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.
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Thursday, April 23, 2015

Stop Military and Civilian Medical Error 'Death Without Disclosure': Petition

Please sign this petition!  Disclosure:  Death from Medical Errors

Mandate Reporting of All Medical Errors to an Independent Oversight Committee, and to the Patient or Their Next of Kin.
We call on President Obama to mandate a national 'Medical Error Transparency Plan'. Medical errors are known to be the third leading cause of death, and medical errors also create a high number of disabilities. Patient's human rights are being violated by the current lack of transparency. We call for mandatory reporting of medical errors by anyone that has knowledge of, or reasonably suspects, that a medical error has occurred. Reporting must be to an independent oversight committee as well as to the patient, or to the deceased / incapacitated patient's healthcare representative.

Background story:  

Service Members Are Left in Dark on Health Errors

FORT WAYNE, Ind. — Lt. Col. Chad Gallagher was T. J. Moore’s squadron leader when the 19-year-old recruit arrived for basic training last spring at Lackland Air Force Base in San Antonio. He was watching at the quarter-mile track nine days later when Mr. Moore, on an easy mile-and-a-half test run, collapsed at the finish line and was rushed to a hospital.
And he was in Indiana shortly afterward to deliver a sorrowful eulogy at Mr. Moore’s funeral. “He had tears in his eyes,” Mr. Moore’s mother, Anita Holmes, said in an interview at her home here. “He said, ‘I didn’t do enough to protect T. J.’ ”
A year later, Ms. Holmes says she still does not know what Colonel Gallagher meant by that.
Outside experts who reviewed her son’s medical records at the request of The New York Times identified a serious medical error at the Lackland clinic: a decision to allow Mr. Moore to make the run even though doctors had pulled him from normal training after he failed the same test just days before. Test results revealing a genetic condition that in rare cases can lead to sudden death during physical exertion were apparently overlooked.

But the official Air Force explanation — in a 15-page report in a white binder, delivered to Ms. Holmes in December after months of inquiries — was that the military had followed proper protocol. No mistakes were identified. No one was faulted.
“I raised T. J. as a single mother on little income for 19 years, and kept him safe. They had him for nine days and sent him home to me in a box,” said Ms. Holmes, who called the report “garbage.”
“No one,” she added, “has really given me good answers about why.”
Tens of thousands of serious medical mistakes happen every year at American hospitals and clinics. While a handful of health care organizations have opted for broad disclosure amid calls for greater openness, most patients and their families still face significant obstacles if they try to find out what went wrong. But as Mr. Moore’s case illustrates, the nation’s 1.3 million active-duty service members are in a special bind, virtually powerless to hold accountable the health care system that treats them.
They are captives of the military medical system, unable, without specific approval, to get care elsewhere if they fear theirs is substandard or dangerous. Yet if they are harmed or die, they or their survivors have no legal right to challenge their care, and seek answers, by filing malpractice suits.
Only 18 months ago did the Pentagon explicitly allow them to file complaints about their treatment, although some had done so earlier. But even then they are barred from learning the results of any inquiry. Under federal law, investigations at military hospitals and clinics are confidential, in part to keep the findings from the roughly two million civilian patients they treat per year — spouses and children of service members, retirees and others — who can and do file malpractice claims.
In scores of interviews, active-duty patients, relatives and military medical workers described how, in that information vacuum, attempts to ferret out the truth about suspected medical mistakes — through freedom-of-information requests, complaints, meetings with military medical officials — produced anodyne letters of condolence, blanket denials of poor care or simply nothing at all.

“There is just no transparency. You can’t sue. You have no insight into the process,” said Cheryl Garner, a military intelligence officer who retired last year. “As active duty, we just don’t have much recourse.”
What’s more, until 2009, clinicians found to have delivered substandard care to active-duty patients in most cases were not reported to a national database that tracks problem medical workers; instead they were reported to an internal database. Even now, those clinicians, typically doctors, are mainly reported only if the service member is disabled or dies, a higher bar than in cases involving civilians.
And comparatively few have been reported, to either database, Pentagon records show. The Army, which runs the bulk of the system’s hospitals, treats four civilian inpatients for every active-duty one. But from 2003 to 2013, it reported nearly 50 times as many medical workers for breaching the standard of care in cases involving civilians.
The experiences of active-duty patients point to broader questions of accountability in a system of 54 hospitals and hundreds of clinics that has recently come under intense scrutiny. As The Times has reported, military hospitals often fail to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die. Many medical workers report reprisals for speaking out about problems with care. And systemwide efforts to limit errors and bolster quality have often foundered in a convoluted bureaucracy.
Amid growing fiscal pressures, the Defense Department has ordered improvements and is pushing to close hospitals where surgeons and other specialists treat too few patients to keep skills honed. In a new report to President Obama and Congress, a blue-ribbon commission argued that the military hospitals are wrongly modeled after typical civilian hospitals and so are stumbling in their central mission — to train a medical corps for injuries in combat zones.
In an interview, Dr. Jonathan Woodson, the Pentagon’s top health official since 2011, said that the federal confidentiality law notwithstanding, the military explicitly requires its clinicians and facilities to be open and accountable to all patients. If patients and the public once were unnecessarily denied information about quality of care, he said, “that went out the door when I came in.”
“From the top we are fully committed to the standard of transparency,” he said, describing efforts that include retraining thousands of doctors. If that message is not being heeded, he said, “we want to know.”
Yet military culture makes service members the least likely to complain, for fear of being branded troublemakers. And when they have spoken up, some said, they have been brushed aside.
Ms. Garner was 35 in 2007 when she saw a physician assistant at the Langley Air Force Base hospital three times for breast pain and other symptoms she feared might point to cancer. The physician assistant not only dismissed her fears as irrational, she said, but threatened to place a note in her file that could have damaged her career if she came back again.

