Monday, April 30, 2012
These upcoming depositions will cover a range of topics including: the design, sale, promotion and marketing of the ASR hip implants, as well as communications relating to complications, post market surveillance and recall of the devices. The DePuy executives have also been asked to produce documents, notes, outlines, presentation materials, testimonies and oral proposals prepared or given to them that reference or relate to the recalled hip replacement systems.
In addition to these upcoming depositions, a status conference in the federal DePuy ASR litigation has been scheduled for May 1, 2012, at 11:30 a.m. at the Paul G. Rogers Federal Building and United States Courthouse in West Palm Beach, Florida. Subsequently, an open court conference will commence at 12:30 p.m. on that same day.**
Developer Of Recalled Hip Replacement Expected To Testify On A Variety ASR Related Topics
In addition to being credited as one of the main designers and developers of the DePuy ASR hip implant, Dr. Thomas Vail also provided the company with a wide range of consulting services.*** According to Bloomberg Businessweek, he was paid $552,000 in royalty income for intellectual property and/or product development in 2009 and 2010. Bloomberg reported that in addition to receiving payments for product development, Dr. Vail attended DePuy meetings in support of the ASR products and actively promoted them to his peers. According to Bloomberg, Dr. Vail’s participation has resulted in him being a named defendant in patient lawsuits against DePuy, alleging that he assured “orthopedic surgeons during these meetings that the ASR System was safe, was the best product on the market, had an excellent track record and a low and acceptable failure rate.”
Sunday, April 29, 2012
Strange Reimbursement letter from the Insurance Company: Will you be liable if the insurance company doesn't submit your expenses for reimbursement?
I have discussed this reimbursement issue with you in prior posts. Depuy/Broadspire has always been cooperative in reimbursing my direct expenses. Earlier this year, I decided to just send a block of expenses in from Blue Cross to Depuy so that all expenses would be reimbursed. Strangely, I got the biggest run a round trying to get the Blue Cross people reimbursed for these expenses. Blue Cross refused to submit all of the remaining $50,000 or so to Broadspire so I decided to do it myself.
I got this utterly stupid shocking note from the office of the CEO telling me the following:
- "We can not continue to process claims in this manner." What the heck? Oh so you want your claims to accrue until you have no chance of getting reimbursed? A very strange business practice in deed. In effect, they told me to let the claims be and they would take care of them.
- "As with any other claim, your providers must submit all of your hip related health care claims to Blue Cross. The claims will then be processed according to your plan" Well, I got news for you Blue Cross, I hope you know that many of my claims have been processed directly. That is, the claims go into Blue cross and then I have the claim refused and sent to Depuy. They have been doing that for a year. Now you are finding out how your subrogation plan is really working in your company?
- "Please contact Broadspire's customer service dept with any questions regarding disbursement." Well, I got news for you again, I reviewed all of this with Broadspire prior to attempting to help you get your money back for claims on my behalf. All you had to do was submit the list of claims to Broadspire and they would have paid them. What kind of insurance business would turn away the reimbursement of a claim through a subrogated right they had to get that money. Essentially, what they did was turned away the ability to collect on a $50,000 receivable! Who would be so stupid?
- So the final phone conversation went like this:
- Connie: Are you telling me that you don't want this money?
- insurance company: I am telling you that we have a process in place with 3rd party attorneys to collect this money.
- Connie: I was told you have collected no money from Broadspire on behalf of your clients
- Insurance company: That is correct but we have a process in place to do so.
- Connie: but I can get that reimbursed now.
- Insurance company: Thank you but we don't need your help.
The issue with this is that, Broadspire is paying all of these claims voluntarily and I think they have been doing a good job. From my perspective, I don't want to be burdened with some lien in the future if these geniuses at the insurance company can't collect. I am going to send the CEO of the insurance company recapping what went on so that it is clear they are turning down the right to collect to get paid now in exchange for perhaps never getting reimbursed.
Now, if I were an insurance company, I would put a plan in place to subrogate those costs immediately as they are submitted for every case. Why? The better question is why not? Who is to say that they will have enough set aside to honor these payments in the long term. The $3 Billion is not going to scratch the surface in my mind. Simple math will tell you that.
Saturday, April 28, 2012
My mission is clear.
- Define the disease and the cause or precipitant of it.
- Eliminate the hip as being some kind of initial precipitant (ongoing/this will take time)
- Review the three test results I have taken (I will share those with you as soon as I have them.)
- metal testing on the biopsied results
- path tests on the diagnostics
- the cytogenetics tests on the DNA changes.
- Select a treatment program.
Here are the 3 key large short term patient metal on metal studies that will prompt me to move forward and serve as my inspiration that there are no answers at this point...only questions. I also will commit to attempt to get some studies funded to move this research forward.
