Monday, March 26, 2018

"Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive

Via Anti-choking device business raided, accused of investment scheme a March 12, 2018 investigative report by Matthew Grant, FOX46 Charlotte, NC:
State investigators raided the Concord, NC office of (Dechoker LLC) last month seizing computers and financial records accusing the business of running an "investment scheme," according to the search warrant and other state records.

The company is accused of raising more than $2 million by defrauding more than 80 investors, mostly from North Carolina. The company did not have a license to work in the state or sell securities but did both illegally, according to the North Carolina Secretary of State.

...(Dechoker inventor Alan) Carver later pointed to a blog post on his website.

"Dechoker is a small organization with growing pains that all companies go through," the post reads.

I. Technical Precision Plastics (Mebane, NC) vs. Dechoker LLC, case no. 17CVS1088, Alamance County (NC) Superior Court, June 6, 2016 complaint:






II. Christopher Kellogg c. Dechoker LLC, case no. 16-CI-005356, Jefferson County, KY Circuit Court,10/26/16 plaintiff's complaint & 12/21/16 defendant's response:




Via FDA approves new lifesaving device based out of Louisville by Ann Bowdan, WLKY News (Louisville, KY), October 30, 2015:
(Recently) the Food and Drug Administration approved a new device being touted as an alternative method to the Heimlich.

The alternative device is called the Dechoker, and its headquarters is right here in Louisville.

"The Heimlich works on positive pressure and we work on negative pressure, or suction. In other words, it's a vacuum,” Dechoker CEO Christopher Kellogg said.

The concept for the Dechoker came while Navy Captain Alan Carver was taking a first aid course with his fellow seamen.

"They're 200 miles off the coast and the instructor says, ‘If the Heimlich doesn't work guys, then there isn't anything else,’” Kellogg said.

...Kellogg set up shop in Louisville as it was tested and approved.
[NOTE: The WLKY story provides no indication that Ms. Bowdan ever contacted the FDA. If she had, she might have learned that the agency simply registered the Dechoker, not "approved" it. In other words, the headline and lead of her story are wrong.]


III. Greenleaf Health Inc. (Washington, DC) vs. Dechoker LLC, case no. 2017CA003434CAAXWS, Pasco County, FL, Sixth Judicial Circuit Court:

Wednesday, March 21, 2018

UK government regulatory agency for medical devices releases determination letters sent last year re: two anti-choking devices


Via the website of the Medicines and Healthcare products Regulatory Agency (MHRA):
What we do

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
This week the MHRA released two identical August 30, 2017 determination letters re: the Dechoker and the LifeVac, two unrelated handheld anti-choking devices being marketed in the UK by Dechoker UK (Northampton) and LifeVac Europe Ltd (Devon) respectively. 

Both devices were developed by companies in the U.S., Dechoker LLC (recently relocated to Denver, CO) and LifeVac LLC (Springfield Gardens, NY).

Page down for copies of each letter. Here's the text.


30 August 2017

I am writing to you further to my letter of 19 May, when I requested additional information which was necessary for the MHRA to give full consideration to the regulatory issues relating to placing your product on the UK market. I am grateful to you for providing that information in a timely manner; we have now had the opportunity to consider the additional information and have reached a conclusion on how we propose to proceed.

In my letter, I referred to MEDDEV 2.7/1, a guide produced by the European Commission, that promotes a- common approach to clinical evaluation and specifically highlighted the section which referred to devices for unmet medical needs. One of our main concerns has been a lack of sufficient data demonstrating effective use of this device and we understand that due to the nature of the device, clinical trials would be extremely difficult. The proposals set out below are intended to allow you to gather clinical data in a controlled environment, with trained healthcare professionals, which will allow you to generate more robust results over time. These can then be incorporated into your clinical evaluation which, once sufficient evidence has been generated, may allow agreement of extending the availability of the device.

