Sunday, November 28, 2010

Questions to ask Your Physician on a First Visit:

This is my preliminary list regarding the initial questions for my first appointment with my surgeon on November 30th. If anyone has additional questions that I missed, let me know.

Discuss any symptoms with my doctor.

How do I know if I need a revision surgery?

If revision surgery is necessary, do I have to receive a replacement hip manufactured by DePuy?

Given the allegations surrounding the problems associated with the devise, should it just be replaced regardless of the presence of symptoms and the severity of them?

Should the surgeon who installed my original hip replacement perform the revision surgery to replace my faulty device?

What tests need to be done for each of the 6 things below and what is the overall plan for monitoring these things?

What is the probability (via data if there is any) or likelihood of any of these conditions below occurring?

What are the symptoms associated with each of these conditions which have been alleged to be caused by this hip replacement? (see other sections of this site for more information on these issues):
  1. Aseptic Lymphocytic Vasculitic Lesion (ALVAL)-
  2. Osteolysis
  3. Metallosis
  4. Cobalt Poisoning
  5. Pseudotumor
  6. Cancer

What are the exact precipitants (describe them) for having the surgery given some of the allegations re problems do not result in pain?

What is the issue with filing with Depuy…Will the patient  have to give up records in order to get reimbursed  for visits like this and or provide releases?

Why have you asked me to register with Depuy prior to this first visit?

What are you going to do with my medical records as they relates to Depuy?

Does my orthopedic surgeon have a financial interest in DePuy?
  • Guarantees to use the product
  •  Financial remuneration for referring patients to Depuy?
  •  other

Why did your letter to patients....
  • Seem to minimize the problem in the light of the evidence?
  • Advise that we should contact Depuy prior to the appointment?
Connie

Saturday, November 27, 2010

Conferece Covering The DePuy Hip Implant Lititgation by HarrisMartin Publishing

 Reprinted from a Post by Michael Phelan November 21, 2010 12:57 PM

"The Judicial Panel on Multi-District Litigation (JPMDL) convened on November 18th in Durham, NC. One of the matters on the docket was the Johnson & Johnson® DePuy hip implant litigation. The day before the hearing, HarrisMartin Publishing put on a fantastic conference covering the DePuy hip implant litigation.....

Here are some highlights from the conference:

• DePuy's early estimates of the failure rate for its recalled hip devices is probably way too low. Some experts estimate failure rates to be between 25% and 100%.

• There may be a defect in the design of the ASR cup making it extremely difficult for good surgeons to properly locate the cup in a position that is consistent for good, long-term function. [This increases the liklihood of failure. DePuy may be blaming innocent surgeons for incorrect positioning of the device rather than accepting responsibility for the design defect.].

• Foreseeable adverse health effects from wear debris from MoM bearings are already starting to appear in the few short years that these devices have been actively marketed.

These include:

1. Aseptic Lymphocytic Vasculitic Lesion (ALVAL)- which is a localized hypersensitivity reaction to metal wear debris. ALVAL may result in persistent groin pain, cup loosening, osteolysis, dislocations, and periprosthetic fractures. Patients with ALVAL who have MoM revision may experience persistent symtoms associated with hypersensitivity to the metal debris.

2. Osteolysis- is loss or dissolution of bone around the implant which causes the implant to loosen. The bone loss is the result of metal wear debris-induced problems, and often requires revision surgery before it progresses to extensive bone loss.

3. Metallosis- is the result of the MoM implant rubbing against itself. The resulting friction creates metal shavings which may be deposited into the metal socket of the device and in surrounding soft tissue. Symptoms include groin, thigh, or hip pain, instability, fluid-filled masses, tissue necrosis, metal staining, and osteolysis.

4. Cobalt Poisoning- is the result of increased levels of cobalt metal in the body. High levels of cobalt from these implants can cause serious toxic health effects, including cognitive impairment, visual impairment, auditory impairment, hypothyroidism, cardiomyopathy, peripheral neuropathy, and rashes.

5. Pseudotumor- is a mass or lesion which is neither infective nor neoplastic. They can be fluid-filled or solid masses around the device. Some research suggests pseudotumors will keep reemerging until all metal is removed from the body, which requires revision surgery utilizing non-metal implants.

6. Cancer- These MoM implants contain cobalt and chromium. Readers may recall that chromium was once used to make automobile bumpers, and that there was a high incidence of cancer associated with chromium in the factory workers who made the bumpers. When wear debris from a malfunctioning MoM implant causes increased chromium load in the body, that toxic exposure may cause adverse health effects including cancer, malignant sarcomas, and leukemia, according to studies.

The bottom line is that people who have been implanted with a defective DePuy MoM implant may be facing more than just a revision surgery. These cases should also be investigated as toxic exposure cases, which means that, when possible, it will be important to analyze not only explanted devices, but also tissue and fluids from explant surgeries. DePuy knows this and is making extraordinary efforts to have its sales representative present in the operating room and taking custody of the explanted devices. DePuy's protocol for handling the explanted devices includes "decontaminating" them. The decontamination process is likely to result in destruction of tissue and fluid evidence. Thus, it is crucial that patients know prior to revision surgery that evidence must be preserved.

