Civil Rights – Vaccine Exemption? * FDA Notice regarding Jet7 Voluntary Recall * Was it too late? * Are physicians responsible for medical device failures?

Phone/Studio Guest - Daniel Lewis or John Mountz

Call to Action

[Notice & Disclosure: TRANSCRIPT Not word-for-word AI Transcribed, but rather an unedited and unrevised Text version provided for key term searches and general outline, audio should be consulted for exact contexts.]

Week 9, Part 2 -

Legal & Admin Docket Report - Chubb Insurance Claims  *  Travel with UM/UIM Coverage the New Year  *  FDA chain saw recall of 550k saws   

Studio Guest -  Daniel Lewis or John Mountz

Call to Action - Call 855-998-7368

Sources:

https://www.healthline.com/health/stroke/cerebral-ischemia

https://topclassactions.com/lawsuit-settlements/medical-devices/penumbra-catheter-defect-prompts-voluntary-recall/

https://www.phillipslaw.com/blog/penumbra-catheter-recall

https://www.simmonsandfletcher.com/blog/urgent-penumbra-catheter-recall-jet-7-reperfusion-catheter/

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter With Xtra Flex Technology (JET 7 Xtra Flex), owing to the risk for "unexpected death or serious injury" during use for clot removal in stroke patients .The Penumbra JET® 7 Reperfusion Catheter is intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion. - Call 855-998-7368.

Transcript

Trenton Garmon
Welcome one Welcome all to I Heart Radio. This is Trenton, Garmon, bringing to you g file news. We are your source for civil rights news. And legal docket reports. We're bringing to you credible information cases that involve encroachment on your civil rights or abuses by big government abuses by big insurance. Got a special guest today by phone mazing attorney, an associate of mine that I'm honored to know named Daniel Lewis. Daniel, welcome to today's show. It's good to have you on.

Daniel Lewis 1:23
I think you drink Good to be here, man.

Trenton Garmon 1:25
Well, tell me there's been some information that the FDA has pushed out, I see where there is a July 27 of 2020 letter that I guess the pronounciation is Penumbra. Is that the name of the company? Is that how you said?

Daniel Lewis 1:40
Correct? Yeah, that's a medical device company.

Trenton Garmon 1:43
So they issued a letter, I guess in July. And then as of December the 15th. Tell us kind of what has transpired with regard to that company. And I believe it's at least two, maybe three of their products.

Daniel Lewis 1:58
Sure. So in July, the number makes a catheter called the jet seven extra flags. And the FDA asked for pin number to voluntarily removed the catheter because of 14 reports of deaths, and then another 190 or so what they call adverse events. So this is a cash

Trenton Garmon 2:24
surgeon would m would use as a tool for stroke victims, is that correct?

Daniel Lewis 2:30
That's correct. Okay. So, right, and the FDA, they have databases for medical devices, pharmaceutical products, all of these that track these adverse events and bad things that happen. And that's how that's how the agency would learn about it. So even though the catheter is voluntarily removed, well, the question becomes, okay, how did we get here? Sure. And one of one of the indicators we're seeing about that is there the there's a hedge fund called quintessential Capital Management, that has has shorted the stock, which is to say they, they sold shares of the number they don't own. And it's a risky technique unless you know, that something is amiss with the company. So for those who are the victim of a number of

Trenton Garmon 3:22
jet seven catheter injury, you send that have a claim against the number and also against equitable, equitable company or the equity.

Daniel Lewis 3:32
It's looking rather, it looks like they would have a claim against the number and the equity companies actions just bolster the strength of that claim. Okay.

Trenton Garmon 3:42
And is that in regards, because I'm not sure what all the FDA has put out there. But as I understand it, not every safety study the company purports to have reached and the results are of the credible clinical findings is always trustworthy. Is that something that's been at issue here? That's public information? Or do we know because I can see where there'd be funding? I could see where there would be the, you know, product manufacturer clearly having responsibility, but I can't see the tie unless there's something else as far as marketing goes. What are your thoughts with that?

Daniel Lewis 4:16
So? Yeah, so as far as marketing goes, transparency is a big thing with with any sort of medical device. And the allegations we're seeing against the number of is that a doctor on both amti k blsa. was just created totally fake Dr. Fake social media profile with fancy cars fancy homes. He was created to be this purported author of scientific research for Penumbra and he doesn't exist.

Trenton Garmon 4:48
Do we know who returned time was the number that that made up this site? This is a doctor who came to this conclusion that they're going to for the purpose of the public's eye, this is our doctor. We've got in places fictional. Who did the numbers people make that decision? Or is that something was put out falsely by the equitable company?

Daniel Lewis 5:09
No. So it's looking like so the equity company is actually who brought attention to this. So it's looking like Penumbra created this doctor to put out scientific research that makes its medical device look safe.

