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

Monday, April 29, 2013

Bad Ad: Johnson & Johnson tarnished halo selling new 'product': love!

Have the FDA and FCC approved this ad?  
What product is this corporation selling?
Does it have to disclose that it is being sued by thousands of harmed patients?
(Metal on metal hips and surgical mesh.)

This bad ad will be aired:

History does not match JNJ we have today:

Thursday, April 25, 2013

Dick Smothers, bankruptcy and the birth of DTC marketing.

DTC is direct to consumer advertising.  This is an example of a new ad that just began airing.

Q. Is it important to the public to know that Dick Smothers may be conflicted by his personal bankruptcy?
Q. Is it important to the TV watching public to know that the need for Covidien's product is limited to 1-2% of the people who have Barrett's Esophagus and only 10-15% of the people who have acid reflux have Barretts Esophagus?  This is rare, rare, rare!!!!
Q. Where is the FDA in providing guidance to the public on providing truth in DTC ads?  Patient harm comes from interventions that are intrusive, costly and potentially dangerous.
Q. Is this one?

Background video:
Scott Corbett, M.D. | Sarasota Memorial Hospital, Sarasota, FL

Covidien Clinical Trial Investigator  
Dick Smothers surgeon (no financial conflict there!)

Barrett's esophagus is a serious complication of GERD, which stands for gastroesophageal reflux disease. In Barrett's esophagus, normal tissue lining the esophagus -- the tube that carries food from the mouth to the stomach -- changes to tissue that resembles the lining of the intestine. About 10%-15% of people with chronic symptoms of GERD develop Barrett's esophagus.
Barrett's esophagus does not have any specific symptoms. Patients with Barrett's esophagus may have symptoms related to GERD. It does, though, increase the risk of developing esophageal adenocarcinoma, which is a serious, potentially fatal cancer of the esophagus.
Although the risk of this cancer is higher in people with Barrett's esophagus, the disease is still rare. Less than 1% of the people with Barrett's esophagus develop this particular cancer. Nevertheless, if you've been diagnosed with Barrett's esophagus, it's important to have routine examinations of your esophagus. With routine examination, your doctor can discover precancerous and cancer cells early, before they spread and when the disease is easier to treat.

Smothers brother files for bankruptcy
Published: Saturday, February 20, 2010 at 1:00 a.m.
Last Modified: Friday, February 19, 2010 at 10:27 p.m.
SARASOTA - Dick Smothers may be renowned for his humor, but there is nothing funny about his current financial situation.
The 71-year-old comedic actor filed for Chapter 11 bankruptcy protection in Tampa earlier this month, listing $2 million in assets and $2.8 million in debts on homes he and his ex-wife, Denby Smothers, own on Bird Key and Golden Gate Point.
Smothers is the younger brother in a two-man comedy team. The brothers hosted the "Smothers Brothers Comedy Hour" on CBS in the 1960s, and still perform together in concert halls across the country.
Dick Smothers could not be reached for comment. His bankruptcy attorney, John Cole, said he is on the road.
"Like a lot of people, he got tied up in property that went south," Cole said.
Court records show that Smothers and his ex-wife, a luxury real estate agent with Michael Saunders & Co., borrowed heavily against their two homes during the boom years. But Denby Smothers said there is no reason why her ex-husband should have stopped making interest payments.
"Dick still works and has money to pay his mortgages," she said. "He just chooses not to."
An income statement included in his bankruptcy filing shows that Smothers made $45,300 per month from performances he and his brother have given across the country.
A look at the Smothers Brothers Web site shows that they are booked for 21 concerts this year from Escondido, Calif., to Chatauqua, N.Y., and are to appear in Plant City on March 12.
But a second income statement included in the court filing projects that Smothers will make only about $7,400 per month going forward.