The JPMDL has not yet decided the judge to whom it will transfer the DePuy MDL."

http://richmond.injuryboard.com/medical-devices-and-implants/update-on-depuy-hip-implant-litigation.aspx?googleid=286204

https://harrismartin.com/conference/materials/786/

Thursday, November 25, 2010

More on the FDA Approval Process for Hip Implants

I have posted other information on this topic but I found the article written by Lacy Boggs very informative in raising questions about the process used by the FDA to approve this particular implant for market.
http://sullolaw.wordpress.com/2010/11/15/what-is-the-fda-approval-process-for-hip-implants/

As noted previously in a former post, the 501(k) process was used to gain approval of the Depuy hip through the FDA. This process is kind of a fast track that enables companies who submit devises that are “substantially similar” to those already on the market, a sort of reprieve from extensive testing. In theory this makes sense however, the definition of “substantially similar” can be viewed by manufacturers in different ways.

Mr. Boggs points out:
• It is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing.
• 90% of claims require no clinical testing whatsoever before being sold to patients
• Many people note that the 501(k) process amounts to an enormous loophole, through which many companies bring under-tested products to market. With better testing, the DePuy hip recall might have been avoided altogether.
• On August 4, 2010, the FDA issued two reports that recommend sweeping changes to the 510(k) process and procedures. We can only hope they include actually testing the products to which the FDA affixes its seal of approval.

Connie

Metallosis (excerpts)

Metallosis is usually defined as aseptic fibrosis, local necrosis, or loosening of a device secondary to metallic corrosion and release of wear debris.

Numerous factors lead to polyethylene wear, which subsequently affects primary THA survival. Progressive polyethylene wear is associated with the occurrence of osteolysis, especially overlying the acetabulum, which can lead to component loosening and subsequent revision.

According to a report at DrugWatch.com, the DePuy devices have been linked to a condition called metallosis. When two metals rub together, as they do with these joint replacement devices, they release dangerous levels of chromium and cobalt ions.

At least 3.4 percent of British patients observed for a recent study of the effects and risks of metallosis eventually developed the condition. The risk is high with these devices - recalled in August - because the natural motion of the hip causes these two metals pieces to rub together constantly, creating tremendous amounts of friction.

Doctors say that the metal toxicity from chromium and cobalt debris entering their blood stream and causing serious injury may affect all DePuy hip patients.

Here is a linnk to a study often cited on the relationship between Metallosis and loosening of the replacement joint:

http://www.ejbjs.org/cgi/content/abstract/88/6/1183 “periprosthetic osteolysis and aseptic loosening in hips with a metal-on-metal articulation are possibly associated with hypersensitivity to metal debris.”

A great article by Taylor Lindstrom on this subject appears at: http://sullolaw.wordpress.com/2010/11/15/how-the-asr-xl-acetabular-system-causes-metallosis/

Generally, I excerpt key issues from longer posts if I find something of interest but this is such a great description on how metallosis is caused that I thought it was worth having you read it. I reprinted this article in its entirety in the post below.

Connie

The Depuy ASR Hip Implant May be Linked with a Condition Called Metallosis

This is an excellent Article reprinted in its entirety from Taylor Lindstrom that I found on Sullo & Sullo's site. It addresses how the Depuy ASR hip implant may cause metallosis. My purpose is not to advocate that the hip implant causes any condition but rather to expose the questions that are arising as a result of investigations into the issues surrounding the device recall.

“Johnson & Johnson has announced that its subsidiary company Depuy issued a voluntarily recall of their ASR hip implant due to a number of patients who required a second hip replacement procedure, called a revision surgery.

No mention was made of metallosis in the Johnson & Johnson press release. In fact, Johnson & Johnson didn’t mention any of the more significant symptoms patients are suffering after receiving a DePuy ASR XL hip implant. They would prefer that the public believed the revision surgery process is simple and fixes the problem of a faulty hip implant with absolutely no long-term effects.

We’re recommending you get a second opinion – and a blood test.

Metal-on-metal hip replacement bearings like the DuPuy ASR XL Acetabular System total hip replacement were originally reintroduced as an alternative to metal-on-plastic or ceramic hip replacement systems. Metal-on-metal implants (for a hip implant, this is a design that involves both a metal ball and a metal socket) have certain advantages over plastic or ceramic when the design is properly engineered. They last longer, have high resistance to wear and tear, and can withstand more vigorous activity, making metal-on-metal the usual choice for surgeons with younger, more active patients who are going to put more strain on their implants.

However, a poorly engineered metal-on-metal hip resurfacing system has considerable complications, many of them more serious than their ceramic or plastic counterparts.

