A tip of the cypercap to Dave Gossett at Mayer Brown, who has just forwarded to us the latest Medtronic preemption win.  It’s Cenac v. Hubble, C.A. No. No. 09-3686, slip op. (E.D. La. Oct. 21, 2010).  After letting the plaintiffs amend their complaint to add “parallel” claims, the court in Cenac grants the motion to dismiss in its entirety.  This was not one of those cases where the plaintiff didn’t try very hard, either.  The plaintiff put considerable time and effort into the amendment.
To no ultimate avail.
The plaintiff’s basic claim was that Medtronic’s pump (this is not a shoulder pain pump case) administered a lethal dose of some sort of medication, allegedly due to some sort of “missing propellant.”
The parallel claims failed for substantive reasons, not just because of TwIqbal.
(1) The plaintiff alleged violations of several sections of the FDA’s Good Manufacturing Practices (“GMPs”) and the reg that required the manufacturer to follow its PMA.  These, however, were all found too generic to support a parallel violation claim.  They essentially told the manufacturer what it had to do, but left it to the manufacturer’s discretion how to do it.  The plaintiff’s allegations claimed that the defendant should have done those things in a different way.  That was a preempted no-no, since by going beyond what the regulations required and demanding specific methods, the plaintiff was asserting “different” and “additional” claims.  Slip op. at 7-9.
(2) The plaintiff alleged violations of reporting requirements.  Sorry, but this sort of post-PMA allegation of fraud on the FDA is preempted.  Slip op. at 9.
(3)  The plaintiff alleged “that [defendant] failed to provide and update information with respect to the device after FDA approved the device.”  Sorry, but warning claims, pre or post, are preempted.  Slip op. at 9-10.
(4) Express and implied warranty claims are preempted.  Slip op. at 10.
(5) The Louisiana statutory (LPLA) claims are all preempted.  Slip op. at 10-12.
Finally, we’d like to point out the footnote, slip op. at 3 n.6, taking judicial notice of FDA approval documents.  Dave Gossett, who sent us the Cenac case, also figured out how to create permanent links to the FDA’s website documents that establish the regulatory history of medical devices.  That’s an issue because the most straightforward way of finding such documents produces links that go away in a couple of weeks max – not a good thing when litigating motions takes longer than that.  If you need to know how to get online FDA documents before the court (with links that don’t disappear), go to this post and read the last part of it.