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.
Twitter: JjrkCh

Wednesday, November 30, 2011

Lawsuit: Public Citizen represents patients' right to criticize dentist.

PUBLIC CITIZEN PRESS RELEASE:
For Immediate Release:                                                                Contact: Angela Bradbery (202) 588-7741
Nov. 30, 2011                                                                                                       Dorry Samuels (202) 588-7742
 
Requiring Patients to Give Up Right to Criticize Medical Practitioners Is Unconscionable, Lawsuit Says
 
Public Citizen Represents Maryland Man in First-of-Its-Kind Suit Against New York Dentist
 
WASHINGTON, D.C. – A New York dentist’s requirement that patients sign a contract agreeing not to criticize her is unconscionable, and the dentist should be prohibited from forcing patients to make such a promise in the future, Public Citizen said in a lawsuit filed late Tuesday.
 
The suit highlights a growing trend: doctors and dentists conditioning medical care on patients promising not to post negative comments about them online. The pledges are contained in paperwork that patients must sign before the doctor or dentist will see them. Public Citizen represents Robert Allen Lee, a Huntingtown, Md., resident and former patient of the New York dentist, Dr. Stacy Makhnevich.
 
A North Carolina company called “Medical Justice” sells forms containing these conditions to medical providers, marketing the forms as an effective way to prevent negative comments that may have an adverse effect on their practices. Medical Justice has been quoted as claiming that about 3,000 doctors and dentists use its products, including these forms. This lawsuit is believed to be the first over the provision restricting criticism. 
 
Moreover, the provision the dentist required the patient to sign in the case purported to give the dentist ownership of the criticism through a copyright clause. And Makhnevich has claimed that by posting criticism online, Lee was violating the copyright clause and so owes Makhnevich $100 a day.
 
“What began as a case of a sore tooth is now showcasing an unconscionable practice in which doctors and dentists force patients to leave their constitutional rights at the office door,” said Paul Alan Levy, the Public Citizen attorney representing Lee. “If people are upset about their care, they have a First Amendment right to tell people about it – by going online and posting their thoughts on Yelp, Facebook, Twitter and the like.”
 
The case began in October 2010, when Lee developed a severely sore tooth. The next month, he went to Makhnevich, whom he selected because the practice was covered by his insurance. Before he could be treated, he was handed forms to sign. One of them required Lee to agree not to publish any commentary about the dentist, not to disparage the dentist and to assign copyright to the dentist for any commentary that Lee wrote. Lee was reluctant to give up his right to publish commentary, but he was in severe pain and so signed the form.
 
Makhnevich billed Lee $4,766 for the dental work performed. Lee paid and asked the dentist to send the necessary paperwork to his insurance company, but the dentist sent the information to the wrong insurance provider. Lee then asked for his records so he could submit the claim himself; Makhnevich refused and instead referred Lee to a third party that demanded five percent of the total bill for copying the records.
 
In August 2011, Lee criticized Makhnevich on Yelp, DoctorBase and other online sites. The dentist then sent Lee a letter warning that Lee had violated the agreement and threatened to sue Lee for breach of contract and copyright infringement. The next month, Makhnevich contacted Yelp and DoctorBase and demanded Lee’s comments be removed. The review sites refused to remove the comments, because they regard purported copyright assignments as legally unenforceable. Makhnevich then sent invoices to Lee for $100 a day for copyright infringement in September and October, and sent another letter threatening to sue Lee.
 
This suit, which seeks class-action status, contends that the agreement Lee was required to sign is unconscionable and should be declared null and void. Further, requiring patients to surrender the right to publish truthful criticism violates medical practitioners’ duty to patients because they are placing their own interests above those of their patients. In addition, the agreement misuses copyright law to suppress expression.
 
“It is outrageous that a patient would have to sign away his constitutionally protected right to get treatment for a toothache,” Lee said. “I have to wonder what this dentist’s other patients have said to make her feel it was necessary to go to this extreme.”
 
Bruce Keller and Jeffrey Cunard of the New York-based law firm Debevoise & Plimpton LLP are co-counsel with Levy in the case.
 
 

25% of an orthopedic surgeons' income may be from device industry payments!

Link to article on study evaluating device industry payments to surgeons.