We are therefore requesting that you take all reasonable steps to ensure that your device should only be used in the following situations:
• By registered healthcare professionals or individuals with advanced life support training, only if currently recognised basic life support protocols have failed; or
• In situations where emergency services are unable to respond, for example on aeroplanes or ships, only if currently recognised basic life support protocols have failed; or
• On individuals in moulded wheelchairs, only if currently recognised basic life support protocols have failed.
Taking this into account, we would request that you alter your instructions for use, as well as any relevant supplementary marketing information to emphasise that your device should only be used under these conditions.

We would also request that you cease to market your device for use on children, in schools and in other public places such as restaurants and shopping centres.

I should advise that, based on the information provided to us thus far, we do not consider that your current plans for post-market surveillance, in particular the lack of structured post-market clinical follow-up, would be able to generate sufficient clinical evidence to expand the use of your device. The approach that we have proposed above should allow you to refine your plans for post-market surveillance; healthcare professionals will understand the experimental nature of your device and how it fits with basic life support and provide more structured post-market surveillance data.

I would like to thank you for your patience and co-operation in this matter. The MHRA believes the approach outlined in this letter, which at this stage is based on voluntary cooperation as opposed to formal regulatory action, strikes a balance that will allow you to continue your business but also gather information for clinical evaluation in a more controlled clinical environment that minimises the potential patient safety issues.

I would be grateful for a response to this letter by 20 September setting out your acceptance of the conditions in this letter and an outline of how you intend to comply with them.

Yours sincerely,

Graeme Tunbridge
Group Manager - Devices Regulatory Affairs
Tel: 0203 080 6901
Email: graeme.tunbridge@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ
United Kingdom
www.gov.uk/mhra
 



Tuesday, March 20, 2018

Re: anti-choking device in service at Union Community Schools, Iowa State Education Director: "This is a local issue" -- so I put it on the desk of the district superintendent

Three Dechoker devices in cabinet installed in Iowa's Union Community School District

On March 8, I blogged An Iowa school district recently installed Dechoker anti-choking device to respond to choking emergencies -- I've asked the state education department to review.

Based on a March 15, 2018 reply I received from Department of Education Director Ryan Wise -- see below -- when it comes to medical guidelines, apparently the state has zero oversight.

How much discretion do local districts have to determine what medical treatments are provided to their students? Are the districts equipped to make those determinations? Are students receiving the highest standard of care?


Read on...

From: Peter.Heimlich@gmail.com 
Subject: blogger inquiry
To: t_fleshner@union.k12.ia.us Cc: ryan.wise@iowa.gov
Date: Tue, 20 Mar 2018 14:10:53 -0400

Travis Fleshner
Superintendent
Union Community School District (UCSD)
200 Adams St.
La Porte City, IA 50651

Dear Mr. Fleshner,

Per the attached pdf [see below], I was referred to you - albeit indirectly - by Ryan Wise, Director of the IA Department of Education.

In a March 8, 2018 e-mail (published on my blog), I asked Mr. Wise to review the reported incorporation and installation of a plunger device called the Dechoker in your district's schools to be used to respond to a choking emergency.

Via my e-mail:

The Dechoker is not included the standards and guidelines of the American Heart Association, the American Red Cross, the American Academy of Pediatrics or, to my knowledge, any established medical organization. And a keyword search today for Dechoker on PubMed provided no results, so it appears the device has not been the subject of any research published in the literature.

In other words, the effectiveness and safety of the device appears to be unproven. Therefore, it's unclear on what basis the (UCSD) chose to equip its schools with the devices, hence this outreach.

...(It's also unclear if any district) officials obtained opinions from any medical experts or first aid organizations, or an opinion from the school district's risk manager. Would you please look into that and provide me with the results?
Via Mr. Wise's March 15 reply:
We have reviewed your inquiry and have determined that this is a local issue. The Department does not have authority over the district's decision to use these devices and there are no State rules that would prohibit the district's use of the devices.
Based on that determination, I'd appreciate your answers to some quick questions for a follow-up item I'm reporting.

1) Would you please provide me with copies of the documentation on which your district relied to determine that the Dechoker was an effective and safe treatment response to a choking emergency?