Nine months later, Ms. Garner was able to switch her care to a Navy hospital. A doctor there speedily ordered a mammogram — and discovered Stage 2 invasive breast cancer. Her persistence, he told her, had saved her life. A double mastectomy and chemotherapy followed.
After she recovered in late 2009, Ms. Garner filed a complaint against the physician assistant, hoping, she said, to protect other patients. But while sympathetic, the hospital’s chief of medical services told her that she had not been mistreated. Not long afterward, the physician assistant was promoted.
‘Drive Families Crazy’

“When it is pretty clear that something occurred, and nobody is being honest with them, that will drive families crazy,” said Dr. Robert Truog, a professor of medical ethics at Harvard Medical School.
To Belinda and Ronald Robinson, that aptly describes the five years they have spent seeking an explanation for what happened to their 27-year-old son, Sgt. Ronald Robinson Jr., at the hospital now called San Antonio Military Medical Center. A gregarious computer technician with a blue Mustang and a love of barbecue, Sergeant Robinson enlisted in the Army at 19, hoping for a long military career like his father’s. But six years later, he was found to have a heart condition called atrial fibrillation, shared by several million Americans and characterized by an abnormal heart rhythm. Exercise sometimes left him disoriented, dizzy, even unable to speak.
Facing a possible lifetime of medication, he decided on an outpatient procedure in which an electrode on a catheter threaded into the heart burns away the problem tissue. Tens of thousands of such procedures are conducted annually in the United States, with an estimated death rate below one in 1,000.
In April 2010, Mrs. Robinson was waiting at the hospital for her son’s procedure to end when a surgeon burst in. “Something went terribly wrong,” he told her. Despite an all-out effort, Sergeant Robinson died within hours.
Two days later, she said, the cardiac electrophysiologist who performed the procedure, Dr. Robert Eckart, telephoned her and her husband. “He said, ‘I wish I could tell you what happened,’ ” Mrs. Robinson recalled in an interview at the family’s restaurant in Slidell, La. “I can never ever forget what he said: ‘It is just an unknown.’
In his notes, Dr. Eckart described the case as an “unexplained rapid death.”
Experts say his caution may have been appropriate. It often takes a thorough inquiry to figure out what happened. But with that one phone call, the Army’s effort to explain Sergeant Robinson’s death came to an end.
Hospital records obtained by The Times suggest the required patient-safety inquiry was never conducted. When the Robinsons asked about the results of an investigation, the Army sent duplicate sets of their son’s medical records. Their Freedom of Information Act requests were answered with a copy of the Army secretary’s condolence letter.
“If we knew the truth, we could deal with what happened,” Mrs. Robinson said. “I could forgive them.”

Two specialists who reviewed Sergeant Robinson’s medical records at The Times’s request called his death both rare and perplexing. But one of them — Dr. Hugh Calkins, director of cardiac arrhythmia services at Johns Hopkins Hospital — said it was not a total mystery. Because of some unknown factor, possibly an equipment malfunction, he said, the doctor inadvertently cauterized too close to two crucial pulmonary veins and the veins shut down, causing fatal hemorrhaging.
“The best people in this field have inadvertently burned inside the veins, and almost always you get away with it,” he said. He called the outcome “a tragic, freak complication,” adding, “I hope that they were straight with the family.”
Told of his comments, Mrs. Robinson fell silent. “No one ever told us that,” she said.
Dr. Eckart, now a civilian physician, said in an email that patient-privacy laws prohibited him from discussing the case. But he wrote, “Sometimes there can be a bad outcome, even if everything was done right.”
Beyond helping bring closure, experts say, honesty about medical errors makes it harder for hospitals to gloss over serious lapses in care.
The San Antonio hospital, the military’s largest, has had a perennial problem with surgical infection control. In 2011, when Mark Probus underwent spinal surgery there, the infection rate of surgical wounds was 77 percent higher than expected, given the mix of cases, according to a Pentagon-ordered comparison with civilian hospitals.
Mr. Probus, then 44, was no average patient: A lieutenant colonel, he worked at Army medical headquarters, assessing hospitals.
But when he nearly died from a surgical infection, requiring three more operations and months of follow-up care, he got no better answers about what had gone wrong than did the Robinsons. When he asked whether the mandatory safety investigation had been conducted, he said, hospital staff members did not respond.
Mr. Probus retired on medical grounds in 2013, utterly disillusioned, he said, by the system’s lack of accountability. “I had no faith whatsoever in what I was doing anymore,” he said.
Honesty With Patients

Defenders of the federal confidentiality law argue that without it, medical workers would not speak freely about mistakes for fear of provoking malpractice suits by the system’s civilian patients. But evidence from some civilian hospitals increasingly raises questions about that argument.
In 2001, the University of Michigan Health System, the state’s largest medical center, decided that officials would inform patients and apologize whenever they discovered a serious preventable error or lapse in care. Administrators say physicians and nurses have grown more open about mistakes — not less — even though, unlike their counterparts in military hospitals, they can be individually sued for malpractice. The hospital has followed its disclosures by negotiating compensation, resulting in lower malpractice costs.
That level of honesty with patients is still rare, but momentum is growing to make it standard. The National Quality Forum, a nonprofit organization whose safety recommendations are followed by hundreds of hospitals, said in 2009 that hospitals should acknowledge and explain preventable errors to patients and apologize.