From Medscape Medical News

Some Orthos Getting 25% of Salary From Device Makers

Ricki Lewis, PhD
 
 
October 25, 2011 — Analysis of data on payments from orthopaedic device manufacturers to orthopaedic surgeons before and after a Department of Justice (DOJ) investigation illuminates a complex situation that requires further analysis, concludes a report published in the October 24 issue of the Archives of Internal Medicine.
Jason M. Hockenberry, PhD, now from the Rollins School of Public Health at Emory University, Atlanta, Georgia, and colleagues examined the information. The DOJ case considered payments for consulting, royalties, and research support, excluding reimbursement of travel costs.
In 2005, the DOJ began investigating payments made to surgeons providing hip and knee implants from the 5 manufacturers that sell 95% of these devices: Biomet Orthopedics, DePuy Orthopaedics Inc, Smith & Nephew plc, Stryker Orthopaedics, and Zimmer Inc. The 2007 settlement required the companies to disclose on their Web sites the name, location, and fees paid to each physician. Only DePuy, Smith & Nephew, and Stryker continued to post data through 2010.
In 2007, 939 orthopaedic surgeons received 1041 payments exceeding $198 million. In 2008, after the settlement, 526 orthopaedic surgeons received 568 payments totaling more than $228 million, but this figure fell to $119 million after subtracting a 1-time royalty buyout payment from Zimmer. Mean payments to orthopaedic surgeons were $212,740 in 2007, $193,943 in 2008, $246,867 in 2009, and $233,108 in 2010, which would make up at least 25% of a surgeon's annual salary. Payments ranged from less than $25,000 to more than $1 million, and the decline in number disproportionately reflected smaller disbursements.
Representation by academia showed a "modest increase" from 39.4% in 2007 to 44.9% in 2008, a percentage maintained in 2009 and 2010. This trend, the authors suggest, could reflect a strategy to target surgeons who train other surgeons. Yet Hockenberry and colleagues also note that more than 25% of the surgeons receiving industry money had fewer than 2 publications, indicating perhaps that industry is also targeting high-volume practices, in which presumably surgeons would have little time to conduct studies or write articles.
The physicians in the DOJ investigation represent only about 4% of the 25,000 orthopaedic surgeons in the United States. Although the settlement required that physicians disclose their relationships with device makers to patients, the authors cite studies suggesting that such payments might "interfere with physician judgment and pose a threat to scientific integrity and patient trust."
Limitations of the study, the authors write, include inconsistencies in categorizing payments and continued disclosure by only 3 firms. In addition, points out Robert Steinbrook, MD, from the Yale School of Medicine, New Haven, Connective, in an invited commentary, "the public data provide no information about how the payments relate to research and device development."
Dr. Hockenberry and colleagues conclude that, "universal and detailed disclosure with standardized reporting formats and data elements would make these data more useful to patients, providers, and policymakers." Because the Patient Protection and Affordable Care Act requires public disclosure of gifts and payments from drug and device industries to physicians, such practices will soon be more transparent.
Dr. Hockenberry and one coauthor received funding from the Department of Veterans Affairs. The coauthor also received support from the National Institutes of Health and the Robert Wood Johnson Physician Faculty Scholars Program, and consulted for Consumers Union and Vanguard Health. None of these sources provided support for this article. Dr. Steinbrook has disclosed no relevant financial relationships.
Arch Intern Med. 2011;171:1759-1766. Abstract


Thursday, November 17, 2011

Mayo Clinic Elbow Replacement "opportunity".

Link to Mayo Clinic YouTube video about elbow replacement.

It takes a mighty good joint replacement to be better than no joint replacement at all.  Joint replacements are now the #1 expenditure of Medicare.

Where is the scientific evidence?  There is no public accessible post-market registry.  No plan to care for patients with the 20% or so failed joint replacements.  No legal requirement for the surgeons to notify the FDA of adverse events.  No warranty on product.  Cleared through 510(k) process that the IOM Institute of Medicine 7/29/11 stated does not protect the patient from unsafe and ineffective joint replacements.  Patient representatives/consumer representatives are restricted from full voting stakeholder position on FDA orthopedic medical device advisory panel.  Aggressive marketing direct-to-consume and no transparency in surgeons' financial incentives from the medical device industry.  How is this patient-centered?

