A Device That Uses Magnetic Levitation Sounds Pretty Innovative to Us

Litigation attorney Eric Alexander published a blog for Drug & Device Law analyzing Galdamez v. Abbott Cardiovascular Sys., Inc., a California state court decision involving product liability claims against the sponsor and manufacturer of a left ventricular assist device used in a clinical trial. The case followed the death of a clinical trial participant who had lived for three years with the device, which was provided through an Investigational Device Exemption (IDE) study and later received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). In his post, Mr. Alexander explains why the court found most of the plaintiffs' claims, including design defect, warning, recall and implied warranty theories, were preempted under established federal law governing PMA and IDE devices. He also discusses the plaintiffs' unsuccessful efforts to recast those theories as parallel claims or other state law causes of action, the court's rejection of attempts to hold the manufacturer responsible for alleged shortcomings in the medical institution's emergency response and the ruling's broader relevance for emerging "duty to innovate" arguments, which he suggests would likely face the same preemption barriers.

READ: A Device That Uses Magnetic Levitation Sounds Pretty Innovative to Us