Medical Malpractice: Apology substitutes for justice?

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Say You're Sorry And Get A Pass?

By ALAN BAVLEY

The Kansas City Star

(FiDA Blog bolded)

Should apologies to injured patients be enough to keep malpractice cases off a doctor’s record?

A campaign has gotten under way to make that happen. And patient safety advocates are raising red flags.

Leading the campaign is an organization called Sorry Works! — yes, the exclamation point is part of its name.

Sorry Works! started as an advocacy group promoting apologies and disclosure of mistakes as a way to defuse the anger and bewilderment of injured patients that often lead to malpractice suits.

It’s a persuasive idea.

Many patients who sue their doctors say they wouldn’t have felt a need to go to court if they had gotten an explanation and an apology. Hospitals have tried full disclosure with offers of compensation and seen declines in lawsuits or the amounts paid to settle claims.

But about five years ago, Sorry Works! changed from a coalition of doctors, lawyers, insurers and patient advocates. Now it’s a commercial consulting firm. Founder Doug Wojcieszak offers training to hospitals and doctors. And he has started crusading for new immunity for doctors who apologize.

The National Practitioner Data Bank is a federal record of doctors’ dirty laundry — license suspensions, health care fraud convictions, malpractice payments. State medical boards consult it before granting licenses. Hospitals check it before offering staff privileges.

Wojcieszak wants the data bank to keep malpractice payments secret in many cases when doctors make apologies and disclosures. Further, he wants doctors shielded from medical board discipline on these cases.

Doctors would get a pass on two cases over 10 years; a third case during that time would open the files.

Wojcieszak considers this only fair for doctors who risk their reputations by admitting to errors.

Two cases may not seem like a lot, but it is. While working on a story last year, I found that most doctors never face more than one lawsuit, and most suits are dropped or dismissed.

Doctors who cross Wojcieszak’s disclosure threshold are rare. For example, Massachusetts regulators estimated that of the 34,000 physicians licensed in the state, fewer than 100 will make more than two payments on malpractice claims over 10 years.

More than two dozen patient safety advocates and organizations like Consumers Union say Wojcieszak’s proposal would give doctors who were going to settle a suit anyway an incentive to apologize just to keep it off their record.

This would gut the data bank as a tool for protecting the public and tie the hands of medical boards by putting many questionable doctors out of reach.

Wojcieszak has gotten some support for his campaign: The Sorry Works! website lists donations from the CEOs of a health care staffing company and an organization that deters “frivolous malpractice claims.”

To reach Alan Bavley, call 816-234-4858 or send email to abavley@kcstar.com.

Patient voices are changing medical devices

LINK
Traditionally pharma and medical device companies design health tools for health care professionals and in clinical settings. What's been missing is any thought about the end user: the patient.

Even with Silicon Valley recently jumping on the "wellness bandwagon," pumping out new mobile health apps at the rate of an automatic tennis ball launcher, these are typically designed by technophiles, engineers more focused on a gadget's operating system than any meaningful outcomes for patients who will use them.

But there's a movement afoot: the rise of patient voices to influence products related to them. Some of our voices are being sought by health care industry providers, some by patients themselves -- particularly, a patient I happen to know, Amy Tenderich, who began stirring these waters several years ago with a famed letter to Steve Jobs.

Tenderich is founder of the news-rich diabetes blog DiabetesMine and has been on a mission to bring the patient's voice to designing the medical devices we use. Her voice just grew louder with the DiabetesMine Patient Voices Contest.

Diagnosed with Type 1 diabetes in her 30s, Tenderich has made it her personal mission to spur innovation that actually originates with patients. After her letter to Jobs, she launched an online contest called the DiabetesMine Design Challenge, calling for any and all new product ideas that could improve life with diabetes. (The contest was underwritten by the California HealthCare Foundation, and supported by IDEO, a leading design firm with close ties to Stanford University.)

The initiative went viral, developing into an international crowdsourcing competition that has awarded more than $50,000 in prize money.

While competitions asking for the public's wants, needs and votes are now en vogue, particularly regarding diabetes, Tenderich responds that, "patient-centered design remains far more a marketing buzzword than a real process."

So this year she and her team launched the DiabetesMine Patient Voices Contest focused on gathering user needs. People living with any type of diabetes, and caregivers, can submit a two- to three-minute video expressing the biggest challenges they live with, what they like and don't like about current diabetes tools and what they want from their diabetes devices.

Ten winners will receive full scholarships to take part in the DiabetesMine Innovation Summit at Stanford campus this November -- a gathering of stakeholders involved in creating tools for living with diabetes that Tenderich kicked off last year. There, informed patient advocates will mix with device designers, Pharma Marketing and R&D, web visionaries, experts from venture capital investment and innovation, regulatory experts, mobile health experts and others involved in creating "solutions" for people with diabetes.