- The incidence of cancer was low after hip replacement (1.25% at one year.)
- There was no evidence that metal on metal bearings were associated with an increased risk of any cancer diagnosis after 7 years
- There was no increase in the risk of malignant melanoma or haematological, prostrate and renal tract cancers.
- The 5 year incidence of all cancers for men aged 60 was approx 5%, with resurfacing approx 6%, with stemmed MOM 7% and were lower with woman.
[There are issues with all of this stuff. How often do patients get hip operations that have been tested for Cancer? Never? While the author does point this out,these studies need to be taken to the next step. For obvious reasons, they all underestimate the cancer risk but we don't really know that someone has cancer unless there is a reason to have discovered it.]
Friday, April 27, 2012
I think I will call the pathologist this morning. By the way...while I may be working outside the normal lines and boundaries with physicians, always remember that there are two people on your team whom you never see that are great information resources: the pathologist and the radiologist. These two sub specialties have loads of information beyond that which you may get from your physician. You can always request their notes and often times may speak with them directly if you are dealing with a patient care centered hospital. (Most hospitals, sadly, are not based on a patient centered care philosophy.)
That philosophy entails the recognition that the patient is an integral part of the care team. That means, you have access to all information and are very much a part of the decision making process. We are lucky to have a hospital run by a CEO (and physician) who does have that philosophy. He had a very bad accident that has left him a paraplegic (for now.) He became a patient at his own medical center and as a result is acutely aware of the interactions that the medical team has with the patients. The point is that many things changed in that hospital.
I experienced first hand those changes last Friday when I underwent that surgery for tumor removal:
- My surgeon called me the day before the surgery to find out if I had any remaining questions (who has ever heard of surgeon doing that?)
- upon admission, every single person shook my hand and introduced themselves and welcomed me to the hospital.
- At lunch, I was not too kean on the food and one of the nurses offered to share their lunch with me
- After recovery, even though this robotic surgery was day surgery, they moved me to a private room when giving me the preliminary news that I had cancer.
- As a result of us discussing the hip and its potential implications requiring certain tests, the pathologist was brought into my room to discuss the testing with me. She mentioned that she started a program to become more interactive with the patients.
- On a prior trip to the sister hospital, I was able to make an appointment to meet with my radiologist went the medical team recommended working with an interventional radiologist to get some tumor samples from a tricky area.
- When I was admitted to the floor for an over nite stay post surgery (that stay was unplanned), I was taken to a private room with an introduction from the nurses telling me that I would not be awakened all nite for tests. They had a "quite time" policy that precluded all of that.
- When the nursing shift changed, I was told I would be introduced by my current nurse to the new nurse.
I feel the radiologist and the pathologist are key members of your medical team because they see the hip images (radiologist) and the tissue samples (pathologist) from the surgery. At the very, very least, you should request the path notes and the radiology notes along with the notes from your surgery from your ortho. surgeon.
Thursday, April 26, 2012
As the healthcare company battles reputational issues, investors Are targeting its Directors.
In 2011, the average J&J (JNJ) director won approval from just 88% of shareholders, down from 94% in 2009. That may not sound like a steep decline, but it's actually quite low for a large corporation, according to Charles Elson, director of the John L. Weinberg Center for Corporate Governance at the University of Delaware. "When you get into the 80s, that's a real problem," he says.
Two J&J directors -- Charles Prince, the former CEO of Citigroup (C), and Michael Johns, the chancellor of Emory University -- received support from about 80% of voters, which is well inside the "danger zone," according to Paul Hodgson, a senior research associate at GMI, a corporate governance ratings firm. "That's a very substantial proportion of shareholders," he says. "It should be enough to make a board sit up and take notice."
A spokesperson for J&J wrote in an email that the board will analyze voting results after its annual meeting, as it does every year.
Red flags: Disappointing financials, recalls
It's easy to see why J&J's shareholders are frustrated. In recent years, the company has been charged with several legal violations and endured a seemingly endless series of product recalls. Its reputation has taken a hit. Back in 2009, before the recalls began, J&J was ranked fifth on Fortune's World's Most Admired Companies list. In 2012, J&J's overall rank dropped to 12.
The company's financial results have also been underwhelming. J&J's stock has delivered a total return of 5.3% over the last two years, while the S&P 500 has returned 17.5%. Its net income declined in both 2009 and 2011, in part because the company lost more than $1 billion in sales because of recalls of over the counter drugs.
Investors are typically wary of punishing directors for individual missteps. But J&J's troubles have been widespread. Two years ago, the Department of Justice charged the company with paying kickbacks to Omnicare (OCR), the nursing home pharmacy operator. Last year, the company agreed to pay a $70 million settlement over allegations that it paid bribes overseas. An Arkansas judge recently ordered J&J to pay $1.2 billion in penalties for illegal marketing practices.
