Friday, August 31, 2012

Interested in Universal Health Care Hugh?

Think Again!

15-month wait for new hip unacceptable

Wait times for surgeryI write as another casualty of our health system. I was scheduled for hip replacement surgery for July 25.

On July 18, I received a letter from my surgeon that my surgery had been cancelled as the Juravinski OR had cancelled all OR times between July 23 and Aug. 23. No reason was given in the letter except that “it was absolutely beyond our control.” I had been on the waiting list since September 2011. On July 23, I was told that my surgery has been rescheduled for Dec. 12, fully 15 months after I was put on the list.

I had gone to all the “pre-op” testing which will now probably have to be rescheduled. I have gone from the front of the line to the back. Of course this is an inconvenience to me and I remain in pain. I am a prisoner of the system, unless I pay out of pocket and head south to have my surgery.
I am a firm believer in “universal health care” but this event has shaken my faith in the system. It seems that a lot of dollars are being wasted in the system.

The manager of the OR at the Juravinski Hospital told me why surgery was cancelled for those weeks mentioned above. It was due to financial restraints imposed by the province. The manager had no other choice because there was no money left in her budget.

I find this incredulous. This from a government that has wasted billions on the eHealth scandal, the Ornge affair, the two cancelled power plants etc., etc.

There is something wrong when this happens to innocent people through no fault of their own. We need an explanation. I hear all this about “wait times” getting shorter and then this happens to me and other unfortunate patients. We pay for our health care here in this province. We pay a lot.

The Ontario government has no right to play with people’s lives. There is no excuse for a 15-month wait for hip replacement surgery in today’s Ontario. I am not a happy camper and I will persist through all means available to get a resolution to this very serious situation.

Medical device units recalled in Q2 represent eight-quarter high

An analysis of data from the U.S. Food and Drug Administration conducted by ExpertRECALL shows that 123.5 million medical device units were recalled in the second quarter of the year, representing an eight-quarter high.

The last time recalls affected 100 million units was the third quarter of 2010.

The number of actual recalls in the second quarter – 242 – fell 13 percent compared with the number of recalls in the previous quarter, but was up 4 percent compared with the second quarter of 2011.Three of second-quarter recalls affected more than 10 million units.
Class I recalls, considered to be the most serious because affected units have the potential to cause severe injury and death, were less than 1 percent of affected units.

The medical device recalls affected both domestic and international markets with 70 of the 242 affecting only U.S. customers while only one recall affected international consumers alone.
Pharma fared better with only 69 drug recalls during the second quarter, essentially flat compared to the first quarter recalls. But, the actual number of units recalled fell dramatically in the second quarter to just one-tenth of the affected units in the first quarter. The reduction represents a 58 percent decrease in the number of affected units, compared with the second quarter of 2011.
Six recalls were hit with a Class I classification by the FDA, while 45 were designated Class II

Judge Sets Date for First DePuy Pinnacle Bellwether Trial

The Legal Examiner

On May 23, 2011, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal DePuy Pinnacle hip implant lawsuits in the U.S. District Court for the Northern District of Texas. The panel assigned Judge James E. Kinkeade to manage the proceedings.

In a recent case management order, Judge Kinkeade scheduled the first bellwether trial for September 14, 2014. As the first case to go to trial, it will help both parties judge how the rest of the litigation may proceed.

Plaintiffs Claim DePuy Pinnacle Complications

Plaintiffs involved in the DePuy Pinnacle Multidistrict Litigation (MDL) seek to hold DePuy Orthopaedics liable for injuries they suffered after being implanted with the Pinnacle metal-on-metal hip implant. Though the device was designed to offer a more durable option to metal-on-ceramic or metal-on-plastic implants, post-marketing studies and reports indicate that the device causes serious problems. Plaintiffs in the MDL allege pain, immobility, and metal contamination that leads to premature loosening and the need for additional surgery.

A similar DePuy hip implant, the DePuy ASR, was pulled from the market in August 2010. The Pinnacle metal-on-metal device remains on the market today.

Case Management Order Sets Discovery Deadlines

The DePuy Pinnacle MDL currently has over 1,800 cases pending. Judge Kinkeade set several pre-trial deadlines to ensure steady progress toward the first bellwether trial in September 2014, .

For example, the judge stated that plaintiff fact sheets should be completed by December 17, 2012, and that the defendants shall affirm that they have produced all relevant documents concerning discovery requests by December 31, 2012.

Depositions will begin in January 2013. The parties have also been told to file their recommended selection of 4-6 cases to be included in the initial bellwether trial process by September 2, 2013. Expert and fact discovery in the first bellwether trial is to be completed by May 27, 2014.

Bellwether Trial Later Than DePuy Wanted

These deadlines create significantly more time than DePuy’s proposed deadlines, which they submitted to the court on July 24, 2012. DePuy suggested that depositions and designations for the first bellwether trial should be completed between May and August of 2013, and that the first bellwether trial take place on December 2, 2013. Judge Kinkeade shot down DePuy’s proposal.

Meanwhile, concern over metal-on-metal hip implants like the DePuy Pinnacle continues. A recent study published in Orthopedics found that when metal-on-metal implants fail, they typically do so in the first two years. Failure of the implant can cause loosening, infection, and metal sensitive reactions. In June 2012, an FDA panel concluded that there were few, if any, cases where they would recommend implanting metal-on-metal devices.

Will a 2-year statute of limitations defense curb J&J's DePuy hip lawsuits?

August 28, 2012 by MassDevice staff

Johnson & Johnson's DePuy subsidiary may see some relief from the ever-accumulating lawsuits over recalled metal-on-metal hip implants if states and judges decide to uphold a 2-year statute of limitations on filed claims.

Patients may be out of time to file lawsuits against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics' recalled metal-on-metal hip implants, with the 2-year anniversary of the recall passing over the weekend.

Although no judges have ordered a halt and rules vary by state, lawyers representing patients warned that DePuy's representatives may argue for a 2-year statute of limitations, cutting off any new claims.
"While the statute of limitations period for each DePuy ASR hip recall lawsuit depends on the state where the surgery took place as well as the circumstances of the injury, many states have a statute of limitations period of 2 years," according to the law firm of Bernstein Liebhard LLP. "Although no court has ruled on this issue with regard to the DePuy ASR hip recall lawsuits, it is possible that DePuy's lawyers may argue that the 2 year window to file a lawsuit started on August 26, 2010 – the date of the recall."

xxxx

From Connie:  Don't you just love these provocative press releases?  So, if I interpret this correctly, it says:
(1) Every state has a statue of limitations which all states operate by
(2) In most states, that statute of limitation ran out last week.
(3) In the few remaining states where the statute is longer  than 2 years, we should rush to file now because there is some minute possibility that Depuy will make a motion which will then be accepted by some judge to overturn the statue of limitations that have been in existence for years....but no one has raised any of these issues yet.....  not a judge, not Depuy, no one.

Well, I am sure there is some logic here which just escapes me. I think some of these hypotheticals are real doozies!




Wednesday, August 29, 2012

DePuy Pinnacle Hip Lawsuits Update: Judge Issues Order Regarding FDA Study

DePuy Pinnacle hip lawsuits included in the federal consolidated action, In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), are subject to a new court order stemming from a mandate issued by the U.S. Food and Drug Administration (“FDA”), Bernstein Liebhard LLP reports.* As described in the court’s order, the FDA mandated that DePuy conduct an explant study protocol pursuant to a Section 522 Order as part of the post-market surveillance study of the metal-on-metal Pinnacle hip replacements, which are the subject of this ongoing litigation. Issued by the FDA, a Section 522 Order mandates a medical device manufacturer to conduct post-market studies of a device that has the potential to cause injury when implanted into patients. On August 27, 2012, the Honorable James E. Kinkeade, who is overseeing the federal DePuy Pinnacle hip lawsuits pending in the U.S. District Court for the Northern District of Texas, issued an order requiring counsel for plaintiffs and defendants to confer in an attempt to reach an agreement on the correspondence to be sent to hospitals and surgeons who perform revision surgeries on patients with the metal-on-metal Pinnacle hip replacements regarding the explant study protocol

In May 2011, the FDA ordered manufacturers of metal-on-metal hip implants to conduct post-market surveillance studies on their products.** According to the New England Journal of Medicine (“NJEM”), as of June 18, 2012, the FDA and manufacturers had reached agreements on study protocols for less than one quarter of the devices. According to the August 27, 2012 order issued by Judge Kinkeade, the FDA recently approved DePuy’s study protocol. Notwithstanding the FDA’s approval of DePuy’s study protocol, the NJEM identified several limitations that may constrain the amount of useful information that emerges once studies proceed. For example, each manufacturer is permitted to conduct its own independent study on its products, making it difficult to pool the data and make cross-product comparisons. Further, manufacturers may measure chromium and cobalt levels differently, which can lead to uncertainty when pooling results. According to the NJEM, “this lack of harmonization limits the public health benefit of the studies.”

