We’re quite happy when readers pass stuff along to us for the edification of our readership. This latest CARE Package comes courtesy of Jeff Holmstand of Flaherty Sensabaugh – from a town known as Wheeling West Virginia. First, he passes along a new medical device preemption decision, Bishoff v. Medtronic, Inc., C.A. No. 1:09CV171, slip op. (N.D.W. Va. Nov. 22, 2010). Bishoff is best on TwIqbal and negligence per se, holding:
An allegation that a medical device manufacturer failed to comply with FDA regulations, without more, does not satisfy the pleading requirements of Rule 8(a). . . . In this case, [plaintiff] alleges without any factual support that [defendant] failed to comply with the PMA process and failed to assemble [plaintiff’s] device in the manner required by the FDA’s regulations. Without specific factual support in her complaint identifying how or why [defendant] failed to comply with the PMA process, however, [plaintiff’s] allegations of negligence per se and manufacturing defect fail to state a plausible claim under Rule 8(a).
The second goodie in the basket is an article, Jeff (and another attorney, Anthony Sammons of Dinsmore & Shohl (we like seeing counsel at different firms collaborate) wrote about TwIqbal for the DRI. Here’s a copy of that for the good of the order (not the Order of the Phoenix, and not the “greater good”). We particularly enjoyed the part (pp. 70-71) that relies on our one of our posts about the Nuvaring farce concerning MDL master complaints. They even call us “popular.” Geez, we feel like Galinda.