J&J has had to recall millions of bottles of over the counter drugs made by its McNeil subsidiary, citing issues such as bad odors and an excessive amount of active ingredients. After the initial spurt of recalls in 2009, J&J shut down the McNeil plant, promising to revamp its quality assurance practices in order to get production back on track. But recalls keep popping up. As recently as February 2012, the company had to recall more than 500,000 bottles of Tylenol. J&J now says it won't reopen the plant until late 2013.
A group of J&J shareholders, including the NECA-IBEW Welfare Trust Fund and the Hawaii Laborers Pension Fund, sued the board in 2010, arguing that directors had ignored red flags. A U.S. District judge dismissed the complaint, but noted in her opinion that the shareholders' allegations against the board were "troubling and pervasive."
In J&J's 2011 proxy statement, the board praised J&J's CEO, William Weldon, for his handling of the recalls. The statement said Weldon "generally met expectations" in 2010, adding, "Mr. Weldon's leadership and engagement with employees, legislators, regulators, investors and the news media enabled the company to deal with the issues."
During a significant portion of 2010, though, Weldon avoided the press. When he first addressed the recalls, he said that they were isolated to the company's McNeil unit; not long after that, J&J issued recalls of hip implants made by its DePuy division. In April 2010, a J&J spokesperson said Weldon didn't think that cost cutting played a role in McNeil's problems. The following July, J&J released a report that conceded that the company's push to cut costs through layoffs had contributed to its quality woes.
The report also said that J&J's officers and directors had not breached their fiduciary duties, and pledged to create a new regulatory compliance committee. In an email, a J&J spokesperson wrote, "The Company's management takes the shareholder concerns and criticisms very seriously."
Weldon's compensation is a sore spot for J&J investors, and may be the primary source of their growing dissatisfaction with the board. The directors on the compensation committee last year -- which, in addition to Prince and Johns, included former Xerox (XRX) CEO Anne Mulcahy and former Wm. Wrigley Jr. CEO William Perez -- were particularly unpopular with voters. Prince, who famously walked away from Citigroup with about $100 million, is the compensation committee's chairman.
ISS told its clients to vote against the company's pay policy, citing a "lack of negative discretion on CEO's pay magnitude despite ongoing reputational challenges." Weldon took home $23.4 million last year, according to research firm Equilar, making him the 13th highest paid leader of a large company (he received a 3% bump in his base salary). J&J recently disclosed that Weldon is set to receive more than $140 million worth of benefits and deferred compensation when he retires.
In 2011 -- the first year that the Dodd-Frank Act mandated "Say-on-Pay" votes -- 39% of J&J's shareholders voted against its compensation plan. The company responded by changing its program, focusing more on performance-based pay. But representatives from the American Federation of State, County and Municipal Employees (AFSCME) say Weldon's pay package was still excessive. "To the executives at J&J who deal with executive compensation, the changes they made were monumental. For shareholders, they just weren't enough," says Lisa Lindsley, the union's director of capital strategies.
AFSCME has also lobbied the company to institute an independent chairman, a proposal that has won support from ISS. Weldon, who recently stepped down as CEO, intends to stay on as chairman. J&J has argued that he should maintain that role, writing in a filing, "Our Board believes that in the context of the upcoming transition to a new CEO, it will be in the best interests of the company to have our former CEO remain as Chairman and work closely with our new CEO to ensure a seamless transition of leadership."
Lindsley says J&J's board needs independent leadership. "When a former CEO is the chair, they tend to protect their protégés," she says. "We just don't think that Mr. Weldon should have anything to do with the company."
Wednesday, April 25, 2012
I am going to pick up on my past series on the Immune system because I think there is a clear link between stress to the immune system (perhaps from metals), cancer and the issues that are seen with the hip. I don't know the order of these nor do I know which comes first but I will begin this immune perspective in the next week.
The tests I have embarked on are tests that might indicate that we should explore this relationship (between the hip and cancer) further. Why bother? Because I believe there are some really smart Research physicians in the medical community who have questions about this link between metals and cancer. I have listed the publications of these studies in numerous prior posts.
The types of things I am looking for in the path tests:
- Are there any metal nanoparticles contained in the tumors, of which I have a number of them? We are only on my first biopsy.
- Do the translocation tests show any abnormalities in the t(14,19) that have shown up previously to occur in metal on metal patients? [having this abnormalities does not mean cancer is inevitable.]
- Are the remainder of these so called tumors/growths etc actually cancerous or are they granulomas?
- If this is a kidney cancer, why did it take the path of growth it did which is atypical of kidney cancer?
- Why did these growths all become apparent after the revision when one year prior there was no evidence of any growths via the CT scans? stay tuned.....
Once I have the path finding from last Fridays surgery, I will have one more data point. Will I prove anything by the time these tests are ready? Absolutely not.
