58 news organizations are investigating medical devices (Cal

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58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Mon Nov 26, 2018 5:33 pm

What happens when 58 news organizations and over 250 journalists from around the world unite to investigate medical devices?

This is a workers' compensation issue as many of these devices are being implanted into injured workers. There is a lot of focus on pharmaceuticals however the medical device industry is bigger than the pharmaceutical industry, with much less oversight.

https://www.icij.org/investigations/imp ... vice-harm/

More info here:

https://www.icij.org/investigations/implant-files/
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: 58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Mon Nov 26, 2018 7:36 pm

New York Times.

https://www.nytimes.com/aponline/2018/1 ... zskER_cIEw

I received some pushback posting information on this site about some of the issues relating to medical device safety, clinical trials and evidence based medicine. Mainstream media has picked up on these topics and is now investigating what is going on with some of these dangerous medical devices, many if which I have written about on this forum. My goal posting this info on a workers' compensation forum that is primarily geared towards the work comp insurance side is to educate and hope that this side of the industry will do more to protect patients from harm. In turn the insurance industry will save money by limiting repeat surgeries, unnecessary surgeries and increased disability. And bare minimum maybe someone reading this information may stop themselves or a loved one from being harmed just by doing some research on a device before it is implanted.There are many good medical devices out there that improve lives. It is important that physicians, insurance companies and patients have a way to research what devices are safe.

There is a story about spinal cord stimulators this morning on Workcompcentral. Some of these stimulator devices are more harmful than others. Adverse event reports can be found on the FDA website if you have product name and code. Please note the newer devices may not have high numbers of reports just because they are new. Also, researching the FDA data base there are devices on their device search look up that have not been FDA cleared. So finding a device listed on this look up does not mean it has been FDA cleared as device manufacturers submit the info on this look up and the FDA does not check it to see if it is cleared. The only way to confirm the device is FDA cleared is to them look up their 510k clearance or PMA. If they do not have it the device is not cleared and is being sold illegally. You would be shocked how many "legitimate" manufactuerers of medical devices sell products that have not been cleared by the FDA. I have tattled on many and have found they sometimes will get a surprise audit by the FDA, and/or a warning letter and MAYBE a fine at most. The manufacturer then will submit it to be cleared. So there is little incentive for device manufacturers to follow the law.
Last edited by 4anewusers on Sat Dec 22, 2018 10:38 am, edited 5 times in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: 58 news organizations are investigating medical devices (Cal

Postby LawAdvocate on Tue Nov 27, 2018 1:58 pm

The reason there was "push back" is this is a forum for the legal practitioners in the field, not for injured workers. Just like with the other information you posted, the issue remains that none of this information is of any value, since attorneys, claims examiners and other non-physicians do not get involved with care at that level. None of the devices allegedly investigated are listed as to why they were allegedly faulty, which then needs to be peer reviewed and if in fact they are still on the market.

Many of the devices are not deemed faulty until they fail in a number of patients and that is how they are deemed faulty.

All of us that are the legal side run on evidence. This is not evidence, it is not even a good story since it identifies a problem with the testing prior to marketing devices, lists no harmful devices that are currently on the market that we could "watch" out for. The articles are simply stating what we already know. The testing of medical devices is not rigorous enough in most countries. So as long as certain politicians "rape" the FDA budget and until there are standards for medical device testing, this is all immaterial in our everyday practice.

We don't even know what medical implantation devices are going to be used until after the fact, we read about it in the operative report. We have to trust the doctors where we send injured workers to do their due diligence. Even if they have done their due diligence, there might not be any evidence against using a device at the time of its implantation. So any surgery and any implantation carries risks, there is no realistic way for us to minimize the risk other than send injured workers to the best physicians we know, limited by most MPNs.

We know the risks of medical implantation devices, we as non-physicians have no way to determine which ones are good and which ones are bad. I have one good medical implantation device and I had one removed that other people still have in their body. The human body is a huge chemistry experiment on legs - you can't tell how each individual will react. You go for the best, but realize there are statistical outliers where any number of medical treatments will fail.

Anecdotes are of no assistance in the practice of advocating for injured workers. That is all we have here, is hey this problem is still here and no one on the Federal level, especially the current administration, will even consider funding the FDA to the level that is most likely necessary.
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Re: 58 news organizations are investigating medical devices (Cal

Postby vampireinthenight on Wed Nov 28, 2018 10:01 am

I have to agree that, while interesting, there are not any WC legal issues to discuss. Perhaps back in the day a QME might have been influences by these articles, but QMEs do not address appropriateness of treatment anymore. It is through PTP/UR/Maximus. This should be posted in the Medical section or the UR section.
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Re: 58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Thu Nov 29, 2018 9:48 am

I agree Vampireinthenight. I posted this under legal by mistake. However this is not just a medical issue. Dangerous medical devices costs insurance companies money. They can result in additional surgeries and disabilities.I don't know how to move this over to medical or I would do so.