Winners will also receive the new iBGStar glucose meter from Sanofi, a lead sponsor of "Patient Voices." The iBGStar is the first blood glucose meter that plugs into your iPhone or iPod touch.

Tenderich says, "This product personifies our whole patient-led initiative. It's about integrating the best and coolest consumer technologies with the medical technologies we depend on to live more comfortable and healthier lives with diabetes."

I credit Tenderich for, on her own, starting a movement that's increasingly getting patients' needs and wants on pharma and medical device companies' agendas, and moving them to follow with their own initiatives.

Sanofi now runs a design crowdsourcing challenge that pulls ideas from the public about what matters most living with diabetes to innovate in quality, delivery and the cost of diabetes care. I've been invited to Roche's annual social media summit to exchange thoughts, ideas, needs and wants between patients and pharma, and I've been invited to Medtronic to see what they're up to.

I am grateful for all these opportunities to cross the bridge and bring health care industry providers and patients closer together.

Now we need to keep our voices raised, for as Tenderich says, "No one knows better how gadgets, devices and apps can help patients than patients themselves."

Go to DiabetesMine Patient Voices Contest to participate. Deadline for submissions is June 12, 2012.

Riva speaks to patients and health care providers about flourishing with diabetes and is the author of "50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It" and "The ABC's Of Loving Yourself With Diabetes." Visit her websiteDiabetesStories.com.

For more by Riva Greenberg, click here.

For more on diabetes, click here.

Follow Riva Greenberg on Twitter: www.twitter.com/diabetesmyths

Please Vote for TEDMed Challenges

Voting Ended 4/12/12 with 'The Role of the Patient' at #3 TEDMED Great Challenges!  Thank you!


Vote for #19 !  LINK HERE

Move your curser over the table to the far right and click on 'The Role of the Patient #19'.  You will be asked for your email address and then you can vote.   Thank you so much!

ACTION ALERT !!! Please join me in supporting FDA employees that are doing their jobs.

LINK HERE: Give FDA Medical Device Safety Whistleblowers your support!

	Stop the FDA's Harassment of Whistleblowers The FDA's illegal program of singling out whistleblowers for special monitoring has become national news. When the FDA found out that employees had reported dangerous medical devices, it decided to squash the employees rather than the faulty products. FDA managers put industry interests above patient safety. Senator Grassley and Representative Issa have now launched Congressional investigations of the FDA, demanding answers about why whistleblowers were singled out for special surveillance Please follow the link above and support the federal employees that are doing their jobs:  protecting the citizens of the United States.

Implanted Medical Device Guinea Pigs no more: Consumers Union on Capitol Hill

LINK HERE:   MDUFA reauthorization must include patient safety

• Improve review of devices before they enter the market
• improve monitoring of devices after they enter the market
• Retain current conflict of interest standards for federal advisory committees

U.S. GAO- Government Accounting Office- uncovers secrecy on medical device prices

LINK HERE to full story by Star Tribune reporter James Walsh

Secrecy on medical-device prices hurts buyers, GAO says

•                Article by: JAMES WALSH

•                Star Tribune

•                February 11, 2012 - 2:40 PM

Hospitals are paying widely varying prices for the same implantable medical devices, according to a new study that suggests that secretive sales agreements prevent many buyers from getting the best deals.

The report from the U.S. General Accounting Office -- which turned up a difference of more than $8,000 for one cardiac device alone -- found that confidentiality clauses in sales contracts keep even the physicians who decide which devices to use in the dark about prices.

The study, which was requested by U.S. Sen. Max Baucus, a Montana Democrat who chairs the Senate Finance Committee, could add fuel to a push to lift the price veil.

"The real problem is that, on the local level, there are these gag clauses that prohibit the sharing of pricing information," said Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA). "I do think [the GAO report] lays the groundwork for more questions to be asked."

Don May, vice president of policy for the American Hospital Association, said the study "highlighted some of the real concerns about devices."

Device pricing is an issue of critical importance locally. Minnesota is a primary medical technology hub, home to industry giants Medtronic and St. Jude Medical and hundreds of other smaller companies employing thousands of people.

Officials with top local device companies declined to comment on the GAO's findings, referring calls to the Advanced Medical Technology Association (AdvaMed), a medical device trade association.

David Nexon, a senior executive vice president for AdvaMed, said the industry is extremely competitive and that pricing involves many factors. Overall, however, he said that medical technology prices "have risen far more slowly than price increases for other medical goods and services and substantially less than even general price increases in the economy as a whole."