The larger number of $45,300 represents the past and the smaller number represents the future, Cole said.
Denby Smothers, 60, declined to comment further about her husband's financial situation.
The couple got married in Las Vegas in 1997 and filed for divorce in late 2005. That was shortly after Denby Smothers complained in court documents that her husband had pushed her into her car, poked his finger into her chest and told her she had no rights to her house and that their marriage was over.
In their divorce settlement, signed in March 2007, Smothers agreed to provide his ex-wife with $10,000 per month for 36 months to cover mortgage, tax and insurance payments on her 2,000-square-foot, first-floor condo unit with views of Sarasota Bay.
That agreement was set to expire next month.
Both Denby Smothers' condo at 226 Golden Gate Point and Dick Smothers' canal-front house at 460 Meadowlark Drive on Bird Key are listed for sale.
His bankruptcy filing says a short sale contract is pending on the Bird Key house.
Smothers has been coming to Sarasota for more than 20 years and initially stayed at the Colony Beach & Tennis Club.
But in June 2001, he and his ex-wife paid $485,000 for a house in eastern Manatee County.
Two years later, they sold the house for $124,000 more than they paid, and then paid $1.15 million for their Bird Key abode, financing it with $1.2 million in loans from Sarasota Bank.
In 2004 and 2005, they refinanced, increasing their indebtedness on the property to $1.9 million.

A January 2006 article in Herald-Tribune said the property had a low-key beach-house feel with "his" and "hers" kitchens. The article said the couple were trying to sell the house because of their pending divorce.
A few months earlier, they bought the Golden Gate condo unit for $780,000 and eventually borrowed $834,000 against it.
Court records show that Smothers defaulted on his home loan in October 2007, but the loan on the condo unit has remained current.
When called by the Herald-Tribune, Denby Smothers said her ex-husband had not informed her of his intention to file for bankruptcy.

News Research Manager Cindy Allegretto contributed to this report.

Barrett’s esophagus
Barrett's Esophagus
Radiofrequency ablation has been shown to be a safe and effective treatment for Barrett's esophagus. While the patient is sedated, a catheter is inserted into the esophagus and radiofrequency energy is delivered to the diseased tissue. This outpatient procedure typically lasts from fifteen to thirty minutes. Two months after the procedure, the physician performs an upper endoscopic examination to assess the esophagus for residual Barrett's esophagus. If any Barrett's esophagus is found, the disease can be treated with a focal RFA device. Between 80-90% or greater of patients in numerous clinical trials have shown complete eradication of Barrett's esophagus in approximately two to three treatments with a favorable safety profile. The treatment of Barrett's esophagus by RFA is durable for up to 5 years.[14][15][16][17]

