Comments on: “Substantially Unsafe”: 30 disturbing facts about medical devices

By: Carolyn Thomas

Carolyn Thomas — Sat, 29 Dec 2012 22:00:08 +0000

Hello Rex,
I’m sorry you find yourself in this horrible situation, along with so many other suffering patients. Unfortunately, I’m not familiar with the specifics of the Hem-O-Lok clip, other than what’s mentioned in the article above (e.g. subject of a series of recalls since 2004 – four years before yours was inserted). My understanding of the Riegel v Medtronic Inc case is that only medical devices that had gone through the “premarket approval” process specified by the Medical Device Amendments of 1976 were covered in that ruling, and that the Supreme Court ruled in 1996 that the FDA’s less rigorous “substantially equivalent” approval process in more recent years did NOT pre-empt state damage suits against the manufacturers of grandfathered devices. Do you know if this is the case? (It may not be, given your current challenges in finding a legal firm to take on your case). Lawyers like to take on cases that have a hope in hell of success. Their reluctance to take on yours is discouraging and demoralizing. Hang in there and best of luck to you in this journey.

LikeLike

By: Rex Burford

Rex Burford — Sat, 29 Dec 2012 18:49:56 +0000

I am dealing with a Hem-O-Lok clip which migrated into my urethra and was discovered and removed on October 4, 2012, some 4 and one-half years later and considerable inconvenience, pain, continuing pain, and other difficulties some three months after removal.

The removal has not been reported to my knowledge by the Hospital where the surgery took place. Unless the Dr. who performed the initial surgery (RALP) informed the manufacturer, there has been no report to them. The removed sample does exist in the office of risk management at the hospital where the surgery was performed and I have secured my claim to the object(s) but for chain of custody purposes choose to leave it in their hands while I continue my investigation.

The best I can figure out to date is that this is a Class II approval under the 510(k) process by FDA and may be the result of predicate creep approvals. I am attending to these reporting details when I am sound on my status. I would like to confirm the Class II 510(k) status. I am also worried that there may be more than one of these devices installed in 2008.

I was never informed that these clips were used, and I was not informed that these foreign bodies would be left in my body or that there was a chance that they would be in a position to “Migrate!”! Nor was I informed that they were translucent. This should be a matter of strict liability for manufacturing a device that was inherently dangerous, regardless of the manner in which it was installed i.e. negligence or not.

Because of the Riegel v. Medtronic Inc. case and Justice Scalia’s ignorant opinion, I am being put to some difficulties in finding a law firm that will even listen to me on this issue, let alone pursue the case. I think most of them just want to pick off the low hanging fruit! I have investigated enough to find that there is a difference between Class III and Class II and the implications of Medtronic.

There are at least two Federal Appeals opinions (4th and 9th [of course]) which create sufficient differences that the the Sup. Ct. of US will consider some clarification. Any comments on this, as to my direction and supplemental information on Law Firms would be appreciated.

LikeLike

By: saltis

saltis — Fri, 16 Mar 2012 21:58:56 +0000

[…] The Ethical Nag Posted in Landscaping | Tags: […]

LikeLike

By: Carolyn Thomas

Carolyn Thomas — Wed, 14 Mar 2012 14:19:00 +0000

Thanks Dr. Joe – this report makes Big Pharma look positively angelic by comparison. For our readers’ benefit, here’s more info via Reuters on the PIP breast implants and metal hips.

LikeLike

By: DrJoe Kosterich

DrJoe Kosterich — Wed, 14 Mar 2012 14:09:03 +0000

There are many issues with pharmaceuticals but at least they are trialled before going to market. Devices are subject to very little testing by comparison. Witness the problems with PIP implants and metal on metal hips

LikeLike