Trenton Garmon 5:24
that's relevant to the general public, because here we have people that have a propensity and a likelihood have a stroke. And they're anticipating having a product meet the standard that's conveyed to the doctor and also to them as the general public. So it sounds like that that is a kind of a double whammy type of cases there because obviously the general public anyone that's had a number of jet seven procedure, loved ones family members, if there's been a subsequent surgery that was required if your loved one passed away, during a procedure that would have been performed by I guess it would be a vascular doctor. Is that not right, Daniel? Yes. Okay. Yeah, it welcome to contact us 855 99. Trent is the number 855 99. Trent? Tell me that, Daniel. So there's the July 27 letter, and the FDA put pressure on Penan. Dre basically told him, You need to have a voluntary recall, which is just like saying, either recall, or we're gonna force it to be recalled. What is what was the reasoning for the delay? Were they just not sure how, how risky this was to patients? They were still assessing it? Or what was the reason for the delay? If you know,

Daniel Lewis 6:37
you mean for the FDA?

Trenton Garmon 6:38
Yes.

Daniel Lewis 6:40
So I don't know that specific reason I do know, generally, the FDA is not very quick to issue either request for recall or, or some sort of additional warning, which is substantial. It's pretty

Trenton Garmon 6:54
healthy, because it allows for the companies to really self regulate. And that's, that's a major concern, when you already have a process that is really not that stringent. You get products all the time that are approved because of a grandfather clause, where it's similar to another product this company has, and I have seen that be a major issue for public safety here with false data, false safety studies by a fictional doctor, that is Uber concerning. Daniel, what are your thoughts with regards to the medical community's awareness? I know that they sent a letter out but do you find I think it to be the case that sometimes doctors use products that are unsafe or are recalled? And they do it because they don't even don't even have the information that awareness? Is that something that you've come across? Yeah, I

Daniel Lewis 7:45
find a lot of times the doctors just don't have the information. I when we're talking about Penumbra you have patients that are getting poor information and and patients who cannot be advised by their doctor on this jet seven catheter, because it's looking like not only did Penumbra, invent, research through an invented doctor, but they also did not report all of the dangerous things that were happening. Sure you had patients dying from the jet seven catheter and the number just did not report them to the FDA. Like they're required to do well and

Trenton Garmon 8:20
encourage each employee whether it be a nurse practitioner, nurse, nursing assistant doctor, and maintain that healthy accounting system and responsive type policy where if something occurs, you don't only to respond to the medical need. You need to document that whether it's on the vaccine adverse reporting, outlet, whether it's on the medical device, database, those kind of things help us as patients, because not only are we here, Daniel as attorneys offering services to help you and look into inform me about this product, but I do with the medical community is, you know, a community that needs to likely understand how pharmaceutical companies and product manufacturing companies don't always present accurate information. And it's good to make sure that the medical community stays aware of that. We've talked before Daniel on the show about the vaccine push that we're seeing now, have you had much of a chance to form by them opinion about what you think illegally? Are we in a state that exemption would be allowed? I mean, state of like pandemic versus just general welfare? Do you think at this point in time that an exemption is something that we're entitled to or what are your thoughts on it?

Daniel Lewis 9:42
You mean, with the with the drug company be exempt from liability?

Trenton Garmon 9:46
Yes, well, no, the exemption, which is I think for sure something that's been defined that should be challenged if you have similar studies, or findings that you have here because I don't know that I'm going to I don't think I trust the reporting of The clinical data from the vaccine industry, I'm, I'd love to get into discovery and look at that, because I'm sure they're hedging it away from really disclosing the number of adverse reactions. But no, I'm talking about an individual's liberty to refuse the vaccine. Where are you with that? Do you think that? And I'm presuming there's going to people that want to do that, I'm going to refuse it. And that's not because I want people to get COVID I just believe that it's the proper thing to do. Based on natural law, my personal convictions, no religious convictions, but what are your thoughts with him?

Daniel Lewis 10:31
I would think so. I see no reason why someone would not be able to say, I don't want that vaccine.

Trenton Garmon 10:41
I agree, but

Daniel Lewis 10:42
I don't know. Yeah, you know, I think and what's unfortunate is, though there are coercive ways to get someone, for example, you don't, I don't think you have to get the chickenpox vaccine, but you can't go to public school, if you know, in order for his parents, and that's a defect

Trenton Garmon 10:58
where it's in theory, it's not required to exist in the culture and to be able to participate in the community, then you have those type of processes and methods that just mean it's really a passive aggressive way to encroach on our rights. Well, thank

Daniel Lewis 11:16
you for sharing that. And that would be the Go ahead. Politically trend that that would I think that would be to your point. Therein lies the constitutional challenge. If you have someone who says, Hey, this is my right, I want to preserve my right not to get the vaccine. I think there's a valid claim later. Sure.