Dr. Thomas Gallagher, director of the University of Washington’s research center for patient safety and quality of care, said hospital officials can summarize the results of investigations without disclosing so much that medical workers would be afraid to talk. At Johns Hopkins, physicians routinely tell patients not only what inquiries found, but what changes resulted, said Dr. Albert W. Wu, a physician there and a health policy professor.
The Pentagon has taken steps to open up: Three years ago, officials successfully pushed Congress to narrow the 1986 confidentiality law, suspecting it was being used to withhold not only judgments about care but medical facts.
Regulations now require that those facts be shared, thousands of doctors are being retrained and a small band of mediators has been hired to help. The military’s policies, Dr. Woodson says, are no different from those of most civilian hospitals.
Still, in the eyes of leaders in the field, like Richard C. Boothman, the Michigan health system’s clinical safety chief, such policies fall short. “If you can’t be honest about the conclusion, about whether what you did was right or wrong, whether it was reasonable or not reasonable, I don’t see how you can say you have a culture of full disclosure,” he said.
Arguing the need to maintain military discipline, the Defense Department has opposed a series of congressional attempts to modify a law that the Supreme Court ruled in 1950 bars active-duty service members or their survivors from filing malpractice claims. Officials insist that the prohibition in no way lessens the quality or scrutiny of care provided to service members.
But it has led to a bifurcated system of review that has produced proportionally fewer reports of medical workers for substandard care of active-duty patients than of civilian ones.
If the department determines that a medical worker breached medical standards in a civilian case that resulted in a malpractice payment, the worker must be reported to the National Practitioner Data Bank, which health care and licensing organizations routinely check to spot problem physicians and nurses. A similar inquiry is supposed to ensue when the Pentagon authorizes death or disability benefits for an active-duty patient — although until 2009, clinicians who were faulted in those cases were reported only to an internal database.
But in practice, few active-duty cases reach that level of scrutiny. Col. Kimberly Kesling, the Army’s chief of patient safety, said that is because service members are typically young, healthy and in need of only routine care.
Even so, service members make up one-fifth of inpatients and one-fourth of the maternity cases at military hospitals. Yet from 2003 to 2009, the military reported just 15 clinicians for substandard care of active-duty patients, while reporting 710 clinicians — 47 times as many — for unacceptable care of civilian patients leading to a payment.

In interviews, other current and former senior health officials attributed the discrepancy to several factors. For one, analysts who review disability cases typically do not focus on whether bad care is to blame. Indeed, at seven military hospitals visited by inspectors, staff members who handled disability claims did not even know they were expected to look for signs of malpractice, according to a 2007 department report.

“The disability system has never been structured to be a quality-of-care review,” said a senior Air Force official in charge of risk management. “It is fundamentally a disconnect.”
Beyond that, clinicians can be reported for substandard care of a civilian patient who wins a malpractice claim no matter the level of harm — not just if the patient is disabled or dies. Finally, service members are often reluctant to even file disability claims for fear of being declared unfit for duty, making their cases less likely to be investigated.
The gap has narrowed since 2009, when the military tightened regulations and started reporting active-duty cases to the national database. But it has not vanished: In the next four and a half years, 17 times as many medical workers were reported for poor care of civilians than of active-duty patients.
From 2003 to 2013, the Army reported not a single clinician for breaching medical standards in a case that left a service member disabled — despite tens of millions of active-duty patient visits and roughly 250,000 hospitalizations.
‘A Terrible Error’
T. J. Moore enlisted in the Air Force two months after high school, telling his mother that he wanted to accomplish “something big” and help care for her and his sisters. “Now you can rest,” he told her.

A former football player with an engaging grin, he seemed to fit in well at the Air Force base in San Antonio. But on his first Saturday of basic training, he flamed out on the 1.5-mile run, part of a mandatory initial fitness test. Given 18 and a half minutes to run six laps, Mr. Moore stopped after three laps. “Running is not for me,” he declared.
The Times pieced together what followed from Mr. Moore’s medical records, the official Air Force report and records of the family’s meeting with Air Force officials.
Dr. Aasif Mirza, who examined Mr. Moore the next Tuesday at the base’s health clinic, pulled him from standard training. Neither alternative he proposed was viable under military regulations, so the next day, another physician, Dr. Charlie Collenborne, sent Mr. Moore to a medical hold unit for trainees with health issues.
A nurse wrote in his chart: “Pt reports that he can not run at all.” The official Air Force report said “a thorough medical evaluation” was ordered.
Had that occurred, someone most likely would have noticed the results of a blood test that had arrived at the clinic the previous afternoon. Routine lab work done when he arrived at Lackland showed that Mr. Moore had sickle-cell trait, a genetic condition affecting 8 percent of African-Americans.
The vast majority of people with sickle-cell trait lead normal lives, and many are not even aware of their status. But in rare cases, people with the trait who engage in sudden, intense exercise suffer a poorly understood metabolic storm that can end in sudden death. Risk factors include heat and poor physical conditioning.
The military has long worried about such cases: Studies decades ago found that African-American recruits with the trait had a 30 percent higher rate of exercise-related death than those without it. The Air Force screens recruits for the trait and requires precautions, not always enforced: Just three years earlier, a Lackland recruit with sickle-cell trait died after the same 1.5-mile timed run. He had never been issued the required armband to alert medics to his status.