Tuesday, August 28, 2012

DePuy Hip Recall Now Includes Unused Custom Hip Implants, Announces the Rottenstein Law Group

PRWEB) August 27, 2012
According to a report from Mass Device, J&J subsidiary DePuy Orthopaedics, manufacturer of several embattled models of hip replacement devices—including the recalled ASR systems—has now recalled “all unused units of its [custom] orthopedic implants” in compliance with a request form the U.S. Food and Drug Administration (FDA).

DePuy shut down its custom orthopedics division in January, after the FDA had inspected company's facilities and “identified concerns with the implants, and further asked the device maker to take steps to retrieve all remaining unused devices, according to a DePuy letter sent to physicians,” Mass Device reports

Acupuncture Reduces Hip Surgery Pain - New Research

Acupuncture reduces the pain and complications caused by total hip replacement surgery. A new clinical investigation of acupuncture applied during total hip replacement surgery demonstrates that acupuncture reduces postoperative pain, reduces the need for medications and prevents complications such as nausea and vomiting. In addition, the research concludes that acupuncture improves the clinical outcome of the surgery by improving hip joint function.

Acupuncture CEUs OnlinePost-Op AcupunctureA nearly 2.5 year study of 60 patients compared a control group with an acupuncture group, 30 in each group. All patients had late-stage osteonecrosis of the femoral head and received total hip replacement surgery. Acupuncture points used in the study were applied to the outer ear region at acupoints Shenmen, Subcortex, Kidney and Hip Joint. The acupuncture group had less pain and experienced significant improvements in hip joint function over that of the control group. Nausea and vomiting occurred in 5 patients in the acupuncture group compared with 21 patients in the control group. The researchers also note that the acupuncture group required significantly less analgesic medications.


Reference:
Zhongguo Gu Shang. 2012 Mar;25(3):220-3. Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty. Wang JF, Bao HX, Cai YH, Zhang JH, Tong PJ. Zhejiang Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.

DePuy ASR Hip Lawsuit Update: Depositions Of Company Executives Scheduled

New York, NY (PRWEB) August 24, 2012 DePuy ASR hip lawsuits in the federal consolidated action, In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), continue to proceed with several depositions of DePuy executives scheduled to take place in the next three months, Bernstein Liebhard LLP reports.* On August 22, 2012, eight depositions were noticed in the federal DePuy ASR hip litigation, which is pending before the Honorable David A. Katz in the U.S. District Court for the Northern District of Ohio. Among those slated to be deposed are David Floyd, former U.S. and Worldwide President of DePuy Orthopaedics at the time the August 2010 ASR hip recall was issued, and Andrew Ekdahl, President of DePuy Orthopaedics, Inc. Floyd resigned as president of DePuy in March 2011. Ekdahl was named president in June 2011.


“Given their high ranking positions within the company, the depositions should shed new light into the circumstances surrounding the August 2010 ASR hip recall,” said Bernstein Liebhard LLP, a nationwide law firm representing clients who have filed DePuy ASR hip recall lawsuits.

In February 2012, a New York Times investigation revealed that Floyd was notified that the U.S. Food and Drug Administration (“FDA”) refused to approve one version of the recalled ASR hip devices.** In August 2009, Pamela Plouhar, a vice president of DePuy Orthopaedics, emailed three executives, including Floyd. In the email, Plouhar explained that the FDA reviewed company studies and clinical data and ultimately concluded that the device did not meet the FDA’s approval standards because of its high early failure rates. She also noted that conducting a new study of the ASR hip replacement might take years, and not change the FDA’s decision. Plouhar wrote, “The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk.” Although company executives knew of the serious ASR hip replacement injuries in August 2009, it took a year for the company to act.

Additional Top Executives To Testify About ASR Hip Recall

In addition to David Floyd and Andrew Ekdahl, other company executives were also noticed, including:

  • Matt Reimink, Manager, Development, DePuy Orthopaedics, Inc.;

  • Mary Stewart, Research & Development, DePuy International Ltd.;

  • Paul Voorhorst, Director, Biostatistics & Data Management, DePuy Orthopaedics, Inc.;

  • Paul Kurring, Director of Marketing, International Hip Business, DePuy Int’l. Ltd.;

  • Rodrigo Diaz, Manager Clinical Research, DePuy Orthopaedics, Inc.; and

  • Tom Camino, WW Hip Development Director, DePuy Orthopaedics Inc.


The DePuy executives have been asked to produce documents, notes, outlines, presentation materials, testimonies and oral proposals prepared or given to them that reference or relate to the ASR hip recall.

'Toxic' hip replacement fears (How the British are dealing with the MOM issue)

 From the Bangor Regis Observer (nice article from the UK)

Many newspapers and TV stations have reported that medical regulators have launched an investigation into a type of hip replacement called a metal-on-metal (MoM) device (DePuy ASR hip replacement implant). The concern is that as the hip replacements wear down, metal particles can be released from the artificial hip, react with the soft tissue (such as muscle and ligaments) surrounding the joint and enter the bloodstream. In 2010, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a product recall for DePuy ASR, a brand of MoM artificial hip. This meant that surgeons were told not to implant DePuy ASR hip replacements and return any unused implants to the manufacturer.

The MHRA has urged surgeons to tell all patients that had received these DePuy ASR hip replacements about the recall, and to schedule them for annual follow-up visits. If the person who had a DePuy ASR hip replacement implant experiences pain, the surgeons should consider measuring the level of metals in their blood and should examine the soft tissue to see if reactions have occurred. If necessary, removal and replacement of the implant should be considered.

The Sunday Telegraph has brought this story to the public attention again because of what it says are subsequent developments. The Telegraph claims that the risk from the devices is greater than previously thought, with greater failure rates. The Telegraph says that the MHRA is drawing up a new alert for anyone with any type of metal-on-metal hip replacement. Channel 4 News reported that around 30,000 people in Britain have received MoM hip replacements.

A statement about the hip implants from the MHRA, issued on January 30 2012, said: “The majority of people with metal on metal hip replacements are at low risk of developing any serious problems. We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given. We have already taken prompt action to investigate safety concerns and have provided advice on patient management to relevant healthcare professionals.”.

Medical devices, like medicines, are regulated but are coming under more scrutiny, from both the regulators and the media following widespread concerns over the emergence of faults with illegally made PIP breast implants. Find out the latest NHS information on PIP breast implants.



What types of hip replacements are there?


In the UK, approximately 70,000 hip replacements are performed each year. In a total hip replacement operation an artificial ball is attached to the top of the leg bone and an artificial socket to the hip bone. The socket can be made out of plastic or ceramic, while the ball is metal. The ball is attached to a shaft, which is placed in the hollow of the leg bone (femur). Some people do not need a total hip replacement, but have a hip resurfacing operation. This has the advantage of removing less of the person’s own bone. The joint surfaces are replaced with metal inserts that cover the surfaces of the hip but do not extend down the inside or hollow of the leg bone. The metal mixtures used in hip replacements contain the metals chromium and cobalt.



What are the risks of problems following a metal-on-metal hip replacement?