The Blue Cross Blue Shield Association Technology Evaluation Center report on metal-on-metal total hip resurfacing notes that metal-on-metal systems have risks of elevated heavy metal ion levels, delayed hypersensitivity to metals, and even carcinogenesis – cancer, to the layman.

All hip replacement systems release tiny particles of the implant’s material into the body when the two parts of the hip replacement rub against one another. In metal-on-metal implants, a small amount of friction and metallosis is predictable and part of the considered risks when the surgeon recommends a certain type of hip implant.

However, when the metal parts are improperly made or installed, the friction releases much more metal into the bloodstream, causing serious metallosis and metal poisoning.

Engineers who have examined the DuPuy ASR hip replacement system noted several design flaws that contributed to increased metallosis and metal poisoning in patients. The implant is shallower than most other hip replacement systems, which made it much more challenging to implant than other systems. DePuy was fully aware of this setback; their instructions to the surgeon recommended a much more precise placement than other implants.

One engineer we consulted with went on to note that the requirements for placement were so specific that only about 3% surgeons would be able to place the hip implant properly. This is not a comment on the surgeon’s skill; the engineer was quick to note that the placement demands would be impossible for all but the most skilled and experienced surgeons, and even then the surgeon would have to be fully informed of the importance of precise placement.

What’s more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal.

Among patients who were experiencing pain with their DePuy ASR XL Acetabular system and took a blood test, we’re seeing levels even higher than that.

These metal particles, or ions, are released enter the bloodstream where they encounter and bond with proteins normally found in the body. The resulting new particles look foreign and activate the body’s immune system. White blood cells are dispatched fight the foreign particles, and the white blood cells create antibodies to fight off what the body believes to be an infection.

The body is really fighting a losing battle against the hip implant itself. The increased friction from the DePuy hip replacement system produces more metal ions with every movement of the hip, the immune system can never fully fight off or cure what it believes to be an infection. As the body tries to clean up the mess made by the hip implant, it can trigger an autoimmune response: the body starts to fight itself.
When the body is trying to fight off the foreign metal ions that have been released into the blood by the metal-on-metal hip replacement, other healthy body tissues can get caught in the crossfire. The soft tissue and bones surrounding the hip implant get infected, which means the blood supply to the bone or tissue is cut off. Without blood, the tissues starve and die, leaving behind black, dead tissue rotting in the body. This condition is called necrosis.

Studies have shown that people at greater risk for metallosis include women, people of small stature, and the obese. Any of these groups are more likely to get metallosis because more weight is put on the joint, and therefore the two metal surfaces grind together more, releasing more metal particles into the blood. Add in the addition of a poorly engineered hip implant, and the amount of metal being released into the bloodstream becomes catastrophic.

A study done in England tested a group of patients who had received a DuPuy hip replacement and found a high percentage of patients developed metallosis-compared to almost no incidents in a group of patients who received a different brand of implant.

Some studies have further found that the metallosis could be the cause of early onset osteolysis, a process in which the body begins to reabsorb living bone tissue, causing bone deterioration. Osteolysis makes revision surgery nearly inevitable in implants that are designed to grow onto the surrounding bone, such as the ASR XL Acetabular system. With no bone to hold onto, the hip replacement system fails.

The DuPuy modular hip system is made from a chromium- and cobalt-based alloy. According to the International Agency for Research on Cancer (USA), cobalt is considered to be a possible carcinogen in humans. Animal studies have shown that cobalt is a direct cause of cancer when placed under the skin or in the muscle. Chromium has been linked to cancer as well, and there is no proven antidote for chromium poisoning.

In a study of nine patients who had received a DuPuy hip replacement and showed signs of early osteolysis, eight of the nine patients tested positive for a sensitivity to cobalt. In fact, metal sensitivity is twice as likely to be found in anyone with a well-functioning metal implant, and more than six times as common in those with a poorly functioning implant. (Y. Park)

The metal-on-metal ASR hip replacement system released far more metal into the bloodstream than other implants of its type due to poor design, which means that in addition to a revision surgery, DePuy should also be accountable for the serious complications of metallosis, metal poisoning, metal hypersensitivity, and early-onset osteolysis – as well as increased risk of cancer.”

http://sullolaw.wordpress.com/2010/11/15/how-the-asr-xl-acetabular-system-causes-metallosis/

• “Class Action” Lawsuits and “Multidistrict Litigation”: What’s the difference to DePuy Replacement Hip Recipients? Part 2 of 2

by Rottenstein Law Group

As of now, a few dozen lawsuits have been filed against DePuy all over the United States, from California to New York. On September 3, 2010, a California plaintiff filed a motion before the US Judicial Panel on Multidistrict Litigation to merge all the DePuy hip recall lawsuits into one MDL case. She cites five separate lawsuits in five states, including one class action lawsuit (class actions can be included in MDL with individual cases). The MDL motion applies only to cases before federal courts not state courts. The plaintiffs are asking for New Jersey federal District Court Judge Susan D. Wigenton to preside over the MDL proceedings, but DePuy is objecting for two reasons. First, it wants the MDL to occur near its headquarters in Warsaw, Indiana. To this end, DePuy is requesting courts in either the Northern District of Indiana at South Bend or the Northern District of Ohio in Toledo to hear the case. Second, DePuy is objecting to Judge Wigenton’s appointment to the cases because she is already presiding over a separate hip implant lawsuit against Zimmer Holdings over its Durom Cup hip implant. DePuy argues that her presence could cause confusion and unintended prejudice to the parties. Some plaintiffs want the lawsuits closer to where they live, such as a large group in and around Chicago, or in California, where DePuy’s hip implant design facilities are located.

