Thursday, September 12, 2024

Statements by government agencies, medical organizations & medical experts re: handheld suction plungers marketed as choking rescue devices (Updated 9/21/24)


NOTE: To my knowledge, no medical organizations or resuscitation experts recommend devices of this nature. If I've oerlooked any, please email details to Peter.Heimlich@gmail.com and I'll include - PMH
 
I. GOVERNMENT AGENCIES

A. Federal

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication, April 22, 2024:
The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve the airway obstruction in choking victims.

These rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults. These protocols do not include anti-choking devices. The safety and effectiveness of anti-choking devices that are being sold over-the-counter have not been established; they are not FDA approved or cleared. Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols.
B. State

1) Health departments (in alphabetical order)

ILLINOISPre-hospital use of Anti-Choking Devices from Jason Kegg, MD, FAAEM, FACEP, CHSE IDPH EMS Medical Director Ashley Thoele, MSN, MBA, RN Division Chief, EMS and Highway Safety, July 6, 2022
IDPH has received requests for the use of suction anti-choking devices by EMS Provides thru their EMS System to be included as new pieces of equipment on their EMS vehicles.
In an effort to consistently provide safe, evidence-based, and data driven care to the people of Illinois, we rely on equipment that have stood the rigors of research and proven benefit including equipment approved by the FDA.

At this time, these devices (ex. LifeVac, DeCHOKER, etc.) are not approved for use by the FDA or by IDPH and if used, could delay treatments that have been shown to be effective. In addition, this device may cause serious injuries. We strive to operate based upon evidence, and not anecdote, and any such device shall not be stocked, deployed, or utilized on any emergency service vehicles licensed and operating with IDPH approved protocols.
MASSACHUSETTSUsing LifeVac Devices From Dr. Safdar Medina, Physician Consultant to MDPH School Health Services re LifeVac devices, June 8, 2023:
Over the past few months, many school districts have been contacted about the use of the LifeVac device during an acute choking episode. At this time, unbiased, peer reviewed data to support its use is lacking. The device is not approved by the FDA and has not been endorsed by the American Red Cross or the American Heart Association. The American Academy of Pediatrics, in 2021, published a statement warranting further research of use of LifeVac in resuscitation of pediatric choking victims if established protocols fail. Current Basic Life Support training provides the universally accepted choking guidelines for both the pediatric and adult populations.

Please also note that the LifeVac website states the device is "FDA Registered", which is not the same as FDA Approved. Please see the following link for an explanation of the difference: Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
NEW JERSEY: From Candace Gardner, Director, Office of Emergency Medical Services, New Jersey Department of Health to New Jersey EMS Community: May 2, 2023: 
The New Jersey Department of Health (Department) Office of Emergency Medical Services (OEMS) recognizes that there are several devices marketed to be used in the case of a foreign body airway obstruction (choking) in the community setting. Such devices include but are not limited to, Lifevac and Dechoker.

...OEMS does not endorse, nor approve of the utilization of these devices by pre-hospital health care providers (EMTs, paramedics, etc.) in pre-hospital settings or during non-emergency medical transports. As such, OEMS continues to endorse that pre-hospital providers follow AHA guidelines and the National EMS Scope of Practice for the management of foreign body airway obstruction appropriate to their level of training.
PENNSYLVANIA: Via EMMCO West (Emergency Medical Management Cooperative), March 25, 2022: 
EMMCO West, Inc. has been made aware that regional EMS agencies have been approached to use the Lifevac anti-choking device. The device has been reviewed by the PA Department of Health, Bureau of EMS, state medical advisory committee. It was identified that there are no published peer reviewed studies supporting the effectiveness and/or safety of this device. It is not recognized in AHA choking guidelines. It is NOT within the current PA scope of practice for EMS personnel. It is NOT authorized to be used by PA DOH licensed EMS agencies.

TENNESSEE: Anti Choking Device – CIC stated not approved for Ambulance use due to no FDA approval at this time. Will reevaluate upon FDA approval. 

WISCONSIN: Wisconsin EMS official approves anti-choking device as backup option, WITI News (Milwaukee), December 24, 2018:
A top state health official is giving emergency workers the green light use a new anti-choking device. The inventor said his design was inspired by a sink plunger...

