Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: JjrkCh

Thursday, January 31, 2013

J&J Patient Harm: Too Big To Fail / Jail ?

New York Times FULL ARTICLE and trial video


During Trial, New Details Emerge About Hip Maker


When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.
Multimedia
Andrew Ekdahl Testifies

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.
In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.
The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.
The information about the depth of Mr. Ekdahl’s involvement with the implant may raise questions about DePuy’s ability to put the A.S.R. episode behind it.
Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company “seeks the most accomplished and competent people for the job.”
On Wednesday, portions of Mr. Ekdahl’s videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it “because it did not meet the clinical standards we wanted in the marketplace.”
Before the device’s recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.
In late 2008, for example, a surgeon who served as one of DePuy’s top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be “redesigned.” At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.
“My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied,” that consultant, Dr. William Griffin, wrote.
A spokesman for Dr. Griffin said he was not available for comment.
The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.
Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.
Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup’s design, documents disclosed during the trial indicate.
Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.
In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.
“The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize,” that executive, Raphael Pascaud wrote in March 2009.
Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.
The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.
DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.
During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was “simply untrue.” “This was purely a business decision,” Mr. Ekdahl stated at that time.
This article has been revised to reflect the following correction:
Correction: February 1, 2013
A headline on Thursday about a patient lawsuit against DePuy Orthopaedics, a unit of Johnson & Johnson, misstated the start of the trial in some copies. It began last week, not on Wednesday.

original postDuring Trial, New Details Emerge About Hip Make
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When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.


Monday, January 28, 2013

Biomet Knee Warranty: Patient Advocates Not Buying It!



Go to the link  Biomet direct-to-consumer ad now running on TV in the U.S.   The Biomet knee warranty is here.

What the warranty should say:

1. This device is designed to last for _______ years.  
2. Normal use is defined as ____________.
3. Patients will encounter no legal/paperwork barriers to accessing the warranty.        
4. Hospital and testing costs are fully covered.The product cost is incidental to patient harm costs such as lost income, pain and suffering. 
5.  Revision is failure and prompts payment under the warranty.  Increased function and pain reduction are expected. Introduction of new patient harm such as exposure to toxic materials or need for increased medical intervention is a failure.  
6. Patients should bear no expense for testing costs for devices with sub-optimal results.
7. Immediate patient compensation in contested cases is assured. Financial responsibility is pre-defined in a default agreement between producer/hospital/surgeon.    
8. Like MSDS sheets, every source and material in the device is listed and the long term health issues related to exposure are disclosed.  Such documentation must be provided to the patient in pre-op informed consent along with history of FDA product approval(510k or PMA) and number implanted to date.
9. A comprehensive federal implanted medical device registry is fully public and free. Exercised warranties will be immediately visible.  The medical device industry functions in a transparent and ethical manner to the benefit of the nation and citizens of the United States.  Profit reflects the value of its' contributions to the health of patients.


Concerns that Prompted this Blogpost:

Direct-to-consumer ads are intended to drive sales.   "The industry's only Lifetime Knee Implant Replacement Warranty in the U.S." is limited to the cost of the component only--not covered are hospital and surgeon fees, related surgery living costs (travel, hotel, transportation, etc.), and loss of economic benefit while surgery is repeated.

Prior to Biomet and the implanted medical device industry reaching the conclusion that "less is more" and advertising an (anemic but much-needed) warranty thousands of patients remain harmed and uncompensated. 

Thursday, January 17, 2013

Monumental regulatory fail: metal on metal hips


http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?emc=tnt&tntemail1=y

After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants.
Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.



Joshua Borough for The New York Times

Some all-metal hip implants have failed prematurely, forcing thousands of patients to undergo operations to replace them.