2) Did any district officials obtain opinions from any medical experts or first aid organizations, and/or an opinion from the school district's risk manager? If so, would you please provide me with details and documentation?

3) To my knowledge the Dechoker is not recommended by any established first aid organizations, therefore some might consider it to be an experimental medical device. With that in mind, have parents and guardians of students been provided the opportunity to approve or deny its use on their children? If so, would you please provide details and documentation? 

Thanks for your time/consideration and I look forward to receiving your answers. And if you have any questions for me, please don't hesitate to ask.

Sincerely,

Peter M. Heimlich
Peachtree Corners, Georgia 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
https://twitter.com/medfraud_pmh

cc: Ryan Wise


 

Saturday, March 10, 2018

Two Scoops: In $2m+ securities probe, state agents seized computers, files of Concord, NC company selling anti-choking device -- meanwhile in Louisville, the company's being sued by its former CEO [UPDATE: North Carolina TV investigative reporter picks up my story]

UPDATE 3/13/14: Last night via Anti-choking device business raided, accused of investment scheme, investigative reporter Matthew Grant at FOX46 in Charlotte, NC,  picked up my scoop and moved it forward, My 3/10/18 item is below the video.



source

In the course of researching my dad's bizarre career and his namesake anti-choking maneuver, I've occasionally reported about anti-choking devices that have been marketed over the years, for example, the Heimlich Helper, the LifeVac, and the Dechoker.

Click the links and you'll see that I've reported mostly about the LifeVac because, based on casual observation, that device has been more aggressively promoted via press releases, media reports, and social media. More promo materials means more for me (or anyone else) to report.

Two unrelated legal cases -- one in North Carolina, the other in Louisville, Kentucky -- involving the company marketing the Dechoker appear likely to provide me with more reporting opportunities.  

I. On February 21, I reported Re: $2 million investment scheme, North Carolina Secretary of State's Securities Division issues temporary cease & desist order to Concord company selling Dechoker anti-choking device -- meanwhile the company's UK division claims the device has saved 14 lives(!)

The date of the temporary cease and desist order was February 15, 2018.

To my knowledge unreported until now, according to a search warrant issued by the Superior Court of Wake County, that same day agents of the North Carolina Secretary of State's Securities Division seized computers and files from the offices of Dechoker LLC located at 4454 Raceway Drive in Concord.


Here's the 36-page search warrant with supporting records -- click here to download a copy.



This was posted yesterday on the website of Dechoker LLC:



 

II. Via FDA approves new lifesaving device based out of Louisville by anchor/reporter Ann Bowdan, WLKY-TV News,WLKY October 30, 2015:

(Recently), the Food and Drug Administration approved a new device being touted as an alternative method to the Heimlich [for responding to a choking emergency].

The alternative device is called the Dechoker, and its headquarters is right here in Louisville.

"The Heimlich works on positive pressure and we work on negative pressure, or suction. In other words, it's a vacuum,” Dechoker CEO Christopher Kellogg said.

..."Obviously there's a health care hub here and the city of Louisville has been absolutely wonderful to work with open arms," Kellogg said.

...But there are some skeptics.

Peter Heimlich, the son of Henry Heimlich, who created the Heimlich maneuver, questions the validity of the FDA’s approval of the device.

He believes more published research is needed. 
The headline and lede of Bowdan's story -- that the Dechoker was approved by the FDA -- appears to have originated with Dechoker LLC:


I'll ask the FDA and report the results.

To my knowledge unreported until now, a year after the WLKY report aired, Christopher Kellogg filed a lawsuit against Dechoker LLC in Jefferson County, Kentucky, Circuit Court claiming breach of contract, unpaid salary, and other allegations.

According to court records accessed today:


Here's the October 26, 2016 complaint and December 21, 2016 response. Click here to download copies.