Its just hard for me to buy into a cancer recurrence when I hear things from the medical team like:
- This is not a recurrence of the primary renal cell carcinoma.
- The tumor path this has taken is not typical of any kind of renal cell carcinoma.
- Something else must be at play given none of these tumors were there a year ago.
- How did they grow so fast?
- Why aren't you experiencing any symptoms?
What I have learned from dealing with this situation is that sadly, the physicians often times do not know what causes a cancer and the cause doesn't seem to be an issue. Once the diagnosis is made, the treatment is already predetermined regardless of the cause. I will never understand this. It makes no sense to me that the cause doesn't inform treatment. It will never make sense to me.
Tuesday, April 24, 2012
Multidistrict Litigation takes all similar DePuy hip recall cases currently in federal court throughout the United States and transfers them to a single federal court where they go through pre-trial proceedings and discovery at one time.
Discovery is when a patient's attorneys have the opportunity to force Johnson & Johnson to turn over documents. Discovery helps determine what the company knew about problems with the DePuy ASR and when they knew it.
After the MDL is complete, your case is sent to a different federal court for trial.
WHAT IS THE LARGEST AND LONGEST LASTING MDL?The largest and longest lasting MDL was created in 1991 in the Eastern District of Pennsylvania to handle asbestos injury cases. Now, 20 years later, there are still thousands of these cases pending in that multidistrict litigation procedure.
WHY THE MDL IS BAD FOR YOUR CASE:
- Your case is taken away from your attorney and handed over to a committee of plaintiff's attorneys who you have never met and didn't hire.
- Your lawyer is cut out of the process until your case is returned from the MDL for trial. At that point your attorney has to try your case with only the evidence given to him/her by the MDL. Effectively, your lawyer looses control of your case.
- For DePuy ASR Recall patients, federal court is almost always NOT considered the best venue for a plaintiff's medical product liability case. Many states have more favorable procedures and laws for patients in medical product liability cases. For example, federal courts will often restrict your side's experts from testifying and even dismiss your product liability case altogether based on technical evidentiary rulings. That means sometimes your product liability case won't even go to trial. In contrast, state courts tend to allow juries of fellow citizens to decide cases
HOW MULTIDISTRICT LITIGATION (MDL) BENEFITS DEPUY:
- Large corporations such as DePuy Orthopaedics, Inc. and Johnson & Johnson prefer the MDL because they only have to defend a single case.
- Johnson & Johnson and DePuy Orthopaedics, Inc. can then devote their armies of lawyers to the single case.
- If the MDL judge rules that Johnson and Johnson can keep a document secret, it remains a secret.
- In contrast, if there are multiple state court cases, when one judge rules that Johnson & Johnson can hide a document, another judge will likely require them to produce it.
WHAT HAPPENS IF MY STATE COURT CASE IS SENT TO THE MDL?The Hip Recall Alliance believes there is little downside to filing your case in state court. This is the venue that is in YOUR best interests, not DePuy's. If DePuy succeeds in forcing your case into the MDL after all, then you will proceed just like thousands of other hip recall patients going through mulitdistrict litigation. The Hip Recall Alliance fights for your rights against these huge corporations as aggressively as the law will allow.
[If there are any lawyers from the MDL committee reading this, feel free to provide a responce and I will publish it.]
Monday, April 23, 2012
\(April 18, 2012 – Las Vegas, Nevada) -- A Nevada judge set the first trial date involving Johnson & Johnson subsidiary DePuy Orthopaedics, Inc.'s recalled ASR hip to begin December 3rd. The trial will take place in a Las Vegas, Nevada state court. The trial involves three patients with recalled DePuy ASR hip devices. All three patients have had their ASR hip implants removed and replaced. A Las Vegas judge and jury will decide the outcome of the case.
"This is the first DePuy ASR hip trial scheduled in the United States" says Brian Franciskato of the Nash & Franciskato Law Firm, "but if Johnson & Johnson continues to refuse to compensate patients, I have no doubt that there will be many, many more."
Representing the patients in the Nevada trial is an alliance of law firms including Maglio Christopher & Toale, P.A., the Nash & Franciskato Law Firm, and the law firm of White & Wetherall, LLP. "Getting this case to trial is one of the reasons that we fought DePuy so hard when they tried to force us into federal court," stated Altom Maglio of the Maglio Christopher & Toale, P.A. Law Firm. "If DePuy had succeeded in forcing this case into federal court, our clients would be stuck in limbo, with no possibility of getting justice for years."
In addition, the second DePuy ASR Hip trial in the U.S. has been set by a Maryland judge to begin the following month in January 2013. The Maryland trial is also on behalf of three patients with recalled DePuy ASR hip implants that had to be replaced. The Maryland patients are also represented by the Maglio Christopher & Toale, P.A. and Nash & Franciskato law firms. The January trial will be held in a Prince George County, Maryland state court.