When hip resurfacing was initially introduced, metal-on-metal (MoM) replacements were popular, especially with younger, active patients. An article by two orthopaedic surgeons working in Britain and published in the British Medical Journal in 2011 said that they were used in 10% of hip operations between 2006 and 2009, and 50% of all hip replacements in people younger than 50 years. However, problems with the metal resurfacing included raised chromium and cobalt in the blood, loosening of the joint, hip fracture and soft tissue reactions around the hip. It reported that problems with metal on metal hip replacements could include reactions to metal debris and associated pain, swelling, loss of movement and limping.

In March 2011, delegates at the British Hip Society annual conference discussed MoM hip replacements. Units in Belfast, Southampton, Cardiff and Stockton-on-Tees that had researched the outcomes for people who had these devices fitted over the short- to mid-term, said that a high proportion of MoM devices from other manufacturers may also be showing similar results to the withdrawn DePuy device. They found that, overall, the MoM devices showed a higher than anticipated early failure rate (most hip replacements last about 20-30 years). They found that 49% of people who had been fitted with the DePuy device needed to have it replaced by six years and between 12 and 15% who had other metal-on-metal hip replacements needed these to be replaced by five years. They said that the patients whose replacements failed tended to come to the doctors when they experienced pain. X-rays showed some patients had loosening of the joint, and some patients had raised levels of cobalt and chromium in their blood.

The inclusion of the word “poisoned” in some newspapers is likely to be wrong. Metal from the hip replacements can enter the bloodstream, but the levels of cobalt and chromium found give an indication of the wear to the hip replacement. No evidence for damage other than local tissue damage was presented. The MHRA’s advice is to monitor the level of chromium and cobalt to see if a patient requires further follow-up.

What is the advice for people who have had a MoM hip replacement?


The MHRA has not issued new guidance as yet. However, the report from the British Hip Society annual conference says that they believe that the existing advice from the MHRA still applies. This means that people who have been treated with a MoM hip replacement should be followed up regularly for five years and probably for the life of the implant. People with the withdrawn MoM hip replacements who experience pain should have this thoroughly investigated. Following the withdrawal of the DePuy device, and the MHRA guidance, the British Hip Society and the British Orthopaedic Association said:

  • Everyone with a hip replacement that has been withdrawn should be informed and told that they will be under close clinical follow-up.
  • Some form of follow-up should be carried out at least annually and patients should be given contact information so that they can be reviewed quickly if they have pain or lose function in their hip.
  • Patients should be followed for the life of the implant until more data are available. If someone with a withdrawn MoM hip replacement experiences no pain or loss of function, no further investigations are required apart from standard follow-up.
  • If a person with a withdrawn MoM hip replacement reports that they are in pain, the cause of the pain should be further investigated. Blood cobalt and chromium levels should be measured to indicate how much the device has worn, but there is no evidence that the implant must be replaced above a certain metal concentration.
  • Treatment decisions should be confirmed with a second experienced “revision” surgeon.

People who have had a hip replacement, who are concerned, should contact their orthopaedic surgeon or GP. They should be given records of the type of hip replacement they had and receive the follow-up, if any, that is required.

DePuy says it is "committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary". The company has set up a freephone helpline on 0800 279 4865 for patients to register, have their questions answered and submit claims for reimbursement. DePuy says it will also cover recall-related patients' out-of-pocket expenses, such as lost wages and travel costs.

 

 

 
 
 

Alcohol Use in Elective Total Hip Arthroplasty: Risk or Benefit?

From Clinical Orthopedic and related research


Carlos J. Lavernia MD, Jesus M. Villa MD, Juan S. Contreras MD
Symposium: Papers Presented at the Annual Meetings of The Hip Society
Online First ™ - August , 2012

Background

Excessive alcohol consumption has been associated with adverse health measures after elective surgery. The effects of low or moderate consumption remain unclear.

Question/purposes

We determined differences among patients with different consumption levels in (1) preoperative and postoperative patient-perceived outcomes and hip scores, (2) changes in those scores from preoperatively to postoperatively, (3) demographics and comorbidities, and (4) length of stay (LOS) and hospitalization charges.

Methods

We retrospectively reviewed 191 patients (218 primary hips). Based on a self-administered consumption questionnaire, patients were stratified into three groups: (1) nondrinkers (n = 52), (2) occasional drinkers (n = 56), and (3) moderate drinkers (n = 17). Demographics, BMI, Charlson Comorbidity Index, and American Society of Anesthesiologists grade; preoperative and postoperative Quality of Well-being Scale, SF-36, WOMAC, Harris hip, and Merle d’Aubigné-Postel hip scores; and LOS and hospital charges were obtained and compared among groups adjusting for patient characteristics. Minimum followup was 1 year (mean, 3.5 years; range, 1–6 years).

Results

Most abstainers were older, female, and Hispanic. Preoperatively, moderate drinkers had better WOMAC function and total scores and Harris hip scores. There were no differences postoperatively among groups. However, nondrinkers had greater improvement (preoperative to postoperative) in the WOMAC function, pain, and total scores. Compared to nondrinkers, moderate drinkers had a higher contribution margin and net income.

Conclusions

Alcohol consumption is more common among men and non-Hispanics. Moderate consumption was associated with better WOMAC and Harris hip scores. After surgery, abstainers achieved greater improvements in the WOMAC function, pain, and total scores.

Monday, August 27, 2012

Update on Connie's condition with respect to the cancer reoccurance

Hi fellow bloggers,  I continue to thank you for your interest and concern.  (For those of you who are new to my condition, you can look at the last 5 posts at the bottom of the list on the home page called: about me/my story:  http://www.mydepuyhiprecall.com/p/about-me-my-story.html)

I have selected my cancer experts and the approach to the treatment for this renal cell recurrence based on the very very high likelihood that this hip revision precipitated the oxidative stress process which weakened my immune system and enabled the cancer to reoccur after being cancer free for almost 6 years.  This process is called free radical chemistry. It is well documented in the orthopedic literature when reviewing the process of the degradation of the Chromium and Cobalt.  

The treatment I have chosen is that which is focused on the cancer reoccurring through the process of free radical chemistry. 

In that line, we have chosen an immune therapy approach called interleukin 2 which is the only chance, albeit small, for a cure to my cancer.  I have entered into a NON DRUG trial at one of the top 3 cancer institutes and am being seen by one of the top guys in the field.

While I am enrolled in this study which focuses on a small sub set of renal cell patients (10%) who get these small slow growing tumors, i am starting certain high dose Vitamin therapy which deals with this free radical chemistry until my oncologists (I have 3) feel I am ready for the IL2.

I am diligently researching the key players in the field so that eventually, I can go to Depuy with this information.  

Most physicians have to be presented with the steps involved in redox/free radical chemistry, renal cell,  hip revision surgery with  the links between them all.   This is not something that is readily apparent to them.  Since my treatment approach is based on this, it is important for the members of the team to see the links.

I will be going for repeat scans every 3 months (next one due in October) in order to decide when to start the interleukin 2.

If you have renal cell carcinoma or melanoma, I would think twice about a hip revision if your cancer is in remission.  I would suppose you have to weigh the risks of an implant vs the terminal cancer.

(Note:  make sure you are not reading this to say the hip revision caused the initial cancer.  No.  in my case, the revision precipitated the recurrence of it and put me on a short life path.  Very few renal cell patients recover from this once the metastatic phase is underway which it is in my case...but given the nature of the recurrence, I am hopeful to find something beyond the "normal and customary approaches" to this disease.  Also note that I am not saying there is no link long term between cancer and this MoM hip revision.  Not enough data to draw any conclusions but as you know, I have frequently published on the POTENTIAL cancer link on many occasions on this blog.)

Other links of interest on the blog:

Advances in carcinogenic metal toxicity and potential molecular markers. (1 of x in a series)

Advances in metal-induced oxidative stress and human disease. (2 of x in a series)

Oxidative Stress process associated with Metal on metal hips (series 3 of x)

Oxidative Stress process associated with Metal on metal hips (series 4 of x)

A great pictorial to illustrate the metal on metal oxidation process (5 of 5 in a series)

In biology...... (free radicals, Oxidative stress and reactive oxygen species are covered.)