“It may be a terrific device. We just don’t know,” said Marc Cohen, executive director of the Wisconsin Emergency Medical Services Association (WEMSA).

...That meant getting the approval of Dr. Riccardo Colella, state medical director for the EMS Division at the Wisconsin Department of Health Services.

The EMS Advisory Board makes recommendations to the Wisconsin Department of Health Services, but its recommendations do not required DHS to take any specific action.

...Dr. Colella stopped short of endorsing Lifevac, but did sign off on the concept.

“I think there’s not a lot of harm in using this. I think it seems fair to recommend the use of a product like this,” he said.
2) Child protective services

Pennsylvania Office of Childhood Development and Early Learning (OCDEL)The Use of Manual Airway Clearance Devices in Child Care Settings, November 22, 2021:
The Office of Child Development and Early Learning (OCDEL) received questions on the use of manual Airway Clearance Devices (ACD). OCDEL’s current regulation is that all child care staff employed in a child care facility are required to have training in pediatric first-aid and pediatric cardiopulmonary resuscitation (CPR). OCDEL recommends child care providers continued use of approved pediatric first-aid and CPR training.

Child care providers may wish to consult with their own legal counsel and insurance company before deciding whether to use an ACD in their facility. It is best practice for the child care provider to have policies and procedures in place to address parental consent.

Per the child care regulations, signed written parental consent is required prior to administration of minor first-aid procedures by facility staff and must be kept current. (55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5)).

If an ACD is used on a child, but the parent/guardian consent is absent from the child’s file, this will result in violation of the regulations at 55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5).

Parent/guardian are not required to provide consent if they don’t want this device used on their child while in care at the facility.
 

II. MEDICAL ORGANIZATIONS 

A. United States

a) American Academy of Pediatrics (Wisonsin chapter): July 20, 2023 letter in opposition to proposed legislation to supplying Anti-Choking Devices in Schools

Given there are no specialty societies (including The American Heart Association, The American Red Cross, and the 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care) that support the use of anti-choking devices, and that the American Academy of Pediatrics does not have a policy in place, we cannot advocate in favor of the use of these.

B. EUROPE


ILCOR member organziations:

a) UK: Does the Resuscitation Council (UK) recommend the use of airway clearance devices (ACD) in the treatment of the choking victim?, UK Resuscitation Council, January 2, 2018

b) Sweden: April 5, 2018 Swedish CPR Council report by Henrik Wagner MD PhD, Jan Gelberg MD, and Andreas Claesson RN PhD. Click here for the original Swedish version; click here for an English version via Google Translate

c) Spain: April 25, 2019 position statement by the Spanish Council of Cardiopulmonary Resuscitation. Click here for original Spanish version; click here for an English version via Google Translate

d) Republic of Ireland: March 31, 2023, position statement by the Emergency Medicine Programme and the Irish Association of Emergency Medicine


III. MEDICAL EXPERTS VIA MEDIA REPORTS & BLOGS (chronological order)

Clip from ABC7 Sarasota, FL, April 7, 2016 story by investigative reporter Kate Flexner, Sarasota Police Department using LifeVac anti-choking device




I’m a nurse and mom and this is what you need to know about anti-choking devices by Sarah Hunstead RN, Pediatric nurse and CPR Kids founder, New York Post, August 8, 2023



What’s an Anti-Choking Device and Does It Work? by Christine Giordano, MD, Reviewed by Mandy Armitage, MD, GoodRX.com, September 10, 2024

Saturday, June 1, 2024

It's "Heimlich Maneuver Day" - meanwhile Cincinnati's notorious Heimlich Institute continues to crumble


Today, our nation celebrates National Heimlich Maneuver Day - along with National Nail Polish Day, National Olive Day, and National Say Something Nice Day. 

As Sidebar readers know, the Heimlich Institute is a Cincinnati nonprofit which for decades circulated my father's deadly quackery: infecting patients with malaria to supposedly "cure" cancer, Lyme Disease, and AIDS; the Heimlich maneuver for drowning rescue, whose use resulted in dozens of poor outcome cases including children; the Heimlich maneuver to treat asthma and cystic fibrosis, and other frauds.

