Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, July 31, 2013

FDA: Preventable Patient Harm - to regulate or not to regulate?

Medical Devices

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Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes”.
The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers.

Date, Time and Location:

This meeting will be held September 18 and 19, 2013,  8:00 a.m. to 5:00 p.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Section A of the Great Room)
Silver Spring, MD, 20993


This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on September 11, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 12, 2013. If you have never attended a Connect Pro event, test your connection at To get a quick overview of the Connect Pro program, visit:

Preliminary Agenda

The agenda will be announced.

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by 4:00 p.m. on September 11, 2013.  There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
Attendance In-Person
    Mr. Mrs. Ms. None
 *  M.D.     Ph.D.
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* (No dashes or spaces in phone numbers please)
 *Do you wish to make a presentation?  Yes  No

Public Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to  The docket number is FDA-2013-N-0865. 

Workshop Details

Food and Beverages will be available for purchase during the breaks.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142,
For questions regarding workshop content please contact Mimi Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5437, Silver Spring, MD 20993-0002, 301-796-4125, email:
Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3623, Silver Spring, MD 20993-0002, 301-796-5427,

Saturday, July 20, 2013

10% of implants fail due to product material allergy

Denver hospital develops a blood test to protect against allergic reactions to hip and knee implants
BY NSIKAN AKPAN | MAY 15, 2013 12:35 AM EDT  FiDA highlight
A new allergy exam from physicians at National Jewish Health in Denver could prevent thousands of hip and knee implants from being rejected by their recipients. The procedure is presented in a study released today in the Journal of Allergy and Clinical Immunology.
Of the 1 million hip and knee replacements that occur each year, about 100,000 -- or 10% -- will fail because of an allergic reaction. Most reactions are caused by the metallic materials used in the implants or bone cement used in surgery.
The symptoms start shortly after the procedure.
"I had horrible itching and intense pain throughout my body," said Paula Spurlock, a patient at National Jewish Health who discovered she was allergic to her implant in 2011.
"I couldn't take it.  Every single thing in me itched."
Joint replacements are typically made from metal, plastic, or ceramic. Patients need to know if they have an allergy before they have surgery, so they can decide which type of implant to put into their bodies.
The current procedure for assessing metal allergies is to administer a skin patch test. A liquid mixture of the potential offending agent is wiped on a pad that is taped to the skin for approximately 72 hours. If a reaction occurs, then the person is allergic.
The main problem with the skin patch test is its duration. A person who has broken their hip, especially if they are elderly, is dealing with a serious medical emergency and may not have the 3 to 5 days that it takes to conduct a skin test. Plus some hospitals aren't equipped or staffed to perform the procedure.
The researchers decided to develop a simple blood test that could detect allergies to nickel, a common material used in joint implants. There are many advantages to using a blood test.
"First of all it's much easier," said lead author Dr. Karin Pacheco, an allergist at National Jewish Health. "You can send the blood in and it will get developed quickly, and you won't need to have somebody available who knows how to do the patch testing."
To validate its accuracy, they compared it in a side-by-side analysis to the skin patch test.
This innovative allergy exam could identify people with nickel allergies about 70% of the time relative to the skin patch test and had an accuracy of 98% at distinguishing people without allergies. 
While more analysis is needed, this new blood test could help thousands of patients in the coming years. More than 11,000 people a day are expected to have implant surgeries by 2030, so the demand, from a public health perspective, would be enormous.
The authors hope the blood test will be approved and widely used in the next couple of years. 

(use link above to access video)

Thursday, July 18, 2013

w00t! National Physicians Alliance October 19 & 20 in DC

2013 National Conference  FiDA highlight

MARK YOUR CALENDARS for the NPA 8th Annual Conference, Washington DC — OCT 19 & 20, 2013

“Leading the Way:  Courage & Innovation in Patient-Centered Reform

Plan to join NPA Members and friends from across the country in Washington DC to share energy, inspiration, and knowledge!

Keynote Address
Courage from the House of Medicine

Otis Webb Brawley, MD, Chief Medical Officer and Executive Vice President of the American Cancer Society

National Grand Rounds
Challenging the Selling of Sickness:
A partnership model for a new social health movement

Leonore Tiefer, PhD, clinical psychologist and author of Sex is Not a Natural Act (Boulder: Westview Press, 2nd edition, 2004)
and Kim Witczak, marketing consultant and patient advocate who became involved in pharmaceutical drug safety issues after the 2003 death of her husband as a result of an undisclosed drug side effect.  In 2008 she was appointed to the FDA’s Psychopharmacologic Drugs Advisory Committee as a Patient Representative.