Trenton Garmon 11:35
I believe so. I think it'd have to be litigated to the Supreme Court though because operation warp speed limited not just the vaccine court but limited to basically a government board the presentation of claims or they've got cats just terrible way to I think police corporate America by how restrictive has been but I understand the circumstances and conditions of our time of this pandemic. Daniel, thank you for being on we've got Part Two coming up. This is Trenton Garmin on iheart. Radio bring it to you g file news, your civil rights news and legal docket reports.

If your loved one has been the victim of police brutality, contact our firm Garmin and Associates eight 599 Trent you or your loved one may be entitled to compensation to a federal civil rights case. So again, if you are loved them have been injured as a result of police brutality contact us Garmin and Associates 855 99 trend or presentation recording legal services to be performed for the quarter legal services performed call today.

Welcome one Welcome all to I Heart Radio. This is attorney Trenton Garman bring to you your G file news. It is relevant civil rights news. And legal docket reports there is big government big insurance issues that need to be discussed so that you may we the people are informed and are able to be happy, productive, fruitful citizens and join our natural law rights. I've got Daniel Lewis and attorney here on for part two of this week's show, we're going to be talking about insurance. preserving your rights when dealing with insurance companies. There was a recent Wall Street Journal article that I found to be fascinating because it almost fits spot on the case that I have against a major conglomerate. Chubb is the name of the company. They have multiple entities are multiple companies in different states. But if you have an insurance claim with Chubb, feel welcome if they are delaying, denying or disputing your client, feel welcome to call us at 855 99 Trent. That's any climates have a Chubb insurance policy for indemnification if you've had property that's been taken if you've been injured if your house has been burned and Chubb is delaying diminishing or denying your client call us 855 99 Trent Daniel, thank you for being back on for part two here. I appreciate the jet formation and perspective on the jet seven and legal opinion if you will about the right to maintain a natural inoculation and say no to the job. I agree. I think it may end up having to go up to the Supreme Court just depending on how the election results turn out. Not you know that certifications haven't been made as of you know, recording and and this being uploaded to the podcast but I do think you get a lot going on in the world right now and our rights matter. So I'm going to be a no jabber, but I'm not going to dispute anybody that wants to get jabbed. But for part two here. What has been your perspective on an underinsured motorist claims? I know that a lot of Alabamians have been as they travel, involved in accidents, and they may not be aware that their own insurance company can provide coverage if the person who calls a wreck doesn't have a sufficient amount. What are your thoughts with with travel? And and how do you do as a as an attorney? If you're dealing with an insurance company, personally, Daniel, and you've got a client? How do you handle that?

Daniel Lewis 15:42
With the uninsured and underinsured motorist,

Trenton Garmon 15:44
but just overall, what are your techniques, you know, obviously, on an under insured is something that would need to be added as a rider. But when you're dealing with insurance companies that I recommend, don't record calls, but they certainly put everything in writing and email them. So give me your kind of perspective. And what would you advise john? q taxpayer john q citizen on how to how to best deal with insurance companies.

Daniel Lewis 16:11
Regarding your email idea, I think that's always good to have a written record of any communication. So

Trenton Garmon 16:18
your recommendation is you get the adjusters name information and an email address if they're willing to share it. On an under insured is what we're talking about. As far as policy recommendations go, you can't control somebody else, but you can control your own insurance. And we recommend that you add an on an under insured rider to your policy, your insurance agent will know what that means. If you deny it, you have to deny it in writing. So if you did not denied in writing and you legitimately wanted it or didn't understand and explain that to us by phone, 89985 599 Trent 855 99 Trent, and we'll talk with you on how we could potentially bring a claim on your behalf. Did you see that wall street journal article? I doubt that you did because I get the print version. And most people read it online. You know the news. But I found it kind of fascinating that that a Stradivarius, which is a rare violin has got as I was talking about earlier, very similar fact pattern that says David saucer, made a last minute phone call on August 16 1962 and was able to be invited to perform at NBC. He went to the Manhattan MUSIC Studios grabbing his violin as he was leaving. And it had been went to grab and had been taken the FBI. This is a case from 1962. But it shows you how if you have a claim for a valuable heirloom, if you have a home that's been damaged, and you've done upgrades to it. Insurance companies responsible for the appreciation in the value here you had a Stradivarius file and that was offered online for $500,000 is it's probably worth in the millions. Literally Chubb insurance back in the day when the claim was first made paid $35,000 on the climb, they were able to maintain the right actually 32,500 they were able to maintain the right if the violin was ever discovered. Daniel, have you had any kind of interesting cases like that with insurance? What's been your most fascinating insurance case that you enjoyed working on?