Therefore, in the spirit of National Say Something Nice Day, I have something nice to say about this vile enterprise. 

It's on life support.

From Letter from Henry J. Heimlich, M.D., published in the Winter 1998 issue of the Heimlich Institute's "Caring World" newsletter, here's some history (emphasis added):
The mission of The Heimlich Institute is "Benefiting Humanity Through Health and Peace." When Deaconess Associations Inc. invited the Institute to become affiliated and to move into the Deaconess Hospital complex, it brought together two organizations with the same goal – saving lives. Most meaningful for me is that the creativity of The Heimlich Institute research will now continue in perpetuity. Some say it will be for Cincinnati what the Pasteur Institute is for Paris.
From the same newsletter:

The work of one of the century’s most influential physicians will continue through a new partnership. In June, The Heimlich Institute became a member of Deaconess Associations Inc. Deaconess will assume responsibility for advancing and promoting the mission and vision of The Heimlich Institute in perpetuity.

Four years later, my wife Karen Shulman and I, along other determined critics, started chipping away at the dangerous scams being run out of the Heimlich Institute (HI), an effort that resulted in scores of mainstream print and broadcast reports.

Per this first-rate ABC7 Chicago expose by Chicago investigative reporter Chuck Goudie - in which "one of the century’s most influential physicians" hid behind my mother - by 2005 the HI was a shell; an empty office with no employees. 

Since then, it's been an "in name only" organization: no assets, no income, no nothing - except filing  near-blank annual IRS filings like this most recent 990-PF dated March 21, 2024.

In other words, "perpetuity" lasted less than seven years.

Here are the two remaining principals, my brother Phil Heimlich (a former high-profile elected official), and E. Anthony "Tony" Woods, the Cincinnati tycoon responsible for making the HI part of Deaconess Associations Inc. about 25 years ago.


Here's a good question.

Decades after the Heimlich Institute collapsed, why are they keeping this defunct organization alive, if only on paper?

Thursday, December 14, 2023

EXCLUSIVE: TN judge finds potential $10M+ judgement against notorious "snake oil salesman" Carrie Madej in negligence lawsuit brought by family of patient who died a "painful death" from "fatal dose of hydrogen peroxide"


From my April 17, 2023 exclusive, Notorious anti-vax doctor Carrie Lynn Madej sued by Tennessee couple, father's estate for malpractice, outrageous conduct, negligence:

Dr. Carrie Lynn Madej ("mah-day"), who McGill University's Office for Science and Society called "a menace to society," has been sued for malpractice, outrageous conduct, negligence, and other allegations. 

The lawsuit involves three patients she allegedly treated on December 5, 2021 in Morgan County, Tennessee, about 60 miles west of Knoxville. 

One patient died less than three weeks later.

...The complaint (click here to download) was filed February 27 in Tennessee's Ninth Judicial District Circuit Court individually by Jana Sutoova Bennun and her husband Steven Bennun, and on behalf of the estate of Ms. Bennun's father, Stefan Suto.  

Dail Cantrell (source)

According to plaintiff's attorney Dail Cantrell, yesterday in a Kingston, TN court Judge Mike Pemberton "ruled in our favor."

"The court determined that Ms Madej - she is not a doctor as her infomercials claim, she is a snake oil salesman - acted recklessly in injecting Mr. Suto with a fatal dose of hydrogen peroxide which resulted in Mr. Suto”s painful death.

"The Judge has requested some additional medical information in order to determine the amount of punative damages which I expect will exceed 10 million dollars.
 
"Ms. Madej is mobile fleeing from town to town but our plan is to use the punative damage award to seize the money she is hiding in trusts."

Mr. Cantrell informed me he'll have court orders in January. I'll post those ASAP.