Lawadvocate, workcompcentral ran a story about this global investigation yesterday. I do not believe they would have done so if it were not a topic that involves this industry. I don't think you clicked my second link as it does identify certain devices with problems. This topic is not only about how easy it is to game the FDA clearance process, it is also about when a device is shown to be ineffective or even dangerous, the FDA usually does nothing or very little to warn the public and rarely takes it off of the market. Even recalled devices continued to be sold. There are ways for the public AND insurance companies to research if devices are causing problems (not new devices). There is at least one insurance company I am aware of that is now doing so.

For applicant attorney's and physicians it is important to be aware of the common problems associated with some of these devices and products to ensure the patients stays safe but also if they are harmed then that the problem can be identified. Some of these symptoms mimic normal aging conditions. One example is with hip implants. They have found it is not just the metal on metal implants that are causing cobalt chromium leeching. Symptoms of cobalt chromium leeching can cause dementia. The patients can start out having pain, depression, headaches and it can move to memory loss. The memory loss can escalate to the point the patient cannot dress or feed themselves. Kidney and heart damage, blindness and hearing loss can also happen. Without removal of the implant the patient can die a horrible death. Many patients who have these hip implants and have been diagnosed with dementia can get their symptoms reversed if caught early enough and the implant is removed. This is just one example of why I believe it is important to have some basic knowledge of medical devices and biologics.

I would like to see insurance companies in the workers compensation system invest some of their resources in monitoring product safety for devices and injectables that they are approving to be placed into patients. If they do not want to do it themselves there are a few patient advocate organizations, not backed or tied to industry who are already doing it and would most likely have no problem sharing their research and data with them if it would help patients in the future. Just an idea I have. And I don't mind kickback.My skin is thick and my spirit is strong, most of the time. I am aware there are more than claims adjuster, lien reps, doctors and attorney's reading these forums. There are decision makers.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: 58 news organizations are investigating medical devices (Cal

Postby LawAdvocate on Thu Nov 29, 2018 9:57 am

Never going to happen. Not their job.

There are too many devices released every year for any private entity to undertake this.

WorkCompCental may run a story but I have the same critique for them. Unless it is relevant to the claims practices, which this is not, it remains immaterial.
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Re: 58 news organizations are investigating medical devices (Cal

Postby jpod on Thu Nov 29, 2018 10:48 am

I think what LawAdvocate is saying is insurance companies are not in the business of ensuring medical devices are appropriate. The business of insurance is to price a product so the company can make a profit by insuring a loss. In WC they set premiums based on the insured's payroll classifications and the insureds ex-mod - insurers have only three years to recoup the cost of a claim through premium adjustments based on how the cost of claims affects the insured's ex-mod rating. If their underwriting did a good job pricing the product and the claims office can settle claims within that three year period, or at least ensure a long term reserve has been posted on the claim within that three years the insurance makes money. If they don't they lose money.

You are starting from the premise the insurers could make more money if they took on policing medical devices thereby lowering claim costs and therefore it would help their profits. But I believe that is fallacy. If claim costs go down so does the ex-mod and in theory so does the premium. Insurance companies are not in the business of taking on the risks and costs of policing medical devices. They can't recoup those costs through premiums. There is simply no financial incentive, nor are they even qualified to undertake such a role. Advocacy is really the only thing they can do, by letting those who are in a position to police medical devices know about how bad devices increase costs, costs which are borne by the insured, not the insurer.
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Re: 58 news organizations are investigating medical devices (Cal

Postby LawAdvocate on Thu Nov 29, 2018 12:14 pm

Touche Jpod.

Not a function of any sane insurance company.
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Re: 58 news organizations are investigating medical devices (Cal

Postby 4anewusers on Mon Dec 03, 2018 7:00 am

Thank you for all of your input. It helps me understand why this would be a challenge.

I have a few more questions about the UR approval process.When the wc adjuster and/or UR receives a request for a knee replacement for example does the request include the manufacturer and name of the device being implanted with the product code? When you receive a request for a spinal epidural does the request include what product is being used and also how much product, and what area of the spine? When there is a request for a spinal fusion surgery does the request state the manufacturer of the hardware, product code, what is being used either autograph, allograph and if a biologic the product name? If this is not included in the request do you foresee any issues with making this a requirement? With medication requests the doctor has to provide what medication and the amounts. A medication that has not been FDA cleared or contraindicated being used off label for that condition would not be approved by UR (I think). Why not have the same standard for a medical device or biologic that is being implanted into a patients body?
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: 58 news organizations are investigating medical devices (Cal

Postby LawAdvocate on Mon Dec 03, 2018 9:09 am

Questions already answered above. Again, we do not know which device was used until we receive the operative report.

Again, once a device has been deemed as failed, it is because it has already been implanted in people and has too high of a failure rate.

Your asking the system to develop a crystal ball which is impossible.

FDA approved drugs are approved by UR for off label uses, if the physician writing the Request for Authorization can show the studies, no physician prescribes contraindicated drugs intentionally. This would not make it past UR as the physician using any medication for off label uses must provide evidenced medicine to use the medication. Medications are tested and approved in an extremely different fashion than implants.
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