits and cause tissue necrosis.

Excerpts from the HarrisMartin Conference (www.HarrisMartin.com) on the issues surrounding the Depuy hip recall held in November. You can purchase this full course directly from HarrisMartin Publishing.

Saturday, December 25, 2010

Excerpts from the HarrisMartin Conference (www.HarrisMartin.com) on the issues surrounding the Depuy hip recall held in November: (You can purchase this full course directly from HarrisMartin Publishing.) I think this first section (Part One: Development of the Product) is very nicely presented in language that is easy to follow. The course is worth purchasing for those of you who want to study the different implications and ramifications of the hip recall issues.

Part One of Two:  The ASR hip Product/What is it?

1.       Depuy ASR hip implants are part of a class of large diameter, monoblock (single piece in which the femoral head and stem are attached as one.)
1.      Large diameter ball purportedly has the advantage of being more stable and has a better range of motion so less likely to dislocate.
2.      The panelists point out however that  as the diameter of the femoral ball increases, the surface area of the bearing increases apparently resulting in increased contact and faster wearing of the bearing
·         THR (total hip replacement) consists of 3 parts:
1.      femoral stem
2.      femoral head/ball (usually plastic)
3.      Acetabular cup or socket
·         Surgeon hollows out the patient’s femur and implants the femoral stem into the patient’s femor which has a head mounted on top of it.
·         The patient’s femoral head is removed and replaced with a new head implant.
·         The cup is fitted into the existing acetabular socket.
·         When the ball is inserted into the liner, the hip joint is formed.

2.       In the MoM (metal of metal) implant, the metal femoral ball is placed in direct contact with the metal acetabular cap WITHOUT USING A LINER.
·         Removing the plastic liner allegedly allows for the use of the femoral heads that are close to the size of the natural hip.  Thus, there should be less friction. Wear and the chance of dislocation are reduced. 
·         Theoretically, these MoM implants are considerably more durable than other implant materials like ceramic-on-ceramic or meal-on-polyethylene and thus more appropriate for younger patients who need a long lasting replacement.
·         The problem arises because the MoM implant generates:
1.      Greater wear debris
2.      This debris can cause complications
3.      Complications can result in
1)      poor functioning of the current implant
2)      future surgeries
3)      systemic disease risk

Watch for part two: How was the product designed?

Connie

Tuesday, December 21, 2010

jan 20th-next MDL hearing

The next court hearing on the MDL is scheduled for January 20 before U.S. District Judge David A. Katz

Canadian suits filed against Depuy

Three more class action lawsuits have been filed in Canada against Johnson & Johnson and its subsidiary, DePuy Orthopaedics, over recalled DePuy ASR metal hip implants
The DePuy hip replacement class action lawsuits were filed this month across Canada, and seek to represent the 1,500 Canadians who received DePuy ASR XL Acetabular System and ASR Hip Resurfacing System implants from 2006 until they were removed from the market in August.
These latest lawsuits follow at least two other DePuy ASR class action suits filed in Canada in November, one of which also included claims for individuals implanted with certain Zimmer hip replacements and Stryker hip replacements.

Part Three: Early Failure of MoM bearings in Hip Resurfacing and large-diameter hip replacement/Jrnl of Bone and Joint Surgery, Jan 2010.

My key take-a-ways (reminder/I am not a physician so this is a consumer perspective of what I believe to be the highlights of this study):

(1)   Although debris from MoM replacements may cause local tissue reaction, systemic effects (materials that affect more than one area of the body) have yet to be demonstrated. I think this is important because the litigators certainly have been claiming that the high levels of Cr and Co levels can cause other things such as cancer, kidney problems that would affect other body areas.

(2)    There  is currently no clear consensus in the literature defining the boundaries of the following terms (interesting given the clear delineation in these terms by the litigators;
a.       Metallosis
b.      ALVAL (aseptic lymphocyte-dominated vasculitis-associated lesion)
c.       Pseudotumor
      
(3)   Generally, tissues examined following revision surgery often exhibit a combination of the above pathologies. They used the term ARMD as an umbrella term to describe joint failures associated with all of these pathologies.
                                                    i.      Without exception, the literature reports an increased incidence of these problems in women.

(4)   87 patients received full hip implants vs a resurfacing procedure not approved for the Depuy hip in the US.  Of these 87 patients, 6% thus far have required replacement after an average of 41 months.
a.       The authors stated that the figures “likely represent the best case scenario.