2 special training sessions
with one of DC’s premier media teams:
KNP Communications

The Art of Persuasion
This core training has been provided to hundreds of Senators, Congressional Representatives, CEOs, and leaders of nonprofit and government organizations.
This session covers:
  • strategies for connecting with various audiences
  • an interactive overview of nonverbal cues
  • the uses of story
  • techniques for compelling Q+A sessions

Effective Messaging for Preventing Gun Violence

This training will cover messaging guidance on gun violence prevention that has helped to frame the public debate on this issue since the Newtown tragedy.  Key themes include:
  • the personal toll of gun violence
  • the right to be free from violence in our daily lives
  • the changing nature of military-style weapons
  • and effective responses to common attacks on issues such as the 2nd Amendment

Additional sessions will include:

  • Quality, Affordable, High Value Care Systems
  • Policy Making in Federal Agencies
  • Choosing Wisely:  Making It Happen
  • Skill building sessions:  How to do a radio interview and a Hill visit
  • Innovators’ Forum – a place to share your ideas
  • And more… Reserve your seat today!


Plan to join us in Washington DC, October 19-21, 2013

Stay over Monday, Oct 21, to join NPA members on Capitol Hill
and meet with your congressional representatives.


Conference Location

A Facility Owned and Managed by the American College of Surgeons
20 F Street, NW (near Union Station), Washington, DC,  20001
Directions -  Area Map

Hotel & Travel

NPA has reserved a limited number of hotel rooms at a special conference rate of $169/night plus tax at the Washington Court Hotel525 New Jersey Avenue NW, Washington DC 20001 (near Union Station)
Reservations must be made directly with  the hotel at
(202) 628.2100 or (800) 321.3010

*Be sure to specify that you are reserving as part of the National Physicians Alliance group.

Deadline for reservations at the conference rate is
Friday, September 20


Submit a Poster!

Are you doing exciting new research, implementing quality improvement, building a local network, or advocating for an important issue in your state or nationally?  Your NPA colleagues want to learn about it!  Submit your work to our 2nd annual poster presentation at the NPA 8th Annual Meeting, October 19-20, 2013 in Washington DC.  Click here for details.
Contact Becky Martin, NPA Project Manager, if you have questions or need additional assistance, or call 202/420-7896