In Mr. Moore’s case, a medical worker had scheduled a Friday appointment to inform him of his test results, sending an email to squadron leaders. But on Thursday, his situation came to a head. Squadron leaders wanted to know if he would repeat the run or should be sent home. A low-level nurse at the base clinic contacted the physicians who had seen him in the previous 48 hours.
Although both had restricted him from basic training, the Air Force report suggests they changed their minds. “Both physicians stated that the Trainee of Concern was medically qualified and simply ‘deconditioned,’ ” it states. It stresses that Mr. Moore himself reported feeling fine since his run five days earlier — the last time he had engaged in any exercise.
The nurse relayed the information to a physician assistant, Seth Kasunick, who cleared Mr. Moore; neither he nor anyone else conducted a physical examination. His note documenting the decision, written after Mr. Moore died, said he had been “informed the trainee was without health concerns.”
That afternoon, in 82-degree heat, Mr. Moore ran five laps quickly. One hundred yards from the finish line, he fell down, got up and collapsed again. He died that night of what the medical examiner later ruled were complications from sickle-cell trait.
Three independent experts who reviewed Mr. Moore’s medical records at The Times’s request agreed that medical workers had failed him. Dr. Janis Abkowitz, a well-known hematologist and medical professor at the University of Washington, said abandoning the precautions just ordered by two physicians “was a terrible error.”
Dr. Stephen Rice, a specialist recommended to The Times by the American College of Sports Medicine, said that based on Mr. Moore’s symptoms when running — especially that his legs felt very hot — physicians should have investigated whether his muscle tissue was breaking down and leaching proteins into the bloodstream. That condition, called rhabdomyolysis, has been associated with sudden death of people with sickle-cell trait who overexert. And the sickle cell test results “should have been communicated to everyone,” he said.
“There was a breakdown here, no question about it,” he said. “You have to gain some lessons here. You can’t just say this is a tragedy.”
The military’s clinicians — Dr. Mirza, Dr. Collenborne and Mr. Kasunick — did not respond to phone calls for comment. Nor did Mr. Moore’s squadron leader, Colonel Gallagher. In a statement late on Friday, the Air Force said that Mr. Moore had died from complications related to a pre-existing condition and that no one who had trained or cared for him was negligent.
Defense Department officials say it is important that patients or relatives hear directly, and promptly, from caregivers in cases of serious harm or death. Surrogates do not work because patients and families do not trust them.
But nine months after her son died, Ms. Holmes said she had only his death certificate, a condolence letter and assurances that inquiries were underway, one of which ultimately produced a report not covered by the confidentiality law. “How can you fight back when they won’t talk to you?” she asked then.
The four Air Force officers who arrived at her house the next month with that report were just messengers, with no ties to the recruit. Their message was that medical workers had come to a careful, deliberate consensus that he could safely repeat the test run. They did not address why the “thorough medical evaluation” described in the report had not been conducted. Nor did they say whether anyone had considered the sickle-cell test results.
Ms. Holmes told the officers that their remarks were scripted. “The people who were in contact with him should have been the ones who came here today,” she said. “It would make me feel so much better if they would just say, ‘We messed up,’ ” she said after reading the report they gave her on their way out. “I just want them to own up and say it, not put up some kind of front.”
In frustration, she wrote to Colonel Gallagher, the squadron leader who said at the funeral that he had not done enough to protect her son. She wanted to ask him directly what he had meant.
There was no reply.
Andrew W. Lehren contributed reporting from New York.

Wednesday, April 22, 2015

Texas Supreme Court: Corporate Trade Secrets Valued Over Consumer Safety?

Texas Supreme Court looks at curbing lawyers' right to share secrets

By SUE AMBROSE  @sgoetinck 
Staff Writer
Published: 18 April 2015 11:27 PM
Updated: 21 April 2015 03:47 PM