Wednesday, November 16, 2011

'Occupy Health' Protesters at the Chamber of Commerce DC/Blue Cross

Link to 5 minute video of peaceful occupation on 11/14/11




Sadly, it has come to this . . .  healthcare is a "profit center" and an "industry" for the Chamber of Commerce.  Health care leaders do things FIRST, not necessarily ethically.

Respect must be earned.


Leadership is doing it first.  Wisdom is knowing the right thing to do. Integrity is doing the right thing. Character is doing it in the face of adversity. Grace is doing it even though the recipient appears undeserving.  
Servant-hood is doing it even if it's "below your pay grade". Generosity is doing it with no expectation of reward or acknowledgement.

Monday, November 14, 2011

Failed implanted medical devices-Senate hearing Tuesday 11/15/11

Click here to view video of Steven Baker's comments.


Hello.
My name is Steven Baker.   These are my comments to be presented to the
November 15, 2011 - 2:30pm Senate Health, Education, Labor and Pensions full committee on Medical Devices: Protecting Patients and Promoting Innovation.

Have any of you heard of the 1950’s radio/TV show ‘Truth or Consequences’?  The medical device industry lobby is playing the game ‘NO Truth and NO Consequences’ with Congress.  Congress is enabling this industry to fleece the taxpayer of essential and limited healthcare funds and endanger patients and their families for profit.  You must change Federal public policy.

On October 5 - ten years ago - I was a valued 23-year union millwright, proud Air Force veteran and father of two middle school children living on Cardiff Lane, less than a mile from Republican Congressman Erik Paulsen’s Minnesota 3rd district office.  That day I was offloading a clients’ catalog printing press to be compressed at a scrap yard when another worker’s mistake pushed me - forcing me to fall four feet down into the scrap.  My right arm was badly mangled.  Seven surgeries and 8 years later, it was clear that I could not return to the work I loved and I reluctantly began receiving SSDI for my permanent injury.  My surgeon recommended that I consult the Mayo Clinic because there was a new innovative elbow joint replacement option that would reduce pain and increase function. 

The Tornier Lateral Elbow prosthesis was surgically implanted in my right arm on May 19, 2008. It was paid for by private insurance covering my work injury.  The healing process went well for several weeks, but then I noticed that - during movement - it would make a popping or creaking sound. Early in September 2008 in a phone conversation, I told my sister, Joleen Chambers, that the elbow was blue/green and I was in extreme pain.  She was so concerned that she took it upon herself to fax the Mayo Clinic.  On September 29, 2008 the prosthesis was surgically “revised” just 4 months after the original implant.  The surgeon designer told me he would re-attach the radial stem to the head, but both components were removed and confiscated for 1 year.  I asked the doctor to report the adverse event to FDA MedWatch.  He didn’t.  On November 18, 2008, number #5009052 was assigned to my self-report.  Freedom of Information FOI reported March 4, 2009 that the file could not be located.  There was no investigation.

I am now in medical and legal purgatory.  The private insurance company is balking at paying for another surgery, I am in extreme and constant pain, the elbow does not function, my teeth are falling out because I have been prescribed long-term, maximum dose hydrocodone pain medication which dries the mouth, producing cavities that weaken my teeth so much that they disintegrate & disappear as I sleep.  Tornier declines to help innovate a custom device solution.  The Mayo Clinic sent me a letter stating that no care other than federally mandated emergency care would be provided.

I have done all the normal things an enlightened and empowered patient could do.  I have tried to communicate first with my doctor, the hospital patient affairs office, the trustees of the Mayo Clinic, my U.S. Congressman Erik Paulsen, the U.S. Senators Al Franken and Amy Klobuchar and the FDA.  All this I have done while disabled, medically impoverished and in pain. 

Too late, I learned that medical devices are not properly regulated.  Implanted medical devices should be given the most rigorous scrutiny, yet they are
cleared through the 510(k) process that on July 29, 2011 the IOM-Institute of Medicine-reported should be scrapped.  There is no clinical testing prior to clearance and no national independent, robust post-market registry to show that innovations are any improvement over no surgical implant device or the ones that are currently available!   Legal entitlement of the medical device industry conflicts with patient’s individual civil rights.  My Mayo Clinic surgeon was the designer of the device and he also is paid to train other doctors by that device company-contrary to Mayo stated policy of having only salaried physicians on staff. 