Because of the disagreement, the US Judicial Panel on Multidistrict Litigation will hear oral arguments as to where and to which judge the DePuy hip implant MDL lawsuits should be assigned. The hearing date is Thursday, November 18, 2010 at Duke Law School in Durham, North Carolina. Plaintiffs’ attorneys expect to meet the day before to confer over their clients’ experiences, pre-trial strategy, gathering evidence, and any problems they foresee while working toward a settlement with DePuy. One estimate suggests that hip implant recipients will file more than 4,000 lawsuits against DePuy, necessitating consolidation.

If a settlement is reached, and hip implant recipients are dissatisfied with it, they are free to return to their local courts and proceed to trial. Hopefully, any hip implant recipient doing so would benefit by accessing the discovery gained from DePuy in MDL, and everyone would save money in the resulting lawsuit.

Class Action vs. Individual Filing?

I found this comment worth mentioning from another law firm’s site. Have often wondered if filing claims in court with cases such as these require that you join a class action suit. Looks like the firm of Schmidt & Clark LLP are filing individual cases. Interesting.

"In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit. However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket 'low ball settlement' and higher attorney fees."

Connie

Notice from My Surgeon on the Recall.

I finally received my recall note from the Surgeon. The letter was sent out on 11/9/10, several months after the recall. I was shocked to see the way in which this was presented:

•“A small number of patients with the hip implant you received experienced problems that require additional care and potentially further treatment…”

Interesting because the whole recall is based on the fact that the problems associated with this implant were way outside the normal range of …normal problems experienced were in the 3% range in a 5 years period and this implant is causing 11%-12% who have problems. That is a 400% increase in problems associated with a typical hip implant! I would not call this small.

•“Please call my office to schedule an appointment for an evaluation of your hip.”

•“Either myself or my Physicians assistants would like to discuss the symptoms you are having, additional testing that has been recommended and the best plan for ongoing testing and treatment for you.”

•“I would urge you to contact Depuy to set up a claim prior to your visit to my office.”

Attachments from DePuy were included with this letter.

What kind of letters have you recieved? Please do not post physcian's names in this blog if you choose to share information.

Thank you!

Connie

Claims Deadlines for filing

What is the deadline for filing claims for the hip recall?

Answer #1:
“There are strict time limits for filing claims against Johnson & Johnson and DePuy that will bar claims that are late. These time periods for filing vary by states and circumstances.”

Not sure what that means!

Answer #2
“This deadline is known as the statute of limitations and it can vary from state to state. Some states have only a one-year statute of limitations.”

It appears that the deadline is state dependent so check with your
attorney if you intend to file.

Connie

Questions about Signing Release Forms

As a patient, the following are important to me in order of priority re the recall:
·         Getting the required medical attention.
·         Not being stuck with any bills ever for this problem.
·         Not having to deal with repeated questions by claims adjusters which I can’t answer.
·         Compensation for what attorneys refer to as “pain and suffering” should I need revision surgery.
My position can be summarized from a clip I found on one of the legal sites:
It should go without saying that a patient in no way should waive any rights to any kind  of medical attention that he or she might need for existing problems or for problems that should arise in the future.  The patient should accept nothing less than complete payment of all current and future medical expenses.”
I see quite a bit of conflicting information  regarding what forms should and shouldn’t be completed by the patient to ensure that your position for complete payment for all medical claims now and in the future is not compromised. The forms that you will be asked to sign:
·         Forms provided by the physician from Depuy
·         Forms provided directly by Depuy re your hip
·         Insurance company forms re your hip
The major conflict I see is the advice from almost every attorney attempting to secure a class action suit vs the Depuy position.  Depuy’s position appears  specifically request to see all of your medical records in order to evaluate your condition for reimbursement if treatment is required.
The Lawyers seem to all have similar opinions:
“By Signing the [Depuy ] Form You Waive Your Federally Protected Right to Medical Privacy. Any Information You Release Can Be Used as Evidence Against You and Affect the Outcome of Your Hip Recall Claim
I have not explored the implications of this and I don’t even know at this point, if by signing the Depuy form, any rights are waived.  Nor do I understand yet whether refusing to sign a Depuy for will delay any required medical attention.
This  is what the Depuy site says about registering your claim with them:
This recall means additional testing and treatment may be necessary to ensure your hip implant is functioning well. DePuy intends to cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall. Even if you do not have out-of-pocket medical expenses, please contact the DePuy ASR Help Line so that you may be assigned a claim number. This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis.
  • On its Web site, DePuy identifies the following steps to be taken by ASR recipients seeking reimbursement:
    1. Call the ASR Call Center.
    2. Confirm whether you were implanted with an ASR device (to find out this information, you should contact your surgeon or the hospital where your surgery took place).
    3. Speak to a Call Center representative, who will initiate a claim on your behalf.
    4. Wait to be contacted by a claims representative who will send you a letter of payment authorization, an ASR claim number, and a medical authorization form.
    5. Visit your orthopedic surgeon for evaluation and/or treatment.
    6. Submit expenses and documentation to the DePuy claims processor for review for eligibility
3 Excerpts explaining the implication of these Depuy directives taken from other law firm sites who are pursuing litigation on behalf of their clients:

