MDUFMA Public Meeting 3/28/12 - open letter

Docket No. FDA-2010-N-0389

March 28, 2012

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061 

Rockville, MD 20852

The MDUFMA agreement process was not inclusive of patient participation and the lack of funding for regulation of implanted medical devices places patients in medical and legal purgatory.  The medical device industry is lucrative and powerful and entitled.  Patients that have been implanted with failed devices are often in pain, disfigured and debilitated both mentally and financially.  They are the very people who had faith in both the FDA and the medical device industry and whose voices are suppressed.  Much evidence exists showing that the medical device industry orchestrated legislation that reduced patient protections while allowing marketing of devices with questionable value.

I am a tenacious patient advocate that has experienced rejection and barriers rather than access and support from the FDA and the device industry.  My brother, Steven Baker (FDA adverse event MedWatch 5009052 reported on 11/18/08)  had a Tornier lateral elbow prosthesis implanted at the Mayo Clinic on 5/19/2008 to reduce pain and increase function.  It did neither, and on 9/29/2008 (just 4 months later) the surgeon/designer performed “revision” surgery and removed - and confiscated- two components.  My brother was placed on long-term maximum dose hydrocodone (opiate).  His teeth began to disintegrate as he slept at night and he learned that was a side effect of the pain medication.  There was no UDI unique device identifier for the implant.  The surgeon refused to report it to the FDA as an adverse event & legally only a fatality is required to be reported. There is no registry of these devices so a patient cannot make an informed decision based upon post-market data.  Steven was not informed that the Minnesota Medical Board is considered one of the worst in the nation.  Steven was not informed that the FDA allows implanted devices on the market with no clinical testing.  Steven was not informed that 2/2008 the Supreme Court provided even more entitlement to the medical device/pharma companies with Riegel v Medtronic decision.  

All the legal wrangling to give preference to these producers of implanted medical devices loses sight of the need of the patient:  care!  Steven has not filed a lawsuit.  He has not attacked the reputation of the surgeon.  He wants care for the failed implanted device.  It is clear that access to care is also trumped by corporate greed and defensiveness:  the Mayo Clinic sent him a letter stating that only Federally mandated emergency care will be provided.  How many other harmed patients does this experience represent?

As a patient advocate, my goal is to change federal public policy to provide for safe and effective implanted medical devices.  Citizens should be able to expect the U.S. government agency (FDA) and the producers of these medical devices to have the same mission.  Financial investment in regulation should not be disparaged by the very businesses that experience the greatest profit margins of all U.S. market segments.  It cannot expect the taxpayers and harmed patients to absorb the cost of device failures.

Sincerely yours,

Joleen Chambers

POGO-Freedom of Information and the Public's Right to Know is personal!

http://pogoblog.typepad.com/pogo/2012/03/senate-judiciary-committee-talks-foia-and-the-publics-right-to-know.html

Mar 21, 2012

Senate Judiciary Committee Talks FOIA and the Public's Right to Know

By SUZANNE DERSHOWITZ

Held during Sunshine Week, last Tuesday's Senate Judiciary Committee hearing, "The Freedom of Information Act: Safeguarding Critical Infrastructure Information and the Public’s Right to Know," was timely indeed. A wide range of issues were discussed, from the multi-agency FOIA portal scheduled to launch October 1 to the cybersecurity legislation pending in both the Senate and the House. The broad scope of topics covered perhaps illustrated the need for more hearings about FOIA and open government issues.

Chairman Patrick Leahy (D-VT), a longtime champion of FOIA and open government, said that “excessive government secrecy can come at an unacceptable price.” Last year, POGO and partners urged Congress to fix the over-broad and ill-defined provision relating to critical infrastructure information (CII) that the Department of Defense (DoD) was seeking in the National Defense Authorization Act (NDAA) for 2012. Sen. Leahy and Rep. Carolyn Maloney (D-NY) were successful in narrowing the blanket exemption to FOIA for CII. Their amendment requires DoD not to use FOIA’s CII exemption in cases where the public interest outweighs national security concerns. Jerry Ensminger’s testimony about the latest developments in the cover-up at Camp Lejeune demonstrated that more work needs to be done to ensure implementation of the law.

