Civil Litigation
Jul. 21, 2025
FDA accused of bypassing safety review for spinal device
A man who became paraplegic after spinal device complications sued Boston Scientific and the FDA, claiming unsafe design changes were approved without proper clinical review or warning under federal law.
The U.S. Food and Drug Administration was accused of bypassing safety protocols when it allowed a biomedical engineering firm to alter the design of an implanted spinal device that paralyzed a man, according to a federal lawsuit filed Friday.
The suit was filed in Los Angeles by The Carlson Law Firm partner Ruth T. Rizkalla. She claimed her client was implanted with a defective spinal cord stimulator system manufactured by Boston Scientific Corp., which culminated in a paraplegia ...
For only $95 a month (the price of 2 article purchases)
Receive unlimited article access and full access to our archives,
Daily Appellate Report, award winning columns, and our
Verdicts and Settlements.
Or
$795 for an entire year!
Or access this article for $45
(Purchase provides 7-day access to this article. Printing, posting or downloading is not allowed.)
Already a subscriber?
Sign In