(5)   There were statistically significant differences in 7 areas between the symptomatic and asymptomatic groups:  Whole blood levels and serum levels of Cr and Co, the angle of the component that fits into the concave surface of the pelvis and the size of the femur.

(6)   Patients experiencing joint failure as a consequence of ARMD:
a.       Have significantly smaller, suboptimally oriented components
b.      Greater wear
c.       Increase in the production of metal debris increases the risk of adverse local tissue reactions
                                                    i.      Levels of blood ion levels correlate well with wear
d.      The location of the articular contact in the standing position of the patient is crucial in the development of high ware states.
                                                    i.      The closer the contact lies to rim of the concave component the greater the chance of increased level of blood/metal ion levels.
                                                  ii.      The smaller the contact patch to the rim distance, the greater the incidence of the symptoms (ARMD.)
                                                iii.      Women are more likely to experience greater ion concentrations due among other things to the smaller joint size.
e.       High metal ion concentrations are associated with a disturbing amount of tissue necrosis even when the patient remains asymptomatic.
f.       Other studies have concluded that massive concentrations of CR and CO ions in the joint fluid alone could alone explain the tissue necrosis.
g.      Chromium is likely sequestered in the joint space while Cobalt is more easily released into the circulation.
h.      Greater failure is experienced when the femoral head is less than 49mm-Ask your surgeon what the size of the femoral joint head was.

(7)   Surgeons must consider the following in placing MoM implants in order to reduce failures when performing the MoM hip implants:
a.       Implant design
b.      Expected component size
c.       Positioning of  the acetabular implant

Connie

Saturday, December 18, 2010

Part Two: Early failure of MoM bearings in hip resurfacing and large-diameter hip replacement/Jrnl of Bone and Joint Surgery, Jan 2010

Abstract Highlights:

·        660 MoM resurfacings –ASR and Birmingham Hip (BHR)-AND large-bearing ASR total hip replacements to establish associations with metal debris and associated failures. (By the way, resurfacings were not approved for sale by the FDA in the US. These results are posted by British MDs which appears to be the origin of most of the study data.)
·         3.4% were identified (all ASR bearings) with adverse reactions to metal debris for which REVISION WAS REQUIRED.
·         This symptomatic group had significantly different observations than the asymptomatic group in 4 areas:
o   Smaller components (more below)
o   Higher component anteversion (more below)
o   Higher concentrations of blood and joint chromium and cobalt ions
o   Greater surface ware

Stay tuned for Part Three

Connie

Part One: Fascinating article published in Jan 2010 in the Journal of Bone and Joint Surgery on the problems associated with failure of MoM hip replacements.

( From the Journal of Bone and Joint Surgery [Br] 2010;92-B:38-46)

I will present my overview of this in two parts.  Following is Part One.

I found this study to be a good encapsulation of the problems surrounding MoM hips dating from 1975 in the bibliography. The bibliography noted the following 35 articles from the medical literature re issues surrounding MoM implants:

·         18 articles dealing with Cobalt Toxicity, abnormal blood metal levels and hypersensitivity with MoM implants.
o   7 of these were pre 2000!.... 10 years ago!
§  1 in 1975
§  1 in the 80’s
§  5 in the 90’s
·         7 articles dealing with hip positioning
o   1 article predated 2000
·         3 articles dealing with soft tissue damage
o   None predated 2000
·         2 articles dealing with the appropriate age and sex targets for the MoM implants
o   None predated 2000
·         2 articles dealing with wear rates
o   None predated 2000
·         2 evaluations
o   Both predated year 2000
·         1 causes and prevention
o   Written in 1990

This is one recent article with what would appear to be a reasonable bibliography on the hip problems.  It would appear that issues surrounding the MoM implants were all surfaced on numerous occasions over the years.

Stay tuned for part two.

Connie

Wednesday, December 15, 2010

My Big Open Question

There have been many reported incidents that have required an immediate hip replacement.  It appears that there is general agreement that 13% of the patients who received that hip fall into that category.  These patients are experiencing consistent pain and can’t function without a replacement.  What about the patients who are in my category…intermittent pain and symptoms or no pain and no symptoms.  Further, what about the patients who are currently asymptomatic?  Is action required only when you are symptomatic with consistent pain? 

In an effort to answer this question for myself, I have ordered the medical studies conducted on these implants to try and get clarity on this question. 