Q. Is this man responsible for the birth of U.S. direct-to-consumer drug/device advertising?

Daniel B. Burke, Leading Media Executive, Dies at 82
Published: October 26, 2011
Daniel B. Burke, who helped engineer the acquisition of the American Broadcasting Company by Capital Cities, one of the boldest corporate takeovers of the 1980s, and went on to become chief executive of the merged company, died on Wednesday at his home in Rye, N.Y. He was 82.
The cause was complications of Type 1 diabetes, according to a statement by the family, which has been powerful in American business and mass communications. His older brother, James, ran Johnson & Johnson, and two of his sons have held top posts at NBC Universal, Disney, TBS, Comcast and the Weather Channel.
Mr. Burke worked for most of his career alongside Thomas S. Murphy, whom he served as a trusted lieutenant and partner. Mr. Murphy had been a Harvard Business School classmate of Mr. Burke’s brother, James.
Daniel Burke and Mr. Murphy were a formidable pair. Together they built Capital Cities through a series of acquisitions and orchestrated the merger with ABC in 1986. While Mr. Murphy was the outside man, happy to be the public face of the company, Mr. Burke thrived as the inside man, the cost-conscious manager much less eager for publicity.
“He was really a partner,” said Mr. Murphy, who described their relationship as a collaboration of equals, even though Mr. Murphy was always a notch higher on the organizational diagram. “It was not a one or a two,” he said of their working relationship.
“As far as running the business and, particularly when we took over ABC, the details of putting that ship in order so we maximized our financial opportunities, a great deal of that was him,” Mr. Murphy said.
Mr. Burke’s son Bill said that Mr. Murphy and Mr. Burke were a “phenomenal team” and became close friends. “They worked together all week,” he said, “and then played golf and tennis all weekend.”
The acquisition of ABC, a much bigger company than Capital Cities, for $3.5 billion stunned the business world. At the time it was the biggest corporate acquisition outside the oil industry.
Despite the surprise, Wall Street reacted positively, not least because Capital Cities brought in Warren E. Buffett to help finance the purchase.
Mr. Burke became president and chief operating officer of the merged company, while Mr. Murphy was chairman and chief executive.
Capital Cities was a highly profitable company that owned television and radio stations, newspapers and trade magazines. ABC was the third-largest network, but still a vast operation that ran television and radio stations and produced programming.
ABC insiders were skeptical about the acquisition at first, but Mr. Murphy and Mr. Burke turned the new company into a well-managed and profitable media conglomerate. Known as cost-cutters, they sought to replace a celebrity-oriented culture at ABC with a less profligate one that emphasized management teamwork.
Mr. Burke could be a tough taskmaster, Mr. Murphy said, but he also had a deft way with people.
Daniel Barnett Burke was born in Albany on Feb. 4, 1929, a son of James and Mary Barnett Burke. His father was an insurance salesman. He grew up in Slingerlands, N.Y., outside Albany, and Dorset, Vt. He graduated from the University of Vermont in 1950, served as an infantry lieutenant in the Korean War in 1951 and 1952, and received an M.B.A. from Harvard in 1955.
After leaving Harvard, he worked for the Jell-O division of General Foods. In 1961, Mr. Murphy hired him to manage an Albany television station owned by Capital Cities. Mr. Burke became chief executive of Capital Cities/ABC in 1990, when Mr. Murphy retired from that position but stayed on as chairman. Mr. Burke retired in 1994.
In 1995 Mr. Murphy pulled off one more mega-deal: negotiating the sale of the company to the Walt Disney Company for $19 billion.
In retirement, Mr. Burke lived in Maine and ran a minor league baseball team, the Portland Sea Dogs.
He was a director of Conrail, the federally operated freight railroad, from 1981 to 1986. He was also a director of the Partnership for a Drug-Free America, and he was a chairman emeritus of New York Presbyterian Hospital in New York City.
Two of his three sons also made careers in media. His oldest son, Stephen, held top posts at Comcast and Disney and in January was named chief executive of NBC Universal. His son Bill was president of TBS and the Weather Channel.
He is also survived by his wife of 54 years, Harriet; another son, Frank; a daughter, Sally McNamara; his brother, James; a sister, Phyllis B. Davis; and 14 grandchildren.
Mr. Burke’s son Bill said he was often asked how the family came to produce so many top corporate executives, across two generations. He said it may have had something to do with Daniel Burke’s parents, a father who was a war hero and a football coach at the University of Vermont and a mother whom he described as highly intelligent and an early feminist. When his father was young, he said, the children were asked to read articles from the newspaper and discuss them at dinner.
But he said it was hard to pinpoint what drove the Burke children to excel in business. “There was something in him and my uncle and my aunts as well,” Bill Burke said. “It was just in their makeup.”

Wednesday, April 17, 2013

Not a final win for metal on metal hip defense.

Never confuse a single defeat with a final defeat.
~ F. Scott Fitzgerald

Re-examine all you have been told.  Dismiss what insults your soul.  Walt Whitman

Laws, like the spider’s web, catch the fly and let the hawk go free.
Spanish Proverb

By BARRY MEIER  April 16, 2013   The New York Times  FiDA highlight
A jury in Chicago rejected claims on Tuesday that the orthopedics unit of Johnson & Johnson inappropriately marketed an artificial hip, which the company recalled in 2010.

The verdict came in the second trial of some 10,000 pending lawsuits involving the all-metal device, which was known as the Articular Surface Replacement, or A.S.R. In March, a jury in Los Angeles awarded $8.3 million in the first trial of an A.S.R.-related case.
The DePuy Orthopaedics unit of Johnson & Johnson said in a statement that all its actions related to the sale, marketing and recall of the device had been appropriate.
Internal DePuy documents introduced at the trials indicated that company officials knew that the design of the A.S.R. was flawed long before they recalled the device and even considered redesigning the implant. They never shared that information with doctors and patients, those documents show.
It was not immediately clear why the two juries returned such differing verdicts.
Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve. Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.
The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.
It 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 in the United States in standard hip replacements that used the same cup component as the resurfacing device.

Friday, April 12, 2013

Proprietary Silo for Medical Devices: PCORI Irrelevant?

Where Is the Patient Stakeholder?  FiDA highlight.

By Jaimy Lee  Modern Healthcare
Posted: April 9, 2013 - 8:00 am ET

Health insurer UnitedHealthcare and about 50 hospitals say they will conduct research comparing some of the costliest medical devices on the market and then use that data to inform their purchasing decisions as part of a joint venture.