General Motors CEO Mary Barra swore under oath to Congress that her embattled company would change and focus on the safety of its customers.
“Today’s GM,” she said, “will do the right thing.”
The promise, made a little more than a year ago, came after company officials admitted they failed to correct faulty ignition switches now linked to more than 80 deaths.
As Barra spoke, GM was asking the Texas Supreme Court to undo a decades-old legal decision that many attorneys say helps hold big companies accountable for unsafe products. That ruling allows attorneys to share company secrets with other lawyers who have similar cases.
In the David vs. Goliath legal battles against big corporations, the ruling has given more punch to attorneys pitted against the GMs of the world. Sharing information allows lawyers to cut costs and compare notes. Undoing the ruling could make suing more difficult.
“It’s about access to justice,” said Jim Wren, a law professor at Baylor Law School in Waco. “Anything that significantly increases the cost for attorneys makes it harder for consumers to find attorneys who are willing to take their case.”
GM says the fight is about protecting trade secrets from leaks to competitors.
The company’s lawyers declined to be interviewed. But when responding to written questions, the company said, “GM considers trade secrets valuable company assets that require, given competitive sensitivity, robust protection from disclosure.”
Others say the fight is about making it harder for regular folks to challenge companies in court. Lawyers cite last year’s revelation that GM quietly settled lawsuits related to lethal defects in ignition switches as an example of the ways companies will try to protect themselves. That scandal landed company CEO Barra in the hot seat before Congress.
The ability to share company information with other attorneys who have similar cases can strengthen cases and counteract corporate malfeasance, lawyers say. And in the case before the Supreme Court, no one disputes that the materials GM was concerned about were trade secrets.
But, “this is not about the right of a legitimate business to protect a trade secret,” said Tyler attorney Randy Roberts. “It’s about corporations using the cover of trade secrets to hide important consumer safety information. I hope the Texas Supreme Court sees the distinction and comes down on behalf of consumers.”
GM’s fight over the right to share — with the Supreme Court of Texas deciding the winner — had the potential to rewrite rules that govern lawsuits against big companies. But a month before the high court was to hear GM’s case, after The Dallas Morning News began asking questions, the lawsuit that set up the issue was settled, leaving the court nothing to rule on.
Legal experts say the issue will be back. Since 2004, the Supreme Court has agreed to consider at least three cases in which companies were unhappy with how judges were following the court’s earlier decision on sharing between attorneys. Each time, the companies and those who sued them resolved their disagreements before the high court could make a decision.
“The fact that the Texas Supreme Court has shown interest in these cases several times indicates the court would like to revisit the rule,” said Austin attorney Lisa Hobbs, representing the Bolaños family. Companies “like GM know this and this will encourage them to take the issue back up if it comes up in their cases. Right now they know they have a friendly court.”
GM’s journey to the Supreme Court started with an accident nearly five years ago on a two-lane road in a remote stretch of South Texas.
On a warm Sunday night in May 2010, Elias Bolaños and a co-worker were southbound on State Highway 16 to Zapata, where Bolaños lived, after a long day of work for an energy company.
Bolaños, 52, was in the right front passenger seat of the 2006 Chevrolet Silverado pickup, wearing his seatbelt. Traveling at 80 mph, the driver dozed off and lost control. The pickup rolled several times before it slid and stopped, wheels up.
The cab’s roof caved in so far that it was level with the hood. The driver and the witness later told authorities that they could hear Bolaños moaning from the flattened truck. A volunteer firefighter told The News Bolaños was so compressed that his chin was pushed against his chest.
An autopsy found Bolaños had no other life-threatening injuries and concluded he suffocated.
In 2012, Bolaños’ wife, Martha, son Elias Jr. and daughter Edlin sued GM and others, alleging the pickup wasn’t sturdy enough to protect those inside. Unlike in most four-door vehicles, the truck’s front and rear doors were designed to open facing each other. Without a pillar between the two doors, at that spot only the door frames support the roof.
All denied wrongdoing. The seller of a rack behind the truck’s rear window settled. The case against the employer is pending.
In the lawsuit against GM, the Bolaños family’s attorneys asked the automaker to turn over details related to the truck’s design.
But GM had conditions: The Bolañoses’ attorneys would have to return the materials when the case ended. And they couldn’t share the design data with other attorneys.
The company argued that the information was proprietary and valuable. “GM has spent millions of dollars and invested thousands of hours so they can develop this,” GM attorney Daniela Gonzales Aldape said at a court hearing. Even most GM employees don’t have access to the detailed electronic blueprint, she said. “That’s how highly guarded this information is.”
But the Bolañoses’ attorneys said they should have the right to share that material, citing a 1987 Texas Supreme Court ruling.
With the two sides unable to agree, the issue would eventually end up back before the Supreme Court. The court would have the opportunity to undo the ruling made almost 30 years earlier. That case also involved GM.
In 1985, San Antonio judge David Peeples was presiding over a lawsuit by a man burned in a rear-end collision of a 1982 GM Buick. The lawsuit alleged the fuel system was poorly designed.
David Perry, the man’s attorney, said in an interview that while preparing for the trial, GM “produced a lot of documents that we thought were going to be important” for a lot of other cases.
After Peeples forbade the sharing of the documents, the Supreme Court ruled in 1987 that he had “abused his discretion.” The court noted the benefits of sharing information:
If lawyers can compare notes, this can force companies who are sued to be honest and give the same information to every lawyer who asks. When lawyers share, attorneys don’t have to prove over and over, in similar cases, that they deserve the same information that other lawyers have already received. The courts are more efficient.
The Supreme Court also said it’s possible to protect trade secrets while allowing them to be shared. A trial court could restrict sharing to attorneys with similar cases and forbid releasing trade secrets to business competitors.
The decision set the standard for such sharing in Texas. It is also often cited by other courts across the country when they weigh whether to allow attorneys to share company information obtained during the course of a lawsuit.
That 1987 ruling set “a very important precedent,” said Dustin Benham, a law professor at Texas Tech University School of Law in Lubbock. “Those who oppose sharing would love to undo it because it would have nationwide implications.”
When GM went back to the Supreme Court over sharing in the Bolaños case, the company’s argument hinged on the notion that the electronic blueprints are trade secrets and thus proprietary. GM argued that sharing in the age of the Internet has made the danger of spreading proprietary business information bigger than ever.
“Modern technology allows for the anonymous, immediate, global and irretrievable sharing of data,” GM wrote in a brief to the Texas Supreme Court. When the court allowed sharing in 1987, the court “did not contemplate a situation where trade secrets could be irreversibly disclosed with the click of a mouse.”
Asked to cite examples in which a trade secret had leaked during a lawsuit where lawyers had been granted the right to share the trade secret with other lawyers, GM offered The News six examples. The News again asked, specifically, whether the leaks occurred because lawyers had exercised their right to share the trade secrets with other lawyers. GM told The News to do its own research.
The News obtained court opinions, original documents and other summaries of the cases. None matched the scenario GM told the court it was concerned about.
The Bolañoses’ attorneys did not question GM’s assertion that the computer data represented trade secrets. But engineers say the computer blueprint of the pickup model isn’t as secret as GM claims. For example, automakers and parts manufacturers can reverse engineer a competitor’s vehicle by taking it apart and inspecting it.
Although it’s not cheap, it is possible for a competitor to create the type of computer blueprint GM wanted to protect. And in the Bolaños case, the Chevrolet Silverado model had already been out of production for five years when the suit was filed.
“If the competitors had wanted it, they would have already created” a blueprint, said Keith Friedman, a vehicle safety engineer and expert witness with offices in Austin and California.
A GM employee even hedged the issue in a sworn affidavit filed early in the case. The data “may” contain information “which cannot be obtained by reverse engineering,” she said.
The News asked GM about that choice of words. GM responded that their data “typically” contain that type of information.
GM also argued that another Supreme Court ruling needed to be considered. In 1998, the court ruled that a tire company didn’t have to turn over a secret rubber formula because the opposing lawyers hadn’t shown they needed it to prove their case.
GM reasoned that if the Supreme Court said then that lawyers should only get information they needed to prove their case, they should not be able to share that information with other lawyers to prove other cases.
Hobbs, Bolaños family’s attorney, argued that the 1998 ruling didn’t apply. When the Texas Supreme Court sided with the tire company, Hobbs noted, it didn’t say it was overturning the earlier ruling that allowed sharing. If it had intended to, it would have said so, she wrote.
Lawyers who take them on say the big companies aren’t really worried about the leaking of trade secrets. They say the companies are trying to make suing more difficult.
“It’s not about trade secrets, it’s about avoiding liability,” said Daniel DeFeo, a Missouri attorney who has tried cases in Texas. “All they’re trying to do is hamstring a plaintiff who has limited resources to not being able to sue on the same level. They’re just being bullies.”
GM disputed that notion, saying the “attorneys’ speculation is simply that — speculation,” the company wrote to The News.
Lawyers who have sued automakers over alleged defects say they need vehicle design data to expose when a company could have made a vehicle safer.
“Once an attorney like myself has their … engineering files, we can simulate the actual crash conditions with and without an alternative design and prove the case,” said Dallas attorney Lee Brown.
Jaime Gonzalez Jr., the attorney for the Bolaños family from the beginning of the case, told The News that without the ability to share that kind of information “then the only thing we can do is simply take it on faith that General Motors has truly produced everything that they were ordered to produce.”
After the Bolaños case was originally filed, GM did give the computer blueprint to the family’s attorneys. When the Supreme Court became involved, a temporary order was issued forbidding any sharing with other attorneys. As part of the settlement, the Bolañoses’ attorneys agreed to return the materials.
The 1987 ruling that allowed lawyers to share was made at a time when the state’s Supreme Court was dominated by Democrats.
Because the court is now dominated by conservative Republicans, many lawyers think the time remains ripe for another push to limit sharing.
“They’re taking it up to a Supreme Court that’s got a track record for protecting corporations and giving them what they ask for,” said Houston attorney Erin Copeland.
If the court gets a similar case again, lawyers see several options:
The court could completely deny a company’s request to restrict sharing, and reaffirm the 30-year-old ruling. Legal experts say this is the least likely outcome.
The court could instruct judges to decide the issue on a case-by-case basis, giving them guidelines for deciding whether trade secrets can be shared.
The court could now say it’s wrong for judges to ever allow attorneys to share trade secrets.
Restricting sharing would make pursuing lawsuits more costly “because each lawyer has to go through the process, essentially reinventing the wheel each time,” said Wren, the Baylor law professor. Attorneys could be more reluctant to sue.
Lawyers predict companies would also try to designate more types of information as secret.
“You’re going to shift the battle to whether or not something is trade secret,” said Hobbs, the Bolaños attorney. Those suing will have to spend more time and money fighting those claims.
As the Supreme Court was to hear the GM case, it had gained national attention from groups that represent the interests of companies who are frequent targets of product liability lawsuits.
Two national groups that represent some of the biggest companies in the world — including makers of automobiles, oil, tobacco, tires and pharmaceuticals — voiced their support for GM’s point of view.
The Product Liability Advisory Council and the Alliance of Automobile Manufacturers both wrote lengthy legal arguments and sent them to the court. Wallace Jefferson, former chief justice of the Texas Supreme Court, authored the brief for the automobile manufacturers.
The Texas Association of Defense Counsel — a group of lawyers who defend their clients against lawsuits — also supported GM.
Merely having the issue pending in front of the high court has affected other lawsuits.
Other car companies have also been seeking court orders to prevent lawyers from sharing certain information with other lawyers. Attorneys who take on big companies sometimes agree to such arrangements despite the 1987 precedent because “Texas is not the place where you want that issue to go to the Supreme Court,” said Chip Martens, a Corpus Christi attorney.
Houston attorney Jeffrey Raizner said that while the GM case was pending, an insurance company tried to use it to get its way in a Dallas courtroom.
Raizner was suing the company, and it didn’t want him to be able to share guidelines on how insurance claims were handled. The insurance company said the guidelines were trade secrets.
“Let me ask you something,” Dallas Judge Ken Molberg said at a hearing. “It is very, very common that information is shared in other cases and even cases like this in other jurisdictions. Why is this any different?”
Attorney Charles Frazier, who works for the same firm as Jefferson, told the judge about the GM case. If Molberg approved the sharing of the insurance guidelines, a higher court might eventually overturn the judge’s decision.
Molberg allowed Raizner more time to investigate why the guidelines wouldn’t qualify as trade secrets. But he also issued a temporary court order forbidding Raizner from sharing them. The case is ongoing.