The December Nevada trial is in the case of Rundle, et al. v. Precision Orthopaedics, Inc. and DePuy Orthopaedics, Inc., case number A-11-636272-C, in the Eighth Judicial District Court of the State of Nevada. The January Maryland trial is in the case of Jackson, et al. v. Chesapeake Orthopaedics, Inc. and DePuy Orthopaedics, Inc., case number CAL10-32147, in the Circuit Court of Prince George's County, Maryland.
Sunday, April 22, 2012
The New Brunswick, N.J.-based health care conglomerate said costs associated with the recall of its DePuy ASR metal-on-metal hip implant and with litigating the 100s of personal injury lawsuits filed over the device slashed $271 million from its quarterly profits.
J&J posted profits of $3.91 billion, or $1.41 per share, on sales of $16.14 billion for the quarter, for essentially flat sales compared with profits of $3.48 billion, or $1.25 EPS, on sales of $16.17 billion during Q1 2011.
Saturday, April 21, 2012
Just wanted to let you know. Should be back hip blogging by tomorrow.
Thanks for your notes!
Thursday, April 19, 2012
As you know from prior posts, on Friday, I will be undergoing my first surgery to determine the nature of these "tumors/Growths" that have appeared in the last 12 months.
Since December, there has been lots of discussion about the nature of these growths. There are at least 4 growths that the surgeons have targeted as unknown in nature and of concern to my medical team.
The objective of the surgery is to determine the nature of the least problematic of the growths (in terms of accessibility) to either biopsy or removal of the lymph node/granuloma or organ. The first growth is either on or near the ovary (could be a lymph node and not the ovary itself.) The ambiguity arises because the first growth is located right near my hip prosthesis and it is difficult to make out the exact nature of it. (The hip shines on the films so it makes it difficult to read.)
The surgery, while not complex, will be done with the Divinci robot laproscopically. It is an important surgery which hopefully will result in some indication as to what the pathology is of this "tumor" and also provide an indication of the nature of the other growths.
As stated in prior posts on this issue, there are a wide range of possibilities which may include but are not limited to cancer ( 5 years ago, I had a cancer in situ removed in one of my kidney's) and or granulomas, the latter likely a result of the hip revision. The surgeon who performed the nephrectomy does not think this is a recurrence of the renal cell carcinoma. The GYN onclogist does not believe it is ovarian cancer. A renal pathologist does not believe these growths have a path that is indicative of kidney cancer. My research has resulted in the possibility of Granuloma formation as a result of the hip revision.
I have discussed the the need to get some metal histochemical staining on the tissue which is removed and have requested the T(14;18) translocation test via the FISH test (flourensence in situ hybridization) which is the one possible test for looking at early DNA alterations which could possibly have resulted from the metals in the hip over time. The latter test is one which has not been exposed to the hip population at large. I am wondering if it should be in a research setting?
The literature suggests a long term gestation period for metal induced cancer. I don't know but by nature, I question everything. DNA alterations are not things that happen quickly. Most of the medical literature concludes that changes such as these take years not months to come about.
I have no clue at this point whether any of these growths are related to this hip. What I can say, and has been mentioned in previous posts re this subject, is that none of these growths were present one year prior to their discovery in December of last year. One month post revision, we became aware of the growths which of course, does not mean there is a connection between the growths and the revision. Maybe its all coincidental?
I will certainly post whatever I can as soon as I can re this investigation and my findings .
My first post on this issue re my condition:
Granulomas Redux...What are they again?
Seeking information.......Granulomas, histiocytosis, type IV immune response.... (part 1 of x in this series)
So what is the cause of these pseudotumors after the second revision? (part 2 of x in this series)
Granulomas, necrotic pseudotumors post revision.....what is the story on this? (part 3 of x)
Background on Type IV Immune response (part 4 of x)
Background on Type IV Immune response (part 5 of x)
Background on Type IV Immune response (part 6 of x)
Connie's status with her investigation into tumor type growths (7 of x)
Granuloma journal articles provided to my medical Team related to the hip (8 of 8)
Wish me luck! Thanks for all of your support. It's important to me.
Wednesday, April 18, 2012
Johnson & Johnson reports profits of $3.8 billion despite expenses tied to hip device recall and litigation
Published: Tuesday, April 17, 2012, 8:17 AM Updated: Tuesday, April 17, 2012, 8:25 AM
The New Brunswick-based company said its net earnings were $3.8 billion, or $1.37 per share, up 1.5 percent over the same period of last year. That topped the average analyst forecast of $1.35 per share compiled by Thomson Reuters.
U.S. sales dropped 5.1 percent while international sales rose 4.1 percent.