Witnesses on the first panel included Miriam Nisbet, director of the Office of Government Information Services (OGIS) and Melanie Pustay, Director of Information Policy (OIP) at the Department of Justice (DOJ). In addition to managing DOJ’s FOIA administration, OIP is responsible for encouraging and overseeing agency compliance with FOIA and for ensuring that the President’s FOIA Memorandum is fully implemented across the government. 

Sen. Grassley (R-IA) said that the President’s promise to build the most transparent administration in history has not translated into meaningful open government reform. Sen. Grassley pointed to the DOJ winning the Rosemary Award for worst open government performance in 2011.

Sens. Grassley and Leahy were clearly exasperated that Congress hadn’t received OGIS’s recommendations for improving agency compliance with FOIA. Nisbet said OGIS submitted recommendations to the Office of Management and Budget (OMB) for review over a year ago. "We haven’t received them yet,” said Leahy. “The law requires us to receive them. When will we receive them?"  He then offered to drive over to OMB to pick the recommendations up himself. When pressed, Nisbet promised to get “something” to Congress within a month.

Appearing in the second panel were Ken Bunting of the National Freedom of Information Coalition (also the executive director of the Missouri School of Journalism), Jerry Ensminger, a retired Marine Sergeant who is working tirelessly to uncover the truth surrounding the Camp Lejeune water contamination scandal, and Paul Rosenzweig, a visiting fellow to the Heritage Foundation and cybersecurity consultant.

Committee members asked DOJ’s Pustay to comment on DOJ winning the infamous Rosemary Award. Pustay said, “I feel like we have a really strong record, and I stand by it.” They also raised the allegation that she proposed a dozen regressive FOIA regulations. One of those was a rule revision proposed last March that would authorize government agencies to lie to FOIA requestors by denying the existence of certain sensitive records—something POGO strongly opposed.

Pustay went on to argue that a 2011 Supreme Court ruling had left federal agencies vulnerable and unable to protect against public disclosure on cybersecurity matters. In Milner v. Department of Navy, the Court threw out the broad use of FOIA Exemption Two, which many agencies used to deny FOIA requests and withhold information. Pustay said DOJ wants to replace the exemption that the Court threw out. She told the Committee that the Milner decision endangered “a wide range of sensitive material whose disclosure could cause harm.” However three other remaining FOIA exemptions can safeguard this information. If the Court’s decision represents such a threat to public safety, Sen. Grassley asked, why hasn’t DOJ submitted a legislative proposal to protect this information?

Ken Bunting warned the Committee that a vague, overly broad provision in the pending cybersecurity bill could serve as the basis for withholding important information from the public (POGO also has big concerns about this provision). “When cybersecurity and critical infrastructure legislation addresses public disclosure, we believe it should contain at a minimum: a tight definition of the information to be exempted; a sunset for the law itself; a sunset for the protection attached to the information; and a public-interest balancing test that allows legitimately protected information to remain protected, but information being withheld primarily to protect the government from embarrassment to be disclosed,” Bunting said.

Public interest star witness Jerry Ensminger testified on why access to information through FOIA matters and how the critical infrastructure classification can be used to keep Americans in the dark. He shared the moving and disturbing story of his personal battle to uncover the truth at Camp Lejeune. The Navy and Marine Corps have apparently strong-armed the Agency for Toxic Substances and Disease Registry (ATSDR) into redacting key portions of a report on the Camp Lejeune water system—redactions that the report’s author say compromised the report’s scientific integrity.

In his testimony, Ensminger noted that most of the documents and information that the Department of the Navy and the Marines Corps are labeling CII have been in the public domain for more than a decade, some for nearly 50 years. The Navy has failed to even mention the new public interest balancing test in its efforts to withhold scientific information on the Camp Lejeune water wells.

Paul Rosenzweig emphasized that the cyber threat is real and said complete transparency might make us less secure, claiming that FOIA exemptions on the basis of critical infrastructure are necessary. While POGO recognizes the need to shield some information from full dissemination to the public for national security purposes, we urge Congress to proceed with caution before enacting unnecessarily far-reaching exemptions. As Sen. Sheldon Whitehouse (D-RI) alluded to in one of his final questions for Rosenzweig, the potential for those with something to hide to abuse of the law is simply too great.

Suzanne Dershowitz is POGO’s public policy fellow.