Examples:
·         If you aren’t experiencing pain, don’t do anything.
·         If you leave this device in, eventually it will cause irreversible problems
·         If you aren’t experiencing pain and the hip is properly placed, your fine.
·         It is difficult to get agreement among the Orthopedic surgeons on what exactly the proper placement is…more on this in a subsequent post.
·         If you aren’t experience pain and your blood levels of Cr and Co are high, we have to monitor you.
·         You don’t need an MRI if the ultra sound and the blood tests are returned with no evidence of a problem.
·         MRI s are the best method of detecting damage caused by this MOM hip.

Get the picture?  Talk about conflicting information!

I personally have found the conflicting information quite distressing and I am close to concluding that no one knows the answers.  In light of that, I thought it might be prudent to examine the studies myself to at least highlight the constancies and inconsistencies I find.

Yesterday, I sent out a note to some of my friends in the medical community whose opinions I value as being objective and informed and was surprised to receive a first answer back yesterday. Based one observation, the first MD thought I should strongly consider removing this hip.  This is a conservative MD.   I would characterize her as smart, cerebral and thoughtful.  Gee, her response  really made me think.

So, I will begin reporting on what I find in my search to help make this decision:
As a patent who is not experiencing constant pain but who has the following symptoms, should the hip be removed?  Yes or No?:

·         Intermittent problems with the hip which sometimes last up to 2 weeks where I have resorted to a cane to improve mobility.
·         Images that show the presence of metal pieces surrounding my hip
·          The presence  of progressing Osteolysis involved in the acetabulum
·         Previously noted fluid collection in the left hip bursa.  It has dissipated now.
·         A hip placement that is “perfect” according to the orthopedic surgeon
·         Blood levels not yet received on the metal levels but let’s just assume they are not at what might be termed toxic levels. (I will report on those results once I get them.)

From what I have read thus far, my hunch is that many more people fall under this category than those that are suffering continuous pain.  It is also my hunch after reading what I have in the last month  that big problems might result from leaving this hip in place.

After having spent a month combing the web news stories, blogs and other sources, I am ready to dive into the medical literature.  While I have no medical training, I am very interested in what I find in reading the studies myself.

More as I uncover the studies.

Connie

Sunday, December 12, 2010

Using MRI’s with an optimized protocol to detect metal debris by Hollis Potter MD http://accordent02.origindigital.net/dmn/NOV18MARS_Archive/main.htm

Great web cast –made for Surgeons-which I found to be very informative but it is very technical.

 Normally, you will be asked to get an x-ray, an ultra sound and blood test to detect metal debris associated with the implant.  Dr Potter proposes 3 observations surrounding MRIs that are optimized using medical artifact reduction sequencing:
·         MRIs can be used to assist in evaluating tissue surrounding the joint replacement with special sequencing.
o   She said that MRIs can detect synovial response before it proceeds to bone loss.
·         MRIs are more sensitive than x-rays with the right protocol.
·         MRIs are the most accurate way to detect bone loss following an implant

I will be asking my Surgeon why I would postpone getting an MRI protocol run even if the blood level of metal is not high (this is used to indicate further testing which might include an MRI.)  My last CTs showed that I have progressing osteolysus involving the anterior medial acetabulum.  Fluid collection was noted last year in the left bursa which has resolved for now. Last year, that accumulation of fluid was attributed to the metal debris.  This CT scan was NOT done to detect problems with the implant.  I was following up on another medical issue and this was all noted by the radiologist because he couldn't see the pelvis very well due to the "streak artifact" in the x-ray from the metal debris.

Connie

Class Action vs Mass Action suits/ some excerpts from http://sullolaw.blogspot.com/2010/12/why-depuy-hip-recall-wont-be-action.html

When a class action lawsuit is filing, it must name one or several plaintiffs on the behalf of a proposed "class" of people. The "class" of people are individuals or business entities who have suffered a common injury or injuries.
Class actions must include a group of individuals with similar damages. Though all the people who received an ASR XL Acetabular System and a notification of the DePuy hip recall have the same hip implant, the injuries they have suffered are extremely wide and varied.

In a mass action lawsuit, most lawyers will agree to bring the case on a contingent fee basis, which means that you owe nothing if the case is lost. The lawyer takes the risk of funding the case up front in exchange for a portion of the awarded compensation at the conclusion of the case.

This is also true for class actions, with one significant difference: there are limits on the percentage of the compensation a lawyer is permitted to recoup at the conclusion of the case in mass action cases. In most states, the limits are between 30-40% of the total compensation. Though that number may seem high, recall that the lawyer is funding the case throughout the time period it is being brought, which may be years. The lawyer is taking significant risk and asking for no fees until the case is successfully concluded.