Monday, June 5, 2023

In observance of National Heimlich Maneuver Day, Long Island doctors' group recommends disemboweling choking victims and other unorthodox treatments

source

source






The poster artist's identity and intent is unknown, but the zombie resembles my father, the late Henry J. Heimlich, MD, pictured here with his cousin once removed, actor Anson Williams, best known for playing the character Potsie on the TV sitcom Happy Days. (Anson is the son of my dad's first cousin, the late Haskell "Hal" Heimlich.")

source


Monday, April 17, 2023

EXCLUSIVE: Notorious anti-vax doctor Carrie Lynn Madej sued by Tennessee couple, father's estate for malpractice, outrageous conduct, negligence (UPDATE: Dr. Madej failed to plead/respond; Defendants file for default judgment)

UPDATE: According to the following May 9, 2023 court filing, after being served on March 27, Carrie Lynn Madej MD has "failed to plead or otherwise defend" against the lawsuit brought against her for allegedly administering "an intravenous injection of 500 mL of D5NS with 21 mL of 3% hydrogen peroxide" to three patients in Morgan County, TN, one of whom died a few weeks later.

As a result, the defendants have asked the court for a default judgment in their favor.

Per my original item (page down), Dr. Madej apparently considers herself a so-called "sovereign citizen." According to this 2011 statement:
The FBI considers sovereign-citizen extremists as comprising a domestic terrorist movement, which, scattered across the United States, has existed for decades, with well-known members, such as Terry Nichols, who helped plan the Oklahoma City, Oklahoma, bombing. Sovereign citizens do not represent an anarchist group, nor are they a militia, although they sometimes use or buy illegal weapons. Rather, they operate as individuals without established leadership and only come together in loosely affiliated groups to train, help each other with paperwork, or socialize and talk about their ideology.   
#####

Dr. Carrie Madej (right) immediately before she received service of process (page down or click here to download) for the lawsuit filed by the Bennuns. Madej was served on March 24 at the House of Restoration Worship Church in Milford, Ohio, where she was appearing at a so-called "Medical & Legal Truth" event hosted by the Salt and Light Brigade which according to Vice.com, is "a far-right group​ that aims to wage 'spiritual warfare' on behalf of Pass the Salt Ministries, which the Southern Poverty Law Center ​has previously identified as an anti-LGBTQ+ hate group."

Dr. Carrie Lynn Madej ("mah-day"), who McGill University's Office for Science and Society called "a menace to society," has been sued for malpractice, outrageous conduct, negligence, and other allegations. 

The lawsuit involves three patients she allegedly treated on December 5, 2021 in Morgan County, Tennessee, about 60 miles west of Knoxville. 

One patient died less than three weeks later.

According to a November 12, 2021 NBC News report by Ben Collins:
(Dr. Madej) is an osteopathic internal medicine doctor who has propagated a variety of debunked theories about the Covid vaccines and posted to Twitter about a variety of other conspiracy theories, including QAnon. She describes herself as “practicing the truth in Jesus through medicine.”

...(On) a podcast called “Reawaken America” she falsely claimed there is a “liquified computing system” inside coronavirus vaccines. She has also claimed the vaccines are a “gateway to transhumanism.” Her theories have been broadly fact-checked as false, including earning a “Pants on Fire” rating from Politifact.

The complaint (page down or click here to download) was filed February 27 in Tennessee's Ninth Judicial District Circuit Court individually by Jana Sutoova Bennun and her husband Steven Bennun, and on behalf of the estate of Ms. Bennun's father, Stefan Suto. 

From the complaint:

2. On or about December 5th, 2021, Mr. Stefan Suto was located at his home in Morgan County, Tennessee. He was feeling ill and had a fever. Steven Bennun and Jana Sutoova Bennun were ill with no fever.

3. On or about December 5th, 2021, Carrie Madej insisted that she come to the house and administer treatment.

4. On or about December 5th, 2021, Carrie Madej entered the residence and directly administered treatment without any medical history, medical treatment, laboratory results, and failed to take a medical history on any patient.

5. On or about December 5th, 2021, Carrie Madej directly administered to Stefan Suto a solution of 21 mL of 3% hydrogen peroxide and 0.5 mL of distilled water that was placed in a nebulizer to create an inhalable mist.