Thank you, POGO! 
March 4, 2009 FOI/CDRH responded "after searching our files, we did not find the requested records" for my brother, Steven Baker's, patient-submitted 11/18/2008 FDA/MedWatch Adverse Event report MW5009052. Joint replacements are the #1 expenditure of Medicare. These devices are approved by the FDA with no clinical testing based upon predicates that may or may not be safe. There is no national registry. There is no way for a patient to make an informed decision just as consumers are able to compare appliances or automobiles. Yet, if a device fails, they are in medical and legal purgatory plus in pain and disfigured. Federal public policy must place patient safety first. Transparency will prevent others from peril and will save taxpayers billions of dollars annually.

PCORI - Patient Centered Outcomes Research - My Testimony today

Hello.  I am Joleen Chambers - a volunteer and uncompensated patient advocate, blogger and tweeter for safer implanted medical devices.    I am grateful that PCORI and this badly needed forum for patient care discussion and research now exists.

Failed implanted medical devices place patients in medical and legal purgatory.

Patient centered outcomes research is essential to provide vulnerable patients with real time information about the #1 expenditure of Medicare:  joint replacements. 

PCORI research could

provide real-time post market data that would help patients & their chosen clinicians select life-enhancing medical device implants

PCORI research could

Facilitate a transparent and accessible registry that would be responsive to patient/consumer input about the quality of life risk/benefits of joint replacement

PCORI research could

Allow scientific information to determine which implanted devices are safe and effective and should remain on the US market.  Devices that underperform will be exposed and will be either recalled or retooled so they would not compete with  successful innovations.

PCORI research could

Clarify when implanted medical devices fail to deliver benefit to patients.  If the device harms patients, the path to patient compensation and care will not be in conflict with device industry, surgeon or regulatory defensiveness.

My personal story is that my brother in 2008 received a rare elbow implant paid by private insurance at one of the most highly respected medical facilities in the US. It failed after just 4 months and was unsuccessfully surgically “revised”.  He lives in constant pain.  Powerful prescribed painkillers have caused his teeth to disentegrate and fall out while he sleeps. He is in medical and legal purgatory.

He is just one of tens of thousands.  Federal public policy must change to alter the entitlement of the medical device industry.  Now the FDA clears these implants through 510(k) with no clinical testing and there is no post-market data that would expose the patient harm and prevent others from selecting the same failed treatment.  FDA patient representatives are not full voting stakeholders and patient advocates are restricted to speaking only at FDA Town Hall meetings for 5 minutes.  Patient-centered it is not.  

In fact, in yesterdays’ Star Tribune Eric Campbell a director of research at Harvard said “ the first thing people have to realize is that (the medical device industry) makes a product to sell a product.”  Patients/citizens wrongfully assume that regulation and science are driving these decisions.  PCORI research will help us all to make better decisions and the medical device industry will benefit from elevation of it’s reputation and products globally.

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!

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.

Insurance decision delayed is treatment denied for patients . . . profit for industry.

Link to Huffington Post story about insurance shenanigans that hurt patients/consumers.
Tom Wilson, CEO of Allstate, earned $9.3 million in 2010.

Insurance Claim Delays Deliver Massive Profits To Industry By Shorting Customers

First Posted: 12/13/11 05:24 PM ET Updated: 12/13/11 05:52 PM ET

WASHINGTON -- Unlike many other businesses, the insurance industry is bound by law to act in good faith with its customers. Because of their protective role in the lives of ordinary citizens, insurers have long operated as semi-public trusts. But since the mid-1990s, a new profit-hungry model, combined with weak regulation, has upended that ancient social contract.

"Claims has been converted into a money-making process," said Russ Roberts, a New Mexico-based management consultant and former business professor at Northwestern University who has studied the insurance industry's evolution from a service business to a profit-driven machine.

The change started when consulting giant McKinsey & Company sold Allstate and other leading insurance companies on a new system to boost the bottom line: Rather than adjusting claims the traditional way, which gave claims managers wide latitude to serve customers, insurers embraced a computer-driven method that produced purposefully low offers to claimants.

Those who took the low-ball offers received prompt service, while those who didn't had their claims delayed and potentially were reduced to bringing expensive lawsuits to fight for their benefits. As former Allstate agent Shannon Kmatz told the American Association for Justice, the trial lawyers' lobby, the strategy was to make claims "so expensive and so time-consuming that lawyers would start refusing to help clients." The strategy was dubbed "Good Hands or Boxing Gloves" by the consultants, riffing on Allstate's advertising slogan.