1.      “In plain English, this means DePuy may pay lost work time and travel expenses but apparently is refusing to pay other damages associated with this product failure, such a pain, suffering, disfigurement, or disability associated with yet another hip surgery and recovery.”

2.      “While the process described [by Depuy]appears to be straightforward and well-intentioned, a closer look reveals that aspects of the claims process could prove to be very sticky for ASR injury victims. In order to help you understand why this is true, it is useful to take a closer look at one particular component of the DePuy hip replacement claims process and the reimbursement policy itself.
The Medical Authorization Form
According to DePuy, signing a medical release form allows your surgeon to share information about your case with DePuy and the claims processor (a third party hired by DePuy), as well as allowing DePuy to share information with you about your ASR hip. Ostensibly, this will help the claims processor handle your claim more efficiently while access to testing data (such as the results of your blood test, imaging [MRI, ultrasound, X-ray] and revision data [related to your follow-up hip replacement procedure, if it is necessary]) will assist DePuy in its efforts to understand why the ASRs have an abnormally high revision rate.
You should be wary of signing this medical authorization form without first letting a hip replacement lawyer review it. DePuy may be telling the truth when it states that the form provides a means to “…share information about the patient’s case…”. You, however, have no guarantees that DePuy won’t try to use information in your medical records to devalue your claim. A lawyer can make sure you do not sign away any important rights.
Reimbursement
You should know that even if you obey DePuy’s wishes and carefully follow every step in the claims process, DePuy alone has discretion over whether you are reimbursed, and in what amount. DePuy admits as much when it states that costs borne by patients, such as co-pays, lost work time, travel expenses and other reimbursable expenses are “…subject to review on a case-by-case basis.”  In other words, you have no way of knowing whether you will be reimbursed for out-of-pocket expenses, not to mention that DePuy has yet to address compensating ASR victims for pain, suffering, and other non-monetary losses.
To be fair, DePuy states that it is still working out the particulars of its reimbursement process, and that more information will be available soon.”

3.       “In our opinion, DePuy's 'offer' may deceive potential claimants into believing that the company has actually agreed to advance or reimburse their costs for medical monitoring or revision surgery. In fact, no specific offer to pay medical costs has been made and no specific plan for reimbursement has been announced. Moreover, DePuy has stated that before reimbursement of expenses will be provided, it will review the patient's medical records to determine if the patient meets DePuy's criteria for payment. According to DePuy, the medical records must confirm that the revision is related to the ASR recall and 'not some other type of cause, such as a traumatic fall.' Blaming the device failure on a fall, or another cause, such as physician error, patient misuse, pre-existing condition or underlying diseases is a standard litigation defense in these types of cases. Thus a patient who releases medical records to DePuy may do nothing but provide DePuy with a jump start on litigation defenses.”
My first appointment with my surgeon will occur on the 30th of November.  
·    Once I see the forms I am asked to sign by the physician, I will post them.
·    Following that first visit but prior to signing anything, I will talk to some of the law firms who are accepting recall claims to determine how to protect my rights for obtaining the appropriate medical care without having to compromise my rights.
·    Finally, I will call Depuy to understand their position on both evaluating information for claims payment and determining whether there is any chance that by accepting any reimbursement will jeopardize my rights now and in the future for reasonable medical compensation for needed surgery.
Hopting  to have all of this completed by mid December.
Connie

Thursday, November 18, 2010

What Does the FDA do in a Recall?

(Exerpts I found of interest on the web.)

A medical device recall is an action on the part of the U.S. Food & Drug Administration to address problems with any medical device found to be in violation of FDA law due to defect, health risk, or both. A recall may mean any of the following singularly or in combination:

- The device in question requires an alteration, adjustment, or repair.
- An inspection of the device is in order.
- Use of the device should be discontinued.
- The patient with the device will require regular medical monitoring.

In most cases, the manufacturer, distributor, or other responsible party issues a recall voluntarily upon being informed that the device is in breach of FDA regulations. Legally, however, the FDA does have the authority to compel a recall if the company is not cooperative and patients are facing significant health risks or death. (Compulsory recalls are extremely rare.)