The company’s first quarter earnings reflected an after-tax gain of $106 million related to the acquisition of the Swiss device maker Synthes and after-tax charges of $271 million connected to litigation expenses and the costs tied to the recall of its hip implant devices
[ I think this article is confusing. not sure whether the 2.8 B includes or excludes the $3B charge for the hips?]
Now, at the time I wrote the preface for that study, I noted a few things below.
-"patients who have undergone joint replacement have a higher than normal incidence of DNA damage to blood lymphocytes. In concentrations found in the blood after hip replacement, cobalt and chromium have the ability to signal across intact barriers in the body and cause irreversible DNA changes to cells on the other side of the barrier
So why am I raising this again? It is not the banking of femoral heads for the purpose of bone grafting that was of interest to me but the following :
Our findings indicate that, even with a detailed medical history and careful physical examination, clinically important diseases including neoplasms and Paget's disease are observed in patients diagnosed with osteoarthritis prior to total hip arthroplasty...105 of 6161 femoral heads demonstrated abnormal or reactive histopathological features not reported prior to surgery. A retrospective review of the histopathological findings was conducted to evaluate and reclassify all previous observations of abnormalities. Nineteen patients had a suspected neoplasm. Of these nineteen, eight cases of non-Hodgkin's lymphoma or chronic lymphocytic leukemia and one case of myelodysplastic syndrome were confirmed on further investigation. One subsequently confirmed malignancy was detected per 770 femoral heads examined.
Histological examination plays an integral role in quality assurance in femoral head banking, and it also represents a possible early diagnostic test for bone and bone-marrow-related diseases in patients undergoing total hip arthroplasty
As the article above in the link pointed out, hip patients are not routinely screened for cancer. It is likely that a targeted screening programme would identify more patients with cancer than were identified here."
Tuesday, April 17, 2012
Magnetic resonance imaging of the postoperative hip.
SourceDepartment of Radiology and Imaging, Hospital for Special Surgery, New York, NY, USA.
AbstractMagnetic resonance imaging (MRI) is ideally suited to imaging the patient with painful hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities, and lack of ionizing radiation. MRI is the most accurate imaging modality in the assessment of periprosthetic osteolysis and wear-induced synovitis, and can also assess regional tendons and neurovascular structures. This article discusses the technical aspects of MRI around metallic implants as well as the appearance of potential complications following hip arthroplasty, including osteolysis, wear-induced synovitis, infection, hemarthrosis, fracture, loosening, component displacement, heterotopic ossification, tendinopathy, and neurovascular impingement. The specific complication of metal hypersensitivity following metal-on-metal prostheses is reviewed. J. Magn. Reson. Imaging 2012;35:1013-1025. © 2012 Wiley Periodicals, Inc.
Sunday, April 15, 2012
On March 5, 2012, Judge Katz vacated a DePuy ASR MDL status conference scheduled for March 15, 2012.** According to the order, the conference was vacated because "discovery is proceeding apace which negates the necessity." In lieu of the meeting, Judge Katz held a telephonic status conference on March 15, 2012. Given that discovery is moving without delay, during the telephonic status conference, Judge Katz requested that lead counsel meet and confer to discuss the issue of bellwether trials for the initial group of hip replacement lawsuits. The purpose of "bellwether" trials is to try cases that are representative of plaintiffs' claims generally and to determine the strength of plaintiffs' claims and the extent of defendants' potential liability. Judge Katz ordered lead counsel to submit a joint proposal of competing bellwether trial selection protocols by April 27, 2012. In the interim, key witnesses in the DePuy ASR MDL continue to be deposed.
Johnson & Johnson Fined $1.2 Billion for Drug Labeling FailurePosted by Pratap Chatterjee on April 12th, 2012
Johnson & Johnson has been fined $1.2 billion over sales of Risperdal, an antipsychotic drug. Tim Fox, a circuit judge in Arkansas, ruled that the company has to pay $5,000 for each of the 240,000 prescriptions that were paid for by the state’s Medicaid program. (The program provides health care for low-income citizens, financed by the taxpayer)
Risperdal was introduced in 1994 by Janssen Pharmaceuticals Inc., a subsidiary of New Jersey-based Johnson & Johnson. It is prescribed for treatment of schizophrenia and short term episodes of bipolar disorder (manic depression) as well as irritability connected to autism in children.
In 2004 the U.S. Food and Drug Administration (FDA) forced the company to put labels on the drug to warn that Risperdal places elderly patients with dementia at an increased risk of strokes, seizures, major weight gain, possible diabetes and fatally high blood sugar, as well as potential death.
Fletch Trammell, a Houston lawyer acting on behalf of Arkansas, told jurors that the company had previously sent out a letter saying the drug did not increase the risk of developing diabetes. Tramell noted that some patients gained 60 to 100 pounds (27 to 45 kilos) in weight as a result of taking the medication, which in turn increased the risk of diabetes.