McKinsey, which was reportedly hired by Allstate in 1992, prepared about 12,500 PowerPoint slides to present its plan. The slides were introduced in litigation in 2005, when the insurer turned them over under a temporary protective order. David Berardinelli, a New Mexico-based trial lawyer who was working on the case, detailed the slides in his 2008 book, "From Good Hands to Boxing Gloves: The Dark Side of Insurance."

McKinsey's strategy put profits above all. One slide in the McKinsey presentation illustrated this philosophy by painting the insurance business as a zero-sum game: "Improving Allstate's casualty economics will have a negative economic impact on some medical providers, plaintiff attorneys, and claimants. ... Allstate gains -- others must lose."

Allstate has certainly gained: It made $4.6 billion in profits in 2007, double its earnings in the 1990s. The stunning increase, said Russ Roberts, came through "driving down loss values to an average of 30 percent below the actual market cost" -- that is, paying dramatically less on claims.

"An insurance company can make a lot of money on the small claims," said Jay Feinman, a professor at Rutgers University School of Law, "because if you save a few dollars on a huge number of claims, it's worth more than saving a lot of dollars on a very small number of claims."

Allstate is the best-known user of the McKinsey model, topping the list of the "Ten Worst Insurance Companies in America" published by the American Association for Justice. But Allstate's rise in profits has led most of the industry to adopt the same approach. McKinsey has worked with State Farm, another insurance giant, and other companies in redesigning their claims systems. Feinman cautioned in his book "Delay, Deny, Defend" that the two major names "are just the largest players in the industry ... [the ones] whose involvement with McKinsey & Company in the transformation of claims is the best documented."

Roberts told HuffPost that, by his estimate, the companies that take in 70 percent of total insurance profits in the United States now abuse their obligations to their policyholders. When Allstate CEO Tom Wilson earned $9.3 million last year, he was not even on the top 10 list of best-paid insurance executives, compiled by New York Law School's Center for Justice and Democracy. (The top 10 list was led by William R. Berkley of W.R. Berkley, who made $24.6 million in 2010.)

Yolande Daeninck, spokeswoman for McKinsey & Company, said, "In line with our firm's longstanding policy to not discuss our client work, we decline to comment."

A HOUSE BURNS DOWN

According to an unpublished Harris Interactive Poll conducted in September, 16 percent of surveyed adults have experienced financial hardship while waiting for an insurance claim to be settled or know someone who has. The same poll found that 59 percent of adults believe that most insurers intentionally delay claims -- and those with an income of $35,000 or less were more likely to agree.

With 15.3 percent of Americans -- about 46.2 million people -- living in poverty, close to 10 percent unemployment, and roughly 2 million people who've been looking for work for more than two years, Allstate's business model is profiting off many consumers at their most vulnerable. A claim delayed by even a month can spell financial disaster for a family. As a National Bureau of Economic Research study found, about 25 percent of Americans could not come up with $2,000 in a 30-day period.

Madeleine Burdette, a retiree, is an Allstate customer who reported her experience on the popular website AllstateInsuranceSucks.com. When her Georgia home burned in November 2010, Burdette was in Ohio, where she lives most of the year. She said the fire marshal in Georgia told her that her house would have to be torn down. "The entire middle of the house was gone," Burdette said. "It took out everything. Just the outside walls were left untouched."

The next day, she said, Burdette's Allstate adjuster told her the house could be repaired. Allstate also said it would have to do a thorough investigation to determine if the fire was caused by arson. If it was arson, the adjuster told Burdette, Allstate would not pay for any damages. According to former employees, such investigations are a common practice at Allstate and are encouraged by supervisors as a way to avoid paying claims quickly.

Burdette, who lives on her Social Security checks, flew from Ohio to survey the damage herself. While in Georgia, she contacted public adjuster Anita Taff. Public adjusters serve as advocates for individuals who feel they need another set of eyes on a claim. Taff met with Burdette at the house, Burdette said, and discussed the damage with the contractor Burdette had hired. Upon returning to Ohio, Burdette spoke with Taff over the phone to find out what her impression was. Burdette said Taff warned her that the contractor might go along with Allstate's insistence that the house could be repaired.