When a company does issue a recall, some or all of the following events take place:

- customers are made directly aware of the recall via letter and public notice,
- information is provided to aid in product identification and to minimize health risks,
- actions are taken to prevent the problem from happening again.

The FDA oversees the recall to ensure that the manufacturer:

- takes adequate steps to protect the public and to achieve legal compliance,
- takes the necessary precautions to prevent the occurrence of similar problems in the future.
There are three “classes” of recalls:
- Class I recalls are the most serious and the greatest efforts are made to notify customers and the public.
- Class II recalls generally address temporary or reversible problems. Customers, but not the public, receive notification.
- Class III recalls involve little danger but, because a violation of FDA law has occurred, customer notification is required.

For a full explanation of the laws governing medical devices and the mechanisms of reporting a device failure or problem (by both consumers and medical institutions), visit http://www.fda.gov/

Connie

Does the Food and Drug Administration share some of the blame for allowing the ASR to go to market without clinical trials being conducted?

(exerpts from web postings I found of interest.)

DePuy sought approval of the ASR system in March 2004 when it filed for 510(k) approval with the FDA. Under this process the company only had to show that the ASR was “substantially similar” to other implants on the market. DePuy compared the ASR to its own prior hip product, the DePuy Pinnacle to the FDA so the new product would be fast tracked into the consumer market.

The FDA apparently did not determine there were differences  between the two devices. The Pinnacle needs external screws anchored to the bone while the ASR uses the surrounding bone to grow into the implant. This seems to be a big a big difference but the FDA granted 510(k) approval to the ASR with no clinical trials or other tests that might have detected defects in its design.

I wonder how difficult the surgery will be to remove a devise and replace it (aka revision surgery) once the bone has grown into the implant.  Surley requires questions to your surgeon.

Connie

Hip Recalls from other Manufacturers since 2001

Exerpts from the web on other hip recalls

 (1) In 2001 Sulzer Medica AG issued a hip implant recall similar to the hip recall recently announced by Johnson & Johnson. Biz Journals reported that the Swiss based company’s American subsidiary Sulzer Orthopedics Inc. recalled 39,000 defective hip implants that put over 12,000 patients at risk of hip replacement failure. The hip implant manufacturer agreed to pay more than 3,500 hip replacement recall victims $200,000 each. The settlement value of the class action lawsuit totaled $1 Billion and was paid to victims over an 18 month period.

The Swiss medical device maker was able to avoid bankruptcy by settling the vast majority of hip recall lawsuits out of court. A small minority of the hip replacement patients chose to opt out of the settlement. In the only hip replacement lawsuit to proceed to trial, a jury awarded three women $15.4 million in damages.
As a result of the negative publicity caused by the hip replacement recall, Sulzer Medica changed the company name to Centerpule.

(2) Trident PSL and Hemispherical Acetabular hip replacement cups made by Stryker Corporation, recalled in January 2008. These devices were left on the market for three years as reports of numerous defects and complications piled up. Stryker Corp is embroiled in  court battles across the nation with victims of their defective hip implants.
(3) Durom Cup sold by Zimmer Holdings on July 24, 2008. These cups were used in 12,000 surgeries from 2006 to 2008 before a recall was finally issued for their tendency to come loose.
Connie

Monday, November 15, 2010

Early Reports of Concerns with the Depuy Hip to FDA

Excerpts from other web sites that I found of interest:
In 2009 nearly one million patients received either a knee or hip implant in the United States. Artificial joint implants are a highly lucrative business worth $6.7 billion to medical device manufacturers. No warranties are offered on these products and because the U.S. lacks a national joint registry, early detection of defective implants rarely occur.
Approximately 200,000 of those annual surgeries [20% of the implants above]  are for the replacement of the hip joint. The number of hip replacement surgeries performed in the U.S. is expected to rise with the aging population of baby boomers. The recent hip replacement recall of the ASR XL Acetabular System, a metal-on-metal implant made by DePuy Orthopaedics, a division of Johnson & Johnson, has raised serious questions about how such prosethitics are tested and how thier real life performance  is tracked.


DePuy Orthopaedics issued a full recall of all ASR hip implant devices on August 26, 2010 when Great Britain’s National Joint Registry released a research report that found the hip implant to fail at a rate of 12-13%. (The industry standard is 5%.) Disturbingly [it has been reported that] the implant remained on the market and was used for two years after the first complaints were filed with the FDA in 2008. [It has been reportered that]Nearly 400 DePuy ASR hip implant patients registered complaints with the FDA before the recall was issued, prompting calls from industry insiders, physicians, and patients to reform the federal organization’s medical device tracking processes.
Connie

Lack of a National Registry to Detect Problems with Hip Implants


Excerpts from other web sites that I found of interest
In 2009 nearly one million patients received either a knee or hip implant in the United States. Artificial joint implants are a highly lucrative business worth $6.7 billion to medical device manufacturers. No warranties are offered on these products and because the U.S. lacks a national joint registry, early detection of defective implants rarely occur.
Approximately 200,000[20% of the implants above] of those annual surgeries are for the replacement of the hip joint. The number of hip replacement surgeries performed in the U.S. is expected to rise with the aging population of baby boomers. The recent hip replacement recall of the ASR XL Acetabular System, a metal-on-metal implant made by DePuy Orthopaedics, a division of Johnson & Johnson, has raised serious questions about how such prosethitics are tested and how thier real life performance  is tracked.

