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

Tuesday, July 15, 2014

Consumers Union Press Release: Establish a National Patient Safety Board


     
Posted 07/15/14 at 8:53 am
News ReleaseConsumers UnionPublic Policy and Advocacy Division of Consumer ReportsTuesday, July 15, 2014
Patient Safety Advocates Urge the Creation of a National Patient Safety Board to Fight Medical Errors
Consumers Union’s Safe Patient Project to Highlight Need in Senate Testimony

WASHINGTON, DC – A network of patient safety advocates is urging Congress to take steps to improve patient safety by preventing hospital acquired infections and other preventable medical errors. The group, which includes Consumers Union, the policy and advocacy division of Consumer Reports, recently sent a letter to House and Senate lawmakers calling for the establishment of a National Patient Safety Board and additional Congressional committee action to improve the quality and safety of care.
Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said, “Hundreds of thousands of people enter the hospital each year for treatment of one ailment, but end up losing their lives due to another. Millions more survive but often after substantial health and financial losses.  Efforts to eliminate these preventable errors and infections must be stepped up to address this crisis – the third leading cause of death in the U.S.”
McGiffert will highlight the need for a National Patient Safety Board and other efforts to improve hospital safety in her testimony at a Senate Health Subcommittee hearing on Thursday, July 17. The proposed safety board would be modeled after the National Transportation Safety Board (NTSB) and investigate instances of medical harm. The hearing, More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety,” is scheduled to begin at 10am.
“We’re calling on Congress to create a National Patient Safety Board to ensure that we investigate medical harm cases properly and institute preventative measures to protect consumers. Just as the NTSB has made our airline industry safer for passengers, a National Patient Safety Board would improve the quality of care in hospitals and elevate patient safety by significantly reducing patients’ injuries and deaths from preventable medical errors,” said Yanling Yu of Washington state, lead organizer of the Congressional letter.
Medical harm is now the third leading cause of death in the United States. Reports show that one out of four hospital patients is harmed by adverse events. At the national level, it is estimated that as many as 440,000 patients die each year from preventable medical harm, including 75,000 deaths from hospital-acquired infections alone. And according to a recent Commonwealth Fund report, the U.S. ranks at the bottom among 11 advanced countries both on aggregate score and many individual health care measures such as outcomes, quality, and efficiency.
To read the full letter, click here or visit www.SafePatientProject.org. For more information on the Senate Subcommittee hearing, visit www.Help.Senate.gov.
###

Media contact:  Kara Kelber, kkelber@consumer.org202-462-6262

Thursday, July 17: Senate Meeting on 1000 PREVENTABLE deaths a day:patient safety



Date:
Thursday, July 17 2014, 10:00a ET, 9:00a CT, 7:00a PT
Place:
430 Dirksen Senate Office Building
to view via livestream on July 17 go to the link above with the meeting announcement or:
CSPAN 2 (U.S. Senate) on cable TV
check Senator Bernie Sanders website www.sanders.senate.gov
@SenSanders
Witnesses
Panel I
         John James, PhD , Founder, Patient Safety America, Houston, TX 

         Ashish Jha, MD, MPH , Professor of Health Policy and Management, Harvard School of Public Health, Boston, MA 

         Tejal Gandhi, MD, MPH , President, National Patient Safety Foundation; Associate Professor of Medicine, Harvard Medical School, Boston, MA 

         Peter Pronovost, MD, PhD , Senior Vice President for Patient Safety and Quality and Director of the Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, MD 

         Joanne Disch, PhD, RN , Professor ad Honorem, University of Minnesota School of Nursing, Minneapolis, MN 

         Lisa McGiffert , Director, Safe Patient Project, Consumers Union, Austin

Committee:
Subcommittee on Primary Health and Aging
Democrats by Rank
         Bernard Sanders (I) (VT)
         Barbara A. Mikulski (MD)
         Kay R. Hagan (NC)
         Sheldon Whitehouse (RI)
         Tammy Baldwin (WI)
         Christopher S. Murphy (CT)
         Elizabeth Warren (MA)
                  Tom Harkin (IA) (ex officio)
Republicans by Rank
         Richard Burr (NC)
         Pat Roberts (KS)
         Lisa Murkowski (AK)
         Michael Enzi (WY)
         Mark Kirk (IL)