Daniel Lewis 18:29
You know, I have not as far as the appreciation, But to your point, I think that something insured party should keep in mind, I wonder if the general public is even aware of that. That as for your home for as it appreciates, you should increase coverage.

Trenton Garmon 18:46
That seems to be where the biggest rub comes is where what they offer is not what it's going to take to get you back in the position before it doesn't. It doesn't make it always hold and so you have to challenge that because unfortunately, that's is that not their duty. How would you describe their duty to indemnify someone

Daniel Lewis 19:06
a dangerous thing? I I'd say they certainly have a moral duty an ethical duty to do it. Yeah, yeah. And that's the thing. Yeah, I know and that's the thing No, like, we're all humans to me that that's the standard by which we should we should gauge our actions.

Trenton Garmon 19:28
But I don't I don't legally speaking depends on the particular channel or if it's a home or placement costs, you know, in there's obviously methods where appraisals can be done and professionals can be brought in which I found fascinating for this article that the Wall Street Journal put out because the claim that we have is very similar of rare family heirloom that I know people when that occurs, cannot be made whole that's unfortunate because that is a heirloom, you know, I've got certain items my my parents have Set of devices that my mom tells a story about how she got it and how much she loves it. And it was mounted to the wall. And we were told, if it falls and breaks, they were gonna kill us, you know, we kind of understood that was not literally gonna occur. But you know, you felt like your parents could put the fear of God in you that way. And so how much were those devices worth to my family, whether we're an airline, but there there are those ways though, that insurance claims can still be made and bring someone that's close to home as possible. So if your loved one has a loss that you believe is being undervalued by an insurance company, feel welcome to contact us, Garmin and Associates, this is Trenton, Garmin, have attorney Daniel Lewis here, you can reach us at 855 99. Trent is the number 855 99. Trent? Just I guess kind of swinging things back around Daniel for the conclusion here, part two. So what are the next steps in your mind for the jet seven litigation and what's gonna probably be years worth of litigation and I don't, I don't know how many climbs and how many people this is affected, it doesn't look like it's as large of a of a pool as you would experience to some class actions. But what are your thoughts with where we see the number of conundrum going, if you will,

Daniel Lewis 21:19
the first thing I would encourage people to do is call like that, because that's the first step to holding any of those companies accountable is for the injured parties to come forward. And, and talk about that. And it's not because of the filter that had the risk of stroke. And we're not even limiting injuries to death. If you have a stroke, you can have cognitive deficit, maybe you have difficulty calling or you can have difficulty understanding what someone's saying. You could have what they call a motor deficit. So you'll see, maybe paralysis of the face or a hand doesn't work. So there's there a litany of injuries, but as far as where do things go next? That depends on someone affirmatively saying, I'm not okay with it. Which next

Trenton Garmon 22:09
step of course, again, 855 99 trainers are number the next step pragmatically speaking would be for them to get additional treatment, right. And I would recommend that the general community consider if you have a product that you believe is unsafe and was implanted, I would go get a second opinion of another doctor because doctors are humans, and they have a very difficult time being critique heavy of their own work many times in their their own craft and art and appreciate doctors among goodness, what a great community and what I realized just last source that we have in the minds and in the skillfulness of surgeons and of general treating physicians, but I'd encourage you if you've had a medical device, specifically this Phnom Penh number on jet seven, vaginal mesh hernia mesh, any of the devices that you think are either recalled or looking to be recalled because there are advertisements out plaintiff attorneys in tennis to help with the people and police corporate america and so if you've seen any of those recalls for welcome to contact us was not something we're handling will be honored to get you in touch with someone that's 855 99 Trent. Just before we close I guess I will pitch this last thing here. chainsaw recall alert issued more than 550,000 products as a chainsaw recall, the mindful of if you've spent some kind of damage because of a craftsman chainsaw, I suppose so you may be entitled damages because of a safety issue with it. Daniel, thank you for joining me and being with us on this journey and on the show. I look forward to having you on again. It's a real privilege to be working with you.

Daniel Lewis 24:00
Merry Christmas to you and your family. Okay,

Trenton Garmon 24:02
Merry Christmas to you as well. Trenton Garmin here on G founders bringing you your civil rights news and legal document reports.

Have you or a loved one been injured in a motorcycle wreck it's important to know your rights as soon as possible. In motorcycle crash cases evidence often is not preserved that prevents injured motorcyclists from prevailing contact us immediately if you have been injured in a motorcycle wreck 855989 trim is the number Garmin and Associates contact us if you've been injured in a motorcycle crash 855 99 Trump delivers internationally the quality legal services to be performed is where the court of legal services before the lawyers

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