Medtronic wins another PMA-preemption-based dismissal.   The cite:  Walker v. Medtronic, Inc., C.A. No.

2:07-00317, slip op. (S.D.W. Va. Nov. 24, 2010).  The reasoning:  It’s a PMA device (an infusion pump), so there’s preemption.  There was some discovery on FDA compliance.
The opinion is a nice citator.  It’s got footnotes that, while we haven’t compared every citation (not even we are that anal), appear to contain a comprehensive collection of PMA preemption cases throwing out strict liability, negligence, and warranty claims.  Slip op. at 10-11, footnotes 2-4.  That can save a lot of research.
The most interesting part was plaintiff claim that the pump failed to meet an FDA “performance standard” that the dosage actually dispensed would be with in 15%, plus or minus, the programmed dosage.  The pump (allegedly anyway) produced a substantial overdose, which in typical plaintiff fashion, was argued as ipso facto proof of a causal FDCA violation.  Slip op. at 12.
Not so fast, the court held.  There were lots of other reasons, stated in the device’s warnings that could account for an overdose.  Id.  A performance deviation does not equate to evidence of non-compliance sufficient to oust preemption:
An alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations.  To hold otherwise would make a manufacturer an insurer of its product.  Indeed, premarket approval does not guarantee that a device is completely safe.
Slip op. at 12-13 (citations omitted).  That’s the good stuff.  With that argument out of the way, the actual preemption rulings – as to negligence, strict liability, and warranty, id. at 15-17, were anticlimactic.

One other thing – The plaintiff also tried to wave around some FDA warning letters, but the court readily saw through that, as the letters had nothing to do with pump at issue in the case.  Slip op. at 3-4 n.1.  We see that a lot on motions to dismiss, but this case was decided on summary judgment.  That plaintiffs, even after discovery, made the same lousy arguments based on irrelevant warning letters says to us that allowing discovery on that issue serves no purpose.  The warning letters are all on the FDA’s website and their applicability to a plaintiff’s specific device is a yes/no question.  If the plaintiffs are just going to make the same arguments, with or without discovery, let’s call it “judicial notice” and get it over with on a motion to dismiss.

Congrats to Dave Gossett over at Mayer Brown for this win, and thanks for passing it along.