Free radicals play an important role in a number of biological processes. Some of these are necessary for life, such as the intracellular killing of bacteria by phagocytic cells such as granulocytes and macrophages. Researchers have also implicated free radicals in certain cell signalling processes.[6] This is dubbed redox signaling.


The two most important oxygen-centered free radicals are superoxide and hydroxyl radical. They derive from molecular oxygen under reducing conditions. However, because of their reactivity, these same free radicals can participate in unwanted side reactions resulting in cell damage. Excessive amounts of these free radicals can lead to cell injury and death, which may contribute to many diseases such as cancer, stroke, myocardial infarction, diabetes and major disorders.[7] Many forms of cancer are thought to be the result of reactions between free radicals and DNA, potentially resulting in mutations that can adversely affect the cell cycle and potentially lead to malignancy.[8] Some of the symptoms of aging such as atherosclerosis are also attributed to free-radical induced oxidation of many of the chemicals making up the body.[citation needed]

Because free radicals are necessary for life, the body has a number of mechanisms to minimize free-radical-induced damage and to repair damage that occurs, such as the enzymes superoxide dismutase, catalase, glutathione peroxidase and glutathione reductase. In addition, antioxidants play a key role in these defense mechanisms. These are often the three vitamins, vitamin A, vitamin C and vitamin E and polyphenol antioxidants. Further, there is good evidence bilirubin and uric acid can act as antioxidants to help neutralize certain free radicals. 

Reactive oxygen species


Reactive oxygen species or ROSs are species such as superoxide, hydrogen peroxide, and hydroxyl radical and are associated with cell damage. ROSs form as a natural by-product of the normal metabolism of oxygen and have important roles in cell signaling.

     

Oxidative stress is an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage. Disturbances in the normal redox state of cells can cause toxic effects through the production of peroxides and free radicals that damage all components of the cell, including proteins, lipids, and DNA. Further, some reactive oxidative species act as cellular messengers in redox signaling. Thus, oxidative stress can cause disruptions in normal mechanisms of cellular signaling.


 As you know, I am not a scientist so sometimes, I may not state things as clearly and articulately as a scientist would.

Why Berkshire Sold Most Of Its Johnson & Johnson Holdings

By Joshua Norman


We are amazed that Johnson & Johnson (JNJ) has seen the recent reversals of fortune that it has endured. We first followed JNJ back in the 1990s, and we remember the company as being able to consistently generate strong profitability, growth, and even a dividend to shareholders. While the company is still able to grow its dividend, we can certainly see that JNJ has lost its mojo. We're sure that Warren Buffett of Berkshire Hathaway (BRK.B) can see that JNJ has been struggling since Berkshire first invested in it back in Q2 2006. This was around the same time that JNJ announced that it was buying Pfizer's (PFE) Consumer Healthcare business for $16.6B in cash. According to Morningstar, JNJ has followed up that deal with $27.5B in additional acquisitions, most notably the $17.7B acquisition of Synthes.

(click images to enlarge)

Source: Morningstar Direct

After further review, we can see that Bill Weldon's deal-crazed acquisition spree as CEO of JNJ did not add value to the organization. However, JNJ was able to post increased product recalls under his watch. No wonder Professor Sydney Finkelstein at Dartmouth named him one of the worst CEOs of 2011. We were glad that Weldon announced his retirement due to ill health in February (JNJ's board was sick and tired of muddling in mediocrity), and his retirement eliminated a huge hole in the CEO's office. JNJ's Board tapped its Vice Chairman, Alex Gorsky as CEO, and Gorsky assumed the role on April 26th.

Despite Weldon's terrible tenure of management mediocrity as Chairman and CEO of JNJ, he remains Chairman of JNJ's board. We can see why Berkshire sold the majority of its JNJ holdings. We believe that Buffett has the patience of a saint with regards to JNJ, considering that Berkshire still holds 10M shares of the company despite the fact that its results have been very pedestrian since its 2006 acquisition of Pfizer Consumer Health.


Source: Morningstar Direct

We now see JNJ pursuing the $100M acquisition of Shanghai Elsker, a Chinese baby-care product maker. Even though it's a tiny little bolt-on acquisition, we think that the company should not bother with any more deals until it can start generating improved levels of adjusted organic growth. JNJ had $4.57 in EPS in 2008, and it is expecting to generate adjusted EPS of $5.06 in 2012, according to consensus estimates. This represents an unremarkable 2.58% compounded annual growth rate during the 2008-2012 time period.

Despite spending nearly $45B on acquisitions since 2006, JNJ's annual revenues have only increased $11.7B from 2006 to 2011. The $45B JNJ spent on acquisitions, net of cash acquired, represents 24% of JNJ's market cap and unfortunately, has only increased its revenues by 23% in the same time period. We see JNJ as a big, hulking ship that is lost at sea and is way off course.

In the first half of 2012, JNJ had generated flat growth relative to H1 2011 levels. Operating revenues only increased by 2.2%, excluding currency headwinds. Negative currency headwinds (-2.7%) ended up absorbing JNJ's meager operating revenue growth, and resulted in a -0.5% revenue decline year-over year in H1 2012 versus H1 2011. Non-recurring expenses the company excluded as adjustments to Net Income included the write down of $939M from its intangible asset base and $611M on litigation expenses.

In conclusion, we can see why Berkshire sold nearly two-thirds of its stake in Johnson & Johnson. While we believe that JNJ is certainly a big, well-established pharmaceutical and health care products company, we believe that its glory days of gazelle-like growth in the 1990s and early 2000s are no more. We have lost confidence in Johnson & Johnson's ability to manage the company effectively on behalf of its shareholders, and we believe that it will take time for Alex Gorsky and his management team to right the ship, especially with Billy Weldon continuing to serve as Non-Executive Chairman.

We would like to see the company bring its focus away from acquisitions and towards organic growth. While we continue to expect the company to boost its dividend and buy back shares, we believe that dividend growth will decelerate. Even with the headwinds facing Johnson & Johnson's growth, the company is still trading within 3% of its 52-week high, and we think that it is too early to establish a long position in this company.

Even adding back non-recurring charges to its 2012 "adjusted EPS results" for Q2 2012 and YTD 2012, JNJ's adjusted EPS only grew by 1.6% year-over-year in Q2 2012 versus Q2 2011, and 1.5% growth in H1 2012 versus H1 2011. JNJ earned $4.57 EPS in 2008, and according to consensus estimates is expected to earn $5.06 EPS in 2012. This represents a compounded annual growth rate of 2.58% in this four year period. At least JNJ's compounded annual return during this period was comparable to the S&P 500 and Berkshire Hathaway, though we normally expect both Berkshire and JNJ to greatly outperform the S&P 500 over extended time periods.


Source: Morningstar Direct (06/30/2006 to 08/17/2012)

Johnson & Johnson unit recalls bone putty

REUTERS/Christian Hartmann

The health regulator said certain lots of bone putty made by Johnson & Johnson unit Synthes were recalled as there was potential for the putty to catch fire if it came in contact with electrosurgical cautery systems during surgery.

The Hemostatic Bone Putty is used to stop bone bleeding by creating a physical barrier along the edges of bones damaged by trauma or cut during a surgical procedure.
The recall, which has been classified as Class I, or the most serious type of recall, was initiated on July 5.

Synthes had issued a medical device recall letter on July 5 requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the putty manufactured between July 6, 2011 and December 14, 2011.
J&J has been hit by several recalls ranging from its consumer medicines Tylenol and Motrin to artificial hip implants. The company had also taken charges of more than $3 billion in the latest fourth quarter largely related to the recall of the defective artificial hips.