Nexon did not specifically address confidentiality clauses. But he said prices reflect "the number of competitors in the marketplace, a particular hospital's volume of business in a particular procedure and the volume of other products sold to that hospital by a manufacturer."

As the GAO report noted, hospitals typically negotiate device prices with manufacturers directly or through group purchasing organizations (GPOs). But device manufacturers often require hospitals to sign confidentiality clauses that forbid them from revealing to third parties the price they paid. Those third parties often include physicians, whose device preferences influence hospital purchasing decisions.

"It really is this relationship between the manufacturer and the physician," Rooney said. "The physician orders the product but can't know what the price is. The hospital becomes the third-party payer."

The GAO sought information for its study from more than five dozen medical centers and others involved in the health care system. It received detailed information on cardiac device prices from 31 hospitals, one GPO and one Department of Defense medical center. Only 14 hospitals and two Department of Defense facilities gave detailed information on orthopedic devices.

Those responses showed huge price differences. For example, the difference between what the lowest- and highest-price hospitals paid for a particular model of automated implantable cardioverter defibrillator (AICD) was $6,844. For another, the price difference was $8,723. Median prices for four AICD models ranged from $16,445 to $19,007.

The cost to the government alone could be substantial. Considering that Medicare spent nearly $20 billion on implantable medical device hospital procedures in 2009, a rate equal to what Medicare spent for all other hospital procedures, "excess or unnecessary IMD costs that hospitals incur may be passed on to the Medicare program," the GAO report said.

'Armed for battle'

There are hospitals that go in with their eyes open.

Minneapolis-based Allina Health won't accept gag clauses in its contracts, according to Cheryl Harelstad, vice president for supply chain management. Years ago, she said, such clauses weren't really questioned.

"A lot of health care providers are working hard, saying, 'Wait a minute. This doesn't put us in a very good position,'" she said.

Allina belongs to a GPO, Novation, that strikes agreements with suppliers and establishes multiple price tiers for devices, Harelstad said. GPO members pay a fee for that information and sharing it is critical, she said. Allina, which has some buying clout because of its size, will then go to manufacturers to adjust prices further.

"We go in armed for battle," Harelstad said of the importance of pricing information.

"To be fair," she said, "our suppliers work well with us on this."

Rooney said confidentially clauses in device contracts are not new. "This has been going on quite a while -- at least a decade," he said. Legislation requiring more price transparency was introduced in Congress in 2007, but was not enacted.

Now, as more Americans age and health care costs become an even bigger issue, Rooney said the issue of device costs is heating up again.

"This begins the conversation that needs to occur in Congress," he said. "In the era of cost containment, people should know they are getting the value they deserve in terms of health care costs. People are getting older and grayer, and more of these devices will be implanted."

James Walsh • 612-673-7428

 

explanthisFeb. 12, 128:07 AM

http://fida-advocate.blogspot.com/ FDA MedWatch Adverse Event #5009052 was not investigated and according to Freedom of Information, the record was "lost". Mayo Clinic and the surgeon/designer are legally able to abandon the patient. The entitlement of the medical device industry will cripple not only our elders, but our nation. Medical and legal purgatory is not an "innovation" that patients demand but if a device fails, that is the result. No pre-market clinical testing, mass production and no registry for devices and an uninformed consumer is the recipe for disaster. Is the GAO report "shrill" or accurate? I vote for accurate!

Knee replacements have tripled from 1997 to 2009

(Link here) 5% of Americans over age 50 have artificial knees!

The article was published today by AP reporter, Lindsey Tanner.   The US does not have a national registry of implanted devices and the medical device industry has resisted it for 20 years.  Consumer/taxpayer outrage must counter the powerful lobby of the medical device industry to propel Congress to change the charter of the FDA.  Give us our damned data so that we can make life-enhancing decisions!  Joint replacements are the #1 expenditure of Medicare.  Taxpayers paid for a large majority of procedures and the aggregate data generated from those purchases should be made available to patients/citizens/taxpayers.  It is NOT proprietary information!

The Department of Transportation investigates/regulates/recalls effectively:

(Link here) Toyota RAV4 recalled for power window switch defect that may cause fire.

Product Safety Commission investigates/regulates/recalls effectively:
(Link here) Coffee makers recalled for burn risk.

The FDA missed the failures of 37,000 failed J&J metal on metal hips.

Our economy is dependent upon getting this right.  No more victims of medical and legal purgatory of failed implanted devices!