TIMELINE: Texas Supreme Court looks at curbing lawyers’ right to share secrets
For years, companies have been trying to keep attorneys from sharing their trade secrets with other attorneys handling similar cases. The Texas Supreme Court decided in favor of such sharing in the 1980s. The justices have since accepted cases that would have allowed the court to reverse that ruling, but each case was resolved before it could make a decision.
April 15, 1983: Manuel Garcia Sr., wife Debra and son Manuel Jr. and Richard Garza are riding in a 1982 GM Buick when the car is struck in the rear and bursts into flames. Only Manuel Garcia Sr. survives.
Jan. 21, 1985: Garcia sues GM in a San Antonio court, saying the Buick’s fuel system was defective and unreasonably dangerous.
Nov. 26, 1985: Judge David Peeples signs an order that prevents Garcia’s lawyers from sharing information they obtain from GM with other lawyers. Garcia’s lawyers later protest.
July 1987: The case ends up at the all-Democrat Texas Supreme Court, where the justices’ campaigns have been funded heavily by trial lawyers, who represent people in lawsuits against big companies. The court rules 8-1 that Peeples erred when he signed the order. The ruling said it is possible to allow lawyers to share information obtained from companies while still protecting trade secrets. The ruling set a precedent in Texas that lawyers for victims say makes filing lawsuits easier because lawyers can share strategy and cut costs.
November 1988: Three Republicans are elected to the Texas Supreme Court, marking the start of the court’s swing to the right. They are backed by corporate, medical and insurance interests. By 1999, all nine justices are Republican.
Dec. 2, 2004: The Supreme Court agrees to consider the first of three challenges to its 1987 ruling that allowed lawyers to share information obtained from companies. They accept similar cases in 2010 and 2012, but all three cases are resolved before the Supreme Court can rule.
May 16, 2010: Elias Bolaños Sr. dies on State Highway 16 near Zapata, Texas, after the GM Chevrolet Silverado pickup he is riding in rolls over, crushing the roof.
April 12, 2012: The Bolaños family sues GM, saying the truck’s design was defective and allowed the roof to cave in.
July 10, 2013: Over GM’s objections, a Zapata County judge allows the Bolañoses’ lawyers to share company information with lawyers who have similar cases. GM protests, and the case heads toward the Texas Supreme Court.
Aug. 22, 2014: The court schedules arguments in the case for Nov. 6, 2014.
Oct. 3: The Bolaños family settles with GM. The Supreme Court will not hear the case. Many believe a corporation defending itself in a lawsuit will bring the issue before the high court again soon.