FDA Aims To Smooth Premarket Review process

Bloomberg BNA

In the world of medical device reviews, timing is everything. Device manufacturers often claim FDA does not review their premarket applications quickly enough. For its part, FDA has said some of the blame lies with the companies that submit applications missing key information. It's a time consuming process to keep sending companies requests for more information. FDA officials have even said they've come across applications that aren't even written in English.
In an effort to improve overall review times and enhance the quality of submissions, FDA in the past month has released a pair of draft guidances for industry and agency staff. The documents are pretty similar, but each covers a different type of premarket review. One addresses the idea of a "refusal to accept" policy for 510(k) applications, and the other addresses essentially the same idea for premarket approval (PMA) applications. The 510(k) process is how most low and moderate-risk devices reach the market, and requires only that they be proven substantially equivalent to a device already being sold. PMAs generally require clinical trials, and are for high risk devices.

Both guidances outline the minimum requirements manufacturers must include in the respective premarket applications. The PMA guidance includes two checklists: acceptance criteria and filing criteria. If the manufacturer doesn't meet the acceptance criteria, the FDA reviewer can send the application back within 15 days without having to look at any other components. The 510(k) "refusal to accept" policy is similar-- if the manufacturer doesn't meet specific criteria (outlined in a checklist), the reviewer can send it back and ask for the correct information before filing the application for a more substantial review.

Both guidances are still just drafts with comment periods, but FDA hopes they will lead to a much more efficient use of agency resources and a higher quality of device submissions. Comments on the 510(k) guidance are due Sept. 27, and comments on the PMA guidance are due Sept. 14.

Additional insights into the Stryker Rejuvenate and ABG II Modular Neck Stem Implants Undergo Recall

Torrance, CA -- (SBWIRE) -- 08/23/2012 -- Csengeri Law experts in defective medical device law have offered several insights into the July 6, 2012 Stryker recall. Both Stryker Orthopedics Rejuvenate hip implants and ABG II modular neck stem have been recalled. The recall measures are voluntarily in the light of significant negative post market data. After 45 adverse results reported to the FDA in 2012 Stryker posted on their website that the units suffered “fretting and/or corrosion at or about the modular neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” At the same time lawsuits surrounding defective metal-on-metal hip replacement units are growing as the implants display increasingly more consistent repetitive corrosion and toxicity patterns.

The Rejuvenate hip implant is a full hip implant whereas the ABG modular neck stem is a component used in several hip replacement systems, both units are undergoing recall. Stuart Simpson, Stryker hip reconstruction vice president and general manager issued the following statement regarding the recall. “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient's anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopedics decided to take this voluntary action.” Essentially, the units corrode and generate metallic debris which can lead to a variety of health problems ending in implant failure.

FDA SpyGate -- New Revelations Challenge The New York Times Investigation of Agency "Enemies List," Raise More Questions About the 'Government's Most Dysfunctional Agency'

Forbes
Jon Entine, Contributor

According to Jon Entine, after a series of stumbles and scandals, the Food and Drug Administration’s ability to oversee the most cutting edge sectors of the medical industry, medical devices and genetic screening tests, is under increasing scrutiny.
The Food and Drug Administration and its Center for Devices and Radiological Health (CDRH) is reeling. In mid July, the New York Times accused the FDA of creating a massive e-mail surveillance program designed to net junior scientists and other critics who complained the agency was too-quick to approve medical devices that the employees maintained posed unacceptable health risks.

The Times’ story generated national headlines with its sympathetic portrayal of harassed scientists risking their careers to protect the public interest. But new revelations suggest the Time’s slanted the story by leaving out critical context. It appears that dissident employees are involved in what could be seen as an ambulance chasing shakedown scheme to profit from their allegations. In December 2009, while these “aggrieved” reviewers were publicly lobbying the FDA and Congress to crack down on scanning devices, they had secretly filed a whistleblower lawsuit against these very same manufacturers that if successful could make them multi-millionaires.

The case has exposed the underbelly of what some critics believe is one of the more dysfunctional regulatory agencies in the federal government.

The July New York Times story was a follow up to a 2010 Times report, based on leaked confidential documents supplied by the junior staffers, accusing the agency’s senior officials of ‘brushing aside’ the potential dangers of mammography and colonoscopy devices in a rush to approve a CT scanning device made by General Electric.

The dispute began less publicly in 2006, when a consultant reviewer, Robert Smith, a controversial radiologist formerly at hospitals operated by Yale and Cornell, and several center employees raised concerns that the agency was overlooking safety concerns in approving substandard medical imaging devices for mammograms and colonoscopies. The agency reviewed and rejected their concerns in 2006 and 2008.

Angered when their recommendations were overruled, and just months after quietly filing their whistleblower suit, the dissident group took the matter into their own hands. In early 2010, they began leaking confidential documents to various media outlets, most notably the Times, which came out with its first exposé in March of that year under the headline “Scientists Say F.D.A. Ignored Radiation Warnings”.
FDA employees who review confidential trade secrets submitted by drug or device makers are prohibited from discussing any data before a regulatory decision has been made. But some junior scientists, convinced that current laws make it near impossible to block products they deem ineffective or dangerous, took the matter into their own hands.

Later that year, responding to appeals by Dr. Smith and by Congressmen who the former reviewer had lobbied, the FDA, then under supervision of the Obama Administration, again investigated the employees claims and found them wanting.

Concluding that the workers had violated agency confidentiality outlined in the Federal Food, Drug and Cosmetic Act, the FDA’s Office of the Inspector General (OIG) recommended that the agency take ”administrative action” against the leaders for talking to the Times. Four employees were eventually dismissed. A fifth scientist was suspended, rehired on appeal, and then left the agency last month.

FDA, culture of dysfunction?
The ‘national paper of record’ and many activist groups are now portraying the self-proclaimed whistleblowers as beleaguered heroes and victims of an agency “enemies list” designed to muzzle public minded employees. They hint at a corrosive and corrupt culture inside the FDA that is captured by big business and limits the agency from encouraging dissent.

New Surgical Approach Allows for Outpatient Total Hip Replacement

WALNUT CREEK, Calif., Aug. 21, 2012 /PRNewswire/ -- A new surgical approach offered in California at a Contra Costa County medical practice now allows for total hip replacement on an outpatient basis, requiring only a 23 hour stay, cutting recovery time in half and potentially saving thousands of dollars per patient.

Until recently, total-hip-replacement patients had to tolerate hospital stays from three to ten days and a physical recovery up to six months, according to the American Academy of Orthopaedic Surgeons (AAOS).

In contrast, ten patients of Dr. Louay Toma of Muir Orthopaedic Specialists, based in Walnut Creek, have undergone a new surgical approach known as anterior total hip replacement and returned home the next day. The anterior, or front-side, surgical approach allows the hip replacement without cutting any muscle.

"I had surgery on a Tuesday and was back to work on Monday," says James Murchison, 63, of San Leandro, who suffered for nearly five years before undergoing the procedure.

"Within two weeks I was doing everything I would normally do, but without pain."

Traditional methods approach the hip from the posterior, or backside, cutting through extensive muscle. The average cost for a patient without health insurance can range from $60,000 to upwards of $100,000. A total hip replacement at a surgery center can cost as little as one-half as much.

"In a time when controlling healthcare costs is of paramount importance, a total hip replacement with only one night in the surgery center is considerable progress," said Dr. Toma, one of only a handful of surgeons in California performing the procedure.
"With time, the anterior surgical procedure will replace traditional methods."

Total hip replacements have doubled in the past 14 years, according to statistical data provided by the AAOS. Candidates for outpatient surgery must meet a number of health requirements.

Muir Orthopaedic Specialists:
A regionally-recognized orthopedic practice located in the Bay Area, Muir Orthopaedic Specialists is comprised of 24 experienced physicians and a team of expert staff. Using state-of-the-art techniques in orthopedic medicine, MOS restores mobility and comfort with musculoskeletal injuries, conditions, and care, treating the foot, ankle, knee, hip, spine, shoulder, elbow and hand. MOS facilities are located east of San Francisco in Walnut Creek, Brentwood, and San Ramon

PR Newswire (http://s.tt/1lkr8)

Sunday, August 26, 2012

Re the alleged $200K settlement for the first Depuy Case in State court.....