DePuy Orthopaedics issued a full recall of all ASR hip implant devices on August 26, 2010 when Great Britain’s National Joint Registry released a research report that found the hip implant to fail at a rate of 12-13%. (The industry standard is 5%.) Disturbingly [it has been reported that] the implant remained on the market and was used for two years after the first complaints were filed with the FDA in 2008. Nearly 400 DePuy ASR hip implant patients registered complaints with the FDA before the recall was issued, prompting calls from industry insiders, physicians, and patients to reform the federal organization’s medical device tracking processes.

Connie

Sunday, November 14, 2010

Key Facts from the DePuy web site

Key Facts from the DePuy web site:
Which Hips have been recalled?
The Recalls involve two products post 2003:
·         The ASR XL Acetabular System
·         The ASR Hip Resurfacing System.  (This one was never approved in the US and was only sold outside the country.)
Symptoms
The patients who reported problems in the first five years and had revision surgery reported a variety of symptoms. These symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. If the symptoms continue or come back, it is a sign that there may be a problem.
Causes
The symptoms above might be caused by problems such as:
· Loosening – when the implant does not stay attached to the bone in the correct position
· Fracture – where the bone around the implant may have broken; and
· Dislocation – where the two parts of the implant that move against each other are no longer aligned.
The ASR Hip is made up of ball and socket components that move against each other. These metal components wear over time and generate very small particles that can only be seen with a microscope. This is an expected process. These particles do not cause problems for most patients, but a small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones, and nerves around the hip.

 If you had hip surgery after July 2003:

DePuy does not maintain a list of patients who received an ASR Hip. Please
contact your orthopaedic surgeon or the hospital where your surgery took place
to determine whether you received an ASR Hip. It may take time for the surgeon
or hospital to locate this information for you.

For privacy reasons, your orthopedic surgeon or the hospital where your
surgery took place may ask you to request this information in person.
Once you have this information:

If you have an ASR Hip, please contact the DePuy ASR Help Line to
inform DePuy. This recall means additional testing and treatment may be
necessary to ensure your hip implant is functioning well. DePuy intends to
cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall.

To Contact DePuy:

You can call this Depuy number to answer any questions about this recall. 
 In the US and Canada:  1 888 627 2677 (9-5 EST Mon-Sat.)
Outside the US:  1 813 287 1651
Depuy Recall web site:  asrrecall.depuy.com
Summary of the Depuy claims  process can be found on this site:
 http://asrrecall.depuy.com/sites/default/files/Patient%20handout%20for%20claims%20and%20reimbursement%20process%20%28Sep%2024%2C%202010%20DPYUS%2033%29.pdf

Blog Mission/My Story

The Mission of this Blog:
There are about 11,000  patients at risk for needing replacement of the DePuy  hips that have been sold on the market since 2003.  I am one of those patients.    Becoming a very informed patient at this point is my objective and I thought there must be many others out there who are going through this awful nite mare.  Maybe we can help each other.  How?  If you are equally concerned about this process by attemptiong to identify  answers to  the questions noted below, I would like to hear from you.  Maybe it is true that there is strength in numbers.  Maybe we can combine the determination of Erin Brokovitch  along with the social media tools available to us today and work as a group to answer these types of  questions and many more which others who are subjected to this recall  might have.  The mission of this blog:
·         Surface as much information for the hip replacement patient
·         Provide independent research into the issues involved in this recall so that we can examine all sides of the questions to become informed patients.