Joint replacements are now the #1 expenditure of Medicare. The life cycle of medical devices from inception to FDA clearance to market to surgical implant excludes the patient stakeholder.  Patients/consumers and their advocates should be full voting partners in this endeavor.  Marketing, politics and lobbying currently drive decisions by practitioners, purveyors, and payers in selecting what they anticipate to be life-enhancing implanted medical devices.  Experience, data and science are evaded and suppressed.

On May 28, 2009 I had an appointment with Representative Paulsen.  He and his staff offered me no constituent services and the meeting was brief.  The revelation that he is spearheading the effort to eliminate medical device industry Medical Device User Fees clarifies his cavalier attitude about the failed implanted medical device that brought me to his office.  My elbow was produced by Tornier, a company with its’ world headquarters just 6 short miles from his office.


Because of my disability I must leave my family and my life-long home in Minnesota each winter to avoid the painful cold and dangerous icy conditions.  

Valuable jobs in the medical device industry will be secured only by a regulatory system that truly rewards safe and effective innovation.  I am a big fan of innovation and proved it by twice trusting Tornier, the surgeon/designer and the Mayo Clinic with my life.  My advice to this committee:  halt this dangerous game of NO Truth and NO Consequences.  Properly regulate this industry.

Contact :
Steven Baker 952.261.5204
Joleen Chambers
1717 Arts Plaza #2109
Dallas, TX  75201
h 214.965.9730
m 214.394.4432
Blog: 
Failed Implanted Medical Devices  
Video: 
Twitter:  @JjrkCh




Friday, November 11, 2011

The monkey is being punished for the organ grinder's offense.

Failed public policy by Congress has put in motion an aggressive and powerful medical device industry unfettered by consequences.  Joint replacements are the #1 expenditure of Medicare.
Watch the Senate HELP Hearing on Medical Devices  2:30P Tuesday, November 15, 2001

Salisbury stent doctor sentenced to federal prison.
Cardiologist falsified patient records to justify unnecessary procedures

By Tricia Bishop, The Baltimore Sun
7:43 p.m. EST, November 10, 2011
John R. McLean, a Salisbury physician, was sentenced to eight years in federal prison Thursday, making him the second cardiologist in the country to face incarceration for implanting unnecessary coronary stents in dozens of patients, then fraudulently billing insurers thousands for the work.
A Louisiana doctor was sentenced to 10 years in prison in 2009 under similar allegations. And a half-dozen other physicians, including Towson's Dr. Mark G. Midei, are accused in civil lawsuits of overusing stents, though they have not been charged criminally.
"I conclude, sadly, that this was a crime of greed," U.S. District Judge William D. Quarles Jr. said of McLean's actions, which include falsifying patient records at Peninsula Regional Medical Center to justify the expensive procedures, then prescribing gratuitous follow-up tests for months afterward.
He was ordered to spend 97 months in prison, forfeit $579,000 in illegal proceeds and to pay the same amount in restitution to the public and private insurers he illegally billed. His lawyer plans to file an appeal and will ask that McLean, who was ordered to report for prison in February shortly after his 60th birthday, be allowed to remain free until the matter is resolved.
The sentence stunned his family, some of whom sobbed throughout the lengthy hearing, and sent a message about the "seriousness" of the crime, Quarles said.
Improper stenting has been a focus at the state and national levels over the past several years after Midei, a star cardiologist at St. Joseph Medical Center, was accused of implanting the tiny mesh tubes in hundreds of people whose arteries didn't need them. The allegations led to national media attention, a U.S. Senate inquiry, a multimillion-dollar settlement from the hospital and a debate in the medical community about the role of a physician's judgment in medical care.
Supporters of the embattled cardiologists — many of them stent patients — contend that the physicians are making sound calls based on certain symptoms. But malpractice attorneys, and in some cases prosecutors, say the doctors are overdoing the relatively simple procedures — which typically cost about $10,000 — driven by money and their egos.
McLean's desire to be the "biggest and the best cardiologist" at PRMC drove him to perform the unwarranted procedures, said Assistant U.S. Attorney Sandra Wilkinson.
"There's just some arrogance there," Wilkinson said. "At the end of the day, he made a lot of money, but he also made a really good reputation for himself."
McLean was indicted last year on charges he ran the fraudulent stent scheme from 2003 through 2007, when he resigned his practice privileges at PRMC after a hospital investigation. He was convicted this summer of health care fraud and of making false statements, and PRMC agreed to a $1.8 million settlement afterward to settle claims it did not put a stop to the improper procedures.
Several patients who received improper stents testified during the trial, according to court papers.
One man said he nearly died from blood loss after being required to take blood thinners. Another patient said she had a heart attack, brought on by the dye used in the procedure, while on the operating table.
"These people are looking to their cardiologists almost as if they're a god … we're talking about [their] hearts," Wilkinson said. "They're thinking that Dr. McLean is saving their life when really he's just looking for an opportunity."
McLean insisted he never meant to hurt anyone.
"I've worked hard all my life," he told the judge, characterizing himself as a perfectionist who lived for his practice, spending every other night on call for a decade and missing many of his daughter's milestones. The young woman, now 25, wiped away tears as he spoke.
"I never ever did anything intentionally dishonest to a patient," he said, denying that money drove him to do wrong. "I did the best I could, I always did the best I could."
He called himself a "broken man" and ticked off a list of ailments, including diabetes, vision problems and a previous heart attack. He said his mother is elderly and begged the court for "leniency and mercy" in sentencing.
His lawyer, Richard W. Westling, said he feared McLean would die in prison if forced to serve a lengthy term.
Quarles noted that McLean, a Baltimore native, had never been in trouble before, and commended him for the many good works he has done. Some of his supposed victims wrote letters to the court praising the doctor for saving lives and doing excellent work.
He "has done many positive things," Quarles said before sentencing him. "It's also clear that Dr. McLean implemented medically unnecessary stents for the basest of reasons … largely for the money."
Louisiana cardiologist Mehmood M. Patel, who was sentenced to 10 years in prison in 2009 after being convicted of 51 counts of fraud connected to improper stents, is also appealing his conviction and is free on bond. Arguments were heard in Patel's appeals case Tuesday.
Westling said he will be watching closely for the outcome.
tricia.bishop@baltsun.com