UnitedHealthcare and Dignity Health, a 37-hospital system based in San Francisco, formed  SharedClarity last year.

Since then, the Phoenix-based venture has added Baylor Health Care System, which operates 11 hospitals in Texas, and Advocate Healthcare, a 10-hosptial system based in Oak Brook, Ill., as its newest members. There are plans to include up to seven other health systems over the next few months.

“Our members have a tremendous thirst for getting independent information about how medical devices perform,” said Mark West, SharedClarity's president and a former vice president of supply chain management for UnitedHealthcare.

Implantable medical devices are among a hospital's most expensive supply costs. The prices of these devices are also rising, making them a concern for hospitals and insurers seeking to better manage the costs of pricey procedures such as hip and knee implants. 

Many hospitals have implemented cost-cutting strategies for devices and other physician-preference items, and some have formed new ventures that aim to address the costs of these products. Earlier this year, the Cleveland Clinic and VHA announced a joint venture that aims to target the costs of physician preference items.

However, SharedClarity is unique in that the venture was formed between an insurer and a health system. SharedClarity said it will identify the best-performing devices in 30 categories by using clinical data gathered from member hospitals and claims information from UnitedHealthcare, West said. The device categories range from stents and defibrillators to pacemakers and knee and hip implants. 

The hospital systems then plan to pool their purchasing volume to negotiate better prices on what they find to be the best-performing devices. In addition, hospitals that are part of UnitedHealthcare's provider networks will have access to those devices at prices negotiated by SharedClarity, although the prices will be less favorable than what the member hospitals receive.

The studies are expected to begin this spring. Richard Roth, Dignity's vice president of strategic innovation, said he expects the first purchasing decisions to be made next fall.

“As Dignity is entering in accountable care organizations and we're doing bundled payments and we're continually demonstrating the tenets of reform, this is going to be a valuable intelligence tool as we're caring for patients,” Roth said.

Both providers and insurers have lamented a lack of independent data about how implants perform, as well as lack of transparency about how they are priced. As more hospitals and insurers are taking on risk-based reimbursement strategies, they say there is a need for better data.

The higher failure rates of metal-on-metal hip implants, which led to revision surgeries and thousands of lawsuits against Johnson & Johnson, would have been caught sooner if data about the performance of those devices had been captured, according to West. 

SharedClarity will not only compare types of device and how they perform, it will also research how some devices fare when compared to different types of treatments or therapies.

“Our goal is to shed a light on this and create transparency,” Roth said.