Consumers Union announcement of hospital rating data availability

CONSUMERS UNION NEWS RELEASE

For Immediate Release:  Wednesday, February 1, 2012

Contact:  Michael McCauley – mmccauley@consumer.org, 415-902-9537 (cell) or 415-431-6747, ext 126 (office) or Lisa McGiffert, lmcgiffert@consumer.org, 512-477-4431, ext 115

Central Line Bloodstream Infections Disclosed at Hospitals Nationwide   

Infection Disclosure Is A Milestone Following A Multi-Year Campaign

By Consumer Advocates to Make Information Public

WASHINGTON, D.C. – The Department of Health & Human Services is now disclosing for the first time how hospitals across the country compare when it comes to central line associated bloodstream infections (CLABSIs) in intensive care units.   CLABSI information for each hospital is posted on the federal Hospital Compare web site and will be updated quarterly.  The web site will provide information for other hospital-acquired infections in the future.

National hospital infection reporting follows a multi-year campaign by Consumers Union and other consumer advocates to mandate such disclosure.  The Centers for Disease Control & Prevention (CDC) estimates that nearly 100,000 people die each year due to hospital-acquired infections and the hospital costs associated with these infections are estimated to be as high as $45 billion annually. 

“Consumer advocates across the nation have worked tirelessly to end the secrecy over hospital infection rates,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org).  “This is a milestone for patient safety that begins to make hospitals accountable for the two million patients who are infected each year.   Finally, Americans in all 50 states will be able to find out how well their hospital prevents these particular infections.  Public disclosure drives hospitals to improve care and helps patients choose hospitals with better safety records.”

Consumers Union, the nonprofit advocacy arm of Consumer Reports,  has prepared a set of tips for accessing the CLABSI information on Hospital Compare web site.   

Since 2004, Consumers Union has worked with a national network of consumer advocates to enact hospital infection reporting laws and helped pass such requirements in thirty states.  The majority of those state laws were based on Consumers Union’s model hospital infection reporting law.  Since launching the Safe Patient Project, Consumers Union has heard from thousands of patients harmed by infections who joined the campaign to push for reform.    
Beginning in January 2011, the federal government’s Medicare payment policies have required hospitals to report to the CDC’s National Healthcare Safety Network (NHSN) when patients develop CLABSIs in intensive care units. The NHSN is the same system used by most of the states with reporting mandates. 
The CDC estimated that 18,000 patients developed CLABSI infections in the ICU in 2009.  Of those patients who develop bloodstream infections in the hospital, up to one in four die. 
The CLABSI infection information disclosed on Hospital Compare are based on only three months of data (January-March 2011) and show how each hospital stacks up against the national benchmark for such infections.  But building a longer record over the coming year will provide a better indication of trends at each hospital. 
“If your hospital is no different than the national benchmark, that means too many patients are still suffering and dying from infections that could have been prevented with better care,” said McGiffert.  “The benchmark for success that hospitals should be striving to reach is zero.”    
Hospitals have started reporting surgical site infection rates to the CDC and that information will be posted on Hospital Compare every quarter beginning in 2013, starting with abdominal hysterectomy and colon surgeries.  According to the CDC, surgical site infections account for 20 percent of all hospital acquired infections.  In addition, information on the incidence of catheter-associated urinary tract infections will be available on Hospital Compare in 2013.
The new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) “pay-for-reporting” program and includes infections occurring in all patients, not just Medicare patients. Virtually all U.S. hospitals, excluding critical access hospitals, participate because they earn a higher Medicare payment for doing so.  

See Consumer Reports’hospital survival guide for advice on staying safe in the hospital. For information on more than 3,000 hospitals in all states, including infection Ratings for over 1,000 hospitals, see Consumer Reports Ratings (available to Consumer Reports subscribers).  Or try the new Consumer Reports hospital Ratings app which can be downloaded from the iTunes app store for $2.99.

###

Medicare Study Shows Most Medical Errors Go Unreported

Link to Consumers Union announcement (text copy below).

Posted 01/06/12 at 3:19 pm

CONSUMERS UNION NEWS RELEASE

For Immediate Release: Friday, January 6, 2012
Contact: Michael McCauley, mmccauley@consumer.org, 415-431-6747, ext 126 or 415-902-9537 (cell) or Lisa McGiffert, lmcgiffert@consumer.org, 512-477-4431, ext 115

Medicare Study Shows Most Medical Errors Go Unreported

CMS Will Work to Make Hospitals Track Errors Better Internally
But Information Will Be Kept From The Public

WASHINGTON, D.C. — A new study released today by the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) found that hospital employees are only reporting fourteen percent of all medical errors and usually don’t change their practices to prevent future harm to patients.