Thursday, November 10, 2011

National Women's Health Network speaks out on failed dangerous medical device implants.


Dear Friends,

Yet again the health and safety of women are taking a backseat to corporate interests
! You’ve heard from us before about terrible harm done to women by dangerous – like
 devices breast implants and weight loss devices – that the Food and Drug Administration (FDA) has approved without adequate research to demonstrate that the products are safe and effective.  Now the House of Representatives is considering 10 bills that would further weaken the FDA’s standards for medical devices. The changes proposed by the leadership of the House Energy and Commerce Committee would: 
  • restrict what questions the FDA can ask the manufacturer about a new device
  • require the FDA to review devices faster without allowing adequate time to review safety concerns
  • change the FDA’s mission, tilting the balance away from protecting public health
Medical device manufacturers claim these changes are needed to foster innovation.  But the NWHN believes that innovative medical devices have to be safe and effective, and they should address unmet health needs.  If these bills become law, many more people would be exposed to untested devices that may be ineffective or dangerous.  Innovative products that harm patients, will do no good for women’s health.

The experience of the millions of women who have been hurt by dangerous devices shows that the standard for approving medical devices is already too low.  In many cases a company doesn’t even have to prove that a new device is safe and effective to be allowed to market it – all they have to do is prove that it is similar to a device already on the market.  Congress needs to make the FDA’s standards for medical devices stronger – not weaker -- and to encourage the agency to do a better job monitoring what happens to the devices it has approved.

Contact your Representative
 and urge them to protect women’s health by opposing these 10 bills and supporting legislation that would raise the standard for device approvals and provide the FDA with the authority it needs to conduct adequate post-market safety surveillance.


Thank you,


Cindy Pearson
Executive Director
P.S. Be sure to "Like" us on Facebook and follow us on Twitter to keep up with the latest women's health news.
National Women's Health Network
PH: 202.682.2640 | FAX: 202.682.2648 | For health information: 202.682.2646
1413 K Street, NW, 4th floor, Washington DC 20005
www.nwhn.org

Wednesday, November 9, 2011

FDA fee for 90% of device applications is less than $5K

The FDA requires adequate industry financial support for essential regulatory protections.