Thursday, April 11, 2013

Proprietary Demands and Threats by Mayo Clinic CEO

                Article by: KEVIN DIAZ , Star Tribune Updated: April 9, 2013 - 11:16 PM
He warned legislators on eve of hearing on $500M tax proposal.
WASHINGTON – In blunt words aimed squarely at the Minnesota Legislature, the president and CEO of the Mayo Clinic warned Tuesday that the hallowed medical institution has “49 states” eager to have Mayo’s planned multibillion-dollar expansion if the state is unwilling to pitch in.
“We’re never going to leave Minnesota, and we don’t want to leave Minnesota,” Dr. John Noseworthy said in an interview at the National Press Club, where the CEO made a pitch for federal investment in health care and medical research. “But we’ve got to decide where we’re going to put the next $3 billion.”
That money would be part of a $5 billion, 20-year expansion in Rochester dubbed “Destination Medical Center,” which would require a half-billion dollars from state officials for infrastructure improvements.
“If they say yes, that’s great, we want to stay in Minnesota,” Noseworthy said. But, he cautioned, “If they say no, or you’re going to have to go for a bonding bill every year for the next 30 years, we’ll have to rethink about whether that’s the best use of our money.”
Noseworthy, a neurologist, said Mayo is not threatening to leave Rochester, where the renowned clinic was established 149 years ago.
But in a clear message to the Legislature, where the clinic’s proposal is encountering significant sticker shock, Noseworthy pointed out that “there are 49 states that would like us to invest in them. That’s the truth.”
Noseworthy’s comments came on the eve of a House tax committee hearing, where skeptical legislators have split Mayo’s $500 million plan into separate tax and bonding provisions, a development that has concerned backers.
Mayo, the state’s largest private employer, says the taxpayer funding is needed for infrastructure improvements to keep up with the clinic’s expansion plans in Rochester.
Noseworthy said the clinic plans to pour $3.5 billion of its own money into the project and $2 billion from other potential private investors, fostering the city’s growth as an international destination, creating 40,000 jobs and expanding its tax base.
None of the proposed state money would be earmarked for the clinic, he said. “We just hope they’ll help us build some sidewalks and sewers,” he said.
Noseworthy also flexed some lobbying muscle in Washington, where he met with members of Congress on Tuesday to promote funding for medical research, quality care and payment reform under Medicare. Lagging federal provider rates have cost the clinic $128 million, he said, on top of another $47 million in the first year of the sequester budget cuts.
“This is a big deal,” he told the National Press Club audience. “It’s a very serious thing for all of us.”
The sold-out event, which included U.S. Sen. Amy Klobuchar, D-Minn., is an indicator of the Mayo Clinic’s influence in promoting a Minnesota model that drives down costs by emphasizing quality of care and collaboration among medical providers.
But the health care giant faces a tougher audience in St. Paul, where legislators are raising questions about the amount of the requested taxpayer assistance to a city of little more than 100,000 residents, about a third of them in the health care industry.
Noseworthy said the clinic is responding to legislators’ concerns.
“Yes, we’re listening to that input, and we’re trying to see how are we going to get the right answer,” he said. “It’s being reviewed, amended, revised and rethought as we go through.”
Some legislators have suggested that Rochester could pony up more for the stadium-size price tag by raising local sales tax rates.
But Noseworthy said the town doesn’t have the tax base to support the infrastructure improvements that could justify Mayo’s further expansion.
“I don’t know whether it will happen,” he said. “I hope it happens. We’ve told the state we want to grow, and we want to grow in Minnesota.”
In the meantime, other states beckon for a piece of the Mayo mystique.
Medicine is a growth industry,” Noseworthy said. “We need to decide where to invest for that growth.”

Kevin Diaz •

In a recent year Mayo Clinic made $7billion  though it is a 'non-profit' institution and it  paid its' CEO more than $1m.  It is so lawyered up that there has been only one conviction of a doctor in two decades.  Is it possible that these demands are being made by an institution that disguises it's mission as community-focused to derive maximum profit?  How can this be healthy for the majority of Minnesotans?   comment

Monday, April 8, 2013

Patient Harm by design: justice is unattainable!