Dear Anonymous:  Can you provide some source for this?

"The plaintiffs are now claiming that some party breached the confidentiality agreement by leaking a misleadingly low figure, and have asked the court to set aside the confidentialty agreement so they can set the record straight. The hearing is in about a month."

see prior posts re this matter:
http://www.mydepuyhiprecall.com/2012/08/200000-for-settelement-of-depuy-hip.html

http://www.mydepuyhiprecall.com/2012/08/j-said-to-pay-600000-to-settle-first.html

Pluristem Therapeutics Shoots From The Hip, Moving Toward The Sports Medicine And Muscle Regeneration Markets

Republished from Seeking Alpha

Pluristem's (PSTI) platform technology is moving into a huge, new industry - hip replacement. The company announced last week that the famous Paul Ehrlich Institute of Germany gave it permission to start a Phase I/II clinical trial to test their PLX cells in healing gluteal (buttock) muscles that have been injured after hip surgery. And today anounced it has renewed a five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy.

There are about 300,000 artificial hips implanted every year in the US alone, over 800 per day, with a global market size of $5 billion growing at 6% per year. Obesity and arthritis are the culprits, and in an aging world, they're here to stay.

Hip replacements, for all of their popularity, have problems. Many times, the metal or plastic ball portion of the device slips out of the socket or doesn't sit in the hip well, and patients experience devastating pain and unbearable swelling. Product recalls and lawsuits are common. Zimmer Holdings (ZMH) suspended sales of its artificial hip device several years ago, starting an avalanche of legal action. There were 12,000 of these devices implanted and the friction of the metal hip ball and metal hip socket rubbing against one another caused microscopic shavings that damaged body tissue, leading not only to physical agony, but also to dangerously high levels of metal in the blood.

More recently, Stryker Corporation (SYK) recalled one of its hip implant system because parts were corroding in the body! In what is becoming a huge case facing DePuy, a Johnson & Johnson (JNJ) company, is the worldwide recall of 93,000 DePuy hip replacement devices that started causing pain shortly after surgery when the device became loose. Even worse, the UK released a report saying that up to 50% of patients with this device could be forced to repeat hip surgery. Naturally, the class action lawsuits are piling up.

Like all of Pluristem's clinical trials, this one will be quick and inexpensive - only 18 patients are needed. As they're getting surgery for a total hip replacement the patients will receive PLX cells injected intramuscularly during the procedure. The patients will be followed for one year and observed for pain.

Because of an aging population and the desire for people to stay active longer, orthopedic medical device companies have exploded over the years. Stryker had revenues of $8 billion last year. Zimmer and Smith & Nephew plc (SNN), had $4 billion each. Sales of the other industry giants, DePuy, Sofamor Danek, a Medtronic, Inc. (MDT) company, and Mitek, also part of JNJ, are harder to determine but were bought at huge premiums because of their rapid growth and innovation.

As I have said before in other articles there is always risk in any stock. Share price could linger or lose steam if the management team fails to execute their game plan and reach announced milestones in a timely manner. As with any biotech, regulatory risk is always present. And cell therapy is a new, cutting-edge market which has yet to be adopted. Still, these possible risks are minimal compared to the upside realities and we are not alone in our enthusiasm. Furthermore, we believe the cost-effectiveness of PSTI's products all point to significant future shares in multiple sizable markets. The company is well-funded with approximately $42 million in cash and equivalents reported in their most recent filings, so it does not have the financing risk that we see in a lot of small biotech companies. We always urge investors to do their own due diligence.

The more procedures, the more chance of failed devices and more opportunities for Pluristem to heal damaged tissue. If Pluristem scores with this indication for its platform technology, it could see an entire new industry open up outside of hip replacement pain - the sports medicine market, at a size of $2.2 billion worldwide and, with even more opportunities that haven't been estimated yet - the market for muscular regeneration.

xxxx

 Hey Pluristem:  there are real live patients involved with these  "failed surgeries" which you are counting on to make your market.  You need a different PR firm releasing your press.  Your press should have been spun differently.  Your agency failed its first test!  Unfortunately, your product was overshadowed by an ultimate bottom feeding mentality.  Try better next time!

Saturday, August 25, 2012

$200,000 for a settelement of the Depuy hip case is a failure in my mind REGARDLESS of whether this was Gross or net payments required to 3rd parties

I was shocked by this settlement!    J&J must have been ecstatic!  It definitely set a precedent at the very, very low end of the payout spectrum.

I wonder if the patients will even see any of this money?  I would like to know the following:
  • Is this settlement NET of any monies due to the insurance companies as they of course are not obligated to pay for the hip hospitalization costs.  If they have not submitted their their claims on behalf of the patients for reimbursement then what?

  • Is this money NET of the monies due to the lawyers?
Get where I am going with this?  Was the  suit worth this?  The settlement number, however poorly I view it, is not the issue.  The question is how much has the patient gotten out of all of this so called "settlement"?  That  is the million dollar question.

J and J "did good" in setting  this precedent  for sure.  If the reports are correct, such that each patient was awarded $200K net of every other payment, I would say this was  huge loss to the patients for what they had to go through.

If the settlement was   $200K gross and  required  any balance  due to insurance companies and lawyers....this was a pitiful waste of the patient's time  to engage in  this process and an embarrassment to the lawyers who ATTEMPTED TO  litigate this case.  Shame on them.

Hey, this is just my opinion.  I would be interested in what others think.

Well Depuy, congratulations on what seems to be excellent lawyering on your part.  Too bad those patients didn't have any better representation.

Who knows if the reports of the settlement are right.  I hope they aren't for those of you who have  choosen to litigate.

You know, I can't help but recall the conversation with that  Judge  with whom I spoke early on in my investigation.  The article on the blog can be found here which he wrote:
  http://www.mydepuyhiprecall.com/2011/05/as-trial-judge-greatest-preventable.html

The point he made was this and he was so right:

"One might think that all lawyers are equipped to represent people in trial. However, in the eight years that I spent as a trial judge nothing surprised me more than the wide disparity in the trial skill levels of the lawyers who appeared before me. As a lawyer, I was used to dealing with competent trial counsel on pharmaceutical cases, medical malpractice cases and various product liability cases. As I presided over increasing numbers of trials as a judge, I became aware that there often is a “mismatch” in the relative skill levels among lawyers in cases. In many cases the outcome of a trial was affected by this lack of experience, ineffective counsel or simply by the difference in skill level between counsel. My observations are not just anecdotal; I canvassed many of my civil panel trial judge colleagues across the state and they consistently relayed the same story − viable cases were lost or their values were greatly diminished due to poor trial skills or the unwillingness to try a case."

What those patients needed were great trial lawyers.  What they got was far less than they deserved....a bunch of shrinking violets!

ASK your lawfirm  questions before you hire them:

-How  many cases they have tried to verdict in the last 3 years?

 -BEWARE OF WEBSITES TOUTING “SETTLEMENTS” VERSUS “VERDICTS”



 The claims of collecting millions might sound  good but the truth of the matter is that every day cases are being settled for significantly less than their full value.  Just as you would not call on your family doctor to do heart surgery, a litigant should not call on just any lawyer to handle their case.


























J&J Said to Pay $600,000 to Settle First Suits Over Hips

Bloomberg

Johnson & Johnson (JNJ), which faces about 8,000 lawsuits over hip implants it recalled in 2010, agreed to pay about $600,000 to resolve three cases in the first settlements of the litigation, people familiar with the accords said.

Officials of J&J’s DePuy unit agreed earlier this month to settle Nevada residents’ suits over the company’s ASR hip implants, two people familiar with the agreement said. The company will pay about $200,000 a case to resolve the suits before they were scheduled to go to trial later this year, the people said. They spoke on condition of anonymity because they weren’t authorized to speak publicly about the accords.