"The law is broken once they tell a lie," Trammell said. "You have to ring the bell. You have to tell the public.” He noted that patients in rural Arkansas were not able to get up to date information from specialists.
Jurors in the Arkansas trial were also told that the company avoided such labels because of the potential impact on its share price, which could have reached $200 million.
But Johnson & Johnson says that Arkansas has no grounds to sue them because it did not pull the drug at the time. “They didn’t run off and sound the alarm at the time this suit was filed,” James Simpson, a lawyer for the companies, told the jury. He says Arkansas should have told patients: “Whoa, whoa, whoa, this stuff is dangerous.”
Dozens of states have sued the company. Last year, Johnson & Johnson and Janssen was fined $327 million in South Carolina and in January, Texas settled a lawsuit against the company for $158 million.
The Arkansas fine is the biggest so far. “Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people,” said Arkansas attorney general Dustin McDaniel.
The company has said it will appeal. "Janssen firmly believes it did not violate the Arkansas Medicaid Fraud False Claims Act or the Arkansas consumer fraud statute. ... It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules," the company said in a statement.
Johnson & Johnson is also facing lawsuits over its hip-replacement technology. DePuy, a division of Johnson & Johnson, recalled 93,000 XL Acetabular metal-on-metal hips in August 2010 after experiencing a 13 percent failure rate. Some 5,000 product liability lawsuits have since been filed against the company. An FDA advisory panel of experts is to examine this issue in late June.
William Weldon, the company’s outgoing CEO, was confident that the company's finances will recover from the string of lawsuits because of their target audience. “Populations in the developed world are ageing rapidly, and we consume more healthcare as we grow older,” Weldon said. “Our investments continue to be aligned with these market opportunities.”
At upcomming Q1 release of financial results to investors in J&J, aAnalysts likely will ask about liability in continued litigation over allegations J&J marketed former blockbuster schizophrenia drug Risperdal too aggressively, including for unapproved uses. On Wednesday, an Arkansas judge fined J&J more than $1.1 billion for downplaying and concealing Risperdal risks such as major weight gain and developing diabetes. That ruling, which will be appealed, could affect dozens of pending lawsuits over the drug, many by states seeking reimbursement for what their Medicaid programs spent on the drug.
WHY IT MATTERS: While J&J has gotten past a spate of generic competition that slashed sales of blockbuster drugs for infections and attention deficit disorder, it continues to lose hundreds of millions of dollars a year due to manufacturing quality problems. About 30 product recalls since September 2009 -- for faulty hip implants and contact lenses, a couple of prescription drugs and Tylenol and many other nonprescription medicines -- have kept products off the market for as long as two years. J&J is operating under increased government oversight and was forced to gut and rebuild a huge factory.
Friday, April 13, 2012
The primary cause of failure in the MITCH THR implant is loosening and movement in part of the hip joint replacement, Medsafe group manager Dr Stewart Jessamine says.
The international recall came after data found there have been higher-than-expected failure rates in the metal-on-metal hip device three years after implantation.
Three people in New Zealand have had surgery after the implant failed.
"As a result of the increased failure rates, patients who have this implant will need to be followed up annually for the life span of the implant," Dr Jessamine said.
"The recall does not mean that patients with the implant will necessarily require revision surgery."
The company which distributed the implant, Stryker, is asking surgeons to contact 41 patients in New Zealand who received the implant.
New Zealand Orthopaedic Association and New Zealand joint registry were also working to ensure people affected knew they needed further follow-ups and were given information.
Anyone concerned they may have the implant should contact their doctor or surgeon, Medsafe says.
The implant was used in New Zealand between 2006 and 2010.
It was manufactured by a UK company, Finsbury Orthopaedics Ltd, acquired by DePuy Orthopaedics in 2009.
DePuy, a division of Johnson and Johnson, recalled another hip implant in 2010, after tiny metal fragments were found to be breaking off the implant, leaking into the blood and poisoning it.
About 500 New Zealanders may have that implant and a group of them are taking legal action against the company, seeking compensation for pain, suffering and financial loss.
Thursday, April 12, 2012
Histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties
Department of Pathology, University hospital of North Tees and Hartlepool NHS Foundation Trust, UK.
- 17 cases showed metallosis
- 60 cases showed chronic lymphocytic sinovitis***
- 40 cases showed lymphoid aggregates* with germinal centers**
*Lymphoid aggregates appear as slightly elevated nodules that may be normal in color or more red than the surrounding tissue. Sometimes they can look like small polyps. This is a harmless, non- cancerous condition.