SOURCE: Dallas Morning News research

Monday, April 13, 2015

Hospital Marketing and Honesty

Online Hospital Promos a Marketing Catch-22

Marianne Aiello, for HealthLeaders Media , April 8, 2015

Accurately representing medical procedures online is a conundrum for hospital marketers, who risk scaring off potential patients by posting facts that would be better explained face-to-face by a physician. But there are ways to tackle this challenge.
Even for those of us who should know better, it's nearly impossible not to Google our health ailments. If you think you might have the flu or possibly sprained your ankle, typing symptoms into your phone's web browser is just plain easier than calling your physician's urgent care line.
And even with the knowledge that we're putting our privacy at risk, there's the alluring element of instant gratification, whether it's an alleviation of our fears or the piling on of even more serious concerns.
Informed healthcare consumers and savvy internet users have figured out how to navigate the plethora of results, choosing WebMD over Wikipedia, .org and .edu URLs over .coms. The Mayo Clinic has even gotten into the medical search game by offering up their doctors to fact check Google results for commonly searched conditions.
Hospital and health system websites have traditionally been above scrutiny in terms of providing accurate medical information— they've been safe harbors in a sea of amateurish Yahoo question boards and unwieldy Reddit threads. According to a recent study published in JAMA Internal Medicine, however, information posted on hospital websites is often misleading.
Promotion Presented as Fact 
"Valuable data and tools—including hospital quality ratings, professional treatment guidelines, and patient decision aids—are increasingly available via the Internet and may help patients facing decisions about where to seek care or whether to undergo a medical procedure," states JAMA's study, titled "Risks of Imbalanced Information on US Hospital Websites."
"Clinicians often encourage patients to engage with these types of information as a means of promoting patient involvement in medical decisions and offloading tasks from the too-brief clinical encounter. Unfortunately, valuable online health information may be hard to identify amid a growing number of online advertisements."
For the study, researchers looked at how the 317 US hospitals offering trans-aortic valve replacement (TAVR) are advertising the procedure. They found that while all of the hospitals touted the procedure as minimally invasive, just one-quarter mentioned the risks, and fewer than one in 20 explained those risks numerically.