6. On or about December 5th, 2021, Carrie Madej directly administered to Stefan Suto, Steve Bennun, and Jana Sutoova Bennun an intravenous injection of 500 mL of D5NS 
with 21 mL of 3% hydrogen peroxide.

7. Immediately after treatment, Mr. Stefan Suto started to react adversely and experienced a rapid decline in health.

8. Steven Bennun and Jana Sutoova Bennun informed Carrie Madej that Stefan Suto's health was rapidly declining and requested further medical treatment. Carrie Madej refused.

9. Stefan Suto passed away on December 23, 2021. Steven Bennun and Jana Sutoova Bennun continue to suffer from the side effects of the harmful injections they received on December 5, 2021.

10. Plaintiffs would aver that Carrie Madej does not have a Tennessee medical license and yet practices medicine in the State of Tennessee.

11. Plaintiffs would aver that the Defendant failed to provide them with basic, appropriate, and necessary medical care and supervision.

12. Plaintiffs would aver that through the Defendant's actions, she significantly deviated from the accepted standard of care for healthcare professionals practicing within their respective specialties within the Morgan County community as it relates to the care provided to them.

13. Plaintiffs would further aver that the Defendant is guilty of the specific torts of negligence; outrageous conduct; and negligent and intentional infliction of emotional distress.

14. The Plaintiffs would further aver that the Defendant violated the medical malpractice laws of the State of Tennessee codified at T. C. A. 29-26-101, et seq., as evidence by the Affidavit of Sal A.D.'Allura, D.O., attached as Exhibit "A".

A search for medical licenses associated with Dr. Madej on the Tennessee Department of Health's website produced no results.

In an exclusive, I reported that on January 6 Dr. Madej had surrendered her Georgia medical license. 

According to a November 22, 2022 document attached to the complaint, the Bennuns' attorney, Dale R. Cantrell of Clinton, TN, sent a legal notifcation to Dr. Madej at ten different Georgia addresses with which she has been associated in Canton, Forest Park, McDonough, Symrna (two different addresses), Peachtree City, Atlanta (two different addresses), Jonesboro, and Locust Grove.

He received the following reponse (page down for the original letter or click here to download) which appears to be related to claims she made at timestamp 7:00 in a rambling podcast interview last month, Carrie Madej On Being A Sovereign Citizen:
Carrie Lynn of the house and lineage of Madej

Daughter of the God of Abraham Isaac and Jacob American Freewoman
Grantor in Original Jurisdiction and Beneficiary of the resultant Trust
Near Post Office Box 1234 Senoia Georgia America Republic

Everything is Trust and there is nothing that is not Trust
No Trust can fail for want of a Trustee
The primary responsibility of the Trustee is to protect the Trust

January 10 2023

Cantrell Law Office
Post Office Box 299
Clinton Tennessee 37716

Dail R. Cantrell,

I Carrie Lynn Beneficiary am responding to your letter dated November eleventh twenty-twenty-two.

Please make note that this is your one time courtesy notice to inform you that any further correspondence regarding the matter of concern as mentioned in your letter, must be forwarded to Matthew Norman MD Chairperson of Georgia Composite Medical Board Indentured Trustee who has accepted and retained custody of the legal person, the Doctor, of whom your letter is addressing. You may contact the Doctor and the Chairperson of the Board Indentured Trustee at
Georgia Composite Medical Board
2 Peachtree Street Northwest 36th Floor
Atlanta, Georgia 30303-3465
Any further communication, correspondence or actions taken against the Beneficiary will be an obvious mistaken identity.

Thank you

CarrieLynnBeneficiary
The Bennuns are seeking a jury trial, $10,000,000 as compensatory damages, and up to $5,000,000 as punitive damages.

It's not known if Dr. Madej has retained legal counsel.

 

Monday, April 10, 2023

President George W. Bush's son-in-law saved the life of a choking victim! Or did he? No one's talking

From Jenna Bush Hager reveals husband Henry saved woman’s life while choking at restaurant: ‘My hero’ by Lindsay Lowe, Today.com, March 9, 2023:


Jenna Bush Hager is calling her husband a “hero” after he jumped into action to save a woman’s life.