**Germinal centers (or germinal centres; GC) are sites within lymph nodes (also within lymph nodules in peripheral lymph tissues) where mature B lymphocytes rapidly proliferate, differentiate, mutate their antibodies (through somatic hypermutation), and class switch their antibodies during a normal immune response to an infection.
***Synovitis is the medical term for inflammation of the synovial membrane. This membrane lines joints which possess cavities, known as synovial joints. The condition is usually painful, particularly when the joint is moved. The joint usually swells due to synovial fluid collection
Wednesday, April 11, 2012
SourceToxicological Information Centre, Department of Occupational Medicine, Charles University, Prague and General University Hospital , Czech Republic.
AbstractContext. Cobalt intoxication has become more frequent due to the wide use of metal hip implants. Case details. A 56-year-old male patient underwent total hip prosthesis, with a ceramics-on-ceramics implant. Almost 3 years later, it was replaced by metal implant containing cobalt, chromium, and titanium. He developed weight loss, heart, thyroid, and neurological toxicity, with severe hearing loss. He was treated with 2,3-dimercaptopropane-1-sulfonate (DMPS), and cobalt excretion increased. Clinical symptoms apart from deafness gradually resolved. Conclusion. We report significant cobalt poisoning from a damaged hip replacement with cobalt containing implant and a slow abrasion of the metal by residual ceramic particles. Chelation therapy resulted in apparent benefit.
[Chelation therapy: (medicine) the process of removing a heavy metal from the bloodstream by means of a chelate as in treating lead or mercury poisoning.
I was told that this therapy only helps after immediate exposure to Metals. I can find only one other article in Pub Med where Chelation was used to remove either chromium or coblat from the blood stream as associated with hip replacments or revisions. the other reference was with Cobalt in 1986.
Tuesday, April 10, 2012
Perhaps the readers can comment?
1. The revision was not legally caused by the product at issue.
2. Allergic Reaction
3. Idiosyncratic reaction:
(pharmacy, medicine) A reaction to a medication that is unusual and unpredictable, specific to a particular person. Unlike allergy, it can occur on first exposure to the medication, unlike a side effect, it affects only very few individuals.
4. Idiopathic reaction
Of, relating to, or designating a disease having no known cause.
5. Unforeseeable accident
6. Preexisting condition
Anyone else get this? comments?
Monday, April 9, 2012
For the second consecutive year, a union is urging Johnson & Johnson shareholders to vote against an executive compensation proposal. At issue again is the pay for Chief Executive Officer Bill Weldon, who is expected to step down this month.
The American Federation of State, County and Municipal Employees, which owns about 20,000 Johnson & Johnson shares, says shareholders need to use their Say on Pay option to vote down compensation that is out of line with other executives’ pay — especially with all the trouble Johnson & Johnson faced during Weldon’s 10 years at the helm.
“The JNJ Board needs to get its hearing checked. After almost 40 percent of its shareholders voted against CEO pay last year, they are still not listening,” said AFSCME President Gerald W. McEntee.
Weldon’s total compensation in 2011 fell to $26.8 million from $28.7 million the previous year. This is largely due to the company’s struggles with recalls. Still, Weldon received a $3.1 million annual bonus for 2011, which is a 55 percent increase from 2010.
Johnson & Johnson has faced more than two dozen product recalls since September 2009, ranging from contaminated drugs to dangerously defective medical devices, such as the DePuy Orthpaedics’ hip implants and vaginal mesh implants. Most recently, the company recalled more than a half million bottles of infants’ Tylenol because of defective dosing system was too difficult to use.
And the problems that have plagued Johnson & Johnson under Weldon’s watch aren’t just recalls. The U.S. Food and Drug Administration (FDA) warned the company about false claims it made about its Listerine mouthwash in September 2010, saying it has not been proven to be effective in removing plaque or preventing gum disease. In April 2011, the SEC charged Johnson & Johnson with bribing doctors to prescribe its drugs and medical devices.
Consequently, consumer confidence has dropped and sales have suffered. The recalls have cost well over $1 billion in lost sales and triggered Senate and regulatory investigations.
“Bill Weldon does not deserve pay far above his peers after Johnson & Johnson’s reputation has been damaged and shareholder value destroyed on his watch,” said McEntee. “Excessive pay is a disease, and the prescription for investors is to just Vote No.”
Johnson & Johnson’s board defends its decision in a recent filing with the U.S Securities and Exchange Commission (SEC): “We significantly changed the architecture of the long-term incentive program – the largest component of compensation for our named executive officers; discontinued the use of cash-based long-term incentives that have been in place for over 60 years; and introduced Performance Share Units with payouts contingent on achievement of sales, earnings per share and total shareholder return goal.”
Shareholders will decide when they vote April 26.
Saturday, April 7, 2012
Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics
Thursday, April 5, 2012
- Blood levels
- plasma levels
- urine levels