The Patient, Consumer, and Public Health Coalition Priorities:
Medical Device User Fee Act (MDUFA III) Reauthorization

Every five years, the FDA’s user fees for prescription drugs and
medical devices must be reauthorized, and that legislation has to pass
because the FDA could not survive without it.  Negotiations between
the medical device industry and FDA on the medical device user fees
have been contentious this year.  If device companies keep refusing to
significantly increase user fees over the next 5 years, patients will
be harmed.
User fees improve staffing and resources needed to ensure the safety
and effectiveness of millions of devices that we all rely on, such as
contact lenses, mammograms, artificial knees, and tests for HIV and
cancer.  However, the user fees should be used to improve the ability
of the FDA to ensure safety and effectiveness, not just to speed up
the review process.  When the FDA lacks resources to do its job well,
it means more recalls, which are bad for patients and companies.  For
example, recent recalls of dangerous hips will cost billions of
dollars for replacement surgery paid by Medicare, Medicaid, VA, and by
individual taxpayers.  Recalls also mean red ink for companies and job
losses for employees.
We support legislative and regulatory efforts to bring safe and
effective devices to market as quickly as possible. However, ensuring
proof of safety and effectiveness is the most important mission of the
FDA.  Careful review and clear, consistent FDA policies ensure that
new medical products will be beneficial to patients and consumers as
well as the companies’ financial health.
More than 90% of medical devices are not required to be proven safe or
effective in clinical trials, and instead are reviewed through the
510(k) process, which is much less rigorous than the approval process
for medications.  The recent Institute of Medicine report on medical
devices stated that the 510(k) process should be replaced because it
does not determine that a device is either safe or effective.  It
notes that 510(k) approval decisions are based on their substantial
equivalence to devices already on the market—which were also not
necessarily proven safe and effective.  The report also concluded that
the process “does not reward innovation” and it can’t be determined if
the process “has had a positive or negative effect on innovation.”
Given the FDA’s lack of resources and pressures from industry to
quickly approve devices, the Agency will not revamp the 510(k) process
in the near future.  We therefore recommend incremental changes based
on the IOM recommendations and other reports.
For MDUFA reauthorization, we support reforms that:
Strengthen the standards for approval, such as requiring clinical
trials for implanted devices
Create a unique ID system for medical devices, similar to the one
for cars and toasters
Improve the adverse event reporting database for devices (called
MAUDE)
Review direct-to-consumer (DTC) advertising before it can be used,
to ensure accuracy
Revamp the de Novo process, but not as a substitute for a PMA for
higher-risk devices.
We oppose efforts to weaken the conflict-of-interest rules for
advisory committee members.
User fees for medical devices are dramatically lower than user fees
for drugs.  The FY2012 user fees for more than 90% of device
applications, including artificial hips and knees and many cardiac
devices, is $4,049 per application (less than half of 1% of the cost
of a drug application). The largest companies currently pay user fees
of $220,050 for the most complicated life-saving device applications,
which is 12% of the same company’s user fees for prescription drug
applications ($1,841,500), and about 20% of what the device review
actually costs the FDA.  Smaller companies pay much less in user
fees.  As a result, FDA lacks the resources it needs to review device
applications in a timely and comprehensive manner, and to require the
clinical trials that are needed to assure the safety of all implanted
devices. Congress must ensure that the FDA has the appropriations it
needs, and device user fees must make a more equitable contribution.

Monday, November 7, 2011

FDA report: Adverse events grew 17%, the medical device industry grew by 9%

Report: Growth in Medical Device Adverse Events Outpaces Industry Growth

The medical device industry grew 9 percent annually from 2001-2009, but serious adverse events — death, life-threatening condition, disability or hospitalization — grew 17 percent during that same time period, according to an FDA report.

The report also found cardiovascular, in vitro diagnostic and general hospital/surgical devices accounted for 60 percent of all adverse events reported. Twenty of the 1189 active product codes accounted for 65 percent of all serious adverse events reported between 2005 and 2009.

The report is part of an FDA initiative with the Center for Devices and Radiological Health to assess and understand gaps in medical device quality and create a plan for improvement.

"Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency's regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA's regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative," the report said.


Saturday, November 5, 2011

My brother was told that his FDA MedWatch #5009052 file could not be located.

FOIA Freedom of information Act  answers may include lies.