The incident occurred Wednesday night when Jenna and her husband, Henry (Hager), were having a quiet dinner at a restaurant with Henry’s mom.

Jenna said she was sitting with her back to the restaurant, while Henry sat facing outward.

“All of a sudden, he says, ‘That woman is choking!’” Jenna said. “He gets up, he runs over, and he gives a woman the Heimlich maneuver for, it felt like it was 10 minutes.”

Jenna said some other people came over to help as Henry continued to try to save the woman.

“He continued, and other men were helping him, and I could tell he thought it wasn’t working, and he was saying, ‘Guys, keep going, keep going, keep going!’” Jenna said. “And she survived. 911 arrived.”

For the past month I've tried to verify Ms. Hager's story by sending a couple dozen emails and leaving messages for various parties: Mr. Hager, senior producers at the Today Show, NBC's head of publicity; and the George W. Bush Presidential Center.

Henry C. Hager 

I simply asked for basic facts: the name and address of the restaurant; the date of the alleged incident; whether the Hagers knew the name of the alleged choking victim; whether they took selfies with anyone at the scene; and if they knew the name of the EMS crew that arrived.

The result was deafening silence - including from Ms. Lowe, the writer who bylined the Today.com item. (Page down for the unanswered DMs I sent her.)

The only response came from Andrew Kaufman, Director of Communications and Marketing at the Bush Center: 

Unfortunately, the best way to reach the Hagers are the methods you used – my powers are limited there.

Did the incident really happen? If not, it wouldn't be the first time a celebrity may have fabricated a dramatic choking rescue. 

For example, in 2012 here's what country star Luke Bryan told People Magazine:

I had a friend do the Heimlich on me last Monday in a pizza restaurant. It was pretty freaky there for about 30 seconds. A piece of flatbread pizza flaked off and got lodged in my airway, and I went down. He picked me up and got it out of there!

As Sidebar readers know, I reported a string of stories about my unsuccessul efforts to verify his claim.

The Bryana and Hager stories story raise an interesting point.

When a celebrity makes a dramatic, newsworthy claim on national television, do they have a responsibility to back it up?

As you might guess, I think they do. 

But I don't have the clout to compel powerful, connected people to respond to my questions. 

If someone out there does have the requisite swat and the Hagers (or Bryan, for that matter) provide the information I requested, I'll update this item with gratitude and without hesitation.






  




Wednesday, January 18, 2023

Keto influencer James "Jimmy" Moore sentenced to 20 years for three-month sexual abuse of a thirteen year old girl

James William Moore (source)


Moore lived in Spartanburg, SC and was charged in Henrico County, VA.

Here's a statement I received this morning from attorney Cynthia R. Micklem who prosecuted Moore on behalf of the office of the Henrico County Commonwealth's Attorney.
James Moore was sentenced to an active sentence of 20 years for carnal knowledge on January 13, 2023. Evidence showed that from September through December of 2019, Moore started a sexual relationship with a thirteen year old. She was the daughter of people he had met in his role as a “social media influencer.” The sexual abuse began on a joint family vacation with Moore and his wife and the victim’s family. After that vacation, Moore would drive from his home in South Carolina to wait outside the home of the victim. On multiple occasions, he would encourage the victim to sneak out of the house after her parents were asleep. Moore would engage in sexual acts with the 13 year old in his vehicle and eventually began taking her to a hotel.

Law enforcement obtained records of Moore’s conversations with the juvenile victim. The records  onfirmed the sexual abuse describing vaginal intercourse and sodomy. Among the sexually explicit messages to the victim, the messages also showed Moore manipulating the victim. Moore would repeatedly tell the victim that he was the only person in her life that cared for her. He would criticize her parents and other relationships creating distance between the victim and her family.

During sentencing, the Henrico County Circuit Court described Moore as being two people: one who is the well-educated community member who everyone sees as a good guy and second as someone who would describe “f- the brains out” of a thirteen-fourteen year old child. Someone who when the victim states she is feeling suicidal tells her “to get over it.” 

The judge sentenced James Moore to an active sentence of 20 years.
In response to my request, Moore's attorney - Aubrey Russell Bowles, IV of Richmond - chose not to comment.