In most cases, Mass Tort claims are brought when consumers are injured on a large scale by defective drugs or defective products. Drugs and product defects can cause a wide range of problems for different individuals, so all cases rarely fit into a single class.

Connie

Did your DePuy Hip Surgeon Receive Compensation from DePuy?

This article was one of the few I’ve seen that actually published the list of surgeons who’ve received compensation from DePuy Orthopaedics. The list includes around 200 surgeons nationwide who received a total of over $80.8 million.  The list is found on the Depuy web site as well.

From the Connecticut Health I-Team (C-HIT), a non-profit publication focusing on health and safety issues.

http://www.lawyersandsettlements.com/blog/did-your-depuy-hip-surgeon-receive-compensation-from-depuy-05970.html

Thursday, December 9, 2010

Summary of the Federal Court suits against Depuy

All of the complaints involve similar allegations that DePuy and Johnson & Johnson failed to adequately research their metal-on-metal hip replacement system and failed to immediately issue a recall after it became apparent that users were experiencing a higher-than-expected rate of problems with DePuy ASR hip implants.

Each of the cases initially being transferred into the MDL come from a different federal court district, including two from different districts in Alabama, and one from California, Kentucky, Illinois, Mississippi and Utah. An eighth case, from the District of Maryland, was excluded because the plaintiff does not have a DePuy ASR-series implant.  Two other cases may be excluded later by Judge Katz if it is discovered the plaintiffs do not have ASR implants.

The MDL panel said that the two cases were vague about the types of implants involved, but decided to allow Judge Katz to make the ruling on whether they should be removed from the MDL after further discovery. In placing the cases in Ohio, the court rejected the plaintiffs’ suggestions of consolidation in Texas and Alabama and chose a federal court which attorneys for DePuy had suggested.

Consolidation of the DePuy hip recall litigation before one judge as part of an MDL is designed to reduce duplicative discovery, avoid contradictory rulings from different judges and to serve the convenience of the court, witnesses and parties. While the pretrial management of the cases in an MDL is often managed similar to how a DePuy ASR class action lawsuit would be handled, each claim will still remain an individual lawsuit.

If a DePuy hip recall settlement agreement is not reached following pretrial proceedings and any bellwether jury trials, each of the consolidated cases would be remanded back to the jurisdiction where they were originally filed for trial.

Published in part from Aboutlawsuits.com http://www.aboutlawsuits.com/depuy-hip-recall-lawsuit-mdl-formed-14692/

Wednesday, December 8, 2010

Nice metal-on-metal round table discussion with 4 orthopedic surgeons: Pros and cons discussed.

Excerpts from that discussion.  The full discussion can be found here:  http://www.orthosupersite.com/view.aspx?rid=78136  
Five questions were asked by the moderator:
(1)    What are the advantages of MOM (metal on metal) bearing use for both total hip and surface replacement?
(2)    What are your patient’s indications and contraindication is considering the use of the MOM bearings?
(3)    Are there particular design caveats which the orthopedic surgeons should be aware of?
(4)    In your practice, what is the current percentage of  MoM use in THA procedures and if applicable, surface replacement?
(5)    The overall percentage use of the MoM bearings has diminished in the US over the past 3 years.  Has this occurred in your practice and for what reasons?


Things I found of interest:
·         MoM is most often used by this group for resurfacing rather than implants. 
·         Contraindications of MoM  implants:  
o   Patients with metal sensitivity
o   Woman of childbearing age
o   Patients with significant renal impairment because the kidney is the primary pathway for ion excretion
o   Woman in general are at greater risk for hypersensitivity reactions to the MoM bearing.
·         Indications:
o   Primarily young active males
o   High demand male patients
·         Design caveats the surgeon should be aware of:
o   Proper positioning of the implant is critical to minimizing wear and tear
o   Even if placed properly, some of these components if placed correctly at a 45 degree angle function with large variances
o   Selection of the implant should be  based on designs that have been shown to work well for at least 5 and preferably 10 years.
o   Not all MoM implants are created equal.
·         The percentage of patients in their practice that are given the MoM implant (4 surgeons):
o   5%-10%
o   25%
o   Use to be 95% now he dropped it down to 2%
o   Only on young , fit, active men with normal hip anatomy
·         They all have reduced the use of metal in their practice now.

Connie