22 THOUSAND Women File Lawsuit in Federal Court in West Virginia: FDA Covers Butt!

by Stephanie Beasley  FiDA highlight
Posted in FDA Week, June 27, 2013
 FDA’s launch of a new registry for controversial surgical transvaginal mesh products as part of a new program focusing on women’s health could signal the agency is planning to prioritize sex-specific device concerns, a consumer advocate said. However, sources said it is still unclear how FDA will tackle other women-specific issues, like a lack of women in device clinical trials, and suggested the agency could examine criteria used to exclude subjects from clinical trials that could be reducing the number of women able to participate in these studies.
FDA device center officials announced Tuesday (June 25) during a two-day workshop for the Improve the Health of Women program that the agency plans to launch a new transvaginal mesh registry that will monitor patient outcomes and collect data on the safety and effectiveness of the products. The agency partnered with the National Institutes of Health, the American Urogynecological Society and the American College of Obstetricians and Gynecologists on the initiative, which will begin enrolling patients later this summer.
“I’m happy to announce that the registry is ironing out its final kinks and will register its first patient in August of this year,” said Colin Anderson-Smits, an epidemiologist at the Office of Surveillance and Biometrics in FDA’s device center.
The Pelvic Floor Disorders Outcomes Registry will begin by collecting information on pelvic organ prolapse (POP) devices but could expand to other types of mesh products, he said. Enrolled patients will be contacted by the system every six months to complete patient-reported outcomes. The registry will also collect real-time safety reports.
Transvaginal mesh, which is used to repair weakened or damaged tissue, was approved as a class II low-risk device but an advisory panel recommended FDA upclassify the products in 2011 after the agency received a number of adverse event reports citing serious complications. The panel also said FDA should require manufacturers to conduct post-market studies of currently marketed products and pre-market studies for new transvaginal mesh products.
A consumer safety advocate called the registry “a step in the right direction” toward prioritizing sex-specific device concerns but said she was concerned that it will only collect data from new patients and not those already using the devices.
“If they start with new patients, it will take years before we get the information that we need,” said Diana Zuckerman, president of the National Research Center for Women & Families.
Data from new patients will allow researchers to have better information about the patient’s health before the device was implanted, which can be compared with later outcomes from the procedure, she said. But the registry would generate information about possible health outcomes much sooner if patients already using the devices were included in the registry. It will be at least five years before there will be any useful information from the registry, she noted.
Further, Zuckerman said she was concerned that no consumer safety or public health advocates had been asked to weigh in on the design of the registry.
“The fact that we were not included suggests that consumer groups and public health groups probably weren’t asked to participate,” she said.
Stakeholders said they would also like the new women’s health program to address the lack of pre- and post-market data for women in device clinical trials.
One researcher said strict clinical trial criteria for orthopedic devices that excludes patients over a certain body mass index could be detrimental to obese women seeking more orthopedic surgeries, and who are also at greater risk for complications and poor outcomes.
Nancy Lynch, founder of the consultancy service Advisorthopaedics Inc., said although women are more likely to undergo orthopedic procedures, and twice as likely to receive joint replacements as men, they are being excluded from clinical trials for the devices because of rigid exclusion criteria like body mass index.
Obese people are at greater risk for adverse events resulting from orthopedic surgeries and generally experience fewer long-term benefits from the devices, she said. That risk has been mitigated by using BMI to exclude patients from clinical trials, but by doing so researchers are also excluding large numbers of women and and some racial groups like blacks and Hispanics.
“Eighteen percent of women have a body mass index of 35 and greater and only 12 percent of men do,” she said. “Let’s overlap race on top of that. Twenty-nine percent of African-American women would not qualify for a trial. That’s pretty significant.”
Lynch said although body weight should be a consideration for orthopedic device trials, overweight patients are more likely to have musculoskeletal conditions like arthritis and utilize orthopedic devices more frequently. Obese patients seek orthopedic treatments ten years earlier and undergo joint replacement surgeries seven years earlier than patients of normal weight, she said.
Lynch also said women of childbearing age are underrepresented in orthopedic device trials because of restrictive, long-term imaging requirements, which is a concern because 43 percent of the U.S. population is between the ages of 21 and 44 and women make up half of that number.
Zuckerman, who has long pushed for the inclusion of more women in clinical trials, said the issue was another example of how FDA has lagged behind other federal agencies like NIH that already require diversity in clinical trials. FDA should require the inclusion of women, people of various ages and obese people in these studies, she said.
“This is a bigger issue, ” she said. “It’s an issue of FDA being reluctant to require the kind of diversity that they need in these trials. FDA needs to be forceful and clear about who they expect to be in these clinical trials.” – Stephanie Beasley

Sunday, July 7, 2013

Medtronic ignores patient harm for profit. Justice?