J&J officials were able to negotiate settlements “at the low end of what the company should have expected” to pay, Eric Gordon, a business professor at the University of Michigan who follows the pharmaceutical industry, said in a telephone interview yesterday. “J&J should have expected to pay in the $200,000-to-$500,000 range per case.”

J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., saying more than 12 percent of the devices failed within five years. Lawsuits in federal and state courts describe patients in pain and immobilized by joint dislocations, infections and bone fractures.

Metal Debris

Patients suing J&J, based in New Brunswick, New Jersey, claim metal debris from the hips, made from a cobalt and chromium alloy, causes tissue death around the joint and may increase metal ions in the bloodstream to harmful levels.

Bill Price, a spokesman for J&J, declined in a phone interview yesterday to comment on the settlements.

J&J faces more than 8,000 cases alleging the ASR hips are defective, according to court filings. U.S. District Judge David Katz in Toledo, Ohio, is overseeing about 6,000 federal suits that have been consolidated for pretrial evidence gathering. The drugmaker also is defending itself in more than 2,000 cases filed in courts in California, Maryland, Nevada and other states.

The first settlements involve cases filed in state court in Las Vegas, the people familiar with the accords said. Claims by Annelise Rundle, Martha Bender and Katherine Guy had been consolidated and set for trial Dec. 3, according to court documents.

Three Women

Rundle, 74, Bender, 69, and Guy, 60, all had ASR hip replacements done by the same surgeon during the past six years, court filings in Las Vegas show. All three later had the artificial hips removed after experiencing pain and other side effects, according to the filings.

Tests on Rundle showed she had health problems associated with metal filings from her hip, her lawyers said in the filings. In Bender’s case, doctors discovered evidence of bone damage from the device, lawyers said.

“Each of these plaintiffs has incurred a painful and debilitating hip-revision surgery as a result of the failure of their DePuy ASR Hip,” their lawyers said in a December filing.

J&J lawyer’s countered in court filings that the hips didn’t cause Rundle and the other women to develop life-threatening illnesses.

Medical records turned over by Rundle’s doctors, for example, showed she was “generally healthy with no major medical problems,” the company’s lawyers said in a Jan. 17 court filing in Las Vegas challenging the women’s request for an early trial date.

Brian Franciskato, a Kansas City, Missouri-based lawyer for the three women, declined in a telephone interview today to comment on the settlement.

$800 Million

The company said in January that it spent about $800 million on the recall during the past two years. It wouldn’t estimate its product-liability costs.

J&J faces a state-court trial in Prince George’s County, Maryland, in January involving three hip-replacement recipients, according to court filings. Those cases would be the first to go to trial if they aren’t settled.

The first federal trial of claims over the devices is expected in March or April, lawyers involved in the consolidated cases said earlier this year.

The University of Michigan’s Gordon contends it may cost the drugmaker as much as $2 billion to resolve all litigation over DePuy’s ASR hips.

‘Giant Number’

“They’re looking at a giant number before it’s done because there are a giant number of cases,” Gordon said. The biggest benefit to J&J out the Nevada settlements is that the drugmaker has “anchored settlement expectations at the low end of the range,” he said.

J&J’s rose 8 cents to $67.78 in New York Stock Exchange composite trading. The company’s 4.95 percent bonds, due to mature in May 2033, fell $1.23, or 1 percent, to $121 after news of the hip settlements was announced.

The consolidated Nevada cases are Rundle v. DePuy Orthopaedics Inc., A-11-636272, Clark County District Court (Las Vegas).

The federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net; David Voreacos in Newark at dvoreacos@bloomberg.net

Variability in Costs Associated with Total Hip and Knee Replacement Implants.


2012 Aug 8. doi: 10.2106/JBJS.K.00355. [Epub ahead of print]

 

Source

University of California, Berkeley, Berkeley Center for Health Technology, 300 Lakeside Drive, Suite 1980, Oakland, CA 94612.

Abstract

BACKGROUND:

Implant costs associated with total hip replacement and total knee replacement procedures account for a large share of total costs and reimbursements to hospitals. Federal policymakers are promoting episode-of-care payment and other value-based delivery and payment reforms in part to encourage physicians and hospitals to cooperate in managing costs for these and other procedures. The present study quantifies the patient, hospital, and market characteristics associated with variation in implant and total procedure costs for hip and knee arthroplasty.

METHODS:

Clinical, demographic, and economic data were collected on 10,155 unilateral primary total knee replacement procedures and 5013 unilateral primary total hip replacement procedures from sixty-one hospitals in 2008. Variation in implant costs per procedure was measured within and across hospitals. Multivariate statistical analyses were used to measure the association between patient and hospital characteristics and implant costs and total procedure costs.

RESULTS:

The average implant cost per case ranged from $1797 to $12,093 for total knee replacement procedures and from $2392 to $12,651 for total hip replacement procedures. For total knee replacement, 2.5% of total variation in device costs was attributable to patient characteristics and 61.0% was attributable to hospital characteristics; the remaining 36.5% of variance was attributable to within-hospital variation not due to patient or hospital characteristics. For total hip replacement, 4.4% of variance was attributed to patient characteristics, 36.1% was attributed to hospital characteristics, and 59.5% was attributed to within-hospital variation not due to patient or hospital characteristics.

CONCLUSIONS:

There are substantial variations in total hip replacement and total knee replacement implant costs within and across hospitals after controlling for patient diagnoses and comorbidities. This variation is responsible for the majority of variation in the overall cost of total hip and knee replacement surgery.

Update to the MDL (multidistrict litigation) for the Federal court cases.

for those of you who would like more detail on what is happening with the Depuy Multidistrict litigation, you can find here:
http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/CMO-14.pdf

The bottom line is the following: (excerpts from the Maryland Lawyer Injury Blog.)

We don’t know which cases are going to trial yet, only that two trials are set. Among the thousands (4,451 as of July 10) of DePuy hip implant cases filed and consolidated in the United States District Court for the District of Ohio, the lawyers get to pick. The judge has requested that each side choose four cases that they would like to see go to trial. The cases chosen must involve a revision surgery, and must satisfy certain discovery requirements.

Here’s the timeline, according to Case Management Order No. 14:
August 8, 2012: Each side selects four potential cases.
November 1, 2012: End of discovery for the eight selected cases. This is not full discovery, but limited discovery to help identify the ideal bellwether cases.
December 1, 2012: The parties should tell the court which of the eight cases should be bellwether cases. The parties can agree on the cases to be used.
December 15, 2012: If the parties do not agree on which cases should be bellwether cases, the court will pick four total (two primary cases, and two backup cases).

Additional time will be allocated for specific discovery in the four cases.
The bellwether trials are a vital part of the MDL process. The cases chosen are meant to guide both plaintiffs and defendants in deciding whether hip replacement settlements are possible, and for how much. It is instructive to see how a jury will evaluate these cases. For that reason, the parties oftentimes must fight the urge to pick what they see as the best cases—it is more instructive to choose garden variety cases that are representative of the majority of cases. That said, there is a certain appeal to winning the bellwether cases, even if they are not necessarily representative of the rest of the cases. Winning plays a huge psychological role in how the other side views their chances for the other cases.

xxx
If you would like to see additional information  on the litigation process, go to the home page of this blog and click on Litigiation here:  http://www.mydepuyhiprecall.com/p/litigation.html

All-metal hips 'wear down faster'


 (A paper in England)
Published on Thursday 23 August 2012 13:34
 
“Experts are calling for controversial metal-on-metal hip implants to be banned,” according to The Guardian. The newspaper said that research has found “unequivocal evidence” of high failure rates of these implants, particularly among women.

In recent months there has great deal of scrutiny about the safety of some types of metal-on-metal hip replacements, with concerns they wear out much faster than implants featuring plastic and ceramic parts.

To examine the issue, researchers working on behalf of the National Joint Registry in England and Wales analysed data on 402,051 hip surgeries performed using implants attached to the thigh bone by a metal stem, including 31,171 metal-on-metal implants. Researchers found that these had higher failure rates than other types of hip replacement, with an overall five-year failure rate of 6.2%. Those with larger ‘heads’ (the part of the implant fitting into the hip joint socket) had a higher failure rate than those with smaller heads, as did hip implants in women.