Thursday, March 8, 2018

An Iowa school district recently installed Dechoker anti-choking device to respond to choking emergencies -- I've asked the state education department to review


In January 2016, some New York City and Long Island public schools were using a handheld anti-choking suction device called the LifeVac to respond to choking emergencies. I asked the city and state departments to review. For more information, see New potentially life saving device questioned by medical watchdog, by Joe Mauceri, PIX11 News, January 18, 2016.

Recently the Union Community School District in Iowa installed another handheld anti-choking suction device called the Dechoker. Today I sent the following letter. (Click here for my other reporting about the Dechoker.)


March 8, 2018

Ryan Wise
Director
Department of Education
Grimes State Office Building
400 E 14th St.
Des Moines, IA 50319-0146

Dear Mr. Wise:

This is to request that your agency review the following information and provide me with a determination if the following actions of the Union Community School District were in compliance with your agency's standards and guidelines.

Via Union schools receive medical ‘dechokers,' an unsigned January 12, 2018 article published by Vinton Newspapers:

LaPorte City/Dysart were gifted some new medical devices called the Dechoker, by the Dechoker company to promote their business.
“We have four cabinets with three different sizes of Adult, Child and Toddler at each of the four school buildings,” said Cheryl Wiebbecke, the school nurse, in a press release.
“They are mounted near the lunchrooms or gymnasiums at each building for choking emergencies...

“We will be prepared for choking emergencies thanks to the Dechoker company," said Wiebbecke.
The Dechoker is not included the standards and guidelines of the American Heart Association, the American Red Cross, the American Academy of Pediatrics or, to my knowledge, any established medical organization. And a keyword search today for Dechoker on PubMed provided no results, so it appears the device has not been the subject of any research published in the literature.

In other words, the effectiveness and safety of the device appears to be unproven. Therefore, it's unclear on what basis the district chose to equip its schools with the devices, hence this outreach.

Would you please include in your review the contents of the file
Iowa Union Community Schools.zip which includes the following referenced e-mails, school board minutes, and what appear to be photos of Dechokers in storage cases installed at the schools?* Please click here to download the file.

According to the e-mails and the school board minutes (see below), the Dechoker company (Dechoker LLC, 4454 Raceway Drive, Concord, NC 28027) gifted the devices and wall-mountable storage cases to the schools
in exchange for Ms. Wiebbecke agreeing to send out press releases about the gift. 

According to the e-mails, Travis Fleshner, Superintendent of Schools for the district, approved a December 18, 2017 presentation to the school board by Ms. Wiebbecke.

According to the minutes of that meeting:

Nurse’s Presentation:

Cheryl Wiebbecke, Union CSD nurse in Dysart, was present to show the board one of the dechokers [sic] the district has received. Cheryl’s attention was caught by the words “Breathing is mandatory” and she began reading about the dechoker. The dechoker is to help those choking when the Heimlich method might not be an option or isn’t working. The cost for the dechokers for all four school buildings would be approximately $1,600. She looked for grants to help pay the cost and when she wasn’t able to secure a grant, she called the company to see if they had ways for the district to purchase the dechokers affordably. The result was the company offering to give the dechokers and the cases to the district at no cost in exchange for some publicity to help grow their business. We now have a set of three dechokers (toddler, child, and adult), along with the cases, in each of the four school buildings.
According to the e-mails, in addition to the Vinton Newspapers article, Ms. Wiebbecke's public relations efforts also resulted in Breathing is mandatory, an unsigned January 17, 2018 article in the La Porte City Progress Review.

What's unclear is if Ms. Wiebbecke or any other school officials obtained opinions from any medical experts or first aid organizations, or an opinion from the school district's risk manager. Would you please look into that and provide me with the results?

Finally, would a representative of your agency please interview Ms. Wiebbecke and ask if she had any other relationship or further communications with anyone associated with Dechoker LLC and provide me with her response?

Thank you for your attention and I look forward to your reply. If your office has any questions I might be able to answer, please don't hesitate to ask.

Sincerely,

Peter M. Heimlich

Peachtree Corners, Georgia 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
https://twitter.com/medfraud_pmh


*