                Article by: JIM SPENCER , Star Tribune Updated: July 6, 2013 - 8:24 PM
Constitutional concept, device law and Supreme Court rulings stymie suits.
WASHINGTON – Hundreds of people who say they’ve been harmed by a Medtronic spinal device are pursuing a new legal pathway around rulings that have kept them from getting a day in court.
They argue that the Food and Drug Administration, which approved limited use of the Infuse bone growth product in 2002, offered a 2008 warning to doctors about “life-threatening complications” from unapproved applications. Then, the Spine Journal in 2011 and the U.S. Senate Finance Committee in 2012 each harshly criticized Medtronic for allegedly paying physicians hundreds of millions of dollars to write scholarly articles about Infuse while editing those articles to downplay Infuse’s dangers.
Yet for all the claims of poor performance, dangerous outcomes and shoddy scholarship, Infuse has never been the subject of a personal-injury trial because of a legal concept called “pre-emption.” That means federal law takes precedence over state law. The Supreme Court has extended this premise to say that almost no one can sue for damages caused by medical devices that received premarket approval from the FDA.
Now, hundreds of new lawsuits — including dozens in Minnesota — aim to find a way around that obstacle by accusing Medtronic of illegally promoting uses of Infuse that differ from what the FDA specifically approved.
If the allegation is upheld, legal experts say the world’s biggest medical device maker could find itself awash in settlements or judgments that could push the entire medical device industry into a new era of corporate liability.
“The cases are important,” said Prof. David Prince of the William Mitchell College of Law. “The whole area of law certainly doesn’t make sense, especially to consumers.”
Medtronic declined a Star Tribune request for an interview, but issued a statement that denied any wrongdoing and disputed “any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the [Senate] report, or that Medtronic intended to under-report adverse events.”
Landmark case
Judges have ruled that pre-emption requires them to throw out Infuse cases before a jury hears evidence. Their decisions are based on a landmark 2008 case, Riegel vs. Medtronic, in which the Supreme Court ruled that patients generally are forbidden from suing device manufacturers because that would let state courts trump federal regulators who review clinical test results and let devices onto the market.
In the case of Infuse, however, patients’ lawyers think they have found a way to get to trial by linking Medtronic to so-called “off-label” uses that the FDA did not approve.
Doctors can legally use devices in off-label applications, and federal health statistics show that Infuse is used off-label 85 percent of the time. Jennifer Fuson, a spokesman for the American Association for Justice, said a critical question is who is responsible “if you are injured by a product that was used in a way not approved by the FDA?”
The Department of Justice dropped a criminal investigation of Medtronic’s off-label promotion of Infuse without explanation in May 2012 and did not respond to a request for comment.
In a statement, the FDA declined to say if it has investigated the promotion of Infuse.
“Promotional materials are unlawful if they promote an unapproved use for the product; contain claims relating to the dosing, safety or effectiveness of the product that are inconsistent with the approved labeling; or if they lack a fair and balanced presentation of information, i.e., of benefits and risks,” the agency said.
In a December 2012 report, the Senate Finance Committee claimed that Medtronic employees, including some in the marketing department, wrote, edited and otherwise influenced the content of scholarly articles about Infuse written by doctors who were collectively paid $210 million by Medtronic from November 1996 through December 2010.
A spokesman for the Finance Committee declined to say whether Chairman Max Baucus, D-Mont., thought Medtronic violated any regulations or laws. “The editing of the journal articles and large payments to the authors of those articles raises troubling questions about whether Medtronic crossed the line regarding off-label promotion of Infuse,” the spokesman said.
Lou Bograd of the Center for Constitutional Litigation said the overwhelming off-label use of Infuse suggests that promotion is going on. Doctors are free to use medical devices any way they see fit, he acknowledged, but in this case more than eight in 10 uses are not FDA-approved.
“[It] defies credibility to say it’s just doctors deciding to do this on their own,” Bograd said. “Medtronic engaged in a false, misleading promotional campaign.”
Bograd argued this point to Hennepin County District Judge Laurie Miller in May in what could become an influential case nationally.
Minneapolis lawyer Stuart Goldenberg, Bograd’s co-counsel, represents clients in 35 Infuse cases in Minnesota who will be affected by ­Miller’s decision. Goldenberg said he has “hundreds more” suits that might be filed.
In the Hennepin County case, Medtronic’s lawyers denied off-label promotion of Infuse and argued that none of the 35 Minnesota plaintiffs has the right to sue.
“Many [cases] have already been dismissed based on the pre-emption doctrine established in Riegel,” Medtronic said in its statement to the Star Tribune. “We have a number of defenses for these cases, including pre-emption, and will stand behind our product and vigorously defend it in court.”
Conflicting opinions
Miller’s decision is expected this summer. It will add to a handful of conflicting lower-court opinions that almost everyone believes will eventually end in a Supreme Court decision.
Prince also believes the issue “cries out for federal legislation.”
“Off-label promotion is prohibited by federal law, but state law could also prohibit it,” he said. In that case, a personal injury law suit might be allowed to go forward. But the courts have thus far “confused this by going off in all directions.”
On June 18, a two-year, $2.5 million Medtronic-funded comprehensive re-analysis of all past Infuse research showed that the bone growth product did not perform as well and had more adverse effects than Medtronic-sponsored researchers had said.
The only use of Infuse that has received FDA approval is to implant it through the front of an adult’s body to help recovery from lower-back spinal fusion surgery and then only if the bone growth factor is constrained in a specific brand of cage.
Otherwise, studies show that unwanted and potentially dangerous bone growth can occur and cancer risks may arise, said Dr. Eugene Carragee, editor of the Spine Journal. Carragee devoted the June 2011 issue to a scathing critique of the Infuse research that Medtronic sponsored.
Carragee said he took on Medtronic because its sponsored research results differed so markedly from research the company did not pay for and because of Medtronic’s influence on the content of scholarly articles.
Still, that may not rise to the level of off-label promotion.
“Manufacturers can send representatives to medical conferences and say, ‘Doctors A, B and C used the device in this way,’ ” said Prince. Doctors can also write about off-label device use in scholarly journals. “That’s not considered promotion.”
Ron Goldman could be the first lawyer in the country to actually get an Infuse off-label-promotion case before a jury. The Los Angeles attorney persuaded a judge there to let his client go to trial. The case is set for November, although Goldman expects a delay.
“Underlying all the legal mumbo jumbo,” he said, “we have people who are severely injured.”

Jim Spencer • 202-383-6123