This study provides more information on the longer-term performance of metal-on-metal hip replacements, and supports claims that they do not last as long as other types of hip implants.
The use of this type of implant in England and Wales is reported to have dropped dramatically since 2008, and the ongoing concerns seem likely to reduce its use further. Overall, this study supports the recent recommendations by UK health regulators. It states that people with large-headed metal-on-metal implants should be monitored carefully over time to identify whether their implants are wearing down at a faster rate.

Where did the story come from?

The study was carried out by researchers from the Universities of Bristol and Exeter, and the Centre for Hip Surgery at the Wrightington Hospital in Lancashire. It was performed on behalf of the National Joint Registry of England and Wales, which also funded the research.
The study was published in the peer-reviewed medical journal The Lancet.
This story was covered in a balanced way by the Guardian.
 [you can find the coverage of this article and discussion that ensued on this blog here back in March:  http://www.mydepuyhiprecall.com/2012/03/counter-point-to-recent-metal-on-metal.html.  I thought the story was well summarized below so I printed it.]

What kind of research was this?

In recent months there has been some concern over the use of certain all-metal hip implants, particularly over whether they wear down at a faster rate compared to other types of implants.
Hip implants come in a variety of different sizes and materials, but the debate has centred on large-headed ‘metal-on-metal’ implants. These implants are designed so that both the ball replacing the top of the thigh bone and the artificial socket placed in the pelvis are made from metal.

This research was a registry study looking at data on hip implants collected by the National Joint Registry of England and Wales, which records all hip and knee replacement surgeries. This includes the first operation to install the implant, and any revision operations carried out to replace or remove part of the original implant.

Just like with natural bone, metal hip implants experience wear and tear and can eventually deteriorate. This means any implant may eventually need revision surgery, although analysing the revision rate gives an estimate of how often and how soon implants fail early. While the revision rate is an important indicator of the outcomes of hip replacement, it should be noted that not all hip implants that do not function well or cause pain will be replaced.

The researchers say that due to their resistance to wear, large diameter metal-on-metal hip stemmed implants have become popular. ‘Large diameter’ refers to the size of the ‘head’ part of the implant that sits in the hip socket section of the implant. Stemmed means the head is attached to an elongated stem that sits inside the top of the high bone and holds the head in place.

The study’s authors note that there have been concerns about the high failure rate of one particular brand of metal-on-metal hip stemmed implant called ASR, which was withdrawn from use in 2010. Given this withdrawal and fresh concerns about other types of metal-on-metal implants, the researchers aimed to look at whether general metal-on-metal hip stemmed implants fail any more regularly than other hip implants (ceramic-on-ceramic or metal-on-polythene). They also looked at whether large diameter hip implants lasted any longer than implants with smaller diameter heads.
This type of registry analysis is useful for monitoring the long-term performance of devices once they are in use. It can help to identify any problems that are occurring with the implants. Ideally, data on the comparative performance of different implants would come from randomised controlled trials, but the researchers report that there are few such studies available.

What did the research involve?

The researchers looked at 402,051 first total-hip replacements using a stemmed implant carried out in England and Wales between April 2003 and September 2011. They then identified any revision operations carried out on these hip implants. This allowed them to determine how long it took before a revision operation was needed for each type.

The researchers did not include data on ASR implants in their analysis, because they are already known to have much higher revision rates than other brands and have already been withdrawn from the market. The researchers also only included data on hip replacements that had sufficient data recorded to allow them to identify which operations were revisions of which earlier hip replacements. This allowed them to analyse data on 82% of all first total-hip replacements using a stemmed implant performed in the study period.

The researchers tried to make sure the hip implant operations being compared were as similar as possible. For example, they only included those where the implants were not ‘cemented’ in, and where the operation was being performed in ‘typical’ patients.

Typical patients were defined as those whose hip replacement was needed due to osteoarthritis only, and who were generally healthy or with only mild illness at the time of primary surgery. This was defined using a recognised measure of pre-operative health. The researchers also took into account the age of the patient, and looked at men and women separately.

What were the basic results?

The researchers found that metal-on-metal hip implants were used in 8% of the 402,051 first total hip replacements using a stemmed implant. This equated to 31,171 replacements. Use of these types of implants peaked around 2008 but then reduced sharply after this.

Overall, metal-on-metal implants required revision due to failure more quickly than other implants, with a 6.2% needing revision within five years of implantation. The size of the head of the metal on metal implant affected the failure rate in men and women, with larger heads failing earlier. Overall, each 1mm increase in head size increased the risk of revision over time by about 2% (hazard ratio [HR] 1.020 in men, 95% confidence interval [CI] 1.004 to 1.037; HR in women 1.019, 95% CI 1.001 to 1.038).

In men aged 60 years, the five-year revision rate was 3.2% for 28mm head metal-on-metal implants, and 5.1% for 52mm head implants. In younger women, the five-year revision rate was 6.1% for 46mm head metal-on-metal implants, compared with 1.6% for 28mm head metal-on-polyethylene implants.

Revision rates for metal-on-metal implants were higher for women than men, even with implants with the same head size. For example, a 36mm head metal-on-metal implant in women aged 60 had a five-year revision rate of 5.1% compared to 3.7% among men of the same age and implant head size.
However, larger head sizes were more durable for ceramic-on-ceramic hip implants. In men aged 60 years, the five-year revision rate was 3.3% with 28mm head ceramic-on-ceramic implants, and 2.0% with 40mm head ceramic-on-ceramic hip implants.

Age also had an effect on hip implant survival for women, with younger women receiving hip implants more likely to have revision surgery.

The most common reasons for revisions were loosening and pain, and these were more common in people who had metal-on-metal implants.

How did the researchers interpret the results?

The researchers concluded that metal-on-metal stemmed hip implants have a higher failure rate than other options, and should no longer be used. They say all patients with these types of implants should be carefully monitored, particularly young women whose hip implants have large diameter heads. They say that their findings support the continued use of large diameter ceramic-on-ceramic bearings as they seem to perform well.

Conclusion

Metal-on-metal hip implants have been under intense scrutiny in recent months, and this analysis provides useful data on how often they require revision and how they compare to hip implants made of other materials. Overall, this research indicates that metal-on-metal hip implants have higher revision rates (rates of replacement) than other types of hip implants in England and Wales.
As with all such studies, there is the possibility that factors other than the implant type differed between the groups being compared, and that these other factors may influence the results. The researchers tried to minimise the risk of this by:
  • comparing similar operations in similar patients
  • looking at men and women separately
  • looking at the effect of age and implant head size
However, there are other factors such as activity levels that could still be having an effect.
As the data used in this study came from a surgical registry, not a lot of information was available about factors such as body mass index (BMI) or activity levels. These two factors could potentially influence the stress implants are placed under and therefore the wear that they display. The researchers say that in their opinion there is no obvious reason to suppose that these factors would vary to a large extent between people receiving the different large head metal and ceramic hip implants.

Due to these inherent limitations with observational research it is difficult to conclude that the differences seen are definitely due to the implants alone. The advantage of this registry data is that a large number of people were assessed. Furthermore, this is not a selected subsample of people receiving hip implants but all patients from different surgeons and using different implants. The researchers say that these strengths and the consistency of their findings support the suggestion that these findings do represent the true effects of the implant types.

Overall, these findings do seem to suggest that metal-on-metal hips do require revisions more frequently than other types of hip implants. This study reports that since 2008 there has been a dramatic reduction in the use of metal-on-metal hip implants in England and Wales. Overall it found that most hip replacements analysed in the study period (92% between April 2003 and September 2011) did not use metal-on-metal implants.

It seems likely that based on this study their use may decline further. It is important to bear in mind that the overall five-year revision rates with metal-on-metal hips is 6.2%, so the majority of these implants have not needed revision in this time. This study supports the authors’ suggestion and MHRA recommendation that people with these implants should be monitored carefully over time, to identify when such revisions might be required.