  Wall Street Journal

            April 4, 2013, 7:17 p.m. ET
Cases Challenge Liability Protection Enjoyed by Device Makers
A raft of lawsuits filed Thursday against St. Jude Medical Inc. STJ -0.99% over an implanted heart device could challenge the broad liability protection that medical-device makers have enjoyed since a key Supreme Court ruling in 2008.
The lawsuits, filed both in Los Angeles Superior Court and federal court in the Central District of California, claim that problems with the manufacturing and oversight of Riata defibrillator "leads" injured or killed more than 30 patients. Faulty leads, which connect the heart to defibrillators that zap irregular heart rhythms back to normal, caused the devices to fail or needlessly deliver blasts of electricity, the suits allege.
One plaintiff, Rebecca Clawson, said in an interview that she was shocked several times over 25 minutes while in bed at her Orange County, Calif., home last November. Her lead was surgically removed and doctors said it displayed faulty wiring, said Ms. Clawson, who is 55 years old.
"As a matter of policy, we generally don't comment on pending litigation," a St. Jude spokeswoman said.
If the new cases succeed, they could help reopen a closed-off corner of the law that has left people who believe they were injured by medical devices with little recourse—and tempered the business of both plaintiff and defense lawyers who once earned hefty fees from device cases.
In recent years, the legal landscape has shifted against would-be plaintiffs injured by devices that go through the Food and Drug Administration's premarket approval process, lawyers specializing in device cases say.
The 2008 Supreme Court ruling, Riegel v. Medtronic, MDT -1.78% shielded makers of such devices from most product-liability claims, which are governed by state law, so long as the companies had complied with the federal standards of the FDA, including those for manufacturing, labeling and device monitoring. That meant that even if such devices were later found to be defective, companies are protected from many suits.
A 1976 law governing medical devices generally prohibits states from attempting to regulate devices, which are subject to federal rules, but Riegel broadly interpreted those provisions in a way that plaintiffs' attorneys say made it much harder to pursue claims.
To push cases through, lawyers generally must find state laws that specifically address violations of the FDA's requirements.
"Riegel was basically a graveyard for" device cases, said George Conk, a professor at Fordham Law School in New York and former product-liability attorney. In 2010, an appeals court upheld the dismissal of more than 8,000 cases alleging that a Medtronic Inc. defibrillator lead had injured patients, after the firm argued Riegel protected it. The company, though, had agreed to pay $268 million to settle the cases days earlier.
Medtronic said that without such protections from state law, "there would be no central standard for device safety, effectiveness, testing, labeling and marketing, which would ultimately be detrimental to patients."
Lawyers in the new Riata cases are alleging that St. Jude violated both the FDA's requirements for the company to report device flaws to the agency, along with state product-liability laws, an emerging approach to clearing Riegel's hurdles that has been buttressed by several recent appeals-court rulings.
They will also attempt to show St. Jude erred in manufacturing the devices in accordance with FDA rules, the approach favored in most device cases since Riegel.
The industry defends Riegel and its broad protections. "There is no absolutely safe medical device," said Ralph Hall, a Minnesota lawyer who has worked with device makers. "Making risk-benefit determinations in any design is FDA's job," he said.
St. Jude's Riata problems led to a recall of the leads in late 2011, and researchers have attributed at least 20 deaths to problems with the leads. Wires inside the Riata leads can break through their insulation, becoming exposed and potentially leading to electrical problems.
Some patients with the leads have seen their cases turned down by lawyers. Greg Jessee, 51, the general manager of a hydraulics-repair firm in Portsmouth, Va., was shocked three times before his heart briefly stopped during his son's football game in late 2011. He consulted an attorney last year to consider suing St. Jude, but the lawyer declined the case. "He studied it and came back to me to say he has found no way around" the protections, Mr. Jessee said.
The lawyer, Duncan Garnett, of Newport News, Va., didn't immediately respond to a request for comment.
Since the ruling "we've had numerous clients—including clients who have had Medtronic devices implanted in them—who have been reluctant to bring a case," said Brian J. McCormick Jr., a partner with Sheller PC, a Philadelphia law firm that specializes in cases involving defective products, drugs and medical devices.
Attorneys at large law firms that once made a lucrative business of defending the industry also say the Riegel ruling affected their businesses. "It has narrowed the playing field by 75%," said one defense lawyer specializing in devices who declined to be named because he still represents the industry in some matters.
Appeals courts are now split on the breadth of claims that Riegel blocks. A January ruling, for instance, in the Ninth U.S. Circuit Court of Appeals, which includes California, found Medtronic wasn't protected from liability related to a Medtronic pain-medicine pump malfunction, in part because the plaintiff, a patient named Richard Stengel, alleged the company failed to warn the FDA about known risks.
Medtronic said it disagreed with the January ruling.
The lawyers in the newly filed cases are hoping such rulings could propel their cases.
"What the judges are recognizing now is that there's no recourse for consumers, and that's changing," said Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new cases.
Write to Christopher Weaver at and Jennifer Smith at

Joleen Chambers                          The medical device industry actively obscures the cascade of harm (and cost) when their products do not perform as advertised. Long-term post-market surveillance that is available in other countries via national registries are proprietary silos here in the U.S. Patients cannot access basic information prior to surgery about which devices perform best. Purchasing a toaster oven is more predictable. And when a device fails the debilitated patient is expected to go to federal court to face a lawyered-up industry. The aviation industry stops everything for a battery issue in a new airplane, Lulu-lemon gets national attention for failed fabric in their yoga pants but vaginal surgical mesh, ICD leads, joint replacement failures: silence! Why is the medical device industry "special"? Follow the money and see the cost of the entitlements to this small segment of our national economy! It is costly and immoral.

Friday, April 5, 2013

The first thing that must done to end profit from patient harm.
In 2011, Lawrence Lessig founded Rootstrikers, an organization dedicated to changing the influence of money in Congress. In his latest book, Republic, Losthe shows just how far the U.S. has spun off course -- and how citizens can regain control. As The New York Times wrote about him, “Mr. Lessig’s vision is at once profoundly pessimistic -- the integrity of the nation is collapsing under the best of intentions --and deeply optimistic. Simple legislative surgery, he says, can put the nation back on the path to greatness.”