Tuesday, January 15, 2013

Medical Device Pledge re: Patient Data


http://www.marketwatch.com/story/medical-technology-leaders-at-inaugural-patient-safety-science-and-technology-summit-sign-pledges-to-make-patient-data-available-to-reduce-preventable-deaths-2013-01-15  
PRESS RELEASE
Jan. 15, 2013, 8:00 a.m. EST



LAGUNA NIGUEL, Calif., Jan. 15, 2013 /PRNewswire via COMTEX/ -- The inaugural Patient Safety Science & Technology Summit made history when for the first time nine leading medical device companies publicly pledged to make their devices interoperable. The groundbreaking pledges will make patient data collected and displayed on their devices accessible for patients and clinicians - launching a movement designed to reverse the rising tide of preventable patient deaths at U.S. hospitals.
Cercacor, Cerner, Drager, GE Healthcare Systems, Masimo, Smiths Medical, Sonosite, Surgicount, and Zoll each announced pledges of interoperability and patient data accessibility during the Patient Safety Science & Technology Summit. The Summit attracted hundreds of prominent doctors, hospital administrators, device makers and patient advocates from across the world, and challenged healthcare leaders to pledge to take actionable, accountable measures toward zero preventable patient deaths.
Helen Haskell
Lenore Alexander
Former President Bill Clinton
Follow link to read full story!

Tuesday, January 8, 2013

Jury trial for first of 7,000 failed implanted hips?


Rochester woman in bellwether case on hip implants
Rochester Business Journal
January 7, 2013
A Rochester area woman’s court complaint has been selected to be heard as one of two bellwether cases that will help decide the outcome of several thousand suits targeting DePuy Orthopaedics Inc. and Johnson & Johnson for selling allegedly defective hip implants.
Owner of the Good Sign Co., Ann McCracken is one of 7,000 U.S. hip-replacement patients who have sued the companies over DePuy’s ASR XL Acetabular System.
http://www.rbj.net/article.asp?aID=193659

READ THE FULL LAWSUIT HERE
http://www.scribd.com/doc/50063815/Hip-Replacement-Lawsuit



Monday, January 7, 2013

'Patients Included' or Dilbert cartoon?


'Binders of Women' (yes! there are plenty of extremely capable women advocates that would be of value at your conference):  The Walking Gallery, SpeakerLink, Regina Holliday, Partnership WITH Patients


Patients Included! Conference designers signal whether 'welcome mat' is out for patients/advocates.  



Let Patients Help!  The value of conferences is elevated by patient/provider diversity in attendees.



An upcoming inaugural Patient Safety Summit limits patient engagement because of these barriers: 

  1. insular invitation limiting diversity of attendees, 
  2. cost/location factors 
  3. gender bias



On the invitation: 'Who Should Attend'? 
 Hospital Executives
 Physicians
 Nurses
 Biomedical Engineers
 Industry Executives
 Payers
 Government Officials
       (  omitted:  patients/advocates  )

  Cost/Location
   $500 Registration
      $700 Flight/Parking/Taxi
      $500 Hotel
$ 1700 minimum total cost

  Presenter Selection Bias
   Predominantly male medical professionals, though selected 'patient voices' are predominantly female/non-medical professionals