"I believe [delaying claims] is an effort to put the squeeze on policyholders," Taff told HuffPost. She explained that while a claim is being held up, the insurance company may stop paying the policyholder's additional living expenses, forcing the policyholder to cover mortgage and rent entirely out of pocket. "That's something that many people cannot afford to do, so they're forced to take a lower settlement," Taff said.

Burdette said she immediately called the contractor and told him not to go near her house. According to Burdette, she received a phone call within 10 minutes from her Allstate adjuster asking her not to hire Taff or any other public adjuster. "He said, 'If you hire a public adjuster, I'm going to deny and delay this claim for as long as possible,'" Burdette told HuffPost. Taken aback, she then asked if it wasn't in his best interest to settle the claim. "Not really," he replied, according to Burdette.

Although the Allstate adjuster eventually agreed to work with Taff on Burdette's claim, her troubles did not end. The contractor who had been banned from her property nevertheless worked on the house and billed Allstate for $22,000. Burdette had explicitly told Allstate not to pay the contractor a dime, she said, but the company paid him under her policy anyway. The contractor couldn't be reached for comment.

More than a year later, Burdette's home is still being repaired and Allstate refuses to reimburse the $22,000. She consulted four different lawyers to see if she had a legal case. While she said they all agreed that she was entitled to reimbursement, she said they also agreed that she lacked the funds to fight the insurance giant. "They told me, 'You'll run out of money,'" she said.

NO FLUKES

Roberts, the management consultant, said that companies like Allstate attempt to pass off claims delays as fluke occurrences. But, he said, they are actually routine and intentional products of the McKinsey system: "The Allstate/McKinsey system for 'lowballing' claims payments ... is driven by the claims performance management and pay systems from the top to the bottom of the organization."

Feinman, the Rutgers law professor, also suggested the deck is stacked against individuals who make claims. "You have an accident or a fire in your house. You call up the insurance company. You describe the circumstances. Maybe they send an adjuster out, and they say it's not covered, or it's covered but here's the dollar amount that we're obligated to pay you," he said. Most people, Feinman said, do not have the expertise "to know whether or not that's right."

Allstate spokeswoman Laura Strykowski said the company can't comment on specific cases because of privacy requirements, but considers its claims process both legal and effective. "Our customers and claimants receive prompt and courteous claim service and our goal is to settle each claim fairly and efficiently," she wrote to HuffPost. "As a regulated company, Allstate's claim practices are available to and regularly reviewed by state departments of insurance."

But experts like Feinman argue that insurance regulation has become little more than a fig leaf. State insurance departments are usually understaffed and overwhelmed. And even if they had the legal firepower to contend with giant insurance companies, Feinman said, "the regulators are closer to the industry than they are consumers." Eleven of the past 15 presidents of the National Association of Insurance Commissioners (NAIC) went on to work for the insurance industry after leaving office, while a 17-year study from two Georgia State University professors found that around half of state-level insurance commissioners did so as well.

When combined with penalties that Feinman described as "laughably low" in many states, this close relationship means that regulation does not provide an effective check on insurance companies. And state governments themselves have incentive to place consumers on the backburner. Because insurance taxes are a major source of revenue for the states, said Roberts, insurance oversight commissions are usually more concerned with keeping companies solvent than resolving the problems of policyholders.

With the exception of the federal Affordable Care Act, insurance is regulated on a state-by-state basis. Although most states set a specific timeline for how quickly an insurance company must initially respond to claims, there is much more leeway when it comes to settling those claims. For example, in Missouri, an insurer must acknowledge receipt of a claim within 10 days and either pay or deny it within 15 days of receiving all necessary documentation. However, if the insurer decides it needs more time to investigate, it may keep delaying as long as it updates the policyholder every 45 days. In Georgia, where Burdette's house burned down, the insurer must notify the policyholder if it will affirm or deny a claim within 60 days. However, the insurer does not have to settle the amount it will pay within that period. Many states have similar provisions that allow insurers to put off paying claims indefinitely.

According to NAIC data, claim delays have long been the most frequent cause of policyholder complaint. As of Nov. 28, 2011, the NAIC had received 11,053 delay-related complaints this year alone, comprising almost a quarter of the year's total complaints. These data only reflect confirmed complaints -- the ones that the state insurance commission has investigated -- so the actual number of delayed claims is likely much higher.

Complaining to state regulators about the insurer's delay is always an option, but its effectiveness is questionable at best. "I have not seen it be successful," said Taff.