"Our findings suggest that web-based advertising of TAVR to the public by hospitals may understate the established risks of this procedure and provide little context for the magnitude of those risks to inform patient decision making," the study reads. "Although consumers who are bombarded by television commercials may be aware that they are viewing an advertisement, hospital websites often have the appearance of [being] an education portal."
A Marketing Catch-22 
Accurately representing procedures online is a conundrum for hospital marketers, who are likely wary of scaring off potential patients by posting risks that would be better explained face-to-face by a physician. And, since this facet of hospital marketing isn't currently regulated, most hospitals probably aren't in a rush to slap a big fat warning label on their online procedure information when their competitor down the street isn't going to.
That said, for hospital websites to keep their pristine status in the public eye as providers of comprehensive medical information, marketing leaders need to reexamine how they're presenting their services online.
While it may take some creativity, there are ways to outline risks without sending patients into a panic. It's important to consider that a decent chunk of patients who are looking on your website about having a procedure done at your hospital have already read all about it on WebMD and are intimately familiar with even the most obscure worst-case scenarios. Those patients will be relieved to read your experts' explanation of those risks and the steps your hospital is taking to minimize them.
Embedded physician videos are a smart way to tackle this sort of sensitive subject, and can act as a stand-in for the face-to-face discussion the patient will ultimately have with their doctor. By explaining the risks in simple terms on video, physicians can simultaneously address patient concerns and win their trust.

It may take some getting used to, but transparency and good marketing aren't mutually exclusive. Smart organizations will take this study to heart and realize their website's copy should be held to higher standards than a billboard.

Friday, April 10, 2015

Apply for a $500 Patient Travel Scholarship to June 4-6 Partnership WITH Patients in Grantsville, MD

More Patient Travel Scholarships!

What does the “Cinderblocks2: The Partnership with PatientsContinues” conference (in Grantsville, MD pop. 825) and Doctors 2.0 & You conference (in Paris, France pop. 2 million) have in common?

Both events are focused on innovation and better communication within healthcare. 

Doctors 2.0 has the over arching goal of identifying the ways in which the inclusion of health 2.0 tools and social media platforms can improve care.

Cinderblocks2 is a mash up of art, activism, medicine, social media, HIT, patient rights and fire-dancing.  It is sort of like if Burning Man met healthcare.

Both events were founded and are organized by two powerful women:

As for Cinderblocks, I am Regina Holliday.  Sometimes called the Rosa Parks of Healthcare.  I graduated Sapulpa high school in Oklahoma. (GO Chieftains!) I worked retail for 16 years before my loving husband Fred died of cancer in 2009; then I became a patient rights activist and artist. I am a keynote speaker, a health information technology change agent and am currently creating The Walking Gallery Center for Arts and Healing in Grantsville, MD.   

Both events are on the same days!!!

Doctors 2.0 is on June 4-5, 2015.  Cinderblocks2 is on June 4-6,2015.  Now some conference planners would be shooting eye daggers at each other over that, not Denise and I.  We are all about spreading the love.

The most important thing both events have in common is that they will benefit from Patient Travel Scholarships issued by the Society for Participatory Medicine!

In 2012, The Society for Participatory Medicine created a patient travel fund so they could award ten $500.00 patient travel scholarships. These were issued to patients so they could afford to attend Cinderblocks1 in Kansas City.  We crowdfunded the money and we asked for direct donation to the site.  We were successful thanks to many kind donors.

When Denise pointed out that our events were on the same days she said it would be great if we could connect them in some way, so we decided we are going do some live streamed interviews between the two conferences. But why stop there?  I said that the Society for Participatory Medicine (#S4PM ) was going to provide patient travel scholarships once again for Cinderblocks, would she like to include Doctors 2.0 in the competition?  She said yes!  #S4PM said yes, they could issue awards for either event!!!

SO…. One day after I announce that HIStalk is epically cool and issuing travel scholarships for HIMSS,

I am announcing that the Society for Participatory Medicine will issue $500.00 Patient Travel Scholarships to attendees of Doctors 2.0 or #Cinderblocks2.

How do you enter?

You must post a blog entry by March 31, 2015 NOW EXTENDED to April 20, 2015 explaining why you want to go to either Doctors 2.0 or Cinderblocks2 and why a patient travel scholarship is needed. 

You must send a link to the post to me by either twitter or facebook prior to  March 31, 2015 NOW EXTENDED to April 20, 2015 If you do not have a blog, please send me your post as an attachment and I will find a blog you can post on as a guest blogger.  

You must also encourage people to donate to the travel fund. These scholarships will come from donations to the fund. I will do my best to encourage companies to sponsor folks but I have found when it comes to patients many small donations add up. (Below is just a screen shot you must go here to donate.) 

How will you be judged?

We will judge entries based on writing ability and need.  We will announce the winners on March 31, 2015 April 24, 2015. Payments will be issued after the conference events.

Responsibilities of the winners: 

You will need to attend the conference of your choice.  We encourage you to use social media during the conference.  We will need you to post a report of your experience on a blog.  After these responsibilities are fulfilled, the Society for Participatory Medicine will issue the $500.00 scholarships.

It is sure a great time to be a patient activist! Spread the word and good luck!

Joleen Chambers:  application for #S4PM scholarship

I want to attend because I will meet with other effective patients/advocates and healthcare leaders who are at the forefront of progress in providing the right healthcare at the right time for those who need it most.  Patients who have been harmed are provided a unique forum to speak of their experience and share what policies and procedures need to be legislated and/or adopted to PREVENT harm of others.  In sharing there is healing and validation.  It is essential to take responsibility for our own health and work together toward public health of our community and nation.  Healthcare spending is now 1/5 of our economy and 400,000 preventable deaths occur because of hospital medical errors annually.  Cinderblocks convenes a diverse group of activists that exponentially shares new information and ideas and will have the greatest impact on how healthcare is delivered in the future.  I want to contribute and participate!  

I support the costs of my patient advocacy (beginning in 2009) with my own personal funds.  Travel to MD from TX and hotel and food will exceed the $500 scholarship.