                  Lamar Alexander (TN) (ex officio)

Lady Parts, Greg Abbott and JNJ Deceptive Trade Practices Mesh Up


By Amy Silverstein
Published Fri., Jul. 11 2014 at 7:08 AM


Future Texas Governor Greg Abbott hates nothing more than he hates abortions, Planned Parenthood and other women's-health-related things, leading the Texas Democratic Party to describe him as "public enemy number one for women in Texas." But now, in a major national fight pitting women's health advocates against a corporate giant, Abbott appears to have jumped in bed with women and their bodies.

For the past two years, the Texas Attorney General's office has been quietly leading an investigation into Johnson & Johnson's Ethicon subsidiary, after thousands of women nationwide alleged in lawsuits and complaints to the FDA that the company's pelvic mesh products are defective.
As I reported in a recent feature story on mesh, Ethicon and other companies thought they'd discovered a new, easy way to cure poor bladder control and similar health ills common in aging women and women who have had babies. The fix, rushed to the market in the late 90s, is a surgical device made out of plastic surgical mesh, inserted through the vagina. Patients have complained en masse that the "fix" destroyed their sex lives, worsened their incontinence and caused horrendous pain. More than 17,000 lawsuits have been filed against Ethicon alone.
The FDA was slow to respond, but in 2011 regulators finally issued a warning that complications from some of the mesh surgeries are "not rare." The FDA has yet to issue a formal recall.
Abbott, meanwhile, is investigating Johnson & Johnson under the Texas Deceptive Trade Practices-Consumer Protection Act. In a demand letter sent in April, the Attorney General asked Johnson & Johnson for physical samples of the mesh, detailed data on the material it's composed of, a list of all websites sponsored by Johnson & Johnson discussing the mesh and other data. That's only the latest request for information, following up on a separate demand the Attorney General sent in March 2013. The whole investigation began two years ago, the AG's office tells Unfair Park.
The investigation became public after a group of Texas women wrote a letter to Abbott asking him to crack down on the company, only to find out that he's already looking into it, as WFAA reported.

Women's health aside, Texas and other states have its own reasons to investigate this. "You, as a tax-payer, you're paying for the Medicare patients who have had this thing in," Dr. Daniel Elliott, a surgeon at the Mayo Clinic who treats women suffering mesh complications, told us a few months ago. "Then the patient has all these complications, and you as the taxpayer are paying for their original surgery and you're paying for all these treatments afterwards. It's a huge financial burden on the system."

Friday, July 11, 2014

J&J $100,000 conflicted FDA panel member on morcellator device?


JjrkCh
#morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas: http://t.co/L3HoWtjxeO
7/10/14, 8:06 AM

JjrkCh
#morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial. http://t.co/AklVXmrvfx
7/10/14, 8:09 AM


http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

Doctor Quits Uterine-Device Safety Panel Over Conflict
Move Comes Before Hearing on Cancer Risk From Morcellation Procedure


