Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pre-emption prevails in California cases

This article was originally published in The Gray Sheet

Executive Summary

California appellate courts rule in favor of FDA pre-emption of state tort liability claims involving PMA-approved devices in two separate cases Jan. 16 and Jan. 11. The case of Blanco v. Baxter, decided in California's fourth district, involved a patient who received a PMA-approved Baxter Edwards-Duromedics model 9120 mitral bileaflet heart valve and later died from a complication. In Jessen v. Mentor, decided in the second district, a plaintiff was implanted with a Mentor testicular prosthesis that had not been filled with saline prior to its implantation. Separately, a U.S. Supreme Court review of a PMA pre-emption case (Riegel v. Medtronic) remains ongoing (1"The Gray Sheet" Jan. 7, 2008, p. 10)

You may also be interested in...

Heart valve suit

A news brief appearing in the Jan. 21, 2008, issue (1back cover) incorrectly stated that a patient death at issue in Blanco v. Baxter - a case decided by a California appeals court in favor of a heart valve device manufacturer that was sued for wrongful death - prompted a Class I recall of the device. In fact, the product recall occurred in 1988 and the patient death in question occurred in 2002

Capitol Hill Roundup: Many Med-Tech Issues Are In Play For 2008

Health care may not have been the most debated issue on Capitol Hill in 2007, but it was close, and issues impacting the medical technology sector were in abundance

US Supply Chain In Brief: White House Aims To Deliver With Block Stowing And Industrial Base Expansion

Biden administration works to expedite medical supplies and expand medical countermeasures production, while US FDA's DSCSA anti-counterfeiting paperwork burden estimate surges.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts