New York’s state court, in the US, has ruled in favour of the UK medical-device manufacturer Corin by dismissing the lawsuit brought by plaintiff Robert Litwin.
The lawsuit claimed that the Cormet device was defective and required replacement surgery.
The state court said it is pre-empting the lawsuit in consideration with the US Food and Drug Administration’s (FDA) review and approval of the Cormet device and its warnings as per the Medical Device Amendments Act.
The FDA granted an approval to Corin’s Cormet device in 2007, upon a rigorous pre-market review and said that the device was safe and effective for intended use.
The warnings and labels used with the device were also reviewed and approved by the FDA.
Class III medical devices, such as the Cormet, are required to undergo the testing and approval before being sold, according to the FDA.
An artificial hip resurfacing Cormet device is used to reduce or relieve pain and / or improve hip function in skeletally mature patients with non-inflammatory degenerative arthritis or inflammatory arthritis.
The same ruling was given by the Supreme Court for the Riegel v. Medtronic case in 2008 that applied to similar medical devices.
Image: New York County Supreme Courthouse in US, Photo courtesy of: wallyg.