By JENNIFER LEVITZ And JON KAMP CONNECT
Updated July 10, 2014 3:25 p.m. ET
SILVER SPRING, Md.—A member of an independent panel weighing the safety of a medical device that can spread cancer in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he had accepted from a device manufacturer, the agency said Thursday.
San Francisco gynecologist Andrew Brill removed himself from the 16-member panel before two days of hearings on the device were set to begin Thursday, an FDA spokesman said. Dr. Brill didn't respond to requests for comment.
In 2013, he received nearly $100,000 in consulting fees from Ethicon, a Johnson & Johnson JNJ -0.08% subsidiary that is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The advisory panel is expected to make a recommendation to the FDA about whether morcellators, used in an estimated 50,000 hysterectomies a year, should be more tightly regulated or even used at all.
"The FDA has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings. During the course of the agency's review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings," an FDA spokesman said.
The Wall Street Journal first asked the FDA and Dr. Brill about the consulting fees on Tuesday after comparing publicly released names of the members of the panel with a list of paid consultants on J&J's website and other public documents. The agency declined to speak until Thursday morning.
J&J, the only manufacturer that releases names of its paid consultants, said Dr. Brill has done professional education consulting for them in their women's health and energy businesses and that he is a recognized leader in the field.
At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website and other public documents. The FDA declined to release its own disclosure statements submitted by panel members, citing privacy laws for advisory-committee members.
Michael P. Diamond, a Georgia gynecologist and acting chairman of the FDA panel meeting on morcellators, was previously a consultant for Ethicon and received a grant from the company, he said Thursday in response to a question from the Journal. He declined to say the amount he received.
Keith Isaacson, a Boston gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. His work for the company has been as a "professional-education consultant," a J&J spokesman said. A spokesman for Dr. Isaacson wasn't available for immediate comment.
Both doctors remain on the panel.
Laparoscopic power morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy, so they can be removed from the body through small incisions. But in some instances, the devices can spread a rare but dangerous cancer that masquerades as benign fibroids.
The risk had been known for years but was believed to be extremely small. In April, the FDA said the risk was higher than previously thought and discouraged doctors from using morcellators while it considered a more permanent position on the tools.
The hearing drew a crowd of patients, relatives, doctors and industry representatives.
"Because morcellation upstaged her cancer, Elizabeth never had a chance," Joanne Jacobson told the panel about her sister, who died from cancer in January 2013 following a morcellation procedure, according to her medical records.
JoAnn Trainer urged a ban on cutting tissue inside the body while speaking on behalf of her daughter Amy Reed, a Boston physician whose post-morcellation cancer case triggered alarm that led to this week's meeting. Dr. Reed, sitting in the audience with her family, plans to speak Friday.
The head of the influential American College of Obstetricians and Gynecologists argued that taking away morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as bleeding and infection. "It is unacceptable that in an effort to avoid one risk, we subject women to another," ACOG Chief Executive Hal C. Lawrence III told the panel.
J&J halted all sales shortly after the FDA advisory in April. Piet Hinoul, vice president of medical affairs at J&J subsidiary Ethicon and a gynecologist, told the panel the company stands by this decision until there is consensus in the medical community about how to mitigate the risk.
He also argued against tougher regulation, which the panel is expected to discuss Friday. Dr. Hinoul urged instead efforts to better identify women who could be more at risk of harboring cancer. The cancer can't be reliably detected before surgery.
Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp at jon.kamp@wsj.com



Thursday, July 10, 2014

PUBLIC COST of J&J surgical mesh: will TX Attorney General act?

FIDA Highlight
Post Date
June 25, 2014




June 25, 2014                         
By Facsimile:  512-275-2994


The Honorable Greg Abbott

Office of the Attorney General

State of Texas

300 W. 15th Street

Austin, TX  78701


Dear Attorney General Abbott,


As survivors of pelvic mesh implants and Texas taxpayers, we request that your office immediately begin investigating whether Johnson & Johnson (JNJ) should be held liable for expenses incurred by the state as a result of dangerous and defective pelvic mesh implants. Johnson & Johnson is the largest producer of pelvic mesh implants in the world. This product is creating a health crisis among women across the state of Texas, which in turn is resulting in significant costs to the state’s public health systems.   

Specifically, we ask for you to investigate Johnson & Johnson and its CEO Alex Gorsky for criminal violation of the Texas Penal Code pursuant to Sec. 32.42 of the Deceptive Business Practices Act for the corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction.

 The pelvic mesh industry also should be held accountable to the Texas State treasury for those funds spent for pelvic mesh-attributable costs to the Medicaid Program, the State Employee Retirement System, the State Employee Group Insurance Program, and charity care.

