Heart valve suit
This article was originally published in The Gray Sheet
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
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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)
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