My Story:
Stories of hip replacements are always associated with people in their late 70s and 80s, or at least that is what I thought until I was advised I needed one at the ripe old age of 52.  In retrospect, I was so debilitated at that point from my inability to do much of anything involving movement,  that I had to take some action.
 I learned that replacing one’s hip is, in part a medical recommendation and in part a personal decision on the timing of the surgery.  Given my tolerance for physical pain, I postponed it as long as I could, as I imagine many do who are advised to replace a hip.  After all, I had my hip for 52 years and parting with it, despite the issues I had walking-(if you want to call leaning on a 3 wheeled walker walking)-or crawling into and out of a car-my Saab sports car (not on the recommended list for people who can’t bend over or even pet and feed  my 13 year old cat)…No, a  hip replacement was not at the top of my list of things to do at the age of 52. However, all tasks ultimately became so insurmountable that the hip replacement was inevitable.  So, I relented, checked into the hospital and had my hip replaced…. But not without a great deal of research to determine which doctor, which procedure, which hospital and where and how would I recuperate as a single person (note, I spent no real time researching  which prosthesis I should  consider other than to read up a bit on the one my surgeon recommended.  I do recall him telling me about the durability of the metal prosthesis for younger patients  vs considering the plastic or the ceramic options that older patients might consider.) 
To make a long story short in 2006, I decided to use a surgeon who came highly recommended by a friend of mine who was a physician on the medical staff at the local medical center.  He would perform a minimally invasive surgery using small incisions to replace the hip which required significantly less recovery time.  Sounded like my kind of procedure!   I was out of the hospital in a few days, recuperated for a week in a local nursing home, spent a week at home and was driving and back to work the 3rd week or so following surgery.  I was left with 2 scars, each measuring  about 2-3 inches in length;  one on the front of my  upper quad and one on the back.
I thought  the whole thing was a medical miracle as most who have hip replacements can attest. You literally get your life back again.  I was so pleased that I really never thought again about my hip until a year ago.  I started having pain on my walks.  Of course, I initially blamed that pain on the sidewalks, my shoes or anything else that could possibly be associated with causing that pain.  I did visit my surgeon at the time and he didn’t think much of it.  I recall speaking to my Internist about the pain and she commented that it was awfully soon to experience hip pain after only 4 years. 
Fast Forward to August 27th 2010.  “J&J’s DePuy Unit Recalls Hip Implants” was the cover page in the Marketplace section of the Wall Street Journal that day. Yikes, this sounded familiar!...As I read on, I noted  the following:
·         93,000 units (hip replacements)  were in question because too many patients needed surgeries to replace the DePuy devices.  (Generally only 5% of hips need replacing after 5 years. These recalled implants had to be replaced at the rate of 12%-13% after 5 years.  That means, at this moment, there are approximately 11,000-12,000 patients who are at risk for the need for a new hip replacement!)
As I read on, I got a really sick feeling in the pit of my stomach:
“Metal on Metal implants have drawn scrutiny because ware can kick up metal debris that damages surrounding muscle and tissue in some patients, thereby requiring that the implants be replaced earlier than usual…Surgeons try to avoid doing hip operations because ‘revision’ surgeries carry risks and successive implants don’t tend to fit  as well as the first ones…revision surgeries ‘are technically more difficult, they take longer and the patient is more at risk of complications and the recovery is more prolonged…’revision’ surgeries are also expensive. “
I knew I had the DePuy hip but perhaps I was lucky and somehow missed the whole recall.  Surely, I would hear if I were one of the anointed.
Fast Forward to the end of October of 2010; eight weeks following  the recall.  I had not been formally notified by my surgeon that I was on the recall list.  I wonder why I never got a notification?  I decided to call the orthopedic surgeon and sure enough, they confirmed that my hip was one on the recall list.  I was told that the hospital had inadequate records so the office staff had to review all of the patients one by one to figure out who was involved with the recall!  What?
To then add insult to injury, while I was not notified by my physician, I got my first e-mail (if you can believe this) from a litigation team-to my office e-mail- soliciting my business for participating in a class action suit for my hip. What?  How in the world would a litigation firm know about my hip replacement when the surgeon didn’t know if I was on the recall list?  Isn’t there a HIPPA law that prohibits disclosure of medical information?
So, there you have it.  My current symptoms (revised on 4/23/11-those symptoms were short lived..a few weeks or so...currently, I have no pain or outward sympoms of any issues):
·         Limping.
·         Hard time getting up out of my chair.
·         Can’t put much weight on my left leg.
·         Difficulty climbing stairs.
Here are a short list of my questions:
1.        Risk from a new hip replacement:
·         What is the real risk to us?
·         What are the complications to revision surgery?
·         What are the symptoms that would necessitate removing this?
·         What are the chances that we might have permanent impairment?
·         What kind of impairment?
·         Who really knows the answers to these questions since this recall is the first one for this unit?
·         Are all patients being told the similar things in answer to these questions?
2.       The Implant:
·         What is the real data that led to the implant being approved in the first place?
·         What new implant should be put in if it has to be replaced?
·         What does that data look like for other hip replacement options?
3.       Physicians :
·         Who best to perform revision surgery?
·         Are the physicians who put the hip in initially the best people to replace them?
·         Are their experts out there in revision hip replacement?
·         Who are they?
·         What is their success rate?
4.       Hospital:
·         Why doesn’t the hospital have computerized records of what prosthetics were placed into patients for rapid response to recalls like this?
5.       J &J:
·            What did they know and when did they know it?
6.       Litigators:
·          Who are all of these litigators out there trying to represent us?  Who should we work with and why?
·         How did these litigators get our name?  Is there a leak in the system that would enable our privacy to be violated by circulating the names of people who have had hip surgery?

My commitment to you:
As a business person in  a small VC funded company, I have more than full time job but I will try to post something  helpful each day that I find in my research to provide me with answers to the above questions.  It would be great if there are more of you out there who can offer feedback and information as well.  I have a strong sense that the patients need to become empowered with information in order to make it through this ordeal.  I look forward to hearing from you.
Connie