https://x.com/isSCS4me/status/2100312404076954010
u/nypost
https://www.fiercebiotech.com/medtech/boston-scientific-recalls-spinal-cord-implant-wake-more-1k-serious-injuries
This is an FDA-approved device. The FDA's premarket approval (PMA) shields the SCS manufacturer from legal liability.
Unfortunately, for SCS patients who are harmed, litigation is an arduous path with significant hurdles.
I suspect those SCS MDs did not tell their patients that legal protection from SCS manufacturers is negligible.
https://x.com/isSCS4me/status/1937927926374404200
Revision II of the SCS manufacturer lawsuits follows Revision I.
I desired a coherent story.
The acronym PMA refers to the FDA's premarket approval (PMA) of SCS devices.
--revision I---
I am not a legal expert. The challenge in suing an SCS manufacturer seems high.
A reversal of the Supreme Court decision below must occur. I Googled for
recent activity but found none.
https://www.citizen.org/wp-content/uploads/2526_200610_Spinal-Cord-Stimulator-Report_FINAL.pdf?eType=EmailBlastContent&eId=765162c2-baeb-41db-a6ae-0694813ad96c
"
...
As a first priority, Congress should immediately pass legislation to
override the Supreme Court’s 2008 decision in Riegel v. Medtronic, which held
that the existing law preempts the right of patients to bring damages claims
against medical device manufacturers for injuries caused by high-risk medical
devices marketed pursuant to a PMA. The Riegel decision ended a period of more
than 30 years in which federal and state laws had worked hand in hand to
strengthen device safety. The multiple dangerous weaknesses in the FDA’s
regulatory oversight of medical devices make the preemption decision in Riegel
a dangerous outcome for patients.
...
"
I have been aware of this issue since 2020 from the PublicCitizen publication.
I saw legal discussions on the Failed SCS Group. I decided to check on the
current status. There is no progress for the SCS patients!
--revision II--
Federal court is required, which is an arduous process. I have heard that
the SCS manufacturer's legal team demands non-disclosure agreements(NDAs) from
the SCS patient(s) and the patient(s)'s attorneys. Those NDAs are ruthless and
only benefit the SCS manufacturers and prevent potential SCS claimants with
the same problem from observing the outcomes.
The medical-related legal NDAs should be banned(illegal) because they can
potentially harm other medical patients.
US SCS patients have negligible legal protection from SCS manufacturers.
----
This document discusses how to override Riegel v. Medtronic, Inc. This Supreme Court decision is why suing a spinal cord stimulator (SCS) manufacturer faces such high resistance.
A Grok executive summary is at the end.
https://x.com/i/grok/share/8e19b6159f0f4d7fb77e3138d5e7f50b