Just before the new year Medtronic’s litigation team brought home yet another preemption win that bears discussion. In Ilarraza v. Medtronic, Inc., slip op. (E.D.N.Y. Dec. 28, 2009), the plaintiff took one look at the law of preemption (but only after filing suit); filed an amended complaint that dropped all his prior claims (the usual stuff); and alleged only a claim encaptioned “negligence per se.” Id. at 3. That, he asserted, was an unpreempted “parallel” claim under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
Not so fast.
This amended complaint was essentially a regulatory “dump.” The plaintiff cited no fewer than eight of the FDA’s Good Manufacturing Practices regulations – it took three pages, slip op. at 8-10, just to quote them. Then he alleged that Medtronic “violated” them – without saying how.
The court sent this plaintiff to the canvass with a one-two punch of Riegel preemption and Twombly/Iqbal pleading. The purported “negligence per se” claim was “different from or in addition to” FDA regulations, and thus preempted, because “each regulation cited is nothing more than a general statement” of good manufacturing practices – an “umbrella quality system.” Slip op. at 10. Because the GMP regulations were designed to be flexible, any tort suit that sought to enforce artificially rigid standards necessarily was both different and addition to the FDA’s regulations. Id. at 10-11 (“[t]he intentionally vague and open-ended nature of the regulations relied upon is the precise reason why they cannot serve as the basis for a parallel claim”).
That makes sense to us – a lot more sense than the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) “specificity” fetish that the Supreme Court decisively held in Riegel did not extend to PMA devices that the FDA in fact evaluated for safety and effectiveness.
The same vagueness precluded a viable claim under Twombly/Iqbal. Plaintiff couldn’t come up with any violative conduct that affected his device or causes his injuries. “[P]laintiff has done nothing more than recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged.” Slip op. at 11.
Basically, all plaintiff had was the fact that one piece of the device broke. Id. at 2. As we demonstrated at some length last week, the syllogism “it broke, therefore it had to be defective” has never been accepted as a basis for liability, and the further reach that “it broke, therefore it had to violate FDA regulations” even less so. The court joined the list cases we mentioned in that post, and also joined the “majority” of courts that eschew the questionable post-Riegel/post-Iqbal reasoning in Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009). Slip op. at 12.
That’s the old one-two.
The court also rejected the claim that its approach made it “impossible” to bring a parallel violation claim, citing Purcell v. Advanced Bionics, 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008) (see our device preemption scorecard) as an example of a properly asserted violation claim. Slip op. at 12-13. We agree. There’s a right way and a wrong way to approach this type of claim, and during decades of “anything goes” pleadings, lawyers got lazy. Ilarraza was a broken device case. Presumably plaintiff has (or could get) the explanted device (nothing in the opinion suggests otherwise). Having the device, plaintiff could hire an expert and test it. The results of the test could then be matched against the FDA-approved specifications, either publicly available or available through a FOIA request. If there’s a discrepancy, then you’ve got a lawsuit. Plaintiffs don’t like that, of course, because they have to spend money up front, but that’s what it takes to have a “plausible” factual basis for a violation claim. A broken device alone does not a lawsuit make. Paraphrasing President Clinton, “the era of big fishing expeditions is over.”
A couple of other things about Ilarraza. Although the plaintiff was neatly floored on the combined strength of preemption and implausible pleading, there are a couple of fatal state-law based flaws that go unmentioned in the opinion. These have to do with New York law of negligence per se. For one thing, New York does not permit negligence per se to be predicated upon the violation of administrative regulations, as opposed to statutes.
[O]nly an enactment of the Legislature can alter the State common law of negligence. . . . [C]haracterizing the vast multitude of ordinances that have been adopted. . .as State statutes would result in considerable fragmentation and uncertainty in the application of the common law of our State. . . . [W]e decline to transform the status of this provision from that of a local enactment to a State statute. In the absence of a violation of a statutorily imposed duty in this case, a negligence per se finding was unwarranted.
Elliott v. City of New York, 747 N.E.2d 760, 763-64 (N.Y. 2001). That’s just one of a number of similar New York decisions (see Bexis’ book for the more). Thus, plaintiff’s attempt to base a negligence per se claim on administrative regulations failed to state a claim for independent state-law reasons.
And one more thing. Elliott also mentioned another aspect of New York negligence per se law – “a violation of a. . .provision that did not impose a specific duty did not constitute negligence per se.” 747 N.E.2d at 763 (characterizing the holding of Juarez v. Wavecrest Management Team, 672 N.E.2d 135 (N.Y. 1996)). Thus the vagueness of the FDA’s GMP regulations, which Ilarraza cited as a basis for both preemption and failure to plead, had a third, purely state law aspect – negligence per se under New York law does not lie for violation of an enactment that fails to impose a definite standard that justifies its substitution for the ordinary common law.
It’s always useful to have a state-law arrow in your quiver (for one thing, it prevents appeals to the U.S. Supreme Court). For more on these – and other – purely state-law defenses to FDCA-based negligence per se claims, see our prior post, here.