 The State of Texas also operates a number of health care facilities that provide medical care to qualifying persons who are not eligible for Medicaid, including state hospitals and university health science centers. The State of Texas pays for all or part of this care. The State of Texas has expended and will continue to expend substantial sums of money due to the increased cost of providing health care services for treatment of pelvic mesh-related injuries. 

This request follows the recent revelation by a West Virginia court that Johnson & Johnson destroyed numerous documents relevant to lawsuits filed against the company by thousands of women across the United States who have been seriously injured by the company’s pelvic mesh implants [1].   

It is critical that the Texas Attorney General’s Office pursue this matter to recoup the state taxpayer dollars Medicaid and other public health systems have been and will be forced to spend to treat women who have been injured.  

Only the Texas Attorney General, not consumers, can bring suit under the statute’s broad prohibition of deceptive acts.

 Action by the state attorney general will also demonstrate that a major U.S. corporation should not destroy evidence in judicial proceedings.  The destruction of this evidence undermines our ability as Texas women who have been hurt by Johnson & Johnson to receive justice.


Background 

In the last few years, medical device manufacturers including Johnson & Johnson have come under fire for marketing dangerous medical devices, drugs and other consumer products, often without receiving proper regulatory approval.  Many of these companies, including Johnson & Johnson, have paid billions of dollars in fines in litigation and settlement costs and made repeated pledges of reform, yet continue to display an indifferent attitude toward the harm they have caused as well as a willingness to evade the law.

 Currently, Johnson & Johnson faces thousands of product liability lawsuits relating to the company’s pelvic mesh implants, marketed most commonly as treatment for pelvic organ prolapse and stress urinary incontinence. There are estimated to be hundreds of thousands of women that have been – and continue to be – implanted with these dangerous products. Women have suffered severe pain and injuries due to these ineffective and dangerous implants.

 Investigations into the pelvic mesh products produced by several companies, including Johnson & Johnson, date back to before October 20, 2008, when the FDA first issued a Public Health Notification [2].   

Beginning in March 2005, Johnson & Johnson sold one of its most popular devices, the Gynecare Prolift, without alerting the Food and Drug Administration for three years. When the FDA was made aware of the Prolift device, the agency informed Johnson & Johnson that the device required government approval [3].  In May 2008, the Prolift was cleared for sale under the 510(k) process under the claim of “substantial equivalence” to devices already on the market. It had never been rigorously tested nor demonstrated effective in clinical trials [4].  

Further indicating Johnson & Johnson knew how harmful pelvic mesh implants were but nevertheless continued marketing the defective product to unsuspecting women, the company destroyed thousands of documents regarding the implants.  Although top company executives initially denied it, a magistrate judge found that Ethicon, the wholly owned subsidiary of Johnson & Johnson that manufactured the implants, destroyed documents pertaining to their effectiveness and safety as far back as 2007 [5].  Alex Gorsky, the current Chairman and CEO of Johnson & Johnson, was named head of Ethicon in 2008, before most of the documents were destroyed, and has continued to oversee it in his climb through the company’s ranks [6].


Apparent Violation of Law

 The pelvic mesh industry led by Johnson & Johnson and its CEO Alex Gorsky may be in criminal violation of Texas Penal Code pursuant to Sec. 32.42 of the Deceptive Business Practices for both his corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction. 

The Texas Attorney General’s Office has the sole authority to conduct a comprehensive and thorough investigation into whether Johnson & Johnson, in the course of advertising, soliciting, selling, promoting and distributing pelvic mesh implants, has engaged in a course of trade or commerce that constitutes deceptive business practices and is therefore unlawful under the Texas consumer protection laws by misrepresenting the safety of pelvic mesh implants. 

Johnson & Johnson also may have violated Texas Case Law pertaining to destroying physical evidence in an official proceeding [7].  After initial denials by top executives and their counsel, it is now clear that Johnson & Johnson destroyed thousands of documents related to Ethicon’s development and marketing of pelvic mesh implants [8]. 

The fact that Johnson & Johnson conducts business throughout Texas only adds to the importance of your office pursuing this matter. 