Wednesday, April 3, 2013

Guilty doctor, angry patient: apology asymmetry.

by SHANKAR VEDANTAM     NPR Morning Edition
April 01, 2013 3:16 AM
To err is human.
So is refusing to apologize for those errors.

From toddlers and talk show hosts to pre-teens and presidents, we all know people who have done stupid, silly and evil things then square their jaw and tell the world they've done nothing wrong.
Parents, educators and even public relations flacks have talked at length about the value of coming clean, and there is abundant research on the psychological value of apologizing. But psychologists recently decided to take a new tack: If so many people don't like to do it, there must be psychological value in not apologizing, too.
In a recent paper, researchers Tyler G. Okimoto, Michael Wenzel and Kyli Hedrick reported on what they've found happens in people's minds when they refuse to apologize. They find that parents who tell their kids that saying sorry will make them feel better have been telling the kids the truth — but not the whole truth.
"We do find that apologies do make apologizers feel better, but the interesting thing is that refusals to apologize also make people feel better and, in fact, in some cases it makes them feel better than an apology would have," Okimoto said in an interview.
Okimoto surveyed 228 Americans and asked them to remember a time they had done something wrong. Most people remembered relatively trivial offenses, but some remembered serious offenses, including crimes such as theft.
The researchers then asked the people whether they had apologized or made a decision not to apologize, even though they knew they were in the wrong. And they also divided the people at random and asked some to compose an email where they apologized for their actions, or compose an email refusing to apologize.
In both cases, Okimoto said, refusing to apologize provided psychological benefits — which explain why people are so often reluctant to apologize.
The same thing happened when people were asked to imagine doing something wrong, and then imagine apologizing or refusing to apologize.

"When you refuse to apologize, it actually makes you feel more empowered," he said. "That power and control seems to translate into greater feelings of self-worth."
Ironically, Okimoto said, people who refused to apologize ended up with boosted feelings of integrity.
The researchers are not suggesting that refusing to apologize is a useful life strategy: Okimoto himself said he has little trouble apologizing. The interpersonal benefits of apologizing are huge, and an apology can not only renew bonds between people, but between countries.
Okimoto believes the research, in fact, may provide a clue on how best to get people to apologize. Our conventional approach, especially with kids, is to force people to apologize. But if people are reluctant to apologize because apologies make them feel threatened, coercion is unlikely to help – that is, if a sincere apology is hoped for.
Support and love, by contrast, may be a more effective way to counter the feelings of threat involved in an apology.
The next time junior — or your partner — does something wrong, pass on the stare and try a hug.
Volume 49, Issue 3, May 2013, Pages 315–324

The apology mismatch: Asymmetries between victim's need for apologies and perpetrator's willingness to apologize
         Joost M. Leunissena, , , David De Cremerb, Christopher P. Reinders Folmerc, Marius van Dijkea
            a Rotterdam School of Management, Erasmus University Rotterdam, The Netherlands
            b China Europe International Business School, Hongfeng Road, Pudong, China
            c Ghent University, Gent, Belgium

Guilt and anger (among perpetrators and victims) explain the asymmetries we see in apologies. #PW
3/27/13 12:02 PM

Although previous research on apologies has shown that apologies can have many beneficial effects on victims' responses, the dyadic nature of the apology process has largely been ignored. As a consequence, very little is known about the congruence between perpetrators' willingness to apologize and victims' willingness to receive an apology. In three experimental studies we showed that victims mainly want to receive an apology after an intentional transgression, whereas perpetrators want to offer an apology particularly after an unintentional transgression. As expected, these divergent apologetic needs among victims and perpetrators were mediated by unique emotions: guilt among perpetrators and anger among victims. These results suggest that an apology serves very different goals among victims and perpetrators, thus pointing at an apology mismatch.

► The present paper investigated the congruity between victims' and perpetrators' need for apologies ► A mismatch between victims' and perpetrators' need for apologies is observed ► This mismatch is driven by the intentionality of the transgression ► This effect was mediated by anger (victims) and guilt (perpetrators) ► This mismatch has consequences for actual apology behavior and subsequent forgiveness