Friday, January 4, 2013

How You Can Help ProPublica & Patient Safety


http://www.propublica.orgAs/article/how-you-can-help-propublica-cover-patient-safety
by Marshall Allen
ProPublica, Jan. 4, 2013, 9:50 a.m.
Among the more active members of our Facebook group on patient safety, Veronica James stands out.
She joined soon after we started the group in May and shared the story of her mother, who suffered a bedsore and had her breathing tube accidentally dislodged in a long-term acute-care hospital. James believes poor care contributed to her 90-year-old mother's death.
James uploaded the complaints she had filed with regulators, as well as their responses validating some of her concerns. She urged others to sign a petition against gag orders that medical providers sometimes negotiate when settling with patients who have been harmed. And she's posted dozens of comments, asking questions and offering advice and encouragement to others in the group.
James, an actress from Paramus, N.J., said she's found the Facebook group to be invaluable. "It gives a voice to patients who have been silenced for too long," she said.
Not everyone in the ProPublica Patient Harm Facebook Community has been as energetic as James. But the group — among our efforts to use social media in the service of journalism — has grown into a robust forum for discussion and learning for participants and reporters alike.
Our goal was to reach out and open a dialogue with patients who've been harmed while undergoing medical care. It's a major problem affecting more than 1 million patients a year, and although the health care system has moved to address the issue, results have been slow in coming.
We've also invited participation from doctors, nurses and other medical providers, many of whom have contributed comments and shared expertise. As of now, we're up to 1,379 members in the Facebook group. Since May, 231 members have contributed more than 3,700 posts.
Because many of the group's members, or their loved ones, have been harmed while undergoing medical care, the discussions cover sensitive topics and are often passionately delivered. (Some highlights are archived on ProPublica's patient safety page.)
James' mother, Vera Eliscu, died in August 2009, about seven months after being admitted to recover from pneumonia in a New Jersey long-term acute-care hospital. During her stay, her breathing tube was accidentally dislodged, which James said deprived her of oxygen for about 15 minutes, causing brain damage. Eliscu also did not receive appropriate care, regulators found, for a bedsore that developed into a large wound.
James said she signed, under protest, a gag clause as part of her settlement with the facility. Typically such clauses prevent a patient or patient's family from speaking out about harm they suffered. But James said she refuses to be bullied. She is now advocating for a law in New Jersey that would ban gag clauses. Her hopes were boosted when, on Dec. 17, another member of the Facebook group posted an article about a new law against gag clauses in California.
Patients who suffer harm face the same obstacles across the country, James said, and the Facebook group helps her keep tabs on what's happening elsewhere.
Anyone who's followed the Facebook group knows we promote our Patient Harm Questionnaire, which allows us to track patient stories in a more detailed manner. So far, we've had 264 people complete the survey. Although the sample is self-selected, the responses have been provocative:
               The medical facility or provider responsible for the harm only disclosed it voluntarily in about one in 10 cases.
               Only one out of 10 patients received an apology for the harm they suffered.
               Some said they spent tens of thousands of dollars on bills related to the harm they suffered.
We've used some of the findings to inform our articles. And with the consent of respondents, we've also shared some survey results with other journalists and with academics who want to conduct research for publication in medical journals.
Medical providers are invited to complete the ProPublica Provider Questionnaire. We've had 53 respond so far, including 16 doctors, 13 nurses and a smattering of administrators, case managers, techs and more. They are sharing story ideas and issues of concern, and we plan to turn to them for expert advice as we investigate patient safety issues in 2013.

COMMENTS                  

I encourage harmed patients & healthcare providers to "stalk" the ProPublica website.  As British author Catherine Aird said "If you can't be a good example, then you'll just have to be a horrible warning." Accounts of patient harm reflect our culture and our humanity that will inform you so that you can avoid pitfalls and help others..  If we do not share them we cannot improve.  Those who would quash this information are self-serving and short-sighted.  Try as they may "they can't stop the beat"!   Joleen Chambers  Today 3:37pm
Arlene Sterne
Brava Veronica. It is time for someone to speak up against gag orders.
I have not experienced anything quite like this, but I feel your pain and 
wish that more of us have had the courage to take action against 
medical “accidents” like your mother’s. My husband died because 
a doctor refused to acknowledge that he had cancer, and I myself, against the doctor’s orders, drove him from Washington DC to Boston
 to a famous clinic where they immediately diagnosed lung cancer which had already metastasized. 
With affection and admiration. Arlene Sterne
Rui Geraldes
I worked as an EMT for more than a decade. Nursing homes are the perfect example of malpractice. Understaffed and with nurses who don’t have any idea of what they are doing. It’s scary to see patients with 2 liters O2 on a non-rebreather mask, patients with nasal canulas fed by empty tanks, patients in positions that provoke choking, nurses calling EMS because respiratory levels are live threatening due to the fact that they are clueless how to suction a tracheostomy tube, patients completely high due to excessive medication. Failing to notice signs of stroke. Every place we went, they tried to cover up what happened and everything happened 15 minutes ago or during someone else shift. Then we go to the state website and see these places getting positive rankings. Its so bad we used to call this places “dumpsters”, and the general opinion was they don’t really care because there are more people on the waiting list, so they will never lose money. It’s sad the situation this patients are forced to endure.