Johnson & Johnson is one of the world’s largest corporations whose products are used throughout Texas.  This investigation is urgently needed as the lives and safety of so many women in Texas and elsewhere depend on it.

 Please do not hesitate to contact us if we can provide any further information.  Thank you for your consideration.  


Sincerely,


Janet Holt – Floresville, TX
Kimberly Fox – Dallas, TX
Diana Coleman – Lavernia, TX
Debbie Mitchell – Red Oak, TX

Donna Hart — Pointblank, TX
Texas survivors of pelvic mesh implants.


[1] Consolidated case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).
[7] Wal-Mart Stores, Inc. v. Johnson, 106 S.W.3d 718, 722 (Tex. 2003) and Sec. 32.47 of the Texas Penal Code


addendum: 
The 9 other states include California, Colorado, Florida, Illinois,  Maryland, Ohio, Pennsylvania, South Carolina,Washington State

JjrkCh
Texas Attorney General http://t.co/opGrIxRIBu #ptsafety #MedX #TEDMED #fda #s4pm
7/8/14, 5:39 PM

Monday, July 7, 2014

States probe failed implant deceptive marketing: Settlement in Oregon with J&J

By Karen Gullo Jul 2, 2014 4:20 PM CT

Johnson & Johnson (JNJ) will pay Oregon $4 million to resolve deceptive marketing claims over recalled metal-on-metal hip implants in its first accord with any governmental unit involving the devices.
While the sum is dwarfed by J&J’s earlier settlement of patient lawsuits linked to the ASR hip, the agreement may lead the way for additional accords as federal and multi-state probes continue into the company’s sales of the device.
“Oregonians in need of a hip replacement deserve to know that the artificial hip they are contemplating in fact has the qualities, and benefits, that a company advertises,” Oregon Attorney General Ellen Rosenblum said in a statement. “Doctors also need to know that the products they suggest to their patients meet certain standards.”
Oregon is at the forefront of the investigations, Rosenblum said. A group of state attorneys general is investigating how the hips were marketed, while the U.S. Justice Department and the U.S. Attorney’s Office in Massachusetts are probing whether the company made false claims or false statements about the devices to federal health care programs, J&J said in a May regulatory filing.
Oregon began looking at the implants in 2011 and opened an investigation about a year before a multi-state probe began, state Assistant Attorney General David Hart said in a phone interview. J&J’s DePuy, the maker of the devices, began settlement discussions with state officials after they prepared a civil complaint, he said. DePuy sold 432 metal-on-metal, chromium and cobalt hip devices in Oregon from 2005 to 2010, according to Rosenblum.
Unfair Practices
The payment to the state resolves claims that the company violated Oregon’s unfair business practices law by telling patients and doctors that the hips functioned properly when evidence showed they were failing at unusually high rates.
“If other government entities obtained similar payments from DePuy based on the number of devices sold, it would be a very large number and significant deterrent,” Hart said. He declined to comment on the multi-state probe.
DePuy didn’t admit wrongdoing under the agreement, Mindy Tinsley, a DePuy spokeswoman, said in an e-mail, declining to comment on the probes.
J&J has voluntarily turned over documents responding to “informal” U.S. requests for information related to the hip device and is fully cooperating with the government’s civil investigation, the company said in the May regulatory filing.
Patient Suits
The company last year said it would pay at least $2.47 billion to resolve thousands of lawsuits over the implants. The agreement resolved about 8,000 U.S. suits against DePuy brought by patients who have already had artificial hips removed.
The New Brunswick, New Jersey-based company recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years.
J&J had touted the metal-on-metal implants, first sold in the U.S. in 2005, as a new design that would last 20 years and offer greater range of motion.
As failures mounted, patients complained in lawsuits that the implants caused dislocations, pain and follow-up surgeries known as revisions. They claimed that debris from the chromium and cobalt device caused tissue death and increased metal ions in the bloodstream.
To contact the reporter on this story: Karen Gullo in federal court in San Francisco at kgullo@bloomberg.net

To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net Fred Strasser, Stephen Farr