POGO Project On Government Oversight

Nov 04, 2011

Did Your FOIA Request Really Not Exist--Or is That Just What the DOJ Told You?

By DANA LIEBELSON
The Department of Justice (DOJ) came to its senses on Thursday and scrapped a controversial proposal that would model the Freedom of Information Act (FOIA) on the first rule of Fight Club. Then it backpedaled by saying it has actually been misleading FOIA requesters about the existence of certain documents for the last nearly 25 years--the proposed rule would have just put the practice into its regulations.
The nixed rule revision, which was originally proposed by the DOJ in March 2011, would have empowered agencies under DOJ—like the FBI and Drug Enforcement Administration—to tell FOIA requesters that some excluded records don’t exist—even when the record do, but are excludable under FOIA (like in the case of certain sensitive law enforcement and national security files.)
Unsurprisingly, this sparked backlash from a number of good government groups, several of whom said that the proposal was tantamount to authorizing the government to lie to U.S. citizens. At the request of POGO and allies, the DOJ reopened the comment period on the propose rule. 
Senators from both sides of the aisle also objected. In a strongly worded letter to Attorney General Eric Holder, Senator Charles Grassley (R-IA) said that the proposal stood “in stark contrast to both the President’s and your prior statements about FOIA, transparency and open government.”
In response to the media uproar that ensued, the DOJ dropped the proposal and issued a letter of response to Sen. Grassley—and that’s where things start to get interesting.
Since the 1970s, the DOJ has been allowed to issue the judicially-recognized “Glomar response” to FOIA requesters, which says that the DOJ can neither “confirm nor deny” the existence of a document in the interest of national security, and with an explanation. This rule came about in 1976, when the American mogul and press magnet, Howard Hughes built a ship, The Glomar Explorer, that was used by the CIA to search for a sunken Soviet submarine. When a hungry journalist caught whiff of the story and made a FOIA request, the CIA told her they could neither “confirm nor deny” the existence of the records—and the response was upheld in court.
But in the letter the DOJ sent to Sen. Grassley, Assistant Attorney General Ronald Weich pointed out the DOJ also has been following another policy since 1987, based on guidance issued by Attorney General Edwin Meese. This memo—which  was certainly not well known—says the same thing as the dropped proposed rule: “A requester can properly be advised…that ‘there exist no records responsive to your FOIA request.’”
Weich denied that this was equivalent to lying, adding that "When a citizen makes a request pursuant to the FOIA, either implicit or explicit in the request is that it seeks records that are subject to the FOIA…where the only records that exist are not subject to the FOIA, the statement that 'there exist no records responsive to your FOIA request' is wholly accurate."
The DOJ says they proposed the rule in an effort to make this “past practice more transparent.”
 The reality is that it’s still misleading and undermines the purpose of FOIA. According to a comments submitted sent by POGO’s allies in open government, ACLUCREW, and OpenTheGovernment.org, the practice is also problematic because it thwarts appeals and judicial review for obtaining the documents.
“Few reasonable requesters would litigate FOIA denials where their requests were denied on the grounds that no documents exist, because as far as they would know there would be nothing for a court to compel the government to disclose,” the groups wrote.
Though as it turns out, there may be a slew of new appeals of responses that records do not exist—as requesters from the past quarter century become aware that they may in fact exist.
Some groups have suggested that instead, DOJ simply acknowledge a FOIA request, but say the documents are not subject to disclosure requirements.
Angela Canterbury, POGO’s director of public policy, said “While it’s promising that the DOJ finally agreed to throw out this absurd proposed rule, it is disturbing to learn that they have had a practice of lying to requesters for nearly 25 years. Until that policy changes, there is more for DOJ to do to restore the integrity of FOIA and the administration.”
However, Canterbury is optimistic that the DOJ can find a way to be factual, but also protect national security and law enforcement investigations.
Senator Patrick Leahy (D-VT) offered this statement:
For five decades, the Freedom of Information Act has given life to the American value that in an open society, it is essential to carefully balance the public’s right to know and government’s need to keep some information secret.  The Justice Department’s decision to withdraw this proposal acknowledges and honors that careful balance, and will help ensure that the American people have confidence in the process for seeking information from their government.
 Dana Liebelson is POGO's Beth Daley Impact Fellow.