The study was based on an independent review of patient records. Federal regulations require hospitals to track all medical errors and adverse events that harm patients and to implement preventive measures to protect patients. Only five of the 293 reported cases of medical errors reviewed by federal investigators led to changes in policies or practices by hospitals to prevent harm to patients.

“One in four hospital patients are harmed by medical errors and infections, which translates to about 9 million people each year,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Today’s report confirms what many other studies have already documented. Too many hospitals are doing a poor job of tracking preventable infections and medical errors and making the changes necessary to keep patients safe. It’s time that hospitals make patient safety a higher priority.”

The OIG report recommends that the Centers for Medicare and Medicaid Services (CMS) provide hospitals with a standard list of medical errors that should be tracked and reported to the agency. But Consumers Union noted that public reporting of medical errors is critical to driving improvement in patient safety.

“Hospitals should be pushed to do a better job at tracking medical harm, but public reporting is what drives change and the public should have access to this critical information,” said McGiffert. “The solutions arrived at in this report take us down the tired and worn out path of secret reporting of medical harm.”

A previous 2010 study by the OIG estimated that an estimated 15,000 Medicare patients experienced medical errors in the hospital that contributed to their deaths each month. That amounts to about 180,000 patients annually. The OIG calculated that Medicare patients harmed during that month required an additional $324 million in hospital care. The study estimated the annual cost for these events in hospital care alone at $4.4 billion.

Act now & you can help!

Call and write to your two U.S. Senators and your U.S. Congress(wo)man :

Let your legislators know you are watching and want to make sure they don't sacrifice safer review of devices when negotiating MDUFA.  The medical device industry has an active, powerful lobby but individual taxpayers/patients/citizens are a potent antidote for the paid lobbyist!   Please join me and many others in this effort. 

Thank you so much and have a very Happy (and healthy) New Year!

Graphite carbon found in metal-on-metal hip implant study

NIH researchers uncover clues related to metal-on-metal hip implants

"Graphite carbon is a key element in the lubricating layer that forms on metal-on-metal hip implants.  The lubricant has more in common with the lubrication of a combustion engine than that of a natural joint."

• research is relevant to several hundred thousand Americans undergo hip replacement each year 
• typical life of implant is more than 10 years but material improvement is needed for patients younger than age 60
• prior to this study, it was thought that proteins from the body entered the joint and adhered to the implant 

Medical Device Double Jeopardy?

Link to NEJM here. Breast Implant disappears during Pilates exercise.

This very brief article remarks upon treatment of a Maryland woman who had breast implant prosthesis (breast cancer).  She reported that her breast implant was swallowed into her body and disappeared.  The medical providers located the implant and added surgical mesh!  

Surgical mesh is a medical device that is being questioned for its' safety and effectiveness, yet surgeons continue to implant it into unsuspecting patients. www.truthinmedicine.us.com

What protections will she be provided if the surgical mesh proves to be a problem rather than a solution?  That is what Congress is responsible for determining:  right now, the charter of the FDA disallows patient stakeholder voting rights, there is no independent, accessible post-market data registry and legal protections unfairly favor the medical provider and medical device industry.   Patients beware!

Study finds improved patient health care delivery a must for orthopedic surgeons

Chair of Orthopedic Surgery at Mayo Clinic: Daniel J. Berry

Study finds improved patient health care delivery a must for orthopedic surgeons

ORLANDO, Fla. — For the specialty to survive, orthopedic surgeons must provide patients with new methods ofhealth care delivery in the form of improved safety, value and care, according to a presentation at the Current Concepts in Joint Replacement 2011 Winter Meeting, here. “We will not thrive as a profession if the population cannot afford our care,” Daniel J. Berry, MD, said. In his presentation, Berry, who chairs the orthopedic department at the Mayo Clinic in Rochester, Minn., outlined five ways that he believes orthopedic medicine can “out distance” other specialties: innovations in patient safety, fostering research and development, creating affordable and accessible care, improving quality of work, and attracting the best talent to the profession.

The tendency to rush to adopt new technology has hurt the specialty in the past, Berry noted, citing the recent metal-on-metal hip implant recalls as an example of this problem.

The public is also aware of these controversies, he said. Berry also mentioned that surgeons should collectively fight for more funds for musculoskeletal research, noting that such scientific efforts are under-funded in orthopedics compared with other medical professions, despite the prevalence of orthopedic care throughout our society. “We keep people working [and] we keep them independent,” Berry said. Reference: Berry DJ. Optimizing health care delivery: best in class. Paper #35. Presented at the Current Concepts in Joint Replacement 2011 Winter Meeting. Dec. 7-10. Orlando, Fla. Disclosure: Berry receives royalties from DePuy.